Benzobicyclon; Pesticide Tolerances, 60368-60372 [2021-23836]
Download as PDF
<![CDATA[
60368
Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Rules and Regulations
text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
178 (see also Unit I.C. of the
Good Cause for No Notice and
Comment
SUPPLEMENTARY INFORMATION).
Issued in College Park, Georgia, on October
26, 2021.
Andreese C. Davis,
Manager, Airspace & Procedures Team South,
Eastern Service Center, Air Traffic
Organization.
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2020–0391, 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.
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 https://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: RDFRNotices@
epa.gov.
[FR Doc. 2021–23789 Filed 11–1–21; 8:45 am]
SUPPLEMENTARY INFORMATION:
Section 553(b) (3) (B) of Title 5,
United States Code, (the Administrative
Procedure Act) authorizes agencies to
dispense with notice and comment
procedures for rules when the agency
for ‘‘good cause’’ finds that those
procedures are ‘‘impracticable,
unnecessary, or contrary to the public
interest.’’ Under this section, an agency,
upon finding good cause, may issue a
final rule without seeking comment
prior to the rulemaking. The FAA finds
that prior notice and public comment to
this final rule is unnecessary due to the
brief length of the extension of the
effective date and the fact that there is
no substantive change to the rule.
Delay of Effective Date
Accordingly, pursuant to the
authority delegated to me, the effective
date of the final rule, Airspace Docket
21–ASO–3, as published in the Federal
Register on September 8, 2021 (86 FR
50245), FR Doc. 2021–19268, is hereby
delayed until March 24, 2022.
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
BILLING CODE 4910–13–P
ADDRESSES:
I. General Information
A. Does this action apply to me?
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0391; FRL–8991–01–
OCSPP]
Benzobicyclon; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
jspears on DSK121TN23PROD with RULES1
SUMMARY:
VerDate Sep<11>2014
15:50 Nov 01, 2021
Jkt 256001
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 eCFR site at https://www.ecfr.gov/cgi-bin/
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
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: 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/where-sendcomments-epa-dockets.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
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
E:\FR\FM\02NOR1.SGM
02NOR1
Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Rules and Regulations
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, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
jspears on DSK121TN23PROD with RULES1
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.
VerDate Sep<11>2014
15:50 Nov 01, 2021
Jkt 256001
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 propesticide, 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 4hydroxyphenylpyruvate 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 HPPDinhibiting 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 HPPDinhibiting 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-
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
60369
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 treatmentrelated 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’’).
E:\FR\FM\02NOR1.SGM
02NOR1
jspears on DSK121TN23PROD with RULES1
60370
Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Rules and Regulations
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 tolerancelevel 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 (nonoccupational) 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-hydroxyphenylpyruvate 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
VerDate Sep<11>2014
15:50 Nov 01, 2021
Jkt 256001
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-AdverseEffect 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, 2generation 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
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
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 2generation 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 2generation 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
E:\FR\FM\02NOR1.SGM
02NOR1
Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Rules and Regulations
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 1year 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 https://
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).
jspears on DSK121TN23PROD with RULES1
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.
VerDate Sep<11>2014
15:50 Nov 01, 2021
Jkt 256001
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,
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
60371
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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
■
2. Revise § 180.693 to read as follows:
§ 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-2one), in or on the following raw
agricultural commodity:
E:\FR\FM\02NOR1.SGM
02NOR1
60372
Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Rules and Regulations
TABLE 1 TO § 180.693(a)
Commodity
Parts per
million
Rice, grain ............................
0.15
(b)–(d) [Reserved]
[FR Doc. 2021–23836 Filed 11–1–21; 8:45 am]
BILLING CODE 6560–50–P
GENERAL SERVICES
ADMINISTRATION
48 CFR Part 532
[GSAR Case 2020–G521; Docket No. GSA–
GSAR–2021–0023; Sequence No. 1]
RIN 3090–AK35
General Services Administration
Acquisition Regulation; Remove OGC
Review for Final Payments
Office of Acquisition Policy,
General Services Administration (GSA).
ACTION: Final rule.
AGENCY:
The General Services
Administration (GSA) is issuing a final
rule amending the General Services
Administration Acquisition Regulation
(GSAR) to revise internal agency
approval procedures for processing a
final payment for construction and
building service contracts where, after
60 days, a contracting officer is unable
to obtain a release of claims from a
contractor.
SUMMARY:
Effective: December 2, 2021.
FOR FURTHER INFORMATION CONTACT: Mr.
Tyler Piper or Mr. Stephen Carroll, GSA
Acquisition Policy Division, at
GSARPolicy@gsa.gov or 817–253–7858,
for clarification of content. For
information pertaining to status or
publication schedules, contact the
Regulatory Secretariat at 202–501–4755.
Please cite GSAR Case 2020–G521.
SUPPLEMENTARY INFORMATION:
DATES:
jspears on DSK121TN23PROD with RULES1
I. Background
GSA published a proposed rule in the
Federal Register at 86 FR 20359 on
April 19th, 2021, to amend the General
Services Administration Regulations
(GSAR) to modify GSAR 532.905–70 so
it no longer requires contracting officers
to obtain approval of legal counsel
before processing final payments for
construction and building service
contracts where, after 60 days, the
contracting officer is unable to obtain a
release of claims from the contractors.
Legal review is not a statutory
requirement, and the decision to process
final payments in such cases is a
VerDate Sep<11>2014
15:50 Nov 01, 2021
Jkt 256001
business decision, rather than a legal
one.
Regulatory Planning and Review, dated
September 30, 1993.
II. Authority for This Rulemaking
Title 40 of the United States Code
(U.S.C.) Section 121 authorizes GSA to
issue regulations, including the GSAR,
to control the relationship between GSA
and contractors.
V. Congressional Review Act
III. Discussion and Analysis
The proposed rule received one
comment. The General Services
Administration has reviewed the
comment in the development of the
final rule. A discussion of the comment
and the changes made to the rule as a
result of the comment is provided as
follows:
A. Summary of Significant Changes
No changes were made between the
proposed rule and this final rule.
B. Comments
1. Changes to Oversight
Comment: The respondent expressed
concern that removing the Office of
General Council (OGC’s) oversight over
contract closing could potentially invite
fraud.
Response: The purpose of OGC review
is to provide legal advice and guidance
to agency personnel, based on
applicable laws, regulations, and
policies, consistent with the best
interests of the United States. It is not
designed as a specific safeguard from
fraud. GSA has determined that removal
of this particular OGC review will
streamline operations without opening a
new area of risk of non-compliance with
laws, regulations, or policies.
From a fraud mitigation standpoint,
the need for separate approval still
exists, but it is more appropriately
nested within the business operations,
not legal counsel.
IV. Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and
13563 direct agencies to assess all costs
and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This rule has been reviewed
and determined by Office of
Management and Budget (OMB) not to
be a significant regulatory action and,
therefore, was not subject to review
under section 6(b) of E.O. 12866,
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
The Congressional Review Act, 5
U.S.C. 801 et seq., as amended by the
Small Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a ‘‘major 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. A major rule cannot take effect
until 60 days after it is published in the
Federal Register. This rule has been
reviewed and determined by OMB not
to be a ‘‘major rule’’ under 5 U.S.C.
804(2).
VI. Regulatory Flexibility Act
The General Services Administration
certifies that this final rule will not have
a significant economic impact on a
substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq.
VIII. Paperwork Reduction Act
The final rule does not contain any
information collection requirements that
require the approval of the Office of
Management and Budget under the
Paperwork Reduction Act (44 U.S.C.
chapter 35).
List of Subjects in 48 CFR Part(s) 532
Government procurement.
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide
Policy, General Services Administration.
Therefore, GSA amends 48 CFR part
532 as set forth below:
PART 532—CONTRACT FINANCING
1. The authority citation for 48 CFR
part 532 continues to read as follows:
■
Authority: 40 U.S.C. 121(c).
2. Amend section 532.905–70 by—
a. Removing from paragraph (a) the
phrase ‘‘amount due the Contractor’’
and adding the phrase ‘‘amount due to
the contractor’’ in its place;
■ b. Revising paragraph (b); and
■ c. Removing paragraphs (c) and (d).
The revision reads as follows:
■
■
532.905–70 Final payment—construction
and building service contracts.
*
*
*
*
*
(b) A contracting officer may only
process the final payment for a
construction or building service contract
once:
E:\FR\FM\02NOR1.SGM
02NOR1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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.
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 https://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 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-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: 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/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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, https://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 https://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
------------------------------------------------------------------------
Rice, grain............................................. 0.15
------------------------------------------------------------------------
(b)-(d) [Reserved]
[FR Doc. 2021-23836 Filed 11-1-21; 8:45 am]
BILLING CODE 6560-50-P
