Methyl Mercaptan; Exemption From the Requirement of a Tolerance, 29630-29633 [2020-08964]
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29630
Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where EPA or an
Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. Section 804,
however, exempts from section 801 the
following types of rules: Rules of
particular applicability; rules relating to
agency management or personnel; and
rules of agency organization, procedure,
or practice that do not substantially
affect the rights or obligations of nonagency parties. 5 U.S.C. 804(3). Because
this is a rule of particular applicability,
EPA is not required to submit a rule
report regarding this action under
section 801.
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by July 17, 2020.
Filing a petition for reconsideration by
the Administrator of this final rule does
not affect the finality of this action for
the purposes of judicial review nor does
it extend the time within which a
petition for judicial review may be filed,
and shall not postpone the effectiveness
of such rule or action. Parties with
objections to this direct final rule are
encouraged to file a comment in
response to the parallel notice of
proposed rulemaking for this action
published in the proposed rules section
of today’s Federal Register, rather than
file an immediate petition for judicial
review of this direct final rule, so that
EPA can withdraw this direct final rule
and address the comment in the
proposed rulemaking. This action may
not be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Ozone, Volatile organic
compounds.
Dated: April 21, 2020.
Dennis Deziel,
Regional Administrator, EPA Region 1.
Part 52 of chapter I, title 40 of the
Code of Federal Regulations is amended
as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart W—Massachusetts
2. In § 52.1120, amend the table in
paragraph (e) by adding the entry for
‘‘Negative declaration for the 2016
Control Techniques Guideline for the
Oil and Natural Gas Industry’’ at the end
of the table, to read as follows:
■
§ 52.1120
*
Identification of plan.
*
*
(e) * * *
*
*
MASSACHUSETTS NON REGULATORY
Applicable
geographic or
nonattainment area
Name of nonregulatory SIP provision
*
*
Negative declaration for the 2016 Control Techniques Guidelines for the Oil and Natural Gas
Industry.
State submittal
date/effective
date
*
*
Statewide .....................
EPA approved date 3
*
10/18/2018
*
5/18/2020, [Insert Federal Register citation].
Explanations
*
Negative declaration.
3 To determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for
the particular provision.
[FR Doc. 2020–09072 Filed 5–15–20; 8:45 am]
BILLING CODE P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
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[EPA–HQ–OPP–2019–0368; FRL–10006–98]
Methyl Mercaptan; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
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Final rule.
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This regulation establishes an
exemption from the requirement of a
tolerance for residues of methyl
mercaptan in or on all food
commodities when methyl mercaptan is
used as a gopher repellent in irrigation
lines in accordance with label directions
and good agricultural practices. Acqua
Concepts, Inc. (d/b/a Ag Water
Chemical) 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
SUMMARY:
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Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations
need to establish a maximum
permissible level for residues of methyl
mercaptan under FFDCA.
DATES: This regulation is effective May
18, 2020. Objections and requests for
hearings must be received on or before
July 17, 2020 and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0368, 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:
Robert McNally, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. General Information
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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
VerDate Sep<11>2014
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Jkt 250001
through the Government Publishing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), 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–2019–0368 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 July
17, 2020. 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–
2019–0368, 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/
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
In the Federal Register of August 2,
2019 (84 FR 37818) (FRL–9996–78),
EPA issued a notice pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
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tolerance exemption petition (PP
8F8713) by Acqua Concepts, Inc. (d/b/
a Ag Water Chemical), 2665 S. Chestnut,
Fresno, CA 93725. The petition
requested that 40 CFR part 180 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of the gopher repellent methyl
mercaptan in or on all food
commodities that use irrigation lines
treated with methyl mercaptan. That
notice referenced a summary of the
petition prepared by the petitioner
Acqua Concepts, Inc. (d/b/a Ag Water
Chemical) and available in the docket
via https://www.regulations.gov. There
were no comments received in response
to the notice of filing.
III. Final Rule
A. EPA’s Safety Determination
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement of 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 in
residential settings but does not include
occupational exposure. Pursuant to
FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C) and (D), which require EPA
to give special consideration to
exposure of infants and children to the
pesticide chemical residue in
establishing a tolerance or tolerance
exemption 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 . . . .’’ Additionally,
FFDCA section 408(b)(2)(D) requires
that EPA consider ‘‘available
information concerning the cumulative
effects of [a particular pesticide’s] . . .
residues and other substances that have
a common mechanism of toxicity.’’
EPA evaluated the available
toxicology and exposure data on methyl
mercaptan and considered their
validity, completeness, and reliability,
as well as the relationship of this
information to human risk. EPA also
considered available information
concerning the variability of the
sensitivities of major identifiable
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Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Rules and Regulations
subgroups of consumers, including
infants and children.
Methyl mercaptan, also known as
methanethiol, is a naturally occurring
compound. In its ambient state, it is a
colorless gas that smells like rotten
cabbage. At lower temperatures, it can
also be expressed as a liquid. Methyl
mercaptan is naturally found in the
blood and brain of humans and other
animals, as well as in plant tissues. It is
excreted from the human and animal
body in feces. It also occurs naturally in
certain foods, such as vegetables and
some nuts and cheeses, and, as such, is
often consumed by humans.
Methyl mercaptan has several
commercial uses. Due to its strong odor,
it is commonly employed as a leak
detector in natural gas lines. Methyl
mercaptan is also used in the
production of plastics to moderate the
growth of free radical polymers. Most
notably, methyl mercaptan is used as a
Food and Drug Administrationapproved food additive to impart an
umami flavor and to act as an adjuvant
(21 CFR 172.515).
As a new biochemical pesticide,
methyl mercaptan is intended for use as
a gopher repellent in irrigation/
chemigation lines (subterranean, surface
drip, and micro irrigation systems). The
repellent mode of action is due to its
noxious, putrid odor. Methyl mercaptan
is intended to be applied in trace
amounts through irrigation/chemigation
lines (subterranean, surface drip, and
micro irrigation systems). No direct
application to food is expected, but it is
possible that some trace amounts of the
active ingredient may be taken up into
the plant.
Overall, methyl mercaptan is
considered to be of low toxicity relative
to its proposed pesticidal use. Based on
the available information and the fact
that humans have been exposed to
methyl mercaptan in food and nonfood
products, the compound is considered
to have a history of safe natural
exposure. With specific regard to human
oral toxicity, EPA notes that the human
digestive system is designed to
accommodate methyl mercaptan in its
digestive processes. Notably, significant
levels of methyl mercaptan (in excess of
1,000 ppm) are naturally produced by
microflora within the human intestine.
Even so, only trivial amounts are
absorbed into the body because methyl
mercaptan is readily oxidized in the
human colon.
Although the available data indicate
moderate acute inhalation toxicity, EPA
does not expect any consumer
exposures due to the proposed use
pattern in irrigation systems. In the 90-
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day inhalation toxicity study, no
adverse effects were identified.
With regard to potential exposure
from the use of methyl mercaptan as a
pesticidal active ingredient, EPA
determined that expected exposures
will be minimal and dietary hazards
negligible. Foremost, EPA does not
anticipate any significant dietary
exposure due to the physical properties
of methyl mercaptan. One, methyl
mercaptan, which presents as a gas at
ambient temperatures, is highly volatile
and dissipates rapidly in the
atmosphere. Two, methyl mercaptan is
readily biodegradable in the soil.
Based primarily on negligible
exposure levels and additionally on the
active ingredient’s volatility (short halflife), its biodegradability, its capacity to
be metabolized by humans, its history of
safe consumption in both naturally
occuring foods (such as nuts and
cheeses) and foods containing methyl
mercaptan as a food additive, and its
use as a food-grade compound in
pesticide products, the remaining
toxicology data requirements were
waived and no points of departure were
identified that would necessitate a
quantitative dietary assessment of
methyl mercaptan.
Therefore, due to the low
toxicological profile of available methyl
mercaptan, its long history of safe
exposure, and the minimal dietary
exposure anticipated from its use as an
active ingredient, EPA determined that
the pesticidal use of methyl mercaptan
(as a gopher repellent) poses no
significant dietary risk.
As part of its risk assessment for
methyl mercaptan, EPA further
considered the potential risks of
residential exposures, aggregate
exposures, and cumulative risk. Based
on methyl mercaptan’s low toxicity,
anticipated negligible dietary exposure,
and history of safe use in consumer
products, no risks of concern have been
identified relative to residential (nonoccupational) pesticidal uses or any
aggregate of exposures to products
containing methyl mercaptan. At this
time, no residential uses of methyl
mercaptan are proposed. Similarly, no
risks of concern were identified for
cumulative exposures to methyl
mercaptan, since no common
mechanism of toxicity was identified for
either methyl mercaptan or its
metabolites.
Therefore, based on the expectation of
negligible exposures and low toxicity,
EPA determined that there is a
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to methyl mercaptan.
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A summary of the data upon which
EPA relied and its risk assessment based
on those data can be found within the
document entitled ‘‘Federal Food, Drug,
and Cosmetic Act (FFDCA) Safety
Determination for Methyl Mercaptan.’’
This document, as well as other relevant
information, is available in the docket
for this action as described under
ADDRESSES.
Based on its safety determination,
EPA is establishing an exemption from
the requirement of a tolerance for
residues of methyl mercaptan in or on
all food commodities when methyl
mercaptan is used as a gopher repellent
in irrigation lines in accordance with
label directions and good agricultural
practices.
B. Analytical Enforcement Methodology
The analytical method ‘‘ASTM D
5504–12 using a gas chromatograph
equipped with a sulfur
chemiluminescence detector (SCD)’’ is
available to EPA for the detection and
measurement of the pesticide residues.
IV. Statutory and Executive Order
Reviews
This action establishes an exemption
from the requirement of a tolerance
under FFDCA section 408(d) in
response to a petition submitted to EPA.
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), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act, 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
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the tolerance exemption in this action,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (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. As a
result, this action does not alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
EPA 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, EPA 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 (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
EPA’s consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act (15
U.S.C. 272 note).
V. Congressional Review Act (CRA)
Under the CRA (5 U.S.C. 801 et seq.),
EPA will submit a rule report 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.
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Dated: April 2, 2020.
Richard Keigwin,
Director, 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:
■
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Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1375 to subpart D to read
as follows:
■
§ 180.1375 Methyl mercaptan; exemption
from the requirement of a tolerance.
Residues of methyl mercaptan are
exempt from the requirement of a
tolerance in or on all food commodities,
when methyl mercaptan is used as a
gopher repellent in irrigation lines in
accordance with label directions and
good agricultural practices.
[FR Doc. 2020–08964 Filed 5–15–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0074; FRL–10007–09]
Fluridone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fluridone in or
on avocados, mandarins, pomegranates,
pistachios, and the stone fruit group
(crop group 12). SePRO Corporation
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May
18, 2020. Objections and requests for
hearings must be received on or before
July 17, 2020, 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–2019–0074, 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,
SUMMARY:
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29633
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 EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Publishing Office’s
e-CFR site at https://www.ecfr.gov/cgibin/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
C. How 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–2019–0074 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 July 17, 2020. 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
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18MYR1
]]>Agencies
[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Rules and Regulations]
[Pages 29630-29633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08964]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0368; FRL-10006-98]
Methyl Mercaptan; 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 methyl mercaptan in or on all food
commodities when methyl mercaptan is used as a gopher repellent in
irrigation lines in accordance with label directions and good
agricultural practices. Acqua Concepts, Inc. (d/b/a Ag Water Chemical)
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
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need to establish a maximum permissible level for residues of methyl
mercaptan under FFDCA.
DATES: This regulation is effective May 18, 2020. Objections and
requests for hearings must be received on or before July 17, 2020 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-2019-0368, 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: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), 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 Publishing Office's e-CFR site at
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2019-0368 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
July 17, 2020. 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-2019-0368, 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/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
In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-
78), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance exemption
petition (PP 8F8713) by Acqua Concepts, Inc. (d/b/a Ag Water Chemical),
2665 S. Chestnut, Fresno, CA 93725. The petition requested that 40 CFR
part 180 be amended by establishing an exemption from the requirement
of a tolerance for residues of the gopher repellent methyl mercaptan in
or on all food commodities that use irrigation lines treated with
methyl mercaptan. That notice referenced a summary of the petition
prepared by the petitioner Acqua Concepts, Inc. (d/b/a Ag Water
Chemical) and available in the docket via https://www.regulations.gov.
There were no comments received in response to the notice of filing.
III. Final Rule
A. EPA's Safety Determination
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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 in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C) and (D), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption 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 . . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
EPA evaluated the available toxicology and exposure data on methyl
mercaptan and considered their validity, completeness, and reliability,
as well as the relationship of this information to human risk. EPA also
considered available information concerning the variability of the
sensitivities of major identifiable
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subgroups of consumers, including infants and children.
Methyl mercaptan, also known as methanethiol, is a naturally
occurring compound. In its ambient state, it is a colorless gas that
smells like rotten cabbage. At lower temperatures, it can also be
expressed as a liquid. Methyl mercaptan is naturally found in the blood
and brain of humans and other animals, as well as in plant tissues. It
is excreted from the human and animal body in feces. It also occurs
naturally in certain foods, such as vegetables and some nuts and
cheeses, and, as such, is often consumed by humans.
Methyl mercaptan has several commercial uses. Due to its strong
odor, it is commonly employed as a leak detector in natural gas lines.
Methyl mercaptan is also used in the production of plastics to moderate
the growth of free radical polymers. Most notably, methyl mercaptan is
used as a Food and Drug Administration-approved food additive to impart
an umami flavor and to act as an adjuvant (21 CFR 172.515).
As a new biochemical pesticide, methyl mercaptan is intended for
use as a gopher repellent in irrigation/chemigation lines
(subterranean, surface drip, and micro irrigation systems). The
repellent mode of action is due to its noxious, putrid odor. Methyl
mercaptan is intended to be applied in trace amounts through
irrigation/chemigation lines (subterranean, surface drip, and micro
irrigation systems). No direct application to food is expected, but it
is possible that some trace amounts of the active ingredient may be
taken up into the plant.
Overall, methyl mercaptan is considered to be of low toxicity
relative to its proposed pesticidal use. Based on the available
information and the fact that humans have been exposed to methyl
mercaptan in food and nonfood products, the compound is considered to
have a history of safe natural exposure. With specific regard to human
oral toxicity, EPA notes that the human digestive system is designed to
accommodate methyl mercaptan in its digestive processes. Notably,
significant levels of methyl mercaptan (in excess of 1,000 ppm) are
naturally produced by microflora within the human intestine. Even so,
only trivial amounts are absorbed into the body because methyl
mercaptan is readily oxidized in the human colon.
Although the available data indicate moderate acute inhalation
toxicity, EPA does not expect any consumer exposures due to the
proposed use pattern in irrigation systems. In the 90-day inhalation
toxicity study, no adverse effects were identified.
With regard to potential exposure from the use of methyl mercaptan
as a pesticidal active ingredient, EPA determined that expected
exposures will be minimal and dietary hazards negligible. Foremost, EPA
does not anticipate any significant dietary exposure due to the
physical properties of methyl mercaptan. One, methyl mercaptan, which
presents as a gas at ambient temperatures, is highly volatile and
dissipates rapidly in the atmosphere. Two, methyl mercaptan is readily
biodegradable in the soil.
Based primarily on negligible exposure levels and additionally on
the active ingredient's volatility (short half-life), its
biodegradability, its capacity to be metabolized by humans, its history
of safe consumption in both naturally occuring foods (such as nuts and
cheeses) and foods containing methyl mercaptan as a food additive, and
its use as a food-grade compound in pesticide products, the remaining
toxicology data requirements were waived and no points of departure
were identified that would necessitate a quantitative dietary
assessment of methyl mercaptan.
Therefore, due to the low toxicological profile of available methyl
mercaptan, its long history of safe exposure, and the minimal dietary
exposure anticipated from its use as an active ingredient, EPA
determined that the pesticidal use of methyl mercaptan (as a gopher
repellent) poses no significant dietary risk.
As part of its risk assessment for methyl mercaptan, EPA further
considered the potential risks of residential exposures, aggregate
exposures, and cumulative risk. Based on methyl mercaptan's low
toxicity, anticipated negligible dietary exposure, and history of safe
use in consumer products, no risks of concern have been identified
relative to residential (non-occupational) pesticidal uses or any
aggregate of exposures to products containing methyl mercaptan. At this
time, no residential uses of methyl mercaptan are proposed. Similarly,
no risks of concern were identified for cumulative exposures to methyl
mercaptan, since no common mechanism of toxicity was identified for
either methyl mercaptan or its metabolites.
Therefore, based on the expectation of negligible exposures and low
toxicity, EPA determined that there is a reasonable certainty that no
harm will result to the U.S. population, including infants and
children, from aggregate exposure to methyl mercaptan.
A summary of the data upon which EPA relied and its risk assessment
based on those data can be found within the document entitled ``Federal
Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Methyl
Mercaptan.'' This document, as well as other relevant information, is
available in the docket for this action as described under ADDRESSES.
Based on its safety determination, EPA is establishing an exemption
from the requirement of a tolerance for residues of methyl mercaptan in
or on all food commodities when methyl mercaptan is used as a gopher
repellent in irrigation lines in accordance with label directions and
good agricultural practices.
B. Analytical Enforcement Methodology
The analytical method ``ASTM D 5504-12 using a gas chromatograph
equipped with a sulfur chemiluminescence detector (SCD)'' is available
to EPA for the detection and measurement of the pesticide residues.
IV. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to EPA. 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), nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act, 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
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the tolerance exemption in this action, do not require the issuance of
a proposed rule, the requirements of the Regulatory Flexibility Act (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. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C.
1501 et seq.).
This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).
V. Congressional Review Act (CRA)
Under the CRA (5 U.S.C. 801 et seq.), EPA will submit a rule report
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: April 2, 2020.
Richard Keigwin,
Director, 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. Add Sec. 180.1375 to subpart D to read as follows:
Sec. 180.1375 Methyl mercaptan; exemption from the requirement of a
tolerance.
Residues of methyl mercaptan are exempt from the requirement of a
tolerance in or on all food commodities, when methyl mercaptan is used
as a gopher repellent in irrigation lines in accordance with label
directions and good agricultural practices.
[FR Doc. 2020-08964 Filed 5-15-20; 8:45 am]
BILLING CODE 6560-50-P
