82 FR 51351 - Formaldehyde, Polymer With 1,3-Benzenediol, 2-Methyloxirane and Oxirane, Ethers With Polyethylene Glycol Mono-Me Ether; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 213 (November 6, 2017)

Page Range		51351-51355
FR Document		2017-24110
This regulation establishes an exemption from the requirement of a tolerance for residues of formaldehyde, polymer with 1,3- benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether (CAS Reg. No. 1998118-31-2) when used as an inert ingredient in a pesticide chemical formulation. Eco Verde Technologies 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 formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether on food or feed commodities.
Federal Register, Volume 82 Issue 213 (Monday, November 6, 2017)
[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Rules and Regulations]
[Pages 51351-51355]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24110]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0362; FRL-9969-99]


Formaldehyde, Polymer With 1,3-Benzenediol, 2-Methyloxirane and 
Oxirane, Ethers With Polyethylene Glycol Mono-Me Ether; Exemption From 
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of formaldehyde, polymer with 1,3-
benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene 
glycol mono-Me ether (CAS Reg. No. 1998118-31-2) when

[[Page 51352]]

used as an inert ingredient in a pesticide chemical formulation. Eco 
Verde Technologies 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 formaldehyde, 
polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with 
polyethylene glycol mono-Me ether on food or feed commodities.

DATES: This regulation is effective November 6, 2017. Objections and 
requests for hearings must be received on or before January 5, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0362, 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, Director Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0362 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 
January 5, 2018. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0362, by one of 
the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of September 15, 2017 (82 FR 43352; FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11043) filed by Eco Verde Technologies Inc., 400 NW. 172nd Avenue, 
Pembroke Pines, FL. The petition requested that 40 CFR 180.960 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of formaldehyde, polymer with 1,3-benzenediol, 
2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me 
ether (CAS Reg. No. 1998118-31-2). 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

[[Page 51353]]

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). Formaldehyde, polymer with 1,3-
benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene 
glycol mono-Me ether 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 a cationic or potentially cationic polymer with 
low cationic density (the percent of cationic or potentially cationic 
species with respect to the overall weight of polymer).
    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 1,000,000 is greater 
than 10,000 daltons. The polymer contains less than 2% oligomeric 
material below MW 500 and less than 5% oligomeric material below MW 
1,000, and the polymer does not contain any reactive functional groups.
    Thus, formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane 
and oxirane, ethers with polyethylene glycol mono-Me ether 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 
formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and 
oxirane, ethers with polyethylene glycol mono-Me ether.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that formaldehyde, polymer with 1,3-
benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene 
glycol mono-Me ether 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 
formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and 
oxirane, ethers with polyethylene glycol mono-Me ether is 1,000,000 
daltons. Generally, a polymer of this size would be poorly absorbed 
through the intact gastrointestinal tract or through intact human skin. 
Since formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and 
oxirane, ethers with polyethylene glycol mono-Me ether 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 formaldehyde, polymer with 1,3-benzenediol, 2-
methyloxirane and oxirane, ethers with polyethylene glycol mono-Me 
ether to share a common mechanism of toxicity with any other 
substances, and formaldehyde, polymer with 1,3-benzenediol, 2-
methyloxirane and oxirane, ethers with polyethylene glycol mono-Me 
ether does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that formaldehyde, polymer with 1,3-benzenediol, 2-
methyloxirane and oxirane, ethers with polyethylene glycol mono-Me 
ether 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 formaldehyde, polymer 
with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with 
polyethylene glycol mono-Me ether, 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 formaldehyde, polymer with 1,3-
benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene 
glycol mono-Me ether.

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

[[Page 51354]]

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 formaldehyde, polymer with 
1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene 
glycol mono-Me ether.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of formaldehyde, 
polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with 
polyethylene glycol mono-Me ether 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 20, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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


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

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
Formaldehyde, polymer with 1,3[hyphen]benzenediol,          1998118-31-2
 2[hyphen]methyloxirane and oxirane, ethers with
 polyethylene glycol mono[hyphen]Me ether, minimum
 number average molecular weight (in amu) 1,000,000.....
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2017-24110 Filed 11-3-17; 8:45 am]
 BILLING CODE 6560-50-P
Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 51351

IV. Statutory and Executive Order EPA, when it reviews a Section 111(d)/ List of Subjects in 40 CFR Part 62
Reviews 129 plan submission, to use VCS in Environmental protection, Air
place of a Section 111(d)/129 plan pollution control, Carbon monoxide,
A. General Requirements
submission that otherwise satisfies the Intergovernmental relations, Lead,
Under Executive Order 12866 (58 FR provisions of the Clean Air Act. Thus,
51735, October 4, 1993), this action is Nitrogen dioxide, Particulate matter,
the requirements of section 12(d) of the Reporting and recordkeeping
not a ‘‘significant regulatory action’’ and National Technology Transfer and
therefore is not subject to review by the requirements, Sulfur oxides.
Advancement Act of 1995 (15 U.S.C.
Office of Management and Budget. For 272 note) do not apply. This rule does Dated: October 18, 2017.
this reason, this action is also not not impose an information collection Cosmo Servidio,
subject to Executive Order 13211, burden under the provisions of the Regional Administrator, Region III.
‘‘Actions Concerning Regulations That Paperwork Reduction Act of 1995 (44
Significantly Affect Energy Supply, For the reasons stated in the
U.S.C. 3501 et seq.). preamble, 40 CFR part 62 is amended as
Distribution, or Use’’ (66 FR 28355 (May
22, 2001)). This action merely approves B. Submission to Congress and the follows:
state law as meeting Federal Comptroller General
PART 62—APPROVAL AND
requirements and imposes no additional
The Congressional Review Act, 5 PROMULGATION OF STATE PLANS
requirements beyond those imposed by
U.S.C. 801 et seq., as added by the Small FOR DESIGNATED FACILITIES AND
state law. Accordingly, the
Business Regulatory Enforcement POLLUTANTS
Administrator certifies that this rule
will not have a significant economic Fairness Act of 1996, generally provides
■ 1. The authority citation for part 62
impact on a substantial number of small that before a rule may take effect, the
continues to read as follows:
entities under the Regulatory Flexibility agency promulgating the rule must
Act (5 U.S.C. 601 et seq.). Because this submit a rule report, which includes a Authority: 42 U.S.C. 7401 et seq.
rule approves pre-existing requirements copy of the rule, to each House of the
Subpart V—Maryland
under state law and does not impose Congress and to the Comptroller General
any additional enforceable duty beyond of the United States. EPA will submit a ■ 2. Section 62.5110 is amended by
that required by state law, it does not report containing this action and other adding paragraph (c) to read as follows:
contain any unfunded mandate or required information to the U.S. Senate,
significantly or uniquely affect small the U.S. House of Representatives, and § 62.5110 Identification of plan.
governments, as described in the the Comptroller General of the United * * * * *
Unfunded Mandates Reform Act of 1995 States prior to publication of the rule in (c) On May 10, 2016, Maryland
(Pub. L. 104–4). This rule also does not the Federal Register. A major rule submitted a revised State Plan and
have a substantial direct effect on one or cannot take effect until 60 days after it related COMAR 26.11.08.08
more Indian tribes, on the relationship is published in the Federal Register. amendments.
between the Federal Government and This action is not a ‘‘major rule’’ as ■ 3. Section 62.5112 is amended by
Indian tribes, or on the distribution of defined by 5 U.S.C. 804(2). adding paragraph (c) to read as follows:
power and responsibilities between the
Federal Government and Indian tribes, C. Petitions for Judicial Review § 62.5112 Effective date.
as specified by Executive Order 13175 * * * * *
Under section 307(b)(1) of the CAA,
(65 FR 67249, November 9, 2000), nor (c) The plan revision is effective
petitions for judicial review of this
will it have substantial direct effects on January 5, 2018.
action must be filed in the United States
the States, on the relationship between [FR Doc. 2017–24116 Filed 11–3–17; 8:45 am]
Court of Appeals for the appropriate
the national government and the States,
or on the distribution of power and circuit by January 5, 2018. Filing a BILLING CODE 6560–50–P

responsibilities among the various petition for reconsideration by the
levels of government, as specified in Administrator of this final rule does not
affect the finality of this action for the ENVIRONMENTAL PROTECTION
Executive Order 13132 (64 FR 43255, AGENCY
August 10, 1999), because it merely purposes of judicial review nor does it
approves a state rule implementing a extend the time within which a petition
40 CFR Part 180
Federal requirement, and does not alter for judicial review may be filed, and
the relationship or the distribution of shall not postpone the effectiveness of [EPA–HQ–OPP–2017–0362; FRL–9969–99]
power and responsibilities established such rule or action. Parties with
objections to this direct final rule are Formaldehyde, Polymer With 1,3-
in the CAA. This rule also is not subject Benzenediol, 2-Methyloxirane and
to Executive Order 13045 (62 FR 19885, encouraged to file a comment in
response to the parallel notice of Oxirane, Ethers With Polyethylene
April 23, 1997), because it approves a Glycol Mono-Me Ether; Exemption
state rule implementing a Federal proposed rulemaking for this action
published in the proposed rules section From the Requirement of a Tolerance
standard.
In reviewing Section 111(d)/129 plan of this Federal Register, rather than file AGENCY: Environmental Protection
submissions, EPA’s role is to approve an immediate petition for judicial Agency (EPA).
state choices, provided that they meet review of this direct final rule, so that ACTION: Final rule.
the criteria of the Clean Air Act. In this EPA can withdraw this direct final rule
Pmangrum on DSK3GDR082PROD with RULES

context, in the absence of a prior and address the comment in the SUMMARY: This regulation establishes an
existing requirement for the State to use proposed rulemaking action. This action exemption from the requirement of a
voluntary consensus standards (VCS), approving Maryland’s revisions to their tolerance for residues of formaldehyde,
EPA has no authority to disapprove a 111(d)/129 State Plan for MWCs may polymer with 1,3-benzenediol, 2-
Section 111(d)/129 plan submission for not be challenged later in proceedings to methyloxirane and oxirane, ethers with
failure to use VCS. It would thus be enforce its requirements. (See section polyethylene glycol mono-Me ether
inconsistent with applicable law for 307(b)(2).) (CAS Reg. No. 1998118–31–2) when

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51354 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations

international standards whenever Regulations That Significantly Affect does not impose any enforceable duty or
possible, consistent with U.S. food Energy Supply, Distribution, or Use’’ (66 contain any unfunded mandate as
safety standards and agricultural FR 28355, May 22, 2001) or Executive described under Title II of the Unfunded
practices. EPA considers the Order 13045, entitled ‘‘Protection of Mandates Reform Act (UMRA) (2 U.S.C.
international maximum residue limits Children from Environmental Health 1501 et seq.).
(MRLs) established by the Codex Risks and Safety Risks’’ (62 FR 19885, This action does not involve any
Alimentarius Commission (Codex), as April 23, 1997). This action does not technical standards that would require
required by FFDCA section 408(b)(4). contain any information collections Agency consideration of voluntary
The Codex Alimentarius is a joint subject to OMB approval under the consensus standards pursuant to section
United Nations Food and Agriculture Paperwork Reduction Act (PRA) (44 12(d) of the National Technology
Organization/World Health U.S.C. 3501 et seq.), nor does it require Transfer and Advancement Act
Organization food standards program, any special considerations under (NTTAA) (15 U.S.C. 272 note).
and it is recognized as an international Executive Order 12898, entitled
food safety standards-setting ‘‘Federal Actions to Address XI. Congressional Review Act
organization in trade agreements to Environmental Justice in Minority Pursuant to the Congressional Review
which the United States is a party. EPA Populations and Low-Income Act (5 U.S.C. 801 et seq.), EPA will
may establish a tolerance that is Populations’’ (59 FR 7629, February 16, submit a report containing this rule and
different from a Codex MRL; however, 1994). other required information to the U.S.
FFDCA section 408(b)(4) requires that Since tolerances and exemptions that Senate, the U.S. House of
EPA explain the reasons for departing are established on the basis of a petition Representatives, and the Comptroller
from the Codex level. under FFDCA section 408(d), such as
General of the United States prior to
The Codex has not established a MRL the tolerance in this final rule, do not
publication of the rule in the Federal
for formaldehyde, polymer with 1,3- require the issuance of a proposed rule,
Register. This action is not a ‘‘major
benzenediol, 2-methyloxirane and the requirements of the Regulatory
rule’’ as defined by 5 U.S.C. 804(2).
oxirane, ethers with polyethylene glycol Flexibility Act (RFA) (5 U.S.C. 601 et
mono-Me ether. seq.), do not apply. List of Subjects in 40 CFR Part 180
This action directly regulates growers,
IX. Conclusion Environmental protection,
food processors, food handlers, and food
Accordingly, EPA finds that retailers, not States or tribes, nor does Administrative practice and procedure,
exempting residues of formaldehyde, this action alter the relationships or Agricultural commodities, Pesticides
polymer with 1,3-benzenediol, 2- distribution of power and and pests, Reporting and recordkeeping
methyloxirane and oxirane, ethers with responsibilities established by Congress requirements.
polyethylene glycol mono-Me ether in the preemption provisions of FFDCA Dated: October 20, 2017.
from the requirement of a tolerance will section 408(n)(4). As such, the Agency Michael Goodis,
be safe. has determined that this action will not Director, Registration Division, Office of
have a substantial direct effect on States Pesticide Programs.
X. Statutory and Executive Order
or tribal governments, on the
Reviews Therefore, 40 CFR chapter I is
relationship between the national
This action establishes a tolerance government and the States or tribal amended as follows:
under FFDCA section 408(d) in governments, or on the distribution of
response to a petition submitted to the power and responsibilities among the PART 180—[AMENDED]
Agency. The Office of Management and various levels of government or between
Budget (OMB) has exempted these types ■ 1. The authority citation for part 180
the Federal Government and Indian
of actions from review under Executive continues to read as follows:
tribes. Thus, the Agency has determined
Order 12866, entitled ‘‘Regulatory that Executive Order 13132, entitled Authority: 21 U.S.C. 321(q), 346a and 371.
Planning and Review’’ (58 FR 51735, ‘‘Federalism’’ (64 FR 43255, August 10, ■ 2. In § 180.960, add alphabetically an
October 4, 1993). Because this action 1999) and Executive Order 13175, entry to the table to read as follows:
has been exempted from review under entitled ‘‘Consultation and Coordination
Executive Order 12866, this action is with Indian Tribal Governments’’ (65 FR § 180.960 Polymers; exemptions from the
not subject to Executive Order 13211, 67249, November 9, 2000) do not apply requirement of a tolerance.
entitled ‘‘Actions Concerning to this action. In addition, this action * * * * *

Polymer CAS No.

* * * * * * *
Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether,
minimum number average molecular weight (in amu) 1,000,000 ................................................................................................... 1998118–31–2

* * * * * * *
Pmangrum on DSK3GDR082PROD with RULES

[FR Doc. 2017–24110 Filed 11–3–17; 8:45 am]
BILLING CODE 6560–50–P

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Document Created: 2017-11-07 10:30:47
Document Modified: 2017-11-07 10:30:47
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 November 6, 2017. Objections and requests for hearings must be received on or before January 5, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Michael Goodis, Director Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation		82 FR 51351
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements