Acetic Acid Ethenyl Ester, Polymer With Ethene and Ethenol; Tolerance Exemption, 32320-32323 [2019-14396]
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INDIANA—2010 SULFUR DIOXIDE NAAQS—Continued
[Primary]
Designation
Designated area 1 3
Date 2
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Terre Haute, IN ........................................................................................................................................................
Vigo County.
Fayette Township, Harrison Township.
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7/8/2019
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Type
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Attainment.
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1 Includes
any Indian country in each county or area, unless otherwise specified. EPA is not determining the boundaries of any area of Indian
country in this table, including any area of Indian country located in the larger designation area. The inclusion of any Indian country in the designation area is not a determination that the state has regulatory authority under the Clean Air Act for such Indian country.
2 This date is April 9, 2018, unless otherwise noted.
3 Porter County will be designated by December 31, 2020.
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[FR Doc. 2019–14359 Filed 7–5–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0096; FRL–9995–17]
Acetic Acid Ethenyl Ester, Polymer
With Ethene and Ethenol; Tolerance
Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of acetic acid
ethenyl ester, polymer with ethene and
ethenol; when used as an inert
ingredient in a pesticide chemical
formulation. Keller and Heckman LLP.
on behalf of Kuraray American, 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 acetic acid ethenyl ester,
polymer with ethene and ethenol on
food or feed commodities.
DATES: This regulation is effective July
8, 2019. Objections and requests for
hearings must be received on or before
September 6, 2019, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
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SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0096, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
ADDRESSES:
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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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
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
PO 00000
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Office’s e-CFR site at https://
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–2019–0096 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 September 6, 2019. 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–
2019–0096, by one of the following
methods.
• Federal eRulemaking Portal: https://
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/
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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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Background and Statutory Findings
In the Federal Register of May 13,
2019 (84 FR 20843) (FRL–9991–91),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the receipt of a pesticide
petition (PP IN–11251) filed by Keller
and Heckman LLP. on behalf of Kuraray
America, INC., 1001 G Street NW—Suite
500 West, Washington, DC 20001. The
petition requested that 40 CFR 180.960
be amended by establishing an
exemption from the requirement of a
tolerance for residues of acetic acid
ethenyl ester, polymer with ethene and
ethenol (CAS Reg. No. 26221–27–2).
That document included a summary of
the petition prepared by the petitioner
and solicited comments on the
petitioner’s request. The Agency did not
receive any comments.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and
use in residential settings, but does not
include occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing an
exemption from the requirement of a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue . . .’’ and specifies
factors EPA is to consider in
establishing an exemption.
III. Risk Assessment and Statutory
Findings
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be shown that the
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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). acetic acid ethenyl ester,
polymer with ethene and ethenol
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 at least
two of the atomic elements carbon,
hydrogen, nitrogen, oxygen, silicon, and
sulfur.
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
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Inventory or manufactured under an
applicable TSCA section 5 exemption.
6. The polymer is not a water
absorbing polymer with a number
average molecular weight (MW) greater
than or equal to 10,000 daltons.
7. The polymer does not contain
certain perfluoroalkyl moieties
consisting of a CF3- or longer chain
length as listed in 40 CFR 723.250(d)(6).
Additionally, the polymer also meets as
required the following exemption
criteria specified in 40 CFR 723.250(e).
The polymer’s number average MW of
20,000 daltons is greater than or equal
to 10,000 daltons. The polymer contains
less than 2% oligomeric material below
MW 500 and less than 5% oligomeric
material below MW 1,000.
Thus, acetic acid ethenyl ester,
polymer with ethene and ethenol 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 acetic
acid ethenyl ester, polymer with ethene
and ethenol.
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that acetic
acid ethenyl ester, polymer with ethene
and ethenol could be present in all raw
and processed agricultural commodities
and drinking water, and that nonoccupational non-dietary exposure was
possible. The number average MW of
acetic acid ethenyl ester, polymer with
ethene and ethenol is 20,000 daltons.
Generally, a polymer of this size would
be poorly absorbed through the intact
gastrointestinal tract or through intact
human skin. Since acetic acid ethenyl
ester, polymer with ethene and ethenol
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 acetic acid ethenyl
ester, polymer with ethene and ethenol
to share a common mechanism of
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Federal Register / Vol. 84, No. 130 / Monday, July 8, 2019 / Rules and Regulations
toxicity with any other substances, and
acetic acid ethenyl ester, polymer with
ethene and ethenol does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that acetic acid ethenyl ester,
polymer with ethene and ethenol does
not have a common mechanism of
toxicity with other substances. For
information regarding EPA’s efforts to
determine which chemicals have a
common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see EPA’s website at https://
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 acetic acid ethenyl ester,
polymer with ethene and ethenol, 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 acetic acid ethenyl ester,
polymer with ethene and ethenol.
VIII. Other Considerations
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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,
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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 acetic acid ethenyl ester, polymer
with ethene and ethenol.
IX. Conclusion
Accordingly, EPA finds that
exempting residues of acetic acid
ethenyl ester, polymer with ethene and
ethenol 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
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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: June 27, 2019.
Donna Davis,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, alphabetically add the
polymer to the table to read as follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
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Polymer
CAS No.
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Acetic acid ethenyl ester, polymer with ethene and ethenol, minimum number average molecular weight (in amu), 20,000 ..........
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[FR Doc. 2019–14396 Filed 7–5–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety
Administration
49 CFR Part 385
Incorporation by Reference; North
American Standard Out-of-Service
Criteria; Hazardous Materials Safety
Permits
Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Final rule.
AGENCY:
FMCSA amends its
Hazardous Materials Safety Permit
regulations to incorporate by reference
the April 1, 2018, edition of the
Commercial Vehicle Safety Alliance’s
(CVSA) ‘‘North American Standard Outof-Service Criteria and Level VI
Inspection Procedures and Out-ofService Criteria for Commercial
Highway Vehicles Transporting
Transuranics and Highway Route
Controlled Quantities of Radioactive
Materials as defined in 49 CFR part
173.403.’’ The Out-of-Service Criteria
provide uniform enforcement tolerances
for roadside inspections to enforcement
personnel nationwide, including
FMCSA’s State partners.
DATES: This final rule is effective July 8,
2019. The incorporation by reference of
certain publications listed in the
regulations is approved by the Director
of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51
as of July 8, 2019.
Petitions for Reconsideration of this
final rule must be submitted to the
FMCSA Administrator no later than
August 7, 2019.
ADDRESSES: Petitions for reconsideration
must be written in English and mailed
or delivered to: Administrator, Federal
Motor Carrier Safety Administration,
1200 New Jersey Avenue SE,
Washington, DC 20590–0001.
FOR FURTHER INFORMATION CONTACT: Mr.
Michael Huntley, Chief, Vehicle and
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Roadside Operations Division, Federal
Motor Carrier Safety Administration,
1200 New Jersey Avenue SE,
Washington, DC 20590–0001 or by
telephone at 202–366–9209. If you have
questions on viewing or submitting
material to the docket, contact Docket
Services, telephone (202) 366–9826.
SUPPLEMENTARY INFORMATION:
A. Availability of Rulemaking
Documents
RIN 2126–AC01
VerDate Sep<11>2014
*
I. Rulemaking Documents
[Docket No. FMCSA–2018–0165]
SUMMARY:
*
For access to docket FMCSA–2018–
0165 to read background documents and
comments received, go to https://
www.regulations.gov at any time, or to
Docket Services at U.S. Department of
Transportation, Room W12–140, 1200
New Jersey Avenue SE, Washington, DC
20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
B. Privacy Act
In accordance with 5 U.S.C. 553(c),
DOT solicits comments from the public
to better inform its rulemaking process.
DOT posts these comments, without
edit, including any personal information
the commenter provides, to
www.regulations.gov, as described in
the system of records notice (DOT/ALL–
14 FDMS), which can be reviewed at
www.dot.gov/privacy.
II. Executive Summary
This rulemaking updates an
incorporation by reference found at 49
CFR 385.4 and referenced at 49 CFR
385.415(b). Section 385.4(b) currently
references the April 1, 2016, edition of
CVSA’s ‘‘North American Standard Outof-Service Criteria and Level VI
Inspection Procedures and Out-ofService Criteria for Commercial
Highway Vehicles Transporting
Transuranics and Highway Route
Controlled Quantities of Radioactive
Materials as defined in 49 CFR part
173.403.’’ The Out-of-Service Criteria,
while not regulations, provide uniform
enforcement tolerances for roadside
inspections to enforcement personnel
nationwide, including FMCSA’s State
partners. In this final rule, FMCSA
incorporates by reference the April 1,
2018, edition, which includes changes
adopted in the April 1, 2017 edition.
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26221–27–2
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III. Legal Basis for the Rulemaking
Congress has enacted several statutory
provisions to ensure the safe
transportation of hazardous materials in
interstate commerce. Specifically, in
provisions codified at 49 U.S.C. 5105(d),
relating to inspections of motor vehicles
carrying certain hazardous material, and
49 U.S.C. 5109, relating to motor carrier
safety permits, the Secretary of
Transportation is required to
promulgate regulations as part of a
comprehensive safety program on
hazardous materials safety permits. The
FMCSA Administrator has been
delegated authority under 49 CFR
1.87(d)(2) to carry out the rulemaking
functions vested in the Secretary of
Transportation. Consistent with that
authority, FMCSA has promulgated
regulations to address the congressional
mandate on hazardous materials. Those
regulations on hazardous materials are
the underlying provisions to which the
material incorporated by reference
discussed in this final rule is applicable.
IV. Background
In 1986, the U.S. Department of
Energy (DOE) and CVSA entered into a
cooperative agreement to develop a
higher level of inspection procedures,
out-of-service conditions and/or criteria,
an inspection decal, and a training and
certification program for inspectors to
conduct inspections on shipments of
transuranic waste and highway route
controlled quantities of radioactive
material. CVSA developed the North
American Standard Level VI Inspection
Program for Transuranic Waste and
Highway Route Controlled Quantities of
Radioactive Material. This inspection
program for select radiological
shipments includes inspection
procedures, enhancements to the North
American Standard Level I Inspection,
radiological surveys, CVSA Level VI
decal requirements, and the ‘‘North
American Standard Out-of-Service
Criteria and Level VI Inspection
Procedures and Out-of-Service Criteria
for Commercial Highway Vehicles
Transporting Transuranics and Highway
Route Controlled Quantities of
Radioactive Materials as defined in 49
CFR part 173.403.’’ As of January 1,
2005, all vehicles and carriers
transporting highway route controlled
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]]>Agencies
[Federal Register Volume 84, Number 130 (Monday, July 8, 2019)]
[Rules and Regulations]
[Pages 32320-32323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14396]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0096; FRL-9995-17]
Acetic Acid Ethenyl Ester, Polymer With Ethene and Ethenol;
Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of acetic acid ethenyl ester, polymer with
ethene and ethenol; when used as an inert ingredient in a pesticide
chemical formulation. Keller and Heckman LLP. on behalf of Kuraray
American, 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 acetic acid
ethenyl ester, polymer with ethene and ethenol on food or feed
commodities.
DATES: This regulation is effective July 8, 2019. Objections and
requests for hearings must be received on or before September 6, 2019,
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-2019-0096, is available at https://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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://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-2019-0096 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
September 6, 2019. 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-2019-0096, by one of
the following methods.
Federal eRulemaking Portal: https://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/
[[Page 32321]]
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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of May 13, 2019 (84 FR 20843) (FRL-9991-
91), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11251)
filed by Keller and Heckman LLP. on behalf of Kuraray America, INC.,
1001 G Street NW--Suite 500 West, Washington, DC 20001. The petition
requested that 40 CFR 180.960 be amended by establishing an exemption
from the requirement of a tolerance for residues of acetic acid ethenyl
ester, polymer with ethene and ethenol (CAS Reg. No. 26221-27-2). That
document included a summary of the petition prepared by the petitioner
and solicited comments on the petitioner's request. The Agency did not
receive any comments.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . .'' and
specifies factors EPA is to consider in establishing an exemption.
III. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of 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). acetic acid ethenyl ester, polymer with
ethene and ethenol 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
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40 CFR
723.250(d)(6). Additionally, the polymer also meets as required the
following exemption criteria specified in 40 CFR 723.250(e).
The polymer's number average MW of 20,000 daltons is greater than
or equal to 10,000 daltons. The polymer contains less than 2%
oligomeric material below MW 500 and less than 5% oligomeric material
below MW 1,000.
Thus, acetic acid ethenyl ester, polymer with ethene and ethenol
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 acetic acid ethenyl ester, polymer with ethene and ethenol.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that acetic acid ethenyl ester, polymer with
ethene and ethenol could be present in all raw and processed
agricultural commodities and drinking water, and that non-occupational
non-dietary exposure was possible. The number average MW of acetic acid
ethenyl ester, polymer with ethene and ethenol is 20,000 daltons.
Generally, a polymer of this size would be poorly absorbed through the
intact gastrointestinal tract or through intact human skin. Since
acetic acid ethenyl ester, polymer with ethene and ethenol 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 acetic acid ethenyl ester, polymer with ethene
and ethenol to share a common mechanism of
[[Page 32322]]
toxicity with any other substances, and acetic acid ethenyl ester,
polymer with ethene and ethenol does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that acetic acid ethenyl
ester, polymer with ethene and ethenol does not have a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at https://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 acetic acid ethenyl
ester, polymer with ethene and ethenol, 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 acetic acid ethenyl ester, polymer
with ethene and ethenol.
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 acetic acid ethenyl ester,
polymer with ethene and ethenol.
IX. Conclusion
Accordingly, EPA finds that exempting residues of acetic acid
ethenyl ester, polymer with ethene and ethenol 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: June 27, 2019.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.960, alphabetically add the polymer to the table to
read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
[[Page 32323]]
------------------------------------------------------------------------
Polymer CAS No.
------------------------------------------------------------------------
* * * * * * *
Acetic acid ethenyl ester, polymer with ethene and 26221-27-2
ethenol, minimum number average molecular weight (in
amu), 20,000...........................................
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2019-14396 Filed 7-5-19; 8:45 am]
BILLING CODE 6560-50-P
