80 FR 63683 - Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 203 (October 21, 2015)

Page Range		63683-63686
FR Document		2015-26617
This regulation establishes an exemption from the requirement of a tolerance for residues of poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen- 1yl]oxy]- (CAS Reg. No. 26571-49-3) when used as an inert ingredient in a pesticide chemical formulation. BYK USA Inc., 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 poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9- octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- on food or feed commodities.
Federal Register, Volume 80 Issue 203 (Wednesday, October 21, 2015)
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Rules and Regulations]
[Pages 63683-63686]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26617]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0442; FRL-9935-34]


Poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-
octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-; Exemption 
From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of poly[oxy(methyl-1,2-ethanediyl)], 
[alpha]-[(9Z)-1-oxo-9-octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-
1yl]oxy]- (CAS Reg. No. 26571-49-3) when used as an inert ingredient in 
a pesticide chemical formulation. BYK USA Inc., 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 poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-
octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- on food or 
feed commodities.

DATES: This regulation is effective October 21, 2015. Objections and 
requests for hearings must be received on or before December 21, 2015, 
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-2015-0442, 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: Susan Lewis, 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: RDFRNotices@epa.gov.

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-2015-0442 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 21, 2015. 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-2015-0442, 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 August 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the receipt of a pesticide petition (PP) IN-10826 
filed by BYK USA Inc., 524 South Cherry Street, Wallingford, CT 06492-
4453. The

[[Page 63684]]

petition requested that 40 CFR 180.960 be amended by establishing an 
exemption from the requirement of a tolerance for residues of 
poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-
yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- (CAS Reg. No. 26571-49-
3). That document included a summary of the petition prepared by the 
petitioner and solicited comments on the petitioner's request. There 
were no comments received in response to the notice of filing. Section 
408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the 
requirement for a tolerance (the legal limit for a pesticide chemical 
residue in or on a food) only if EPA determines that the exemption is 
``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines ``safe'' to mean 
that ``there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.'' This includes exposure through drinking 
water and use in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing an exemption from the 
requirement of a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue . . .'' and 
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be shown that the risks from aggregate 
exposure to pesticide chemical residues under reasonably foreseeable 
circumstances will pose no appreciable risks to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the requirement of 
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. In the case of certain chemical substances that 
are defined as polymers, the Agency has established a set of criteria 
to identify categories of polymers expected to present minimal or no 
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the 
exclusion criteria for identifying these low-risk polymers are 
described in 40 CFR 723.250(d). Poly[oxy(methyl-1,2-ethanediyl)], 
[alpha]-[(9Z)-1-oxo-9-octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-
1yl]oxy]- 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.
    Additionally, the polymer also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's minimum number average MW of 2,300 is greater than 
1,000 and less than 10,000 daltons. The polymer contains less than 10% 
oligomeric material below MW 500 and less than 25% oligomeric material 
below MW 1,000, and the polymer does not contain any reactive 
functional groups.
    Thus, poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-
octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- 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 
poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-
yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that poly[oxy(methyl-1,2-ethanediyl)], 
[alpha]-[(9Z)-1-oxo-9-octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-
1yl]oxy]- 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 
poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-
yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- is 2,300 daltons. 
Generally, a polymer of this size would be poorly absorbed through the 
intact gastrointestinal tract or through intact human skin. Since 
poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-
yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- conform 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 poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-
1-oxo-9-octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- to 
share a common mechanism of toxicity with any other substances, and 
poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-
yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-
yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- does not have a common 
mechanism of toxicity with other

[[Page 63685]]

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 poly[oxy(methyl-1,2-
ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-yl]-[omega]-[[(9Z)-1-
oxo-9-octadecen-1yl]oxy]-, 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 poly[oxy(methyl-1,2-ethanediyl)], 
[alpha]-[(9Z)-1-oxo-9-octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-
1yl]oxy]-.

VIII. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for poly[oxy(methyl-1,2-
ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-yl]-[omega]-[[(9Z)-1-
oxo-9-octadecen-1yl]oxy]-.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of poly[oxy(methyl-
1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-octadecen-1-yl]-[omega]-[[(9Z)-
1-oxo-9-octadecen-1yl]oxy]- 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: October 13, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


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


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

* * * * *

[[Page 63686]]



------------------------------------------------------------------------
                          Polymer                              CAS No.
------------------------------------------------------------------------
 
                                * * * * *
Poly[oxy(methyl-1,2-ethanediyl)], [alpha]-[(9Z)-1-oxo-9-      26571-49-3
 octadecen-1-yl]-[omega]-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-
 , minimum number average molecular weight (in amu) 2,300..
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-26617 Filed 10-20-15; 8:45 am]
 BILLING CODE 6560-50-P
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations 63685

substances. For information regarding FFDCA section 408(b)(4) requires that government and the States or tribal
EPA’s efforts to determine which EPA explain the reasons for departing governments, or on the distribution of
chemicals have a common mechanism from the Codex level. power and responsibilities among the
of toxicity and to evaluate the The Codex has not established a MRL various levels of government or between
cumulative effects of such chemicals, for poly[oxy(methyl-1,2-ethanediyl)], a- the Federal Government and Indian
see EPA’s Web site at http://www.epa. [(9Z)-1-oxo-9-octadecen-1-yl]-w-[[(9Z)-1- tribes. Thus, the Agency has determined
gov/pesticides/cumulative. oxo-9-octadecen-1yl]oxy]-. that Executive Order 13132, entitled
VI. Additional Safety Factor for the IX. Conclusion ‘‘Federalism’’ (64 FR 43255, August 10,
Protection of Infants and Children Accordingly, EPA finds that 1999) and Executive Order 13175,
Section 408(b)(2)(C) of FFDCA exempting residues of poly[oxy(methyl- entitled ‘‘Consultation and Coordination
provides that EPA shall apply an 1,2-ethanediyl)], a-[(9Z)-1-oxo-9- with Indian Tribal Governments’’ (65 FR
additional tenfold margin of safety for octadecen-1-yl]-w-[[(9Z)-1-oxo-9- 67249, November 9, 2000) do not apply
infants and children in the case of octadecen-1yl]oxy]- from the to this action. In addition, this action
threshold effects to account for prenatal requirement of a tolerance will be safe. does not impose any enforceable duty or
and postnatal toxicity and the contain any unfunded mandate as
X. Statutory and Executive Order
completeness of the data base unless described under Title II of the Unfunded
Reviews
EPA concludes that a different margin of Mandates Reform Act (UMRA) (2 U.S.C.
safety will be safe for infants and This action establishes a tolerance 1501 et seq.).
children. Due to the expected low under FFDCA section 408(d) in
response to a petition submitted to the This action does not involve any
toxicity of poly[oxy(methyl-1,2- technical standards that would require
ethanediyl)], a-[(9Z)-1-oxo-9-octadecen- Agency. The Office of Management and
Budget (OMB) has exempted these types Agency consideration of voluntary
1-yl]-w-[[(9Z)-1-oxo-9-octadecen-
of actions from review under Executive consensus standards pursuant to section
1yl]oxy]-, EPA has not used a safety
factor analysis to assess the risk. For the Order 12866, entitled ‘‘Regulatory 12(d) of the National Technology
same reasons the additional tenfold Planning and Review’’ (58 FR 51735, Transfer and Advancement Act
safety factor is unnecessary. October 4, 1993). Because this action (NTTAA) (15 U.S.C. 272 note).
has been exempted from review under
VII. Determination of Safety XI. Congressional Review Act
Executive Order 12866, this action is
Based on the conformance to the not subject to Executive Order 13211, Pursuant to the Congressional Review
criteria used to identify a low-risk entitled ‘‘Actions Concerning Act (5 U.S.C. 801 et seq.), EPA will
polymer, EPA concludes that there is a Regulations That Significantly Affect submit a report containing this rule and
reasonable certainty of no harm to the Energy Supply, Distribution, or Use’’ (66 other required information to the U.S.
U.S. population, including infants and FR 28355, May 22, 2001) or Executive Senate, the U.S. House of
children, from aggregate exposure to Order 13045, entitled ‘‘Protection of Representatives, and the Comptroller
residues of poly[oxy(methyl-1,2- Children from Environmental Health General of the United States prior to
ethanediyl)], a-[(9Z)-1-oxo-9-octadecen- Risks and Safety Risks’’ (62 FR 19885,
publication of the rule in the Federal
1-yl]-w-[[(9Z)-1-oxo-9-octadecen- April 23, 1997). This action does not
1yl]oxy]-. Register. This action is not a ‘‘major
contain any information collections
rule’’ as defined by 5 U.S.C. 804(2).
VIII. Other Considerations subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 List of Subjects in 40 CFR Part 180
A. Analytical Enforcement Methodology U.S.C. 3501 et seq.), nor does it require
An analytical method is not required any special considerations under Environmental protection,
for enforcement purposes since the Executive Order 12898, entitled Administrative practice and procedure,
Agency is establishing an exemption ‘‘Federal Actions to Address Agricultural commodities, Pesticides
from the requirement of a tolerance Environmental Justice in Minority and pests, Reporting and recordkeeping
without any numerical limitation. Populations and Low-Income requirements.
Populations’’ (59 FR 7629, February 16, Dated: October 13, 2015.
B. International Residue Limits 1994).
In making its tolerance decisions, EPA Since tolerances and exemptions that Susan Lewis,
seeks to harmonize U.S. tolerances with are established on the basis of a petition Director, Registration Division, Office of
international standards whenever under FFDCA section 408(d), such as Pesticide Programs.
possible, consistent with U.S. food the tolerance in this final rule, do not Therefore, 40 CFR chapter I is
safety standards and agricultural require the issuance of a proposed rule, amended as follows:
practices. EPA considers the the requirements of the Regulatory
international maximum residue limits Flexibility Act (RFA) (5 U.S.C. 601 et PART 180—[AMENDED]
(MRLs) established by the Codex seq.), do not apply.
Alimentarius Commission (Codex), as This action directly regulates growers,
■ 1. The authority citation for part 180
required by FFDCA section 408(b)(4). food processors, food handlers, and food
continues to read as follows:
The Codex Alimentarius is a joint retailers, not States or tribes, nor does
United Nations Food and Agriculture this action alter the relationships or Authority: 21 U.S.C. 321(q), 346a and 371.
Organization/World Health distribution of power and
Organization food standards program, responsibilities established by Congress ■ 2. In § 180.960, add alphabetically the
tkelley on DSK3SPTVN1PROD with RULES

and it is recognized as an international in the preemption provisions of FFDCA following polymer to the table to read as
food safety standards-setting section 408(n)(4). As such, the Agency follows:
organization in trade agreements to has determined that this action will not
which the United States is a party. EPA have a substantial direct effect on States § 180.960 Polymers; exemptions from the
requirement of a tolerance.
may establish a tolerance that is or tribal governments, on the
different from a Codex MRL; however, relationship between the national * * * * *

VerDate Sep<11>2014 17:49 Oct 20, 2015 Jkt 238001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\21OCR1.SGM 21OCR1
63686 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations

Polymer CAS No. the visitor instructions and additional submit a copy of the filing (excluding
information about the docket available any Confidential Business Information
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
* * * * * FOR FURTHER INFORMATION CONTACT: Information not marked confidential
Poly[oxy(methyl-1,2- pursuant to 40 CFR part 2 may be
ethanediyl)], a-[(9Z)-1-oxo-9-
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
octadecen-1-yl]-w-[[(9Z)-1-
oxo-9-octadecen-1yl]oxy]-, Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
minimum number average Pennsylvania Ave. NW., Washington, objection or hearing request, identified
molecular weight (in amu) DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
2,300 ..................................... 26571–49–3 number: (703) 305–7090; email address: 2015–0012, by one of the following
RDFRNotices@epa.gov. methods:
* * * * * • Federal eRulemaking Portal: http://
SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online
[FR Doc. 2015–26617 Filed 10–20–15; 8:45 am] I. General Information instructions for submitting comments.
BILLING CODE 6560–50–P Do not submit electronically any
A. Does this action apply to me?
information you consider to be CBI or
You may be potentially affected by other information whose disclosure is
ENVIRONMENTAL PROTECTION this action if you are an agricultural restricted by statute.
AGENCY producer, food manufacturer, or • Mail: OPP Docket, Environmental
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
40 CFR Part 180 list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
[EPA–HQ–OPP–2015–0012; FRL–9935–11] Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
not intended to be exhaustive, but rather • Hand Delivery: To make special
Pyrimethanil; Pesticide Tolerances provides a guide to help readers arrangements for hand delivery or
AGENCY: Environmental Protection determine whether this document delivery of boxed information, please
Agency (EPA). applies to them. Potentially affected follow the instructions at http://www.
entities may include: epa.gov/dockets/contacts.html.
ACTION: Final rule.
• Crop production (NAICS code 111). Additional instructions on
SUMMARY: This regulation establishes • Animal production (NAICS code commenting or visiting the docket,
tolerances for residues of pyrimethanil 112). along with more information about
in or on multiple commodities which • Food manufacturing (NAICS code dockets generally, is available at
are identified and discussed later in this 311). http://www.epa.gov/dockets.
document. Interregional Research • Pesticide manufacturing (NAICS II. Summary of Petitioned-For
Project Number 4 (IR–4) requested the code 32532). Tolerance
tolerances associated with pesticide B. How can I get electronic access to In the Federal Register of December
petition number (PP 4E8302), and Bayer other related information?
CropScience requested the tolerances 17, 2014 (79 FR 75107) (FRL–9918–90),
associated with PP 4F8291, under the You may access a frequently updated EPA issued a document pursuant to
Federal Food, Drug, and Cosmetic Act electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C.
(FFDCA). regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of (PP
the Government Printing Office’s e-CFR 4E8302) by IR–4, 500 College Road East,
DATES: This regulation is effective Suite 201 W, Princeton, NJ 08540. The
site at http://www.ecfr.gov/cgi-bin/text-
October 21, 2015, except for the petition requested that 40 CFR part 180
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
amendment to § 180.661 in amendatory be amended by establishing tolerances
40tab_02.tpl.
instruction number 3, which is effective for residues of the fungicide
April 21, 2016. Objections and requests C. How can I file an objection or hearing pyrimethanil, (4,6-dimethyl-N-phenyl-2-
for hearings must be received on or request? pyrimidinamine), in or on cucumber at
before December 21, 2015, and must be Under FFDCA section 408(g), 21 1.5 parts per million (ppm); fruit, pome,
filed in accordance with the instructions U.S.C. 346a, any person may file an group 11–10 at 14 ppm; fruit, stone,
provided in 40 CFR part 178 (see also objection to any aspect of this regulation group 12–12 at 10 ppm; grapefruit
Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those subgroup 10–10C at 10 ppm; lemon
INFORMATION). subgroup 10–10B at 11 ppm; orange
objections. You must file your objection
ADDRESSES: The docket for this action, or request a hearing on this regulation subgroup 10–10A at 10 ppm; and
identified by docket identification (ID) in accordance with the instructions tomato subgroup 8–10A at 0.5 ppm.
number EPA–HQ–OPP–2015–0012, is provided in 40 CFR part 178. To ensure Upon approval of the tolerances in this
available at http://www.regulations.gov proper receipt by EPA, you must petition, the petition requested that the
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– tolerances for fruit, citrus, group 10
Regulatory Public Docket (OPP Docket) OPP–2015–0012 in the subject line on except lemon, postharvest; fruit, pome,
in the Environmental Protection Agency the first page of your submission. All group 11 (preharvest and post-harvest);
Docket Center (EPA/DC), West William objections and requests for a hearing fruit, stone, group 12; lemon (preharvest
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be and postharvest); and tomato be
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or removed as they are superseded. This
20460–0001. The Public Reading Room before December 21, 2015. Addresses for petition additionally requested that 40
tkelley on DSK3SPTVN1PROD with RULES

is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections CFR 180.518 be amended by revising
Monday through Friday, excluding legal and hearing requests are provided in 40 the existing tolerance for onion, bulb,
holidays. The telephone number for the CFR 178.25(b). subgroup 3–07A from 2.0 ppm to 0.20
Public Reading Room is (202) 566–1744, In addition to filing an objection or ppm. That document referenced a
and the telephone number for the OPP hearing request with the Hearing Clerk summary of the petition prepared on
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please behalf of IR–4 by Bayer CropScience,

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Document Modified: 2018-02-27 08:54:13
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective October 21, 2015. Objections and requests for hearings must be received on or before December 21, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 63683
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements