[Federal Register Volume 86, Number 209 (Tuesday, November 2, 2021)]
[Rules and Regulations]
[Pages 60368-60372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23836]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0391; FRL-8991-01-OCSPP]
Benzobicyclon; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation increases a tolerance for residues of
benzobicyclon in or on rice grain and removes any restriction on
regional use. Gowan Company requested this tolerance increase under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective November 2, 2021. Objections and
requests for hearings must be received on or before January 3, 2022,
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-2020-0391, 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 emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide customer service via email, phone, and
webform. For the latest status information on EPA/DC services, docket
access, visit http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 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(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-2020-0391 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
January 3, 2022. 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-2020-0391, 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/where-send-comments-epa-dockets.
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 April 22, 2021 (86 FR 21317) (FRL-10022-
59) 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
0F8831) by
[[Page 60369]]
Gowan Company, P.O. Box 5569, Yuma, AZ 85364. The petition requested to
amend the tolerance in 40 CFR 180.693 for residues of the herbicide
benzobicyclon in or on rice to 0.15 parts per million (ppm). That
document referenced a summary of the petition prepared by Gowan, the
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
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 therein, 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 benzobicyclon, including exposure resulting from
the tolerance established by this action. EPA's assessment of exposures
and risks associated with benzobicyclon follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking, and EPA considers referral back to those sections
as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published a tolerance rulemaking for
benzobicyclon, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to benzobicyclon and established a
tolerance for residues of that chemical. See the benzobicyclon
tolerance rulemaking published in the Federal Register of April 25,
2017 (82 FR 18995) (FRL-9961-02). EPA is incorporating previously
published sections from that rulemaking that remain unchanged, as
described further in this rulemaking.
Toxicological profile. There have been updates to the toxicological
profile from the previous assessment. The parent compound,
benzobicyclon, is a pro-pesticide, which means it requires hydrolysis
of the thiophenyl group to generate the anticipated pesticidal active
moiety, metabolite B (also referred to as 1315P-070). The toxicological
database is considered complete for risk assessment purposes for both
the parent, benzobicyclon, and metabolite B. The enzyme 4-
hydroxyphenylpyruvate dioxygenase (HPPD) is involved in the catabolism
of tyrosine, an essential amino acid for mammals. While benzobicyclon
may be referred to as an HPPD inhibitor, typical HPPD-inhibiting
effects are not observed in its toxicological database. However,
metabolite B does exhibit HPPD-inhibiting effects and is therefore
considered an HPPD-inhibiting chemical. The initiating event in the
mode-of-action (MOA)/adverse-outcome pathway (AOP) for HPPD-inhibiting
chemicals, including metabolite B, involves binding of the chemical to
the HPPD enzyme causing complete or virtually complete enzyme
inhibition, which leads to a build-up of systemic tyrosine levels
(tyrosinemia) and a spectrum of tyrosine-mediated effects. In
laboratory animals, these have been identified as ocular and skeletal
developmental effects. Species differences exist in laboratory animals
related to the ability of a species to clear excess tyrosine from its
system, which can impact its sensitivity to HPPD-inhibiting chemicals
and its relevance for human health risk assessment. In this risk
assessment, endpoints were selected for both benzobicyclon and
metabolite B. Taking into account species differences, endpoints for
human health risk assessment of HPPD inhibitors, including metabolite
B, were selected from studies available in mice and dogs. Studies from
other HPPD inhibitors were used for bridging to metabolite B as needed.
Since benzobicyclon does not exhibit HPPD-inhibiting properties,
endpoints were selected from the most sensitive species and effects in
its database (not restricted to mice and dogs).
Benzobicyclon: An acute dietary endpoint was not selected for
benzobicyclon, as there were no effects attributable to a single dose
identified in the database. The chronic dietary, incidental oral, and
inhalation endpoints were based on increased incidence of hydropic
degeneration (basophilic cells) in the pituitary observed in the two-
generation reproduction toxicity study in rats. A dermal endpoint was
not selected since no hazard was identified in the dermal toxicity
study and there was no evidence of increased quantitative
susceptibility in the database. Benzobicyclon is classified as ``Not
Likely to be Carcinogenic to Humans'' based on the absence of
treatment-related tumors in two adequate rodent carcinogenicity
studies.
Metabolite B: There were no effects attributable to a single dose
available in the metabolite B database or in studies from other HPPD
inhibitors; therefore, an acute dietary endpoint was not selected for
metabolite B. The chronic dietary endpoint is based on gallstones,
eosinophilic cytoplasmic alteration, subepithelial mixed cell
infiltrate, and dilatation in/of the gallbladder; hepatocellular
vacuolation, hepatocellular hypertrophy, and increased liver weight in
males and females; and papillary mineralization of the kidney and
changes in hematological parameters indicative of anemia in females
observed in the chronic/carcinogenicity study in mice from another HPPD
chemical available for bridging (tembotrione). Since the only
anticipated exposure is through drinking water, no additional points of
departure (PODs) were selected for metabolite B. There are no
carcinogenicity studies available for metabolite B; however,
carcinogenicity studies are available for bridging for all of the other
currently registered HPPD inhibitors. Overall, potential
carcinogenicity is not a concern for the HPPD inhibitors, and the
chronic dietary endpoint and POD for metabolite B is considered
protective of any potential carcinogenicity.
Additional information is available in the docket for this action
in the document titled ``Benzobicyclon: Section 3 Risk Assessment for
Proposed New Formulation, Increase to the Established Tolerance, and
National Use Expansion on Rice'' (hereafter, the ``Benzobicyclon Human
Health Risk Assessment'').
[[Page 60370]]
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
benzobicyclon and metabolite B used for human health risk assessment,
please reference section 4.6.3 on pages 25-27 of the ``Benzobicyclon
Human Health Risk Assessment''.
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the tolerance increase
on rice grain and national use expansion.
No effects attributable to a single dose were observed for
benzobicyclon or metabolite B; therefore, acute dietary exposure
assessments were not conducted.
Based on the toxicological effects of benzobicyclon and metabolite
B, separate chronic dietary exposure and risk assessments were
conducted. The assessments were conducted using Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID) Version 3.16, which uses food consumption data from the
U.S. Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008.
The benzobicyclon chronic dietary exposure assessment assumed
tolerance-level residues for rice, 100 percent crop treated (PCT), and
a modeled estimated drinking water concentration (EDWC) of 0.199 parts
per billion (ppb). The DEEM default processing factor of 1.25 was used
for both rice flour and rice bran.
There is no anticipated exposure in food to metabolite B. As
metabolite B is only a residue of concern in drinking water, the
chronic dietary exposure assessment was conducted for drinking water
only. The chronic analysis used a modeled EDWC of 4.27 ppb and assumed
100 PCT.
There are no residential (non-occupational) exposures associated
with benzobicyclon or metabolite B.
Cumulative exposure. The Agency is required to consider the
cumulative risks of chemicals sharing a common mechanism of toxicity.
The Agency has determined that the (p-hydroxyphenyl-pyruvate
dioxygenase) HPPD inhibitors share a common mechanism of toxicity as
discussed in the document titled ``HPPD Inhibiting Herbicides: State of
the Science,'' which is available in the docket for this action. As
explained in that document, the members of this group of chemicals
share the ability to bind to and inhibit the HPPD enzyme resulting in
elevated systemic tyrosine levels and common apical outcomes that are
mediated by tyrosine, including ocular and developmental effects. In
2021, after establishing a common mechanism grouping for the HPPD
inhibitors, the Agency conducted the ``P-Hydroxyphenyl-Pyruvate
Dioxygenase (HPPD) Inhibitors Cumulative Risk Assessment:
Benzobicyclon, Bicyclopyrone, Isoxaflutole, Mesotrione, Pyrasulfotole,
Tembotrione, Tolpyralate, and Topramezone,'' which is available in the
docket for the action, and concluded that cumulative exposures to HPPD
inhibitors (based on proposed and registered pesticidal uses at the
time the assessment was conducted) did not present risks of concern.
Safety Factor (SF) for Infants and Children. The Food Quality
Protection Act (FQPA) section has been updated since the last
assessment. EPA has determined that the required FQPA SF of 10X for the
protection of infants and children be reduced to 1X for all exposure
scenarios for benzobicyclon (parent). For metabolite B, since the
chronic dietary endpoint is based on a study with no No-Observed-
Adverse-Effect Level (NOAEL), a 10X FQPA SF/Uncertainty Factor
(UFL) has been retained for extrapolation from a Lowest-
Observed-Adverse-Effect Level (LOAEL) to a NOAEL.
Completeness of the Toxicology Database: The existing toxicological
database for benzobicyclon is adequate for FQPA evaluation.
Developmental and two-generation reproduction studies in rats are
available for benzobicyclon. However, the active moiety of
benzobicyclon, metabolite B, has been shown to be more toxic than the
parent compound. Therefore, studies were conducted with metabolite B,
including a developmental toxicity study in mice. Additionally, 2-
generation reproduction toxicity studies are available from other HPPD
inhibitors for bridging.
Evidence of Neurotoxicity: There was no neurotoxicity observed
throughout the database for benzobicyclon or metabolite B. The
subchronic neurotoxicity study with benzobicyclon tested up to 1,290
mg/kg with no adverse effects observed, nor was there evidence of
neurotoxicity in any of the guideline studies in the databases for
either chemical.
Evidence of Sensitivity/Susceptibility in the Developing or Young
Animal: For benzobicyclon, there was no increased qualitative or
quantitative susceptibility observed in the two-generation reproduction
or developmental toxicity studies in rats. A developmental study in
rabbits was submitted but was considered unacceptable and subsequently
waived by EPA.
For metabolite B, a developmental toxicity study in mice did not
show any increased qualitative or quantitative susceptibility. A 2-
generation reproduction study is not available for metabolite B;
however, there are 2-generation reproduction studies from other HPPDs
inhibitors that can be used for bridging. In one of the 2-generation
studies in mice for another HPPD inhibitor (mesotrione), quantitative
susceptibility was observed in offspring. However, concern is low
because there are clear NOAEL/LOAEL values for the observed effects,
the offspring LOAEL of 300 mg/kg/day from the mesotrione 2-generation
reproduction toxicity study was set conservatively based on a low
incidence of opaque/cloudy eyes, and the selected endpoints used in
this risk assessment are protective of any potential sensitivity
observed in mice.
Residual Uncertainty in the Exposure Database: The exposure
databases are complete or are estimated based on data that reasonably
account for potential exposures. There are no registered or proposed
residential uses and/or commercial uses at residential sites for
benzobicyclon at this time. Therefore, a residential exposure
assessment is not required. The dietary exposure assessments (food and
drinking water) are considered to be conservative estimates of
exposure. Tolerance-level residues for rice and 100 PCT were assumed
for the food exposure assessment. Drinking water exposure estimates
(for both benzobicyclon and metabolite B) are based on conservative
models assuming maximum use rates and are not expected to underestimate
the exposure. The Agency is confident that the assessments do not
underestimate risk from dietary exposure to benzobicyclon or metabolite
B.
Aggregate risks and Determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population-adjusted dose
(aPAD) and the chronic population-adjusted dose (cPAD). Short-,
intermediate-, and chronic term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure.
There are no acute dietary endpoints for benzobicyclon or
metabolite B; therefore, an acute risk assessment is
[[Page 60371]]
unnecessary. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD for both benzobicyclon and metabolite B. It
is less than 1% of the cPAD for benzobicyclon for all population
subgroups and 5.8% of the cPAD for metabolite B for all infants less
than 1-year old, the population subgroup with the highest exposure
estimate for both benzobicyclon and metabolite B.
As noted earlier, there are no residential uses associated with
benzobicyclon. Because there is no short- or intermediate-term
residential exposure and chronic dietary exposure has been assessed
under the appropriately protective cPAD, EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for benzobicyclon and metabolite B.
Based on the lack of evidence of carcinogenicity in two adequate
rodent carcinogenicity studies, benzobicyclon is not expected to pose a
cancer risk to humans. For metabolite B, potential carcinogenicity is
not a concern for the HPPD inhibitors and the chronic dietary endpoint
and POD for metabolite B is considered protective of any potential
carcinogenicity.
Therefore, based on the risk assessments and information described
above, EPA concludes there is reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to benzobicyclon or metabolite B residues. More
detailed information can be found at http://www.regulations.gov in the
Benzobicyclon Human Health Risk Assessment in docket ID number EPA-HQ-
OPP-2020-0391.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the April 25, 2017 rulemaking (82 FR 18995) (FRL-
9961-02).
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 has not established an MRL for residues of benzobicyclon
in or on rice grain.
V. Conclusion
Therefore, the tolerance for residues of benzobicyclon on rice,
grain is increased from 0.01 ppm to 0.15 ppm and is no longer a
tolerance with regional restrictions.
VI. Statutory and Executive Order Reviews
This action increases 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 to 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: October 27, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 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. Revise Sec. 180.693 to read as follows:
Sec. 180.693 Benzobicyclon; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide benzobicyclon, including its metabolites and degradates, in
or on the commodity in the table below. Compliance with the tolerance
level specified below is to be determined by measuring only
benzobicyclon, 3-[2-chloro-4-(methylsulfonyl)benzoyl]-4-
(phenylthio)bicyclo-[3.2.1]oct-3-en-2-one), in or on the following raw
agricultural commodity:
[[Page 60372]]
Table 1 to Sec. 180.693(a)
------------------------------------------------------------------------
Parts per
Commodity million
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Rice, grain............................................. 0.15
------------------------------------------------------------------------
(b)-(d) [Reserved]
[FR Doc. 2021-23836 Filed 11-1-21; 8:45 am]
BILLING CODE 6560-50-P