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Acrylic Acid, Styrene, <greek-a>-Methyl Styrene Copolymer, Ammonium Salt; and Styrene, 2-Ethylhexyl Acrylate, Butyl Acrylate Copolymer; Exemption from the Requirements of a Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: September 29, 1998 (Volume 63, Number 188)]
[Rules and Regulations]
[Page 51835-51840]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se98-25]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300722; FRL 6032-4]
RIN 2070-AB78
Acrylic Acid, Styrene, <greek-a>-Methyl Styrene Copolymer,
Ammonium Salt; and Styrene, 2-Ethylhexyl Acrylate, Butyl Acrylate
Copolymer; Exemption from the Requirements of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of acrylic acid, styrene, <greek-a>-methyl
styrene copolymer, ammonium salt; and styrene, 2-ethylhexyl acrylate,
butyl acrylate copolymer when used as inert ingredients (encapsulating
agent, dispensers, resins, fibers, and beads) in pesticide formulations
applied to growing crops, raw agricultural commodities after harvest,
and animals. Westvaco Corporation, Chemical Division requested these
exemptions from the requirement of a tolerance under the Federal Food,
Drug and
[[Page 51836]]
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996.
DATES: This regulation is effective September 29, 1998. Objections and
requests for hearings must be received by EPA on or before November 30,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, OPP-300722, must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified by the docket control
number, OPP-300722, must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number OPP-
300722. No Confidential Business Information (CBI) should be submitted
through e-mail. Electronic copies of objections and hearing requests on
this rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, Registration
Division (7505W), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 707A, Crystal Mall
#2, 1921 Jefferson Davis Hwy, Arlington, VA, (703) 308-8380;
gandhi.bipin@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 20, 1998 (63
FR 27727) (FRL 5788-8), EPA issued a notice pursuant to section 408 of
the FFDCA, 21 U.S.C. 346a(e) announcing the filing of pesticide
petition (PP) 6E4749 and 6E4750 for a tolerance exemption by Westvaco
Corporation, Chemical Division, 3950 Faber Place Drive, North
Charleston, SC 29405. This notice included a summary of the petition
prepared by Westvaco Corporation, Chemical Division, the petitioner.
There were no comments received in response to the notice of filing.
The petitions requested that 40 CFR 180.1001(c) and (e) be amended
by establishing an exemption from the requirement of a tolerance for
residues of acrylic acid, styrene, <greek-a>-methyl styrene copolymer,
ammonium salt; and styrene, 2-ethylhexyl acrylate, butyl acrylate
copolymer when used as an inert ingredient (encapsulating agent,
dispensers, resins, fibers, and beads) in pesticide formulations
applied to growing crops, raw agricultural commodities after harvest,
and animals.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the FFDCA, 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went
into effect immediately. Among other things, FQPA amends FFDCA to bring
all EPA pesticide tolerance-setting activities under a new section 408
with a new safety standard and new procedures.
New section 408(c)(2)(A)(i) allows EPA to establish an exemption
from the requirement of a tolerance for a pesticide chemical residue on
food only if EPA determines that the exemption is ``safe.'' Section
408(c)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water, but does not include
occupational exposure. Section 408(c)(2)(B) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue'' and specifies
factors EPA is to consider in establishing an exemption.
II. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply non-
toxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
III. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance
only in those cases where it can be clearly demonstrated that the risks
from aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert ingredient in conjunction with possible exposure to residues of
the inert ingredient in food, drinking water, and other non-
occupational exposures. If EPA is able to determine that a finite
tolerance is not necessary to ensure that there is a reasonable
certainty that no harm will result from aggregate exposure to the inert
ingredient, an exemption from the requirement of a tolerance may be
established.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of acrylic
acid, styrene, <greek-a>-methyl styrene copolymer, ammonium salt; and
styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer and to make a
determination on aggregate exposure, consistent with section 408(b)(2),
for a tolerance exemptions for residues on acrylic acid, styrene,
<greek-a>-methyl styrene copolymer, ammonium salt; and styrene, 2-
ethylhexyl acrylate, butyl
[[Page 51837]]
acrylate copolymer on growing crops, raw agricultural commodities after
harvest, and animals. EPA's assessment of the dietary exposures and
risks associated with establishing these tolerances follows.
The data submitted in the petitions and other relevant material
have been evaluated. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305), the Agency set forth a list of studies which would generally be
used to evaluate the risks posed by the presence of an inert ingredient
in a pesticide formulation. However, where it can be determined without
that data that the inert ingredient will present minimal or no risk,
the Agency generally does not require some or all of the listed studies
to rule on the proposed tolerance or exemption from the requirement of
a tolerance for an inert ingredient.
A. Toxicological Profile
In the case of certain chemical substances that are defined as
``polymers,'' the Agency has established a set of criteria which
identify categories of polymers that present low risk. These criteria
(described in 40 CFR 723.250) identify polymers that are relatively
unreactive and stable compared to other chemical substances as well as
polymers that typically are not readily absorbed. These properties
generally limit a polymer's ability to cause adverse effects. In
addition, these criteria exclude polymers about which little is known.
The Agency believes that polymers meeting these criteria will present
minimal or no risk. Acrylic acid, styrene, <greek-a>-methyl styrene
copolymer, ammonium salt; and styrene, 2-ethylhexyl acrylate, butyl
acrylate copolymer conform to the definition of polymer given in 40 CFR
723.250(b) and meet the following criteria that are used to identify
low-risk polymers:
Acrylic acid, styrene, <greek-a>-methyl styrene copolymer,
ammonium salt:
1. Acrylic acid, styrene, <greek-a>-methyl styrene copolymer
ammonium salt is not a cationic polymer, nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
2. Acrylic acid, styrene, <greek-a>-methyl styrene copolymer
ammonium salt contains as an integral part of its composition the
atomic elements carbon hydrogen, and oxygen.
3. Acrylic acid, styrene, <greek-a>-methyl styrene copolymer
ammonium salt does not contain as an integral part of its composition,
except as impurities, any elements other than those listed in 40 CFR
723.250(d)(2)(ii).
4. Acrylic acid, styrene, <greek-a>-methyl styrene copolymer,
ammonium salt is not designed, nor is it reasonably anticipated to
substantially degrade, decompose, or depolymerize.
5. Acrylic acid, styrene, <greek-a>-methyl styrene copolymer
ammonium salt is not manufactured or imported from monomers and/or
other reactants that are not already included on the Toxic Substance
Control Act (TSCA) Chemical Substance Inventory or manufactured under
an applicable TSCA section 5 exemption.
6. Acrylic acid, styrene, <greek-a>-methyl styrene copolymer
ammonium salt is not a water absorbing polymer.
7. Acrylic acid, styrene, <greek-a>-methyl styrene copolymer
ammonium salt contains carboxylic acid as the only reactive functional
group.
8. The minimum number-average molecular weight of the acrylic
acid, styrene, <greek-a>-methyl styrene copolymer is listed as 1,250
daltons. Substances with molecular weights greater than 400 generally
are not absorbed through the intact skin, and substances with molecular
weights greater than 1,000 generally are not absorbed through the
intact gastrointestinal (GI) tract. Chemicals not absorbed through the
skin or GI tract generally are incapable of eliciting a toxic response.
9. The acrylic acid, styrene, <greek-a>-methyl styrene copolymer
has a number-average molecular weight of 1,250 and contains less than
10% oligomeric material below the molecular weight 500 and less than
25% oligomeric material below the molecular weight 1,000.
In addition, acrylic acid, styrene, <greek-a>-methyl styrene
copolymer is approved by the Food and Drug Administration (FDA) under
21 CFR for contact with food as a component in adhesives (21 CFR
175.105), coatings (21 CFR 175.300), and paper and paperboard (21 CFR
176.170). The ammonium hydroxide utilized to form the ammonium salt is
listed in 21 CFR 184.1139 under the section, ``Direct food substances
affirmed as generally recognized as safe.''
Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer:
1. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer is not
a cationic polymer, nor is it reasonably anticipated to become a
cationic polymer in a natural aquatic environment.
2. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer
contains as an integral part of its composition the atomic elements
carbon, hydrogen, and oxygen.
3. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer does
not contain as an integral part of its composition, except as
impurities, any elements other than those listed in 40 CFR 723.250
(d)(2)(ii).
4. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer is not
designed, nor is it reasonably anticipated to substantially degrade,
decompose, or depolymerize.
5. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer is not
manufactured or imported from monomers and/or other reactants that are
not already included on the TSCA Chemical Substance Inventory or
manufactured under an applicable TSCA section 5 exemption.
6. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer is not
a water absorbing polymer.
7. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer
contains only the carboxylic acid ester group as the reactive
functional group.
8. The minimum number-average molecular weight of styrene, 2-
ethylhexyl acrylate, butyl acrylate copolymer is listed as 4,200
daltons. Substances with molecular weights greater than 400 generally
are not absorbed through the intact skin, and substances with molecular
weights greater than 1,000 generally are not absorbed through the GI
tract. Chemicals not absorbed through the skin or GI tract generally
are incapable of eliciting a toxic response.
9. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer has a
number-average molecular weight of 4,200 and contains less than 10%
oligomeric material below the molecular weight 500 and less than 25%
oligomeric material below the molecular weight 1,000.
B. Aggregate Exposure
Acrylic acid, styrene, <greek-a>-methyl styrene copolymer ammonium
salt formulations have been in commerce since the mid 1960's. The
copolymer is ubiquitous in our every day environment and as it is
commonly used in flexographic printing inks and coatings, such as on
newspapers, corrugated boxes (e.g. pizza boxes), and disposable
drinking cups.
Although exposure to acrylic acid, styrene, <greek-a>-methyl
styrene copolymer, ammonium salt may occur through dietary (e.g., food
wrapping containing copolymer) and non-occupational (e.g., printed
articles) sources, the chemical characteristics of acrylic acid,
styrene, <greek-a>-methyl styrene copolymer, ammonium salt lead to the
conclusion that there is a reasonable certainty of no
[[Page 51838]]
harm from aggregate exposure to the polymer. Given the existing
widespread and historic use of acrylic acid, styrene, <greek-a>-methyl
styrene copolymer, ammonium salt, any additional exposure resulting
from the approval of the copolymer as an inert ingredient in pesticide
formulations for use on growing crops or to raw agricultural
commodities after harvest is not warranted.
Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer
formulations have been in commerce since the mid 1960's. The copolymer
is ubiquitous in our every day environment and as it is commonly used
in flexographic printing inks and coatings such as on newspapers,
corrugated boxes, and disposable drinking cups.
Although exposure to styrene, 2-ethylhexyl acrylate, butyl acrylate
copolymer may occur through dietary (e.g., food wrapping containing
copolymer) and non-occupational (e.g., printed articles) sources, the
chemical characteristics of styrene, 2-ethylhexyl acrylate, butyl
acrylate copolymer lead to the conclusion that there is a reasonable
certainty of no harm from aggregate exposure to the polymer. Given the
existing widespread and historic use of styrene, 2-ethylhexyl acrylate,
butyl acrylate copolymer, any additional exposure resulting from the
approval of the copolymer as an inert ingredient in pesticide
formulations for use on growing crops or to raw agricultural
commodities after harvest is not warranted.
In addition, styrene, 2-ethylhexyl acrylate, butyl acrylate
copolymer is approved by the FDA under 21 CFR for contact with food as
a component in adhesives (21 CFR 175.105), coatings (21 CFR 175.300),
and paper and paperboard (21 CFR 176.170).
Based on the conformance of acrylic acid, styrene, <greek-a>-methyl
styrene copolymer, ammonium salt; and styrene, 2-ethylhexyl acrylate,
butyl acrylate copolymer to the criteria in Unit IV.A. of this
preamble, no mammalian toxicity is anticipated from dietary, inhalation
or dermal exposure to acrylic acid, styrene, <greek-a>-methyl styrene
copolymer, ammonium salt; and styrene, 2-ethylhexyl acrylate, butyl
acrylate copolymer.
C. Exposures and Risks
1. From food and feed uses, drinking water, and non-dietary
exposures. For the purposes of assessing the potential dietary
exposure, EPA considered that these tolerance exemptions could be
present in all raw and processed agricultural commodities and drinking
water and that non-occupational, non-dietary exposure was possible. EPA
concluded that, based on these chemical's categorization as a polymer
conforming to the definition of a polymer under 40 CFR 723.250(b) that
also meet the criteria used to identify low-risk polymers, there are no
concerns for risks associated with any potential exposure scenarios
that are reasonably foreseeable.
2. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
In the case of acrylic acid, styrene, <greek-a>-methyl styrene
copolymer, ammonium salt; and styrene, 2-ethylhexyl acrylate, butyl
acrylate copolymer, the lack of expected toxicity of these substances
based on its conformance to the definition of polymers as given in 40
CFR 723.250(b) as well as the criteria that identify low-risk polymers
results in no expected cumulative effects; a cumulative risk assessment
is therefore not necessary.
D. Aggregate Risks and Determination of Safety for U.S. Population
Based on these chemical's conformance to the definition of a
polymer given in 40 CFR 723.250(b) as well as the criteria that are
used to identify low-risk polymers, EPA concludes that there is a
reasonable certainty that no harm to the U.S. population will result
from aggregate exposure to acrylic acid, styrene, <greek-a>-methyl
styrene copolymer, ammonium salt; and styrene, 2-ethylhexyl acrylate,
butyl acrylate copolymer. EPA believes these compounds present no
dietary risk under reasonably foreseeable circumstances.
E. Aggregate Risks and Determination of Safety for Infants and Children
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre- and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a Margin of Exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans.
Because EPA has concluded these substances pose minimal or no risk
it did not use a margin of safety analysis for assessing risk to the
general population of this compound. For the same reason, application
of an additional margin of safety is unnecessary.
V. Other Considerations
The Agency proposes to establish an exemption from the requirement
of a tolerance without any numerical limitation; therefore, the Agency
has concluded that analytical methods are not required for enforcement
purposes for acrylic acid, styrene, <greek-a>-methyl styrene copolymer,
ammonium salt; and styrene, 2-ethylhexyl acrylate, butyl acrylate
copolymer.
There are no Codex Alimentarius Commission (Codex), Canadian or
Mexican, residue limits for acrylic acid, styrene, <greek-a>-methyl
styrene copolymer, ammonium salt; and styrene, 2-ethylhexyl acrylate,
butyl acrylate copolymer.
VI. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of acrylic acid, styrene, <greek-a>-methyl
styrene copolymer, ammonium salt; and styrene, 2-ethylhexyl acrylate,
butyl acrylate copolymer.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by November 30, 1998, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40
[[Page 51839]]
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issues on which a hearing is
requested, the requestor's contentions on such issues, and a summary of
any evidence relied upon by the requestor (40 CFR 178.27). A request
for a hearing will be granted if the Administrator determines that the
material submitted shows the following: There is 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 in the manner sought by the requestor
would be adequate to justify the action requested (40 CFR 178.32).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as Confidential Business Information (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.
VIII. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number OPP-300722 (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes an exemption from the tolerance
requirement under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). 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) (Pub. L. 104-4). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950) and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the preamble to the rule, a description of the
extent of EPA's prior consultation with representatives of affected
tribal governments, a summary of the nature of their concerns, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 13084 requires EPA to develop an effective process
permitting elected
[[Page 51840]]
officials and other representatives of Indian tribal governments ``to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
X. 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 to 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 Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 21, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180 -- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.1001, the table in paragraphs (c) and (e) are
amended by adding alphabetically the following inert ingredients to
read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Acrylic acid, styrene, <greek- ................ Encapsulating agent,
a>-methyl styrene Copolymer, dispensers, resins,
ammonium salt (CAS Reg. No. fibers and beads
89678-90-0), minimum number
average molecular weight (in
amu) 1250.
* * * * * * *
Styrene, 2-ethylhexyl ................ Encapsulating agent,
acrylate, butyl acrylate dispensers, resins,
copolymer (CAS Reg. No. fibers and beads
30795-23-4), minimum number
average molecular weight (in
amu) 4200.
* * * * * * *
------------------------------------------------------------------------
* * * * *
(e) * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Acrylic acid, styrene, <greek- ................ Encapsulating agent,
a>-methyl styrene copolymer, dispensers, resins,
ammonium salt (CAS Reg. No. fibers and beads
89678-90-0), minimum number
average molecular weight (in
amu) 1250.
* * * * * * *
Styrene, 2-ethylhexyl ................ Encapsulating agent,
acrylate, butyl acrylate dispensers, resins,
copolymer (CAS Reg. No. fibers and beads
30795-23-4), minimum number
average molecular weight (in
amu) 4200.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 98-26003 Filed 9-28-98; 8:45 am]
BILLING CODE 6560-50-F