[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Rules and Regulations]
[Pages 60122-60125]
[FR Doc No: 2017-27300]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0248; FRL-9970-89]

Amine Salt of Styrene Acrylic Polymer, Ammonium Salt; 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 amines, coco alkyl, ethoxylated, compds.
with acrylic acid-Bu acrylate-methylstyrene-styrene polymer, ammonium
salts (CAS Reg. No. 1186094-73-4) also known as amine salt of styrene
acrylic polymer, ammonium salt when used as an inert ingredient in a
pesticide chemical formulation. BASF Corp. 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 amines, coco alkyl, ethoxylated, compds. with acrylic acid-
Bu acrylate-methylstyrene-styrene polymer, ammonium salts on food or
feed commodities.

DATES: This regulation is effective December 19, 2017. Objections and
requests for hearings must be received on or before February 20, 2018,
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-2017-0248, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; 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-2017-0248 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
February 20, 2018. 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-2017-0248, 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 September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11044) filed by BASF Corporation, 100 Park Avenue, Florham Park, NJ
07932. The petition requested that 40 CFR 180.960 be amended by
establishing an exemption from the requirement of a tolerance for
residues of amines, coco alkyl, ethoxylated, compds. with acrylic acid-
Bu acrylate-methylstyrene-styrene polymer, ammonium salts (CAS Reg. No.
1186094-73-40). 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). Amine salt
of styrene acrylic polymer, ammonium salt 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 polymers do not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as specified 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 2700 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, amine salt of styrene acrylic polymer, ammonium salt 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 amine salt of styrene acrylic polymer, ammonium salt.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that amine salt of styrene acrylic polymer,
ammonium salt 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 amine salt of styrene
acrylic polymer, ammonium salt is 2700 daltons. Generally, a polymer of
this size would be poorly absorbed through the intact gastrointestinal
tract or through intact human skin. Since amine salt of styrene acrylic
polymer, ammonium salt 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 amine salt of styrene acrylic polymer, ammonium
salt to share a common mechanism of toxicity with any other substances,
and amine salt of styrene acrylic polymer, ammonium salt does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
amine salt of styrene acrylic polymer, ammonium salt 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 website 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
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 amine salt of styrene
acrylic polymer, ammonium salt, 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 amine salt of styrene acrylic
polymer, ammonium salt.

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 amine salt of styrene
acrylic polymer, ammonium salt.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of amine salt of
styrene acrylic polymer, ammonium salt 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: November 30, 2017.
Michael Goodis,
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 ``Amines, coco
alkyl, ethoxylated, compounds with acrylic acid-Bu acrylate-
methylstyrene-styrene polymer, ammonium salts; minimum number average
molecular weight (in amu), 2700'' to the table to read as follows:

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

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                         Polymer                              CAS No.
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                                * * * * *
Amines, coco alkyl, ethoxylated, compounds with acrylic     1186094-73-4
 acid-Bu acrylate-methylstyrene-styrene polymer,
 ammonium salts; minimum number average molecular weight
 (in amu), 2700.........................................

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[FR Doc. 2017-27300 Filed 12-18-17; 8:45 am]
 BILLING CODE 6560-50-P