82_FR_60364 82 FR 60122 - Amine Salt of Styrene Acrylic Polymer, Ammonium Salt; Tolerance Exemption

82 FR 60122 - Amine Salt of Styrene Acrylic Polymer, Ammonium Salt; Tolerance Exemption

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 242 (December 19, 2017)

Page Range60122-60125
FR Document2017-27300

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.

Federal Register, Volume 82 Issue 242 (Tuesday, December 19, 2017)
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Rules and Regulations]
[Pages 60122-60125]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

[[Page 60123]]

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 (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 L. 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-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

[[Page 60124]]

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

[[Page 60125]]

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.

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------
 
                                * * * * *
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.........................................
 
                                * * * * *
------------------------------------------------------------------------

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



                                              60122            Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations

                                              of the Paperwork Reduction Act (44                      tribe has jurisdiction. In those areas of                postpone the effectiveness of such rule
                                              U.S.C. 3501 et seq.);                                   Indian country, the rule does not have                   or action. This action may not be
                                                 • Is certified as not having a                       tribal implications and will not impose                  challenged later in proceedings to
                                              significant economic impact on a                        substantial direct costs on tribal                       enforce its requirements. (See section
                                              substantial number of small entities                    governments or preempt tribal law as                     307(b)(2)).
                                              under the Regulatory Flexibility Act (5                 specified by Executive Order 13175 (65
                                              U.S.C. 601 et seq.);                                                                                             List of Subjects in 40 CFR Part 52
                                                                                                      FR 67249, November 9, 2000).
                                                 • Does not contain any unfunded                         The Congressional Review Act, 5                         Environmental protection, Air
                                              mandate or significantly or uniquely                    U.S.C. 801 et seq., as added by the Small                pollution control, Incorporation by
                                              affect small governments, as described                  Business Regulatory Enforcement                          reference, Intergovernmental relations,
                                              in the Unfunded Mandates Reform Act                     Fairness Act of 1996, generally provides                 Nitrogen dioxide, Reporting and
                                              of 1995 (Pub. L. 104–4);                                that before a rule may take effect, the                  recordkeeping requirements, Sulfur
                                                 • Does not have Federalism                           agency promulgating the rule must                        oxides.
                                              implications as specified in Executive                  submit a rule report, which includes a                     December 6, 2017.
                                              Order 13132 (64 FR 43255, August 10,                    copy of the rule, to each House of the
                                              1999);                                                                                                           Ken Moraff,
                                                                                                      Congress and to the Comptroller General
                                                 • Is not an economically significant                                                                          Acting Regional Administrator, EPA New
                                                                                                      of the United States. The EPA will                       England.
                                              regulatory action based on health or
                                                                                                      submit a report containing this action
                                              safety risks subject to Executive Order                                                                            Part 52 of chapter I, title 40 of the
                                                                                                      and other required information to the
                                              13045 (62 FR 19885, April 23, 1997);                                                                             Code of Federal Regulations is amended
                                                 • Is not a significant regulatory action             U.S. Senate, the U.S. House of
                                                                                                      Representatives, and the Comptroller                     as follows:
                                              subject to Executive Order 13211 (66 FR
                                              28355, May 22, 2001);                                   General of the United States prior to                    PART 52—APPROVAL AND
                                                 • Is not subject to requirements of                  publication of the rule in the Federal                   PROMULGATION OF
                                              section 12(d) of the National                           Register. A major rule cannot take effect                IMPLEMENTATION PLANS
                                              Technology Transfer and Advancement                     until 60 days after it is published in the
                                              Act of 1995 (15 U.S.C. 272 note) because                Federal Register. This action is not a                   ■ 1. The authority citation for part 52
                                              application of those requirements would                 ‘‘major rule’’ as defined by 5 U.S.C.                    continues to read as follows:
                                              be inconsistent with the Clean Air Act;                 804(2).
                                                                                                                                                                   Authority: 42 U.S.C. 7401 et seq.
                                              and                                                        Under section 307(b)(1) of the Clean
                                                 • Does not provide EPA with the                      Air Act, petitions for judicial review of                Subpart OO—Rhode Island
                                              discretionary authority to address, as                  this action must be filed in the United
                                              appropriate, disproportionate human                     States Court of Appeals for the                          ■  2. In § 52.2070, the table in paragraph
                                              health or environmental effects, using                  appropriate circuit by February 20,                      (e) is amended by adding the entry
                                              practicable and legally permissible                     2018. Filing a petition for                              ‘‘Transport SIP for the 2010 NO2 and
                                              methods, under Executive Order 12898                    reconsideration by the Administrator of                  SO2 Standards’’ at the end of the table
                                              (59 FR 7629, February 16, 1994).                        this final rule does not affect the finality             to read as follows:
                                                 In addition, the SIP is not approved                 of this action for the purposes of judicial
                                              to apply on any Indian reservation land                 review nor does it extend the time                       § 52.2070    Identification of plan.
                                              or in any other area where EPA or an                    within which a petition for judicial                     *       *    *        *     *
                                              Indian tribe has demonstrated that a                    review may be filed, and shall not                           (e) * * *

                                                                                                            RHODE ISLAND NON REGULATORY
                                                                                            Applicable          State submittal
                                                  Name of nonregulatory SIP               geographic or          date/effective              EPA approved date                           Explanations
                                                          provision                       nonattainment              date
                                                                                              area


                                                       *                 *                              *                         *                      *                       *                      *
                                              Transport SIP for the 2010 NO2             Statewide ..........      10/15/2015         12/19/2017, [insert Federal Reg-
                                                and SO2 Standards.                                                                      ister citation].



                                              [FR Doc. 2017–27305 Filed 12–18–17; 8:45 am]            ACTION:    Final rule.                                   requesting an exemption from the
                                              BILLING CODE 6560–50–P                                                                                           requirement of a tolerance. This
                                                                                                      SUMMARY:   This regulation establishes an                regulation eliminates the need to
                                                                                                      exemption from the requirement of a                      establish a maximum permissible level
                                              ENVIRONMENTAL PROTECTION                                tolerance for residues of amines, coco                   for residues of amines, coco alkyl,
                                              AGENCY                                                  alkyl, ethoxylated, compds. with acrylic                 ethoxylated, compds. with acrylic acid-
                                                                                                      acid-Bu acrylate-methylstyrene-styrene                   Bu acrylate-methylstyrene-styrene
                                              40 CFR Part 180                                         polymer, ammonium salts (CAS Reg.                        polymer, ammonium salts on food or
sradovich on DSK3GMQ082PROD with RULES




                                                                                                      No. 1186094–73–4) also known as                          feed commodities.
                                              [EPA–HQ–OPP–2017–0248; FRL–9970–89]                     amine salt of styrene acrylic polymer,                   DATES: This regulation is effective
                                              Amine Salt of Styrene Acrylic Polymer,                  ammonium salt when used as an inert                      December 19, 2017. Objections and
                                              Ammonium Salt; Tolerance Exemption                      ingredient in a pesticide chemical                       requests for hearings must be received
                                                                                                      formulation. BASF Corp. submitted a                      on or before February 20, 2018, and
                                              AGENCY: Environmental Protection                        petition to EPA under the Federal Food,                  must be filed in accordance with the
                                              Agency (EPA).                                           Drug, and Cosmetic Act (FFDCA),                          instructions provided in 40 CFR part


                                         VerDate Sep<11>2014   16:00 Dec 18, 2017   Jkt 244001   PO 00000    Frm 00024   Fmt 4700     Sfmt 4700   E:\FR\FM\19DER1.SGM   19DER1


                                                               Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations                                       60123

                                              178 (see also Unit I.C. of the                          and may also request a hearing on those               included a summary of the petition
                                              SUPPLEMENTARY INFORMATION).                             objections. You must file your objection              prepared by the petitioner and solicited
                                              ADDRESSES:    The docket for this action,               or request a hearing on this regulation               comments on the petitioner’s request.
                                              identified by docket identification (ID)                in accordance with the instructions                   The Agency did not receive any
                                              number EPA–HQ–OPP–2017–0248, is                         provided in 40 CFR part 178. To ensure                comments.
                                              available at http://www.regulations.gov                 proper receipt by EPA, you must                          Section 408(c)(2)(A)(i) of FFDCA
                                              or at the Office of Pesticide Programs                  identify docket ID number EPA–HQ–                     allows EPA to establish an exemption
                                              Regulatory Public Docket (OPP Docket)                   OPP–2017–0248 in the subject line on                  from the requirement for a tolerance (the
                                              in the Environmental Protection Agency                  the first page of your submission. All                legal limit for a pesticide chemical
                                              Docket Center (EPA/DC), West William                    objections and requests for a hearing                 residue in or on a food) only if EPA
                                              Jefferson Clinton Bldg., Rm. 3334, 1301                 must be in writing, and must be                       determines that the exemption is ‘‘safe.’’
                                              Constitution Ave. NW, Washington, DC                    received by the Hearing Clerk on or                   Section 408(c)(2)(A)(ii) of FFDCA
                                              20460–0001. The Public Reading Room                     before February 20, 2018. Addresses for               defines ‘‘safe’’ to mean that ‘‘there is a
                                              is open from 8:30 a.m. to 4:30 p.m.,                    mail and hand delivery of objections                  reasonable certainty that no harm will
                                              Monday through Friday, excluding legal                  and hearing requests are provided in 40               result from aggregate exposure to the
                                              holidays. The telephone number for the                  CFR 178.25(b).                                        pesticide chemical residue, including
                                              Public Reading Room is (202) 566–1744,                    In addition to filing an objection or               all anticipated dietary exposures and all
                                              and the telephone number for the OPP                    hearing request with the Hearing Clerk                other exposures for which there is
                                              Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please               reliable information.’’ This includes
                                              the visitor instructions and additional                 submit a copy of the filing (excluding                exposure through drinking water and
                                              information about the docket available                  any Confidential Business Information                 use in residential settings, but does not
                                              at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.            include occupational exposure. Section
                                                                                                      Information not marked confidential                   408(b)(2)(C) of FFDCA requires EPA to
                                              FOR FURTHER INFORMATION CONTACT:
                                                                                                      pursuant to 40 CFR part 2 may be                      give special consideration to exposure
                                              Michael L. Goodis, Registration Division                                                                      of infants and children to the pesticide
                                                                                                      disclosed publicly by EPA without prior
                                              (7505P), Office of Pesticide Programs,                                                                        chemical residue in establishing an
                                                                                                      notice. Submit the non-CBI copy of your
                                              Environmental Protection Agency, 1200                                                                         exemption from the requirement of a
                                                                                                      objection or hearing request, identified
                                              Pennsylvania Ave. NW, Washington, DC                                                                          tolerance and to ‘‘ensure that there is a
                                                                                                      by docket ID number EPA–HQ–OPP–
                                              20460–0001; main telephone number:                                                                            reasonable certainty that no harm will
                                                                                                      2017–0248, by one of the following
                                              (703) 305–7090; email address:                                                                                result to infants and children from
                                                                                                      methods.
                                              RDFRNotices@epa.gov.                                      • Federal eRulemaking Portal: http://               aggregate exposure to the pesticide
                                              SUPPLEMENTARY INFORMATION:                              www.regulations.gov. Follow the online                chemical residue . . .’’ and specifies
                                                                                                      instructions for submitting comments.                 factors EPA is to consider in
                                              I. General Information
                                                                                                      Do not submit electronically any                      establishing an exemption.
                                              A. Does this action apply to me?                        information you consider to be CBI or                 III. Risk Assessment and Statutory
                                                 You may be potentially affected by                   other information whose disclosure is                 Findings
                                              this action if you are an agricultural                  restricted by statute.
                                              producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                      EPA establishes exemptions from the
                                                                                                      Protection Agency Docket Center (EPA/                 requirement of a tolerance only in those
                                              pesticide manufacturer. The following
                                                                                                      DC), (28221T), 1200 Pennsylvania Ave.                 cases where it can be shown that the
                                              list of North American Industrial
                                                                                                      NW, Washington, DC 20460–0001.                        risks from aggregate exposure to
                                              Classification System (NAICS) codes is
                                              not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    pesticide chemical residues under
                                                                                                      arrangements for hand delivery or                     reasonably foreseeable circumstances
                                              provides a guide to help readers                                                                              will pose no appreciable risks to human
                                              determine whether this document                         delivery of boxed information, please
                                                                                                      follow the instructions at http://                    health. In order to determine the risks
                                              applies to them. Potentially affected                                                                         from aggregate exposure to pesticide
                                              entities may include:                                   www.epa.gov/dockets/contacts.html.
                                                                                                        Additional instructions on                          inert ingredients, the Agency considers
                                                 • Crop production (NAICS code 111).
                                                 • Animal production (NAICS code                      commenting or visiting the docket,                    the toxicity of the inert in conjunction
                                              112).                                                   along with more information about                     with possible exposure to residues of
                                                 • Food manufacturing (NAICS code                     dockets generally, is available at http://            the inert ingredient through food,
                                              311).                                                   www.epa.gov/dockets.                                  drinking water, and through other
                                                 • Pesticide manufacturing (NAICS                                                                           exposures that occur as a result of
                                                                                                      II. Background and Statutory Findings                 pesticide use in residential settings. If
                                              code 32532).
                                                                                                         In the Federal Register of September               EPA is able to determine that a finite
                                              B. How can I get electronic access to                   15, 2017 (82 FR 43352) (FRL–9965–43),                 tolerance is not necessary to ensure that
                                              other related information?                              EPA issued a document pursuant to                     there is a reasonable certainty that no
                                                You may access a frequently updated                   FFDCA section 408, 21 U.S.C. 346a,                    harm will result from aggregate
                                              electronic version of 40 CFR part 180                   announcing the receipt of a pesticide                 exposure to the inert ingredient, an
                                              through the Government Printing                         petition (PP IN–11044) filed by BASF                  exemption from the requirement of a
                                              Office’s e-CFR site at http://                          Corporation, 100 Park Avenue, Florham                 tolerance may be established.
                                              www.ecfr.gov/cgi-bin/text-                              Park, NJ 07932. The petition requested                   Consistent with FFDCA section
                                              idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    that 40 CFR 180.960 be amended by                     408(b)(2)(D), EPA has reviewed the
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                                              40tab_02.tpl.                                           establishing an exemption from the                    available scientific data and other
                                                                                                      requirement of a tolerance for residues               relevant information in support of this
                                              C. Can I file an objection or hearing                   of amines, coco alkyl, ethoxylated,                   action and considered its validity,
                                              request?                                                compds. with acrylic acid-Bu acrylate-                completeness and reliability and the
                                                Under FFDCA section 408(g), 21                        methylstyrene-styrene polymer,                        relationship of this information to
                                              U.S.C. 346a, any person may file an                     ammonium salts (CAS Reg. No.                          human risk. EPA has also considered
                                              objection to any aspect of this regulation              1186094–73–40). That document                         available information concerning the


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                                              60124            Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations

                                              variability of the sensitivities of major               IV. Aggregate Exposures                               toxicity of amine salt of styrene acrylic
                                              identifiable subgroups of consumers,                      For the purposes of assessing                       polymer, ammonium salt, EPA has not
                                              including infants and children. In the                  potential exposure under this                         used a safety factor analysis to assess
                                              case of certain chemical substances that                exemption, EPA considered that amine                  the risk. For the same reasons the
                                              are defined as polymers, the Agency has                 salt of styrene acrylic polymer,                      additional tenfold safety factor is
                                              established a set of criteria to identify                                                                     unnecessary.
                                                                                                      ammonium salt could be present in all
                                              categories of polymers expected to                      raw and processed agricultural                        VII. Determination of Safety
                                              present minimal or no risk. The                         commodities and drinking water, and
                                              definition of a polymer is given in 40                                                                          Based on the conformance to the
                                                                                                      that non-occupational non-dietary                     criteria used to identify a low-risk
                                              CFR 723.250(b) and the exclusion                        exposure was possible. The number
                                              criteria for identifying these low-risk                                                                       polymer, EPA concludes that there is a
                                                                                                      average MW of amine salt of styrene                   reasonable certainty of no harm to the
                                              polymers are described in 40 CFR                        acrylic polymer, ammonium salt is 2700
                                              723.250(d). Amine salt of styrene acrylic                                                                     U.S. population, including infants and
                                                                                                      daltons. Generally, a polymer of this                 children, from aggregate exposure to
                                              polymer, ammonium salt conforms to                      size would be poorly absorbed through
                                              the definition of a polymer given in 40                                                                       residues of amine salt of styrene acrylic
                                                                                                      the intact gastrointestinal tract or                  polymer, ammonium salt.
                                              CFR 723.250(b) and meets the following                  through intact human skin. Since amine
                                              criteria that are used to identify low-risk             salt of styrene acrylic polymer,                      VIII. Other Considerations
                                              polymers.                                               ammonium salt conforms to the criteria
                                                1. The polymer is not a cationic                                                                            A. Analytical Enforcement Methodology
                                                                                                      that identify a low-risk polymer, there
                                              polymer nor is it reasonably anticipated                                                                         An analytical method is not required
                                                                                                      are no concerns for risks associated with
                                              to become a cationic polymer in a                                                                             for enforcement purposes since the
                                                                                                      any potential exposure scenarios that
                                              natural aquatic environment.                                                                                  Agency is establishing an exemption
                                                2. The polymer does contain as an                     are reasonably foreseeable. The Agency
                                                                                                                                                            from the requirement of a tolerance
                                              integral part of its composition the                    has determined that a tolerance is not
                                                                                                                                                            without any numerical limitation.
                                              atomic elements carbon, hydrogen, and                   necessary to protect the public health.
                                                                                                                                                            B. International Residue Limits
                                              oxygen.                                                 V. Cumulative Effects From Substances
                                                3. The polymer does not contain as an                 With a Common Mechanism of Toxicity                      In making its tolerance decisions, EPA
                                              integral part of its composition, except                                                                      seeks to harmonize U.S. tolerances with
                                                                                                         Section 408(b)(2)(D)(v) of FFDCA                   international standards whenever
                                              as impurities, any element other than
                                                                                                      requires that, when considering whether               possible, consistent with U.S. food
                                              those listed in 40 CFR 723.250(d)(2)(ii).
                                                4. The polymer is neither designed                    to establish, modify, or revoke a                     safety standards and agricultural
                                              nor can it be reasonably anticipated to                 tolerance, the Agency consider                        practices. EPA considers the
                                              substantially degrade, decompose, or                    ‘‘available information’’ concerning the              international maximum residue limits
                                              depolymerize.                                           cumulative effects of a particular                    (MRLs) established by the Codex
                                                5. The polymer is manufactured or                     pesticide’s residues and ‘‘other                      Alimentarius Commission (Codex), as
                                              imported from monomers and/or                           substances that have a common                         required by FFDCA section 408(b)(4).
                                              reactants that are already included on                  mechanism of toxicity.’’                              The Codex Alimentarius is a joint
                                              the TSCA Chemical Substance                                EPA has not found amine salt of                    United Nations Food and Agriculture
                                              Inventory or manufactured under an                      styrene acrylic polymer, ammonium salt                Organization/World Health
                                              applicable TSCA section 5 exemption.                    to share a common mechanism of                        Organization food standards program,
                                                6. The polymer is not a water                         toxicity with any other substances, and               and it is recognized as an international
                                              absorbing polymer with a number                         amine salt of styrene acrylic polymer,                food safety standards-setting
                                              average molecular weight (MW) greater                   ammonium salt does not appear to                      organization in trade agreements to
                                              than or equal to 10,000 daltons.                        produce a toxic metabolite produced by                which the United States is a party. EPA
                                                7. The polymers do not contain                        other substances. For the purposes of                 may establish a tolerance that is
                                              certain perfluoroalkyl moieties                         this tolerance action, therefore, EPA has             different from a Codex MRL; however,
                                              consisting of a CF3- or longer chain                    assumed that amine salt of styrene                    FFDCA section 408(b)(4) requires that
                                              length as specified in 40 CFR                           acrylic polymer, ammonium salt does                   EPA explain the reasons for departing
                                              723.250(d)(6).                                          not have a common mechanism of                        from the Codex level.
                                                Additionally, the polymer also meets                  toxicity with other substances. For                      The Codex has not established a MRL
                                              as required the following exemption                     information regarding EPA’s efforts to                for amine salt of styrene acrylic
                                              criteria specified in 40 CFR 723.250(e).                determine which chemicals have a                      polymer, ammonium salt.
                                                8. The polymer’s number average MW                    common mechanism of toxicity and to
                                              of 2700 is greater than 1,000 and less                  evaluate the cumulative effects of such               IX. Conclusion
                                              than 10,000 daltons. The polymer                        chemicals, see EPA’s website at http://                  Accordingly, EPA finds that
                                              contains less than 10% oligomeric                       www.epa.gov/pesticides/cumulative.                    exempting residues of amine salt of
                                              material below MW 500 and less than                                                                           styrene acrylic polymer, ammonium salt
                                                                                                      VI. Additional Safety Factor for the
                                              25% oligomeric material below MW                                                                              from the requirement of a tolerance will
                                                                                                      Protection of Infants and Children
                                              1,000, and the polymer does not contain                                                                       be safe.
                                              any reactive functional groups.                           Section 408(b)(2)(C) of FFDCA
                                                Thus, amine salt of styrene acrylic                   provides that EPA shall apply an                      X. Statutory and Executive Order
                                              polymer, ammonium salt meets the                        additional tenfold margin of safety for               Reviews
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                                              criteria for a polymer to be considered                 infants and children in the case of                     This action establishes a tolerance
                                              low risk under 40 CFR 723.250. Based                    threshold effects to account for prenatal             under FFDCA section 408(d) in
                                              on its conformance to the criteria in this              and postnatal toxicity and the                        response to a petition submitted to the
                                              unit, no mammalian toxicity is                          completeness of the data base unless                  Agency. The Office of Management and
                                              anticipated from dietary, inhalation, or                EPA concludes that a different margin of              Budget (OMB) has exempted these types
                                              dermal exposure to amine salt of styrene                safety will be safe for infants and                   of actions from review under Executive
                                              acrylic polymer, ammonium salt.                         children. Due to the expected low                     Order 12866, entitled ‘‘Regulatory


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                                                               Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations                                                      60125

                                              Planning and Review’’ (58 FR 51735,                     relationship between the national                     and pests, Reporting and recordkeeping
                                              October 4, 1993). Because this action                   government and the States or tribal                   requirements.
                                              has been exempted from review under                     governments, or on the distribution of                  Dated: November 30, 2017.
                                              Executive Order 12866, this action is                   power and responsibilities among the                  Michael Goodis,
                                              not subject to Executive Order 13211,                   various levels of government or between
                                                                                                                                                            Director, Registration Division, Office of
                                              entitled ‘‘Actions Concerning                           the Federal Government and Indian                     Pesticide Programs.
                                              Regulations That Significantly Affect                   tribes. Thus, the Agency has determined
                                              Energy Supply, Distribution, or Use’’ (66                                                                       Therefore, 40 CFR chapter I is
                                                                                                      that Executive Order 13132, entitled
                                              FR 28355, May 22, 2001) or Executive                                                                          amended as follows:
                                                                                                      ‘‘Federalism’’ (64 FR 43255, August 10,
                                              Order 13045, entitled ‘‘Protection of                   1999) and Executive Order 13175,                      PART 180—[AMENDED]
                                              Children from Environmental Health                      entitled ‘‘Consultation and Coordination
                                              Risks and Safety Risks’’ (62 FR 19885,                  with Indian Tribal Governments’’ (65 FR               ■ 1. The authority citation for part 180
                                              April 23, 1997). This action does not                   67249, November 9, 2000) do not apply                 continues to read as follows:
                                              contain any information collections                     to this action. In addition, this action                  Authority: 21 U.S.C. 321(q), 346a and 371.
                                              subject to OMB approval under the                       does not impose any enforceable duty or
                                              Paperwork Reduction Act (PRA) (44                       contain any unfunded mandate as                       ■ 2. In § 180.960, add alphabetically the
                                              U.S.C. 3501 et seq.), nor does it require               described under Title II of the Unfunded              polymer ‘‘Amines, coco alkyl,
                                              any special considerations under                        Mandates Reform Act (UMRA) (2 U.S.C.                  ethoxylated, compounds with acrylic
                                              Executive Order 12898, entitled                         1501 et seq.).                                        acid-Bu acrylate-methylstyrene-styrene
                                              ‘‘Federal Actions to Address                               This action does not involve any                   polymer, ammonium salts; minimum
                                              Environmental Justice in Minority                       technical standards that would require                number average molecular weight (in
                                              Populations and Low-Income                              Agency consideration of voluntary                     amu), 2700’’ to the table to read as
                                              Populations’’ (59 FR 7629, February 16,                 consensus standards pursuant to section               follows:
                                              1994).                                                  12(d) of the National Technology                      § 180.960 Polymers; exemptions from the
                                                 Since tolerances and exemptions that                 Transfer and Advancement Act                          requirement of a tolerance.
                                              are established on the basis of a petition              (NTTAA) (15 U.S.C. 272 note).                         *        *       *       *         *
                                              under FFDCA section 408(d), such as
                                              the tolerance in this final rule, do not                XI. Congressional Review Act
                                                                                                                                                                          Polymer                          CAS No.
                                              require the issuance of a proposed rule,                  Pursuant to the Congressional Review
                                              the requirements of the Regulatory                      Act (5 U.S.C. 801 et seq.), EPA will
                                              Flexibility Act (RFA) (5 U.S.C. 601 et                  submit a report containing this rule and                *           *              *             *         *
                                              seq.), do not apply.                                    other required information to the U.S.                Amines, coco alkyl,
                                                 This action directly regulates growers,              Senate, the U.S. House of                              ethoxylated, compounds
                                              food processors, food handlers, and food                Representatives, and the Comptroller                   with acrylic acid-Bu acry-
                                              retailers, not States or tribes, nor does                                                                      late-methylstyrene-styrene
                                                                                                      General of the United States prior to
                                              this action alter the relationships or                                                                         polymer, ammonium salts;
                                                                                                      publication of the rule in the Federal                 minimum number average
                                              distribution of power and                               Register. This action is not a ‘‘major                 molecular weight (in amu),
                                              responsibilities established by Congress                rule’’ as defined by 5 U.S.C. 804(2).                  2700 ..................................   1186094–73–4
                                              in the preemption provisions of FFDCA
                                              section 408(n)(4). As such, the Agency                  List of Subjects in 40 CFR Part 180
                                                                                                                                                                 *           *             *           *         *
                                              has determined that this action will not                 Environmental protection,
                                              have a substantial direct effect on States              Administrative practice and procedure,                [FR Doc. 2017–27300 Filed 12–18–17; 8:45 am]
                                              or tribal governments, on the                           Agricultural commodities, Pesticides                  BILLING CODE 6560–50–P
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Document Created: 2017-12-19 01:31:14
Document Modified: 2017-12-19 01:31:14
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 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).
ContactMichael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation82 FR 60122 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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