Tiafenacil; Pesticide Tolerances, 55380-55385 [2020-19673]
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[FR Doc. 2020–17572 Filed 9–4–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
Tiafenacil; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of tiafenacil in or
on multiple commodities which are
identified and discussed later in this
document. ISK Biosciences Corporation
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
September 8, 2020. Objections and
requests for hearings must be received
on or before November 9, 2020, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0413, 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 concerns related to
COVID–19, the EPA Docket Center
(EPA/DC) and Reading Room is closed
to visitors with limited exceptions. The
staff continues to provide remote
customer service via email, phone, and
webform. For the latest status
information on EPA/DC services and
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
DATES:
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Washington, DC 20460–0001; main
telephone number: (703) 305–7090;
email address: RDFRNotices@epa.gov.
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 eCFR site at https://www.ecfr.gov/cgi-bin/
text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
OCSPP test guidelines referenced in this
document electronically, please go to
https://www.epa.gov/test-guidelinespesticides-and-toxic-substances.
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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–2019–0413 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 November 9, 2020. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
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pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2019–0413, 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 August 30,
2019 (84 FR 45702) (FRL–9998–15),
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 8F8676) by ISK
Biosciences Corporation, 7470 Auburn
Road, Suite A., Concord, OH 44077. The
petition requested that 40 CFR part 180
be amended by establishing tolerances
for residues of the herbicide tiafenacil,
methyl N-[2-[[2-chloro-5-[3,6-dihydro-3methyl-2,6-dioxo-4-(trifluoromethyl)1(2H)-pyrimidinyl]-4fluorophenyl]thio]-1-oxopropyl]-balaninate, including its metabolites and
degradates, in or on corn, which
includes field corn and popcorn, at 0.01
parts per million (ppm); cottonseed
subgroup 20C, gin byproducts at 3.0
ppm; cottonseed subgroup 20C,
undelinted seed at 0.5 ppm; grape at
0.01 ppm; grape, raisin at 0.01 ppm;
soybean seed at 0.01 ppm; and wheat
grain at 0.01 ppm. That document
referenced a summary of the petition
prepared by ISK Biosciences
Corporation, the registrant, which is
available in the docket, https://www.
regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the data
supporting the petition, EPA has revised
the tolerance expressions, revised
tolerance values and definitions for
some commodities, and established
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tolerances on livestock feed
commodities. The reasons for these
changes are explained 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 tiafenacil
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with tiafenacil 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 data indicate that
exposure to tiafenacil caused consistent
decreases in absolute body weights,
alterations in the erythropoietic system,
minor clinical chemical changes, and
histopathological changes in the liver,
bone marrow and the spleen of mice,
rats and dogs. There was no evidence of
carcinogenicity, genotoxicity,
mutagenicity, dermal toxicity,
neurotoxicity, or immunotoxicity.
There was evidence of an increased
fetal quantitative susceptibility in rats
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but not rabbits. In rats, no maternal
effects were observed up to the highest
dose tested, while there was a decrease
in fetal weights at the high dose. The
decrease in fetal body weights is not
considered a single dose effect. No
adverse effects were observed in rabbits
in maternal or fetal animals. There was
no evidence of increased postnatal
susceptibility in the 2-generation
reproductive study up to the highest
dose tested. Increased levels of
porphyrin were observed in the liver at
the highest doses tested in parents and
offspring. While not adverse, this effect
is consistent with the hematotoxicity
observed throughout the database at
higher doses. At the highest dose in the
1-generation reproductive study,
parental effects included pale skin,
decreased body weight and food
consumption, low hemoglobin
concentrations, hematocrit, mean
corpuscular volume, and mean
corpuscular hemoglobin and platelet
count. F1 offspring were not generated
based upon the effects in adults as it
was predicted that similar effects and
increased mortality would occur.
Tiafenacil has low acute lethality
through oral, dermal, and inhalation
routes. It is not an ocular or dermal
irritant, nor is it a dermal sensitizer.
Specific information on the studies
received and the nature of the adverse
effects caused by tiafenacil as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document,
‘‘Tiafenacil. Human Health Risk
Assessment for the Section 3
Registration Action of the New Active
Ingredient on Grapes, Corn, Cotton,
Soybeans, and Wheat’’. First Food Use.
in docket ID number EPA–HQ–OPP–
2019–0413.
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
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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 https://www.epa.
gov/pesticide-science-and-assessingpesticide-risks/assessing-human-healthrisk-pesticides.
The toxicological endpoints used to
assess safety of exposures to tiafenacil
are discussed in the Human Health Risk
Assessment mentioned above.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to tiafenacil, EPA considered
exposure under the petitioned-for
tolerances. EPA assessed dietary
exposures from tiafenacil 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 tiafenacil; therefore, a quantitative
acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used the food
consumption data from the United
States Department of Agriculture
(USDA) National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA; 2003–
2008). As to residue levels in food, EPA
assumed 100% CT and tolerance-level
residues for all commodities.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that tiafenacil does not pose
a cancer risk to humans. Therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for tiafenacil. Tolerance level residues
and/or 100% CT were assumed for all
food commodities.
2. Dietary exposure from drinking
water. The Agency used screening-level
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water exposure models in the dietary
exposure analysis and risk assessment
for tiafenacil in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of tiafenacil.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Modeled estimates of drinking water
concentrations based on the Pesticides
in Water Calculator (PWC) version 1.52
were directly entered into the dietary
exposure model. For chronic dietary
risk assessment, the highest estimated
drinking water concentration of 66 parts
per billion was used to assess the
contribution to drinking water from
groundwater sources.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets). There are
no uses for tiafenacil that will 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.’’
EPA has not found tiafenacil to share
a common mechanism of toxicity with
any other substances, and tiafenacil
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that tiafenacil 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 https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-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
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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 is evidence from a rat
developmental study of an increased
quantitative fetal susceptibility
following in utero exposure to tiafenacil
in rats. Although a 2-generation
reproductive study would typically
further characterize this susceptibility,
no effects were observed in parents and
offspring in the definitive study.
Therefore, EPA conducted a weight-ofevidence (WOE) analysis taking into
consideration a 1-generation
reproductive study and determined that
the concern for the observed effects is
low because: (1) The effects are well
characterized and clear NOAELs were
established; (2) the PODs selected for
risk assessment are protective for the
effects observed in the rat
developmental and 1-generation
reproductive studies; (3) the 2generation reproductive study and the
1-generation reproductive study are
considered co-critical based upon
similar doses allowing them to be
considered together; (4) the parental
effects were observed in the 1generation reproductive study are six to
seven-fold higher than the NOAEL; (5)
increased porphyrin levels which are
thought to be a precursor to
hematotoxicity occur at the same dose
in parental animals and offspring in the
2-generation reproductive study and not
the lower two doses; and (6)
quantitative susceptibility was not
observed in the two-generation
reproductive study for a similar
chemical saflufenacil.
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 tiafenacil
is complete.
ii. There is no indication that
tiafenacil is a neurotoxic chemical and
there is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
iii. The selected endpoints are
protective of the observed increased
fetal and offspring susceptibilities in
rats. They are also protective of
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potential offspring effects which are
expected to occur at the same dose as
parental effects or higher.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to tiafenacil in
drinking water. These assessments will
not underestimate the exposure and
risks posed by tiafenacil.
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. There are no residential uses for
tiafenacil.
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, tiafenacil 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 chronic exposure to tiafenacil from
food and water will utilize 14% of the
cPAD for the general population, and
36% of the cPAD for infants (<1 year
old), the population group receiving the
greatest exposure.
3. Short- and intermediate-term risks.
Short- and intermediate-term aggregate
exposures takes into account short- and
intermediate-term residential exposures
plus chronic exposure to food and water
(considered to be a background
exposure level). Because there are no
residential uses for tiafenacil, short- and
intermediate-term aggregate exposures
are equivalent to the chronic dietary
exposure.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
tiafenacil is not expected to pose a
cancer risk to humans.
5. Determination of safety. Based on
these risk assessments, EPA concludes
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55383
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to tiafenacil
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high-performance liquid
chromatography method with tandem
mass spectrometry detection (LC/MS/
MS), Method No. GPL–MTH–113) is
available to enforce the tolerance
expression for determination of residues
of tiafenacil and metabolites M–36 (2-(2chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4(trifluoromethyl)-2,3-dihydropyrimidin1(6H)-yl)phenylsulfinyl)propanoic acid)
and M–56 (2-(2-chloro-5-(2,6-dioxo-4(trifluoromethyl)-2,3-dihydropyrimidin1(6H)-yl)-4fluorophenylsulfinyl)propanoic
acid) in crop commodities.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level. The Codex has not
established any MRL for tiafenacil.
C. Revisions to Petitioned-for Tolerances
Based upon review of supporting
residue data, EPA has made several
modifications to the petition. The
petitioner did not propose tolerances for
residues in or on the livestock feed raw
agricultural commodities (RACs)
associated with the use of tiafenacil on
corn, wheat, and soybeans; however,
EPA has determined that tolerances for
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residues in these RACs are needed
based on the tolerances requested, as the
crop field trial data showed quantifiable
residues of tiafenacil and its
metabolites. For livestock feed items
(both preplant and desiccation),
significant amounts of metabolites M–
01, M–10, M–52, M–53, M–36, and/or
M–56 were found in the corn, cotton,
soybean, and wheat field trials. For
tolerance enforcement in livestock feed
items, tiafenacil, M–36, and M–56 are
appropriate marker compounds as the
metabolites are common to these RACs
following preplant use and tiafenacil is
the major residue following desiccation
treatment. Therefore, EPA is
establishing a separate tolerance
expression for livestock feed RACs by
including the sum of tiafenacil, M–36,
and M–56 for compliance with the
tolerance values specified. In addition
to establishing the petitioned-for
tolerance on cotton gin byproducts
under this separate tolerance
expression, EPA also established
tolerances on livestock RACs for corn
(field, forage and stover; pop, stover),
soybean (forage and hay), and wheat
(forage, hay, straw). The tolerance
values for cottonseed subgroup 20C
undelinted seed and cottonseed
subgroup 20C gin byproducts were
corrected by removing the trailing zero
to be consistent with EPA’s Rounding
Class Practice and the commodity
definitions were revised to be consistent
with Agency practice. All livestock feed
RAC tolerance values were calculated
using the Organization for Economic Cooperation and Development’s (OECD)
MRL calculation procedures.
The proposed tolerance expression
was revised for primary crops by
removing the metabolite M–01 (3-(2-(2chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4(trifluoromethyl)-2,3-dihydropyrimidin1(6H)yl)phenylthio)propanamido)propanoic
acid), as parent tiafenacil was the
predominant residue and is thus the
residue of concern for tolerance
enforcement purposes. Residues in
these human consumption commodities
(seeds, grains, and fruits) will result
only from desiccation use.
A lower tolerance value was
established for the cottonseed subgroup
20C after adjusting the residue levels
using proportionality to account for the
exaggerated rate used in the cotton field
trials and using the OECD MRL
calculation procedures. The submitted
processing studies indicate that a
tolerance for residues of tiafenacil is not
required for grape, raisin (i.e., no
concentration of residues was observed).
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V. Conclusion
Therefore, tolerances are established
for residues of tiafenacil, methyl N-[2[[2-chloro-5-[3,6-dihydro-3-methyl-2,6dioxo-4-(trifluoromethyl)-1(2H)pyrimidinyl]-4-fluorophenyl]thio]-1oxopropyl]-b-alaninate, including its
metabolites and degradates, in or on
Corn, field, forage at 0.05 ppm; Corn,
field, grain at 0.01 ppm; Corn, field,
stover at 0.05 ppm; Corn, pop, grain at
0.01 ppm; Corn, pop, stover at 0.05
ppm; Cotton, gin byproducts at 3 ppm;
Cottonseed subgroup 20C at 0.3 ppm;
Grape at 0.01 ppm; Soybean, forage at
0.15 ppm; Soybean, hay at 0.3 ppm;
Soybean, seed at 0.01 ppm; Wheat,
forage at 0.05 ppm; Wheat, grain at 0.01
ppm; Wheat, hay at 0.08 ppm; and
Wheat, straw at 0.07 ppm.
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), or 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 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
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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: August 23, 2020.
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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Add § 180.713 to subpart C to read
as follows:
(b)–(d) [Reserved]
■
[FR Doc. 2020–19673 Filed 9–4–20; 8:45 am]
§ 180.713 Tiafenacil; tolerances for
residues.
BILLING CODE 6560–50–P
(a) General. (1) Tolerances are
established for residues of the herbicide
tiafenacil, including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only
tiafenacil, methyl N-[2-[[2-chloro-5-[3,6dihydro-3-methyl-2,6-dioxo-4(trifluoromethyl)-1(2H)-pyrimidinyl]-4fluorophenyl]thio]-1-oxopropyl]-balaninate, in or on the following
commodities:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
TABLE 1 TO PARAGRAPH (a)(1)
Parts per
million
Commodity
Corn, field, grain .........................
Corn, pop, grain ..........................
Cottonseed subgroup 20C .........
Grape ..........................................
Soybean, seed ............................
Wheat, grain ...............................
0.01
0.01
0.3
0.01
0.01
0.01
(2) Tolerances are established for
residues of the herbicide tiafenacil,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only the sum
of tiafenacil, methyl N-[2-[[2-chloro-5[3,6-dihydro-3-methyl-2,6-dioxo-4(trifluoromethyl)-1(2H)-pyrimidinyl]-4fluorophenyl]thio]-1-oxopropyl]-balaninate and its metabolites 2-(2chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4(trifluoromethyl)-2,3-dihydropyrimidin1(6H)-yl)phenylsulfinyl)propanoic acid
and 2-(2-chloro-5-(2,6-dioxo-4(trifluoromethyl)-2,3-dihydropyrimidin1(6H)-yl)-4fluorophenylsulfinyl)propanoic acid,
calculated as the stoichiometric
equivalent of tiafenacil, in or on the
following commodities:
TABLE 2 TO PARAGRAPH (a)(2)
Parts per
million
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Commodity
Cotton, gin byproducts ...............
Corn, field, forage .......................
Corn, field, stover .......................
Corn, pop, stover ........................
Soybean, forage .........................
Soybean, hay ..............................
Wheat, forage .............................
Wheat, hay .................................
Wheat, straw ...............................
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3
0.05
0.05
0.05
0.15
0.3
0.05
0.08
0.07
Centers for Medicare & Medicaid
Services
42 CFR Parts 402, 403, 411, 412, 422,
423, 460, 483, 488, and 493
[CMS–6076–RCN2]
RIN 0991–AC07
Medicare and Medicaid Programs;
Adjustment of Civil Monetary Penalties
for Inflation; Continuation of
Effectiveness and Extension of
Timeline for Publication of the Final
Rule
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Continuation of effectiveness
and extension of timeline for
publication of the final rule.
AGENCY:
This document announces the
continuation of, effectiveness of, and the
extension of the timeline for publication
of a final rule. We are issuing this
document in accordance with section
1871(a)(3)(C) of the Social Security Act
(the Act), which allows an interim final
rule to remain in effect after the
expiration of the timeline specified in
section 1871(a)(3)(B) of the Act if the
Secretary publishes a notice of
continuation explaining why we did not
comply with the regular publication
timeline.
SUMMARY:
Effective September 4, 2020, the
Medicare provisions adopted in the
interim final rule published on
September 6, 2016 (81 FR 61538),
continue in effect and the regular
timeline for publication of the final rule
is extended for an additional year, until
September 6, 2021.
FOR FURTHER INFORMATION CONTACT:
Steve Forry (410) 786–1564 or Jaqueline
Cipa (410) 786–3259.
SUPPLEMENTARY INFORMATION: Section
1871(a) of the Social Security Act (the
Act) sets forth certain procedures for
promulgating regulations necessary to
carry out the administration of the
insurance programs under Title XVIII of
the Act. Section 1871(a)(3)(A) of the Act
requires the Secretary, in consultation
with the Director of the Office of
Management and Budget (OMB), to
establish a regular timeline for the
publication of final regulations based on
the previous publication of a proposed
DATES:
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55385
rule or an interim final rule. In
accordance with section 1871(a)(3)(B) of
the Act, such timeline may vary among
different rules, based on the complexity
of the rule, the number and scope of the
comments received, and other relevant
factors. However, the timeline for
publishing the final rule, cannot exceed
3 years from the date of publication of
the proposed or interim final rule,
unless there are exceptional
circumstances. After consultation with
the Director of OMB, the Secretary
published a document, which appeared
in the December 30, 2004 Federal
Register on (69 FR 78442), establishing
a general 3-year timeline for publishing
Medicare final rules after the
publication of a proposed or interim
final rule.
Section 1871(a)(3)(C) of the Act states
that upon expiration of the regular
timeline for the publication of a final
regulation after opportunity for public
comment, a Medicare interim final rule
shall not continue in effect unless the
Secretary publishes a notice of
continuation of the regulation that
includes an explanation of why the
regular timeline was not met. Upon
publication of such notice, the regular
timeline for publication of the final
regulation is treated as having been
extended for 1 additional year.
On September 6, 2016 Federal
Register (81 FR 61538), the Department
of Health and Human Services (HHS)
issued a department-wide interim final
rule titled ‘‘Adjustment of Civil
Monetary Penalties for Inflation’’ that
established new regulations at 45 CFR
part 102 to adjust for inflation the
maximum civil monetary penalty
amounts for the various civil monetary
penalty authorities for all agencies
within the Department. HHS took this
action to comply with the Federal Civil
Penalties Inflation Adjustment Act of
1990 (the Inflation Adjustment Act) (28
U.S.C. 2461 note 2(a)), as amended by
the Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015 (section 701 of the Bipartisan
Budget Act of 2015, (Pub. L. 114–74),
enacted on November 2, 2015). In
addition, this September 2016 interim
final rule included updates to certain
agency-specific regulations to reflect the
new provisions governing the
adjustment of civil monetary penalties
for inflation in 45 CFR part 102.
One of the purposes of the Inflation
Adjustment Act was to create a
mechanism to allow for regular
inflationary adjustments to federal civil
monetary penalties. Section 2(b)(1) of
the Inflation Adjustment Act. The 2015
amendments removed an inflation
update exclusion that previously
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Agencies
[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Rules and Regulations]
[Pages 55380-55385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19673]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0413; FRL-10013-02]
Tiafenacil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
tiafenacil in or on multiple commodities which are identified and
discussed later in this document. ISK Biosciences Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective September 8, 2020. Objections and
requests for hearings must be received on or before November 9, 2020,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0413, 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 concerns related to
COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to
visitors with limited exceptions. The staff continues to provide remote
customer service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW,
[[Page 55381]]
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. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.
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-2019-0413 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
November 9, 2020. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0413, 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 August 30, 2019 (84 FR 45702) (FRL-9998-
15), 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
8F8676) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A.,
Concord, OH 44077. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the herbicide
tiafenacil, methyl N-[2-[[2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluorophenyl]thio]-1-oxopropyl]-
[beta]-alaninate, including its metabolites and degradates, in or on
corn, which includes field corn and popcorn, at 0.01 parts per million
(ppm); cottonseed subgroup 20C, gin byproducts at 3.0 ppm; cottonseed
subgroup 20C, undelinted seed at 0.5 ppm; grape at 0.01 ppm; grape,
raisin at 0.01 ppm; soybean seed at 0.01 ppm; and wheat grain at 0.01
ppm. That document referenced a summary of the petition prepared by ISK
Biosciences Corporation, the registrant, which is available in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the tolerance expressions, revised tolerance values and
definitions for some commodities, and established tolerances on
livestock feed commodities. The reasons for these changes are explained
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 tiafenacil including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with tiafenacil 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 data indicate that exposure to tiafenacil caused
consistent decreases in absolute body weights, alterations in the
erythropoietic system, minor clinical chemical changes, and
histopathological changes in the liver, bone marrow and the spleen of
mice, rats and dogs. There was no evidence of carcinogenicity,
genotoxicity, mutagenicity, dermal toxicity, neurotoxicity, or
immunotoxicity.
There was evidence of an increased fetal quantitative
susceptibility in rats
[[Page 55382]]
but not rabbits. In rats, no maternal effects were observed up to the
highest dose tested, while there was a decrease in fetal weights at the
high dose. The decrease in fetal body weights is not considered a
single dose effect. No adverse effects were observed in rabbits in
maternal or fetal animals. There was no evidence of increased postnatal
susceptibility in the 2-generation reproductive study up to the highest
dose tested. Increased levels of porphyrin were observed in the liver
at the highest doses tested in parents and offspring. While not
adverse, this effect is consistent with the hematotoxicity observed
throughout the database at higher doses. At the highest dose in the 1-
generation reproductive study, parental effects included pale skin,
decreased body weight and food consumption, low hemoglobin
concentrations, hematocrit, mean corpuscular volume, and mean
corpuscular hemoglobin and platelet count. F1 offspring were not
generated based upon the effects in adults as it was predicted that
similar effects and increased mortality would occur.
Tiafenacil has low acute lethality through oral, dermal, and
inhalation routes. It is not an ocular or dermal irritant, nor is it a
dermal sensitizer.
Specific information on the studies received and the nature of the
adverse effects caused by tiafenacil 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 https://www.regulations.gov in the document, ``Tiafenacil. Human Health Risk
Assessment for the Section 3 Registration Action of the New Active
Ingredient on Grapes, Corn, Cotton, Soybeans, and Wheat''. First Food
Use. in docket ID number EPA-HQ-OPP-2019-0413.
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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
The toxicological endpoints used to assess safety of exposures to
tiafenacil are discussed in the Human Health Risk Assessment mentioned
above.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tiafenacil, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from tiafenacil 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 tiafenacil; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the United States
Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008).
As to residue levels in food, EPA assumed 100% CT and tolerance-level
residues for all commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that tiafenacil does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for tiafenacil. Tolerance level residues and/or 100%
CT 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 tiafenacil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of tiafenacil. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Modeled estimates of drinking water concentrations based on the
Pesticides in Water Calculator (PWC) version 1.52 were directly entered
into the dietary exposure model. For chronic dietary risk assessment,
the highest estimated drinking water concentration of 66 parts per
billion was used to assess the contribution to drinking water from
groundwater sources.
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). There are no uses for
tiafenacil that will 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.''
EPA has not found tiafenacil to share a common mechanism of
toxicity with any other substances, and tiafenacil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
tiafenacil 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 https://www.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
[[Page 55383]]
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 is evidence from a rat
developmental study of an increased quantitative fetal susceptibility
following in utero exposure to tiafenacil in rats. Although a 2-
generation reproductive study would typically further characterize this
susceptibility, no effects were observed in parents and offspring in
the definitive study. Therefore, EPA conducted a weight-of-evidence
(WOE) analysis taking into consideration a 1-generation reproductive
study and determined that the concern for the observed effects is low
because: (1) The effects are well characterized and clear NOAELs were
established; (2) the PODs selected for risk assessment are protective
for the effects observed in the rat developmental and 1-generation
reproductive studies; (3) the 2-generation reproductive study and the
1-generation reproductive study are considered co-critical based upon
similar doses allowing them to be considered together; (4) the parental
effects were observed in the 1-generation reproductive study are six to
seven-fold higher than the NOAEL; (5) increased porphyrin levels which
are thought to be a precursor to hematotoxicity occur at the same dose
in parental animals and offspring in the 2-generation reproductive
study and not the lower two doses; and (6) quantitative susceptibility
was not observed in the two-generation reproductive study for a similar
chemical saflufenacil.
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 tiafenacil is complete.
ii. There is no indication that tiafenacil is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. The selected endpoints are protective of the observed
increased fetal and offspring susceptibilities in rats. They are also
protective of potential offspring effects which are expected to occur
at the same dose as parental effects or higher.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to tiafenacil in drinking water. These assessments
will not underestimate the exposure and risks posed by tiafenacil.
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. There are no residential uses for tiafenacil.
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,
tiafenacil 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 chronic exposure to
tiafenacil from food and water will utilize 14% of the cPAD for the
general population, and 36% of the cPAD for infants (<1 year old), the
population group receiving the greatest exposure.
3. Short- and intermediate-term risks. Short- and intermediate-term
aggregate exposures takes into account short- and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Because there are no
residential uses for tiafenacil, short- and intermediate-term aggregate
exposures are equivalent to the chronic dietary exposure.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, tiafenacil is not expected to pose a cancer risk to humans.
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 tiafenacil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high-performance liquid
chromatography method with tandem mass spectrometry detection (LC/MS/
MS), Method No. GPL-MTH-113) is available to enforce the tolerance
expression for determination of residues of tiafenacil and metabolites
M-36 (2-(2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-
2,3-dihydropyrimidin-1(6H)-yl)phenylsulfinyl)propanoic acid) and M-56
(2-(2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-2,3-dihydropyrimidin-
1(6H)-yl)-4-fluorophenylsulfinyl)propanoic acid) in crop commodities.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established any MRL for tiafenacil.
C. Revisions to Petitioned-for Tolerances
Based upon review of supporting residue data, EPA has made several
modifications to the petition. The petitioner did not propose
tolerances for residues in or on the livestock feed raw agricultural
commodities (RACs) associated with the use of tiafenacil on corn,
wheat, and soybeans; however, EPA has determined that tolerances for
[[Page 55384]]
residues in these RACs are needed based on the tolerances requested, as
the crop field trial data showed quantifiable residues of tiafenacil
and its metabolites. For livestock feed items (both preplant and
desiccation), significant amounts of metabolites M-01, M-10, M-52, M-
53, M-36, and/or M-56 were found in the corn, cotton, soybean, and
wheat field trials. For tolerance enforcement in livestock feed items,
tiafenacil, M-36, and M-56 are appropriate marker compounds as the
metabolites are common to these RACs following preplant use and
tiafenacil is the major residue following desiccation treatment.
Therefore, EPA is establishing a separate tolerance expression for
livestock feed RACs by including the sum of tiafenacil, M-36, and M-56
for compliance with the tolerance values specified. In addition to
establishing the petitioned-for tolerance on cotton gin byproducts
under this separate tolerance expression, EPA also established
tolerances on livestock RACs for corn (field, forage and stover; pop,
stover), soybean (forage and hay), and wheat (forage, hay, straw). The
tolerance values for cottonseed subgroup 20C undelinted seed and
cottonseed subgroup 20C gin byproducts were corrected by removing the
trailing zero to be consistent with EPA's Rounding Class Practice and
the commodity definitions were revised to be consistent with Agency
practice. All livestock feed RAC tolerance values were calculated using
the Organization for Economic Co-operation and Development's (OECD) MRL
calculation procedures.
The proposed tolerance expression was revised for primary crops by
removing the metabolite M-01 (3-(2-(2-chloro-4-fluoro-5-(3-methyl-2,6-
dioxo-4-(trifluoromethyl)-2,3-dihydropyrimidin-1(6H)-
yl)phenylthio)propanamido)propanoic acid), as parent tiafenacil was the
predominant residue and is thus the residue of concern for tolerance
enforcement purposes. Residues in these human consumption commodities
(seeds, grains, and fruits) will result only from desiccation use.
A lower tolerance value was established for the cottonseed subgroup
20C after adjusting the residue levels using proportionality to account
for the exaggerated rate used in the cotton field trials and using the
OECD MRL calculation procedures. The submitted processing studies
indicate that a tolerance for residues of tiafenacil is not required
for grape, raisin (i.e., no concentration of residues was observed).
V. Conclusion
Therefore, tolerances are established for residues of tiafenacil,
methyl N-[2-[[2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluorophenyl]thio]-1-oxopropyl]-
[beta]-alaninate, including its metabolites and degradates, in or on
Corn, field, forage at 0.05 ppm; Corn, field, grain at 0.01 ppm; Corn,
field, stover at 0.05 ppm; Corn, pop, grain at 0.01 ppm; Corn, pop,
stover at 0.05 ppm; Cotton, gin byproducts at 3 ppm; Cottonseed
subgroup 20C at 0.3 ppm; Grape at 0.01 ppm; Soybean, forage at 0.15
ppm; Soybean, hay at 0.3 ppm; Soybean, seed at 0.01 ppm; Wheat, forage
at 0.05 ppm; Wheat, grain at 0.01 ppm; Wheat, hay at 0.08 ppm; and
Wheat, straw at 0.07 ppm.
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), or 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 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: August 23, 2020.
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.
[[Page 55385]]
0
2. Add Sec. 180.713 to subpart C to read as follows:
Sec. 180.713 Tiafenacil; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
herbicide tiafenacil, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only
tiafenacil, methyl N-[2-[[2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluorophenyl]thio]-1-oxopropyl]-
[beta]-alaninate, in or on the following commodities:
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Corn, field, grain.......................................... 0.01
Corn, pop, grain............................................ 0.01
Cottonseed subgroup 20C..................................... 0.3
Grape....................................................... 0.01
Soybean, seed............................................... 0.01
Wheat, grain................................................ 0.01
------------------------------------------------------------------------
(2) Tolerances are established for residues of the herbicide
tiafenacil, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
tiafenacil, methyl N-[2-[[2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluorophenyl]thio]-1-oxopropyl]-
[beta]-alaninate and its metabolites 2-(2-chloro-4-fluoro-5-(3-methyl-
2,6-dioxo-4-(trifluoromethyl)-2,3-dihydropyrimidin-1(6H)-
yl)phenylsulfinyl)propanoic acid and 2-(2-chloro-5-(2,6-dioxo-4-
(trifluoromethyl)-2,3-dihydropyrimidin-1(6H)-yl)-4-
fluorophenylsulfinyl)propanoic acid, calculated as the stoichiometric
equivalent of tiafenacil, in or on the following commodities:
Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cotton, gin byproducts...................................... 3
Corn, field, forage......................................... 0.05
Corn, field, stover......................................... 0.05
Corn, pop, stover........................................... 0.05
Soybean, forage............................................. 0.15
Soybean, hay................................................ 0.3
Wheat, forage............................................... 0.05
Wheat, hay.................................................. 0.08
Wheat, straw................................................ 0.07
------------------------------------------------------------------------
(b)-(d) [Reserved]
[FR Doc. 2020-19673 Filed 9-4-20; 8:45 am]
BILLING CODE 6560-50-P