Pesticide Chemicals Not Requiring a Tolerance or an Exemption from a Tolerance; Rhodamine B; Revocation of Unlimited Tolerance Exemption

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: December 27, 2001 (Volume 66, Number 248)]
[Rules and Regulations]
[Page 66769-66773]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de01-22]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 153 and 180
[OPP-301026A; FRL-6813-6]
RIN 2070-AB78

Pesticide Chemicals Not Requiring a Tolerance or an Exemption
from a Tolerance; Rhodamine B; Revocation of Unlimited Tolerance
Exemption

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

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SUMMARY: This final rule creates a new subpart E in 40 CFR part 180.
This subpart will be titled: Pesticide Chemicals Not Requiring a
Tolerance or an Exemption from a Tolerance. It will contain a list of
the pesticide chemicals (including, as appropriate, their limitations
and use patterns) for which the Agency has determined that neither a
tolerance nor an exemption from the requirement of a tolerance is
needed under the Federal Food, Drug, and Cosmetic Act (FFDCA). The
Agency is acting on its own initiative. This document also revokes the
unlimited tolerance exemption for the inert ingredient Rhodamine B in
40 CFR 180.1001 (c), and amends by time-limiting the unlimited
tolerance exemption for Rhodamine B in 40 CFR 180.1001 (e). These
regulatory actions are part of the tolerance reassessment requirements
of the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as
amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA
is required to reassess 66% of the tolerances in existence on August 2,
1996, by August 2002, or about 6,400 tolerances. The regulatory actions
taken in this document, would be counted toward the August 2002
deadline.

DATES: This final rule is effective on December 27, 2001.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle , Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 305-6304; fax number: (703) 305-0599; e-mail address:
boyle.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this table could also be
affected. The North American Industrial Classification System (NAICS)
codes are provided to assist you and others in determining whether or
not this action might apply to certain entities. If you have questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR parts 153 and 180 are available at: http://
www.access.gpo.gov/nara/cfr/cfrhtml_153/Title_40/40cfr153_00.html and
http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/
40cfr180_00.html , a beta site currently under development.
2. In person. The Agency has established an official record for
this

[[Page 66770]]

action under docket control number OPP-301026A. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.

II. Background

In the Federal Register of August 2, 2001 (66 FR 40170) (FRL-6598-
4), EPA issued a proposal pursuant to section 408 of the FFDCA, 21
U.S.C. 346a as amended by the FQPA (Public Law 104-170) to amend 40 CFR
by creating a new subpart E, and to revoke two unlimited tolerance
exemptions for the inert ingredient Rhodamine B (CAS Reg. No. 81-88-9).
New subpart E will contain a list of the pesticide chemicals
(including, as appropriate, their limitations and use patterns) for
which the Agency has determined that neither a tolerance nor an
exemption from the requirement of a tolerance is needed under the
FFDCA. The only chemical included in subpart E at its creation is the
inert ingredient Rhodamine B (CAS Reg. No. 81-88-9) when used as a dye
for seed treatment. The revocations of the Rhodamine B tolerance
exemptions were based on EPA's conclusion that the exemptions are for
uses of Rhodamine B that are no longer extant other than the use
included in subpart E. Three comments were received in response to the
proposed rule.
The comments from both the American Chemistry Council and from
Gustafson supported the creation of the new subpart E. Gustafson has
also suggested an additional chemical (an active ingredient) that it
believes could be appropriately added to the new subpart. The Agency
will consider this request, and, if appropriate, initiate such
procedures as necessary to add this additional chemical to subpart E. A
comment was also received from Boehringer Ingelheim Vetmedica, Inc.
(BIVI) informing the Agency that currently there are two animal ear tag
products containing Rhodamine B that are being manufactured and
distributed. BIVI has agreed to remove the Rhodamine B from their
products. To allow time for BIVI to reformulate and then for the ear
tags containing Rhodamine B to clear the channels of trade, the Agency
will time-limit the Rhodamine B tolerance exemption under 40 CFR
180.1001 (e) to expire in 3 years.
Based on the reasons set forth in the preamble to the proposed
rule, and considering the comments received by the Agency in response
to the proposed rule, EPA is creating a new subpart E, revoking one
unlimited tolerance exemption, and revising one tolerance exemption by
time-limiting the exemption to expire in three years.
These regulatory actions are part of the tolerance reassessment
requirements of section 408(q) of the FFDCA, as amended by the FQPA of
1996. By law, EPA is required to reassess 66% of the tolerances in
existence on August 2, 1996, by August 2002, or about 6,400 tolerances.
The regulatory actions in this document, the revocation of two
tolerance exemptions, would be counted toward the August 2002 deadline.

III. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301026A in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before February
25, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

[[Page 66771]]

If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301026A, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

IV. Regulatory Assessment Requirements

The Agency is acting on its own initiative under FFDCA section
408(e) in revoking these tolerances and in establishing a new subpart E
in 40 CFR part 180 that will contain a list of the pesticide chemicals
(including, as appropriate, their limitations and use patterns) for
which the Agency has determined that neither a tolerance nor an
exemption from the requirement of a tolerance is needed under FFDCA.
Under Executive Order 12866, entitled Regulatory Planning and Review
(58 FR 51735, October 4, 1993), this action is not a ``significant
regulatory action'' subject to review by the Office of Management and
Budget (OMB). Because this rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001).
This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review
or any Agency action under Executive Order 13045, entitled Protection
of Children from Environmental Health Risks and Safety Risks (62 FR
19885, April 23, 1997).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
This rule simply establishes a new subpart E in 40 CFR part 180
that will contain a list of the pesticide chemicals (including, as
appropriate, their limitations and use patterns) for which the Agency
has determined that neither a tolerance nor an exemption from the
requirement of a tolerance is needed under FFDCA, and only amends an
existing unlimited tolerance exemption to make it time limited. The
Agency has determined that this action will not result in significant
adverse economic impacts. Pursuant to the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether
revocations of tolerances or tolerance exemptions might significantly
impact a substantial number of small entities and concluded that, as a
general matter, these actions do not impose a significant economic
impact on a substantial number of small entities. This analysis was
published on December 17, 1997 (62 FR 66020), and was provided to the
Chief Counsel for Advocacy of the Small Business Administration. Taking
into account this analysis, the available information concerning the
pesticide chemicals listed in this rule, the Agency knows of no
extraordinary circumstances that exist as to the present revocation
that would change EPA's previous analysis. Therefore, the Agency hereby
certifies pursuant to the section 605(b) of the RFA that this rule will
not have a significant negative economic impact on a substantial number
of small entities.
In addition, the Agency has determined that this action will not
have a substantial direct effect on 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 Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 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'' is 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.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
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.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal

[[Page 66772]]

government and Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes, as
specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

V. Submission to Congress and the Comptroller General

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 the Comptroller General of the United
States. EPA will submit a report containing this 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 of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 153 and 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: December 14, 2001.
James Jones,
Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I be amended as follows:

PART 153--[AMENDED]

1. In part 153:
a. The authority citation for part 153 would continue to read as
follows:

Authority: 15 U.S.C. 136 et seq.

b. Section 153.155 (c) is revised to read as follows.

Sec. 153.155 Seed treatment products.

* * * * *
(c) EPA-approved dyes for seed treatment are listed in:
(1) Section 180.1001(c) and (d) if an exemption from the
requirement of a tolerance has been established.
(2) Section 180.2010 if EPA has determined that residues of the dye
will be present, if at all, at levels that are below the threshold of
regulation.
(3) Section 180.2020 if it has been determined that no tolerance or
exemption from the requirement of a tolerance is needed as a result of
a determination by EPA that the use is unlikely to result in residues
in food/feed.

PART 180--[AMENDED]

2. In part 180:

a. The authority citation for part 180 would continue to read as
follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

b. In Sec. 180.1001 the table in paragraph (c) is amended by
removing the entry for ``Rhodamine B'' and in paragraph (e) the table
is amended by revising the entry to read as follows:

Sec. 180.1001 Exemptions from the requirement of a tolerance.

* * * * *
(e) * * *

------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * *
* * *
Rhodamine B Expires December 27, Dye for use in
2004. ear tags only
* * * *
* * *
------------------------------------------------------------------------

c. By adding new subpart E, consisting of Sec. 180.2000-180.2020,
to read as follows:

Subpart E--Pesticide Chemicals Not Requiring a Tolerance or an
Exemption from a Tolerance

Sec.
180.2000 Scope.
180.2003 Definitions.
180.2010 Threshold of regulation determinations. [Reserved]
180.2020 Non-food determinations.

Sec. 180.2000 Scope.

This subpart sets forth the pesticide chemicals for use in
agricultural or other food-related settings for which neither a
tolerance nor an exemption is deemed to be needed by EPA.

Sec. 180.2003 Definitions.

(a) Food uses are the uses of a pesticide chemical that are likely
to yield residues in food or feed crops, meat, milk, poultry or eggs.
(b) Non-food uses are those uses that are not likely to yield
residues in food or feed crops, meat, milk, poultry or eggs.

Sec. 180.2010 Threshold of regulation determinations. [Reserved]

Sec. 180.2020 Non-food determinations.

The following pesticide chemical uses do not need a tolerance or
exemption from the requirement of a tolerance based on EPA's
determination that they are not likely to result in residues in or on
food.

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Pesticide Chemical CAS Reg. No. Limits Uses
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Rhodamine B 81-88-9 Not to exceed 2% by Dye for seed treatment
weight of the formulated
product and 60 ppm on
the treated seed
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[[Page 66773]]

[FR Doc. 01-31802 Filed 12-26-01; 8:45 am]
BILLING CODE 6560-50-S

Pesticide Chemicals Not Requiring a Tolerance or an Exemption from a Tolerance; Rhodamine B; Revocation of Unlimited Tolerance Exemption

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