Hazardous Waste Management System; Identification and Listing of Hazardous Waste; Dyes and/or Pigments Production Wastes; Land Disposal Restrictions for Newly Identified Wastes; CERCLA Hazardous Substance Designation and Reportable Quantities; Designation of Five Chemicals as Appendix VIII Constituents; Addition of Four Chemicals to the Treatment Standards of F039 and the Universal Treatment Standards

[Federal Register: February 24, 2005 (Volume 70, Number 36)]
[Rules and Regulations]
[Page 9137-9180]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe05-13]
[[Page 9138]]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 148, 261, 268, 271, and 302
[RCRA-2003-0001; FRL-7875-8]
RIN 2050-AD80

Hazardous Waste Management System; Identification and Listing of
Hazardous Waste; Dyes and/or Pigments Production Wastes; Land Disposal
Restrictions for Newly Identified Wastes; CERCLA Hazardous Substance
Designation and Reportable Quantities; Designation of Five Chemicals as
Appendix VIII Constituents; Addition of Four Chemicals to the Treatment
Standards of F039 and the Universal Treatment Standards

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is today listing as
hazardous nonwastewaters generated from the production of certain dyes,
pigments, and FD&C colorants. EPA is promulgating this regulation under
the Resource Conservation and Recovery Act (RCRA), which directs EPA to
determine whether these wastes pose a substantial present or potential
hazard to human health or the environment when they are improperly
treated, stored, transported, disposed of or otherwise managed. This
listing sets annual mass loadings for constituents of concern, such
that wastes would not be hazardous if the constituents are below the
regulatory thresholds. If the wastes meet or exceed the regulatory
levels for any constituents of concern, the wastes must be managed as
listed hazardous wastes, unless the wastes are either disposed in a
landfill unit that meets certain liner design criteria, or treated in a
combustion unit as specified in the listing description. This rule also
adds five toxic constituents to the list of hazardous constituents that
serves as the basis for classifying wastes as hazardous. In addition,
this rule establishes Land Disposal Restrictions (LDR) treatment
standards for the wastes, and designates these wastes as hazardous
substances subject to the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA). This rule does not adjust the
one pound statutory reportable quantity (RQ) for the waste.

DATES: This final rule is effective on August 23, 2005.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. RCRA-2003-0001. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information may not be publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET or in hard
copy at the RCRA Docket, EPA/DC, EPA West, Room B102, 1301 Constitution
Ave., NW, Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the RCRA Docket is (202) 566-0270. This Docket
Facility is open from 8:30 a.m.-4:30 p.m., Monday through Friday,
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: For general information, review our
website at http://www.epa.gov/epaoswer/hazwaste/id/dyes/index.htm.
For information on specific aspects of the rule, contact Robert Kayser,
Hazardous Waste Identification Division, Office of Solid Waste (5304W),
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number: (703) 308-7304; fax number:
(703) 308-0514; e-mail address: kayser.robert@epa.gov. For technical
information on the CERCLA aspects of this rule, contact Ms. Lynn
Beasley, Office of Emergency Prevention, Preparedness, and Response,
Emergency Response Center (5204G), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone
number: (703) 603-9086; e-mail address: beasley.lynn@epa.gov.

SUPPLEMENTARY INFORMATION:

Readable Regulations

Today's preamble and regulations are written in ``readable
regulations'' format. The authors tried to use active rather than
passive voice, plain language, a question-and-answer format, the
pronouns ``we'' for EPA and ``you'' for the owner/generator, and other
techniques to make the information in today's rule easier to read and
understand. This format is part of our efforts toward regulatory
improvement. We believe this format helps readers understand the
regulations, which should then increase compliance, make enforcement
easier, and foster better relationships between EPA and the regulated
community.

Acronyms Used in the Rule
------------------------------------------------------------------------
Acronym Definition
------------------------------------------------------------------------
BDAT............................. Best Demonstrated Available
Technology.
BIODG............................ Biodegradation.
CAA.............................. Clean Air Act.
CARBN............................ Carbon absorption.
CAS.............................. Chemical Abstract Services.
CBI.............................. Confidential Business Information.
CCL.............................. Compacted clay liner.
CERCLA........................... Comprehensive Environmental Response
Compensation and Liability Act.
CFR.............................. Code of Federal Regulations.
CHOXD............................ Chemical or electrolytic oxidation.
CMBST............................ Combustion.
CoC.............................. Constituent of concern.
CI............................... Colour Index.
CPMA............................. Color Pigments Manufacturers
Association.
CWA.............................. Clean Water Act.
CWTP............................. Centralized wastewater treatment
plant.
ED............................... Environmental Defense (previously the
Environmental Defense Fund or EDF).
E.O.............................. Executive Order.
EP............................... Extraction Procedure.

[[Page 9139]]

EPA.............................. Environmental Protection Agency.
EPACMTP.......................... EPA's Composite Model for Leachate
Migration with Transformation
Products.
EPCRA............................ Emergency Planning and Community
Right-To-Know Act.
ETAD............................. Ecological and Toxicological
Association of Dyes and Organic
Pigments Manufacturers.
EU............................... European Union.
fb............................... Followed by.
FDA.............................. Food and Drug Administration.
FD&C............................. Food, Drug and Cosmetic.
FR............................... Federal Register.
GCL.............................. Geosynthetic clay liner.
GC/MS............................ Gas Chromatography/Mass Spectroscopy.
GM............................... Geomembrane.
GSCM............................. General Soil Column Model.
HELP............................. Hydrologic Evaluation of Landfill
Performance.
HGDB............................. Hydrogeologic Database.
HPLC............................. High Performance Liquid
Chromatography.
HQ............................... Hazard Quotient.
HSWA............................. Hazardous and Solid Waste Amendments.
ICR.............................. Information Collection Request.
kg/yr............................ Kilogram/year.
LDR.............................. Land Disposal Restriction.
mg/kg............................ Milligram per kilogram.
mg/L............................. Milligram per liter.
MSW.............................. Municipal Solid Waste.
MT............................... Metric ton.
NAICS............................ North American Industrial
Classification System.
OMB.............................. Office of Management and Budget.
OSW.............................. Office of Solid Waste.
OSWER............................ Office of Solid Waste and Emergency
Response.
POTW............................. Publicly owned treatment works.
ppm.............................. Parts per million.
PRA.............................. Paperwork Reduction Act.
QA............................... Quality Assurance.
QC............................... Quality Control.
RCRA............................. Resource Conservation and Recovery
Act.
RFA.............................. Regulatory Flexibility Act.
RFSA............................. Regulatory Flexibility Screening
Analysis.
RQ............................... Reportable Quantity.
SAB.............................. Science Advisory Board.
SBA.............................. Small Business Administration.
SBREFA........................... Small Business Regulatory Enforcement
Fairness Act.
SIC.............................. Standard Industry Code.
SW-846........................... Test Methods for Evaluating Solid
Wastes.
TRI.............................. Toxic Release Inventory.
UCLM............................. Upper confidence limit of the mean.
UMRA............................. Unfunded Mandates Reform Act.
U.S.C............................ United States Code.
UTS.............................. Universal Treatment Standard.
WETOX............................ Wet air oxidation.
------------------------------------------------------------------------

Contents of This Final Rule

I. Overview
A. Who Will Be Affected by This Final Rule?
B. What Are the Statutory Authorities for This Final Rule?
C. How Does the ED v. Johnson Consent Decree Impact This Final Rule?
II. Summary of Today's Action
III. Summary of Proposed Rule
A. What Wastes Did EPA Propose To List as Hazardous?
B. How Was This Proposal Different From Prior Hazardous Waste
Listing Determinations?
C. Which Constituents Did EPA Propose To Add to Appendix VIII of
40 CFR Part 261?
D. What Was the Proposed Status of Landfill Leachate From
Previously Disposed Wastes?
E. What Were the Proposed Treatment Standards Under RCRA's Land
Disposal Restrictions Standards?
F. What Risk Assessment Approach Was Used for the Proposed Rule?
IV. What Is the Rationale for Today's Final Rule?
A. Final Listing Determination
1. Toluene-2,4-diamine
2. Use of Clay-Lined and Composite-Lined Landfills
3. Status of Wastes That Are Combusted
4. Scope of Listing Definition
5. Waste Quantities
6. Prevalence of Constituents of Concern
7. Availability of Analytical Methods for Constituents of Concern
8. Risk Assessment
9. Implementation
10.Exemption for Non-Municipal Landfills
B. Final ``No List'' Determination for Wastewaters
C. What Is the Status of Landfill Leachate Derived From Newly-
Listed K181 Wastes?
D. What Are the Final Treatment Standards Under RCRA's Land
Disposal Restrictions for the Newly-Listed Hazardous Wastes?
1. What Are EPA's Land Disposal Restrictions (LDRs)?
2. How Does EPA Develop LDR Treatment Standards?
3. What Are the Treatment Standards for K181?
E. Is There Treatment Capacity for the Newly Listed Wastes?

[[Page 9140]]

1. Introduction
2. What Are the Capacity Analysis Results for K181?
V. When Must Regulated Entities Comply With the Provisions in
Today's Final Rule?
A. Effective Date
B. Section 3010 Notification
C. Generators and Transporters
D. Facilities Subject to Permitting
1. Facilities Newly Subject to RCRA Permit Requirements
2. Existing Interim Status Facilities
3. Permitted Facilities
4. Units
5. Closure
VI. State Authority and Compliance
A. How Are States Authorized Under RCRA?
B. How Does This Rule Affect State Authorization?
VII. CERCLA Designation and Reportable Quantities
A. How Does EPA Determine Reportable Quantities?
B. What Is the RQ for the K181 Waste?
C. When Would I Need To Report a Release of These Wastes Under CERCLA?
D. How Would I Report a Release?
VIII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
1. Summary of Proposed Rule Findings: Costs, Economic Impacts, Benefits
2. Public Comments and Agency Responses
3. Revised Findings
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
H. Executive Order 12898: Environmental Justice
I. Executive Order 13211: Actions Affecting Energy Supply,
Distribution, or Use
J. National Technology Transfer and Advancement Act
K. The Congressional Review Act (5 U.S.C. 801 et seq., as Added
by the Small Business Regulatory Enforcement Fairness Act of 1996)

I. Overview

A. Who Will Be Affected by This Final Rule?

Today's final action will affect those who handle the wastes that
we are adding to EPA's list of hazardous wastes under the RCRA program.
This regulation could directly impact businesses that generate and
manage certain organic dyes and/or pigment production wastes. In
addition, manufacturers that do not make dyes or pigments, but that
generate wastes containing selected constituents of concern, may be
indirectly impacted. This is because we are adding new treatment
standards for four chemicals, and we are adding five new constituents
to the list of hazardous constituents on Appendix VIII of part 261.
Thus, these actions may result in indirect impacts on these
manufacturers. In addition, landfill owners/operators who previously
accepted these wastes may be indirectly impacted. This action may also
affect entities that need to respond to releases of these wastes as
CERCLA hazardous substances. Impacts on potentially affected entities,
direct and indirect, are summarized in section VIII of this Preamble.
The document, ``Economic Assessment for the Proposed Loadings-Based
Listing of Non-Wastewaters from the Production of Selected Organic
Dyes, Pigments, and Food, Drug, and Cosmetic Colorants,'' November 2003
(hereafter known as the Economic Assessment Document) presents a
comprehensive analysis of potentially impacted entities. Further
updated analysis is also presented in the ``Revised Impacts
Assessment.'' \1\ These documents are available in the docket for
today's rule. A summary of potentially affected businesses is provided
in the table below.
---------------------------------------------------------------------------

\1\ Memorandum from Lyn D. Luben to the RCRA Docket, July 21, 2004.

Table 1.--Summary of Facilities Potentially Affected by the U.S. EPA's 2005 Dyes and/or Pigments Manufacturing
Waste Listing Final Rule
----------------------------------------------------------------------------------------------------------------
Estimated number of
SIC code NAICS code Industry sector name relevant facilities*
----------------------------------------------------------------------------------------------------------------
Directly Impacted:
2865........................... 325132-1.............. Synthetic Organic Dyes..... 31.
325132-4.............. Synthetic Organic Pigments,
Lakes, and Toners.
Indirectly Impacted:
2800 (except 2865)............. 325 (except 325132)... Chemical Manufacturing..... Less than 50
facilities total.**
4953........................... 562212................ Solid Waste Landfills and
Disposal Sites,
Nonhazardous.
5169........................... 42269................. Other Chemicals and Allied
Products (wholesale) .
----------------------------------------------------------------------------------------------------------------
SIC--Standard Industrial Classification.
NAICS--North American Industry Classification System.
*Note: The figures in this column represent individual facilities, not companies. A total of 22 companies are
expected to be impacted under this NAICS.
**Estimate based on 13 expanded scope facilities plus no more than 37 separate solid waste landfills (562212)
potentially receiving wastes of concern.

The list of potentially affected entities in the above table may
not be exhaustive. Our aim is to provide a guide for readers regarding
entities likely to be regulated by this action. This table lists those
entities that we are aware of that potentially could be affected by
this action. However, this action may affect other entities not listed
in the table. To determine whether your facility is regulated by this
action, you should examine 40 CFR parts 260 and 261 carefully in
concert with the final rules amending these regulations that are found
at the end of this Federal Register document. If you have questions
regarding the applicability of this action to a particular entity,
consult the person listed in the preceding section entitled FOR FURTHER
INFORMATION CONTACT.

B. What Are the Statutory Authorities for This Final Rule?

Today's hazardous waste regulations are promulgated under the
authority of Sections 2002(a), 3001(b), 3001(e)(2), 3004(d)-(m) and
3007(a) of the Solid Waste Disposal Act, 42 U.S.C. 6912(a), 6921(b) and
(e)(2), 6924(d)-(m) and 6927(a), as amended several times, most
importantly by the Hazardous and Solid

[[Page 9141]]

Waste Amendments of 1984 (HSWA). These statutes commonly are referred
to as the Resource Conservation and Recovery Act (RCRA), are codified
at Volume 42 of the United States Code (U.S.C.), Sections 6901 to
6992(k) (42 U.S.C. 6901-6992(k)).
Section 102(a) of the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980 (CERCLA), 42 U.S.C. 9602(a) is
the authority under which the CERCLA aspects of this rule are promulgated.

C. How Does the ED v. Johnson Consent Decree Impact This Final Rule?

HSWA established deadlines for completion of a number of listing
determinations, including for dyes and pigment production wastes (see
RCRA section 3001(e)(2)). Due to competing demands for Agency resources
and shifting priorities, these deadlines were not met. As a result, in
1989, the Environmental Defense Fund (EDF, currently Environmental
Defense or ED) filed a lawsuit to enforce the statutory deadlines for
listing decisions in RCRA section 3001(e)(2). (Environmental Defense v.
Johnson, D.D.C. Civ. No. 89-0598, subsequently referred to in this
notice as the ED consent decree.) To resolve most of the issues in the
case, in 1991 ED and EPA entered into a consent decree which has been
amended several times to revise the deadlines for EPA action. Paragraph
1.h.(i) (as amended in December 2002) of the consent decree addresses
the organic dyes and pigment production industries:

EPA shall promulgate final listing determinations for azo/
benzidine, anthraquinone, and triarylmethane dye and pigment
production wastes on or before February 16, 2005* * * These listing
determinations shall be proposed for public comment on or before
November 10, 2003.

Furthermore, paragraph 6.e. (as amended) stipulates that:

On or before November 10, 2003, EPA's Administrator shall sign a
notice of proposed rulemaking proposing land disposal restrictions
for dye and pigment wastes proposed for listing under paragraph
1.h.(i). EPA shall promulgate a final rule establishing land
disposal restrictions for dye and pigment wastes listed under
paragraph 1.h.(i) on the same date that it promulgates a final
listing determination for such wastes.

Today's final rule satisfies EPA's duty under paragraphs 1.h and
6.e of the ED consent decree to finalize listing determinations and
land disposal restrictions for the specified organic dyes and/or
pigment production wastes.

II. Summary of Today's Action

In today's notice, EPA is promulgating regulations that add one
waste generated by the dyes and/or pigments manufacturing industries to
the list of hazardous waste in 40 CFR 261.32:

K181--Nonwastewaters from the production of dyes and/or pigments
(including nonwastewaters commingled at the point of generation with
nonwastewaters from other processes) that, at the point of
generation, contain mass loadings of any of the constituents
identified in paragraph (c) of this section that are equal to or
greater than the corresponding paragraph (c) levels, as determined
on a calendar year basis. These wastes will not be hazardous if the
nonwastewaters are: (i) Disposed in a subtitle D landfill unit
subject to the design criteria in Sec. 258.40, (ii) disposed in a
subtitle C landfill unit subject to either Sec. 264.301 or Sec.
265.301, (iii) disposed in other subtitle D landfill units that meet
the design criteria in Sec. 258.40, Sec. 264.301, or Sec.
265.301, or (iv) treated in a combustion unit that is permitted
under subtitle C, or an onsite combustion unit that is permitted
under the Clean Air Act. For the purposes of this listing, dyes and/
or pigments production is defined in paragraph (b)(1) of this
section. Paragraph (d) of this section describes the process for
demonstrating that a facility's nonwastewaters are not K181. This
listing does not apply to wastes that are otherwise identified as
hazardous under Sec. Sec. 261.21-261.24 and 261.31-261.33 at the
point of generation. Also, the listing does not apply to wastes
generated before any annual mass loading limit is met.

This listing provides a flexible approach that focuses the regulation
on wastes that present a risk to human health and the environment. All
quantities of wastes generated during a calendar year up to the mass
loading limits are not listed hazardous waste. Only wastes subsequently
generated that meet or exceed the annual limits would potentially
become hazardous waste. However, the listing includes a conditional
exemption for wastes that are disposed of in a subtitle D or subtitle C
landfill unit that meet the design standards specified in the listing
description and for wastes treated in certain combustion units with the
specified permits. Therefore, wastes that are below the mass loading
limits, or wastes that meet the conditional exemption as described in
the regulation, are excluded from the listing from their point of
generation, and would not be subject to any RCRA subtitle C management
requirements for generation, storage, transport, treatment, or disposal
(including the land disposal restrictions).
EPA is listing this waste as hazardous based on the criteria set
out in 40 CFR 261.11. As described in the November 25, 2003 proposed
rule (68 FR 66164), we assessed and considered these criteria to
determine whether nonwastewaters and wastewaters from the manufacture
of dyes and/or pigments warranted listing. We evaluated the risks
potentially posed by these residuals using quantitative risk assessment
techniques.
After assessing public comments submitted in response to our
proposal, we are finalizing the K181 hazardous waste listing, with
several modifications. The final rule continues to establish mass-
loading limits for seven of the eight proposed constituents of concern
(CoCs), and continues to allow for the contingent exemption of wastes
that meet or exceed these limits but that are managed in landfill units
that are subject to the design criteria of either Sec. 258.40, Sec.
264.301, or Sec. 265.301. We revised the exemption to also include
wastes that are disposed in other non-municipal landfills (industrial
landfills) that meet the liner design requirements in Sec. 258.40,
Sec. 264.301 or Sec. 265.301. We also added an exemption for wastes
that are treated in combustion units that are either permitted under
subtitle C, or that are onsite units permitted under the Clean Air Act
(CAA). We are not, however, finalizing the proposed mass-loading levels
for toluene-2,4-diamine; neither are we adding this constituent to
Appendix VII of part 261 or to part 268.20 or 268.40 of the Land
Disposal Restriction (LDR) standards.
Upon the effective date of today's final rule, wastes meeting the
K181 listing description will become hazardous wastes and must be
managed in accordance with RCRA subtitle C requirements, unless the
wastes are to be managed in a manner that complies with the contingent
management exemptions contained in the listing description. Residuals
from the treatment, storage, or disposal of this newly listed hazardous
waste also will be classified as hazardous waste pursuant to the
``derived-from'' rule (40 CFR 261.3(c)(2)(i)). Also, any mixture of a
listed hazardous waste and a solid waste is itself a RCRA hazardous
waste (40 CFR 261.3(a)(2)(iii) and (iv), ``the mixture rule''). We are
not promulgating any exemption for treatment residuals from the
derived-from rule for the reasons set out in the proposed rule (68 FR
66199). The mass-based approach already builds in an exemption for
wastes that are generated with constituent masses below the loading
limit, are disposed of in landfills with liner design requirements, or
are treated in certain combustion units. Once a waste meets the
classification for K181, any treatment residuals remain hazardous
wastes, unless delisted under Sec. 260.22.

[[Page 9142]]

Today's rule also takes final action on our proposed decision not
to list as hazardous, as discussed in the proposal, wastewaters from
the production of dyes and/or pigments.
Descriptions of wastes from the production of dyes and/or pigments
can be found in the document entitled ``Background Document for
Identification and Listing of Wastes from the Production of Organic
Dyes and Pigments,'' November 2003 (hereafter referred to as the
Listing Background Document), available in the docket for the
rulemaking. Responses to public comments submitted on the November 25,
2003 proposal can be found in the ``Response to Comments Background
Document--Hazardous Waste Listing Determination for Dyes and/or
Pigments Manufacturing Wastes (Final Rule),'' dated February 2005
(hereafter referred to as the ``Response to Comments Background
Document''), also available in the docket. In addition, a number of
commenters incorporated comments submitted in prior rulemakings into
their 2003 public comments. Our responses to these ``incorporated''
comments are also available in the docket for today's final rule in a
document entitled, ``Background Document--Responses to Incorporated
Historical Comments on Prior Rulemakings,'' dated February 2005.
We are also promulgating other changes to the RCRA regulations as a
result of this final listing determination. These changes include
adding constituents to Appendices VII and VIII of part 261, and setting
land disposal restrictions for the newly listed waste. We are adding
the following seven constituents to Appendix VII of 40 part CFR 261 due
to the fact that these constituents serve as the basis for the new
listing: Aniline, o-anisidine, 4-chloroaniline, p-cresidine, 2,4-
dimethylaniline, 1,2-phenylenediamine, and 1,3-phenylenediamine. We are
adding the following five constituents to Appendix VIII of 40 CFR part
261 as ``hazardous constituents'' because scientific studies show the
chemicals have toxic, carcinogenic, mutagenic, or teratogenic effects
on humans or other life forms (see Sec. 261.11(a)(3)): o-anisidine, p-
cresidine, 2,4-dimethylaniline, 1,2-phenylenediamine, and 1,3-
phenylenediamine.\2\ Section IV.D of today's rule describes the changes
to the land disposal restrictions establishing treatment standards for
the specific constituents in the newly-listed waste.
---------------------------------------------------------------------------

\2\ For toxicity information, see section 7 of the ``Risk
Assessment Technical Background Document for the Dye and Pigment
Industries Listing Determination,'' November 2003 in the docket.
---------------------------------------------------------------------------

Also, as a result of this final rule, this listed waste becomes a
hazardous substance under CERCLA. Therefore, in today's rule we are
designating these wastes as CERCLA hazardous substances. These changes
are described in section VII of today's final rule.

III. Summary of Proposed Rule

A. What Wastes Did EPA Propose To List as Hazardous?

In the November 25, 2003 proposed rule (68 FR 66164), EPA proposed
to list one waste generated by the dyes and/or pigments manufacturing
industry as hazardous waste under RCRA:

K181: Nonwastewaters from the production of dyes and/or pigments
(including nonwastewaters commingled at the point of generation with
nonwastewaters from other processes) that, at the point of
generation, contain mass loadings of any of the constituents
identified in paragraph (c)(1) of this section that are equal to or
greater than the corresponding paragraph (c)(1) levels, as
determined on a calendar year basis. These wastes would not be
hazardous if: (i) The nonwastewaters do not contain annual mass
loadings of the constituent identified in paragraph (c)(2) of this
section at or above the corresponding paragraph (c)(2) level; and
(ii) the nonwastewaters are disposed in a Subtitle D landfill cell
subject to the design criteria in Sec. 258.40 or in a Subtitle C
landfill cell subject to either Sec. 264.301 or Sec. 265.301. For
the purposes of this listing, dyes and/or pigments production is
defined in paragraph (b)(1) of this section. Paragraph (d) of this
section describes the process for demonstrating that a facility's
nonwastewaters are not K181. This listing does not apply to wastes
that are otherwise identified as hazardous under Sec. Sec. 261.21-
24 and 261.31-33 at the point of generation. Also, the listing does
not apply to wastes generated before any annual mass loading limit is met.

A summary of the proposed listing determination is presented below.
More detailed discussions are provided in the preamble to the proposed
rule and in the Background Documents included in the docket for the
proposed rule.
In connection with the proposed K181 listing, EPA proposed to amend
Appendix VIII of 40 CFR part 261 to add o-anisidine, p-cresidine, 2,4-
dimethylaniline, 1,2-phenylenediamine, and 1,3-phenylenediamine to the
list of hazardous constituents.
We proposed to establish treatment standards for K181. We also
proposed to add the following constituents to the Universal Treatment
Standards (UTS) Table in 268.24 and to the F039 treatment standards
applicable to hazardous waste landfill leachate: o-anisidine, p-
cresidine, 2,4-dimethylaniline, toluene-2,4-diamine, and 1,3-
phenylenediamine. The effect of adding these constituents to the UTS
Table (in addition to the requirements for treatment of these
constituents in K181 wastes) would be to require all characteristic
hazardous wastes that contain any of these constituents as underlying
hazardous constituents above their respective UTS levels to be treated
for those constituents prior to land disposal.
We also proposed to add K181 to the list of CERCLA hazardous substances.

B. How Was This Proposal Different From Prior Hazardous Waste Listing
Determinations?

In previous hazardous waste listings promulgated by EPA, we
typically describe the scope of the listing in terms of the waste
material and the industry or process generating the waste. However, we
proposed to use a newly developed ``mass loadings-based'' approach for
listing dyes and/or pigment production wastes. In a mass loadings-based
listing, a waste would be hazardous once a determination is made that
it contains any of the constituents of concern (CoC) at or above the
specified mass-based levels of concern.
In the proposed rule, we identified CoCs likely to be present in
nonwastewaters which may pose a risk above specified mass loading
levels. Using risk assessment tools developed to support our hazardous
waste identification program, we assessed the potential risks
associated with the CoCs in plausible waste management scenarios. From
this analysis, we developed ``listing loading limits'' for each of the
CoCs.
We proposed that if you generate any dyes and/or pigment production
nonwastewaters addressed by the proposed rule, you would be required
either to determine whether or not your waste is hazardous or assume
that it is hazardous as generated under the proposed K181 listing.
(Note, we proposed that if wastes are otherwise hazardous due to an
existing listing in Sec. Sec. 261.31-261.33 or the hazardous waste
characteristics in Sec. Sec. 261.21-261.24, the listing under K181
would not apply.) We proposed a three-step determination process. The
first step was a categorical determination where you would determine
whether your waste falls within the categories of wastes covered by the
listing (e.g., nonwastewaters generated from the production of dyes
and/or pigments that fall within the product classes of azo,
triarylmethane, perylene or anthraquinone) and whether any of the
regulated constituents could be in your waste. We proposed that if you

[[Page 9143]]

determine under this first step that your waste meets the categorical
description of K181 and that your waste may contain any K181
constituent, you would then in the second step determine whether your
waste meets the numerical standards for K181 (e.g., compare the mass
loadings of the regulated constituents in your waste to the numerical
standards). Your waste would be a listed hazardous waste if it contains
any of the CoCs at a mass loading equal to or greater than the annual
hazardous mass limit identified for that constituent (unless the waste
is eligible for a conditional exemption under step three). Under the
proposed approach, all waste handlers could manage as nonhazardous all
wastes generated up to the mass loading limit, even if the waste
subsequently exceeds one or more annual mass loading limits. Finally,
in the third step, we proposed that you would be able to determine
whether your waste is eligible for a conditional exemption from the
K181 listing. We proposed that you would need to demonstrate that your
waste does not exceed a higher mass loading limit for one constituent
and that it is being disposed of in a landfill subject to design
standards set out in Sec. 258.40, Sec. 264.301, or Sec. 265.301.
The 2003 proposal (and today's final rule) differs markedly from
two prior proposed listing determinations for the dyes and/or pigment
manufacturing wastes. On December 22, 1994, we previously proposed
traditional listings of five specific wastes from these industries (59
FR 66072). On July 23, 1999, we subsequently proposed to list an
additional two wastes using a concentration-based listing approach (64
FR 40192). The 2003 proposal, and the final rule promulgated today,
completely supercede the prior 1994 and 1999 proposals. See 68 FR 66171
for further discussion of the early background of this listing
determination.

C. Which Constituents Did EPA Propose To Add to Appendix VIII of 40 CFR
Part 261?

EPA proposed to add five constituents to the list of hazardous
constituents at 40 CFR part 261. These chemicals and their Chemical
Abstract Services (CAS) numbers are:

o-anisidine (CAS No. 90-04-0),
p-cresidine (CAS No. 120-71-8),
2,4-dimethylaniline (CAS No. 95-68-1),
1,2-phenylenediamine (CAS No. 95-54-5), and
1,3-phenylenediamine (CAS No. 108-45-2).

We proposed these chemicals as CoCs for the proposed K181 listing.
Based on our assessment of the available toxicity data, we believed
that these chemicals met the Sec. 261.11(a) criteria for inclusion on
Appendix VIII. Therefore, we proposed to add them to Appendix VIII of
40 CFR part 261.

D. What Was the Proposed Status of Landfill Leachate From Previously
Disposed Wastes?

We proposed to amend the existing exemption from the definition of
hazardous waste for landfill leachate generated from certain previously
disposed hazardous waste (40 CFR 261.4(b)(15)) to include leachate
collected from non-hazardous waste landfills that previously accepted
the proposed K181 waste. We proposed to temporarily defer the
application of the proposed new waste code to such leachate to avoid
disruption of ongoing leachate management activities.
The Agency proposed the deferral because information available to
EPA at the time indicated that the wastes proposed to be listed as
hazardous have been managed previously in non-hazardous waste
landfills. Leachate derived from the treatment, storage, or disposal of
listed hazardous wastes is classified as hazardous waste by the
derived-from rule in 40 CFR 261.3(c)(2). Without such a deferral, we
were concerned about forcing pretreatment of leachate even though
pretreatment is neither required by nor needed under the Clean Water
Act (CWA).

E. What Were the Proposed Treatment Standards Under RCRA's Land
Disposal Restrictions Standards?

We proposed, where possible, to apply existing universal treatment
standards (UTS) for the proposed K181 constituents of concern (CoCs).
We proposed to apply the UTS to these wastes because the waste
compositions were found to be similar to other wastes for which
applicable treatment technologies have been demonstrated.
We found that there is significant structural similarity among many
of the CoCs, including those for which we had not previously set
technology-specific standards. We proposed that all CoCs for these
wastes can be treated with equal effectiveness (i.e., destroyed or
removed so as to be no longer detectable) by similar methods of
treatment. We proposed combustion as the most effective BDAT treatment
for nonwastewater forms of these wastes. For wastewaters derived from
K181, we proposed a treatment train of wet air oxidation (WETOX) or
chemical oxidation (CHOXD) followed by carbon adsorption (CARBN), or
application of combustion (CMBST) as BDAT for the CoCs for which
treatment standards had not previously been developed.
We also assessed the potential of developing numerical standards
for those constituents with current technology-based treatment
standards and those CoCs in K181 that lack current treatment
requirements. Commenters to the July 23, 1999 listing proposal (64 FR
40192) suggested that EPA establish numerical standards, because they
allow any treatment, other than impermissible dilution, to be used to
comply with the land disposal restrictions. We found that there was
adequate documentation in existing SW-846 \3\ methods 8270, 8315, and
8325 to calculate numerical standards for the CoCs, with the exception
of 1,3-phenylenediamine; 1,2-phenylenediamine; and 2,4-dimethylaniline.
For 1,3-phenylenediamine and 2,4-dimethylaniline, we proposed to
transfer the numerical standards of similar constituents as the
universal treatment standards.
---------------------------------------------------------------------------

\3\ Manual of test methods from EPA/OSW: ``Test Methods for
Evaluating Solid Waste, Physical/Chemical Methods,'' SW-846; see
http://www.epa.gov/epaoswer/hazwaste/test/sw846.htm.

---------------------------------------------------------------------------

For 1,2-phenylenediamine, we found during past method performance
evaluations that it can be difficult to achieve reliable recovery from
aqueous matrixes and precise measurements. Therefore, for this
constituent, we proposed that wastewaters be treated by CMBST; or CHOXD
followed by BIODG or CARBN; or BIODG followed by CARBN, and all
nonwastewaters would be treated by CMBST. We noted that if data
adequate for the development of a numerical standard were presented in
comments, the Agency might promulgate a numerical standard as an
alternative, or as the treatment requirement.
We indicated, however, that if these numerical standards were shown
in comments not to be achievable or otherwise appropriate, we would
adopt methods of treatment as the exclusive treatment standard. Under
this technology only approach, all nonwastewaters identified as K181
would be treated by CMBST, and all derived from wastewaters would be
treated by either WETOX or CHOXD, followed by CARBN or CMBST.
We also proposed to add the constituents in K181 with numerical
treatment standards to the Universal Treatment Standards listed at 40
CFR 268.48. As a result, characteristic wastes that also contain these
constituents would require additional treatment before disposal, if
constituent

[[Page 9144]]

concentrations exceed the proposed levels.
We proposed to amend the CoCs in F039 as necessary to include the
constituents identified in K181 not already specified in F039. F039
applies to landfill leachates generated from multiple listed wastes in
lieu of the original waste codes. F039 wastes are subject to numerical
treatment standards equivalent to the universal treatment standards
listed at 40 CFR 268.48. Without this change in existing regulations,
F039 landfill leachates may not receive proper treatment for the
constituents of K181.
The proposed treatment standards reflected the performance of best
demonstrated treatment technologies, and were not based on the listing
levels of concern derived from the risk assessment for dyes and/or
pigments wastes. In that risk assessment, our analysis focused on the
plausible management practices for only the dyes and pigment
industries. As a result, our models did not attempt to assess all
possible pathways, because the plausible management practice (disposal
in a municipal subtitle D landfill) provides a certain level of control
over some potential release pathways. In addition, our assessment of
potential releases modeled engineered barriers in the form of various
types of liner systems.
As discussed in the proposal, it was not appropriate to use the
mass loading levels derived from these risk assessments as levels at
which threats to human health and to the environment are minimized.
Because there remained significant uncertainties as to what levels of
hazardous constituents in these wastes would minimize threats to human
health and to the environment posed by these wastes' land disposal, we
chose to develop treatment standards for these wastes based on
performance of the Best Demonstrated Available Technology for these
wastes. HWTC III, 886 F. 2d at 361-363 (accepting this approach). For
the same reason, we found that these technology-based treatment
standards were not more stringent than the risk-based levels at which
we could find that threats to human health and to the environment are
minimized.

F. What Risk Assessment Approach Was Used for the Proposed Rule?

For the proposed rule, we conducted a risk assessment to calculate
the maximum mass loading of individual constituents that could be
present in dye and pigment waste and remain below a specified level of
risk to both humans and the environment.
To establish these listing levels, we: (1) Selected constituents of
potential concern in waste from dye and/or pigment production, (2)
evaluated plausible waste management scenarios, (3) calculated exposure
concentrations by modeling the release and transport of the
constituents from the waste management unit to the point of exposure,
and (4) calculated waste constituent loadings that are likely to pose
an unacceptable risk. In addition, we conducted a screening level
ecological risk assessment to ensure that the mass loading limits were
protective of the environment.
The risk analysis for the dyes and/or pigment production wastes
estimated the mass loading of individual constituents that can be
present in each waste without exceeding a specified level of protection
to human health and the environment. The risk assessment evaluated
waste management scenarios that may occur nationwide. We selected a
national analysis that captures variability in meteorological and
hydrogeological conditions for this listing determination because
facilities that manage these wastes are found in many areas of the country.
For this listing determination, we defined the target level of
protection for human health to be an incremental lifetime cancer risk
of no greater than one in 100,000 (10-5) for carcinogenic chemicals and
a hazard quotient (HQ) of 1.0 for non-carcinogenic chemicals. The
hazard quotient is the ratio of an individual's daily dose of a
constituent to the reference dose for that constituent, where the
reference dose is an estimate of the daily dose that is likely to be
without appreciable risk of harmful effects over a lifetime.
To determine the allowable mass loadings for CoCs, we used a
probabilistic analysis to calculate the exposure to nearby residents
from disposal of those constituents in the types of waste management
units that could be used by the dyes and pigments industries. We then
established the allowable mass loading level such that the exposure to
each constituent would not exceed the target level of protection for 90
percent of the nearby residents including both adults and children.
Thus, the allowable mass loadings met a target cancer risk level of 10-
5 or hazard quotient of one for 90 percent of the receptor scenarios we
evaluated.
In this probabilistic analysis, we varied sensitive parameters for
the distributions of data that were available. The parameters varied
for this analysis include waste management unit size, parameters
related to the location of the waste management unit such as climate
and hydrogeologic data, location of the receptors relative to the waste
management units, and exposure factors such as intake rates and
residence times.
The preamble to the proposed rule (see 68 FR 66181, November 25,
2003) and the Risk Assessment Technical Background Document for the Dye
and Pigment Industries Listing Determination (hereafter known as the
Risk Assessment Background Document) provide more detail on this risk
assessment.

IV. What Is the Rationale for Today's Final Rule?

A. Final Listing Determination

We are promulgating today a final listing for nonwastewaters
generated from the production of dyes and/or pigments. As explained
below, we are revising the listing language slightly from the proposal
in response to comments. The final listing description follows:

K181: Nonwastewaters from the production of dyes and/or pigments
(including nonwastewaters commingled at the point of generation with
nonwastewaters from other processes) that, at the point of
generation, contain mass loadings of any of the constituents
identified in paragraph (c) of this section that are equal to or
greater than the corresponding paragraph (c) levels, as determined
on a calendar year basis. These wastes will not be hazardous if the
nonwastewaters are: (i) Disposed in a Subtitle D landfill unit
subject to the design criteria in Sec. 258.40, (ii) disposed in a
Subtitle C landfill unit subject to either Sec. 264.301 or Sec.
265.301, (iii) disposed in other Subtitle D landfill units that meet
the design criteria in Sec. 258.40, Sec. 264.301, or Sec.
265.301, or (iv) treated in a combustion unit that is permitted
under Subtitle C, or an onsite combustion unit that is permitted
under the Clean Air Act. For the purposes of this listing, dyes and/
or pigments production is defined in paragraph (b)(1) of this
section. Paragraph (d) of this section describes the process for
demonstrating that a facility's nonwastewaters are not K181. This
listing does not apply to wastes that are otherwise identified as
hazardous under Sec. Sec. 261.21-24 and 261.31-33 at the point of
generation. Also, the listing does not apply to wastes generated
before any annual mass loading limit is met.

EPA is listing nonwastewaters from the production of dyes and/or
pigments as hazardous because this wastestream meets the criteria set
out at 40 CFR 261.11(a)(3) for listing a waste as hazardous. As
described in the proposal (68 FR 66179), the criteria provided in 40
CFR 261.11(a)(3) include eleven factors for determining ``substantial
present or potential hazard to human health or the environment.'' Most
of these factors were incorporated into EPA's risk assessment, as discussed

[[Page 9145]]

further below. The risk analyses conducted in support of our proposed
listing determination are presented in detail in the Risk Assessment
Background Document, which is in the docket for today's rule.
We considered the toxicity of the chemicals potentially present in
these wastes (Sec. 261.11(a)(3)(i)). We found that the CoCs are toxic
chemicals with established health-based benchmarks for cancer and
noncancer endpoints.\4\ We considered constituent concentrations (Sec.
261.11(a)(3)(ii)) and the quantities of waste generated (Sec.
261.11(a) (3)(viii)) in establishing mass loading limits for specific
CoCs. Thus, the listing description for K181 includes mass loading
limits for specific CoCs that present risk to consumers of groundwater.
In setting the mass loading limits, we used fate and transport models
to determine the potential for migration, persistence, and degradation
of the hazardous constituents and any degradation products (Sec. Sec.
261(a)(3)(iii), 261.11(a)(3)(iv), and 261.11(a)(3)(v)).\5\
Bioaccumulation of the constituents (Sec. 261.11(a)(3)(vi)) is not
relevant to the key exposure pathway EPA assessed (consumption of
groundwater).
---------------------------------------------------------------------------

\4\ Risk Assessment Background Document, Section 7.
\5\ Risk Assessment Background Document, Sections 4 and 5.
---------------------------------------------------------------------------

As discussed in the proposal (68 FR 66178), we considered two other
factors, plausible mismanagement and other regulatory actions
((Sec. Sec. 261.11(a)(3)(vii) and 261.11(a)(3)(x)) in establishing the
waste management scenario(s) modeled in the risk assessment. We
considered mass loading limits based on two plausible waste management
scenarios, clay-lined and composite-lined landfills. We are
promulgating a final listing with mass loading limits for wastes in a
clay-lined landfill, and a conditional exemption for wastes managed in
landfills that are subject to (or otherwise meet) the liner design
requirements specified in the listing description for municipal
landfills (Sec. 258.40) or hazardous waste landfills (Sec. 264.301 or
Sec. 265.301). We are also adding an exemption for wastes treated in
certain permitted combustion units. Thus, if generators of wastes
potentially subject to the K181 listing use landfills meeting these
design standards, or treat the waste in the specified combustion units,
then the loading limits set forth in K181 would not apply and the waste
would not be hazardous.
We also considered one factor beyond the risk assessment, that is,
whether damage cases indicate impacts on human health or the
environment from improper management of the wastes of concern (Sec.
261.11(a)(3)(ix)).\6\ We concluded that the wastes in the damage cases
may include wastes not in the scope of today's rule, and that the cases
reflect management scenarios that are not currently common or plausible
(see 68 FR 66189). Thus, while the damage cases indicated that some
dyes and/or pigment production wastes may sometimes pose risks, EPA relied
on its quantitative risk assessment in formulating today's final rule.
---------------------------------------------------------------------------

\6\ The final factor allows EPA to consider other factors as
appropriate (Sec. 261.11(a)(3)(xi)), however we did not consider
such factors.
---------------------------------------------------------------------------

Significant comments submitted on this proposal and the supporting
analyses are summarized below. The Response to Comment Background
Document provides all of the comments and our responses to them.
1. Toluene-2,4-diamine
Toluene-2,4-diamine was one of the eight constituents of concern
(CoC) for which EPA proposed a Sec. 261.31(c)(1) mass loading limits.
We also proposed a higher mass loading limit for toluene-2,4-diamine
under Sec. (c)(2) that would have identified a mass loading limit
above which wastes would no longer be eligible for a contingent
management exemption and would have been a hazardous waste. Toluene-
2,4-diamine was the only CoC for which we proposed a Sec. 261.32(c)(2)
level.
Commenters argued that it is inappropriate to use toluene-2,4-
diamine as a CoC because it is ``not typically or frequently used in
dyes production'' (Ecological and Toxicological Association of Dyes and
Organic Pigments Manufacturers or ETAD) and is ``not used in any color
pigment facility for the production of color pigments'' (Color Pigments
Manufacturing Association or CPMA). In the proposal, we described data
collected from the Toxic Release Inventory (TRI), the Colour Index
(CI), and two facilities' websites that potentially link use of
toluene-2,4-diamine to facilities known to manufacture dyes and/or
pigments. The commenters have addressed these potential links. Based on
these arguments, we believe the commenters have successfully
demonstrated that toluene-2,4-diamine is rarely used. Only one dye
manufacturer reported using this constituent, and this use does not
generate any waste containing this CoC; it is not used at all by any
pigment manufacturers. (See Response to Comments Background Document
for more detailed discussion regarding the use, or lack of use of
toluene-2,4-diamine.) As a result, we do not believe it is appropriate
to include toluene-2,4-diamine as a basis for listing K181 in today's
final rule. Accordingly, we have removed this constituent from the
proposed Sec. 261.31(c)(1) standards, and have deleted entirely the
proposed Sec. 261.32(c)(2) standard in this action.
2. Use of Clay-Lined and Composite-Lined Landfills
We proposed to list nonwastewaters from dye and/or pigment
manufacturing that met or exceeded mass loading limits for eight
constituents of concern. These ``baseline'' loading limits were based
on our risk assessment of management of the waste in a clay-lined
landfill. We also proposed to conditionally exempt wastes managed in
landfills subject to liner regulations for municipal or hazardous waste
landfills, if the mass of one constituent of concern (toluene-2,4-
diamine) was below a specified mass loading limit. The basis for this
conditional exemption was a risk assessment of wastes managed in a
composite-lined landfill.
A number of dye and pigment manufacturers submitted comments
stating that they do not use unlined or clay-lined landfills, and most
indicated that their waste is managed in landfills that have
``synthetic liners.'' The trade association for the dye manufacturers
(ETAD) surveyed their members and stated that there is ``no use of
unregulated clay-lined landfills or unlined landfills'' and that ``all
known landfills currently in use are subtitle C or subtitle D landfills
that incorporate a synthetic liner into their liner system.'' The
association further noted that the design standards for municipal solid
waste landfills promulgated in 1991 call for use of a composite liner
(Sec. 258.40). The association also resubmitted a survey it originally
submitted in 1999 in comments on the prior July 23, 1999 proposal,
claiming that this showed all identified liner systems included a
synthetic liner. The trade association for pigment manufacturers (CPMA)
also surveyed their members and stated that their members do not use
unlined or clay-lined landfills, but rather use ``synthetic lined
industrial landfills'' and ``synthetic lined municipal landfills'' for
their nonwastewaters. Based on this information, commenters argued that
the risk assessment EPA used to establish mass loading limits for K181
should have been based on composite-lined landfills with a synthetic liner.
We continue to believe that the clay-lined landfill is an
appropriate scenario for the baseline mass loading limits for K181 for
several reasons. First, as noted

[[Page 9146]]

in the proposal, our data show that the industries use municipal solid
waste (MSW) landfills, and the liner requirements in Sec. 258.40 are
not applicable to existing units in operation since before October 9,
1993, or certain exempt units (Sec. 258.1(f)(1)). Thus, our data
indicate that disposal of dye and pigment wastes into older clay-lined
MSW landfills in operation is a plausible management scenario (see
proposal at 68 FR 66191). In addition, the information provided by the
commenters is insufficient to rebut this finding for these industries.
In fact, the information provided by the commenters shows that
industrial landfills are in use by some pigment manufacturers. There
are no Federal liner requirements that are in place for such units.
While many states have regulations for these type of industrial
landfills, the requirements for liners appear variable and do not
necessarily provide the same level of protection as the standards for
municipal solid waste landfills in Sec. 258.40. Finally, while
commenters claimed that the landfills currently in use by respondents
to their surveys have ``synthetic'' liners, they did not confirm that
all landfills in use had composite liners that met the standards set
out in Sec. 258.40.
The specific landfill information resubmitted by ETAD was for
seventeen landfills relevant to dye manufacturers only, and thus not
representative of the landfills that could be used throughout the dye
and pigment industries. (EPA estimated that there were about 2,300 MSW
landfills in operation in 2000.) Furthermore, ETAD originally submitted
this information in response to the proposed listing decision in 1999
for only three wastestreams generated by the dye and pigment
industries; as such, ETAD did not clarify if other landfills may have
been in use for other wastestreams. Finally, the limited information
provided in this submission shows that the type of liner system was not
specified for some landfills, and thus, it is not clear if the liner
systems are composite liners that would meet the Sec. 258.40 requirements.
We proposed mass loading limits based on two specific types of
lined and fills, clay-lined and composite-lined landfills. We are
promulgating a final listing with a conditional exemption for wastes
managed in landfill units that meet the liner design requirements
specified in the listing description (Sec. 258.40, 264.301 or
265.301).\7\ Unlike the proposal, the final rule no longer sets a mass
loading limit for toluene-2,4-diamine, and thus there are no testing
requirements associated with this exemption. If generators of wastes
potentially subject to the K181 listing use composite-lined municipal
or subtitle C landfills, then the mass loading limits set forth in K181
would not apply and the waste would not be hazardous. (The final
listing also includes an exemption for combustion, as discussed in the
following section). Therefore, given the uncertainties in the types of
liner systems that may be in place in landfills used by dye and pigment
manufacturers, and based on the information available that indicates
this is a plausible management scenario, we believe that it is
appropriate to base the mass-loading limits on a clay-lined landfill.
---------------------------------------------------------------------------

\7\ Note that in the final rule we have replaced the term
``landfill cell'' with ``landfill unit.'' We made this change so
that the terminology used in this rule is more consistent with the
use of the term ``unit'' in the RCRA regulations for landfills (Part
258 and in Sec. Sec. 264.301 and 265.301).
---------------------------------------------------------------------------

3. Status of Wastes That Are Combusted
While we proposed a conditional exemption for wastes managed in
units meeting the liner design criteria for municipal or hazardous
waste landfills, we proposed that wastes that met or exceeded the
baseline listing levels would be hazardous if treated by combustion.
However, we solicited comment in the preamble on the option to exempt
wastes going to combustion, provided the units are permitted under
subtitle C or have other relevant permits under the Clean Air Act (CAA).
The comments generally supported the option of exempting wastes
destined for combustion. Commenters stated that EPA should exempt
wastes being combusted or include combustion in the contingent
management practices qualifying for an exemption from the listing.
Surveys submitted by the trade associations (ETAD and CPMA) confirmed
that some facilities treated nonwastewaters by combustion, and other
comments by specific companies stated they want to have the option of
incineration in the future. Commenters pointed out that the proposed
approach would mean that wastes that met or exceeded the baseline
listing levels and are incinerated would be hazardous, while the same
waste would be nonhazardous if it is managed in a landfill meeting
appropriate criteria. Commenters contended that this would encourage
facilities to shift from combustion to disposal in landfills, even for
wastes with high organic content. Commenters suggested that wastes
going to ``permitted'' combustion units should be exempt, because
permitting authorities consider input fuels for commercial boilers and
combustion units.
Commenters stated that regulating incineration in the absence of a
risk assessment or data is not warranted, and that combustion provides
at least as much protection for the environment as a synthetic-lined
landfill. Commenters cited the preamble discussion in the proposal,
which stated that previous analyses for other wastes determined that
potential risks from the release of constituents through incineration
would be several orders of magnitude below potential air risks from
releases from tanks or impoundments. Commenters also noted that EPA had
concluded that combustion was effective and protective in setting BDAT
standards for K181. One commenter submitted a risk assessment for
combustion of their waste, which was previously submitted in their
comments on the 1994 proposal, and indicated that the risks are below
levels of concern.
After reviewing the comments and the available information, we have
decided to exempt wastes treated in certain combustion units from the
K181 listing. As we noted in the proposed rule, we expect risks from
combustion of the key constituents of concern to be relatively low,
based on the relatively low air risks exhibited by these constituents
from treatment in tanks and surface impoundments. Analyses in previous
listing determinations have shown that air risks arising from releases
of constituents not destroyed in combustion are much lower than risks
from releases of constituents from tanks and surface impoundments (68
FR 66196). Thus, while we did not model the specific dye and pigment
wastes at issue in this rule, we believe that risks from combustion
would be relatively low.
As commenters pointed out, by exempting wastes going to certain
landfills, but not wastes treated by combustion, we would effectively
be encouraging landfill disposal over combustion. The exemption for
landfill disposal may therefore cause some facilities with organic
waste having significant fuel (BTU) value to change from combustion
(either offsite or onsite) to disposal in landfills, to take advantage
of the landfill exemption. Exempting wastes treated in appropriate
combustion units would avoid this unintended outcome of the listing.
As noted in the proposal, we found ten facilities reporting in the
TRI that they send wastes off site for combustion (e.g., incineration,
energy recovery). All of the treatment facilities are RCRA Subtitle C
facilities. Because this is a management practice we believe is

[[Page 9147]]

especially appropriate for waste with high organic content, we have
decided to include an exemption for wastes treated in Subtitle C
combustion units. To the extent that these wastes are already managed
as hazardous because they exhibit a hazardous waste characteristic or
meet another hazardous waste listing description, today's final rule
will have no impact on them, because the K181 listing does not apply to
wastes that are hazardous for other reasons (see the listing description).
We are more concerned about the combustion of dye and pigment
wastes in units that are not subject to Subtitle C regulations. We know
of only two facilities that use onsite thermal treatment of dye or
pigment production wastes. One of these facilities indicated that it
does not produce any in-scope wastes containing any of the CoCs. The
other facility generates a still bottom that may exceed the mass
loading limit for aniline. This facility resubmitted a risk assessment
previously included in comments on the 1994 proposal in an attempt to
show no significant risk for its onsite boiler. The risk assessment,
while specific to this one combustion unit, provides information on the
unit that indicates that it has relatively high destruction and removal
efficiency (>99% in this case for the CoC known to be present,
aniline). This particular unit is also permitted by the state under the
CAA, and the permit contains specific limitations on the release of the
key CoC (40 kg/year).\8\ Therefore, in this specific case, the state
regulatory authority has evaluated and controlled the releases of this
CoC through this permit. We find the comments submitted by the company
compelling, given that the waste has high organic content (98.7%) and a
high fuel value. Therefore, we have also decided to include an
exemption for onsite combustion units (units that are located at the
site of generation) that are permitted under the CAA. We are limiting
the exemption to onsite combustion units because: (1) Currently we have
no information that offsite combustion is occurring in non-subtitle C
units, and (2) we lack information on whether any permits for non-
subtitle C offsite units would necessarily address all potential CoCs.
Offsite combustion units are likely to accept a wide variety of other
wastes, and seem less likely to address the specific constituents of
concern for dye and pigment production wastes. We have less information
on the various kinds of existing or potential permits relevant to
offsite combustion units that may be used for dye and pigment wastes.
Permits for offsite units under the CAA would not necessarily consider
the CoCs for the dye and pigment wastes (e.g., of the seven CoCs, only
aniline and o-anisidine are Hazardous Air Pollutants under the CAA),
whereas permits for onsite units are likely to be more specific for the
dye and pigment industries.
---------------------------------------------------------------------------

\8\ See the air permit for BASF in the docket for this rule.
---------------------------------------------------------------------------

4. Scope of Listing Definition
Commenters identified several issues related to the scope of the
proposed listing, as summarized below, and discussed in more detail in
the Response to Comments Background Document.
a. Perylenes and Anthraquinones. One trade association commented
that EPA erred in including perylenes in the proposed listing because
Paragraph l.h.(i) of the ED consent decree (as amended in December
2002) states that ``EPA shall promulgate final listing determinations
for azo/benzidine, anthraquinone, and triarylmethane dye and pigment
production wastes.'' The commenter argued that perylenes are not a
subclass of the anthraquinone category, and that none of the eight CoCs
are used as raw materials in the manufacture of perylene color pigments.
We note, as discussed previously in the proposal, that the ED
consent decree (under which today's listing determination is mandated)
further specifies that ``The anthraquinone listing determination shall
include the following anthraquinone dye and pigment classes:
anthraquinone and perylene'' (68 FR 66173). Therefore, we must make
listing determinations that cover any corresponding wastes, regardless
of whether or not perylenes are properly classified as anthraquinones.
Furthermore, as discussed in the proposal and in the Response to
Comments Background Document, we are not differentiating between dye
manufacture and pigment manufacture. While the pigments industry may
not use the K181 CoCs for manufacturing perylene pigments as contended
by the commenter, it is possible that the dyes industry may still use
some of them for perylene dyes. Note that ETAD and its member dye
manufacturers did not provide comments in this respect. Finally, we
note that the consent decree does not limit EPA's authority to list
wastes, but merely identifies those wastes for which EPA must make a
listing determination.
Another commenter argued that none of the eight CoCs are used to
produce anthraquinone dyes or pigments and, therefore, EPA should
remove anthraquinone dyes and pigments from the proposed rule. The
commenter further pointed out that in the 1994 proposal (59 FR 66072),
EPA proposed a no-list decision for wastewater from the production of
anthraquinone dyes and pigments, and in the 1999 proposal (64 FR
40192), EPA proposed a no-list decision for wastewater treatment sludge
from the production of anthraquinone dyes and pigments. As discussed in
the proposal, EPA identified the constituents by developing a list of
chemicals that could reasonably be expected to be associated with
wastes from the production of various classes of dyes and pigments,
including anthraquinone dyes and pigments. See 68 FR at 66180-66182,
and ``Background Document: Development of Constituents of Concern for
Dyes and Pigments Listing Determination'' in the docket. This commenter
did not provide any documentation to support its argument that none of
the eight CoCs are used to produce anthraquinone dyes or pigments, or
otherwise specifically address the information and findings presented
in the proposal. In addition, none of the other companies or trade
associations made similar claims. Finally, we note that, as discussed
in the 2003 proposal (68 FR 66171-2), our 2003 proposed rule completely
supercedes the 1994 and 1999 proposals. In any case, unlike the 1999
concentration-based listing in which we evaluated specific waste types
from the production of individual dyes/pigments classes,\9\ the 2003
proposal grouped all of the wastes that are identified in the ED
consent decree into wastewaters and nonwastewaters.
---------------------------------------------------------------------------

\9\ Spent filter aids, triarylmethane sludges and anthraquinone
sludges were deferred from the 1994 proposed listing decisions for
11 of the wastes covered in the ED consent decree (59 FR 66072,
December 22, 1994). EPA did not take final action on either of the
1994 and 1999 proposals.
---------------------------------------------------------------------------

Moreover, some of the listing constituents might be present in the
dyes and/or pigments production nonwastewaters as a result of reaction
byproducts, impurities in raw materials, or as a result of degradation
of raw materials or products. Therefore, we believe it is appropriate
to retain both perylene and anthraquinone production within the scope
of this final K181 listing. If, however, as the commenter suggests, the
CoCs are not present in the generators' wastes, then the wastes would
not be considered the K181 listed waste.
b. Post-Production. Two commenters stated that the proposed rule
does not adequately define ``production'' of dyes and/or pigments, and
that some wastes covered by the ED consent decree could

[[Page 9148]]

be generated from certain types of ``post-production'' activities. They
contended that the listing should not apply to ``post-production''
activities, in reference to 68 FR 66173 in which the Agency stated that
the proposed rule does not apply to the end-users of dyes and/or
pigments and similarly does not apply to post-production formulation
and packaging. One commenter suggested that EPA should include the
appropriate clarifications in the CFR language that defines the scope
of the proposed listing.
In response to the commenters' request for clarification, we are
adding the following language to the final rule at the end of the
Listing Specific Definitions in Sec. 261.32(b)(1): ``Wastes that are
not generated at a dyes and/or pigments manufacturing site, such as
wastes from the off-site use, formulation, and packaging of dyes and/or
pigments, are not included in the K181 listing.'' Thus, we are
specifically including this in the regulatory language to clarify that
we are not including in K181 those wastes that are not generated at a
dyes and/or pigments manufacturing site. However, wastes resulting from
the blending, formulation, preparation, processing (grinding,
dispersing, drying, finishing, filtering, purification, product
standardization, etc.), dust collection, packaging and any other
operations related to in-scope dyes and/or pigments that occur on site
at the covered dyes and/or pigments manufacturers are potentially
within the scope of today's final listing, if they meet the relevant
criteria. Note that, as required under the ED consent decree, we
addressed a variety of dyes and/or pigment waste streams in this
listing determination. The ED consent decree states that ``Listing
determinations under paragraph 1(h) of this Decree shall include the
following wastes, where EPA finds such wastes are generated: spent
catalysts, reactor still overhead, vacuum system condensate, process
waters, spent adsorbent, equipment cleaning sludge, product mother
liquor, product standardization filter cake, dust collector fines,
recovery still bottoms, treated wastewater effluent, and wastewater
treatment sludge.'' Some of the wastes identified in the ED consent
decree (such as product standardization filter cake and dust collector
fines) can be generated from various ``post-production'' activities at
the dyes and/or pigments facilities.
c. Commingling. We described in the proposal (68 FR 66195) that the
scope of the listing covers commingled wastes with mass contributions
from other processes (i.e., that other process wastes commingled with
in-scope process wastes would be covered by the proposed K181 listing).
We requested comment, however, on an alternative approach which would
allow facilities to count only those mass loadings associated with azo/
triarylmethane/perylene/anthraquinone dyes and/or pigments manufacture
when assessing whether their wastes meet or exceed the K181 listing
levels. One commenter, a trade association, favored this alternative
approach. This commenter reasoned that not allowing facilities to count
only those mass loadings associated with covered production will result
in ``an artificial incentive to inefficiently segregate wastes,
potentially increasing risks associated with their management.''
However, this commenter did not elaborate or provide any specifics.
We have carefully considered the commenter's argument, but we have
decided to retain the proposed approach. The dye and pigment industries
use batch processes and numerous raw materials to produce a wide
variety of products, thereby generating various nonwastewaters.\10\
Therefore, we believe it would not only be more difficult for the
facilities to implement the proposed alternative approach (i.e.,
tracking and keeping adequate documentation of all the mass
contributions prior to commingling), but it would also be very
difficult for the regulating authorities to make their own
determinations for oversight and enforcement purposes. For this reason
and the reasons stated at 68 FR 66195, we have decided to take the more
straightforward approach of structuring the mass-based K181 listing as
proposed, and not to adopt the alternative approach. Therefore, the
K181 listing covers mass contributions from other processes when in-
scope and out-of-scope waste sources are commingled, and the entire
commingled volume is included in the waste quantity and mass loading
calculations. On the other hand, if the in-scope waste sources contain
none of the K181 listing constituents, the commingled volume is not
subject to the K181 listing even though its mass loadings may meet or
exceed the K181 listing levels.
---------------------------------------------------------------------------

\10\ ETAD also indicated in its comment that ``Dyes production
involves batch processes, numerous distinct products and highly
variable waste streams * * *'' and that ``The production mix and
scale is entirely subject to somewhat unpredictable customer demand.''
---------------------------------------------------------------------------

As discussed in the proposal, a facility might choose to segregate
K181 sources from non-K181 sources, so that nonwastewaters from
noncovered processes would not be subject to the K181 listing. One
trade association felt that the general concept of segregating waste
which has no in-scope K181 contribution is reasonable.\11\
---------------------------------------------------------------------------

\11\ Facilities might also choose to treat the K181 listing
levels as valuable pollution prevention goals and engage in process
modifications designed to reduce mass loadings (irrespective of
their source) below the K181 loading limits.
---------------------------------------------------------------------------

To help clarify these concepts, we present below several examples
of how wastes might be commingled. (See also the examples previously
presented in the proposal at 68 FR 66205-66207.)

Example 1: In-scope wastes without CoCs, commingled with out-of-
scope wastes.
Facility A produces numerous chemical products including a small
amount of azo dyes. This facility uses none of the K181 CoCs in the
manufacture of azo dyes, and it finds no CoCs in the dye
manufacturing process wastewaters based on recent analytical
results. Thus, according to the procedure in Sec. 261.32(d)(1), the
facility determines that any resulting treatment sludge is not K181.
The in-scope azo dye process wastewaters are commingled and co-
treated with a much larger volume of nonhazardous wastewaters
generated from the production of various out-of-scope chemicals in a
centralized wastewater treatment plant (CWTP) prior to discharge to
a publicly owned treatment works (POTW). The facility uses aniline
in some of the other out-of-scope chemical production processes. The
facility determines that the resultant wastewater treatment sludges,
though found to contain aniline above the listing level, are not
subject to K181 because the azo dye process wastewaters treated in
the plant do not contain any of the CoCs. The facility also
determines that other nonwastewaters (including filtration sludges,
spent filter aids, and other process solids) generated from dye
manufacturing also do not contain any CoCs, based on its knowledge
of the feed raw materials (including major and minor ingredients,
and impurities) and the manufacturing processes (reaction, chemical
degradation, waste generation, etc.). The facility documents its
findings, and appropriately manages all the CWTP sludges and dye
process nonwastewaters (also determined to be not characteristically
hazardous and not meeting any other listing descriptions) as nonhazardous.
Example 2: In-scope wastes with traces of CoCs, co-managed with
out-of-scope wastes.
Facility B is an organic pigment manufacturer operating a number
of in-scope and out-of-scope production process lines. The facility
generates a total of 450 metric tons per year (MT/yr) of
nonwastewaters, consisting of 350 MT/yr of sludge from the
facility's onsite wastewater treatment system and as much as 100 MT/
yr of production waste solids generated from all onsite processes
combined. Historically, all the nonwastewaters were stored in
dumpsters and periodically shipped off site for disposal in a
Subtitle D landfill. Following the promulgation of the K181 listing,
the facility carefully examines the material safety data

[[Page 9149]]

sheets and finds traces of p-cresidine in some of the raw materials
used. Based on the material purity information, the facility uses
its knowledge and, based on mass balance (see Sec. 261.32(d)(2) for
generated quantities less than 1,000 MT/yr), determines that a
maximum of 30 kg/yr of p-cresidine could be released to and
contained in the combined volume of nonwastewaters generated for the
year. Since the annual mass loading of p-cresidine is less than the
K181 listing level of 660 kg/yr, the facility concludes that its in-
scope nonwastewaters are not a K181 waste. The facility thus
documents its findings, and appropriately continues to ship the
commingled wastes to a subtitle D landfill.
Example 3: Segregation of wastes destined for disposal in a
municipal landfill; total in-scope waste quantities over 1,000 MT/yr.
Facility C uses some of the CoCs in its production of various
organic dyes and pigments covered by the K181 listing. It commingles
and co-treats all the manufacturing process wastewaters on site,
generating 1,200 MT/yr of wastewater treatment sludge. In addition,
it generates 50 MT/yr of process wastes with high organic content
(still bottoms). Therefore, this facility's manufacturing and
treatment processes yield a total of 1,250 MT/yr of in-scope
nonwastewaters. Given that the K181 listing allows nonwastewaters to
be disposed in a municipal landfill subject to the Sec. 258.40
design criteria regardless of constituent levels in the wastes, the
facility decides to send all the wastewater treatment sludges to a
municipal landfill subject to Sec. 258.40. The still bottoms,
however, would not be managed in the same manner due to their high
liquid content.
The still bottoms do not exhibit any of the hazardous waste
characteristics nor meet any other listing descriptions. Because the
total annual waste quantity of dyes/pigments nonwastewaters
generated by all the processes would exceed 1,000 MT/yr, the
facility considers the options of either: (1) Complying with the
annual testing requirements of Sec. 261.32(d)(3) and, if the CoCs
are below the mass-loading levels, sending the still bottom waste
offsite for combustion in a nonhazardous combustion unit, or (2)
sending the waste offsite to a subtitle C combustion unit. The
facility suspects that the still bottom waste will exceed the mass
loading limits for several constituents. Rather than going to the
expense of confirming this through testing representative samples of
the waste, the facility decides to send the waste off site for
treatment at a subtitle C combustion facility. Thus, this waste is
also exempt from the K181 listing because it is treated in a
combustion unit permitted under Subtitle C.
5. Waste Quantities
As described in the proposal at 68 FR 66176-66177, we estimated
facility by facility nonwastewater quantities (for 37 active organic
dyes and/or pigment production facilities known to the Agency at the
time) by using engineering estimates of wastewater treatment sludge
generation rates and, wherever possible, facility-specific information
provided in portions of RCRA Section 3007 surveys and public comments
that were not claimed as confidential business information (CBI). We
then used the average of the estimated annual waste quantities (1,894
MT/yr) and a high-end waste constituent concentration of 5,000 parts
per million (ppm) to calculate a mass loading cutoff of 10,000
kilograms per year (kg/yr); that is, we assumed it would be highly
unlikely to find the CoC above this level in typical dyes and/or
pigment production nonwastewaters (see discussion at 68 FR 66186).\12\
In addition, we used the estimated waste quantities for cost and
economic analyses of the potential impacts of the proposed listing, and
for waste treatment and management capacity analyses. Below we address
the public comments on our use of the estimated waste quantities for
establishing the proposed mass loading levels. Comments on our use of
the estimated waste quantities for economic impacts and waste
management capacity analyses are addressed separately in section VIII
and section IV.E, respectively.
---------------------------------------------------------------------------

\12\ That is, a constituent of concern was eliminated if the
calculated allowable loading from risk modeling exceeds 10,000 kg/yr.
---------------------------------------------------------------------------

Two trade associations and several dyes/pigments manufacturers
submitted comments on the Agency's estimates of waste quantities
generated by the organic dyes and pigments industries. They argued that
our waste quantity estimates were overstated, and thus our estimates of
possible amounts of CoCs present in the wastes were too high.
Subsequent to the November 25, 2003 proposal, ETAD conducted a
confidential survey of 15 organic dye production facilities, and
submitted as part of their comments masked waste quantity data from the
survey.\13\ Based on its survey results, ETAD contended that the
proposed rule greatly exaggerates the quantity of proposed K181 wastes
generated at dyes production facilities and therefore, the proposed
mass loading cutoff of 10,000 kg/yr should be revised. ETAD also
indicated in its survey summary that two dye production facilities use
none of the proposed K181 listing constituents in dyes production.
Furthermore, ETAD confirmed that two dye manufacturers ceased operation
during the past year.
---------------------------------------------------------------------------

\13\ The survey waste quantity results initially included in
ETAD's February 23, 2004 comments and attachments are annual
quantities of nonwastewaters relating to the manufacturing of in-
scope dyes (i.e., specifically covered by the proposed rule). In
response to our inquiry, ETAD later submitted an amended summary of
waste quantities that include the other wastestreams commingled with
the in-scope wastes.
---------------------------------------------------------------------------

CPMA similarly conducted a confidential survey of 21 organic
pigment manufacturers following the proposal, and provided masked waste
quantity summary data for both total and in-scope nonwastewaters as
part of their comments. CPMA commented that, based on its survey, EPA's
estimates of nonwastewater quantities overestimate the amount of
nonwastewater generated by the pigments industry by at least 400
percent, and that the actual amount of nonwastewaters generated by the
dyes and pigments production industries is much less than one-half the
amount estimated by the Agency.
Six organic dyes and/or pigments manufacturers also presented their
waste quantities and disputed the Agency's estimates for their
facilities. Several other pigment manufacturers mirrored CPMA's comment
that the Agency overestimated the waste quantities generated by the
industries by at least 400 percent, although they did not specifically
provide their own waste quantities. Several manufacturers informed us
that their in-scope manufacturing processes do not contribute any of
the proposed K181 constituents to their wastes.
We reviewed the waste quantity information and data provided by the
commenters, but found some data discrepancies and deficiencies that
limit use of the data. Our findings are summarized below:

--Two dye manufacturers have closed.
--The organic pigment manufacturing operation of one dye and pigment
production facility was recently sold to a pigments manufacturer.
--Two facilities use none of the proposed K181 listing constituents.
--Three facilities do not generate any nonwastewater.
--CPMA's survey encompassed wastes generated in 2002, while ETAD did
not specify the time period covered by its survey. As such, these two
sets of survey quantity data may not be fully compatible.
--Three facilities making both dyes and pigments products responded to
both ETAD and CPMA surveys. However, for the reported waste quantities
possibly associated with these facilities, there appears to be some
discrepancies between ETAD's and CPMA's masked annual quantity data.
--Three known Food, Drug and Cosmetic (FD&C) colorant production
facilities were not covered by either the ETAD or CPMA survey.

We removed from the database the two facilities using none of the

[[Page 9150]]

proposed K181 listing constituents, as well as the three facilities
generating zero waste quantities, because they would not be impacted by
the proposed rule. Next, we made assumptions in trying to match the
masked data points for the three facilities that responded to both the
ETAD and CPMA surveys in order to account for the overlap, using
publicly available data and our best judgement. To revise our previous
estimates of facility-specific waste quantities, we adopted the
specific waste quantity data provided by the commenting dyes/pigments
manufacturers, made assumptions based on certain comments, and applied
the estimated annual revenues to match the masked waste quantities with
facilities. Finally, we added the three facilities not covered by
either the CPMA or ETAD survey, using waste quantities we estimated for
these facilities. The consolidated data points created a set of annual
waste quantities with high uncertainties for the potentially impacted
dyes/pigment facilities.
In any case, we have analyzed the commenters' data and concluded
that the average estimated waste quantity we used for the proposed rule
(i.e., 1,894 MT/yr) is well within the distributions of values reported
in comments; the estimated value of 1,894 MT/yr is comparable to the
80th percentile value (1,815 MT/yr) of the consolidated data set
described above. For a detailed analysis of the commenters' data, see
the Response to Comments Background Document, available in the public
docket for today's final rule.
Based on our analysis of the commenters' waste quantity data, and
in view of the data uncertainty in the ETAD and CPMA surveys, we
continue to believe that it is reasonable to retain the proposed mass
loading cutoff of 10,000 kg/yr for eliminating constituents from
consideration.
6. Prevalence of Constituents of Concern
Commenters submitted critiques of each of the CoCs, arguing that
they do not warrant inclusion in the final listing. With the exception
of the arguments submitted for toluene-2,4-diamine (as discussed in a
prior section of this notice), EPA has concluded that our basis for
setting standards for the seven CoCs is valid. The comments for these
seven CoCs and our responses are summarized below, and provided in more
detail in the Response to Comments Background Document in the docket
for today's final rule.
a. Aniline. We proposed to include aniline as a CoC because it is
widely reported to be used in the manufacture of dyes and/or pigments.
We detected aniline in a variety of wastes in our analysis of waste
samples, it is reported to be an intermediate in the production of
various products reported by U.S. manufacturers in the Colour Index, it
is reported in the TRI by various known dye and/or pigment
manufacturers, it was reported to be a waste component in the RCRA
Sec. 3007 survey and in comments on our 1994 proposal, and is a known
intermediate for various products reported as available on the Web
sites of various U.S. dye and/or pigment manufacturers (see the Listing
Background Document).
In addition, ETAD and CPMA comments on the November 2003 proposal
provided recent survey data indicating that seven dye manufacturers use
aniline in their processes, and that four pigment manufacturers use
this CoC. Twelve pigment survey respondents also indicated that it is
present in their wastes. Further, although CPMA stated that less than
25 percent of U.S. pigment manufacturers use aniline, nine pigment
manufacturers individually commented that aniline is actually used or
is likely present in their production of pigments. These data confirm
our position at proposal that aniline is used widely in the manufacture
of dyes and pigments.
ETAD argued that the available analytical data does not support a
conclusion that aniline is likely to be present in dye wastes at levels
exceeding the proposed listing level. One commenter (BASF) noted that
the maximum concentration of aniline in wastewater treatment sludges
reported in the proposal (31,000 ppm) was from their process, and
reflects a process waste that was eliminated from their manufacturing
process in 1996.
While we agree with ETAD and BASF that the available analytical
data (as described in the proposal) are older, these data do provide a
snapshot in time of the composition of wastes from the manufacture of
dyes and/or pigments. BASF did not provide a profile of their currently
generated wastes, so it is not possible to ascertain whether other
wastes generated from their process(es) are as contaminated as the
stream that was eliminated in 1996. BASF did, however, provide in their
comments a risk assessment of releases from their onsite boiler.\14\
This risk assessment contains limited waste characterization data which
depicts aniline concentrations in their boiler feed even higher than
the levels observed in most of the available analytical data (1.45%
aniline). We note also that the commenters focused solely on the
analytical data available for wastewater treatment sludges; we reported
in the proposal three additional samples of ``other nonwastewaters''
that contain aniline, with a maximum value of 180,000 ppm.\15\
---------------------------------------------------------------------------

\14\ See Comment RCRA-2003-0001-0258.
\15\ See the aggregated EPA data in Appendix I of the Background
Document for Identification and Listing of Wastes from the
Production of Organic Dyes and Pigments, which is in the docket for
today's rule.
---------------------------------------------------------------------------

ETAD also argued that if EPA's estimated average waste quantity is
adjusted to reflect the results of their survey, the 10,000 kilograms/
year (kg/yr) screening level would be lower, eliminating aniline as a
potential CoC. As discussed more fully in section IV.A.5, we believe
that the waste quantity that we used in the development of the proposal
is well within the distribution of waste quantities reported by
commenters, and we accordingly have not adjusted it.
After considering the commenters' concerns, we believe that it is
appropriate to retain the mass-loading levels for aniline in today's
final rule.
b. o-Anisidine. We proposed to include o-anisidine as a CoC because
it is widely reported to be used in the manufacture of dyes and/or
pigments. We detected o-anisidine in several wastes in our analysis of
waste samples, it is reported to be an intermediate in the production
of various products reported by U.S. manufacturers in the Colour Index,
it is reported in the TRI by known dye and/or pigment manufacturers,
azo dyes derived from it are subject to regulation by the European
Union (EU), and it is a known intermediate for products reported as
available on the Web sites of several U.S. dye and/or pigment
manufacturers (see the Listing Background Document).
In addition, ETAD and CPMA comments on the November 2003 proposal
provided recent survey data indicating that three dye manufacturers and
two pigment manufacturers use o-anisidine in their processes. Further,
five CPMA survey respondents reported this CoC being present in their
wastes as a contaminant. Six pigment manufacturers (which represent 11
facilities manufacturing in-scope pigments) also indicated in their
individual comments that o-anisidine is actually used or likely to be
present in their pigment processes.
ETAD argued that o-anisidine is only used or generated at 3 of 15
dye production facilities. CPMA stated that it is only used in the
production of pigments by less than 25 percent of U.S. pigment
manufacturers. We believe, however, that these usage rates are not
insignificant, particularly for an

[[Page 9151]]

industry known to manufacture a wide variety of products over time and
between companies using batch operations. Further, as noted above, six
pigment manufacturers also reported using or generating this CoC.
Therefore, the available information indicates that o-anisidine is
likely to be present in dye/pigment wastes, and it is reasonable to
keep this as a constituent of concern. Moreover, even if o-anisidine
were considered infrequently used, EPA would still consider that o-
anisidine met the listing criteria set out in Sec. 261.11.
ETAD noted that o-anisidine was only detected in one sample, and
that the sample is outdated and of limited value as it was qualified as
a ``J'' value \16\ and difficult to differentiate from 2-/4-
aminoaniline. We agree that the particular analytical result noted is
an insufficient basis by itself to include o-anisidine in the K181
listing. However, we have other sources that confirm that this
constituent is used by a number of generators in the manufacture of
relevant colorants. We note that o-anisidine was also tentatively
identified in four wastewater samples in the data summary presented in
the proposal's Listing Background Document, and that the ETAD and CPMA
surveys confirm that this constituent is still in use at a number of
their members' facilities.
---------------------------------------------------------------------------

\16\ ``J'' values are chemical concentrations that were detected
below the analytical reporting limit, but above the limit of
detection for the method used. See OSW's methods manual, especially
Chapter 1, Quality Control; ``Test Methods for Evaluating Solid
Waste, Physical/Chemical Methods, SW-846.''
---------------------------------------------------------------------------

ETAD noted that o-anisidine was not reported in the RCRA Sec. 3007
survey. We note that the survey data used to support the proposal
represented a limited subset of the census survey (i.e., those surveys
without CBI claims), and may not be fully indicative of waste composition.
ETAD also argued that there is no evidence that either the
calculated theoretical average concentration of o-anisidine (58 ppm) or
the average waste volume of 1,894 MT/yr (described in the proposal's
Listing Background Document) occurs in dyes production wastes. We agree
that the data available to the Agency do not identify specific wastes
that would exceed the listing levels. Nevertheless, given the format of
the proposed rule (i.e., a mass loadings-based listing), we believe
that such data are not critical. Instead, we have demonstrated that the
range of both expected waste quantities and organic waste constituent
concentrations are broad enough that CoC levels in real wastes could
potentially exceed the K181 loading limits.
ETAD further asserts that their newly collected data show that the
median volume of o-anisidine is zero, and the maximum reported volume
is less than one percent of the proposed mass loading. We do not
believe these statistics are particularly meaningful. First, the
commenter provided very little information about the nature of its
data. For example, it is unclear what year the data reflect, or even if
they represent the same calendar year among ETAD's survey respondents.
Also, ETAD provided no information regarding the variability of these
data over time (e.g., were the data representative of typical
operations? Are there relevant trends in the use of raw materials?). In
an industry that produces a very diverse range of products from plant
to plant and from year to year, we would not expect that the majority
of manufacturers would utilize any one of the K181 constituents at any
given time. Thus, the commenter's findings of a median value of zero is
not surprising or relevant. Similarly, the commenter did not provide
sufficient information regarding their assertion that there are no dye
manufacturers whose mass loading of o-anisidine in their wastes exceed
1 percent of the K181 limit for us to remove this constituent from the
listing, given all the information supporting this constituent. The
commenter did not provide any information on how the survey respondents
determined mass loadings of o-anisidine or other constituents in their
waste, so we have no way of judging the validity of such claims. We
also expect that any given facility's raw material slate will change
over time in response to market demands for different colors and
product characteristics. Retaining this constituent in the listing
provides a clear incentive for generators to make choices in their
manufacturing processes to avoid excessive levels of o-anisidine in
their wastes. We note that there are three facilities that reported o-
anisidine in Form A under TRI. Form A is used for chemicals with
releases below 500 pounds per year (as well as other restrictions
related to usage volume). The K181 mass loading level for o-anisidine
is 110 kg, or 242 pounds, thus it is possible that these three
facilities are above or near the K181 level.
Finally, ETAD also argued that because the groundwater modeling
results indicated that the time-to-impact is more than 250 years for o-
anisidine, this constituent should be excluded from the listing. As
discussed later with respect to the comments on the risk assessment, we
do not believe this is an unreasonable time frame.
In conclusion, we have determined that our basis for including o-
anisidine in the listing is sound, and we are finalizing the o-
anisidine level as proposed.
c. 4-Chloroaniline. We proposed to include 4-chloroaniline as a CoC
because it is reported to be used in the manufacture of dyes and/or
pigments. We detected 4-chloroaniline in a variety of wastes in our
analysis of waste samples, it is reported in the TRI by a known dye
and/or pigment manufacturer, and azo dyes derived from it are subject
to regulation by the EU (see the Listing Background Document).
In addition, ETAD and CPMA comments on the November 2003 proposal
provided recent survey data indicating that two dye manufacturers use
4-chloroaniline in their processes, and that one pigment manufacturer
also uses this CoC, although not in a process covered by the scope of
the proposed K181 listing.
ETAD argued that 4-chloroaniline is only used or generated at 2 of
15 dye production facilities. We believe that this is not an
insignificant response, particularly for an industry known to
manufacture a wide variety of products over time at companies using
batch operations. Therefore, the available information indicates that
4-chloroaniline is likely to be present in dye/pigment wastes, and it
is reasonable to keep this as a constituent of concern. Moreover, even
if 4-chloroaniline were considered infrequently used, EPA would still
consider that 4-chloroaniline met the listing criteria set out in Sec.
261.11.
ETAD noted that 4-chloroaniline was only detected in two samples.
We point out, however, that 4-chloroaniline was also identified in two
wastewater samples and one ``other nonwastewater'' sample in the data
summary presented in the proposal's Listing Background Document, and
that CPMA had reported the presence of this constituent in three split
samples of the noted data. In addition, several commenters on prior
proposals for these wastes described the presence of this CoC in their
wastes. Further, the ETAD survey confirms that this constituent is
currently in use at several of their members' facilities.
ETAD also pointed out that the referenced TRI data are limited to a
single report in a single year. Bayer, the company that reported this
TRI release, explained in their comments that 4-chloroaniline is not
used by any covered dyes process and was never present in

[[Page 9152]]

the wastewater or wastewater treatment sludge generated at the facility
of interest (Bushy Park, SC). While this may be the case, it is not
clear whether 4-chloroaniline is used in pigment production at this
site as the pigment operations were sold to Sun Chemical in January
2003.\17\
---------------------------------------------------------------------------

\17\ http://www.timesleader.com/mld/timesleader/5122083.htm.

---------------------------------------------------------------------------

In addition, ETAD argued that the Agency's basis for regulating
this constituent is weak because there are no references to the use of
this chemical in the Colour Index, or in the RCRA Sec. 3007 survey. We
acknowledge both points, but note that the Colour Index, while very
useful, provides an incomplete compendium of intermediates used in the
production of dyes and pigments, particularly for those products that
have only recently been brought to market. Furthermore, the information
presented in the Colour Index is limited by certain confidentiality
concerns manufacturers may have for colorants produced. In our research
of products reported by manufacturers on their Web sites and those
listed in the Colour Index, there were many products for which no
intermediate information was available. Further, the Colour Index does
in fact identify a number of manufacturers that produce colorants
derived from 4-chloroaniline (e.g., CI 37510, 37610), although none of
them appear to be based in the U.S. This information implies that a
market exists for these products, and U.S. manufacturers might produce
these colorants. With respect to the lack of Sec. 3007 survey data, we
have previously described the incomplete nature of the survey data
available for use in the proposed rule.
Furthermore, ETAD argued that there is no evidence that either the
calculated theoretical average concentration of 4-chloroaniline (2,534
ppm) or the average waste volume of 1,894 MT/yr (described in the
proposal's Listing Background Document) occurs in dyes production
wastes. ETAD asserts that their newly collected data show that the
median volume of 4-chloroaniline is zero, and the maximum reported
volume is less than one percent of the proposed mass loading. We refer
the reader to our earlier responses to similar comments on o-anisidine.
Finally, ETAD also argued that if EPA's estimated average waste
quantity is adjusted to reflect the results of their survey and the
assumed plausible maximum constituent concentration (5,000 ppm) were
more reasonable, the 10,000 kg/yr screening level would be lower,
eliminating 4-chloroaniline as a potential CoC. As discussed more fully
in section IV.A.5, we believe that the waste quantity that we used in
the development of the proposal is well within the distribution of
waste quantities reported by commenters, and we accordingly have not
adjusted it. Similarly, we believe that the assumed plausible maximum
constituent concentration is appropriate, noting that we considered
analytical data for both ``wastewater treatment sludge'' and ``other
nonwastewaters,'' while the commenter appears to be focused only on the
wastewater treatment sludge data. The data for ``other nonwastewaters''
show several constituents with concentrations in the thousands of parts
per million.
In conclusion, we have determined that our basis for including 4-
chloroaniline in the listing is sound, and we are finalizing the 4-
chloroaniline level as proposed.
d. p-Cresidine. We proposed to include p-cresidine as a CoC because
it is reported to be used in the manufacture of dyes and/or pigments.
p-Cresidine is reported to be an intermediate in the production of
various products reported by U.S. manufacturers in the Colour Index, it
is reported in the TRI by a known dye and/or pigment manufacturer, azo
dyes derived from it are subject to regulation by the EU, and it is a
known intermediate for several products reported as available on the
website of a U.S. dye and/or pigment manufacturer (see the Listing
Background Document).
In addition, ETAD and CPMA comments on the November 2003 proposal
provided recent survey data indicating that four dye manufacturers use
p-cresidine in their processes, and that two pigment manufacturers also
use this CoC (although these uses may be from onsite dye manufacture).
ETAD argued that p-cresidine is only used or generated at 4 of 15
dye production facilities. As noted previously, we believe that this is
not insignificant, particularly for an industry known to manufacture a
wide variety of products over time at companies using batch operations.
Two pigment facilities were reported by CPMA to also use or generate
this CoC. Therefore, the available information indicates that p-
cresidine is likely to be present in dye/pigment wastes, and it is
reasonable to keep this as a constituent of concern. Moreover, even if
p-cresidine were considered infrequently used, EPA would still consider
that p-cresidine met the listing criteria set out in Sec. 261.11.
ETAD also argued that p-cresidine should be removed as a basis for
the listing in part because there are no sampling and analysis data or
RCRA section 3007 survey data demonstrating its presence in wastes. We
acknowledge that p-cresidine was not detected in any of the samples
collected in support of the 1994 rulemaking. However, the sampling was
conducted at a subset of the manufacturing sites in operation at that
time, and thus it is likely that these data are an incomplete profile
of potential waste composition. In fact, the commenter's own data
indicate that four dye manufacturers currently use p-cresidine as an
intermediate, and thus the likelihood that this CoC exists in wastes at
these sites is high. As mentioned previously, the Sec. 3007 data
presented in the proposal represents that portion of the data which
were not subject to any confidentiality claims and, therefore, does not
represent a complete profile of reported waste constituents.
In addition, ETAD argued that the TRI data does not support
inclusion of p-cresidine because only one Form R and one Form A were
submitted. However, we believe that it is significant that the TRI data
confirm that current manufacturers of impacted colorants do use and
release this CoC, supporting our basis for including p-cresidine in the
K181 listing.
Further, ETAD argued that there is no evidence that either the
calculated theoretical average concentration of p-cresidine (348 ppm)
or the average waste volume of 1,894 MT/yr (described in the proposal's
Listing Background Document) occurs in dyes production wastes. ETAD
asserts that their newly collected data show that the median volume of
p-cresidine is zero, and the maximum reported volume is less than one
percent of the proposed mass loading. We refer the reader to our
earlier responses to similar comments on o-anisidine.
Moreover, ETAD also argued that if EPA's estimated average waste
quantity is adjusted to reflect the results of their survey and the
assumed plausible maximum constituent concentration (5,000 ppm) were
more reasonable, the 10,000 kg/yr screening level would be lower,
eliminating p-cresidine as a potential CoC. We refer the reader to our
earlier response to a similar comment on 4-chloroaniline.
Finally, ETAD argued that because the groundwater modeling results
indicated that the time-to-impact is more than 250 years for p-
cresidine, this constituent should be excluded from the listing. As
discussed later with respect to the comments on the risk assessment, we
do not believe this is an unreasonable time frame.

[[Page 9153]]

In conclusion, we have determined that our basis for including p-
cresidine in the listing is sound, and we are finalizing the p-
cresidine level as proposed.
e. 2,4-Dimethylaniline. We proposed to include 2,4-dimethylaniline
as a CoC because it is reported to be used in the manufacture of dyes
and/or pigments. We detected 2,4-dimethylaniline in several wastes, it
was reported to be a waste component in the RCRA Sec. 3007 survey, and
it is a known intermediate for several products reported as available
on the websites of several U.S. dye and/or pigment manufacturers (see
the Listing Background Document).
In addition, ETAD and CPMA comments on the November 2003 proposed
rule provided recent survey data that two dye manufacturing facilities
report the use of this CoC, and confirming the presence of 2,4-
dimethylaniline in wastes at two pigment manufacturing facilities. Six
pigment manufacturers indicated in their individual comments that this
constituent is actually used or likely present in their production of
pigments.
ETAD argued that 2,4-dimethylaniline is only used or generated at 2
of 15 dye production facilities. CPMA stated that it is only used in
the production of pigments by less than 25 percent of U.S. pigment
manufacturers. We believe, however, that these usage rates are not
insignificant, particularly for an industry known to manufacture a wide
variety of products over time and at companies using batch operations.
Further, we note that CPMA has confirmed that this CoC is a waste
component at two pigment facilities, and that six pigment manufacturers
have specifically confirmed that 2,4-dimethylaniline is relevant to
their processes and/or wastes. Therefore, the available information
indicates that 2,4-dimethylaniline is likely to be present in dye/
pigment wastes, and it is reasonable to keep this as a constituent of
concern. Moreover, even if 2,4-dimethylaniline were considered
infrequently used, EPA would still consider that 2,4-dimethylaniline
met the listing criteria set out in Sec. 261.11.
ETAD argued that our basis for including this constituent is
weakened because this CoC was not detected in nonwastewaters. While we
confirm this specific observation, we note that 2,4-dimethylaniline was
detected in wastewaters by EPA, and CPMA reported this chemical in
split sample analyses. These data support EPA's finding that this
constituent may reasonably be expected to be present in some wastes
from the production of dyes and/or pigments.
ETAD also suggests that our basis for including this constituent as
a basis for the listing is weakened because we presented no linkages to
the TRI, the Colour Index (or similar sources), or the EU ban for this
constituent. First, we would note that 2,4-dimethylaniline is not
listed in section 313 of the Emergency Planning and Community Right-to-
Know Act (EPCRA), and thus is not subject to TRI reporting. With
respect to the Colour Index, this source does in fact identify a number
of manufacturers that produce azo colorants derived from 2,4-
dimethylaniline (e.g., CI 14900, 16150, 29105), although none of them
appear to be based in the U.S.\18\ This information implies that a
market exists for these products, and U.S. manufacturers might in the
future choose to produce these colorants. Finally, with respect to the
EU ban [Directive for a Community Ban on Azocolourants (76/769/EEC,
Annex I, point 43)], as discussed in the proposal, this constituent has
been studied for possible inclusion in a related ban of certain compounds
in cosmetics and is regulated as a class 2 carcinogen in Germany.\19\
---------------------------------------------------------------------------

\18\ One U.S. company, Bernscolor (Poughkeepsie, NY), is listed
in the Colour Index as marketing CI 16150, however, neither trade
association identified this facility as manufacturing in-scope dyes
and/or pigments.
\19\ Studied by EU in the context of Directive 76/768/EEC:
SCCNFP/0495/01, Opinion of the Scientific Committee on Cosmetic
Products and Non-Food Products Intended for Consumers concerning
``The Safety Review of the Use of Certain Azo-Dyes in Cosmetic
Products,'' 2/27/02. http://europa.eu.int/comm/food/fs/sc/sccp/out155_en.pdf.

---------------------------------------------------------------------------

In addition, ETAD argued that there is no evidence that either the
calculated theoretical average concentration of 2,4-dimethylaniline (53
ppm) or the average waste volume of 1,894 MT/yr (described in the
proposal's Listing Background Document) occurs in dyes production
wastes. We refer the reader to our earlier response to a similar
comment on o-anisidine.
Furthermore, ETAD asserts that their newly collected data show that
the median volume of 2,4-dimethylaniline is zero, and the maximum
reported volume is less than one percent of the proposed mass loading.
We refer the reader to our earlier response to a similar comment on o-
anisidine.
Finally, ETAD argued that because the groundwater modeling results
indicated that the time-to-impact is more than 250 years for 2,4-
dimethylaniline, this constituent should be excluded from the listing.
As discussed later with respect to the comments on the risk assessment,
we do not believe this is an unreasonable time frame.
In conclusion, we have determined that our basis for including 2,4-
dimethylaniline in the listing is sound, and we are finalizing the 2,4-
dimethylaniline level as proposed.
f. 1,2-Phenylenediamine. We proposed to include 1,2-
phenylenediamine as a CoC because it is reported to be used in the
manufacture of dyes and/or pigments. We detected 1,2-phenylenediamine
in several wastes in our analysis of waste samples, it is reported to
be an intermediate in the production of various products reported by
U.S. manufacturers in the Colour Index, it was reported in the TRI by
known dye and/or pigment manufacturers, and it is a known intermediate
for several products reported as available on the websites of several
U.S. dye and/or pigment manufacturers (see the Listing Background Document).
In addition, ETAD and CPMA comments on the November 2003 proposal
provided recent survey data indicating that two dye manufacturers use
1,2-phenylenediamine in their processes, and that two pigment
manufacturers also use this CoC. Two pigment manufacturers also
indicated in their individual comments that it is present in their
wastes (although possibly not from in-scope pigment processes).
ETAD argued that 1,2-phenylenediamine is only used or generated at
2 of 15 dye production facilities. We believe that this is not
insignificant, particularly for an industry known to manufacture a wide
variety of products over time at companies using batch operations. In
addition, CPMA has confirmed that this CoC is a waste component at two
pigment facilities, and that it is used in the production of pigments
at two facilities. Therefore, the available information indicates that
1,2-phenylenediamine is likely to be present in dye/pigment wastes, and
it is reasonable to keep this as a constituent of concern. Moreover,
even if 1,2-phenylenediamine were considered infrequently used, EPA
would still consider that 1,2-phenylenediamine met the listing criteria
set out in Sec. 261.11.
ETAD also argued that the TRI data does not support inclusion of
1,2-phenylenediamine because only one Form A was submitted for one
year. While it is true that only one Form A was reported, the TRI data
confirm that there is current use and release of this CoC, supporting
our basis for including 1,2-phenylenediamine in the K181 listing.
In addition, ETAD argued that 1,2-phenylenediamine should not be

[[Page 9154]]

included as a basis for this listing in part because there are no RCRA
Sec. 3007 survey data demonstrating its presence in wastes. As
mentioned previously, the Sec. 3007 data presented in the proposal
represent that portion of the data which were not subject to any
confidentiality claims and, therefore, does not represent a complete
profile of reported waste constituents. In fact, ETAD's (and CPMA's)
own data indicate that a number of dye and/or pigment manufacturers
currently use 1,2-phenylenediamine as an intermediate, providing
further confirmation that this CoC exists in wastes at these sites.
Furthermore, ETAD noted that 1,2-phenylenediamine was only detected
in one sample, and that the sample is outdated and of limited value as
it was qualified as a ``J'' value, and difficult to differentiate from
1,4-phenylenediamine and o-anisidine. We agree that the particular
analytical result noted is insufficient by itself to be a basis to
include 1,2-phenylenediamine in the K181 listing. However, we have
other sources of information that confirm that this constituent is used
by a number of generators in the manufacture of relevant colorants. We
note that 1,2-phenylenediamine was also tentatively identified in four
wastewater samples in the data summary presented in the proposal's
Listing Background Document. Two comments on the earlier proposed
listing determination for these wastes also refer to the use or
presence of this constituent in the wastes of concern. In addition, the
ETAD and CPMA surveys confirm that this constituent is currently in use
at a number of their members' facilities.
Moreover, ETAD argued that there is no evidence that either the
calculated theoretical average concentration of 1,2-phenylenediamine
(375 ppm) or the average waste volume of 1,894 MT/yr (described in the
proposal's Listing Background Document) occurs in dyes production
wastes. We refer the reader to our earlier response to a similar
comment on o-anisidine.
ETAD also asserts that their newly collected data show that the
median volume of 1,2-phenylenediamine is zero, and the maximum reported
volume is less than one percent of the proposed mass loading. We refer
the reader to our earlier response to a similar comment on o-anisidine.
Finally, ETAD argued that if EPA's estimated average waste quantity
is adjusted to reflect the results of their survey and the assumed
plausible maximum constituent concentration (5,000 ppm) were more
reasonable, the 10,000 kg/yr screening level would be lower,
eliminating 1,2-phenylenediamine as a potential CoC. We refer the
reader to our earlier response to a similar comment on 4-chloroaniline.
In conclusion, we have determined that our basis for including 1,2-
phenylenediamine in the listing is sound, and we are finalizing the
1,2-phenylenediamine level as proposed.
g. 1,3-Phenylenediamine. We proposed to include 1,3-
phenylenediamine as a CoC because it is reported to be used in the
manufacture of dyes and/or pigments. Specifically, 1,3-phenylenediamine
is reported to be an intermediate in the production of various products
reported by U.S. manufacturers in the Colour Index, it was reported in
the TRI by a known dye and/or pigment manufacturer, it was reported to
be a waste component in the RCRA Sec. 3007 survey, and it is a known
intermediate for several products reported as available on the websites
of several U.S. dye and/or pigment manufacturers (see the Listing
Background Document).
In addition, ETAD and CPMA comments on the November 2003 proposal
provided recent survey data indicating that three dye manufacturers use
1,3-phenylenediamine in their processes, and that one pigment
manufacturer indicated that it is present in their wastes (although not
from in-scope pigment processes).
ETAD argued that 1,3-phenylenediamine is only used or generated at
three of 15 dye production facilities. We believe that this is not
insignificant, particularly for an industry known to manufacture a wide
variety of products over time at companies using batch operations. In
addition, the available RCRA Sec. 3007 survey results indicate that
this constituent was reported by industry in at least 17 in-scope
discrete wastestreams. Therefore, the available information indicates
that 1,3-phenylenediamine is likely to be present in dye/pigment
wastes, and it is reasonable to keep this as a constituent of concern.
Moreover, even if 1,3-phenylenediamine were considered infrequently
used, EPA would still consider that 1,3-phenylenediamine met the
listing criteria set out in Sec. 261.11.
ETAD also argued that 1,3-phenylenediamine should not be included
as a basis for the listing in part because there are no sampling and
analysis data demonstrating its presence in wastes. We acknowledge that
1,3-phenylenediamine was not detected in any of the samples collected
in support of the 1994 rulemaking. However, the sampling was conducted
at a subset of the manufacturing sites in operation at that time, and
thus it is likely that these data are an incomplete profile of
potential waste composition. The commenter's own data indicate that
three dye manufacturers currently use 1,3-phenylenediamine as an
intermediate, providing further confirmation that this CoC exists in
wastes at these sites.
In addition, ETAD also argued that there is no evidence that either
the calculated theoretical average concentration of 1,3-
phenylenediamine (634 ppm) or the average waste volume of 1,894 MT/yr
(described in the proposal's Listing Background Document) occurs in
dyes production wastes. We refer the reader to our earlier response to
a similar comment on o-anisidine.
Furthermore, ETAD asserts that their newly collected data show that
the median volume of 1,3-phenylenediamine is zero, and the maximum
reported volume is less than 10 percent of the proposed mass loading.
We refer the reader to our earlier response to a similar comment on o-
anisidine, and note that ``10 percent'' is not insignificant--process
changes or stepped up production volumes might increase this maximum
value to exceed the K181 loading limit.
Finally, ETAD argued that if EPA's estimated average waste quantity
is adjusted to reflect the results of their survey and the assumed
plausible maximum constituent concentration (5,000 ppm) were more
reasonable, the 10,000 kg/yr screening level would be lower,
eliminating 1,3-phenylenediamine as a potential CoC. We refer the
reader to our earlier response to a similar comment on 4-chloroaniline.
In conclusion, we have determined that our basis for including 1,3-
phenylenediamine in the listing is sound, and we are finalizing the
1,3-phenylenediamine level as proposed.
7. Availability of Analytical Methods for Constituents of Concern
Commenters contend that EPA did not adequately address the
availability of analytical methods necessary to implement the proposed
rule. The commenters pointed out that EPA's economic analysis suggested
that four proposed constituents (toluene-2,4-diamine, 1,2-
phenylenediamine, 1,3-phenylenediamine, and 2,4-dimethylaniline) lack
established analytical methods. Most commenters were especially
concerned with the lack of a verified method for one of the four
constituents, toluene-2,4-diamine. One commenter also expressed concern
specifically over the lack of methods for

[[Page 9155]]

1,2-phenylenediamine. Commenters questioned the adequacy of the methods
for analyzing another proposed constituent (aniline). They referred to
previous studies that indicated gas chromatography methods may cause
false positive readings for aniline, because another chemical sometimes
present (acetoacetanilide) often breaks down into aniline in the analysis.
We continue to believe that adequate analytical methods exist for
most CoCs. However, as described previously, we have decided to no
longer include toluene-2,4-diamine as a constituent of concern for
K181. Therefore, analysis of this chemical will not be necessary.
Concerning 1,2-phenylenediamine, we noted the problems with this
constituent in the proposed rule (68 FR 66194). We have reexamined the
available EPA methods and determined that, while some methods (e.g.,
SW-846 method 8321B) show promise, the recoveries remain low. Thus, we
have decided to allow generators to use their knowledge of the waste
instead of determining the level of this constituent through testing.
We have revised the final K181 regulatory language to reflect this
change in the testing requirements by inserting (d)(3)(ii), which reads:

(d)(3)(ii) If 1,2-phenylenediamine is present in the wastes, the
generator can use either knowledge or sampling and analysis
procedures to determine the level of this constituent in the wastes.
For determinations based on use of knowledge, the generator must
comply with the procedures for using knowledge described in
paragraph (d)(2) and keep the records described in paragraph
(d)(2)(iv) of this section. For determinations based on sampling and
analysis, the generator must comply with the sampling and analysis
and recordkeeping requirements described below in this section.

We believe that the other constituents have adequate methods. While
2,4-dimethylaniline is not included as an analyte in EPA's SW-846
manual of methods, the chemical has been measured in dye and pigment
waste samples by both EPA \20\ and by industry.\21\ As the 2003 BDAT
background document indicated, the standard EPA gas chromatography/mass
spectrum method (GC/MS method 8270) should be effective for this
constituent. We are also confident that this GC/MS method is adequate
for 1,3-phenylenediamine. This is further supported by an EPA technical
paper showing that 1,3-phenylenediamine can be determined using GC/MS
methods.\22\ As noted by the commenters, this same technical paper
describes the breakdown of the chemical acetoacetanilide to aniline
during GC/MS analysis. While this could theoretically present
difficulties in determining a precise concentration of aniline in
wastes that also contain acetoacetanilide, generators may deal with
this potential problem in several ways. The technical paper cited above
shows that aniline may also be determined by other methods, i.e., High
Performance Liquid Chromatography (HPLC) methods. HPLC methods do not
require the high temperatures needed for GC/MS analysis; thus, the
presence of acetoacetanilide should not present any problems.
Alternatively, a generator could conduct the GC/MS analysis,
recognizing that some of the aniline detected may arise from the
breakdown of acetoacetanilide. If the measured aniline in the waste is
still below the aniline loading limit for K181, then the waste would
not be a hazardous waste due to aniline. Because the loading limit for
aniline is rather high (9,300 kg/yr), there would have to be a high
level of acetoacetanilide present in the waste to cause any significant
problem. In any case, the generators have the option of using the HPLC
method if they believe that aniline levels would approach the mass
loading limit, and if they know that the waste contains acetoacetanilide.
---------------------------------------------------------------------------

\20\ See the aggregated EPA data in Appendix I of the Background
Document for Identification and Listing of Wastes from the
Production of Organic Dyes and Pigments, which is in the docket for
today's rule.
\21\ See final table in the industry data attached to the Letter
from J. Lawrence Robinson, President of the CPMA, to Ed Abrams of
EPA, regarding aggregated test data resulting from analyses of the
split samples, April 20, 1994, in the docket for today's rule.
\22\ See the technical paper attached to the Letter from J.
Lawrence Robinson, President of the CPMA, to Ed Abrams of EPA,
regarding aggregated test data resulting from analyses of the split
samples, April 20, 1994, in the docket for today's rule.
---------------------------------------------------------------------------

8. Risk Assessment
The Agency received comments on a number of issues that focused on
the risk analysis that EPA conducted for the proposed K181 listing
determination. The most significant of these comments, summarized
below, pertain to the General Soil Column Model, biodegradation rates,
infiltration rates, well distance, hydraulic conductivity, simulation
durations and exposure parameters. We have developed responses for all
of the public comments received on the proposed rule. The verbatim
comments and our responses are provided in the Response to Comments
Background Document in the docket for today's rule.
a. General Soil Column Model (GSCM). The landfill model that we
used approximates the dynamic effects of the gradual filling of active
landfills. The Generic Soil Column Model (GSCM) is a critical submodel
or algorithm that predicts the fate and transport of constituents
within the landfill and partitions contaminants to three phases:
adsorbed (solid), dissolved (liquid), and gaseous.
Commenters contended that the GSCM is under review by the EPA's
Science Advisory Board (SAB) and that the SAB panel identified
significant errors that are expected to produce erroneous results. The
commenters expected that the SAB panel would recommend that EPA not use
the GSCM to make any regulatory decisions until a more thorough
evaluation, including reanalysis of the underlying model code is
completed. As a result, the commenters argued that it is unacceptable
for EPA to use the GSCM to make regulatory decisions for the dyes
manufacturing industry. The commenters noted that EPA has performed
limited comparison simulations between the GSCM and another model
(MODFLOW-SURFACT). While the results from this comparison indicated
that the two simulations yield similar results, the commenters stated
that the tests completed by EPA represent only a simple and potential
worst-case scenario that does not test soil zone complexity. Although
uniform soil zone properties are expected to result in maximum
leaching, the commenters argued that EPA should also complete an
evaluation of the GSCM under conditions with significant heterogeneity.
We continue to believe that the use of the GSCM is appropriate and
does not produce erroneous results. In the final SAB report,\23\ the
SAB acknowledged that 3MRA--in its current state--could be used to
support regulatory decisions for national exit concentrations. However,
the SAB also recognized that 3MRA is the product of a collection of
submodels (which includes the GSCM) and that any regulatory decisions
that rely on 3MRA will reflect the uncertainty and the limitations of
these models. The SAB panelists conducted a thorough evaluation of the
GSCM and agreed with the EPA's thoughts on the strengths and
limitations of the GSCM. The SAB pointed out that the GSCM--as compared
to some of the legacy models in 3MRA--``is relatively untested and has
some potential (italics added) theoretical inadequacies.'' The SAB
review goes on to report on several model evaluation studies (e.g.,

[[Page 9156]]

conducting model-to-model studies and comparing estimated and
experimental data) conducted by EPA, suggesting that these types of
studies are important steps in building confidence in the model and
increasing our understanding of the limitations of the GSCM.
---------------------------------------------------------------------------

\23\ Report of the U.S. EPA Science Advisory Board Review Panel;
EPA's Multimedia, Multipathway, and Multireceptor Risk Assessment
(3MRA) Modeling System; EPA-SAB-05-003, November 2004
(http://www.epa.gov/sab/fiscal04.htm).

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One of the major theoretical issues raised by the SAB was the
concern with the GSCM's ability to produce reliable leachate profiles
for short time scales; that is, less-than-annual chemical concentration
profiles for leachate. However, the Agency's risk assessment of waste
from dye and/or pigment manufacture is based on long-term chronic
exposures and, therefore, the concentrations at the point of exposure
are averaged according to the exposure duration for each receptor. In
particular, the comparison between the GSCM and MODFLOW/SURFACT (a
widely used flow and transport simulator) demonstrated that long-term,
average leachate concentration profiles generated by the GSCM were
similar to those generated by the more robust solution technique used
in MODFLOW-SURFACT. Thus, the comparison between the GSCM and MODFLOW-
SURFACT demonstrated that the theoretical limitations in the GSCM do
not appear to be significant when generating annual averages for the
purposes of estimating long-term potential risks to humans and
ecological receptors for the dyes and pigments assessment.
b. Biodegradation. Within the landfill, we simulated losses of mass
through anaerobic biodegradation (i.e., degradation processes that
occur in an oxygen-free environment). In the absence of biodegradation
data for seven organic chemicals, we used surrogate information for
similar compounds. Commenters generally supported the use of surrogates
and the appropriateness of considering biodegradation in anaerobic
landfill conditions. However, commenters believed that EPA
overestimated concentrations at receptor wells, because EPA used the
maximum half-life from the available data (i.e., we used the slowest
degradation rates). Commenters suggested that it would be more
appropriate to use average values for the half-life.
We continue to believe that our use of the maximum half-life for
biodegradation is appropriate to ensure that the mass-loading levels
are protective to compensate for the uncertainties inherent in the
data. We used anaerobic degradation rates that were available in our
primary reference,\24\ and when degradation data were not available, we
used degradation rates based on surrogate chemicals. This reference
provides ranges of half lives in environmental media and the Agency
acknowledges there is considerable uncertainty associated with these
data. Where available, the authors use preferred data from experimental
values. However, in cases where experimental values were not available,
scientific judgements were made in order to estimate a value. The
amount of biodegradation that occurs will also vary depending on
various site-specific environmental parameters, including temperature,
pH, and available biomass. In light of these uncertainties, we believe
that it is prudent to use the high value in the range of values presented
rather than to use an average value as suggested by the commenters.
---------------------------------------------------------------------------

\24\ Howard, P.H., R.S. Boethling, W.F. Jarvis, W.M. Meylan,
E.M. Michalenko, and H.T. Printup (ed.). 1991. Handbook of
Environmental Degradation Rates. Lewis Publishers.
---------------------------------------------------------------------------

c. Landfill Infiltration Rates. Our modeling for landfills included
analyses for both clay liner and composite liner scenarios. For the
clay-liner scenario, we used the existing databases of landfill
infiltration rates and ambient regional recharge rates calculated using
the Hydrologic Evaluation of Landfill Performance (HELP) water-balance
model. For the composite liner scenario, we used empirical
distributions of infiltration rates for composite-lined landfills
compiled in a recent report (TetraTech report).\25\
---------------------------------------------------------------------------

\25\ ``Characterization of Infiltration Rate Data to Support
Groundwater Modeling Efforts,'' Draft Final. TetraTech, Inc.
September 28, 2001.
---------------------------------------------------------------------------

The commenters stated that they identified several errors and
inconsistencies with the infiltration estimates used to predict
downgradient concentrations. The commenters indicated that the
composite liner infiltration rates EPA used in the modeling analysis
were not consistent with the infiltration rates shown in the TetraTech
report. The commenters claimed that EPA incorrectly used infiltration
rates for the single synthetic liner instead of the infiltration rates
for the composite liner. One commenter noted that the Risk Assessment
Background Document provides a leak density variable, as well as an
infiltration rate for landfills, suggesting that infiltration rates
through the liner are calculated. Thus, the commenter suggested that
EPA clarify exactly how leachate curves are estimated. The commenter
also stated that the HELP model is not an appropriate tool to determine
liner percolation rates because (1) the HELP model is intended to be
used as a landfill design tool to evaluate the merits of different
design alternatives, and (2) the HELP model has been found to
overestimate infiltration rates at landfills and to erroneously predict
the timing of events.
As we described in the proposal, we based the composite liner
scenario on infiltration rates extracted from the TetraTech report for
composite lined landfill units, i.e., units with a combination of
geomembrane (GM) and clay liners (compacted clay, CCL, or geosynthetic
clay, GCL). We screened the data to yield a data set of forty
infiltration rates. The composite liner scenario represented only those
rates from the screened set of rates and, thus, we did not use rates
from single synthetic liners in this analysis. We then generated the
specific values used for modeling the composite liner scenario through
interpolation using the available forty infiltration rates. Thus, the
interpolated values are a representative distribution of the forty
rates and do not reflect single synthetic liners. Finally, we also note
that we are not using the composite liner results to set mass-loading
levels since we have decided to no longer include toluene-2,4-diamine
as a constituent of concern for K181.
Regarding the HELP model, the Agency used the model to determine
infiltration rates through capped unlined and clay lined landfills
hypothetically sited at each of the 102 climate stations available in
the model. Neither permeability nor leak density were included as
parameters in these simulations. EPA used the HELP model, in
conjunction with data from climate stations across the United States,
to develop recharge and infiltration rate distributions for different
liner designs.\26\ Further, the landfills modeled in this analysis were
consistent with standard design practices, and similar to the type of
landfill HELP was designed to simulate. The Agency used the HELP model
to estimate long-term infiltration rates based on the historical data
available with the model. Recent evaluations of actual leachate
generation rates have shown that the HELP model can also be a very good
approximation of actual conditions.
---------------------------------------------------------------------------

\26\ See Appendix A of the EPA's Composite Model for Leachate
Migration with Transformation Products (EPACMTP)--Parameters/Date
Background Documents (2003).
---------------------------------------------------------------------------

d. Well Distance. The commenters contended that the information on
well distance from EPA's National Survey of Municipal Landfills is not
representative of disposal practices in the dye industry. The commenters'

[[Page 9157]]

review of the survey used to estimate well distance indicated that EPA
only collected well distance information if a well was located within
one mile of the landfill. The commenters contended that the survey
results used by EPA are significantly skewed and any distribution
calculated from these results will not be representative of municipal
landfills, but only those municipal landfills with well distances less
than one mile. The commenters suggested that EPA should have limited
the well distance information to those facilities currently used by dye
manufacturers, and resubmitted a survey of landfills originally
submitted in comments on the previous 1999 proposed rule. According to
the data supplied, seven of sixteen landfills have no nearby wells or
have wells greater than one mile from the landfill boundary. Based on
this information, the commenters argued that the Agency's well distance
distribution was irrelevant for the dye industry and thereby
overestimated potential migration of constituents from the landfill to
the receptor well.
We believe that the use of a national distribution of landfill
characteristics is appropriate. The populations of concern to EPA are
those with private wells near landfills, and the selected distribution
covers that population. The data supplied by the commenters are
incomplete with respect to coverage of all facilities in the dyes and/
or pigments industries and, therefore, may not be representative of
disposal facility characteristics that could be used. The Agency
adopted an approach to use a nationwide risk assessment methodology
that has been applied in previous listing determinations, and this
approach has been subject to peer review. As noted in our response to
comments on landfill liners in section IV.A.2, the specific landfill
information submitted by the commenters was for a small number of
landfills relevant to dye manufacturers only, and would not be
representative of the landfills that could be used (EPA estimated that
there are about 2,300 MSW landfills in operation in 2000). Moreover,
disposal locations, in addition to well locations, can change over
time. Therefore, we used probabilistic analyses in an attempt to
incorporate the variability and uncertainty in the data.
e. Hydraulic Conductivity Values. The commenters questioned a
number of hydraulic conductivity values used in the regional
hydrogeologic database. The commenters believed that these ``extremely
high'' hydraulic conductivity values are implausible and skewed the
model results. The commenters contended that this would over predict
concentrations at the receptor well, and significantly under predict
the travel time to the receptor well. Moreover, they believed that
these high hydraulic permeabilities are not representative of any
shallow or deep zone aquifer system in the United States.
It is the Agency's position that the hydrogeologic database (HGDB)
is the best data source available to characterize subsurface parameters
for conducting nationwide, probabilistic, groundwater pathway analyses.
The hydraulic conductivity values used in this analysis were compiled
under the auspices of the American Petroleum Institute and the National
Well Water Association.\27\ The objective of the data compilation was
to provide the Agency an up-to-date, screened datasource for
probabilistic modeling. Hydraulic conductivity values from site
investigations at 400 hazardous waste sites were collected, subjected
to internal review, and were subsequently published in a peer-reviewed
journal.
---------------------------------------------------------------------------

\27\ Newell, C.J., L.P. Hopkins, and P.B. Bedient. 1989.
Hydrogeologic Database for Ground Water Modeling. American Petroleum
Institute, Washington, DC; and Newell, C.J., L.P. Hopkins, and P.B.
Bedient. 1990. A hydrogeologic database for ground water modeling.
Ground Water 28(5):703-714.
---------------------------------------------------------------------------

The groundwater velocity at a specific location, such as a receptor
well, has regional and local contributions. Regional groundwater
velocities are proportional to hydraulic conductivity, while local
velocities are governed by areal recharge and are almost independent of
hydraulic conductivity. Of the entire hydraulic conductivity database,
there are only two values equal to 2.21 x 10\7\ m/yr. These values are
relatively high but not implausible for fractured sedimentary rocks
(Region 2). Regions 4, 5, and 6 (Sand and Gravel; Alluvial Basins,
Valleys, and Fans; and River Valleys and Flood Plains, respectively)
have four hydraulic conductivity values which are in excess of 10\5\ m/
yr. These values, although relatively high, are also not implausible.
For example, literature references indicate that values of hydraulic
conductivities for gravelly deposits may range from 10\4\ to 10\7\ m/
yr.\28\ We also note that these values make up an extremely small
fraction of the values in the data base, thereby reflecting the
likelihood of their occurrence nationally. This is consistent with the
nationwide probabilistic approach we used in the risk evaluation.
f. Simulation Durations. The commenters pointed out that for
several chemicals (o-anisidine, p-cresidine, and 2,4-dimethylaniline),
the groundwater time to impact is more than 250 years. The commenters
stated that simulations over this time period are computationally
intensive and generate results that are unrealistic and not
interpretable, because we cannot predict human behaviors that influence
exposure or land uses so far in the future. Commenters suggested that
EPA should limit the results to the maximum concentration within the
next 100 years.
---------------------------------------------------------------------------

\28\ See Freeze, R.A., J.A. Cherry. 1979. Groundwater; Prentice
Hall, Englewood Cliffs, New Jersey, and Driscoll, F.G. 1986.
Groundwater and Wells, Second Edition; Johnson Screens, Publisher,
St. Paul, Minnesota.
---------------------------------------------------------------------------

As a matter of policy, the Agency has adopted long time frames for
assessing risks in the hazardous waste listing program because it
allows peak concentrations to be observed at most receptor locations.
This time frame is consistent with other listing determinations.\29\
The EPACMTP computer model, developed by the Agency, can perform the
simulation over these time frames in a computationally efficient manner
on modern computers. It is well documented in the scientific literature
that groundwater travel can span hundreds to thousands of years.
---------------------------------------------------------------------------

\29\ Paints Listing Determination; February 13, 2001; 66 FR
10093; Inorganic Chemical Manufacturing Listing Determination;
September 14, 2000; 65 FR 55697.
---------------------------------------------------------------------------

Therefore, we do not agree that simulations over a 250-year time
period will generate results that are unrealistic and not
interpretable. Furthermore, the commenter did not provide any reason
why arbitrarily restricting the modeling to a 100-year time frame would
be more appropriate. The Agency agrees that future changes in human
behavior and environments are subject to uncertainty. However, the
Agency's probabilistic approach in conjunction with relatively
conservative assumptions is designed to provide a reasonable level of
protection for future generations.
g. Exposure Parameters. Commenters stated that EPA has selected
maximum values for several exposure parameters for the probabilistic
analyses, and that use of maximum values overestimates potential risk.
Ingestion and inhalation rates: Commenters argued that EPA's
current ranges for groundwater ingestion rates are overly conservative
and that EPA overestimated the amount of water ingested by potential
adult receptors. The commenters noted that the maximum values used by
EPA are higher than the 99th percentile value presented in EPA's
Exposure Factors

[[Page 9158]]

Handbook (EPA 1997a).\30\ The commenters also argued that EPA
overestimates maximum inhalation rates for adult and child residents,
noting that the maximum rate used by EPA exceeds the 99th percentile
inhalation rates for men and women given in EPA guidance (EPA (2000),
Options for Development of Parametric Probability Distributions for
Exposure Factors).
---------------------------------------------------------------------------

\30\ U.S. EPA Exposure Factors Handbook, August 1997; EPA/600/P-
95/002Fa. http://www.epa.gov/ncea/pdfs/efh/front.pdf.

---------------------------------------------------------------------------

We do not agree that the water ingestion and inhalation rates we
used are overly conservative. The maximum values were used to truncate
the distribution during sampling using a statistical software package.
A large range was used in order to prevent the shape of the data
distributions from being distorted. For groundwater ingestion, the
mean, 50th, 90th, 95th, and 99th percentiles from the sampled data were
verified by comparing them against the data provided in EPA's Exposure
Factors Handbook. Similarly for inhalation, the simulated 99th
percentile value for the adult inhalation rate we used was consistent
with the values cited in the above document. In addition, the
probabilistic analyses use values throughout the distribution of
parameter values. The maximum value is only one point on the
distribution curve, and thus, has a minor impact on the overall
modeling results.
Exposure Duration: The commenters contended that EPA used exposure
durations that are inappropriate for the receptors identified. The
commenters argued that EPA overestimated the period of exposure,
thereby arbitrarily increasing the risk estimates calculated. The
commenters pointed out that the exposure duration for a child varied
between one and 50 years, even though the greatest length of potential
exposure is five years for a one-to five-year-old. Commenters stated
that EPA correctly holds all other inputs within the one-to five-year
age bracket; therefore, EPA's methodology could result in modeling a
22-year-old that has the body weight and ingestion rate of a five-year-old.
EPA does not agree that the exposure duration is inappropriate for
the receptors identified. The exposure duration used in the analysis is
selected once for each receptor at the beginning of each iteration. As
we described in the proposal (68 FR 66182-66183), we evaluated a child
whose exposure begins at a random age between one and six years old. We
then aged the child for the number of years defined by the randomly
selected exposure duration. As children mature, their physical
characteristics and behavior patterns change. Depending on the exposure
duration selected, a receptor (e.g., a 1-to 5-year-old) ages through
successive age groups (also known as cohorts). Other exposure
parameters (i.e., body weight, inhalation rate, drinking rate) are held
constant while a receptor is in a given age cohort, but are selected
again as a receptor enters the successive age cohort. For example, a
receptor initiated at age three would have a constant 1- to 5-year-old
body weight at ages 3, 4, and 5. At age 6, a new body weight would be
selected from the 6- to 11-year-old body weight distribution to be used
for the duration spent in this cohort (and so on). A 22-year-old would
have a body weight selected from the adult body weight distribution,
not that of a 1- to 5-year-old.
Indoor air exposures: The commenters believe that the shower model
used by EPA overestimates potential exposure and risk. The commenters
claim that EPA used several overly conservative exposure parameters,
including the time in the bathroom. Commenters contended that it is
highly unlikely that individuals regularly spend four hours in the
bathroom showering and in related activities, and suggested that the
total duration should not exceed a plausible value (e.g., one hour
total). The commenters also argued that EPA assumed that the entire
constituent concentration is available for uptake and did not consider
that only a fraction of that inhaled may be available and absorbed.
EPA does not believe that the indoor air exposure parameters are
overly conservative. During the Monte Carlo simulation, the
distributions for the time spent in showering and related activities
are sampled independently, such that the combined shower exposure used
in the Monte Carlo simulation is significantly lower than four hours.
For example, the 50th percentile value of the combined shower exposures
results in a duration of 32 minutes in the bathroom; the 99th
percentile value of the combined shower exposures results in a total
duration of 83 minutes in the bathroom. These are not implausible
values. The commenters did not suggest any alternative exposure periods
for the showering scenario, so we cannot compare any suggested values
to those we used in our analysis. We note, however, that the mean,
50th, 90th, 95th, and 99th percentiles were verified by comparing them
against the data provided in EPA's Exposure Factors Handbook. In
addition, shower inhalation exposure was a determining exposure pathway
for only two constituents (naphthalene and dichlorobenzene) and neither
of these two constituents served as a basis for listing K181. Drinking
water ingestion was the determining pathway for all other constituents.
In order to be protective of human health, EPA assumes that the
entire constituent concentration in indoor and ambient air is available
for respiratory uptake, unless chemical-specific data indicate
otherwise. Data on the fraction absorbed from inhalation are not
frequently available, and the commenter did not provide any such data.
However, when data are available, the fraction absorbed is incorporated
into the cancer and noncancer inhalation benchmarks.
Monte Carlo Distributions: In the Monte Carlo analysis, the Agency
used distributions to describe several exposure parameters, including
body weight, exposure duration, and drinking water intake. The
commenters contended that EPA failed to follow its own guidance when
developing these distributions, noting that the document Guiding
Principles for Monte Carlo Analysis (EPA 1997c) stated ``risk assessors
should never depend solely on goodness-of-fit tests to select the
analytic form for a distribution.'' The commenters pointed out that for
the distributions used in the exposure assessment, the Agency did not
complete any graphical analyses of the data to ensure that the
distributions selected were consistent with the results of the
statistical analyses. The commenters also stated that EPA did not
provide enough information to support the distribution selected for
drinking water ingestion (a gamma distribution) instead of a lognormal
distribution, as described in EPA's Exposure Factors Handbook.
We agree that graphical representations are often useful and we
have provided such graphical representations for key exposure
parameters in the Response to Comment document. However, as part of our
analysis for the proposal, EPA conducted a thorough review of sampled
data to ensure that the selected percentiles were representative of the
data. Regarding the specific distribution selected for drinking water
ingestion, the gamma model provided a better fit. In any case, we found
no significant difference between using the gamma versus the log normal
distributions for this data set. For example, using a gamma
distribution for drinking water intake of adults, the 50th and 90th
percentile simulated values are 1,272 mL/day and 2,302 mL/day, compared to

[[Page 9159]]

1,252 mL/day and 2,268 mL/day for the log normal distribution.
9. Implementation
EPA received comments on a number of issues concerning the proposed
implementation approach for the K181 listing determination. The most
significant issues include: (1) EPA's alternative to consider all
wastes generated during the year to be hazardous if the mass loading
limit for a CoC in the wastes is met or exceeded at any time during the
year; (2) not allowing higher quantity waste generators the option of
using knowledge of their wastes to demonstrate that the wastes are
nonhazardous; (3) use of the maximum detected concentration or a
concentration based on the 95th percentile upper confidence limit of
the mean to determine the mass of a CoC; (4) EPA's onsite recordkeeping
requirements to support a nonhazardous determination for the wastes;
and (5) EPA's annual follow-up testing requirements to verify that
wastes remain nonhazardous. The Agency's responses to these comments
are summarized below. The verbatim comments and our responses to all
comments are provided in the Response to Comments Background Document.
a. Alternative Option for Wastes Which Meet or Exceed Mass Loading
Limit. EPA took comment on an alternative option that would consider
all wastes generated during the year to be hazardous if the mass
loading limit for a CoC in the wastes is met or exceeded at any time
during the year. Commenters on the proposed rule did not support this
option. They argued that this alternative is not necessary or practical
for several reasons. First, waste quantities determined to be
nonhazardous based on the results of the risk assessment would be
subject to hazardous waste regulation. Second, it would require the
waste generators to accurately forecast customer demand for products
and the amount of constituents in wastes over a one year period from
highly variable waste streams that often result from batch
manufacturing processes. Third, customers may have to be turned away
and potential new products put on hold if a company's forecast for the
mass of any CoC in its wastes is approached before the end of the
calendar year and the wastes have been disposed in a nonhazardous
landfill. Finally, waste management facilities (for nonhazardous
wastes) may not accept such nonhazardous wastes if the wastes may later
be declared hazardous.
EPA generally agrees with the concerns stated by the commenters on
the alternative option. We noted some of these concerns in the proposed
rule as part of our request for comment on this option. Specifically,
we agree that the alternative approach would cause significant
difficulties for waste management facilities that might accept initial
batches of wastes as nonhazardous, but later find that these wastes are
declared hazardous. As a result, the generators may have difficulty in
finding waste management facilities that would accept wastes as
nonhazardous under this approach. Therefore, we are finalizing the
proposed approach, which considers all K181 potential wastes generated
up to the mass loading limits of the CoCs to be nonhazardous and allows
these wastes to be managed as nonhazardous. In other words, the K181
listing would apply to only the portion of wastes that meets or exceeds
the mass loading limits for any of the K181 CoCs in a calendar year.
While the K181 listing only applies to wastes that meet or exceed
the mass loading limits, the Agency notes that the annual mass loading
limits, the landfill design requirements, and treatment in specified
combustion units are conditions of the listing. Dyes and/or pigments
nonwastewaters become K181 wastes unless a generator fulfills one of
these conditions. If one or more of these conditions are not met, EPA
or authorized states could bring enforcement actions for violations of
hazardous waste requirements against anyone who has not managed the
waste in compliance with applicable Subtitle C requirements.
Furthermore, EPA can take action under section 7003 of RCRA if the
management of dyes and/or pigment nonwastewaters may pose an imminent
and substantial endangerment to human health or the environment. Thus,
we advise generators to properly store nonwastewaters that are
potentially hazardous under the K181 listing. At a minimum, we
encourage generators to store all wastes in proper containers (i.e.,
such that wastes are not placed directly on the ground) prior to disposal.
b. Using Knowledge of Wastes To Demonstrate that Wastes are
Nonhazardous. EPA proposed that waste generators who generate or expect
to generate 1,000 metric tons per year or less of K181 categorized
wastes would have the option of using knowledge of their wastes to
demonstrate that their wastes are nonhazardous. On the other hand, we
proposed that generators who generate more than 1,000 metric tons per
year (MT/yr) of K181 would be required to use the more extensive
procedures in Sec. 261.32(d)(3), which include a requirement to test
for constituents reasonably expected to be present. Commenters objected
to EPA's proposal that would limit who could use knowledge of their
wastes to demonstrate that their wastes are nonhazardous. They stated
that all waste generators should have the option of using knowledge to
demonstrate that their wastes are nonhazardous, irrespective of how
much waste they generate. This is because, in most cases, commenters
believe that testing of wastes by generators is unnecessary and
burdensome. They pointed out that waste generators have sufficient
knowledge about their wastes to make appropriate determinations for any
quantity of wastes that they generate. They also noted that the wastes
do not contain many of the proposed CoCs for K181 and, when present,
they are not likely to exceed threshold quantities. Finally, the
commenters emphasized that, if toluene-2,4-diamine is not present in
the wastes and the wastes are being disposed in lined landfills, then
the testing requirements are irrelevant and should be deleted.
We proposed and are finalizing that all manufacturers can use
knowledge of their wastes to determine which K181 constituents of
concern are reasonably expected to be present in their wastes. However,
we do not agree that manufacturers who generate more than 1,000 MT/yr
should have the option to use knowledge to determine the level of K181
CoCs present in their wastes. This is in part because, as stated in the
proposal, we believe that the larger quantities of wastes have the
potential for posing greater environmental risks than smaller
quantities of wastes if a nonhazardous determination based on knowledge
turns out to be inaccurate (see 68 FR 66202). In addition, as discussed
previously (section IV.A.6), we believe that the information available
indicates that the constituents of concern are present in dye/pigment
production wastes, and that the levels of the constituents have the
potential to exceed the annual mass loading limits. Therefore, we
believe that it is reasonable to require larger quantity waste
generators to test their wastes. Test data represent the best
information that can be obtained on the concentrations of CoCs present
in the waste and for use in determining the mass loading levels for
CoCs, because waste testing provides a direct indication of constituent
levels. It should also be noted that, based on the conditional nature
of the final listing

[[Page 9160]]

determination, the generators who generate more than 1,000 metric tons
per year of K181 would only have to test their wastes if they are
managing them in a landfill that does not meet the liner standards
identified in the listing. That is, if such generators are managing
their wastes in lined landfills that are subject to (or otherwise meet)
Sec. 258.40, 264.301 or 265.301, there is no need to determine the
levels of K181 CoCs and thus no need to test. Finally, we note that if
facilities generating 1,000 MT/yr or less use some level of waste
analysis data to determine the levels of CoCs present, they are still
only subject to the requirements in Sec. 261.32(d)(2), and not the
more extensive testing requirements in Sec. 261.32(d)(3).
We are adding further language in the regulations to clarify when
the generators are required to evaluate their wastes and to demonstrate
their wastes are not hazardous. We have revised the beginning of Sec.
261.32(d) to make it clear that only generators that do not dispose of
the wastes in landfill units that meet the design requirements in the
listing description are required to evaluate their wastes for CoCs
under Sec. 261.32(d)(1) through Sec. 261.32(d)(3). Generators that
dispose of their wastes in landfills meeting the specified design
requirements do not have to evaluate their wastes, however they must
document the disposal in an appropriate landfill (Sec. 261.32(d)(4)).
Furthermore, we added language to the beginning of Sec. 261.32(d)(3)
to clarify that all steps in this subparagraph must be completed.
c. Use of the Maximum Detected Concentration or a Concentration
Based on the 95th Percentile Upper Confidence Limit of the Mean. EPA
proposed that waste generators use the maximum detected concentration
or, if multiple samples are collected, use either the maximum
concentration or a concentration based on the 95th percentile upper
confidence limit of the mean (UCLM) in order to determine the mass of a
CoC in the waste. Commenters did not support the use of the maximum
concentration, since they believe it is overly conservative and would
overstate the mass loading generated by a facility. The commenters also
considered the use of a concentration based on the 95th percentile UCLM
as complicated and open to interpretation. Instead of requiring the use
of the maximum concentration or a concentration based on the 95th
percentile UCLM, commenters suggested that waste generators should be
allowed to use rolling averages, or average concentrations, or median
concentrations.
To ensure protection of human health and the environment, we want
to be reasonably conservative and see that generators use the most
appropriate concentrations of CoCs to calculate the mass of each CoC in
the wastes. Therefore, the use of rolling averages, average
concentrations, or median concentrations would not be appropriate.
Rolling averages and average concentrations are based on the simple
average of the measured concentrations, with no statistical measure of
the confidence limit associated with these concentrations. Therefore,
the use of simple averages would not account for the possibility of a
wide variability in the levels of CoCs in the waste. The median is
simply the middle value in the data (i.e., one-half of the values are
above the median, and one-half are below it) and may not be
representative of the average concentration of a CoC in the waste.
The use of maximum sample concentration is appropriate when the
waste generator takes insufficient samples of a particular amount of
waste. In general, because potential K181 wastes are likely to be
highly variable, waste generators should be taking multiple samples to
properly characterize the wastes. For multiple samples, the waste
generator may use the maximum detected concentration or a concentration
based on the 95th percentile upper confidence limit of the mean for a
CoC. The upper confidence limit approach takes into account the
variability of the waste and provides a measure of confidence that the
mean concentration is below the upper bound of the confidence limit.
Thus, using the 95th percentile upper confidence limit of the mean for
a CoC gives a greater degree of confidence that its mass in the waste
is below the mass loading limit. The 95th percentile upper confidence
limit calculation, although it requires some statistical analysis, is
relatively simple to calculate and has been used in other parts of the
RCRA program (e.g., see the implementation of the Comparable/Syngas
Fuel Exclusion under 40 CFR 261.38(c)(8)(iii)(A)). [Use of the 95th
percentile upper confidence level provides assurance that the mass
loadings established in the regulation will be protective of human
health and the environment.]
d. Onsite Recordkeeping Requirements. EPA proposed onsite
recordkeeping requirements to support a nonhazardous determination.
These included keeping records on waste sampling and analysis.
Commenters questioned the need for waste analysis and onsite
recordkeeping requirements associated with waste analysis if toluene-
2,4-diamine is not present in the waste and the wastes are being
disposed in a lined landfill. The commenters stated that EPA, at most,
should require records of wastes limited to proof of transportation to
the appropriate landfill.
As described previously, the Agency has reviewed the comments on
toluene-2,4-diamine and has decided to no longer include toluene-2,4-
diamine as a constituent of concern for K181. As a result of this
decision, one of the two conditions that were proposed for the dyes
and/or pigment nonwastewaters to be considered nonhazardous under the
landfill exemption has been eliminated. The only remaining condition
for these wastes to be considered nonhazardous in the final listing is
for the wastes to be disposed in a landfill unit that meets the liner
design standards specified in the listing description. (As discussed in
section IV.A.3, the listing also includes an exemption for combustion.)
Therefore, as long as the wastes are being disposed in these types of
landfills, the waste generators do not have to test or maintain records
associated with waste sampling or testing. The Agency agrees that
records demonstrating that each shipment of waste was received by an
acceptable type of landfill must be maintained.
A generator claiming that it is not subject to the listing would
have to maintain sufficient documentation to demonstrate that it has
not exceeded the relevant annual mass loading limits, that it has sent
its waste to a landfill meeting the liner design standards specified
under the conditional exemption, or that the waste was treated in a
permitted combustion unit as specified in the listing description. EPA
believes that it is critical for generators to have documentation
demonstrating that the waste is below the mass loading limits, or that
shipments of waste have been (or will be) sent to landfills meeting the
specified design requirements or combustion units as specified in the
listing. Paragraphs (d)(1), (d)(2), (d)(3) and (d)(4) of Sec. 261.32
of the rule require generators of dyes and/or pigment nonwastewaters
from the listed product classes to keep records under the authority of
sections 2002 and 3007 of RCRA. Failure to comply with the
recordkeeping requirements could result in an enforcement action by EPA
under section 3008 of RCRA or by an authorized State under similar
State authorities. Without adequate documentation, the regulating
agency may presume that the generator is not complying with the
requirements for

[[Page 9161]]

demonstrating that the wastes are nonhazardous.
Note that in the final rule, we are also clarifying that the
requirement for keeping records on site for three years under
paragraphs (d)(2) and (d)(3) refers to the three most recent calendar
years by including more specific text in Sec. 261.32(d)(2)(iv) and
Sec. 261.32(d)(3)(x) (i.e., ``Keep the following records on site for
the three most recent calendar years in which the hazardous waste
determinations are made''). We believe this clarification makes the
recordkeeping requirement more consistent with the calendar year basis
of the annual loading limits.
Below we provide examples to illustrate the types of records that
need to be kept on site for two facilities, one that sends all wastes
to a municipal landfill, and another that tests their waste.

Example 1: Facility D is a producer of a variety of in-scope
organic dyes and pigments, generating 2,000 metric tons per year of
wastewater treatment sludges. The generated wastes do not exhibit
any hazardous waste characteristic nor meet any other listing
descriptions. While the total quantity of wastes exceeds 1,000 MT/
yr, the facility decides to send all of the wastes to a municipal
landfill where the receiving units meet the liner design criteria of
Sec. 258.40. Therefore, the facility has no obligation to test for
the presence of CoCs. To comply with the recordkeeping requirements
of Sec. 261.32(d)(4), the facility keeps records on site for three
years to show that shipments of the wastes received by the landfill
are disposed of properly. These records include documentation of the
types of wastes shipped, shipping records from the transporter and
the landfill documenting receipt of the waste shipment, and
documentation from the landfill or state indicating that the
landfill units meet the Sec. 258.40 design standards.
Example 2: Facility E is a producer of in-scope organic dyes and
pigments generating 3,500 MT/yr of process sludges. Facility E would
like to manage as much as possible of the 3,500 MT as nonhazardous
(e.g., dispose of the waste in an industrial landfill that does not
meet the liner criteria specified in the listing description), as
long as the wastes are below the mass-loading limits in Sec.
263.32(c). Since the total volume of nonwastewaters exceeds 1,000
MT/yr, the facility must follow the procedures set forth in Sec.
263.32(d)(3) to determine the status of its nonwastewaters.

Therefore, the facility first determines that one of the K181
listing constituents is expected to be present in the facility's wastes
(4-chloroaniline). This determination is based on the raw materials
used for manufacturing, the impurities likely present in the process
feeds, and the production chemistry involved. The facility documents
this finding using the MSDS sheets for the materials used, the process
reaction information reviewed, and the results of past analyses performed.
The facility develops a sampling and analysis plan that includes
the requirements of Sec. 263.32(d)(3)(iii) for characterizing the
levels of the K181 constituents present in the wastes destined for
disposal in an industrial landfill that does not meet the liner
requirements. The facility collects and analyzes representative waste
samples according to the developed sampling and analysis plan and the
Sec. 263.32(d)(3)(iv) testing requirements. The analytical results
show that the annual amount of waste contains up to 6,800 kg/yr of 4-
chloroaniline. The facility maintains on site the sampling and analysis
plan, documents showing the analytical results and the accompanying
quality assurance/quality control (QA/QC) data, and records showing the
waste batches and quantities represented by the test results.
The facility keeps a running total of the 4-chloroaniline mass
loadings determined throughout the year and documents the calculations
performed. The facility manages those batches with cumulative mass
loadings of less than 4,800 kg/yr of 4-chloroaniline as nonhazardous
waste, and ships them to an industrial landfill that does not meet the
design requirements of Sec. 258.40, Sec. 264.301, or Sec. 265.301.
The facility is careful to document the mass loadings in those batches.
The facility ships the remaining waste to a municipal landfill subject
to the Sec. 258.40 design criteria. The facility keeps all of the
above waste determination and management records on site for three years.
e. Annual Follow-up Testing Requirements. EPA proposed that waste
generators continue to perform waste analysis annually after the wastes
have been determined to be nonhazardous for the purpose of verifying
that the wastes remain nonhazardous. However, we also proposed that the
annual testing requirements for the wastes could be suspended if the
annual running total mass levels for the CoCs during any three
consecutive years based on the sampling and analysis results for the
CoCs in the wastes are determined to be nonhazardous. We also proposed
that following a significant process change (i.e., if it could result
in significantly higher levels of the CoCs for K181 in the wastes and
greatly increase the potential for the wastes to become hazardous), the
annual testing requirements for the wastes would be reinstituted.
Commenters questioned the need for annual testing requirements over a
period of at least three years. They believe that, after a
demonstration that the wastes are nonhazardous for one year, annual
follow-up testing requirements are not necessary, unless there is a
significant change in the process. Also, if there is a significant
process change, the commenters believe that a one year repeat
demonstration should be considered sufficient to demonstrate that the
wastes remain nonhazardous. In addition, commenters believe that there
is no reason for annual testing of wastes disposed in lined landfills,
if they do not contain toluene-2,4-diamine or if the concentration of
toluene-2,4-diamine in the wastes does not change. Finally, commenters
pointed out that EPA, in other hazardous waste exclusions, required an
initial demonstration and repeat demonstration only when there is a
significant change in the process that generates the wastes.
The Agency notes that toluene-2,4-diamine is no longer a
constituent of concern for the K181 waste listing. Therefore, any waste
generator that is disposing of these wastes in a landfill unit subject
to the liner design criteria specified in the listing description, is
not required to test or conduct repeat testing under the conditional
final listing for the dyes and/or pigments nonwastewaters. However, any
large waste generator that tests their wastes and is not disposing of
them in this type of landfill (or treating the waste by combustion as
specified in the listing) is subject to the testing requirements (as
proposed) in today's final rule at Sec. 261.32(d)(3). This is because
the wastes produced by the dyes and/or pigments industries using batch
processes can be highly variable.\31\ As a result, we do not believe
that testing for one year is sufficient to demonstrate that the waste
would remain nonhazardous over a sufficiently long period of time.
Thus, the Agency is requiring test data to show that the dyes and/or
pigment wastes are nonhazardous for three consecutive years to provide
a greater degree of confidence in the waste determination. The follow-
up testing can only be suspended if it is demonstrated that the wastes
are nonhazardous for three consecutive years.
---------------------------------------------------------------------------

\31\ As ETAD indicated in its comment that ``Dyes production
involves batch processes, numerous distinct products and highly
variable waste streams * * * ''
---------------------------------------------------------------------------

10. Exemption for Non-Municipal Landfills
The proposed rule included an exemption for wastes disposed in
landfill units that are subject to the liner design requirements in
Sec. 258.40. This

[[Page 9162]]

was based on our risk analysis that demonstrated that wastes disposed
in landfills with composite liners did not present significant risks
for K181 dye and pigment wastes. (In the proposal, we also included a
mass-loading limit for toluene-2,4-diamine for composite-lined units,
but as noted previously, we are dropping this constituent in the final
rule.) We also sought comment on the option of including in the
exemption wastes that are disposed in other non-municipal landfills
(industrial landfills) that meet the liner design requirements in Sec.
258.40 or Subtitle C landfills. One commenter indicated that, since
lined landfills do not pose a significant risk for disposal of the
waste, manufacturers generating potential K181 waste should have the
option of utilizing synthetic membrane lined industrial landfills which
are as protective as lined municipal landfills. The commenter suggested
that the generators could be responsible for assuring that a landfill
is designed with an appropriate synthetic liner system.
After considering this issue fully, we agree that it would be
appropriate to include industrial landfill units (e.g., non-municipal
landfill units) in the landfill exemption for the K181 listing,
provided the units meet the specified liner design standards. While the
available information indicates that generators are using primarily
municipal landfills for disposal of dyes and pigment manufacturing
wastes, comments submitted (see CPMA comments, Appendix B) indicate
that industrial landfills are in use to some extent. We do not wish to
preclude use of commercial industrial landfills that meet the liner
standards for municipal landfills in Sec. 258.40 (or for subtitle C
landfills). As the commenter suggested, the generator would be
responsible for documenting that the landfill meets the specified liner
standards. States have regulations governing the design of non-
municipal non-hazardous landfills.\32\ Thus landfill operators are
likely to have certifications or permit conditions available to provide
to generators who wish to use such landfills instead of municipal
landfill units. As described previously in the discussion on
recordkeeping requirements, generators wishing to qualify for the
exemption are required to maintain records to show that they are using
an appropriate landfill unit, whether the unit is a municipal landfill,
subtitle C landfill, or an industrial landfill. Therefore, we are
finalizing the listing to include an exemption for wastes disposed in
subtitle D landfills that meet the design requirements in Sec. 258.40,
Sec. 264.301, or Sec. 265.301. The landfill exemption in the K181
listing now reads as follows (the final rule also includes an exemption
for certain combustion units, as well):
---------------------------------------------------------------------------

\32\ Association of State and Territorial Solid Waste Management
Officials (``ASTSWMO''), Non-Municipal, Subtitle D Waste Survey.

These wastes will not be hazardous if the nonwastewaters are:
(i) Disposed in a subtitle D landfill unit subject to the design
criteria in Sec. 258.40, (ii) disposed in a subtitle C landfill
unit subject to either Sec. 264.301 or Sec. 265.301, (iii)
disposed in other subtitle D landfill units that meet the design
criteria in Sec. 258.40, Sec. 264.301, or Sec. 265.301, or (iv)
treated in a combustion unit that is permitted under subtitle C, or
an onsite combustion unit that is permitted under the Clean Air Act.

B. Final ``No List'' Determination for Wastewaters

The Agency proposed not to list as hazardous wastewaters from the
production of dyes and/or pigments. We received numerous comments
supporting this proposal, and no adverse comments on this proposed
decision. We have not independently learned of any new information
requiring us to change our position on these wastes. Therefore, we are
making a final decision not to list wastewaters from the production of
dyes and/or pigments.

C. What Is the Status of Landfill Leachate Derived From Newly-Listed
K181Wastes?

As noted in the proposed rule, actively managed landfill leachate
and gas condensate generated at non-hazardous waste landfills derived
from previously-disposed and newly-listed wastes could be classified as
K181. We proposed to temporarily defer the application of the new waste
code to such leachate to avoid disruption of ongoing leachate
management activities while the Agency decides if any further
integration is needed of the RCRA and CWA regulations consistent with
RCRA section 1006(b)(1).
We are finalizing the revisions to the temporary deferral in Sec.
261.4(b)(15) with no change from the proposed rule. Commenters
generally supported the proposed deferral. However, two commenters
stated that EPA should make the deferral permanent. One of the
commenters stated that the various approaches used by EPA in listings,
including the mass loadings approach proposed for the current dyes and
pigments waste listing, creates uncertainty for the municipal landfill
operator regarding leachate management. The other commenter also urged
EPA to expand this deferral to include leachate that is derived from a
surface impoundment.
As we noted in the proposal, we believe a temporary deferral is
warranted. We believe that it is appropriate to defer regulation on a
case-by-case basis to avoid disrupting leachate management activities,
and to allow us to decide whether any further integration of the two
programs is needed.\33\ While the commenter suggested there were
``uncertainties'' in leachate management requirements, no specific
problems were identified. In any case, a broader exemption for landfill
leachate is beyond the scope of the current rulemaking. Similarly, we
see no need to expand the deferral to include leachate from surface
impoundments, as well as landfills. The issues raised by this commenter
relate to the management of leachate from closed surface impoundments
located on site. We believe that these issues are site-specific and are
best left to the local regulatory agency. Therefore, we are not
expanding the deferral to include impoundment leachate.
---------------------------------------------------------------------------

\33\ EPA's Office of Water examined the need for national
effluent limitations guidelines and pretreatment standards for
wastewater discharges (including leachate) from certain types of
landfills (see proposed rule at 63 FR 6426, February 6, 1998). EPA
decided such standards were not required and did not issue
pretreatment standards for Subtitle D landfill wastewaters sent to
POTWs (see 65 FR 3008, January 19, 2000).
---------------------------------------------------------------------------

One commenter sought clarification on our use of the term ``active
management,'' in the context of our statement in the proposal that
``The Agency often uses the term `active management' as a catch-all
term to describe the types of activities that may trigger RCRA subtitle
C permitting requirements.'' (See 68 FR 66199, Footnote 57). The
commenter noted that actions not requiring a permit may be active
management and wanted to clarify that active management would include
situations like 90-day storage of excavated K181 waste, which does not
require a permit. The commenter is correct. We did not mean to imply
that active management can only occur for actions requiring a RCRA
subtitle C permit. In the case of a typical listed waste, excavated
wastes stored in 90-day containers (e.g., roll-off bins) would indeed
be considered ``active management'' and carry the hazardous waste code
designation. For the K181 listing, however, the only excavated wastes
that could carry the K181 designation would be wastes that meet or
exceed the mass loadings of any of the specified constituents.
Furthermore, if the excavated waste is disposed in a suitable landfill
that is subject to or

[[Page 9163]]

meets the specified design criteria, or treated by combustion as
specified in the listing description, then the waste would be exempt
from the listing.

D. What Are the Final Treatment Standards Under RCRA's Land Disposal
Restrictions for the Newly-Listed Hazardous Wastes?

1. What are EPA's Land Disposal Restrictions (LDRs)?
The RCRA statute requires EPA to establish treatment standards for
all wastes destined for land disposal. These are the so called ``land
disposal restrictions'' or LDRs. For any hazardous waste identified or
listed after November 8, 1984, EPA must promulgate LDR treatment
standards within six months of the date of identification or final
listing (RCRA section 3004(g)(4), 42 U.S.C. 6924(g)(4)). RCRA also
requires EPA to set as these treatment standards ``* * * levels or
methods of treatment, if any, which substantially diminish the toxicity
of the waste or substantially reduce the likelihood of migration of
hazardous constituents from the waste so that short-term and long-term
threats to human health and the environment are minimized.'' RCRA
section 3004(m)(1), 42 U.S.C. 6924(m)(1). Once a hazardous waste is
prohibited, the statute provides only two options for legal land
disposal: Meet the treatment standard for the waste prior to land
disposal, or dispose of the waste in a land disposal unit that
satisfies the statutory no migration test. A no migration unit is one
from which there will be no migration of hazardous constituents for as
long as the waste remains hazardous. RCRA sections 3004 (d), (e), (f),
and (g)(5).
We are finalizing the prohibitions and treatment standards for the
K181 wastes which we are listing as hazardous. The date of the
prohibition and treatment standard is August 23, 2005.
2. How Does EPA Develop LDR Treatment Standards?
In an effort to make treatment standards as uniform as possible,
while adhering to the fundamental requirement that the standards must
minimize threats to human health and the environment, EPA developed the
so called Universal Treatment Standards (codified at 40 CFR 268.48).
Under the UTS, whenever technically and legally possible, the Agency
adopts the same technology-based numerical limit for a hazardous
constituent, regardless of the type of hazardous waste in which the
constituent is present. See 63 FR 28560 (May 26, 1998); 59 FR 47982
(September 19, 1994). The UTS, in turn, reflects the performance of
Best Demonstrated Available Treatment (BDAT) technologies of the
constituents in question. EPA is also authorized in section 3004(m) to
establish methods of treatment as a treatment standard. Doing so
involves specifying an actual method by which the waste must be treated
(unless a variance or determination of equivalency is obtained). Given
this constraint, EPA prefers to establish numerical treatment
standards, which leaves the option of using any method of treatment
(other than impermissible dilution) to achieve the treatment standard.
EPA also finds that the treatment standards established in today's
rule are not established below levels at which threats to human health
and the environment are minimized. See Hazardous Waste Treatment
Council v. EPA, 886 F. 2d 355, 362 (D.C. Cir. 1990). That case held
that the statute can be read to allow either technology-based or risk-
based standards, and further held that technology-based LDR treatment
standards are permissible so long as they are not established ``beyond
the point at which there is no `threat' to human health or the
environment.'' Id. at 362. EPA's finding that today's standards are not
below a ``minimize threat'' level is based on the Agency's inability at
the present time to establish concentration levels for hazardous
constituents which represent levels at which threats to human health
and the environment are minimized. See 63 FR at 28560 (May 26, 1998)
explaining at greater length why these difficulties remain. Thus, the
Agency continues to find that technology-based standards remain the
best approach for the national treatment standards for these wastes
since such standards eliminate as much of the inherent uncertainty of
hazardous waste land disposal and so fulfill the Congressional intent
in promulgating the land disposal restrictions provisions. 55 FR at
6642 (Feb. 26, 1990).
3. What Are the Treatment Standards for K181?
Of the seven CoCs that form the basis of the final listing, two of
them--aniline and 4-chloroaniline--have an existing UTS. For two of the
other CoCs--o-anisidine, p-cresidine--there is adequate documentation
in existing SW-846 methods 8270, 8315, and 8325 to calculate numerical
standards. Finally, for two other constituents--2,4-dimethylaniline and
1,3-phenylenediamine--we are transferring the numerical standards of
similar constituents as the universal treatment standards.
In the proposal, we had stated that if the numerical standards for
these constituents were shown in comments not to be achievable or
otherwise appropriate, we might adopt methods of treatment as the
exclusive treatment standard. We did not receive any such comments
suggesting that these numerical standards were not achievable or
otherwise appropriate. Therefore, we are finalizing the proposed
numerical treatment standards for these six CoCs.
For the remaining constituent of concern, 1,2-phenylenediamine, we
stated in the proposed rule that in past method performance
evaluations, we have found it difficult to achieve reliable recovery
from aqueous matrixes and precise measurements. Therefore, we proposed
technology-specific LDR treatment standards for this constituent. We
also noted that if commenters submitted data adequate for us to develop
a numerical standard, then we might promulgate a numerical standard in
addition to, or in lieu of, the technology standard.
Because we did not receive data on 1,2-phenylenediamine, we are
maintaining the technology-specific standard as the LDR treatment
standard, with one change. We are expanding the treatment options for
K181 nonwastewaters to include, in addition to combustion (CMBST), a
treatment train of chemical oxidation (CHOXD) followed by BIODG
(biodegradation) or CARBN (carbon adsorption) and a treatment train of
BIODG followed by CARBN. We are making this change based on a comment
we received on the proposed rule. The commenter asserted that the
proposed LDR standard of CMBST has the potential to significantly
disrupt the company's on-site biosolids disposal. More specifically,
because of the mixture and derived-from rule, if the facility were to
accept into its wastewater treatment facility wastes that meet the
nonwastewater definition of K181, and it contains 1,2-phenylenediamine,
the biosolids resulting from treatment would have to be combusted.
In the above scenario, we do not believe it makes sense to
establish a treatment standard that would require the wastewater
treatment biosolids to be combusted. As the commenter points out, and
with which we agree, if a facility were to introduce a nonwastewater
into its wastewater treatment system, the nonwastewater would
immediately become a wastewater (by LDR definition) and would be
amenable to treatment by a wastewater treatment system. Therefore, we
are adding to the LDR treatment

[[Page 9164]]

standard for 1,2-phenylenediamine a treatment train of CHOXD followed
by BIODG or CARBN and a treatment train of BIODG followed by CARBN.
Note that the treatment standard for K181 wastes containing 1,2-
phenylenediamine now is identical for wastewaters and nonwastewaters.
We have revised the BDAT Background Document to reflect this change and
placed it in the docket for today's rule.
The following table summarizes the final treatment standards for
the constituents of concern.

Table IV-I.--Treatment Standards for Constituents in K181
----------------------------------------------------------------------------------------------------------------
Constituents of concern CAS No. Wastewater (mg/L) Nonwastewater (mg/kg)
----------------------------------------------------------------------------------------------------------------
Aniline....................................... 62-53-3 0.81 14
o-Anisidine (2-methoxyaniline)................ 90-04-0 0.010 0.66
4-Chloroaniline............................... 106-47-8 0.46 16
p-Cresidine................................... 120-71-8 0.010 0.66
2,4-Dimethylaniline (2,4-xylidine)............ 95-68-1 0.010 0.66
1,2-Phenylenediamine.......................... 95-54-5 CMBST; or CHOXD fb CMBST; or CHOXD fb
(BIODG or CARBN); or (BIODG or CARBN); or
BIODG fb CARBN BIODG fb CARBN
1,3-Phenylenediamine.......................... 108-45-2 0.010 0.66
----------------------------------------------------------------------------------------------------------------
Note: ``fb'' means ``followed by.''

In this final rule, we are also finalizing the following
provisions, all of which are consistent with the proposed rule. See the
Response to Comments Background Document for other LDR-specific issues
raised in comments.

--We are adding the CoCs in K181 with numerical treatment standards to
the Universal Treatment Standards listed at 40 CFR 268.48, which
results in the addition of four new chemicals to the list: o-anisidine,
p-cresidine, 2,4-dimethylaniline, and 1,3-phenylenediamine. Adding
these constituents to the UTS list will ensure that, if they are
present in a characteristic waste, they will be treated prior to land
disposal, which in turn will minimize any risks they present to human
health and the environment. (Note: Because toluene-2,4-diamine is not
being included as a constituent of concern for this waste, it will no
longer be added to the UTS list at 40 CFR 268.48.)
--We are adding to F039 those constituents identified in K181 not
already specified in F039 (the same constituents named above for
addition to the UTS list). F039 applies to landfill leachates generated
from multiple listed wastes in lieu of the original waste codes. F039
wastes are subject to numerical treatment standards equivalent to the
universal treatment standards listed at 40 CFR 268.48. Making this
change ensures F039 landfill leachates receive proper treatment for the
CoCs in K181.
--For debris contaminated with K181 waste, the provisions in Sec.
268.45 apply. This means debris contaminated with K181 would be
required to be treated prior to land disposal, using specific
technologies from one or more of the following families of debris
treatment technologies: extraction, destruction, or immobilization. If
such debris is treated by immobilization, it remains a hazardous waste
and must be managed in a hazardous waste facility. Residuals generated
from the treatment of debris contaminated with K181 would remain
subject to the treatment standards being finalized today.
--We are prohibiting K181 wastes from underground injection. Therefore,
K181 wastes may not be injected underground, unless they meet the LDR
treatment standards or are injected into a Class 1 well from which it
has been determined that there will be no migration of hazardous
constituents for as long as the wastes remain hazardous.

E. Is There Treatment Capacity for the Newly Listed Wastes?

1. Introduction
Under the land disposal restrictions (LDR) determinations, the
Agency must demonstrate that adequate commercial capacity exists to
manage listed hazardous wastes in compliance with the LDR treatment
standards before the Agency can restrict the listed waste from further
land disposal. The Agency performs capacity analyses to determine the
effective date of the LDR treatment standards for the proposed listed
wastes. This section summarizes the results of EPA's capacity analysis
for the wastes covered by today's rule. For a detailed discussion of
capacity analysis-related data sources, methodology, and analysis
results for the wastes covered in this rule, see ``Background Document
for Capacity Analysis for Land Disposal Restrictions: Newly Identified
Dye and Pigment Manufacturing Wastes (Final Rule), February 2005''
(i.e., the Capacity Background Document), available in the RCRA docket
established for today's final rule.
EPA's decisions on whether to grant a national capacity variance
are based on the availability of alternative treatment or recovery
technologies capable of achieving the prescribed treatment standards.
Consequently, the methodology focuses on deriving estimates of the
quantities of newly-listed hazardous waste that will require either
commercial treatment or the construction of new onsite treatment or
recovery technology as a result of the LDRs. The resulting estimates of
required commercial capacity are then compared to estimates of
available commercial capacity. If adequate commercial capacity exists,
the waste is prohibited from further land disposal, unless it meets the
LDR treatment standards prior to disposal. If adequate capacity does
not exist, RCRA Section 3004(h)(2) authorizes EPA to grant a national
capacity variance for the waste for up to two years or until adequate
alternative treatment capacity becomes available, whichever is sooner.
2. What Are the Capacity Analysis Results for K181?
In the proposed rule, EPA estimated nonwastewater quantities
applying engineering estimates of wastewater treatment sludge
generation rates and, wherever possible, using information provided in
non-CBI portions of the RCRA section 3007 surveys and public comments
in response to the 1994 and 1999 proposed rules for dyes and pigments
production wastes. EPA received comments in response to the November
25, 2003 proposed rule (68 FR 66164), which stated that the Agency
overestimated the amount of

[[Page 9165]]

nonwastewaters generated by the dyes and pigments production industry.
We reviewed the information submitted by commenters on waste
characteristics, quantities, and management practices. EPA found some
data discrepancies and deficiencies that limit the use of the submitted
data (see discussion on waste quantities in section IV.A.5). However,
we believe the additional data from the commenters provide useful
information on the likely waste quantities generated. Therefore, we
have analyzed the commenters' data and revised our estimated waste
quantities affected by this rule. We recognize that the actual quantity
of waste requiring commercial treatment will probably be smaller due to
waste-specific assessments of actual K181 CoC loadings, use of the
contingent management exemptions, facility closures, changes in product
formulations, or waste management practices. We also recognize the
batch process nature of this industry and the speed at which facilities
may change product formulations. Even relying on the larger quantities
estimated for the proposed rule, we find more than adequate waste
management capacity exists to accommodate wastes that would be treated
or disposed as a result of today's rule.
As described in section IV.D.3 above, EPA is finalizing numerical
treatment standards or methods of treatment as the treatment standards
for the CoCs of the newly listed K181 waste. We expect that the CoCs in
the nonwastewater or wastewater (if K181-derived wastewater is
generated) forms of K181 are amenable to the treatment by combustion or
other technologies in a treatment train. EPA estimates that, at most,
approximately 36,000 metric tons per year of nonwastewater forms of
K181 may require alternative commercial treatment and be managed off
site at a commercial hazardous waste treatment facility. Furthermore,
EPA anticipates that much less than 36,000 metric tons per year of the
wastes may require combustion capacity because not all of these wastes
are expected to exceed the mass loading limits. Furthermore, these
wastes would not be hazardous if the nonwastewaters are disposed in a
landfill unit that meets liner design criteria specified in the listing
description, or are treated in certain combustion units. Therefore,
these wastes will not require treatment to meet LDR treatment
standards. In any case, we estimate that the commercially available
combustion capacity for sludge, solid, and mixed media/debris/devices
is approximately 0.5 million tons per year and, therefore, sufficient
to treat the newly listed waste which may require treatment. We also
expect that adequate landfill capacity exists for managing residuals
from treating these wastes. Also, there is adequate wastewater
treatment capacity available should the need for treatment of the
wastewater form of K181 wastes arise. In addition, we are not listing
wastewaters generated at these facilities, so there is no need for
additional treatment of wastewater from the production of dyes and/or
pigments (other than K181-derived wastewaters). No commenters
challenged either the variance determination or available treatment or
disposal capacity for nonwastewater or wastewater forms of K181 wastes.
Therefore, we conclude that sufficient treatment or disposal capacity
is available to manage newly-listed K181 wastes.
As discussed in section IV.D, we are also finalizing the addition
of the CoCs in K181 with numerical standards to the constituent listed
in F039 and the universal treatment standards. EPA does not anticipate
that waste volumes subject to the treatment standards for F039 or
characteristic wastes would increase because of the addition of these
organic constituents to F039 and the UTS lists. Based on available
data, waste generators already appear to be required to comply with the
treatment requirements for other organic constituents in F039 and
characteristic wastes. We received no comments, data, or information to
warrant any change of this conclusion. Therefore, we expect that
additional treatment due to the addition of the constituents to the
F039 and UTS lists will not be required. When changing the treatment
requirements for wastes already subject to LDR (including F039 wastes),
EPA no longer has authority to use RCRA Sec. 3004(h)(2) to grant a
capacity variance to these wastes. However, EPA is guided by the
overall objective of section 3004(h), namely that treatment standards
which best accomplish the goal of RCRA Sec. 3004(m) (to minimize
threats posed by land disposal) should take effect as soon as possible,
consistent with availability of treatment capacity.
For soil and debris contaminated with K181, as indicated in the
proposed rule, we believe that the vast majority of contaminated soil
and debris, if any, will be managed on site and, therefore, would not
require substantial commercial treatment capacity. Thus, we proposed
not to grant a national capacity variance for hazardous soil and debris
contaminated with this newly listed waste. EPA received no comments
regarding this issue. There also were no data showing mixed radioactive
wastes or underground injected wastes associated with the newly listed
K181 based on the public information used in the proposed rule. Thus,
we also proposed not to grant a national capacity variance for mixed
radioactive waste (i.e., radioactive wastes mixed with K181) or waste
being injected underground. EPA did not receive comments indicating
that the newly listed wastes are underground injected or that they are
mixed with radioactive wastes or with both radioactive wastes and soil
or debris.
Therefore, EPA is finalizing its decision not to grant a national
capacity variance for wastewater and nonwastewater forms of K181
wastes. We also are finalizing our decision not to grant a national
capacity variance for hazardous soil and debris contaminated with the
newly listed wastes, radioactive wastes mixed with K181 or contaminated
soil or debris of K181, or K181 wastes being injected underground. The
customary time period of six months is sufficient to allow facilities
to determine whether their wastes are affected by this rule, to
identify onsite or commercial treatment and disposal options, and to
arrange for treatment or disposal capacity, if necessary. Therefore,
LDR treatment standards for the affected wastes covered under today's
rule become effective when the listing determinations become
effective--the earliest possible date. This conforms to RCRA Sec.
3004(h)(1), which indicates that land disposal prohibitions must take
effect immediately when there is sufficient protective treatment
capacity available for the waste.
Finally, EPA may consider a case-by-case extension to the effective
date based on the requirements outlined in 40 CFR 268.5, which includes
a demonstration that adequate alternative treatment, recovery, or
disposal capacity for the petitioner's waste cannot reasonably be made
available by the effective date due to circumstances beyond the
applicants' control, and that the petitioner has entered into a binding
contractual commitment to construct or otherwise provide such capacity.

V. When Must Regulated Entities Comply With the Provisions in Today's
Final Rule?

A. Effective Date

The effective date of today's rule is August 23, 2005. These
provisions, promulgated under HSWA authorities, will take effect in
both the federal regulations and authorized state programs at that time.

[[Page 9166]]

B. Section 3010 Notification

Under RCRA Sec. 3010, the Administrator may require all persons
who handle hazardous wastes to notify EPA of their hazardous waste
management activities within 90 days after the wastes are identified or
listed as hazardous. This requirement may be applied even to those
generators, transporters, and treatment, storage, and disposal
facilities (TSDFs) that have previously notified EPA with respect to
the management of other hazardous wastes. The Agency has decided to
waive this notification requirement for persons who handle wastes that
are covered by today's hazardous waste listing and already have (1)
notified EPA that they manage other hazardous wastes, and (2) received
an EPA identification number. The Agency has waived the notification
requirement in this case because it believes that most, if not all,
persons who manage the wastes listed as hazardous in today's rule
already have notified the Agency and received an EPA identification
number. However, any person who generates, transports, treats, stores,
or disposes of this newly listed waste and has not previously received
an EPA identification number must obtain an identification number
pursuant to 40 CFR 262.12 to generate, transport, treat, store, or
dispose of these hazardous wastes by May 25, 2005, for K181.
Note that nonwastewaters would not become newly listed K181 wastes
if the constituent mass loadings do not meet the levels in Sec.
261.32(c). If the wastes meet or exceed the mass loading limits, the
wastes would also not be listed K181, provided the nonwastewaters are
disposed in a landfill unit or treated in combustion unit as specified
in the listing description. Persons who generate only wastes that meet
one of these conditions need not notify EPA or obtain an identification
number, because the waste would not be K181.

C. Generators and Transporters

Persons who generate newly identified hazardous wastes may be
required to obtain an EPA identification number if they do not already
have one (as discussed in section V.B above). If person(s) generate
these wastes after the effective date of this rule, they will be
subject to the generator requirements set forth in 40 CFR part 262.
These requirements include standards for hazardous waste determination
(40 CFR 262.11), compliance with the manifest (40 CFR 262.20 through
262.23), pre-transport procedures (40 CFR 262.30 through 262.34),
generator accumulation (40 CFR 262.34), record keeping and reporting
(40 CFR 262.40 to 262.44), and import/export procedures (40 CFR 262.50
through 262.60). The generator accumulation provisions of 40 CFR 262.34
allow generators to accumulate hazardous wastes without obtaining
interim status or a permit only in certain specified units (container
storage units, tank systems, drip pads, or containment buildings).
These regulations also place a limit on the maximum amount of time that
wastes can be accumulated in these units. If K181 wastes are managed in
units that are not tank systems, containers, drip pads, or containment
buildings as described in 40 CFR 262.34, accumulation of these wastes
is subject to the requirements of 40 CFR parts 264 and 265, and the
generator is required to obtain interim status and seek a permit (or
modify interim status or a permit, as appropriate). Also, persons who
transport newly identified hazardous wastes will be required to obtain
an EPA identification number (if they do not already have one) as
described above and will be subject to the transporter requirements set
forth in 40 CFR part 263.
Nonwastewaters that do not meet the mass loading levels in Sec.
261.32(c) are not listed K181. Furthermore, in cases where the wastes
meet or exceed the mass loading limits, the wastes would also not be
listed K181, provided the nonwastewaters are disposed in a landfill
unit or treated in a combustion unit as specified in the listing
description. Therefore, persons who generate or transport wastes that
meet either of these conditions are not subject to the regulations
governing hazardous waste generation and transport in part 262 and 263.

D. Facilities Subject to Permitting

The listing for dyes and/or pigment wastes, K181, in today's rule
is issued pursuant to HSWA authority. Therefore, EPA will regulate the
management of the newly listed hazardous waste until states are
authorized to regulate these wastes.
1. Facilities Newly Subject to RCRA Permit Requirements
Facilities that treat, store, or dispose of K181 wastes that are
subject to RCRA regulation for the first time by this rule (that is,
facilities that have not previously received a permit pursuant to
section 3005 of RCRA and are not currently operating pursuant to
interim status), might be eligible for interim status (see section
3005(e)(1)(A)(ii) of RCRA). To obtain interim status based on
treatment, storage, or disposal of such newly identified wastes,
eligible facilities are required to comply with 40 CFR 270.70(a) and
270.10(e) by providing notice under section 3010 and submitting a Part
A permit application no later than August 23, 2005. Such facilities are
subject to regulation under 40 CFR part 265 until a permit is issued.
In addition, under section 3005(e)(3) and 40 CFR 270.73(d), not
later than August 24, 2006, land disposal facilities newly qualifying
for interim status under section 3005(e)(1)(A)(ii) also must submit a
part B permit application and certify that the facility is in
compliance with all applicable groundwater monitoring and financial
responsibility requirements. If the facility fails to submit these
certifications and a permit application, interim status will terminate
on that date.
2. Existing Interim Status Facilities
Pursuant to 40 CFR 270.72(a)(1), all existing hazardous waste
management facilities (as defined in 40 CFR 270.2) that treat, store,
or dispose of the newly listed K181 wastes and are currently operating
pursuant to interim status under section 3005(e) of RCRA, must file an
amended part A permit application with EPA no later than the effective
date of today's rule, (i.e., August 23, 2005). By doing this, the
facility may continue managing the newly listed wastes, pending final
disposition of the permit application. If the facility fails to file an
amended part A application by that date, the facility will not receive
interim status for management of the newly listed hazardous wastes and
may not manage those wastes until the facility receives either a permit
or a change in interim status allowing such activity (40 CFR 270.10(g)).
3. Permitted Facilities
Facilities that already have RCRA permits must request permit
modifications if they want to continue managing newly listed K181
wastes (see 40 CFR 270.42(g)). This provision states that a permittee
may continue managing the newly listed waste by following certain
requirements, including submitting a Class 1 permit modification
request by the date on which the waste or unit becomes subject to the
new regulatory requirements (i.e., the effective date of today's rule),
complying with the applicable standards of 40 CFR parts 265 and 266 and
submitting a Class 2 or 3 permit modification request within 180 days
of the effective date.
Generally, a Class 2 modification is appropriate if the newly
listed wastes will be managed in existing permitted units or in newly
regulated tanks, container units, or containment

[[Page 9167]]

buildings, and will not require additional or different management
practices than those authorized in the permit. A Class 2 modification
requires the facility owner to provide public notice of the
modification request, a 60-day public comment period, and an informal
meeting between the owner and the public within the 60-day period. The
Class 2 process includes a ``default provision,'' which provides that
if the Agency does not reach a decision within 120 days, the
modification is automatically authorized for 180 days. If the Agency
does not reach a decision by the end of that period, the modification
is authorized for the life of the permit (see 40 CFR 270.42(b)).
A Class 3 modification is generally appropriate if management of
the newly listed wastes requires additional or different management
practices than those authorized in the permit or if newly regulated
land-based units are involved. The initial public notification and
public meeting requirements are the same as for Class 2 modifications.
However, after the end of the 60-day public comment period, the Agency
will grant or deny the permit modification request according to the
more extensive procedures of 40 CFR Part 124. There is no default
provision for Class 3 modifications (see 40 CFR 270.42(c)).
Under 40 CFR 270.42(g)(1)(v), for newly regulated land disposal
units, permitted facilities must certify that the facility is in
compliance with all applicable 40 CFR part 265 groundwater monitoring
and financial responsibility requirements no later than August 24,
2006. If the facility fails to submit these certifications, authority
to manage the newly listed wastes under 40 CFR 270.42(g) will terminate
on that date.
4. Units
Units in which newly listed hazardous wastes are generated or
managed will be subject to all applicable requirements of 40 CFR part
264 for permitted facilities or 40 CFR part 265 for interim status
facilities, unless the unit is excluded from such permitting by other
provisions, such as the wastewater treatment tank exclusion (40 CFR
264.1(g)(6) and 265.1(c)(10)) and the product storage tank exclusion
(40 CFR 261.4(c)). Examples of units to which these exclusions could
never apply include landfills, land treatment units, waste piles,
incinerators, and any other miscellaneous units in which these wastes
may be generated or managed.
5. Closure
All units in which newly listed hazardous wastes are treated,
stored, or disposed after the effective date of this regulation that
are not excluded from the requirements of 40 CFR parts 264 and 265 are
subject to both the general closure and post-closure requirements of
subpart G of 40 CFR 264 and 265 and the unit-specific closure
requirements set forth in the applicable unit technical standards
subpart of 40 CFR part 264 or 265 (e.g., Subpart N for landfill units).
In addition, EPA promulgated a final rule that allows, under limited
circumstances, regulated landfills, surface impoundments, or land
treatment units to cease managing hazardous waste, but to delay
subtitle C closure to allow the unit to continue to manage nonhazardous
waste for a period of time prior to closure of the unit (see 54 FR
33376, August 14, 1989). Units for which closure is delayed continue to
be subject to all applicable 40 CFR parts 264 and 265 requirements.
Dates and procedures for submittal of necessary demonstrations, permit
applications, and revised applications are detailed in 40 CFR
264.113(c) through (e) and 265.113(c) through (e).

VI. State Authority and Compliance

A. How Are States Authorized Under RCRA?

Under section 3006 of RCRA, EPA may authorize qualified States to
administer their own hazardous waste programs in lieu of the federal
program within the State. Following authorization, EPA retains
enforcement authority under sections 3008, 3013, and 7003 of RCRA,
although authorized states have primary enforcement responsibility. The
standards and requirements for State authorization are found at 40 CFR
part 271.
Prior to enactment of the Hazardous and Solid Waste Amendments of
1984 (HSWA), a State with final RCRA authorization administered its
hazardous waste program entirely in lieu of EPA administering the
federal program in that State. The federal requirements no longer
applied in the authorized State, and EPA could not issue permits for
any facilities in that state, since only the state was authorized to
issue RCRA permits. When new, more stringent federal requirements were
promulgated, the State was obligated to enact equivalent authorities
within specified time frames. However, the new federal requirements did
not take effect in an authorized State until the State adopted the
federal requirements as State law.
In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which
was added by HSWA, new requirements and prohibitions imposed under HSWA
authority take effect in authorized States at the same time that they
take effect in unauthorized States. EPA is directed by the statute to
implement these requirements and prohibitions in authorized States,
including the issuance of permits, until the State is granted
authorization to do so. While States must still adopt HSWA-related
provisions as State law to retain final authorization, EPA implements
the HSWA provisions in authorized States until the States do so.
Authorized States are required to modify their programs only when
EPA enacts federal requirements that are more stringent or broader in
scope than existing federal requirements. RCRA section 3009 allows the
States to impose standards more stringent than those in the federal
program (see also 40 CFR 271.1). Therefore, authorized States may, but
are not required to, adopt federal regulations, both HSWA and non-HSWA,
that are considered less stringent than previous federal regulations.

B. How Does This Rule Affect State Authorization?

We are finalizing today's rule pursuant to HSWA authority. The
listing of the new K-waste is promulgated pursuant to RCRA section
3001(e)(2), a HSWA provision. Therefore, we are adding this rule to
Table 1 in 40 CFR 271.1(j), which identifies the Federal program
requirements that are promulgated pursuant to HSWA and take effect in
all States, regardless of their authorization status. The land disposal
restrictions for these wastes are promulgated pursuant to RCRA section
3004(g) and (m), also HSWA provisions. Table 2 in 40 CFR 271.1(j) is
modified to indicate that these requirements are self-implementing.
States may apply for final authorization for the HSWA provisions in
40 CFR 271.1(j), as discussed below. Until the States receive
authorization for these more stringent HSWA provisions, EPA would
implement them. The procedures and schedule for final authorization of
State program modifications are described in 40 CFR 271.21.
Section 271.21(e)(2) of EPA's State authorization regulations (40
CFR part 271) requires that States with final authorization modify
their programs to reflect Federal program changes and submit the
modifications to EPA for approval. The deadline by which the States
would need to modify their programs to adopt this regulation is
determined by the date of promulgation of a final rule in accordance with

[[Page 9168]]

Sec. 271.21(e)(2). Once EPA approves the modification, the State
requirements would become RCRA Subtitle C requirements.
States with authorized RCRA programs already may have regulations
similar to those in this final rule. These State regulations have not
been assessed against the Federal regulations finalized today to
determine whether they meet the tests for authorization. Thus, a State
would not be authorized to implement these regulations as RCRA
requirements until State program modifications are submitted to EPA and
approved, pursuant to 40 CFR 271.21. Of course, States with existing
regulations that are more stringent than or broader in scope than
current Federal regulations may continue to administer and enforce
their regulations as a matter of State law. In implementing the HSWA
requirements, EPA will work with the States under agreements to avoid
duplication of effort.

VII. CERCLA Designation and Reportable Quantities

CERCLA (Comprehensive Environmental Response, Compensation, and
Liability Act of 1980) defines the term ``hazardous substance'' to
include RCRA listed and characteristic hazardous wastes. When EPA adds
a hazardous waste under RCRA, the Agency also will add the waste to its
list of CERCLA hazardous substances. EPA establishes a reportable
quantity, or RQ, for each CERCLA hazardous substance. EPA provides a
list of the CERCLA hazardous substances along with their RQs in Table
302.4 at 40 CFR 302.4. If you are the person in charge of a vessel or
facility that releases a CERCLA hazardous substance in an amount that
equals or exceeds its RQ, then you must report that release to the
National Response Center (NRC) pursuant to CERCLA section 103. You also
may have to notify State and local authorities.

A. How Does EPA Determine Reportable Quantities?

Under CERCLA section 102(b)(1), hazardous substances are assigned a
reportable quantity of one pound, unless and until EPA changes the RQ
by regulation. EPA has wide discretion to adjust the RQ of the
hazardous substance(s). The Agency's methodology involves an evaluation
of the intrinsic physical, chemical, and toxic properties. The
intrinsic properties, called ``primary criteria,'' are aquatic
toxicity, mammalian toxicity (oral, dermal, and inhalation),
ignitability, reactivity, chronic toxicity, and potential
carcinogenicity. EPA evaluates the data for a hazardous substance for
each primary criterion. To adjust the RQs, EPA ranks each criterion on
a scale that corresponds to an RQ value of 1, 10, 100, 1,000, or 5,000
pounds. For hazardous substances evaluated for potential
carcinogenicity, each substance is assigned a hazard ranking of
``high,'' ``medium,'' or ``low,'' corresponding to RQ levels of 1, 10,
and 100 pounds, respectively. For each criterion, EPA establishes a
tentative RQ. A hazardous substance may receive several tentative RQ
values based on its particular intrinsic properties. The lowest of the
tentative RQs becomes the ``primary criteria RQ'' for that substance.
After the primary criteria RQs are assigned, EPA further evaluates
substances for their susceptibility to certain degradative processes.
These are secondary adjustment criteria. The natural degradative
processes are biodegradation, hydrolysis, and photolysis (BHP). If a
hazardous substance, when released into the environment, degrades
rapidly to a less hazardous form by one or more of the BHP processes,
EPA generally raises its RQ (as determined by the primary RQ adjustment
criteria) by one level. Conversely, if a hazardous substance degrades
to a more hazardous product after its release, EPA assigns an RQ to the
original substance equal to the RQ for the more hazardous substance.
The standard methodology used to adjust the RQs for RCRA hazardous
waste streams differs from the methodology applied to individual
hazardous substances. The procedure for assigning RQs to RCRA waste
streams is based on the results of an analysis of the hazardous
constituents of the waste streams. The constituents of each RCRA
hazardous waste stream are identified in 40 CFR part 261, Appendix VII.
EPA first determines an RQ for each hazardous constituent within the
waste stream using the methodology described above. The lowest RQ value
of these constituents becomes the adjusted RQ for the waste stream.
When there are hazardous constituents of a RCRA hazardous waste stream
that are not CERCLA hazardous substances, the Agency develops an RQ,
called a ``reference RQ,'' for these constituents in order to assign an
appropriate RQ to the waste stream (see 48 FR 23565, May 25, 1983). In
other words, the Agency derives the RQ for waste streams based on the
lowest RQ of all the hazardous constituents, regardless of whether they
are CERCLA hazardous substances.

B. What Is the RQ for the K181 Waste?

In today's final rule, EPA is assigning a one-pound RQ to the K181
waste. The RQ for each constituent contained in the waste is presented
in the table below.

Table VIII-1.--RQs for Constituents Identified in K181 Waste
------------------------------------------------------------------------
Constituent RQ (kg) (40 CFR
Constituents in K181 waste stream 302.4)
------------------------------------------------------------------------
Aniline................................. 5000 (2270)
o-Anisidine............................. 100 (45.4)
4-Chloroaniline......................... 1000 (454)
p-Cresidine............................. 1* (0.454)
2,4-Dimethylaniline..................... 1* (0.454)
1,2-Phenylenediamine.................... 1* (0.454)
1,3-Phenylenediamine.................... 1* (0.454)
------------------------------------------------------------------------
*RQ of 1 pound assigned to this constituent because we have not yet
developed a ``waste constituent RQ'' for this substance.

As noted in the proposed rule (68 FR 66213), we are not adjusting
the RQ for K181 at this time because we have not yet developed a
``reference RQ'' for the following CoCs in this waste: p-cresidine;
2,4-dimethylaniline; 1,2-phenylenediamine; and 1,3-phenylenediamine.
Therefore, the RQ for K181 will be one pound. As noted elsewhere in
this notice, we have dropped toluene-2,4-diamine as a constituent of
concern for K181. While this chemical has an existing RQ, EPA does not
expect that its RQ will be considered should the Agency decide to
propose any further adjustment to the RQ for K181 wastes.
Note, however, that all quantities of wastes generated during a
calendar year up to the mass loading limits are not listed K181 waste;
only wastes subsequently generated that meet or exceed the annual
limits would be hazardous waste. Wastes that are below the mass loading
limits are excluded from the listing from their point of generation,
and would not be subject to the CERCLA reporting requirements.
Commenters urged EPA not to adopt the statutory RQ, but rather to
adjust the RQ for K181 waste. They noted that EPA's risk analysis for
the proposal indicates that a higher RQ is warranted. Commenters stated
that it is counterintuitive for a company to be able to dispose of tons
of dyes and/or pigment production wastes as nonhazardous in a landfill,
yet have to report a release of just one pound of K181 waste to the
environment. They noted that EPA conceded that it would be unreasonable
to expect the CoCs to be present at concentrations higher than 5,000
parts per million.
While we agree with the commenters that an adjustment of the RQ may be

[[Page 9169]]

warranted based on the mass loading limits and the landfill disposal
exclusion established in the final rule, until we develop waste
constituent RQs for p-cresidine; 2,4-dimethylaniline; 1,2-
phenylenediamine; and 1,3-phenylenediamine the RQ for K181 will remain
at the statutory one-pound level. We will consider adjusting the RQ for
K181 after we develop these constituent RQs; however, the RQ for K181
will remain one pound until such an adjustment is made.

C. When Would I Need To Report a Release of These Wastes Under CERCLA?

Today's final hazardous waste listing is based on the mass loadings
of the hazardous constituents in the wastes. An RQ of one-pound is
assigned for the waste based on the lowest RQ of the hazardous
constituents in the waste. Notification is required under CERCLA when a
waste meeting the listing description and threshold for that hazardous
waste is released into the environment in a quantity that equals or
exceeds the RQ for the waste.
For CERCLA reporting purposes, the Clean Water Act mixture rule (40
CFR 302.6) may be adapted to apply to releases of this waste when the
quantity (or mass limit) of all of the K181 hazardous constituents in
the waste are known and the waste meets the K181 listing description
(i.e., any of the K181 mass loading levels are met or exceeded). In
such a case, notification is required where an amount of waste is
released that contains an RQ or more of any hazardous substance
contained in the waste. When the quantity (or mass limit) of one or
more of the K181 hazardous constituents is not known, notification is
required when the quantity of K181 waste released equals or exceeds the
RQ for the waste stream.

D. How Would I Report a Release?

To report a release of K181 (or any other CERCLA hazardous
substance) that equals or exceeds its RQ, you must immediately notify
the National Response Center (NRC) as soon as you have knowledge of
that release. The toll-free telephone number of the NRC is 1-800-424-
8802; in the Washington, DC, metropolitan area, the number is (202)
267-2675.
You may also need to notify State and local authorities. The
Emergency Planning and Community Right-to-Know Act (EPCRA) requires
that owners and operators of certain facilities report releases of
CERCLA hazardous substances and EPCRA extremely hazardous substances
(see the list in 40 CFR part 355, Appendix A) to State and local
authorities. After the release of an RQ or more of any of those
substances, you must report immediately to the community emergency
coordinator of the local emergency planning committee for any area
likely to be affected by the release, and to the State emergency
response commission of any State likely to be affected by the release.

VIII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

Under Executive Order 12866 [58 FR 51735 (October 4, 1993)], the
Agency, in conjunction with the Office of Management and Budget (OMB),
must determine whether a regulatory action is ``significant'' and
therefore subject to OMB review and the requirements of the Executive
Order. The Order defines ``significant regulatory action'' as one that
is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of this Executive Order, we have found that
this final action does not represent an economically significant
regulatory action, as defined under point number one above. The total
nationwide costs associated with this final action are estimated to be
less than $3 million per year. Furthermore, this final rule is not
expected to adversely effect, in a material way, the economy, a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or State, local, or tribal governments or
communities. The annualized benefits associated with today's rule have
not been monetized, but are believed to be less than $100 million.
However, this final rule has been determined to potentially raise novel
legal or policy issues due to the unique mass loading-based approach
used in the risk assessment modeling. As a result, it has been
determined that this rule is a ``significant regulatory action,'' as
identified under point number four above. Therefore, this action was
submitted to OMB for review. Any substantive changes made in response
to OMB review have been documented in the public record. The following
paragraphs briefly summarize findings presented in the Economic
Assessment \34\ conducted for the Proposed Rule, substantive economic
related issues brought up in stakeholder comments and Agency responses,
and revised findings in support of the final action.
---------------------------------------------------------------------------

\34\ Economic Assessment for the Proposed Loadings-Based Listing
of Non-wastewaters from the Production of Selected Organic Dyes,
Pigments, and Food, Drug, and Cosmetic Colorants, Final Report,
November 2003.
---------------------------------------------------------------------------

1. Summary of Proposed Rule Findings: Costs, Economic Impacts, Benefits
The impacts of our proposed action were presented in two supporting
documents: Economic Assessment for the Proposed Loadings-Based Listing
of Non-Wastewaters from the Production of Selected Organic Dyes,
Pigments, and Food, Drug, and Cosmetic Colorants, Final Report,
November 2003, and Regulatory Flexibility Screening Analysis for the
Proposed Loadings-Based Listing of Non-Wastewaters from the Production
of Selected Organic Dyes, Pigments, and Food, Drug, and Cosmetic
Colorants, Final Report, November 2003.
We identified a total of 37 facilities in the November 2003
Economic Assessment that were expected to be impacted by the proposed
action. These facilities were found to be operated by 29 different
companies. Of these companies, 15 were categorized as ``small
businesses'' under the Small Business Administration size
definition.\35\ We estimated the total quantity of potentially affected
waste to range from 44,215 to 68,368 metric tons per year. Aggregate
nationwide compliance costs were estimated to range from $0.6 million/
year to $4.3 million/year, depending upon assumptions regarding total
waste quantity affected and presence of targeted constituents.
Corporate level economic impacts were negligible, ranging from
virtually zero to 0.52 percent of gross annual revenues. We determined
that there were no significant economic impacts on any small entities.
---------------------------------------------------------------------------

\35\ Less than 750 total employees at the corporate level.
---------------------------------------------------------------------------

Benefits of the proposed action were presented in a general
qualitative assessment. Types of benefits included the potential for
reduced or avoided human health damage cases, avoided or

[[Page 9170]]

reduced acute events, avoided or reduced resource damage, and avoided
or reduced response costs. Depending upon actual or future exposure
patterns, the primary benefits identified in the preamble to the
proposed rule were associated reductions in human health and
environmental effects from targeted releases. Increased waste
minimization practices were discussed as upstream benefits potentially
stimulated by the proposed action.
2. Public Comments and Agency Responses
a. Summary of Substantive Cost, Economic, and Benefits Issues, and
Responses. The Agency received 25 public comments on the proposed rule.
Nearly all of these addressed some aspect related to cost of
compliance, economic impacts, and/or benefit of the rule, as proposed.
Related to these issues, there were four categories of crucial concern
presented by the commenters: industry profile/characterization, waste
quantities, analytical costs, and benefits (i.e., need for the rule). A
summary of these issues and the Agency's responses are presented below.
Stakeholder comments are addressed in more detail in the Agency's
response-to-comment document,\36\ available in the docket established
for today's action.
---------------------------------------------------------------------------

\36\ Response to Comments Document: Hazardous Waste Listing
Determination for Dyes and/or Pigments Manufacturing Wastes (Final
Rule), February 2005.
---------------------------------------------------------------------------

b. Industry Profile/Characterization. Numerous commenters indicated
that the profiles presented in the Economic Assessment were overly
optimistic concerning the projected growth and general health of the
dyes and pigment industries. Additional plant closures were noted. In
addition, several commenters noted that products affected by the
proposed rulemaking, e.g., azo dyes and pigments, tend to be
experiencing lower growth rates and profitability margins than other
product lines from the dyes and pigments industries.
Our determination of average annual growth and industry health, as
presented in the November 2003 Economic Assessment, was based on the
best publicly available information at the time. However, upon detailed
review of the public comments, and review of public information sources
available after proposal, we find that our assumption of revenues
increasing by an average of 3 percent per year was overly optimistic.
This may be especially true for dye manufacturers where production has
been plagued by downward trends in the textile industry, coupled with
pressure from inexpensive imports.\37\ However, we have no reliable
source of information that would indicate that product production
quantities (as opposed to gross revenues) for affected dye
manufacturers are substantially different from estimates presented in
the Economic Assessment. Thus, we expect waste quantities generated
from this production, and corresponding waste management costs to be
relatively unaffected. As discussed in section VIII.A.2.c below (see
also the July 21, 2004 Revised Impacts Assessment memo), we believe
that our low-end estimate of waste quantity generated per year reflects
a reasonable approximation of adjusted quantities based on comments.
Thus, economic impacts estimated under this scenario may be considered
a reasonable worst case estimate when unadjusted for revenue
projections. We also developed economic impact estimates based on a
linear reduction in compliance costs corresponding to adjusted waste
quantities, and assuming gross revenues were 100 percent (2-fold)
overstated. Economic impacts under this scenario were found to still be
less than 1 percent of annual gross revenues (see section VIII.A.3;
more details are provided in the July 21, 2004 Revised Impacts
Assessment memo).
---------------------------------------------------------------------------

\37\ PR Newswire, 2004 (March 26), Synalloy Corporation
Announces Fourth Quarter Results Financial Services News.
---------------------------------------------------------------------------

c. Waste Quantities. Commenters indicated that waste quantities
presented in the November 2003 Economic Assessment were substantially
overestimated. New information was provided regarding potentially
affected quantities of nonwastewaters. Some of this information was
facility-specific. Most information, however, was derived from
association survey responses. These new survey data were linked to
individual facilities by number only. None of the waste quantity
information provided in comments was claimed as confidential business
information.
The November 2003 Economic Assessment (EA) presented both high and
low estimates for potentially affected nonwastewaters. We recognize
that the total ``high estimate'' quantity, as presented in the EA
represents an overestimation. However, our ``low estimate'' appears to
represent a good approximation of total quantity, as compared to data
presented by the commenters. This ``low estimate'' is approximately 22
percent greater than the total quantity derived from commenter data.
The waste quantities presented in the EA were based only on information
that was publically available at the time.
We accept, with modifications, the waste quantity information
provided by the manufacturers/associations. Facility-specific
quantities, where available by facility name, are generally accepted,
as identified. For the other facilities, we have derived waste quantity
estimates based on the survey response information correlated to
facility revenue rankings. These derived waste quantities are based
only on the publicly available data, and reflect our best attempt to
assign the available quantity data from the comments with specific
facilities (applying our revenue ranking estimates, as needed). Revised
cost, economic impact, and benefit estimates have been developed based
on this new waste quantity information (see below under Revised Findings).
d. Analytical Costs. Commenters expressed concern relating to some
of our assumptions and determinations regarding analytical costs,
especially as they related to waste characterization, process
knowledge, and new method development. Commenters indicated a perceived
need to take a large number of samples due to the batch operations.
There was also concern that processor knowledge would have to be
buttressed by at least limited sampling in order to have adequate proof
that wastes generated were eligible for the exclusion. For wastes that
are determined by the generator to be nonhazardous, commenters raised
the concern that landfills may refuse the waste, or require
certification to track the annual mass loadings. Commenters also raised
technical issues relating to the development of analytical methods for
sampling the CoCs to be added to 40 CFR Part 261 Appendix VIII.
Specifically, there were concerns that the development of appropriate
analytical methods would be more complex and costly than estimated in
the proposal.
In the November 2003 Economic Assessment, we included sampling and
analysis costs for facilities assumed to be generating greater than
1,000 metric tons of potentially impacted nonwastewaters per year.
Facilities generating less than 1,000 metric tons/year were assumed to
use operator knowledge. While the rule as proposed did not require any
specific number of samples, sampling procedure, or analytical methods
for waste characterization or determination of mass-loading limits, the
Economic Assessment applied conservative assumptions for the
development of cost estimates. We assumed 15 samples per

[[Page 9171]]

wastestream for initial characterization, and an additional five
samples per year (including the first year) to assess stream
fluctuations. Annual retesting is assumed to continue for three
consecutive years to cover variations in processes and products. It was
also assumed that the three-year time period would allow the generator
to determine if any process fluctuations, waste changes, or minor
process changes may alter the waste stream characterization from
nonhazardous to hazardous.
We believe our assumptions for waste stream characterization and
annual retesting reflect a very conservative cost scenario for
facilities generating greater than 1,000 metric tons of potentially
affected nonwastewaters per year. For facilities generating less than
1,000 metric tons, process knowledge may be used. Proper documentation
of the process used to generate the waste (e.g., raw materials,
quantities, reactions, and typical constituent concentrations) is
expected to be adequate to demonstrate full process knowledge.
Facilities that are uncomfortable with this approach may choose to
purchase insurance or implement a testing procedure. However, the
Agency is not requiring such options.
We believe that the potential for landfills to require
certification to track the annual mass loadings is highly unlikely (and
was not raised in comments by any waste management firm), particularly
in light of our modification of the proposal to remove the proposed
(c)(2) requirements that would have prohibited subtitle D landfilling
once a waste's mass loading of toluene-2,4-diamine exceeded the
proposed (c)(2) limit. However, if for some reason a particular
landfill were to reject the waste outright, other subtitle D landfills
are prevalent. Additional costs from switching subtitle D landfills
would be minimal due to the relatively high number of available
subtitle D landfills within similar transportation distances.
For the development of analytical methods for sampling the CoCs to
be added to 40 CFR part 261 Appendix VIII, we assumed that the industry
would utilize common laboratories to share the costs for developing
analytical procedures. All facilities are assumed to use one of three
contracting analytical laboratories to perform the analyses. The
development costs were spread across all dye and pigment manufactures
generating more than 1,000 metric tons and selected ``expanded scope''
facilities known (at the time of the proposal) to generate waste with
constituent(s) of concern. EPA identified three laboratories that would
independently develop the analytical methods, for a total development
cost of $61,171 ($20,390 per laboratory). A five-year capital recovery
factor at 7 percent (0.24389) was applied to the development cost.
Development costs were spread equally across all facilities generating
waste with the CoCs.
The annual development cost per dye and pigment facility was
estimated at $1,083 (assuming the waste must be sampled for all CoCs).
In addition to this annual development cost, the analytical cost
(assuming all eight proposed constituents) is estimated to be $1,089
per sample. Thus, assuming five samples per year, total annual costs
would be $1,306 per sample [this is based on five samples at $1,089/
sample, plus $1,083 passed through development costs, equals $6,530.
Dividing this by five samples per year equals $1,306 per sample]. This
total analytical cost per sample is within the range of $1,000 to
$3,000 per sample, as identified by commenters. With the elimination of
toluene-2,4-diamine from the list of CoCs, analytical method
development costs will be lower because generators can avoid all
testing requirements by certifying that their wastes are being managed
in landfill units that meet the liner design requirements (or treated
by combustion) as specified in the listing description. Furthermore,
the method costs would also be reduced because we have modified the
regulations to allow use of knowledge for the problematic analyte, 1,2-
phenylenediamine.
Therefore, the Agency believes that the analytical costs and
assumptions applied in our proposed action, as summarized above,
represent a very conservative (high) cost estimate and will maintain
these costs for estimating impacts associated with the final action.
Today's final action does not require any specific number of samples,
sampling type, or analytical methods. The actual number of samples
necessary to appropriately represent the waste will be determined by
the generator.
e. Benefits. Commenters expressed concern over the lack of concrete
benefit estimates in support of the proposed rulemaking. Several
commenters questioned the need for the regulation due to the lack of
quantified and monetized benefits, resulting in a perceived
unsubstantiated actual risk to humans or the environment from the
existing management of these wastes. Commenters noted that the wastes
of concern are currently managed in lined landfills with little or no
risk documented by the risk assessment for this scenario. Commenters
noted that there were few facilities that generate wastes with the
CoCs, and that the only constituent of concern that resulted in
substantial risk to human health and the environment under current
management practices was toluene-2,4-diamine, which they argued should
be (and has been) deleted. Furthermore, commenters believed that the
overestimation of waste quantities, as discussed above, results in
exaggerated benefits associated with compliance management.
The Agency believes that, to the extent that dye, pigment and FD&C
colorant wastes are managed in landfills that do not meet the liner
requirements in 40 CFR 258.40, 264.301, or 265.301, waste management
practices have the potential to contaminate groundwater, resulting in
greater risk to human health and the environment. To the extent that
all wastes are managed in compliant landfills, there would be minimal
benefit from the listing. However, the Agency is uncertain of industry
claims that all wastes are so managed, nor is it clear that without the
regulatory action, current waste management practices would not change
to higher risk landfilling.
3. Revised Findings
We have revised our cost, economic impact, and benefits estimates
for the final rule. These revisions are based on the new waste quantity
information presented in public comments, and rule modifications. The
scope and impacts of this final action do not warrant the completion of
a full revised Economic Assessment and Regulatory Flexibility Screening
Analysis (RFSA).
The total potentially affected nonwastewater quantity presented in
the November 2003 Economic Assessment (EA) ranged from 44,215 metric
tons/year to 68,368 metric tons/year. Aggregate annual compliance costs
associated with these quantities ranged from $0.6 million/year to $4.3
million/year for the proposed regulatory approach (Economic Assessment,
Table 5-1). Corresponding economic impacts were found to range from
negligible to 0.52 percent, when measured as the ratio of compliance
costs to gross corporate revenues (Economic Assessment, Table 5-7).
Cost estimates associated only with the low waste quantity estimate
(44,215 metric tons), ranged from $0.6 million/year to $2.9 million/
year, with corresponding economic impacts ranging from negligible to
0.29 percent.
The revised total waste quantity, as derived from public comments,
is estimated at 36,142 metric tons/year. The cost and economic impact
findings

[[Page 9172]]

associated with our ``low estimate'' waste quantity (44,215 MT/yr), as
presented above, may be considered a reasonable approximation of
impacts associated with the final rule. However, more refined estimates
may be developed assuming a linear relationship between total waste
quantity and cost/economic impacts. Under this scenario, total costs
and economic impacts would decline by approximately 18 percent,
corresponding to the decline in total waste quantity (44,215 MT/yr to
36,142 MT/yr). Under this approach, the total compliance costs for the
final rule would range from an estimated $0.49 million per year to
$2.38 million/year, with economic impacts ranging from negligible to
0.238 percent of gross corporate revenues. These findings assume all
other cost parameters are unchanged (e.g., analytical assumptions,
transportation costs, administrative). In reality, the more refined
cost and economic impact estimates would be even lower due to the
elimination of toluene-2,4-diamine as a CoC for the final rule and the
likely use by industry of the conditional exemptions.
Some commenters have suggested that our estimated gross annual
corporate revenue estimates may be overstated due to overly optimistic
growth projections for the affected industries, as derived from some of
our public sources. This issue pertains primarily to private or
privately held companies where no independent revenue source was
identified (see Economic Assessment, Table 5-3). An overestimate of
gross revenues would be reflected in an artificially low economic
impact estimate. We assessed this possibility and found that, even
under the most highly impacted scenario, impacts would remain less than
1 percent (see July 21 memo, Revised Impacts Assessment).
Reduced waste quantities, as discussed above, would correspond to
reduced benefits from compliant management. However, we continue to
believe that, to the extent that affected dye, pigment and FD&C
colorant wastes may be managed in landfills not compliant with 40 CFR
section 258.40, 264.301 or 265.301, these wastes have the potential to
contaminate groundwater, resulting in unacceptable risk to human health
and the environment.

B. Paperwork Reduction Act

The information collection requirements in this rule have been
submitted for approval to the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The
information collection requirements are not enforceable until OMB
approves them. The Information Collection Request (ICR) Supporting
Statement prepared by EPA (available in the public docket for this
final rule) has been assigned EPA ICR number 1189.13
The effect of listing the wastes described earlier is to subject
certain wastes generated by the dyes and pigments industries to
management and treatment standards under the Resource Conservation and
Recovery Act (RCRA). This final rule represents an incremental increase
in burden for generators and subsequent handlers of the newly listed
wastes, and affects the existing RCRA information collection
requirements for the Land Disposal Restrictions.
In addition to complying with the existing subtitle C recordkeeping
and reporting requirements for the newly listed waste stream, EPA is
requiring that facilities generating organic dyes and/or pigment
nonwastewaters to be able to document their compliance with the new
K181 demonstration (through use of knowledge or testing) and
recordkeeping requirements, as well as the conditions provided for
exemption from the scope of the conditional hazardous waste listing
promulgated today. This requirement is necessary to ensure that in-
scope nonwastewaters are managed in a manner that is safe for human
health and the environment.
As a result of the final rule, EPA estimates that up to 33
facilities may be subject to an additional burden for existing and new
RCRA information collection requirements for the newly listed wastes.
We have estimated the annual hour and cost burden for these facilities
to comply with the existing and new recordkeeping and reporting
requirements associated with generating and managing K181 wastes. The
hourly recordkeeping burden from the new requirements ranges between
6.5 and 20.40 hours per respondent per year. This burden includes time
for reading the regulations, determining whether organic dyes and/or
pigment production nonwastewaters exceed regulatory listing levels, and
keeping documentation on site, as specified. We estimate that these
facilities would incur an annual burden of approximately 563 hours and
$123,776 in carrying out new information collection requirements. We
also estimated that these facilities would incur an annual burden of
approximately 2 hours and $86,102 in carrying out existing information
collection requirements. See the ICR Supporting Statement for details.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information, unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9. When this ICR is approved by
OMB, the Agency will publish a technical amendment to 40 CFR part 9 in
the Federal Register to display the OMB control number for the approved
information collection requirements contained in this final rule.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) of 1980, as Amended by the
Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5
U.S.C. 601 et seq., generally requires an agency to prepare a
regulatory flexibility analysis of any rule subject to notice and
comment rulemaking requirements under the Administrative Procedures Act
or any other statute. This is required unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions. The Agency
has determined that no small organizations or small governmental
jurisdictions are impacted by today's final rulemaking.
For purposes of assessing the impacts of today's final
determination on businesses, a small business is defined either by the
number of employees or by the annual dollar amount of sales/revenues.
The level at which an entity is considered small is determined for each
North American Industry Classification System (NAICS) code by the Small
Business Administration (SBA). Organic dye and pigment manufacturers
are classified under NAICS 325132. The SBA has

[[Page 9173]]

determined that manufacturers classified under this NAICS code are
``small businesses'' if their total corporate employment is less than
750 persons.
After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The small
entities directly regulated by this final rule are organic dye and
pigment manufacturers classified under NAICS 325132. We have determined
that all potentially impacted small businesses are projected to
experience compliance cost impacts of less than 1 percent of gross
annual revenues. Based on the available information, there are ten
potentially affected firms that constitute small entities under the
size definition established by the SBA. Assuming all ten companies
generate wastes containing any of the constituents of concern, no
company would experience impacts greater than 0.29 percent of annual
gross revenues (see July 21, 2004 memo: Revised Impacts Assessment).
Although this final rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. Today's
final action was designed to mitigate economic impacts to small
entities while, at the same time ensuring full protection of human
health and the environment. This was accomplished through our
innovative mass-based approach for the determination of regulatory
levels. Our waste quantity-based implementation approach also helped
mitigate potential impacts to small entities.

D. Unfunded Mandates Reform Act

Signed into law on March 22, 1995, the Unfunded Mandates Reform Act
(UMRA) supersedes Executive Order 12875, reiterating the previously
established directives while also imposing additional requirements for
federal agencies issuing any regulation containing an unfunded mandate.
Today's final rule is not subject to the requirements of sections
202, 204 and 205 of UMRA. In general, a rule is subject to the
requirements of these sections if it contains ``Federal mandates'' that
may result in the expenditure by State, local, and tribal governments,
in the aggregate, or by the private sector, of $100 million or more in
any one year. Today's final rule does not result in $100 million or
more in expenditures. The aggregate annualized compliance costs for
today's rule are projected to be less than $3 million.
Today's rule is not subject to the requirements of section 203 of
UMRA. Section 203 requires agencies to develop a small government
Agency plan before establishing any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments. EPA has determined that this rule will not significantly
or uniquely affect small governments.

E. Executive Order 13132: Federalism

Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' are defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
Today's final rule does not have federalism implications. No State
or local governments own or operate potentially impacted organic dye
and/or pigment manufacturing facilities. Furthermore, this action will
not impose excessive enforcement or review requirements. Thus, this
rule will not have substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in the Order. Executive Order 13132 does not
apply to this final rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (59 FR 22951, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.''
Today's final rule does not have tribal implications. This rule
will not significantly or uniquely affect the communities of Indian
tribal governments, nor impose substantial direct compliance costs. No
tribal governments own or operate potentially impacted organic dye and/
or pigment manufacturing facilities. Furthermore, this action will not
impose any enforcement or review requirements for tribal entities.
Thus, this rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in the
Order.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under E.O. 12866, and (2) concerns an environmental health
or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, the Agency must evaluate the environmental health or
safety effects of the rule on children, and explain why the regulation
is preferable to other potentially effective and reasonably feasible
alternatives considered by the Agency.
Today's final rule is not subject to the Executive Order because it
is not economically significant as defined under point one of the
Order, and because the Agency does not have reason to believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children. However, the Agency is particularly
concerned with environmental threats to children.
The topic of environmental threats to children's health is growing
in importance as scientists, policy makers, and community leaders
recognize the extent to which children are particularly vulnerable to
environmental hazards. Recent EPA actions are in the forefront of
addressing environmental threats to the health of children. Setting
environmental standards that address combined exposures and that are
protective of the heightened risks faced by children are both goals
named within EPA's ``National Agenda to Protect Children's Health from
Environmental Threats.'' Areas for potential reductions in risks and
related health effects are all targeted as priority issues within EPA's

[[Page 9174]]

September 1996 report, Environmental Health Threats to Children.
A few significant physiological characteristics are largely
responsible for children's increased susceptibility to environmental
hazards. First, children eat proportionately more food, drink
proportionately more fluids, and breathe more air per pound of body
weight than do adults. As a result, children potentially experience
greater levels of exposure to environmental threats than do adults.
Second, because children's bodies are still in the process of
development, their immune systems, neurological systems, and other
immature organs can be more easily and considerably affected by
environmental hazards. The connection between these physical
characteristics and children's susceptibility to environmental threats
was a consideration in developing the hazardous waste listing under
today's final action.

H. Executive Order 12898: Environmental Justice

Executive Order 12898, ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (February
11, 1994), is designed to address the environmental and human health
conditions of minority and low-income populations. EPA is committed to
environmental justice for all citizens and has assumed a leadership
role in such initiatives. The Agency's goals are to ensure that no
segment of the population, regardless of race, color, national origin,
income, or net worth bears disproportionately high and adverse human
health and/or environmental impacts as a result of EPA's policies,
programs, and activities. We have no data indicating that today's final
rule would result in disproportionately negative impacts on minority or
low income communities.

I. Executive Order 13211: Actions Affecting Energy Supply,
Distribution, or Use

Executive Order 13211, ``Actions Concerning Regulations That Affect
Energy Supply, Distribution, or Use'' (May 18, 2001), addresses the
need for regulatory actions to more fully consider the potential energy
impacts of the proposed rule and resulting actions. Under the Order,
agencies are required to prepare a Statement of Energy Effects when a
regulatory action may have significant adverse effects on energy
supply, distribution, or use, including impacts on price and foreign
supplies. Additionally, the requirements obligate agencies to consider
reasonable alternatives to regulatory actions with adverse effects and
impacts the alternatives might have upon energy supply, distribution,
or use.
This final rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Affect Energy Supply, Distribution, or
Use'' (66 FR 28355 (May 22, 2001)) because it is not an economically
significant regulatory action under Executive Order 12866. Furthermore,
it is not expected to have a significant adverse impact on the supply,
distribution, or use of energy.

J. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Pub L. 104-113, section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
This final rule does not involve the establishment of voluntary
technical standards; thus, the requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) do not apply.

K. The Congressional Review Act (5 U.S.C. 801 et seq., as Added by the
Small Business Regulatory Enforcement Fairness Act of 1996)

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA submitted a report containing this final rule, and
other required information, to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication in the Federal Register. A ``major rule'' cannot take
effect until 60 days after it is published in the Federal Register.
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 148

Administrative practice and procedure, Hazardous waste, Reporting
and record keeping requirements, Water supply.

40 CFR Part 261

Environmental protection, Hazardous materials, Waste treatment and
disposal, Recycling.

40 CFR Part 268

Environmental protection, Hazardous materials, Waste management,
Reporting and record keeping requirements, Land Disposal Restrictions,
Treatment Standards.

40 CFR Part 271

Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous material transportation,
Hazardous waste, Indians--lands, Intergovernmental relations,
Penalties, Reporting and record keeping requirements, Water pollution
control, Water supply.

40 CFR Part 302

Environmental protection, Air pollution control, Chemicals,
Emergency Planning and Community Right-to-Know Act, Extremely hazardous
substances, Hazardous chemicals, Hazardous materials, Hazardous
materials transportation, Hazardous substances, Hazardous wastes,
Intergovernmental relations, Natural resources, Reporting and record
keeping requirements, Superfund, Waste treatment and disposal, Water
pollution control, Water supply.

Dated: February 15, 2005.
Stephen L. Johnson,
Acting Administrator.

? For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:

PART 148--HAZARDOUS WASTE INJECTION RESTRICTIONS

? 1. The authority citation for part 148 continues to read as follows:

Authority: Sec. 3004, Resource Conservation and Recovery Act, 42
U.S.C. 6901, et seq.

? 2. Section 148.18 is amended by revising paragraph (l) and adding
paragraph (m) to read as follows:

Sec. 148.18 Waste-specific prohibitions--newly listed and identified
wastes.

* * * * *
(l) Effective August 23, 2005, the waste specified in 40 CFR 261.32 as

[[Page 9175]]

EPA Hazardous Waste Number K181 is prohibited from underground injection.
(m) The requirements of paragraphs (a) through (l) of this section
do not apply:
(1) If the wastes meet or are treated to meet the applicable
standards specified in subpart D of 40 CFR part 268; or
(2) If an exemption from a prohibition has been granted in response
to a petition under subpart C of this part; or
(3) During the period of extension of the applicable effective
date, if an extension has been granted under Sec. 148.4.

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

? 3. The authority citation for part 261 continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y), and 6938.

Subpart A--[Amended]

? 4. Section 261.4 is amended by revising paragraph (b)(15) to read as
follows:

Sec. 261.4 Exclusions.

* * * * *
(b) * * *
(15) Leachate or gas condensate collected from landfills where
certain solid wastes have been disposed, provided that:
(i) The solid wastes disposed would meet one or more of the listing
descriptions for Hazardous Waste Codes K169, K170, K171, K172, K174,
K175, K176, K177, K178 and K181 if these wastes had been generated
after the effective date of the listing;
(ii) The solid wastes described in paragraph (b)(15)(i) of this
section were disposed prior to the effective date of the listing;
(iii) The leachate or gas condensate do not exhibit any
characteristic of hazardous waste nor are derived from any other listed
hazardous waste;
(iv) Discharge of the leachate or gas condensate, including
leachate or gas condensate transferred from the landfill to a POTW by
truck, rail, or dedicated pipe, is subject to regulation under sections
307(b) or 402 of the Clean Water Act.
(v) As of February 13, 2001, leachate or gas condensate derived
from K169-K172 is no longer exempt if it is stored or managed in a
surface impoundment prior to discharge. As of November 21, 2003,
leachate or gas condensate derived from K176, K177, and K178 is no
longer exempt if it is stored or managed in a surface impoundment prior
to discharge. After February 26, 2007, leachate or gas condensate
derived from K181 will no longer be exempt if it is stored or managed
in a surface impoundment prior to discharge. There is one exception: if
the surface impoundment is used to temporarily store leachate or gas
condensate in response to an emergency situation (e.g., shutdown of
wastewater treatment system), provided the impoundment has a double
liner, and provided the leachate or gas condensate is removed from the
impoundment and continues to be managed in compliance with the
conditions of this paragraph (b)(15)(v) after the emergency ends.
* * * * *

Subpart D--[Amended]

? 5. Section 261.32 is amended by:
? a. Designating the existing text and table as paragraph (a),
? b. In the table by adding a new entry in alphanumeric order (by first
column) under the heading ``Organic Chemicals'',
? c. Adding paragraphs (b), (c) and (d).
The revisions and additions read as follows:

Sec. 261.32 Hazardous wastes from specific sources.

(a) * * *

------------------------------------------------------------------------
Industry and EPA hazardous
waste No. Hazardous waste Hazard code
------------------------------------------------------------------------

* * * * * * *
Organic Chemicals
------------------------------------------------------------------------

* * * * * * *
K181............................ Nonwastewaters from (T)
the production of
dyes and/or
pigments
(including
nonwastewaters
commingled at the
point of
generation with
nonwastewaters
from other
processes) that,
at the point of
generation,
contain mass
loadings of any of
the constituents
identified in
paragraph (c) of
this section that
are equal to or
greater than the
corresponding
paragraph (c)
levels, as
determined on a
calendar year
basis. These
wastes will not be
hazardous if the
nonwastewaters
are: (i) disposed
in a Subtitle D
landfill unit
subject to the
design criteria in
Sec. 258.40,
(ii) disposed in a
Subtitle C
landfill unit
subject to either
Sec. 264.301 or
Sec. 265.301,
(iii) disposed in
other Subtitle D
landfill units
that meet the
design criteria in
Sec. 258.40,
Sec. 264.301, or
Sec. 265.301, or
(iv) treated in a
combustion unit
that is permitted
under Subtitle C,
or an onsite
combustion unit
that is permitted
under the Clean
Air Act. For the
purposes of this
listing, dyes and/
or pigments
production is
defined in
paragraph (b)(1)
of this section.
Paragraph (d) of
this section
describes the
process for
demonstrating that
a facility's
nonwastewaters are
not K181. This
listing does not
apply to wastes
that are otherwise
identified as
hazardous under
Sec. Sec.
261.21-261.24 and
261.31-261.33 at
the point of
generation. Also,
the listing does
not apply to
wastes generated
before any annual
mass loading limit
is met.

* * * * * * *
------------------------------------------------------------------------

* * * * *
(b) Listing Specific Definitions: (1) For the purposes of the K181
listing, dyes and/or pigments production is defined to include
manufacture of the following product classes: dyes, pigments, or FDA
certified colors that are classified as azo, triarylmethane, perylene
or anthraquinone classes. Azo products include azo, monoazo, diazo,
triazo, polyazo, azoic, benzidine, and pyrazolone products.
Triarylmethane products include both triarylmethane and
triphenylmethane products. Wastes that are not generated at a dyes and/
or pigments manufacturing site, such as wastes from the offsite use,
formulation, and packaging of dyes and/or pigments, are not included in
the K181 listing.
(c) K181 Listing Levels. Nonwastewaters containing constituents in
amounts equal to or exceeding the following levels during any calendar
year are subject to the K181 listing, unless the conditions in the K181
listing are met.

[[Page 9176]]

------------------------------------------------------------------------
Chemical Mass
Constituent abstracts levels
No. (kg/yr)
------------------------------------------------------------------------
Aniline........................................... 62-53-3 9,300
o-Anisidine....................................... 90-04-0 110
4-Chloroaniline................................... 106-47-8 4,800
p-Cresidine....................................... 120-71-8 660
2,4-Dimethylaniline............................... 95-68-1 100
1,2-Phenylenediamine.............................. 95-54-5 710
1,3-Phenylenediamine.............................. 108-45-2 1,200
------------------------------------------------------------------------

(d) Procedures for demonstrating that dyes and/or pigment
nonwastewaters are not K181. The procedures described in paragraphs
(d)(1)-(d)(3) and (d)(5) of this section establish when nonwastewaters
from the production of dyes/pigments would not be hazardous (these
procedures apply to wastes that are not disposed in landfill units or
treated in combustion units as specified in paragraph (a) of this
section). If the nonwastewaters are disposed in landfill units or
treated in combustion units as described in paragraph (a) of this
section, then the nonwastewaters are not hazardous. In order to
demonstrate that it is meeting the landfill disposal or combustion
conditions contained in the K181 listing description, the generator
must maintain documentation as described in paragraph (d)(4) of this
section.
(1) Determination based on no K181 constituents. Generators that
have knowledge (e.g., knowledge of constituents in wastes based on
prior sampling and analysis data and/or information about raw materials
used, production processes used, and reaction and degradation products
formed) that their wastes contain none of the K181 constituents (see
paragraph (c) of this section) can use their knowledge to determine
that their waste is not K181. The generator must document the basis for
all such determinations on an annual basis and keep each annual
documentation for three years.
(2) Determination for generated quantities of 1,000 MT/yr or less
for wastes that contain K181 constituents. If the total annual quantity
of dyes and/or pigment nonwastewaters generated is 1,000 metric tons or
less, the generator can use knowledge of the wastes (e.g., knowledge of
constituents in wastes based on prior analytical data and/or
information about raw materials used, production processes used, and
reaction and degradation products formed) to conclude that annual mass
loadings for the K181 constituents are below the paragraph (c) of this
section listing levels of this section. To make this determination, the
generator must:
(i) Each year document the basis for determining that the annual
quantity of nonwastewaters expected to be generated will be less than
1,000 metric tons.
(ii) Track the actual quantity of nonwastewaters generated from
January 1 through December 31 of each year. If, at any time within the
year, the actual waste quantity exceeds 1,000 metric tons, the
generator must comply with the requirements of paragraph (d)(3) of this
section for the remainder of the year.
(iii) Keep a running total of the K181 constituent mass loadings
over the course of the calendar year.
(iv) Keep the following records on site for the three most recent
calendar years in which the hazardous waste determinations are made:
(A) The quantity of dyes and/or pigment nonwastewaters generated.
(B) The relevant process information used.
(C) The calculations performed to determine annual total mass
loadings for each K181 constituent in the nonwastewaters during the year.
(3) Determination for generated quantities greater than 1,000 MT/yr
for wastes that contain K181 constituents. If the total annual quantity
of dyes and/or pigment nonwastewaters generated is greater than 1,000
metric tons, the generator must perform all of the steps described in
paragraphs ((d)(3)(i)-(d)(3)(xi) of this section) in order to make a
determination that its waste is not K181.
(i) Determine which K181 constituents (see paragraph (c) of this
section) are reasonably expected to be present in the wastes based on
knowledge of the wastes (e.g., based on prior sampling and analysis
data and/or information about raw materials used, production processes
used, and reaction and degradation products formed).
(ii) If 1,2-phenylenediamine is present in the wastes, the
generator can use either knowledge or sampling and analysis procedures
to determine the level of this constituent in the wastes. For
determinations based on use of knowledge, the generator must comply
with the procedures for using knowledge described in paragraph (d)(2)
of this section and keep the records described in paragraph (d)(2)(iv)
of this section. For determinations based on sampling and analysis, the
generator must comply with the sampling and analysis and recordkeeping
requirements described below in this section.
(iii) Develop a waste sampling and analysis plan (or modify an
existing plan) to collect and analyze representative waste samples for
the K181 constituents reasonably expected to be present in the wastes.
At a minimum, the plan must include:
(A) A discussion of the number of samples needed to characterize
the wastes fully;
(B) The planned sample collection method to obtain representative
waste samples;
(C) A discussion of how the sampling plan accounts for potential
temporal and spatial variability of the wastes.
(D) A detailed description of the test methods to be used,
including sample preparation, clean up (if necessary), and
determinative methods.
(iv) Collect and analyze samples in accordance with the waste
sampling and analysis plan.
(A) The sampling and analysis must be unbiased, precise, and
representative of the wastes.
(B) The analytical measurements must be sufficiently sensitive,
accurate and precise to support any claim that the constituent mass
loadings are below the paragraph (c) of this section listing levels of
this section.
(v) Record the analytical results.
(vi) Record the waste quantity represented by the sampling and
analysis results.
(vii) Calculate constituent-specific mass loadings (product of
concentrations and waste quantity).
(viii) Keep a running total of the K181 constituent mass loadings
over the course of the calendar year.
(ix) Determine whether the mass of any of the K181 constituents
listed in paragraph (c) of this section generated between January 1 and
December 31 of any year is below the K181 listing levels.
(x) Keep the following records on site for the three most recent
calendar years in which the hazardous waste determinations are made:
(A) The sampling and analysis plan.
(B) The sampling and analysis results (including QA/QC data)
(C) The quantity of dyes and/or pigment nonwastewaters generated.
(D) The calculations performed to determine annual mass loadings.
(xi) Nonhazardous waste determinations must be conducted annually
to verify that the wastes remain nonhazardous.
(A) The annual testing requirements are suspended after three
consecutive successful annual demonstrations that the wastes are
nonhazardous. The generator can then use knowledge of the wastes to
support subsequent annual determinations.
(B) The annual testing requirements are reinstated if the
manufacturing or

[[Page 9177]]

waste treatment processes generating the wastes are significantly
altered, resulting in an increase of the potential for the wastes to
exceed the listing levels.
(C) If the annual testing requirements are suspended, the generator
must keep records of the process knowledge information used to support
a nonhazardous determination. If testing is reinstated, a description
of the process change must be retained.
(4) Recordkeeping for the landfill disposal and combustion
exemptions. For the purposes of meeting the landfill disposal and
combustion condition set out in the K181 listing description, the
generator must maintain on site for three years documentation
demonstrating that each shipment of waste was received by a landfill
unit that is subject to or meets the landfill design standards set out
in the listing description, or was treated in combustion units as
specified in the listing description.
(5) Waste holding and handling. During the interim period, from the
point of generation to completion of the hazardous waste determination,
the generator is responsible for storing the wastes appropriately. If
the wastes are determined to be hazardous and the generator has not
complied with the subtitle C requirements during the interim period,
the generator could be subject to an enforcement action for improper
management.

? 6. Appendix VII to part 261 is amended by adding the following entry in
alphanumeric order (by the first column) to read as follows.

Appendix VII to Part 261--Basis for Listing Hazardous Waste

------------------------------------------------------------------------
Hazardous constituents for which
EPA hazardous waste No. listed
------------------------------------------------------------------------

* * * *
K181.............................. Aniline, o-anisidine, 4-
chloroaniline, p-cresidine, 2,4-
dimethylaniline, 1,2-
phenylenediamine, 1,3-
phenylenediamine.

* * * *
------------------------------------------------------------------------

* * * * *

Appendix VIII to Part 261--Hazardous Constituents

? 7. Appendix VIII to part 261 is amended by adding in alphabetical
sequence of common name the following entries:
* * * * *

------------------------------------------------------------------------
Chemical
Common name Chemical abstracts Hazardous
abstracts name No. waste No.
------------------------------------------------------------------------

* * * * * * *
o-Anisidine (2- Benzenamine, 2- 90-04-0 ...........
methoxyaniline). Methoxy-.

* * * * * * *
p-Cresidine.................. 2-Methoxy-5- 120-71-8 ...........
methylbenzenam
ine.

* * * * * * *
2,4-Dimethylaniline (2,4- Benzenamine, 95-68-1 ...........
xylidine). 2,4-dimethyl-.

* * * * * * *
1,2-Phenylenediamine......... 1,2- 95-54-5 ...........
Benzenediamine.

* * * * * * *
1,3-Phenylenediamine......... 1,3- 108-45-2 ...........
Benzenediamine.

*...............
------------------------------------------------------------------------

PART 268--LAND DISPOSAL RESTRICTIONS

? 8. The authority citation for part 268 continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6921, and 6924.

Subpart C--Prohibitions on Land Disposal

? 9. Subpart C is amended by adding Sec. 268.20 and adding and reserving
Sec. Sec. 268.21 through 268.29 to read as follows:

Sec. 268.20 Waste specific prohibitions--Dyes and/or pigments
production wastes.

(a) Effective August 23, 2005, the waste specified in 40 CFR part
261 as EPA Hazardous Waste Number K181, and soil and debris
contaminated with this waste, radioactive wastes mixed with this waste,
and soil and debris contaminated with radioactive wastes mixed with
this waste are prohibited from land disposal.
(b) The requirements of paragraph (a) of this section do not apply if:
(1) The wastes meet the applicable treatment standards specified in
subpart D of this Part;
(2) Persons have been granted an exemption from a prohibition
pursuant to a petition under Sec. 268.6, with respect to those wastes
and units covered by the petition;
(3) The wastes meet the applicable treatment standards established
pursuant to a petition granted under Sec. 268.44;
(4) Hazardous debris has met the treatment standards in Sec.
268.40 or the alternative treatment standards in Sec. 268.45; or
(5) Persons have been granted an extension to the effective date of
a prohibition pursuant to Sec. 268.5, with respect to these wastes
covered by the extension.
(c) To determine whether a hazardous waste identified in this
section exceeds the applicable treatment standards specified in Sec.
268.40, the initial generator must test a sample of the waste extract
or the entire waste, depending on whether the treatment standards are
expressed as concentrations in the waste extract of the waste, or the
generator may use knowledge of the waste. If the waste contains
regulated constituents in excess of the applicable subpart D levels,
the waste is prohibited from land

[[Page 9178]]

disposal, and all requirements of part 268 are applicable, except as
otherwise specified.

? 10. In Sec. 268.40, the Table of Treatment Standards is amended by
revising the entry for F039 to add constituents in alphabetical
sequence, and by adding in alphanumeric order the new entry for K181 to
read as follows:

Sec. 268.40 Applicability of treatment standards.

* * * * *

Treatment Standards for Hazardous Wastes
[Note: NA means not applicable]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulated hazardous constituent
Waste description and ---------------------------------------- Wastewaters Concentration in mg/ Nonwastewater Concentration in
Waste code treatment/regulatory CAS \2\ L \3\, or technology code \4\ mg/kg \5\ unless noted as ``mg/
subcategory \1\ Common name No. L TCLP'', or technology code
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * * * *
F039............. Leachate (liquids that * * * * * .......... ................................ ...............................
have percolated through o-Anisidine (2- 90-04-0 0.010 0.66
land disposed wastes) methoxyaniline). .......... ................................ ...............................
resulting from the * * * * *................. 120-71-8 0.010 0.66
disposal of more than one p-Cresidine............... .......... ................................ ...............................
restricted waste * * * * *................. 95-68-1 0.010 0.66
classified as hazardous 2,4-Dimethylaniline (2,4- .......... ................................ ...............................
under Subpart D of this xylidine). 108-45-2 0.010 0.66
part. (Leachate resulting * * * * *.................
from the disposal of one 1,3-Phenylenediamine......
or more of the following * * * * *.................
EPA Hazardous Wastes and
no other Hazardous Waste
retains its EPA Hazardous
Waste Number(s): F020,
F021, F022, F026, F027,
and/or F028).

* * * * * * *
K181............. Nonwastewaters from the Aniline................... 62-53-3 0.81 14
production of dyes and/or o-Anisidine (2- 90-04-0 0.010 0.66
pigments (including methoxyaniline). 106-47-8 0.46 16
nonwastewaters commingled 4-Chloroaniline........... 120-71-8 0.010 0.66
at the point of p-Cresidine............... 95-68-1 0.010 0.66
generation with 2,4-Dimethylaniline (2,4- 95-54-5 CMBST; or CHOXD fb (BIODG or CMBST; or CHOXD fb (BIODG or
nonwastewaters from other xylidine). CARBN); or BIODG fb CARBN CARBN); or BIODG fb CARBN
processes) that, at the 1,2-Phenylenediamine......
point of generation,
contain mass loadings of
any of the constituents
identified in paragraph
(c) of section 261.32
that are equal to or
greater than the
corresponding paragraph
(c) levels, as determined
on a calendar year basis.
1,3-Phenylenediamine...... 108-45-2 0.010 0.66

* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

Footnotes to Treatment Standard Table 268.40

1 The waste descriptions provided in this table do not replace
waste descriptions in 40 CFR Part 261. Descriptions of Treatment/
Regulatory Subcategories are provided, as needed, to distinguish
between applicability of different standards.
2 CAS means Chemical Abstract Services. When the waste code and/or
regulated constituents are described as a combination of a chemical
with its salts and/or esters, the CAS number is given for the parent
compound only.
3 Concentration standards for wastewaters are expressed in mg/L and
are based on analysis of composite samples.
4 All treatment standards expressed as a Technology Code or
combination of Technology Codes are explained in detail in 40 CFR
268.42 Table 1-Technology Codes and Descriptions of Technology-Based
Standards.
5 Except for Metals (EP or TCLP) and Cyanides (Total and Amenable)
the nonwastewater treatment standards expressed as a concentration were
established, in part, based upon incineration in units operated in
accordance with the technical requirements of 40 CFR part 264, Subpart
O or 40 CFR part 265, Subpart O, or based upon combustion in fuel
substitution units operating in accordance with applicable technical
requirements. A facility may comply with these treatment standards
according to provisions in 40 CFR 268.40(d). All concentration
standards for nonwastewaters are based on analysis of grab samples.
* * * * *

? 11. The Table--Universal Treatment Standards in Sec. 268.48 is amended
by adding in alphabetical sequence the following entries under the
heading organic constituents:

Sec. 268.48 Universal treatment standards.

(a) * * *

[[Page 9179]]

Universal Treatment Standards
[Note: NA means not applicable]
----------------------------------------------------------------------------------------------------------------
Nonwastewater
standard
Wastewater Concentration
Regulated constituent common name CAS \1\ number standard in mg/kg \3\
Concentration unless noted
in mg/L \2\ as ``mg/L
TCLP''
----------------------------------------------------------------------------------------------------------------

* * * * * * *
o-Anisidine (2-methoxyaniline).................................. 90-04-0 0.010 0.66

* * * * * * *
p-Cresidine..................................................... 120-71-8 0.010 0.66

* * * * * * *
2,4-Dimethylaniline (2,4-xylidine).............................. 95-68-1 0.010 0.66

* * * * * * *
1,3-Phenylenediamine............................................ 108-45-2 0.010 0.66

* * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
1 CAS means Chemical Abstract Services. When the waste code and/or
regulated constituents are described as a combination of a chemical
with its salts and/or esters, the CAS number is given for the parent
compound only.
2 Concentration standards for wastewaters are expressed in mg/L and
are based on analysis of composite samples.
3 Except for Metals (EP or TCLP) and Cyanides (Total and Amenable)
the nonwastewater treatment standards expressed as a concentration were
established, in part, based upon incineration in units operated in
accordance with the technical requirements of 40 CFR Part 264, Subpart
O, or Part 265, Subpart O, or based upon combustion in fuel
substitution units operating in accordance with applicable technical
requirements. A facility may comply with these treatment standards
according to provisions in 40 CFR 268.40(d). All concentration
standards for nonwastewaters are based on analysis of grab samples.
* * * * *

PART 271--REQUIREMENTS FOR AUTHORIZATION OF STATE HAZARDOUS WASTE
PROGRAMS

? 12. The authority citation for Part 271 continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), and 6926.

? 13. Section 271.1(j) is amended by adding the following entries to
Table 1 and Table 2 in chronological order by date of publication to
read as follows.

Sec. 271.1 Purpose and scope.

* * * * *
(j) * * *

Table 1.--Regulations Implementing the Hazardous and Solid Waste Amendments of 1984
----------------------------------------------------------------------------------------------------------------
Federal Register
Promulgation date Title of regulation reference Effective date
----------------------------------------------------------------------------------------------------------------

* * * * * * *
Feb. 15, 2005........................ Listing of Hazards [INSERT FEDERAL Aug. 23, 2005
Waste K181. REGISTER PAGE NUMBERS
FOR FINAL RULE].

* * * * * * *
----------------------------------------------------------------------------------------------------------------

Table 2.--Self-Implementing Provisions of the Solid Waste Amendments of 1984
----------------------------------------------------------------------------------------------------------------
Self-implementing Federal Register
Effective date provision RCRA citation reference
----------------------------------------------------------------------------------------------------------------

* * * * * * *
Aug. 23, 2005........................ Prohibition on land 3004(g)(4)(C) and Feb. 24, 2005, (INSERT
disposal of K181 3004(m). FEDERAL REGISTER PAGE
waste, and prohibition NUMBERS).
on land disposal of
radioactive waste
mixed with K181
wastes, including soil
and debris.

* * * * * * *
----------------------------------------------------------------------------------------------------------------

[[Page 9180]]

PART 302--DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION

? 14. The authority citation for Part 302 continues to read as follows:

Authority: 42 U.S.C. 9602, 9603, and 9604; 33 U.S.C. 1321 and 1361.

? 15. In Sec. 302.4, Table 302.4 is amended by adding the following new
entry in alphanumeric order at the end of the table to read as follows:

Sec. 302.4 Designation of hazardous substances.

* * * * *

Table 302.4.--List of Hazardous Substances and Reportable Quantities
[Note: All comments/notes are located at the end of this table]
----------------------------------------------------------------------------------------------------------------
Statutory
Hazardous substance CASRN code? RCRA waste number Final RQ pounds (Kg)
----------------------------------------------------------------------------------------------------------------

* * * * * * *
K181.................................. ........... 4 K181 ##
Nonwastewaters from the production of
dyes and/or pigments (including
nonwastewaters commingled at the
point of generation with
nonwastewaters from other processes)
that, at the point of generation,
contain mass loadings of any of the
constituents identified in paragraph
(c) of section 261.32 that are equal
to or greater than the corresponding
paragraph (c) levels, as determined
on a calendar year basis.
----------------------------------------------------------------------------------------------------------------
? Indicates the statutory source defined by 1, 2, 3, and 4, as described in the note preceding Table
302.4.

* * * * *
## The Agency may adjust the statutory RQ for this hazardous substance in a future rulemaking;
until then the statutory RQ applies.

* * * * *
[FR Doc. 05-3454 Filed 2-23-05; 8:45 am]
BILLING CODE 6560-50-P

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