81_FR_69137 81 FR 68944 - Acrylic acid-butyl acrylate-styrene copolymer; Tolerance Exemption

81 FR 68944 - Acrylic acid-butyl acrylate-styrene copolymer; Tolerance Exemption

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 193 (October 5, 2016)

Page Range68944-68946
FR Document2016-24083

This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, polymer with butyl 2- propenoate and ethenylbenzene, also known as acrylic acid-butyl acrylate-styrene copolymer, when used as an inert ingredient in a pesticide chemical formulation. Momentive Performance Materials submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, polymer with butyl 2-propenoate and ethenylbenzene on food or feed commodities.

Federal Register, Volume 81 Issue 193 (Wednesday, October 5, 2016)
[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Rules and Regulations]
[Pages 68944-68946]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24083]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0330; FRL-9952-34]


Acrylic acid-butyl acrylate-styrene copolymer; Tolerance 
Exemption

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 2-propenoic acid, polymer with butyl 2-
propenoate and ethenylbenzene, also known as acrylic acid-butyl 
acrylate-styrene copolymer, when used as an inert ingredient in a 
pesticide chemical formulation. Momentive Performance Materials 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of 2-propenoic acid, polymer with butyl 
2-propenoate and ethenylbenzene on food or feed commodities.

DATES: This regulation is effective October 5, 2016. Objections and 
requests for hearings must be received on or before December 5, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0330, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. 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 OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0330 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 5, 2016. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0330, by one of 
the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of July 20, 2016 (81 FR 47150) (FRL-9948-
45), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the receipt of a pesticide petition (PP IN-10925) 
filed by

[[Page 68945]]

Momentive Performance Materials, 260 Hudson River Rd., Waterford, NY 
12188. The petition requested that 40 CFR 180.960 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of acrylic acid-butyl acrylate-styrene copolymer; CAS Reg. No. 
25586-20-3. That document included a summary of the petition prepared 
by the petitioner and solicited comments on the petitioner's request. 
The Agency did not receive any comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA 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 and use in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA 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.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be shown 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 in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. 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.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. In the case of certain chemical substances that 
are defined as polymers, the Agency has established a set of criteria 
to identify categories of polymers expected to present minimal or no 
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the 
exclusion criteria for identifying these low-risk polymers are 
described in 40 CFR 723.250(d). Acrylic acid-butyl acrylate-styrene 
copolymer conforms to the definition of a polymer given in 40 CFR 
723.250(b) and meets the following criteria that are used to identify 
low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. The polymer does contain as an integral part of its composition 
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its 
composition, except as impurities, any element other than those listed 
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably 
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or 
reactants that are already included on the TSCA Chemical Substance 
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number 
average molecular weight (MW) greater than or equal to 10,000 daltons.
    7. The polymer does not contain certain perfluoroalkyl moieties 
consisting of a CF3- or longer chain length as listed in 40 
CFR 723.250(d)(6).
    Additionally, the polymer also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    8. The polymer's number average MW of 5,200 is greater than 1,000 
and less than 10,000 daltons. The polymer contains less than 10% 
oligomeric material below MW 500 and less than 25% oligomeric material 
below MW 1,000, and the polymer does not contain any reactive 
functional groups.
    Thus, acrylic acid-butyl acrylate-styrene copolymer meets the 
criteria for a polymer to be considered low risk under 40 CFR 723.250. 
Based on its conformance to the criteria in this unit, no mammalian 
toxicity is anticipated from dietary, inhalation, or dermal exposure to 
acrylic acid-butyl acrylate-styrene copolymer.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that acrylic acid-butyl acrylate-styrene 
copolymer could be present in all raw and processed agricultural 
commodities and drinking water, and that non-occupational non-dietary 
exposure was possible. The number average MW of acrylic acid-butyl 
acrylate-styrene copolymer is 5,200 daltons. Generally, a polymer of 
this size would be poorly absorbed through the intact gastrointestinal 
tract or through intact human skin. Since acrylic acid-butyl acrylate-
styrene copolymer conforms to the criteria that identify a low-risk 
polymer, there are no concerns for risks associated with any potential 
exposure scenarios that are reasonably foreseeable. The Agency has 
determined that a tolerance is not necessary to protect the public 
health.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA 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.''
    EPA has not found acrylic acid-butyl acrylate-styrene copolymer to 
share a common mechanism of toxicity with any other substances, and 
acrylic acid-butyl acrylate-styrene copolymer does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
acrylic acid-butyl acrylate-styrene copolymer does not have a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an

[[Page 68946]]

additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base unless EPA concludes 
that a different margin of safety will be safe for infants and 
children. Due to the expected low toxicity of acrylic acid-butyl 
acrylate-styrene copolymer, EPA has not used a safety factor analysis 
to assess the risk. For the same reasons the additional tenfold safety 
factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no 
harm to the U.S. population, including infants and children, from 
aggregate exposure to residues of acrylic acid-butyl acrylate-styrene 
copolymer.

VIII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for acrylic acid-butyl 
acrylate-styrene copolymer.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of acrylic acid-
butyl acrylate-styrene copolymer from the requirement of a tolerance 
will be safe.

X. Statutory and Executive Order Reviews

    This action establishes a tolerance 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). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 action 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 26, 2016.
Michael L. Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.960, add alphabetically the polymer ``Acrylic acid-
butyl acrylate-styrene copolymer, minimum number average molecular 
weight (in amu), 5,200'' to the table to read as follows:


Sec.  [emsp14]180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

------------------------------------------------------------------------
                        Polymer                              CAS No.
------------------------------------------------------------------------
 
                                * * * * *
Acrylic acid-butyl acrylate-styrene copolymer, minimum       25586-20-3
 number average molecular weight (in amu), 5,200.......
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2016-24083 Filed 10-4-16; 8:45 am]
BILLING CODE 6560-50-P



                                           68944            Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Rules and Regulations

                                           PART 180—[AMENDED]                               permissible level for residues of 2-                         Office’s e-CFR site at http://
                                                                                            propenoic acid, polymer with butyl 2-                        www.ecfr.gov/cgi-bin/text-
                                           ■ 1. The authority citation for part 180         propenoate and ethenylbenzene on food                        idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                           continues to read as follows:                    or feed commodities.                                         40tab_02.tpl.
                                              Authority: 21 U.S.C. 321(q), 346a and 371.    DATES: This regulation is effective                          C. Can I file an objection or hearing
                                           ■ 2. In § 180.675, revise paragraph (b) to       October 5, 2016. Objections and                              request?
                                           read as follows:                                 requests for hearings must be received
                                                                                            on or before December 5, 2016, and                             Under FFDCA section 408(g), 21
                                           § 180.675 Tolfenpyrad; tolerances for            must be filed in accordance with the                         U.S.C. 346a, any person may file an
                                           residues.                                        instructions provided in 40 CFR part                         objection to any aspect of this regulation
                                           *        *     *       *     *                   178 (see also Unit I.C. of the                               and may also request a hearing on those
                                              (b) Section 18 emergency exemptions. SUPPLEMENTARY INFORMATION).                                           objections. You must file your objection
                                           Time-limited tolerances specified in the ADDRESSES: The docket for this action,                               or request a hearing on this regulation
                                           following table are established for                                                                           in accordance with the instructions
                                                                                            identified by docket identification (ID)
                                           residues of tolfenpyrad, (4-chloro-3-                                                                         provided in 40 CFR part 178. To ensure
                                                                                            number EPA–HQ–OPP–2016–0330, is
                                           ethyl-1-methyl-N-[4-(p-                                                                                       proper receipt by EPA, you must
                                                                                            available at http://www.regulations.gov
                                           tolyloxy)benzyl]pyrazole-5-                                                                                   identify docket ID number EPA–HQ–
                                                                                            or at the Office of Pesticide Programs
                                           carboxamide, including its metabolites                                                                        OPP–2016–0330 in the subject line on
                                                                                            Regulatory Public Docket (OPP Docket)
                                           and degradates, in or on the specified                                                                        the first page of your submission. All
                                                                                            in the Environmental Protection Agency
                                           agricultural commodities, resulting from Docket Center (EPA/DC), West William                                 objections and requests for a hearing
                                           use of the pesticide pursuant to FFIFRA Jefferson Clinton Bldg., Rm. 3334, 1301                               must be in writing, and must be
                                           section 18 emergency exemptions.                                                                              received by the Hearing Clerk on or
                                                                                            Constitution Ave. NW., Washington, DC
                                           Compliance with the tolerance levels                                                                          before December 5, 2016. Addresses for
                                                                                            20460–0001. The Public Reading Room
                                           specified below is to be determined by                                                                        mail and hand delivery of objections
                                                                                            is open from 8:30 a.m. to 4:30 p.m.,
                                           measuring only tolfenpyrad, 4-chloro-3- Monday through Friday, excluding legal                                and hearing requests are provided in 40
                                           ethyl-1-methyl-N-[4-(p-                                                                                       CFR 178.25(b).
                                                                                            holidays. The telephone number for the                         In addition to filing an objection or
                                           tolyloxy)benzyl]pyrazole-5-                      Public Reading Room is (202) 566–1744,
                                           carboxamide. The tolerances expire on                                                                         hearing request with the Hearing Clerk
                                                                                            and the telephone number for the OPP                         as described in 40 CFR part 178, please
                                           the date specified in the table.                 Docket is (703) 305–5805. Please review                      submit a copy of the filing (excluding
                                                                                            the visitor instructions and additional                      any Confidential Business Information
                                                                    Parts  per  Expiration
                                               Commodity                                    information about the docket available
                                                                     million        date                                                                 (CBI)) for inclusion in the public docket.
                                                                                            at http://www.epa.gov/dockets.                               Information not marked confidential
                                           Vegetable,                                       FOR FURTHER INFORMATION CONTACT:                             pursuant to 40 CFR part 2 may be
                                              fruiting, group                               Michael Goodis, Registration Division
                                              8–10 ..............          0.70  12/31/2019 (7505P), Office of Pesticide Programs,
                                                                                                                                                         disclosed publicly by EPA without prior
                                                                                                                                                         notice. Submit the non-CBI copy of your
                                                                                            Environmental Protection Agency, 1200                        objection or hearing request, identified
                                           *        *     *       *     *                   Pennsylvania Ave. NW., Washington,
                                           [FR Doc. 2016–24093 Filed 10–4–16; 8:45 am]                                                                   by docket ID number EPA–HQ–OPP–
                                                                                            DC 20460–0001; main telephone                                2016–0330, by one of the following
                                           BILLING CODE 6560–50–P
                                                                                            number: (703) 305–7090; email address:                       methods.
                                                                                            RDFRNotices@epa.gov.                                           • Federal eRulemaking Portal: http://
                                                                                            SUPPLEMENTARY INFORMATION:                                   www.regulations.gov. Follow the online
                                           ENVIRONMENTAL PROTECTION
                                           AGENCY                                           I. General Information                                       instructions for submitting comments.
                                                                                                                                                         Do not submit electronically any
                                           40 CFR Part 180                                         A. Does this action apply to me?                      information you consider to be CBI or
                                                                                                      You may be potentially affected by                 other information whose disclosure is
                                           [EPA–HQ–OPP–2016–0330; FRL–9952–34]
                                                                                                   this action if you are an agricultural                restricted by statute.
                                           Acrylic acid-butyl acrylate-styrene                     producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                           copolymer; Tolerance Exemption                          pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                                                                   list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                           AGENCY:  Environmental Protection                       Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                           Agency (EPA).                                           not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                           ACTION: Final rule.                                     provides a guide to help readers                      arrangements for hand delivery or
                                                                                                   determine whether this document                       delivery of boxed information, please
                                           SUMMARY:   This regulation establishes an                                                                     follow the instructions at http://
                                           exemption from the requirement of a                     applies to them. Potentially affected
                                                                                                   entities may include:                                 www.epa.gov/dockets/contacts.html.
                                           tolerance for residues of 2-propenoic                                                                         Additional instructions on commenting
                                                                                                      • Crop production (NAICS code 111).
                                           acid, polymer with butyl 2-propenoate                      • Animal production (NAICS code                    or visiting the docket, along with more
                                           and ethenylbenzene, also known as                       112).                                                 information about dockets generally, is
                                           acrylic acid-butyl acrylate-styrene                        • Food manufacturing (NAICS code                   available at http://www.epa.gov/
                                           copolymer, when used as an inert                        311).                                                 dockets.
                                           ingredient in a pesticide chemical                         • Pesticide manufacturing (NAICS
                                           formulation. Momentive Performance                                                                            II. Background and Statutory Findings
                                                                                                   code 32532).
ehiers on DSK5VPTVN1PROD with RULES




                                           Materials submitted a petition to EPA                                                                            In the Federal Register of July 20,
                                           under the Federal Food, Drug, and                       B. How can I get electronic access to                 2016 (81 FR 47150) (FRL–9948–45),
                                           Cosmetic Act (FFDCA), requesting an                     other related information?                            EPA issued a document pursuant to
                                           exemption from the requirement of a                       You may access a frequently updated                 FFDCA section 408, 21 U.S.C. 346a,
                                           tolerance. This regulation eliminates the               electronic version of 40 CFR part 180                 announcing the receipt of a pesticide
                                           need to establish a maximum                             through the Government Printing                       petition (PP IN–10925) filed by


                                      VerDate Sep<11>2014   15:06 Oct 04, 2016   Jkt 241001   PO 00000   Frm 00012   Fmt 4700   Sfmt 4700   E:\FR\FM\05OCR1.SGM   05OCR1


                                                            Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Rules and Regulations                                       68945

                                           Momentive Performance Materials, 260                      Consistent with FFDCA section                          Thus, acrylic acid-butyl acrylate-
                                           Hudson River Rd., Waterford, NY                         408(b)(2)(D), EPA has reviewed the                    styrene copolymer meets the criteria for
                                           12188. The petition requested that 40                   available scientific data and other                   a polymer to be considered low risk
                                           CFR 180.960 be amended by                               relevant information in support of this               under 40 CFR 723.250. Based on its
                                           establishing an exemption from the                      action and considered its validity,                   conformance to the criteria in this unit,
                                           requirement of a tolerance for residues                 completeness and reliability and the                  no mammalian toxicity is anticipated
                                           of acrylic acid-butyl acrylate-styrene                  relationship of this information to                   from dietary, inhalation, or dermal
                                           copolymer; CAS Reg. No. 25586–20–3.                     human risk. EPA has also considered                   exposure to acrylic acid-butyl acrylate-
                                           That document included a summary of                     available information concerning the                  styrene copolymer.
                                           the petition prepared by the petitioner                 variability of the sensitivities of major             IV. Aggregate Exposures
                                           and solicited comments on the                           identifiable subgroups of consumers,
                                           petitioner’s request. The Agency did not                including infants and children. In the                  For the purposes of assessing
                                           receive any comments.                                   case of certain chemical substances that              potential exposure under this
                                                                                                   are defined as polymers, the Agency has               exemption, EPA considered that acrylic
                                              Section 408(c)(2)(A)(i) of FFDCA
                                                                                                   established a set of criteria to identify             acid-butyl acrylate-styrene copolymer
                                           allows EPA to establish an exemption
                                                                                                   categories of polymers expected to                    could be present in all raw and
                                           from the requirement for a tolerance (the
                                                                                                   present minimal or no risk. The                       processed agricultural commodities and
                                           legal limit for a pesticide chemical
                                                                                                   definition of a polymer is given in 40                drinking water, and that non-
                                           residue in or on a food) only if EPA
                                                                                                   CFR 723.250(b) and the exclusion                      occupational non-dietary exposure was
                                           determines that the exemption is ‘‘safe.’’
                                                                                                   criteria for identifying these low-risk               possible. The number average MW of
                                           Section 408(c)(2)(A)(ii) of FFDCA
                                                                                                   polymers are described in 40 CFR                      acrylic acid-butyl acrylate-styrene
                                           defines ‘‘safe’’ to mean that ‘‘there is a
                                                                                                   723.250(d). Acrylic acid-butyl acrylate-              copolymer is 5,200 daltons. Generally, a
                                           reasonable certainty that no harm will
                                                                                                   styrene copolymer conforms to the                     polymer of this size would be poorly
                                           result from aggregate exposure to the
                                                                                                   definition of a polymer given in 40 CFR               absorbed through the intact
                                           pesticide chemical residue, including
                                                                                                   723.250(b) and meets the following                    gastrointestinal tract or through intact
                                           all anticipated dietary exposures and all
                                                                                                   criteria that are used to identify low-risk           human skin. Since acrylic acid-butyl
                                           other exposures for which there is
                                                                                                   polymers.                                             acrylate-styrene copolymer conforms to
                                           reliable information.’’ This includes
                                                                                                     1. The polymer is not a cationic                    the criteria that identify a low-risk
                                           exposure through drinking water and
                                                                                                   polymer nor is it reasonably anticipated              polymer, there are no concerns for risks
                                           use in residential settings, but does not
                                                                                                   to become a cationic polymer in a                     associated with any potential exposure
                                           include occupational exposure. Section
                                                                                                   natural aquatic environment.                          scenarios that are reasonably
                                           408(b)(2)(C) of FFDCA requires EPA to
                                                                                                     2. The polymer does contain as an                   foreseeable. The Agency has determined
                                           give special consideration to exposure
                                                                                                   integral part of its composition the                  that a tolerance is not necessary to
                                           of infants and children to the pesticide
                                                                                                   atomic elements carbon, hydrogen, and                 protect the public health.
                                           chemical residue in establishing an
                                           exemption from the requirement of a                     oxygen.                                               V. Cumulative Effects From Substances
                                           tolerance and to ‘‘ensure that there is a                 3. The polymer does not contain as an               With a Common Mechanism of Toxicity
                                           reasonable certainty that no harm will                  integral part of its composition, except                 Section 408(b)(2)(D)(v) of FFDCA
                                           result to infants and children from                     as impurities, any element other than                 requires that, when considering whether
                                           aggregate exposure to the pesticide                     those listed in 40 CFR 723.250(d)(2)(ii).             to establish, modify, or revoke a
                                           chemical residue . . .’’ and specifies                    4. The polymer is neither designed                  tolerance, the Agency consider
                                           factors EPA is to consider in                           nor can it be reasonably anticipated to               ‘‘available information’’ concerning the
                                           establishing an exemption.                              substantially degrade, decompose, or                  cumulative effects of a particular
                                                                                                   depolymerize.                                         pesticide’s residues and ‘‘other
                                           III. Risk Assessment and Statutory
                                                                                                     5. The polymer is manufactured or                   substances that have a common
                                           Findings
                                                                                                   imported from monomers and/or                         mechanism of toxicity.’’
                                              EPA establishes exemptions from the                  reactants that are already included on                   EPA has not found acrylic acid-butyl
                                           requirement of a tolerance only in those                the TSCA Chemical Substance                           acrylate-styrene copolymer to share a
                                           cases where it can be shown that the                    Inventory or manufactured under an                    common mechanism of toxicity with
                                           risks from aggregate exposure to                        applicable TSCA section 5 exemption.                  any other substances, and acrylic acid-
                                           pesticide chemical residues under                         6. The polymer is not a water                       butyl acrylate-styrene copolymer does
                                           reasonably foreseeable circumstances                    absorbing polymer with a number                       not appear to produce a toxic metabolite
                                           will pose no appreciable risks to human                 average molecular weight (MW) greater                 produced by other substances. For the
                                           health. In order to determine the risks                 than or equal to 10,000 daltons.                      purposes of this tolerance action,
                                           from aggregate exposure to pesticide                      7. The polymer does not contain                     therefore, EPA has assumed that acrylic
                                           inert ingredients, the Agency considers                 certain perfluoroalkyl moieties                       acid-butyl acrylate-styrene copolymer
                                           the toxicity of the inert in conjunction                consisting of a CF3- or longer chain                  does not have a common mechanism of
                                           with possible exposure to residues of                   length as listed in 40 CFR 723.250(d)(6).             toxicity with other substances. For
                                           the inert ingredient through food,                        Additionally, the polymer also meets                information regarding EPA’s efforts to
                                           drinking water, and through other                       as required the following exemption                   determine which chemicals have a
                                           exposures that occur as a result of                     criteria specified in 40 CFR 723.250(e).              common mechanism of toxicity and to
                                           pesticide use in residential settings. If                 8. The polymer’s number average MW                  evaluate the cumulative effects of such
                                           EPA is able to determine that a finite                  of 5,200 is greater than 1,000 and less               chemicals, see EPA’s Web site at http://
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                                           tolerance is not necessary to ensure that               than 10,000 daltons. The polymer                      www.epa.gov/pesticides/cumulative.
                                           there is a reasonable certainty that no                 contains less than 10% oligomeric
                                           harm will result from aggregate                         material below MW 500 and less than                   VI. Additional Safety Factor for the
                                           exposure to the inert ingredient, an                    25% oligomeric material below MW                      Protection of Infants and Children
                                           exemption from the requirement of a                     1,000, and the polymer does not contain                 Section 408(b)(2)(C) of FFDCA
                                           tolerance may be established.                           any reactive functional groups.                       provides that EPA shall apply an


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                                           68946            Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Rules and Regulations

                                           additional tenfold margin of safety for                 X. Statutory and Executive Order                      described under Title II of the Unfunded
                                           infants and children in the case of                     Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                           threshold effects to account for prenatal                  This action establishes a tolerance                1501 et seq.).
                                           and postnatal toxicity and the                          under FFDCA section 408(d) in                           This action does not involve any
                                           completeness of the data base unless                    response to a petition submitted to the               technical standards that would require
                                           EPA concludes that a different margin of                Agency. The Office of Management and                  Agency consideration of voluntary
                                           safety will be safe for infants and                     Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                           children. Due to the expected low                       of actions from review under Executive                12(d) of the National Technology
                                           toxicity of acrylic acid-butyl acrylate-                Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                           styrene copolymer, EPA has not used a                   Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                           safety factor analysis to assess the risk.              October 4, 1993). Because this action
                                           For the same reasons the additional                     has been exempted from review under                   XI. Congressional Review Act
                                           tenfold safety factor is unnecessary.                   Executive Order 12866, this action is
                                                                                                                                                           Pursuant to the Congressional Review
                                                                                                   not subject to Executive Order 13211,
                                           VII. Determination of Safety                            entitled ‘‘Actions Concerning                         Act (5 U.S.C. 801 et seq.), EPA will
                                                                                                   Regulations That Significantly Affect                 submit a report containing this rule and
                                             Based on the conformance to the                                                                             other required information to the U.S.
                                           criteria used to identify a low-risk                    Energy Supply, Distribution, or Use’’ (66
                                                                                                   FR 28355, May 22, 2001) or Executive                  Senate, the U.S. House of
                                           polymer, EPA concludes that there is a                                                                        Representatives, and the Comptroller
                                           reasonable certainty of no harm to the                  Order 13045, entitled ‘‘Protection of
                                                                                                   Children from Environmental Health                    General of the United States prior to
                                           U.S. population, including infants and                                                                        publication of the rule in the Federal
                                           children, from aggregate exposure to                    Risks and Safety Risks’’ (62 FR 19885,
                                                                                                   April 23, 1997). This action does not                 Register. This action is not a ‘‘major
                                           residues of acrylic acid-butyl acrylate-                                                                      rule’’ as defined by 5 U.S.C. 804(2).
                                                                                                   contain any information collections
                                           styrene copolymer.
                                                                                                   subject to OMB approval under the                     List of Subjects in 40 CFR Part 180
                                           VIII. Other Considerations                              Paperwork Reduction Act (PRA) (44
                                                                                                   U.S.C. 3501 et seq.), nor does it require               Environmental protection,
                                           A. Analytical Enforcement Methodology                   any special considerations under                      Administrative practice and procedure,
                                              An analytical method is not required                 Executive Order 12898, entitled                       Agricultural commodities, Pesticides
                                           for enforcement purposes since the                      ‘‘Federal Actions to Address                          and pests, Reporting and recordkeeping
                                           Agency is establishing an exemption                     Environmental Justice in Minority                     requirements.
                                           from the requirement of a tolerance                     Populations and Low-Income
                                                                                                   Populations’’ (59 FR 7629, February 16,                  Dated: September 26, 2016.
                                           without any numerical limitation.                                                                             Michael L. Goodis,
                                                                                                   1994).
                                           B. International Residue Limits                            Since tolerances and exemptions that               Acting Director, Registration Division, Office
                                                                                                   are established on the basis of a petition            of Pesticide Programs.
                                              In making its tolerance decisions, EPA               under FFDCA section 408(d), such as
                                           seeks to harmonize U.S. tolerances with                 the tolerance in this final rule, do not                Therefore, 40 CFR chapter I is
                                           international standards whenever                        require the issuance of a proposed rule,              amended as follows:
                                           possible, consistent with U.S. food                     the requirements of the Regulatory
                                           safety standards and agricultural                       Flexibility Act (RFA) (5 U.S.C. 601 et                PART 180—[AMENDED]
                                           practices. EPA considers the                            seq.), do not apply.
                                           international maximum residue limits                       This action directly regulates growers,            ■ 1. The authority citation for part 180
                                           (MRLs) established by the Codex                         food processors, food handlers, and food              continues to read as follows:
                                           Alimentarius Commission (Codex), as                     retailers, not States or tribes, nor does                 Authority: 21 U.S.C. 321(q), 346a and 371.
                                           required by FFDCA section 408(b)(4).                    this action alter the relationships or
                                           The Codex Alimentarius is a joint                       distribution of power and                             ■ 2. In § 180.960, add alphabetically the
                                           United Nations Food and Agriculture                     responsibilities established by Congress              polymer ‘‘Acrylic acid-butyl acrylate-
                                           Organization/World Health                               in the preemption provisions of FFDCA                 styrene copolymer, minimum number
                                           Organization food standards program,                    section 408(n)(4). As such, the Agency                average molecular weight (in amu),
                                           and it is recognized as an international                has determined that this action will not              5,200’’ to the table to read as follows:
                                           food safety standards-setting                           have a substantial direct effect on States
                                                                                                                                                         § 180.960 Polymers; exemptions from the
                                           organization in trade agreements to                     or tribal governments, on the
                                                                                                                                                         requirement of a tolerance.
                                           which the United States is a party. EPA                 relationship between the national
                                                                                                   government and the States or tribal                   *        *       *        *        *
                                           may establish a tolerance that is
                                           different from a Codex MRL; however,                    governments, or on the distribution of
                                                                                                   power and responsibilities among the                                Polymer                           CAS No.
                                           FFDCA section 408(b)(4) requires that
                                           EPA explain the reasons for departing                   various levels of government or between
                                           from the Codex level.                                   the Federal Government and Indian
                                                                                                                                                            *           *              *             *         *
                                                                                                   tribes. Thus, the Agency has determined
                                              The Codex has not established a MRL                                                                        Acrylic acid-butyl acrylate-
                                                                                                   that Executive Order 13132, entitled                    styrene copolymer, min-
                                           for acrylic acid-butyl acrylate-styrene                 ‘‘Federalism’’ (64 FR 43255, August 10,
                                           copolymer.                                                                                                      imum number average mo-
                                                                                                   1999) and Executive Order 13175,                        lecular weight (in amu),
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                                           IX. Conclusion                                          entitled ‘‘Consultation and Coordination                5,200 .................................   25586–20–3
                                                                                                   with Indian Tribal Governments’’ (65 FR
                                             Accordingly, EPA finds that                           67249, November 9, 2000) do not apply                      *            *            *            *         *
                                           exempting residues of acrylic acid-butyl                to this action. In addition, this action
                                           acrylate-styrene copolymer from the                     does not impose any enforceable duty or               [FR Doc. 2016–24083 Filed 10–4–16; 8:45 am]
                                           requirement of a tolerance will be safe.                contain any unfunded mandate as                       BILLING CODE 6560–50–P




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Document Created: 2016-10-05 03:29:06
Document Modified: 2016-10-05 03:29:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective October 5, 2016. Objections and requests for hearings must be received on or before December 5, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation81 FR 68944 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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