
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Rules and Regulations]
[Pages 63683-63686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26617]


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

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


