[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]


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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.

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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

[[Page 29631]]

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 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: 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 
http://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: 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

    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 http://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