81_FR_60792 81 FR 60621 - Butanedioic Acid, 2-Methylene-, Polymer With 1,3-Butadiene, Ethylbenzene and 2-Hydroxyethyl-2-Propenoate; Tolerance Exemption

81 FR 60621 - Butanedioic Acid, 2-Methylene-, Polymer With 1,3-Butadiene, Ethylbenzene and 2-Hydroxyethyl-2-Propenoate; Tolerance Exemption

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 171 (September 2, 2016)

Page Range60621-60625
FR Document2016-21219

This regulation establishes an exemption from the requirement of a tolerance for residues of butanedioic acid, 2-methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate; when used as an inert ingredient (emulsifier or binder) in a pesticide chemical formulation. Keller and Heckman on behalf of Trinseo LLC 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 butanedioic acid, 2-methylene-, polymer with 1,3- butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate on food or feed commodities.

Federal Register, Volume 81 Issue 171 (Friday, September 2, 2016)
[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Rules and Regulations]
[Pages 60621-60625]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21219]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0201; FRL-9950-63]


Butanedioic Acid, 2-Methylene-, Polymer With 1,3-Butadiene, 
Ethylbenzene and 2-Hydroxyethyl-2-Propenoate; 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 butanedioic acid, 2-methylene-, polymer 
with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate; 
when used as an inert ingredient (emulsifier or binder) in a pesticide 
chemical formulation. Keller and Heckman on behalf of Trinseo LLC 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA),

[[Page 60622]]

requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of butanedioic acid, 2-methylene-, polymer with 1,3-
butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate on food or 
feed commodities.

DATES: This regulation is effective September 2, 2016. Objections and 
requests for hearings must be received on or before November 1, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0201, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

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

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0201 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 
November 1, 2016. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0201, 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 May 19, 2016 (81) FR (31585) (FRL-9946-
02), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the receipt of a pesticide petition (PP IN-10907) 
filed by Keller and Heckman (1001 G Street NW., Suite 500, Washington, 
DC 20001) on behalf of Trinseo LLC (1000 Chesterbrook Blvd., Berwyn, PA 
19312-1084). The petition requested that 40 CFR 180.960 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of butanedioic acid, 2-methylene-, polymer with 1,3-butadiene, 
ethenylbenzene and 2-hydroxyethyl 2-propenoate (CAS Reg. No. 36089-06-
2). 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

[[Page 60623]]

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). Butanedioic acid, 2-methylene-, polymer 
with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate 
conforms to the definition of a polymer given in 40 CFR 723.250(b) and 
meets the following criteria that are used to identify low-risk 
polymers.
    1. The polymer is not a cationic polymer nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. The polymer does contain as an integral part of its composition 
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its 
composition, except as impurities, any element other than those listed 
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably 
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or 
reactants that are already included on the TSCA Chemical Substance 
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number 
average molecular weight (MW) greater than or equal to 10,000 daltons.
    7. The polymer does not contain certain perfluoroalkyl moieties 
consisting of a CF3- or longer chain length as 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 10,000 is greater than or 
equal to 10,000 daltons. The polymer contains less than 2% oligomeric 
material below MW 500 and less than 5% oligomeric material below MW 
1,000.
    Thus, butanedioic acid, 2-methy- lene-, polymer with 1,3-butadiene, 
ethenylbenzene and 2-hydroxyethyl 2-propenoate 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 butanedioic 
acid, 2-methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-
hydroxyethyl 2-propenoate.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that the butanedioic acid, 2-methylene-, 
polymer with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-
propenoate could be present in all raw and processed agricultural 
commodities and drinking water, and that non-occupational non-dietary 
exposure was possible. The minimum number average MW of butanedioic 
acid, 2-methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-
hydroxyethyl 2-propenoate is 10,000 daltons. Generally, a polymer of 
this size would be poorly absorbed through the intact gastrointestinal 
tract or through intact human skin. Since butanedioic acid, 2-
methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-
hydroxyethyl 2-propenoate 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 butanedioic acid, 2-methylene-, polymer with 1,3-
butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate to share a 
common mechanism of toxicity with any other substances, and butanedioic 
acid, 2-methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-
hydroxyethyl 2-propenoate does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that butanedioic acid, 2-methylene-, 
polymer with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-
propenoate does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
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 butanedioic acid, 2-
methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-
hydroxyethyl 2-propenoate, 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 butanedioic acid, 2-methylene-, 
polymer with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-
propenoate.

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

    There are no existing exemptions from the requirements of a 
tolerance.

B. 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.

[[Page 60624]]

C. 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 butanedioic acid, 2-
methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-
hydroxyethyl 2-propenoate.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of butanedioic acid, 
2-methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-
hydroxyethyl 2-propenoate 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: August 17, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
 2. In Sec.  180.960, alphabetically add the polymer(s) to the table to 
read as follows:


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

* * * * *

------------------------------------------------------------------------
                        Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
Butanedioic acid, 2-methylene-, polymer with 1,3-            36089-06-2
 butadiene, ethenylbenzene and 2-hydroxyethyl 2-
 propenoate, minimum number average molecular weight
 (in amu), 10,000......................................
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 60625]]

[FR Doc. 2016-21219 Filed 9-1-16; 8:45 am]
 BILLING CODE 6560-50-P



                                                            Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Rules and Regulations                                              60621

                                           ACTION:Notice of deviation from                            In accordance with 33 CFR 117.35(e),               least one hour notice is given, as
                                           drawbridge regulation.                                  the drawbridge must return to its regular             required by 33 CFR 117.149. Navigation
                                                                                                   operating schedule immediately at the                 on the waterway is recreational.
                                           SUMMARY:   The Coast Guard has issued a                 end of the effective period of this                      The drawspan will be secured in the
                                           temporary deviation from the operating                  temporary deviation. This deviation                   closed-to-navigation position from 5
                                           schedule that governs the US40–322                      from the operating regulations is                     a.m. to 12 p.m. on September 11, 2016,
                                           (Albany Avenue) Bridge across the                       authorized under 33 CFR 117.35.                       to allow participants to cross the bridge
                                           NJICW (Inside Thorofare), mile 70.0, at                                                                       during the San Francisco Giant Race at
                                                                                                     Dated: August 23, 2016.
                                           Atlantic City, NJ. The deviation is                                                                           AT&T Park event. This temporary
                                           necessary to facilitate the Atlantic City               Hal R. Pitts,
                                                                                                                                                         deviation has been coordinated with the
                                           IRONMAN Triathlon. This deviation                       Bridge Program Manager, Fifth Coast Guard
                                                                                                   District.
                                                                                                                                                         waterway users. No objections to the
                                           allows the bridge to remain in the                                                                            proposed temporary deviation were
                                           closed-to-navigation position.                          [FR Doc. 2016–21174 Filed 9–1–16; 8:45 am]
                                                                                                                                                         raised.
                                                                                                   BILLING CODE 9110–04–P
                                           DATES: The deviation is effective from                                                                           Vessels able to pass through the
                                           6:30 a.m. to 2 p.m. on September 18,                                                                          bridge in the closed position may do so
                                           2016.                                                                                                         at anytime. The bridge will be able to
                                                                                                   DEPARTMENT OF HOMELAND
                                                                                                                                                         open for emergencies and there is no
                                           ADDRESSES:   The docket for this                        SECURITY
                                                                                                                                                         immediate alternate route for vessels to
                                           deviation, [USCG–2016–0613] is
                                                                                                   Coast Guard                                           pass. The Coast Guard will also inform
                                           available at http://www.regulations.gov.
                                                                                                                                                         the users of the waterway through our
                                           Type the docket number in the
                                                                                                   33 CFR Part 117                                       Local and Broadcast Notices to Mariners
                                           ‘‘SEARCH’’ box and click ‘‘SEARCH’’.
                                                                                                                                                         of the change in operating schedule for
                                           Click on Open Docket Folder on the line                 [Docket No. USCG–2016–0851]                           the bridge so vessel operators can
                                           associated with this deviation.
                                                                                                                                                         arrange their transits to minimize any
                                           FOR FURTHER INFORMATION CONTACT: If                     Drawbridge Operation Regulation;
                                                                                                                                                         impact caused by the temporary
                                           you have questions on this temporary                    China Basin, San Francisco, CA
                                                                                                                                                         deviation.
                                           deviation, call or email Mr. Michael                    AGENCY: Coast Guard, DHS.                                In accordance with 33 CFR 117.35(e),
                                           Thorogood, Bridge Administration                                                                              the drawbridge must return to its regular
                                                                                                   ACTION:Notice of deviation from
                                           Branch Fifth District, Coast Guard,                                                                           operating schedule immediately at the
                                                                                                   drawbridge regulation.
                                           telephone 757–398–6557, email                                                                                 end of the effective period of this
                                           Michael.R.Thorogood@uscg.mil.                           SUMMARY:   The Coast Guard has issued a               temporary deviation. This deviation
                                           SUPPLEMENTARY INFORMATION: The                          temporary deviation from the operating                from the operating regulations is
                                           DelMoSports, LLC, on behalf of the New                  schedule that governs the 3rd Street                  authorized under 33 CFR 117.35.
                                           Jersey Department of Transportation,                    Drawbridge across China Basin, mile 0.0                 Dated: August 29, 2016.
                                           who owns the US 40–322 (Albany                          at San Francisco, CA. The deviation is                D.H. Sulouff,
                                           Avenue) Bridge across the NJICW                         necessary to allow participants to cross
                                                                                                                                                         District Bridge Chief, Eleventh Coast Guard
                                           (Inside Thorofare), mile 70.0, at Atlantic              the bridge during the San Francisco                   District.
                                           City, NJ, has requested a temporary                     Giant Race at AT&T Park event. This
                                                                                                                                                         [FR Doc. 2016–21109 Filed 9–1–16; 8:45 am]
                                           deviation from the current operating                    deviation allows the bridge to remain in
                                                                                                                                                         BILLING CODE 9110–04–P
                                           regulations set out in 33 CFR 117.733(f)                the closed-to-navigation position during
                                           to ensure the safety of the participants                the deviation period.
                                           and spectators associated with the                      DATES: This deviation is effective from
                                           Atlantic City IRONMAN Triathlon.                                                                              ENVIRONMENTAL PROTECTION
                                                                                                   5 a.m. to 12 p.m. on September 11,
                                              Under this temporary deviation, the                                                                        AGENCY
                                                                                                   2016.
                                           bridge will be maintained in the closed-                                                                      40 CFR Part 180
                                                                                                   ADDRESSES:   The docket for this
                                           to-navigation position from 6:30 a.m. to
                                                                                                   deviation, [USCG–2016–0851], is                       [EPA–HQ–OPP–2016–0201; FRL–9950–63]
                                           2 p.m. on September 18, 2016. The
                                                                                                   available at http://www.regulations.gov.
                                           bridge is a double bascule bridge and
                                                                                                   Type the docket number in the                         Butanedioic Acid, 2-Methylene-,
                                           has a vertical clearance in the closed-to-
                                                                                                   ‘‘SEARCH’’ box and click ‘‘SEARCH.’’                  Polymer With 1,3-Butadiene,
                                           navigation position of 10 feet above
                                                                                                   Click on Open Docket Folder on the line               Ethylbenzene and 2-Hydroxyethyl-2-
                                           mean high water.
                                                                                                   associated with this deviation.                       Propenoate; Tolerance Exemption
                                              The NJICW (Inside Thorofare) is used
                                           by recreational vessels. The Coast Guard                FOR FURTHER INFORMATION CONTACT: If
                                                                                                                                                         AGENCY:  Environmental Protection
                                           has carefully considered the nature and                 you have questions on this temporary
                                                                                                                                                         Agency (EPA).
                                           volume of vessel traffic in publishing                  deviation, call or email David H.
                                                                                                   Sulouff, Chief, Bridge Section, Eleventh              ACTION: Final rule.
                                           this temporary deviation.
                                              Vessels able to pass through the                     Coast Guard District; telephone 510–                  SUMMARY:   This regulation establishes an
                                           bridge in the closed position may do so                 437–3516, email David.H.Sulouff@                      exemption from the requirement of a
                                           at anytime. The bridge will be able to                  uscg.mil.                                             tolerance for residues of butanedioic
                                           open in case of an emergency. The Coast                 SUPPLEMENTARY INFORMATION:      The City              acid, 2-methylene-, polymer with 1,3-
                                           Guard will also inform the users of the                 of San Francisco has requested a                      butadiene, ethenylbenzene and 2-
                                           waterways through our Local and                         temporary change to the operation of the              hydroxyethyl 2-propenoate; when used
Lhorne on DSK30JT082PROD with RULES




                                           Broadcast Notice to Mariners of the                     3rd Street Drawbridge, mile 0.0, over                 as an inert ingredient (emulsifier or
                                           change in operating schedule for the                    China Basin, at San Francisco, CA. The                binder) in a pesticide chemical
                                           bridge so that vessel operators can                     drawbridge navigation span provides a                 formulation. Keller and Heckman on
                                           arrange their transits to minimize any                  vertical clearance of 3 feet above Mean               behalf of Trinseo LLC submitted a
                                           impact caused by the temporary                          High Water in the closed-to-navigation                petition to EPA under the Federal Food,
                                           deviation.                                              position. The draw opens on signal if at              Drug, and Cosmetic Act (FFDCA),


                                      VerDate Sep<11>2014   15:05 Sep 01, 2016   Jkt 238001   PO 00000   Frm 00041   Fmt 4700   Sfmt 4700   E:\FR\FM\02SER1.SGM   02SER1


                                           60622            Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Rules and Regulations

                                           requesting an exemption from the                        B. How can I get electronic access to                 II. Background and Statutory Findings
                                           requirement of a tolerance. This                        other related information?                               In the Federal Register of May 19,
                                           regulation eliminates the need to                                                                             2016 (81) FR (31585) (FRL–9946–02),
                                           establish a maximum permissible level                     You may access a frequently updated
                                                                                                   electronic version of 40 CFR part 180                 EPA issued a document pursuant to
                                           for residues of butanedioic acid, 2-                                                                          FFDCA section 408, 21 U.S.C. 346a,
                                           methylene-, polymer with 1,3-                           through the Government Printing
                                                                                                   Office’s e-CFR site at http://                        announcing the receipt of a pesticide
                                           butadiene, ethenylbenzene and 2-                                                                              petition (PP IN–10907) filed by Keller
                                           hydroxyethyl 2-propenoate on food or                    www.ecfr.gov/cgi-bin/text-
                                                                                                   idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  and Heckman (1001 G Street NW., Suite
                                           feed commodities.                                                                                             500, Washington, DC 20001) on behalf
                                                                                                   40tab_02.tpl.
                                           DATES: This regulation is effective                                                                           of Trinseo LLC (1000 Chesterbrook
                                           September 2, 2016. Objections and                       C. Can I file an objection or hearing                 Blvd., Berwyn, PA 19312–1084). The
                                           requests for hearings must be received                  request?                                              petition requested that 40 CFR 180.960
                                           on or before November 1, 2016, and                                                                            be amended by establishing an
                                           must be filed in accordance with the                      Under FFDCA section 408(g), 21
                                                                                                                                                         exemption from the requirement of a
                                           instructions provided in 40 CFR part                    U.S.C. 346a, any person may file an
                                                                                                                                                         tolerance for residues of butanedioic
                                           178 (see also Unit I.C. of the                          objection to any aspect of this regulation
                                                                                                                                                         acid, 2-methylene-, polymer with 1,3-
                                           SUPPLEMENTARY INFORMATION).                             and may also request a hearing on those
                                                                                                                                                         butadiene, ethenylbenzene and 2-
                                                                                                   objections. You must file your objection
                                           ADDRESSES: The docket for this action,                                                                        hydroxyethyl 2-propenoate (CAS Reg.
                                                                                                   or request a hearing on this regulation
                                           identified by docket identification (ID)                                                                      No. 36089–06–2). That document
                                                                                                   in accordance with the instructions
                                           number EPA–HQ–OPP–2016–0201, is                                                                               included a summary of the petition
                                                                                                   provided in 40 CFR part 178. To ensure
                                           available at http://www.regulations.gov                                                                       prepared by the petitioner and solicited
                                                                                                   proper receipt by EPA, you must
                                           or at the Office of Pesticide Programs                                                                        comments on the petitioner’s request.
                                                                                                   identify docket ID number EPA–HQ–
                                           Regulatory Public Docket (OPP Docket)                                                                         The Agency did not receive any
                                                                                                   OPP–2016–0201 in the subject line on
                                           in the Environmental Protection Agency                                                                        comments.
                                                                                                   the first page of your submission. All
                                           Docket Center (EPA/DC), West William                                                                             Section 408(c)(2)(A)(i) of FFDCA
                                                                                                   objections and requests for a hearing
                                           Jefferson Clinton Bldg., Rm. 3334, 1301                                                                       allows EPA to establish an exemption
                                                                                                   must be in writing, and must be
                                           Constitution Ave. NW., Washington, DC                                                                         from the requirement for a tolerance (the
                                                                                                   received by the Hearing Clerk on or
                                           20460–0001. The Public Reading Room                                                                           legal limit for a pesticide chemical
                                                                                                   before November 1, 2016. Addresses for
                                           is open from 8:30 a.m. to 4:30 p.m.,                                                                          residue in or on a food) only if EPA
                                                                                                   mail and hand delivery of objections
                                           Monday through Friday, excluding legal                                                                        determines that the exemption is ‘‘safe.’’
                                                                                                   and hearing requests are provided in 40
                                           holidays. The telephone number for the                                                                        Section 408(c)(2)(A)(ii) of FFDCA
                                                                                                   CFR 178.25(b).
                                           Public Reading Room is (202) 566–1744,                                                                        defines ‘‘safe’’ to mean that ‘‘there is a
                                           and the telephone number for the OPP                      In addition to filing an objection or               reasonable certainty that no harm will
                                           Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk                result from aggregate exposure to the
                                           the visitor instructions and additional                 as described in 40 CFR part 178, please               pesticide chemical residue, including
                                           information about the docket available                  submit a copy of the filing (excluding                all anticipated dietary exposures and all
                                           at http://www.epa.gov/dockets.                          any Confidential Business Information                 other exposures for which there is
                                                                                                   (CBI)) for inclusion in the public docket.            reliable information.’’ This includes
                                           FOR FURTHER INFORMATION CONTACT:
                                                                                                   Information not marked confidential                   exposure through drinking water and
                                           Michael Goodis, Registration Division
                                                                                                   pursuant to 40 CFR part 2 may be                      use in residential settings, but does not
                                           (7505P), Office of Pesticide Programs,
                                                                                                   disclosed publicly by EPA without prior               include occupational exposure. Section
                                           Environmental Protection Agency, 1200
                                                                                                   notice. Submit the non-CBI copy of your               408(b)(2)(C) of FFDCA requires EPA to
                                           Pennsylvania Ave. NW., Washington,
                                                                                                   objection or hearing request, identified              give special consideration to exposure
                                           DC 20460–0001; main telephone
                                                                                                   by docket ID number EPA–HQ–OPP–                       of infants and children to the pesticide
                                           number: (703) 305–7090; email address:
                                                                                                   2016–0201, by one of the following                    chemical residue in establishing an
                                           RDFRNotices@epa.gov.
                                                                                                   methods.                                              exemption from the requirement of a
                                           SUPPLEMENTARY INFORMATION:
                                                                                                     • Federal eRulemaking Portal: http://               tolerance and to ‘‘ensure that there is a
                                           I. General Information                                  www.regulations.gov. Follow the online                reasonable certainty that no harm will
                                                                                                   instructions for submitting comments.                 result to infants and children from
                                           A. Does this action apply to me?
                                                                                                   Do not submit electronically any                      aggregate exposure to the pesticide
                                              You may be potentially affected by                   information you consider to be CBI or                 chemical residue . . .’’ and specifies
                                           this action if you are an agricultural                  other information whose disclosure is                 factors EPA is to consider in
                                           producer, food manufacturer, or                         restricted by statute.                                establishing an exemption.
                                           pesticide manufacturer. The following
                                                                                                     • Mail: OPP Docket, Environmental                   III. Risk Assessment and Statutory
                                           list of North American Industrial
                                                                                                   Protection Agency Docket Center (EPA/                 Findings
                                           Classification System (NAICS) codes is
                                                                                                   DC), (28221T), 1200 Pennsylvania Ave.
                                           not intended to be exhaustive, but rather                                                                        EPA establishes exemptions from the
                                                                                                   NW., Washington, DC 20460–0001.
                                           provides a guide to help readers                                                                              requirement of a tolerance only in those
                                           determine whether this document                           • Hand Delivery: To make special                    cases where it can be shown that the
                                           applies to them. Potentially affected                   arrangements for hand delivery or                     risks from aggregate exposure to
                                           entities may include:                                   delivery of boxed information, please                 pesticide chemical residues under
                                              • Crop production (NAICS code 111).                  follow the instructions at http://                    reasonably foreseeable circumstances
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                                              • Animal production (NAICS code                      www.epa.gov/dockets/contacts.html.                    will pose no appreciable risks to human
                                           112).                                                     Additional instructions on                          health. In order to determine the risks
                                              • Food manufacturing (NAICS code                     commenting or visiting the docket,                    from aggregate exposure to pesticide
                                           311).                                                   along with more information about                     inert ingredients, the Agency considers
                                              • Pesticide manufacturing (NAICS                     dockets generally, is available at http://            the toxicity of the inert in conjunction
                                           code 32532).                                            www.epa.gov/dockets.                                  with possible exposure to residues of


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                                                            Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Rules and Regulations                                       60623

                                           the inert ingredient through food,                      length as specified in 40 CFR                         2-hydroxyethyl 2-propenoate to share a
                                           drinking water, and through other                       723.250(d)(6).                                        common mechanism of toxicity with
                                           exposures that occur as a result of                        Additionally, the polymer also meets               any other substances, and butanedioic
                                           pesticide use in residential settings. If               as required the following exemption                   acid, 2-methylene-, polymer with 1,3-
                                           EPA is able to determine that a finite                  criteria specified in 40 CFR 723.250(e).              butadiene, ethenylbenzene and
                                           tolerance is not necessary to ensure that                  8. The polymer’s number average MW                 2-hydroxyethyl 2-propenoate does not
                                           there is a reasonable certainty that no                 of 10,000 is greater than or equal to                 appear to produce a toxic metabolite
                                           harm will result from aggregate                         10,000 daltons. The polymer contains                  produced by other substances. For the
                                           exposure to the inert ingredient, an                    less than 2% oligomeric material below                purposes of this tolerance action,
                                           exemption from the requirement of a                     MW 500 and less than 5% oligomeric                    therefore, EPA has assumed that
                                           tolerance may be established.                           material below MW 1,000.                              butanedioic acid, 2-methylene-, polymer
                                             Consistent with FFDCA section                            Thus, butanedioic acid, 2-methy-                   with 1,3-butadiene, ethenylbenzene and
                                           408(b)(2)(D), EPA has reviewed the                      lene-, polymer with 1,3-butadiene,                    2-hydroxyethyl 2-propenoate does not
                                           available scientific data and other                     ethenylbenzene and 2-hydroxyethyl                     have a common mechanism of toxicity
                                           relevant information in support of this                 2-propenoate meets the criteria for a                 with other substances. For information
                                           action and considered its validity,                     polymer to be considered low risk under               regarding EPA’s efforts to determine
                                           completeness and reliability and the                    40 CFR 723.250. Based on its                          which chemicals have a common
                                           relationship of this information to                     conformance to the criteria in this unit,             mechanism of toxicity and to evaluate
                                           human risk. EPA has also considered                     no mammalian toxicity is anticipated                  the cumulative effects of such
                                           available information concerning the                    from dietary, inhalation, or dermal                   chemicals, see EPA’s Web site at http://
                                           variability of the sensitivities of major               exposure to butanedioic acid,                         www.epa.gov/pesticides/cumulative.
                                           identifiable subgroups of consumers,                    2-methylene-, polymer with 1,3-
                                           including infants and children. In the                  butadiene, ethenylbenzene and                         VI. Additional Safety Factor for the
                                           case of certain chemical substances that                2-hydroxyethyl 2-propenoate.                          Protection of Infants and Children
                                           are defined as polymers, the Agency has                 IV. Aggregate Exposures                                 Section 408(b)(2)(C) of FFDCA
                                           established a set of criteria to identify                                                                     provides that EPA shall apply an
                                           categories of polymers expected to                        For the purposes of assessing
                                                                                                   potential exposure under this                         additional tenfold margin of safety for
                                           present minimal or no risk. The                                                                               infants and children in the case of
                                           definition of a polymer is given in 40                  exemption, EPA considered that the
                                                                                                   butanedioic acid, 2-methylene-, polymer               threshold effects to account for prenatal
                                           CFR 723.250(b) and the exclusion                                                                              and postnatal toxicity and the
                                           criteria for identifying these low-risk                 with 1,3-butadiene, ethenylbenzene and
                                                                                                   2-hydroxyethyl 2-propenoate could be                  completeness of the data base unless
                                           polymers are described in 40 CFR                                                                              EPA concludes that a different margin of
                                           723.250(d). Butanedioic acid,                           present in all raw and processed
                                                                                                   agricultural commodities and drinking                 safety will be safe for infants and
                                           2-methylene-, polymer with 1,3-                                                                               children. Due to the expected low
                                           butadiene, ethenylbenzene and                           water, and that non-occupational non-
                                                                                                   dietary exposure was possible. The                    toxicity of butanedioic acid,
                                           2-hydroxyethyl 2-propenoate conforms                                                                          2-methylene-, polymer with 1,3-
                                           to the definition of a polymer given in                 minimum number average MW of
                                                                                                   butanedioic acid, 2-methylene-, polymer               butadiene, ethenylbenzene and
                                           40 CFR 723.250(b) and meets the                                                                               2-hydroxyethyl 2-propenoate, EPA has
                                           following criteria that are used to                     with 1,3-butadiene, ethenylbenzene and
                                                                                                   2-hydroxyethyl 2-propenoate is 10,000                 not used a safety factor analysis to
                                           identify low-risk polymers.                                                                                   assess the risk. For the same reasons the
                                             1. The polymer is not a cationic                      daltons. Generally, a polymer of this
                                                                                                   size would be poorly absorbed through                 additional tenfold safety factor is
                                           polymer nor is it reasonably anticipated
                                                                                                   the intact gastrointestinal tract or                  unnecessary.
                                           to become a cationic polymer in a
                                           natural aquatic environment.                            through intact human skin. Since                      VII. Determination of Safety
                                             2. The polymer does contain as an                     butanedioic acid, 2-methylene-, polymer
                                           integral part of its composition the                    with 1,3-butadiene, ethenylbenzene and                  Based on the conformance to the
                                           atomic elements carbon, hydrogen, and                   2-hydroxyethyl 2-propenoate conforms                  criteria used to identify a low-risk
                                           oxygen.                                                 to the criteria that identify a low-risk              polymer, EPA concludes that there is a
                                             3. The polymer does not contain as an                 polymer, there are no concerns for risks              reasonable certainty of no harm to the
                                           integral part of its composition, except                associated with any potential exposure                U.S. population, including infants and
                                           as impurities, any element other than                   scenarios that are reasonably                         children, from aggregate exposure to
                                           those listed in 40 CFR 723.250(d)(2)(ii).               foreseeable. The Agency has determined                residues of butanedioic acid, 2-
                                             4. The polymer is neither designed                    that a tolerance is not necessary to                  methylene-, polymer with 1,3-
                                           nor can it be reasonably anticipated to                 protect the public health.                            butadiene, ethenylbenzene and 2-
                                           substantially degrade, decompose, or                                                                          hydroxyethyl 2-propenoate.
                                                                                                   V. Cumulative Effects From Substances
                                           depolymerize.                                                                                                 VIII. Other Considerations
                                             5. The polymer is manufactured or                     With a Common Mechanism of Toxicity
                                           imported from monomers and/or                              Section 408(b)(2)(D)(v) of FFDCA                   A. Existing Exemptions From a
                                           reactants that are already included on                  requires that, when considering whether               Tolerance
                                           the TSCA Chemical Substance                             to establish, modify, or revoke a
                                           Inventory or manufactured under an                      tolerance, the Agency consider                           There are no existing exemptions
                                           applicable TSCA section 5 exemption.                    ‘‘available information’’ concerning the              from the requirements of a tolerance.
                                             6. The polymer is not a water                         cumulative effects of a particular                    B. Analytical Enforcement Methodology
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                                           absorbing polymer with a number                         pesticide’s residues and ‘‘other
                                           average molecular weight (MW) greater                   substances that have a common                            An analytical method is not required
                                           than or equal to 10,000 daltons.                        mechanism of toxicity.’’                              for enforcement purposes since the
                                             7. The polymer does not contain                          EPA has not found butanedioic acid,                Agency is establishing an exemption
                                           certain perfluoroalkyl moieties                         2-methylene-, polymer with 1,3-                       from the requirement of a tolerance
                                           consisting of a CF3- or longer chain                    butadiene, ethenylbenzene and                         without any numerical limitation.


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                                           60624                Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Rules and Regulations

                                           C. International Residue Limits                                   entitled ‘‘Actions Concerning                                      does not impose any enforceable duty or
                                              In making its tolerance decisions, EPA                         Regulations That Significantly Affect                              contain any unfunded mandate as
                                           seeks to harmonize U.S. tolerances with                           Energy Supply, Distribution, or Use’’ (66                          described under Title II of the Unfunded
                                           international standards whenever                                  FR 28355, May 22, 2001) or Executive                               Mandates Reform Act (UMRA) (2 U.S.C.
                                           possible, consistent with U.S. food                               Order 13045, entitled ‘‘Protection of                              1501 et seq.).
                                           safety standards and agricultural                                 Children from Environmental Health                                   This action does not involve any
                                           practices. EPA considers the                                      Risks and Safety Risks’’ (62 FR 19885,                             technical standards that would require
                                           international maximum residue limits                              April 23, 1997). This action does not                              Agency consideration of voluntary
                                           (MRLs) established by the Codex                                   contain any information collections                                consensus standards pursuant to section
                                           Alimentarius Commission (Codex), as                               subject to OMB approval under the                                  12(d) of the National Technology
                                           required by FFDCA section 408(b)(4).                              Paperwork Reduction Act (PRA) (44                                  Transfer and Advancement Act
                                           The Codex Alimentarius is a joint                                 U.S.C. 3501 et seq.), nor does it require                          (NTTAA) (15 U.S.C. 272 note).
                                           United Nations Food and Agriculture                               any special considerations under
                                                                                                             Executive Order 12898, entitled                                    XI. Congressional Review Act
                                           Organization/World Health
                                           Organization food standards program,                              ‘‘Federal Actions to Address                                         Pursuant to the Congressional Review
                                           and it is recognized as an international                          Environmental Justice in Minority                                  Act (5 U.S.C. 801 et seq.), EPA will
                                           food safety standards-setting                                     Populations and Low-Income                                         submit a report containing this rule and
                                           organization in trade agreements to                               Populations’’ (59 FR 7629, February 16,                            other required information to the U.S.
                                           which the United States is a party. EPA                           1994).                                                             Senate, the U.S. House of
                                           may establish a tolerance that is                                    Since tolerances and exemptions that
                                                                                                                                                                                Representatives, and the Comptroller
                                           different from a Codex MRL; however,                              are established on the basis of a petition
                                                                                                                                                                                General of the United States prior to
                                           FFDCA section 408(b)(4) requires that                             under FFDCA section 408(d), such as
                                                                                                                                                                                publication of the rule in the Federal
                                           EPA explain the reasons for departing                             the tolerance in this final rule, do not
                                                                                                                                                                                Register. This action is not a ‘‘major
                                           from the Codex level.                                             require the issuance of a proposed rule,
                                                                                                                                                                                rule’’ as defined by 5 U.S.C. 804(2).
                                              The Codex has not established a MRL                            the requirements of the Regulatory
                                           for butanedioic acid, 2-methylene-,                               Flexibility Act (RFA) (5 U.S.C. 601 et                             List of Subjects in 40 CFR Part 180
                                           polymer with 1,3-butadiene,                                       seq.), do not apply.
                                                                                                                This action directly regulates growers,                           Environmental protection,
                                           ethenylbenzene and 2-hydroxyethyl 2-                                                                                                 Administrative practice and procedure,
                                           propenoate.                                                       food processors, food handlers, and food
                                                                                                             retailers, not States or tribes, nor does                          Agricultural commodities, Pesticides
                                           IX. Conclusion                                                    this action alter the relationships or                             and pests, Reporting and recordkeeping
                                                                                                             distribution of power and                                          requirements.
                                             Accordingly, EPA finds that
                                           exempting residues of butanedioic acid,                           responsibilities established by Congress                              Dated: August 17, 2016.
                                           2-methylene-, polymer with 1,3-                                   in the preemption provisions of FFDCA                              Michael Goodis,
                                           butadiene, ethenylbenzene and 2-                                  section 408(n)(4). As such, the Agency                             Acting Director, Registration Division, Office
                                           hydroxyethyl 2-propenoate from the                                has determined that this action will not                           of Pesticide Programs.
                                           requirement of a tolerance will be safe.                          have a substantial direct effect on States
                                                                                                             or tribal governments, on the                                        Therefore, 40 CFR chapter I is
                                           X. Statutory and Executive Order                                  relationship between the national                                  amended as follows:
                                           Reviews                                                           government and the States or tribal
                                                                                                                                                                                PART 180—[AMENDED]
                                             This action establishes a tolerance                             governments, or on the distribution of
                                           under FFDCA section 408(d) in                                     power and responsibilities among the                               ■ 1. The authority citation for part 180
                                           response to a petition submitted to the                           various levels of government or between                            continues to read as follows:
                                           Agency. The Office of Management and                              the Federal Government and Indian
                                           Budget (OMB) has exempted these types                             tribes. Thus, the Agency has determined                                Authority: 21 U.S.C. 321(q), 346a and 371.
                                           of actions from review under Executive                            that Executive Order 13132, entitled                               ■ 2. In § 180.960, alphabetically add the
                                           Order 12866, entitled ‘‘Regulatory                                ‘‘Federalism’’ (64 FR 43255, August 10,                            polymer(s) to the table to read as
                                           Planning and Review’’ (58 FR 51735,                               1999) and Executive Order 13175,                                   follows:
                                           October 4, 1993). Because this action                             entitled ‘‘Consultation and Coordination
                                           has been exempted from review under                               with Indian Tribal Governments’’ (65 FR                            § 180.960 Polymers; exemptions from the
                                           Executive Order 12866, this action is                             67249, November 9, 2000) do not apply                              requirement of a tolerance.
                                           not subject to Executive Order 13211,                             to this action. In addition, this action                           *        *        *       *        *

                                                                                                                            Polymer                                                                                          CAS No.


                                                    *                   *                    *                                 *                                 *                                *                           *
                                           Butanedioic acid, 2-methylene-, polymer with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-propenoate, minimum num-
                                             ber average molecular weight (in amu), 10,000 ..............................................................................................................................   36089–06–2

                                                       *                            *                           *                            *                           *                            *                       *
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                                                            Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Rules and Regulations                                        60625

                                           [FR Doc. 2016–21219 Filed 9–1–16; 8:45 am]              hearing aid-compatible handsets that                  interface over which its models operate,
                                           BILLING CODE 6560–50–P                                  service providers and manufacturers are               (1) at least an M3 rating for acoustic
                                                                                                   required to offer with two new                        coupling for at least one-third of its
                                                                                                   percentage benchmarks: (1) 66 Percent                 models using that air interface (rounded
                                           FEDERAL COMMUNICATIONS                                  of offered handset models must be                     down), with a minimum of two models,
                                           COMMISSION                                              compliant following a two-year                        and (2) at least a T3 rating for inductive
                                                                                                   transition period for manufacturers,                  coupling for at least one-third of its
                                           47 CFR Part 20                                          with additional compliance time for                   models using that interface (rounded
                                                                                                   service providers, and (2) 85 percent of              down), with a minimum of two models.
                                           [WT Docket No. 15–285; FCC 16–103]
                                                                                                   offered handset models must be                        Similarly, a service provider must meet,
                                           Improvements to Benchmarks and                          compliant following a five-year                       for each air interface over which its
                                           Related Requirements Governing                          transition period for manufacturers,                  models operate, (1) at least an M3 rating
                                           Hearing Aid-Compatible Mobile                           with additional compliance time for                   for acoustic coupling for at least 50
                                           Handsets                                                service providers. The Commission also                percent of its models using that air
                                                                                                   expands the de minimis exception to                   interface (rounded up) or ten models,
                                           AGENCY:  Federal Communications                         provide a more limited obligation for                 and (2) at least a T3 rating for inductive
                                           Commission.                                             entities offering four or five handsets.              coupling for at least one-third of its
                                           ACTION: Final rule.                                        2. The Commission also reconfirms its              models using that interface (rounded
                                                                                                   commitment to pursuing 100 percent                    up) or ten models.
                                           SUMMARY:    The Commission adopts this                  hearing aid compatibility to the extent                  5. In general, under the de minimis
                                           Report and Order to implement a                         achievable. The Commission therefore                  exception, most manufacturers and
                                           historic consensus proposal for ensuring                invites consensus plan stakeholders and               service providers that offer two or fewer
                                           that people with hearing loss have full                 other interested parties to make                      digital wireless handset models
                                           access to innovative handsets.                          supplemental submissions over the next                operating over a particular air interface
                                           DATES: These rules are effective October                several years on the achievability of a               are exempt from the benchmark
                                           3, 2016.                                                100 percent hearing aid compatibility                 deployment requirements in connection
                                           FOR FURTHER INFORMATION CONTACT: Eli
                                                                                                   deployment benchmark considering                      with that air interface. Larger
                                                                                                   technical and market conditions. As                   manufacturers with two or fewer
                                           Johnson, Wireless Telecommunications
                                                                                                   part of this process, the Commission                  handset models in an air interface have
                                           Bureau, (202) 418–1395, email
                                                                                                   also expects stakeholders to make                     a limited obligation, as do service
                                           Eli.Johnson@fcc.gov, and Michael
                                                                                                   submissions on additional points of                   providers offering two or fewer models
                                           Rowan, Wireless Telecommunications
                                                                                                   agreement regarding other unresolved                  that obtain those models only from
                                           Bureau, (202) 418–1883, email
                                                                                                   issues raised in this proceeding,                     larger manufacturers. The provision
                                           Michael.Rowan@fcc.gov.
                                                                                                   including using alternative technologies              further provides that any manufacturer
                                           SUPPLEMENTARY INFORMATION: This is a                    to achieve hearing aid compatibility and              or service provider that offers three
                                           summary of the Federal                                  establishing a safe harbor for service                digital wireless handset models
                                           Communications Commission’s Report                      providers based on a public                           operating over a particular air interface
                                           and Order in WT Docket 15–285,                          clearinghouse that claims to identify                 must offer at least one such handset
                                           adopted August 4, 2016, and released                    compliant handsets.                                   model that meets the Commission’s
                                           August 5, 2016. The document is                            3. In order to advance towards the                 acoustic and inductive coupling
                                           available for download at http://                       Commission’s proposed 100 percent                     requirements for that air interface.
                                           fjallfoss.fcc.gov/edocs_public/. The                    compatibility deployment benchmark,                      6. To help ensure compliance with
                                           complete text of this document is also                  the Commission seeks to continue the                  these benchmarks, the Commission’s
                                           available for inspection and copying                    productive collaboration between                      hearing aid compatibility rules also
                                           during normal business hours in the                     stakeholders and other interested parties             require wireless handset manufacturers
                                           FCC Reference Information Center,                       so that it can obtain data and                        and wireless service providers to submit
                                           Portals II, 445 12th Street SW., Room                   information about the technical and                   annual reports to the Commission
                                           CY–A257, Washington, DC 20554. To                       market conditions involving wireless                  detailing the covered handsets that they
                                           request materials in accessible formats                 handsets and hearing improvement                      offer for sale, the models that are
                                           for people with disabilities (Braille,                  technologies. In this regard, the                     hearing aid-compatible (and the specific
                                           large print, electronic files, audio                    Commission suggests a timeline                        rating), and other information relating to
                                           format), send an email to FCC504@                       identifying general milestones over the               the requirements of the rule. In June
                                           fcc.gov or call the Consumer &                          next several years when the consensus                 2009, the Commission introduced the
                                           Governmental Affairs Bureau at 202–                     plan stakeholders and other interested                electronic FCC Form 655 as the
                                           418–0530 (voice), 202–418–0432 (TTY).                   parties may, at their election, make                  mandatory form for filing these reports,
                                                                                                   additional submissions. Based in                      and since that time, both service
                                           Introduction
                                                                                                   significant part on the information it                providers and manufacturers have filed
                                             1. In this Report and Order, the                      receives, the Commission intends to                   reports using the electronic system.
                                           Commission takes several steps to                       determine the achievability of a 100                  Service provider compliance filings are
                                           implement a historic consensus                          percent compliance standard for                       due January 15 each year and
                                           proposal for ensuring that people with                  wireless hearing aid compatibility by no              manufacturer reports are due July 15
                                           hearing loss have full access to                        later than 2024.                                      each year.
                                           innovative handsets. First, the                                                                                  7. On November 12, 2015, three
Lhorne on DSK30JT082PROD with RULES




                                           Commission amends the hearing aid                       Background                                            consumer advocacy organizations and
                                           compatibility requirements that are                       4. The current hearing aid                          three industry trade associations
                                           generally applicable to wireless service                compatibility deployment benchmarks                   submitted a Joint Consensus Proposal
                                           providers and manufacturers of digital                  require that, subject to a de minimis                 (JCP) providing for a process for moving
                                           wireless handsets. Specifically, the                    exception described below, a handset                  away from the current fractional
                                           Commission increases the number of                      manufacturer must meet, for each air                  benchmark regime. The parties to the


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Document Created: 2018-02-09 11:55:22
Document Modified: 2018-02-09 11:55:22
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 September 2, 2016. Objections and requests for hearings must be received on or before November 1, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation81 FR 60621 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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