[Federal Register Volume 78, Number 13 (Friday, January 18, 2013)]
[Notices]
[Pages 4153-4154]
[FR Doc No: 2013-01031]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0032]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling; Notification Procedures for Statements
on Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the PRA),
Federal Agencies are required to publish notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
invites comments on the information collection provisions of the
regulation requiring manufacturers, packers, and distributors of
dietary supplements to notify us that they are marketing a dietary
supplement product that bears on its label or in its labeling a
statement provided for in the Federal Food, Drug, and Cosmetic Act (the
FD&C Act).

DATES: Submit either electronic or written comments on the collection
of information by March 19, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility;

(2) the accuracy of our estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) ways to minimize
the burden of the collection of information on respondents, including
through the use of automated collection techniques, when appropriate,
and other forms of information technology.

Food Labeling; Notification Procedures for Statements on Dietary
Supplements--21 CFR 101.93 (OMB Control Number 0910-0331--Extension)

    Section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) requires
that FDA be notified by manufacturers, packers, and distributors of
dietary supplements that they are marketing a dietary supplement
product that bears on its label or in its labeling a statement provided
for in section 403(r)(6) of the FD&C Act. Section 403(r)(6) of the FD&C
Act requires that FDA be notified, with a submission about such
statements, no later than 30 days after the first marketing of the
dietary supplement. Information that is required in the submission
includes: (1) The name and address of the manufacturer, packer, or
distributor of the dietary supplement product; (2) the text of the
statement that is being made; (3) the name of the dietary ingredient or
supplement that is the subject of the statement; (4) the name of the
dietary supplement (including the brand name); and (5) a signature of a
responsible individual who can certify the accuracy of the information
presented, and who must certify that the information contained in the
notice is complete and accurate, and that the notifying firm has
substantiation that the statement is truthful and not misleading.
    The procedural regulation for this program is codified at Sec.
101.93 (21 CFR 101.93). Section 101.93 provides submission procedures
and identifies the information that must be included in order to meet
the requirements of section 403 of the FD&C Act.
    Description of Respondents: Respondents to this collection of
information include manufacturers, packers, or distributors of dietary
supplements that bear section 403(r)(6) of the FD&C Act statements on
their labels or labeling.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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101.93.............................................................           2,200                1            2,200             0.75            1,650
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We believe that there will be minimal burden on the industry to
generate information to meet the requirements of section 403 of the
FD&C Act in submitting information regarding section 403(r)(6) of the
FD&C Act statements on labels or in labeling of dietary supplements. We
are requesting only information that is immediately available to the
manufacturer, packer, or distributor of the dietary supplement that
bears such a statement on its label or in its labeling. We estimate
that, each year, approximately 2,200 firms will submit the information
required by section 403 of the FD&C Act. We estimate that a firm will
require 0.75 hours to gather the information needed and prepare a
submission, for a total of 1,650 hours (2,200 x 0.75). This estimate is
based on the average number of notification submissions received by us
in the preceding 3 years.

    Dated: January 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01031 Filed 1-17-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Pages 16680-16681]
[FR Doc No: 2013-06165]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1044]

Shu Bei Yuan: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Shu Bei Yuan for a period of 5 years from importing articles of food or
offering such articles for importation into the United States. FDA
bases this order on a finding that Ms. Yuan was convicted of one felony
count under Federal law for conduct relating to the importation into
the United States of an article of food. Ms. Yuan was given notice of
the proposed debarment and an opportunity to request a hearing within
the timeframe prescribed by regulation. As of December 31, 2012 (30
days after receipt of the notice), Ms. Yuan had not responded. Ms.
Yuan's failure to respond constitutes a waiver of her right to a
hearing concerning this action.

DATES: This order is effective March 18, 2013.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a felony for conduct relating to the
importation into the United States of any food.
    On June 22, 2012, Ms. Yuan was convicted, as defined in section
306(l)(1)(B) of the FD&C Act, when the U.S. District Court for the
Northern District of Illinois accepted her plea of guilty and entered
judgment against her for the following offense: One count of entry of
goods into the United States by means of false statements, in violation
of 18 U.S.C. 542.
    FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein for conduct relating to the importation
into the United States of any food. The factual basis for this
conviction is as follows: In or around March 2005 and continuing until
in or around November 2005, Ms. Yuan conducted a scheme to fraudulently
enter goods into the United States by means of false statements and
documents in violation of 18 U.S.C. 542. The purpose of Ms. Yuan's
scheme was to import, enter, and sell Chinese-origin honey into the
United States and avoid the payment of antidumping duties by falsely
declaring to the U.S. Department of Homeland Security, Bureau of
Customs and Border Protection (CBP) that the imported honey originated
from countries other than China, including South Korea, when in fact
Ms. Yuan knew that the honey originated from China.
    Between August and November 2005, Ms. Yuan and others caused the
fraudulent import and entry into the United States of approximately 26
entries of Chinese origin honey falsely declared as Korean honey,
having a total declared entry value of approximately $808,287, thereby
avoiding antidumping duties totaling approximately $1,485,631.
    As a result of her conviction, on November 30, 2012, FDA sent Ms.
Yuan a notice by certified mail proposing to debar her for a period of
5 years from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Ms. Yuan was convicted
of a felony under Federal law for conduct relating to the importation
into the United States of an article of food because she committed an
offense related to the importation of Chinese honey into the United
States by means of false statements.
    The proposal was also based on a determination, after consideration
of the factors set forth in section 306(c)(3) of the FD&C Act, that Ms.
Yuan should be subject to a 5-year period of debarment. The proposal
also offered Ms. Yuan an opportunity to request a hearing, providing
her 30 days from the date of receipt of the letter in which to file the
request, and advised her that failure to request a hearing constituted
a waiver of the opportunity for a hearing and of any contentions
concerning this action. Ms. Yuan failed to respond within the timeframe
prescribed by regulation and has, therefore, waived her opportunity for
a hearing and waived any contentions concerning her debarment (21 CFR
part 12).

II. Findings and Order

    Therefore, the Associate Commissioner for Regulatory Affairs,
Office of Regulatory Affairs, under section 306(b)(1)(C) of the FD&C
Act, and under authority delegated to the Associate Commissioner (Staff
Manual Guide 1410.21), finds that Ms. Shu Bei Yuan has been convicted
of a felony under Federal law for conduct relating to the importation
of an article of food into the United States and that she is subject to
a 5-year period of debarment.
    As a result of the foregoing finding, Ms. Yuan is debarred for a
period of 5 years from importing articles of food or offering such
articles for import into the United States, effective (see DATES).
Under section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Ms. Yuan is
a prohibited act.
    Any application by Ms. Yuan for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2012-N-1044 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).

    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 28, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of
Regulatory Affairs.
[FR Doc. 2013-06165 Filed 3-15-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 93 (Monday, May 17, 2021)]
[Rules and Regulations]
[Pages 26672-26677]
[FR Doc No: 2021-10286]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0762; FRL-10019-62]

Trifludimoxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
trifludimoxazin in or on multiple commodities which are identified and
discussed later in this document. BASF corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 17, 2021. Objections and
requests for hearings must be received on or before July 16, 2021 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-2018-0762, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    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, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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-2018-0762 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
July 16, 2021. 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-2018-0762, 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 April 19, 2019 (84 FR 16430) (FRL-9991-
14), 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
8F8709) by BASF corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the herbicide
trifludimoxazin, in or on almond, hulls at 0.15 parts per million
(ppm); fruit, citrus, group 10-10 at 0.01 ppm; fruit, pome, group 11-10
at 0.01 ppm; grain, cereal, forage, fodder and straw, group 16 (except
rice) at 0.01 ppm; grain, cereal, group 15 at 0.01 ppm; nut, tree,
group 14-12 at 0.01 ppm; peanut at 0.01 ppm; peanut, hay at 0.01 ppm;
vegetable, foliage of legume, group 07 at 0.01 ppm; vegetable, legume,
group 06 at 0.01 ppm. That document referenced a summary of the
petition prepared by BASF Corporation, the registrant, which is
available in the docket, http://www.regulations.gov. One comment was
received on the notice of filing. EPA's response to this comment is
discussed in Unit IV.C.

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 trifludimoxazin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with trifludimoxazin
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The available database of guideline studies for trifludimoxazin
indicates that the primary target organs are the thyroid and liver.
Trifludimoxazin is a protoporphyrinogen oxidase (PPO)-inhibitor. PPO is
a key enzyme in chlorophyll and cytochrome pigments, as well as in
heme. Although hematological effects associated with this class were
observed, they are not considered adverse at the selected lowest-
observable adverse-effects levels (LOAELs). Effects on the thyroid
occurred in rats and consisted primarily of follicular cell
hypertrophy/hyperplasia and altered colloid of the thyroid after
subchronic and chronic exposure durations. Increased relative thyroid
weights were also observed in male rats; however, thyroid hormones were
not adversely affected after subchronic exposure for males and females.
Liver effects (increased alanine aminotransferase (ALT) and alkaline
phosphatase (ALP), organ weight, and histopathology) were also observed
at the same dose as thyroid effects in male rats after subchronic
exposure. In mice, increased liver weight, increased [gamma]-glutamyl
transferase (GGT), and hypertrophy were observed after subchronic
exposures. Increased liver

weight, foci of (eosinophilic) cellular alteration, centrilobular
hypertrophy, macrovesicular fatty change and centrilobular pigment
storage was observed in male mice and oval cell hyperplasia and
(multi)focal necrosis was observed in female mice after chronic
exposure. After chronic exposure to the rat, increased pigment,
multinucleated hepatocytes, and bile duct hyperplasia in the liver was
observed at the same dose as thyroid effects. Effects on the
reproductive system were observed as evidence of increased abnormal
sperm in male rats in the extended one generation reproductive toxicity
study (EOGRTS), and as effects to the epididymis in rats after
subchronic and chronic exposure.
    Trifludimoxazin did not demonstrate neurotoxic potential in either
acute or subchronic neurotoxicity studies in rats. Observations
suggestive of neurotoxicity were seen in the 90-day subchronic study in
dogs (e.g., functional observational battery (FOB) deficits,
histopathological findings in the spinal cord and medulla oblongata
(degeneration of fasciculus gracilis and white matter)), but no
neurotoxicity effects were seen in either the 28-day dog study, which
tested lower doses, or the chronic dog study, which tested higher doses
relative to the 90-day study.
    There were no adverse maternal or developmental effects observed in
the rat developmental toxicity study at the limit dose. However, in the
rabbit developmental study, decreased fetal body weight was observed at
a lower dose than maternal toxicity (increased incidence of late
abortions); thus, increased quantitative susceptibility was observed.
The Extended One-Generation Reproductive Toxicity Study (EOGRTS) in
rats demonstrated no increase in susceptibility as no effects were
observed in the offspring while increased incidence and severity of
follicular cell hypertrophy/hyperplasia and altered colloid in the
thyroid was observed in the parental animals.
    Immunotoxicity was not observed throughout the toxicity database.
Additionally, there were no effects in the dermal toxicity study,
including any effects to the thyroid.
    The Agency has classified trifludimoxazin as ``suggestive evidence
of carcinogenic potential'' based on thyroid tumors, driven by
adenomas, observed in male rats at 750 ppm (33 mg/kg/day); an absence
of treatment-related tumors in female rats and in male and female mice,
and a lack of concern for mutagenicity. The Agency has concluded that
quantification of cancer risk using a non-linear approach (i.e.,
reference dose (RfD)) will adequately account for all chronic toxicity,
including potential carcinogenicity, that could result from exposure to
trifludimoxazin. The chronic reference dose (0.11 mg/kg/day) is several
times lower than the level at which tumors were observed.
    Specific information on the studies received and the nature of the
adverse effects caused by trifludimoxazin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in pages 13-19 of document Trifludimoxazin: New
Active Ingredient Human Health Risk Assessment for Registrations on
Legume Vegetable Group 6, Foliage of Legume Vegetable Group 7, Citrus
Fruit Group 10-10, Pome Fruit Group 11-10, Tree Nut Group 14-12, Cereal
Grain Group 15 (except rice), Forage Fodder and Straw of Cereal Grain
Group 16 (except rice), Peanut and Peanut Hay (hereinafter
``Trifludimoxazin Human Health Risk Assessment'') in docket ID number
EPA-HQ-OPP-2018-0762.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for trifludimoxazin used
for human risk assessment can be found in the Trifludimoxazin Human
Health Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to trifludimoxazin, EPA considered exposure under the
petitioned-for trifludimoxazin tolerances in 40 CFR part 180. EPA
assessed dietary exposures from trifludimoxazin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for trifludimoxazin; therefore,
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the 2003-2008 food consumption data from the United
States Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, EPA conducted an unrefined chronic
dietary exposure assessment using tolerance-level residues, 100 percent
crop treated (PCT), and default processing factors.
    iii. Cancer. Based on the Agency's analysis of the available data,
EPA has concluded that a nonlinear RfD approach is appropriate for
assessing cancer risk to trifludimoxazin. Quantification of cancer risk
using a non-linear RfD approach will adequately account for all chronic
toxicity, including carcinogenicity that could result from exposure to
trifludimoxazin; therefore, a separate cancer dietary assessment was
not conducted.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for trifludimoxazin. Tolerance level residues and/or 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for trifludimoxazin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of trifludimoxazin. Further information
regarding EPA drinking water models

used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Using the Pesticides in Water Calculator (PWC), Pesticide Root Zone
Model and the Varying Volume Water Model (PRZM/VVWM), EPA calculated
the estimated drinking water concentrations (EDWCs) of trifludimoxazin
for acute and chronic exposures in surface and ground water. EPA used
the modeled EDWCs directly in dietary exposure model to account for the
contribution of trifludimoxazin residues in drinking water as follows:
5.0 ppb was used in acute dietary assessment and 3.6 ppb was used in
chronic dietary risk assessment.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Trifludimoxazin is not registered for any specific use patterns
that would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    The Agency has not found trifludimoxazin to share a common
mechanism of toxicity with any other substances, and trifludimoxazin
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that trifludimoxazin does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was evidence of
quantitative pre-natal susceptibility in the rabbit developmental
toxicity study. However, the degree of concern is low because clear
NOAELs were identified for the effects, and the selected endpoints and
doses are protective of the observed developmental effects and observed
susceptibility.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for trifludimoxazin is complete.
    ii. Although there was evidence for neurotoxicity in the 90-day
subchronic dog study, the degree of concern for the toxicity is low
because this study is used as the basis for the risk assessment PODs
and is protective of any potential neurotoxicity.
    iii. Clear NOAELs were identified for the developmental/offspring
effects observed in the rat and rabbit prenatal developmental studies,
and endpoints selected for risk assessment are protective of these
effects and the quantitative susceptibility observed in the rabbit
developmental study and rat EOGRTS.
    iv. There is no concern due to any residual uncertainties in the
exposure database. No data gaps were identified, and exposure estimates
are based upon conservative default assumptions. Tolerance-level
residues and 100PCT are used in dietary exposure assessments, and
residential exposures are not anticipated from the proposed use
pattern. As such, residual uncertainty is negligible and does not
impact considerations for the FQPA Safety Factor. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to trifludimoxazin in drinking water. These
assessments will not underestimate the exposure and risks posed by
trifludimoxazin.

E. 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
trifludimoxazin is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that the chronic risk
estimates of food and drinking water for trifludimoxazin are below the
Agency's LOC at <1% of the cPAD for the United States population and
all population subgroups. There are no residential uses for
trifludimoxazin.
    3. Short-term risk and Intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    A short-term and intermediate-term adverse effect was identified;
however, trifludimoxazin is not registered for any use patterns that
would result in short-term or intermediate-term residential exposure.
Short-term and intermediate-term risk is assessed based on short-term
or intermediate-term residential exposure plus chronic dietary
exposure. Because there is no short-term or intermediate-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term and
intermediate-term risk for trifludimoxazin.
    4. Aggregate cancer risk for U.S. population. As indicated above,
the Agency has determined that the non-cancer chronic dietary
assessment would account for any dietary cancer

risks. Based on the level of chronic risk being below the Agency's
level of concern, EPA concludes aggregate exposure to trifludimoxazin
will not pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to trifludimoxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High-Performance Liquid
Chromatography with tandem Mass Spectroscopy (HPLC-MS/MS) method
(Method D147/02 in plant matrices)) is available to enforce the
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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.
    Trifludimoxazin is a new active ingredient, and no maximum residue
limits (MRLs) have yet been established by Codex.

C. Response to Comments

    One commenter expressed concern about the release of pesticide
chemicals to the environment. The FFDCA does not authorize EPA to
consider risks to the environment, per se; rather, 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
tolerances are safe. Taking into consideration the factors required in
the FFDCA, EPA has made that safety determination for the tolerances
subject to this action; the commenter provided no information relevant
to that conclusion.

D. Revisions to Petitioned-For Tolerances

    Based upon review of submitted data, the Agency is establishing
tolerances that vary from what the petitioner requested. The petitioner
had requested to establish tolerance on the entire cereal crop groups
15 and 16; however, the Agency has determined that the petitioned
tolerance for cereal crop groups 15 and 16 must be revised to exclude
rice commodities. While there are no data gaps for human health, the
Agency has insufficient environmental fate data to support a tolerance
on rice; therefore, the request to allow use on rice on the
trifludimoxazin label will not be granted at this time. Because the
product will not be used on rice, tolerances are not needed for
residues in or on rice. Consequently, EPA is excluding rice from the
tolerances being set on cereal crop groups 15 and 16.

V. Conclusion

    Therefore, tolerances are established for residues of
trifludimoxazin in or on almond, hulls; fruit, citrus, group 10-10;
fruit, pome, group 11-10; grain, cereal, forage, fodder and straw,
group 16 (except rice); grain, cereal, group 15 (except rice); nut,
tree, group 14-12; peanut; peanut, hay; vegetable, foliage of legume,
group 07 and vegetable, legume, group 06.

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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (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 tolerances 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: May 5, 2021.
Edward Messina,
Acting Director, 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. Add Sec.  180.717 to subpart C to read as follows:

Sec.  180.717  Trifludimoxazin; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide trifludimoxazin, including its metabolites and degradates, in
or on the commodities to Table 1 of this section. Compliance with the
tolerance levels specified in Table 1 is to be determined by measuring
only trifludimoxazin, dihydro-1,5-dimethyl-6-thioxo-3-[2,2,7-trifluoro-
3,4-dihydro-3-oxo-4-(2-propyn-1-yl)-2H-1,4-benzoxazin-6-yl]-1,3,5-
triazine-2,4(1H,3H)-dione, in or on the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls................................................       0.15
Fruit, citrus, group 10-10...................................       0.01
Fruit, pome, group 11-10.....................................       0.01
Grain, cereal, forage, fodder, and straw, Group 16, except          0.01
 rice........................................................
Grain, cereal, group 15, except rice.........................       0.01
Nut, tree, group 14-12.......................................       0.01
Peanut.......................................................       0.01
Peanut, hay..................................................       0.01
Vegetable, legume, group 6...................................       0.01
Vegetable, foliage of legume, group 7........................       0.01
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2021-10286 Filed 5-14-21; 8:45 am]
BILLING CODE 6560-50-P