[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Rules and Regulations]
[Pages 67288-67291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22190]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0291; FRL-10012-67]
Diquat; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of diquat
in or on pea and bean, dry and shelled, except soybean, subgroup 6C.
Syngenta Crop Protection, LLC requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 22, 2020. Objections and
requests for hearings must be received on or before December 21, 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-2017-0291, 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.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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 EPA's
tolerance regulations at 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, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0291 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
December 21, 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-2017-0291, 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. Summary of Petitioned-For Tolerance
In the Federal Register of September 15, 2017 (82 FR 43354) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8571) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the herbicide diquat in or on
pea and bean, dry and shelled, except soybean, subgroup 6C at 0.08
parts per million (ppm). In the Federal Register of May 7, 2018 (83 FR
20008) (FRL-9976-34), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing a correction to the
pesticide petition (PP 7E8571) by Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC 27419. The corrected petition requested that
40 CFR part 180 be amended by establishing tolerances for residues of
the herbicide diquat in or on pea and bean, dry and shelled, except
soybean, subgroup 6C at 0.9 parts per million (ppm). Both documents
referenced a summary of the petition prepared by Syngenta, the
registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
[[Page 67289]]
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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.
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 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. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for diquat including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with diquat follows.
EPA conducted a human health risk assessment to evaluate the safety
of the requested tolerances. See ``Diquat. Human Health Risk Assessment
for the Establishment of a Tolerance without U.S. Registration for
Residues in/on Crop Subgroup 6C Dried Shelled Pea and Bean (Except
Soybean)'' (July 21, 2020), which is available in the docket
established by this action, which is described under ADDRESSES. Locate
and click on the hyperlink for docket ID number EPA-HQ-OPP-2017-0291.
In that document, EPA evaluated the available hazard and exposure data
to conduct dietary, residential, and aggregate assessment to determine
risk to human health and refers back to the discussions of the hazard
profile, residue chemistry database, and residential exposures
contained in the previous human health risk assessment conducted for
registration review, ``Diquat Dibromide: Draft Human Health Risk
Assessment for Registration Review'' (Sept. 17, 2015) (``Registration
Review RA''), which can be found in the docket EPA-HQ-OPP-2009-0846 and
is included in this docket. Based on the discussion in the Registration
Review RA, the Agency has determined that there is reliable data to
support the use of a 1X margin of safety for the protection of infants
and children.
While the acute dietary assessment was unrefined, using tolerance-
level residues and 100% crop treated (PCT), the chronic dietary
assessment was more refined and used anticipated-residue levels from
magnitude of residue studies for crops irrigated with water treated
with diquat in conjunction with estimates of percentage of crops
irrigated. Default processing factors were also used in both the acute
and chronic dietary analyses and both analyses incorporated the Office
of Water's Maximum Contaminant Level (0.02 ppm) as a worst-case
drinking water estimate due to domestic uses of diquat. EPA's aggregate
exposure assessment incorporated the total dietary exposure, as well as
exposure from residential sources, which is not impacted by the
tolerance without U.S. registrations on pea and bean, dry and shelled,
except soybean, subgroup 6C and thus has not changed since the
Registration Review RA.
Acute aggregate dietary risks (food and water) are below the
Agency's level of concern of 100% of the acute population adjusted
dose: 1.4% of the aPAD for children 1 to 2 years old, the population
group receiving the greatest exposure. Chronic dietary risks are below
the Agency's level of concern of 100% of the chronic population
adjusted dose (cPAD): 41% of the cPAD for children 1 to 2 years old the
population group receiving the greatest exposure. For the short-/
intermediate-term aggregate risk assessment, potential residential
exposures were combined with dietary exposures. For both adults and
children 1 to <2, exposures from high-contact activities on outdoor
treated turf resulted in the highest residential exposures for
aggregate consideration. Short-/intermediate-term aggregate margins of
exposure (MOEs) are greater than the LOC of 100 (2,010 for adults and
280 for children 1 to 2 years old) and are therefore not of concern.
Due to the lack of carcinogenicity, the Agency concludes that exposure
is not expected to pose a cancer risk to the U.S. population.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to diquat residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (analytical method number RAM 272/
02 ``The Determination of Residues of Paraquat and Diquat in crops and
Soil--A High Performance Liquid Chromatographic Method'') is available
to enforce the tolerance expression.
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 established an MRL for diquat in or on dry pea
(subgroup) at 0.9 ppm. This MRL is the same as the tolerance
established for diquat in this decision. However, Codex has established
MRLs for diquat in or on dry bean (subgroup) at 0.4 ppm. Canada has
established MRLs for both dry pea and dry bean at 0.9 ppm.
C. Response to Comments
Two general comments were received on the notices of filing
expressing general concern about the potential of pesticide residues in
food, although none provided any substantive information to take into
consideration in EPA's safety assessment. The FFDCA authorizes EPA to
establish tolerances that permit certain levels of pesticide residues
in or on food when the Agency can determine that such residues are
safe. EPA has made that determination for the tolerances subject to
this action; commenters provided no information relevant to that
conclusion.
V. Conclusion
Therefore, tolerances are established for residues of diquat in or
on pea and bean, dry and shelled, except soybean, subgroup 6C at 0.9
ppm and the tolerance expression is being updated.
[[Page 67290]]
Also, in accordance with EPA's policy to update its tolerance
expressions where applicable, EPA is revising the tolerance expression
to clarify that (1) as provided in FFDCA section 408(a)(3), the
tolerance covers metabolites and degradates of diquat not specifically
mentioned; and (2) compliance with the specified tolerance levels is to
be determined by measuring only the specific compounds mentioned in the
tolerance expression. EPA has determined that it is reasonable to make
this change final without prior proposal and opportunity for comment
because public comment is not necessary since the change is merely
intended to clarify the existing tolerance expression and has no
substantive effect on the tolerance.
VI. Statutory and Executive Order Reviews
This action establishes tolerances 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).
VII. 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: September 16, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
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. 180.226, amend paragraph (a)(1) by:
0
a. Revising the introductory text and adding a heading for the table;
and
0
b. Adding in alphabetical order to the table the entry for ``Pea and
bean, dry and shelled, except soybean, subgroup 6C'' and footnote 1.
The revision and additions read as follows:
Sec. 180.226 Diquat; tolerances for residues.
(a) * * *
(1) Tolerances are established for the residues of the herbicide
diquat, including its metabolites and degradates, in or on the
commodities in Table 1 to this paragraph (a)(1) resulting from the
application of the dibromide salt of diquat. Compliance with the
tolerance levels specified in Table 1 to this paragraph (a)(1) is to be
determined by measuring only diquat (6,7-dihydrodipyrido[1,2-a:2',1'-
c]pyrazinediium):
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Commodity Parts per million
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* * * * * * *
Pea and bean, dry and shelled, except soybean, 0.9
subgroup 6C \1\..................................
* * * * * * *
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\1\ There are no U.S. registrations for these commodities as of October
22, 2020.
[[Page 67291]]
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[FR Doc. 2020-22190 Filed 10-21-20; 8:45 am]
BILLING CODE 6560-50-P