[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51835-51840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26003]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300722; FRL 6032-4]
RIN 2070-AB78


Acrylic Acid, Styrene, -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, -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: [email protected]. 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; 
[email protected].

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, -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, -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, 
-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, -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, -methyl styrene copolymer, 
ammonium salt:
     1. Acrylic acid, styrene, -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, -methyl styrene copolymer 
ammonium salt contains as an integral part of its composition the 
atomic elements carbon hydrogen, and oxygen.
     3. Acrylic acid, styrene, -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, -methyl styrene copolymer, 
ammonium salt is not designed, nor is it reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
     5. Acrylic acid, styrene, -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, -methyl styrene copolymer 
ammonium salt is not a water absorbing polymer.
     7. Acrylic acid, styrene, -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, -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, -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, -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, -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, -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, -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, -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, -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, -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, -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, -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, -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, -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, -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:
    [email protected].


    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, -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, -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.
         *        *        *        *        *        *        *
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[FR Doc. 98-26003 Filed 9-28-98; 8:45 am]
BILLING CODE 6560-50-F