Fomesafen; Pesticide Tolerances, 5312-5317 [2018-02344]
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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: January 19, 2018.
Donna S. Davis,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
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■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.650, revise the table in
paragraph (a) to read as follows:
■
§ 180.650 Isoxaben; tolerances for
residues.
(a) * * *
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Parts per
million
Commodity
Almond, hulls ........................
Apple .....................................
Bushberry subgroup 13–07B
Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13–07F ....................
Nut, tree, group 14–12 .........
*
*
*
*
0.40
0.01
0.01
0.01
0.02
*
[FR Doc. 2018–02346 Filed 2–6–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0629; FRL–9972–66]
Fomesafen; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fomesafen in
or on the tuberous and corm vegetable
subgroup 1C, the legume vegetable
group 6, and the low growing berry
subgroup 13–07G (except cranberry).
Interregional Research Project Number 4
(IR–4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective
February 7, 2018. Objections and
requests for hearings must be received
on or before April 9, 2018, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0629, 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. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
ADDRESSES:
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Environmental Protection Agency, 1200
Pennsylvania Ave. NW, 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 Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&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–2015–0629 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 April 9, 2018. 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
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notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2015–0629, 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/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
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II. Summary of Petitioned-For
Tolerance
In the Federal Register of October 21,
2015 (80 FR 63731) (FRL–9935–29),
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 5E8395) by
Interregional Research Project Number 4
(IR–4), 500 College Road East, Suite 201
W., Princeton, NJ 08540. The petition
requested that 40 CFR 180.433 be
amended by establishing tolerances for
residues of fomesafen, 5-[2-cloro-4(trifluoromethyl)phenoxy]-N(methylsulfonyl)-2-nitrobenzamide in or
on the following raw agricultural
commodities: Vegetable, tuberous and
corm, subgroup 1C at 0.025 parts per
million (ppm); berry, low growing
subgroup 13–07G except cranberry at
0.02 ppm; and vegetable, legume group
6 at 0.05 ppm. The petition also
requested to amend 40 CFR 180.433 by
removing the existing tolerances on the
raw agricultural commodities bean, dry
at 0.05 ppm; bean, snap, succulent at
0.05 ppm; bean Lima, succulent at 0.05
ppm; pea, succulent at 0.025 ppm;
potato at 0.025 ppm; soybean at 0.05
ppm; and soybean, vegetable succulent
at 0.05 ppm. That document referenced
a summary of the petition prepared by
Syngenta Crop Protection, LLC, the
registrant, which is available in the
docket, https://www.regulations.gov.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit IV.C.
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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 fomesafen
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with fomesafen 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 primary target organs of
fomesafen are the liver and
hematological system. Generally,
hyalinization of hepatocytes provided
the most sensitive toxicological
endpoint (intermediate, and long term)
in mammals. In the subchronic and
chronic toxicity studies in rats and
mice, food consumption, food
efficiency, body weight, body weight
gain, and histopathological changes in
the liver were parameters that were
most often affected. In addition, dogs,
rats, and mice also showed
hematological changes (e.g., decreased
erythrocyte count, hemoglobin, or
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hematocrit). No progression of
hematological effects was observed
beyond 90 days. Neurotoxicity
(decreased motor activity) was observed
at doses above those causing liver
toxicity or impacting hematological
parameters. Post-implantation loss was
noted in the developmental study, but
no quantitative or qualitative evidence
of increased susceptibility was seen
following in utero exposure to rats or
rabbits in developmental studies or in
the reproduction study. As the etiology
of the post-implantation loss is
unknown, it is considered to be both a
maternal and fetal endpoint. Fomesafen
can result in suppression of anti-SRBC
IgM response; however, this
immunotoxic potential was noted only
at high doses.
Carcinogenicity was not observed in
the rat chronic toxicity/carcinogenicity
study. Liver tumors were produced in
the mouse carcinogenicity study;
however, the Agency determined that
fomesafen should be classified as ‘‘Not
Likely to be Carcinogenic to Humans.’’
This decision was based on the weightof-evidence which supports activation
of peroxisome proliferator-activated
receptor alpha (PPARa) as the mode of
action for fomesafen-induced
hepatocarcinogenesis in mice.
Fomesafen was not considered to be
mutagenic.
Specific information on the studies
received and the nature of the adverse
effects caused by fomesafen 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
titled ‘‘Fomesafen: Draft Human Health
Risk Assessment for Registration Review
and for the Section 3 Registration
Action on Tuberous and Corm
Vegetables (Crop Group 1C), Legume
Vegetable (Crop Group 6) and Low
Growing Berry (Except Cranberry) (Crop
Group 13–07G)’’ on pages 36–45 in
docket ID number EPA–HQ–OPP–2015–
0629.
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
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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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for fomesafen used for human
risk assessment is shown in the Table of
this unit.
TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FOMESAFEN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (Females 13–49
years of age).
No toxic effects of fomesafen attributable to a single dose and specific to females of ages 13–49 were found in
the database.
Acute dietary (General population including infants and
children).
NOAEL = 100 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 1 mg/
kg/day.
aPAD = 1 mg/kg/day
Acute neurotoxicity test in rats.
LOAEL = 250 mg/kg/day based on decreased motor activity
(horizontal and vertical activity and time in central quadrant)
in males.
Chronic dietary (All populations)
NOAEL = 1 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.01
mg/kg/day.
cPAD = 0.01 mg/kg/
day.
Subchronic toxicity in the dog.
LOAEL = 25 mg/kg/day based on hematology (decreased hemoglobin and hematocrit concentrations and erythrocyte
count and increased platelet count and prothrombin time).
Cancer (Oral, dermal, inhalation).
Classification: The Agency has classified Fomesafen as ‘‘Not Likely to be Carcinogenic to Humans’’
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fomesafen, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
fomesafen tolerances in 40 CFR 180.433.
EPA assessed dietary exposures from
fomesafen 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.
Such effects were identified for
fomesafen. In estimating acute dietary
exposure, EPA used 2003–2008 food
consumption data from the U.S.
Department of Agriculture’s (USDA’s)
National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA). As to
residue levels in food, EPA assumed
tolerance level residues and 100 percent
crop treated (PCT).
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used 2003–2008 food consumption
data from the USDA’s NHANES/
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WWEIA. As to residue levels in food,
EPA assumed tolerance level residues
and 100 PCT.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that fomesafen 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 PCT
information. EPA did not use
anticipated residue or PCT information
in the dietary assessment for fomesafen.
Tolerance level residues and 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 fomesafen in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of fomesafen.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
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Based on the Pesticide in Water
Calculator (PWC) model (Version 1.52)
the estimated drinking water
concentrations (EDWCs) of fomesafen
for acute exposures are estimated to be
168 parts per billion (ppb) and for
chronic exposures are estimated to be
125 ppb. These modeled estimates of
drinking water concentrations were
directly entered into the dietary
exposure model.
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).
Fomesafen 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
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substances that have a common
mechanism of toxicity.’’
EPA has not found fomesafen to share
a common mechanism of toxicity with
any other substances, and fomesafen
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that fomesafen 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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
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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
Food Quality Protection Act Safety
Factor (FQPA 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 no evidence of increased
susceptibility of rat fetuses to in utero
exposure to fomesafen. Postimplantation loss was observed in the
rat developmental toxicity study.
However, as the etiology of the effect is
unknown, it is considered to be a part
of both a maternal and fetal effect. The
2-generation reproduction study in rats
did not show evidence of increased
susceptibility to fomesafen. Although
the developmental toxicity study in
rabbits was classified as unacceptable
due to mortality from bacterial
infections, there was adequate
information to show that there was no
evidence of increased susceptibility of
rabbit fetuses due to the treatment with
fomesafen.
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:
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i. The toxicology database for
fomesafen is complete and sufficient for
assessing potential susceptibility to
infants and children. Although the
developmental toxicity study in rabbits
was classified unacceptable due to
mortality from bacterial infections, there
was no evidence of increased
susceptibility of rabbit fetuses due to the
treatment with fomesafen. Therefore,
the lack of an acceptable developmental
toxicity study in non-rodents is not
considered a data gap.
ii. There is no need for a
developmental neurotoxicity study or a
need to retain the FQPA SF to account
for the lack of such study. Decreased
motor activity (horizontal and vertical
activity and time in central quadrant)
was observed in male rats in the acute
neurotoxicity screening battery. In the
subchronic neurotoxicity test, neither
general systemic toxicity nor
neurotoxicity was observed at the
highest dose tested. All points of
departure used in the risk assessment
are protective of potential neurotoxicity.
iii. There is no evidence that
fomesafen results in increased
susceptibility in in utero rats in the
prenatal developmental studies or in
young rats in the 2-generation
reproduction study. Although the
developmental toxicity study in rabbits
was classified as unacceptable due to
mortality from bacterial infections, there
was adequate information to show that
there was no evidence of increased
susceptibility of rabbit fetuses due to the
treatment with fomesafen.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to fomesafen in
drinking water. These assessments will
not underestimate the exposure and
risks posed by fomesafen.
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.
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1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
fomesafen will occupy 2.9% of the
aPAD for all infants less than 1-years
old, the population group receiving the
greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to fomesafen from
food and water will utilize 70% of the
cPAD for all infants less than 1 year old,
the population group receiving the
greatest exposure. There are no
residential uses for fomesafen.
3. Short- and Intermediate-term risk.
Short- and intermediate-term aggregate
exposure takes into account short- and
intermediate-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Both short- and intermediate-term
adverse effects were identified;
however, fomesafen is not registered for
any use patterns that would result in
either short- or intermediate-term
residential exposure. Short- and
intermediate-term risk is assessed based
on short- and intermediate-term
residential exposure plus chronic
dietary exposure. Because there is no
short- 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 either short- or intermediate-term
risk), no further assessment of short- or
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating short- and
intermediate-term risk for fomesafen.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
fomesafen 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 fomesafen
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate residue analytical methods
are available for the purpose of
fomesafen tolerance enforcement for
plant commodities. A high performance
liquid chromatography method with
tandem mass spectrometry detection
(LC/MS/MS) method (GRM045.01A) has
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previously been submitted as an
enforcement method. The method uses
extraction procedures similar to
previous methods, SPE cleanup
procedures, and the final determination
step by LC/MS/MS for analysis of
fomesafen residues. The validated limit
of quantitation (LOQ) of the method is
0.02 ppm.
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
MRLs for fomesafen.
sradovich on DSK3GMQ082PROD with RULES
C. Response to Comments
Two comments were received in
response to the notice of filing. The first
was related to a different chemical,
azoxystrobin, and is therefore not
relevant to this action. The second was
from the Center for Biological Diversity
and centered primarily around impacts
on endangered and threatened species.
This comment is not relevant to the
Agency’s evaluation of safety of the
fomesafen tolerances under section 408
of the FFDCA, which requires the
Agency to evaluate the potential harms
to human health, not effects on the
environment.
V. Conclusion
Therefore, tolerances are established
for residues of fomesafen, including its
metabolites and degradates, in or on the
following commodities: Berry, low
growing, subgroup 13–07G, except
cranberry at 0.02 ppm; vegetable,
legume, group 6 at 0.05 ppm; and
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17:31 Feb 06, 2018
Jkt 244001
vegetable, tuberous and corm, subgroup
1C at 0.025 ppm. In addition, the
following existing tolerances are
removed as unnecessary since they are
superseded by the newly established
tolerances: Bean, dry at 0.05 ppm; bean,
lima, succulent at 0.05 ppm; bean, snap,
succulent at 0.05 ppm; pea, succulent at
0.025 ppm; potato at 0.025 ppm;
soybean at 0.05 ppm; and soybean,
vegetable, succulent at 0.05 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); 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 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
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
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: January 25, 2018.
Michael L. Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.433, amend the table in
paragraph (a) by:
■ i. Removing the commodities ‘‘Bean,
dry’’; ‘‘Bean, lima, succulent’’; and
‘‘Bean, snap, succulent’’;
■ ii. Adding alphabetically the
commodity ‘‘Berry, low growing,
subgroup 13–07G, except cranberry’’;
■ iii. Removing the commodities ‘‘Pea,
succulent’’; ‘‘Potato’’; ‘‘Soybean’’; and
‘‘Soybean, vegetable, succulent’’; and
■
E:\FR\FM\07FER1.SGM
07FER1
Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Rules and Regulations
iv. Adding alphabetically the
commodities ‘‘Vegetable, legume, group
6’’ and ‘‘Vegetable, tuberous and corm,
subgroup 1C’’.
The additions read as follows:
The EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OLEM–2016–0248. All
documents in the docket are listed on
the https://www.regulations.gov
website. Although listed in the index,
§ 180.433 Fomesafen; tolerances for
some information is not publicly
residues.
available, e.g., Confidential Business
(a) * * *
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
Parts per
Commodity
the internet and will be publicly
million
available only in hard copy form.
Publicly available docket materials are
available either electronically at https://
*
*
*
*
*
Berry, low growing, subgroup
www.regulations.gov or in hard copy at
13–07G, except cranberry ....
0.02 the RCRA Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Ave. NW,
*
*
*
*
*
Washington, DC. The Public Reading
Vegetable, legume, group 6 .....
0.05
Room is open from 8:30 a.m. to 4:30
Vegetable, tuberous and corm,
subgroup 1C .........................
0.025 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 RCRA Docket is (202) 566–0270.
*
*
*
*
*
[FR Doc. 2018–02344 Filed 2–6–18; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 6560–50–P
George Faison, Office of Resource
Conservation and Recovery, Materials
Recovery and Waste Management
ENVIRONMENTAL PROTECTION
Division, MC 5303P, Environmental
AGENCY
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460;
40 CFR Part 241
telephone number: (703) 305–7652;
email: faison.george@epa.gov.
[EPA–HQ–OLEM–2016–0248; FRL–9969–
80–OLEM]
SUPPLEMENTARY INFORMATION: The
following outline is provided to aid in
RIN 2050–AG83
locating information in this preamble.
Additions to List of Categorical NonI. General Information
A. List of Abbreviations and Acronyms
Waste Fuels: Other Treated Railroad
Used in This Final Rule
Ties
■
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is issuing amendments to
the Non-Hazardous Secondary Materials
regulations, which generally established
standards and procedures for
identifying whether non-hazardous
secondary materials are solid wastes
when used as fuels or ingredients in
combustion units. In February 2013, the
EPA listed particular non-hazardous
secondary materials as ‘‘categorical nonwaste fuels’’ provided certain
conditions are met. This final rule adds
the following other treated railroad ties
(OTRT) to the categorical non-waste fuel
list: Processed creosote-borate, copper
naphthenate and copper naphthenateborate treated railroad ties, under
certain conditions depending on the
chemical treatment.
DATES: This rule is effective February 7,
2018.
sradovich on DSK3GMQ082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
17:31 Feb 06, 2018
Jkt 244001
ADDRESSES:
B. What is the statutory authority for this
final rule?
C. Does this action apply to me?
D. What is the purpose of this final rule?
E. Effective Date
II. Background
A. History of the NHSM Rulemakings
B. Background to This Final Rule
C. How will EPA make categorical nonwaste determinations?
III. Comments on the Proposed Rule and
Rationale for Final Decisions
A. Detailed Description of OTRTs
B. OTRTs Under Current NHSM Rules
C. Scope of the Final Categorical NonWaste Listing for OTRTs
D. Rationale for Final Rule
E. Copper and Borates Literature Review
and Other EPA Program Summary
F. Summary of Comments Requested
G. Responses to Comments
IV. Effect of This Final Rule on Other
Programs
V. State Authority
A. Relationship to State Programs
B. State Adoption of the Rulemaking
VI. Costs and Benefits
VII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
5317
Order 13563: Improving Regulation and
Regulatory Review
B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Costs
C. Paperwork Reduction Act (PRA)
D. Regulatory Flexibility Act (RFA)
E. Unfunded Mandates Reform Act
(UMRA)
F. Executive Order 13132: Federalism
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
H. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
J. National Technology Transfer and
Advancement Act (NTTAA)
K. Executive Order 12898: Federal Actions
To Address Environmental Justice in
Minority Populations and Low-Income
Populations
L. Congressional Review Act (CRA)
I. General Information
A. List of abbreviations and acronyms used
in this final rule
AWPA American Wood Protection
Association
Btu British thermal unit
C&D Construction and demolition
CAA Clean Air Act
CBI Confidential business information
CFR Code of Federal Regulations
CISWI Commercial and Industrial Solid
Waste Incinerator
CTRT Creosote-treated railroad ties
EPA U.S. Environmental Protection Agency
FR Federal Register
HAP Hazardous air pollutant
MACT Maximum achievable control
technology
MDL Method detection limit
NAICS North American Industrial
Classification System
ND Non-detect
NESHAP National emission standards for
hazardous air pollutants
NHSM Non-hazardous secondary material
OMB Office of Management and Budget
OTRT Other Treated Railroad Ties
PAH Polycyclic aromatic hydrocarbons
ppm Parts per million
RCRA Resource Conservation and Recovery
Act
RIN Regulatory information number
RL Reporting Limits
SBA Small Business Administration
SO2 Sulfur dioxide
SVOC Semi-volatile organic compound
TCLP Toxicity characteristic leaching
procedure
UPL Upper prediction limit
U.S.C. United States Code
VOC Volatile organic compound
B. What is the statutory authority for
this final rule?
The EPA is amending 40 CFR 241.4(a)
to list additional non-hazardous
secondary materials (NHSMs) as
E:\FR\FM\07FER1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Rules and Regulations]
[Pages 5312-5317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02344]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0629; FRL-9972-66]
Fomesafen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fomesafen in or on the tuberous and corm vegetable subgroup 1C, the
legume vegetable group 6, and the low growing berry subgroup 13-07G
(except cranberry). Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective February 7, 2018. Objections and
requests for hearings must be received on or before April 9, 2018, 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-2015-0629, 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. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2015-0629 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
April 9, 2018. 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
[[Page 5313]]
notice. Submit the non-CBI copy of your objection or hearing request,
identified by docket ID number EPA-HQ-OPP-2015-0629, 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/contacts.html.
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 October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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
5E8395) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W., Princeton, NJ 08540. The petition requested
that 40 CFR 180.433 be amended by establishing tolerances for residues
of fomesafen, 5-[2-cloro-4-(trifluoromethyl)phenoxy]-N-
(methylsulfonyl)-2-nitrobenzamide in or on the following raw
agricultural commodities: Vegetable, tuberous and corm, subgroup 1C at
0.025 parts per million (ppm); berry, low growing subgroup 13-07G
except cranberry at 0.02 ppm; and vegetable, legume group 6 at 0.05
ppm. The petition also requested to amend 40 CFR 180.433 by removing
the existing tolerances on the raw agricultural commodities bean, dry
at 0.05 ppm; bean, snap, succulent at 0.05 ppm; bean Lima, succulent at
0.05 ppm; pea, succulent at 0.025 ppm; potato at 0.025 ppm; soybean at
0.05 ppm; and soybean, vegetable succulent at 0.05 ppm. That document
referenced a summary of the petition prepared by Syngenta Crop
Protection, LLC, the registrant, which is available in the docket,
https://www.regulations.gov. Comments were received on the notice of
filing. EPA's response to these comments 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 fomesafen including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fomesafen 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 primary target organs of fomesafen are the liver and
hematological system. Generally, hyalinization of hepatocytes provided
the most sensitive toxicological endpoint (intermediate, and long term)
in mammals. In the subchronic and chronic toxicity studies in rats and
mice, food consumption, food efficiency, body weight, body weight gain,
and histopathological changes in the liver were parameters that were
most often affected. In addition, dogs, rats, and mice also showed
hematological changes (e.g., decreased erythrocyte count, hemoglobin,
or hematocrit). No progression of hematological effects was observed
beyond 90 days. Neurotoxicity (decreased motor activity) was observed
at doses above those causing liver toxicity or impacting hematological
parameters. Post-implantation loss was noted in the developmental
study, but no quantitative or qualitative evidence of increased
susceptibility was seen following in utero exposure to rats or rabbits
in developmental studies or in the reproduction study. As the etiology
of the post-implantation loss is unknown, it is considered to be both a
maternal and fetal endpoint. Fomesafen can result in suppression of
anti-SRBC IgM response; however, this immunotoxic potential was noted
only at high doses.
Carcinogenicity was not observed in the rat chronic toxicity/
carcinogenicity study. Liver tumors were produced in the mouse
carcinogenicity study; however, the Agency determined that fomesafen
should be classified as ``Not Likely to be Carcinogenic to Humans.''
This decision was based on the weight-of-evidence which supports
activation of peroxisome proliferator-activated receptor alpha
(PPAR[alpha]) as the mode of action for fomesafen-induced
hepatocarcinogenesis in mice. Fomesafen was not considered to be
mutagenic.
Specific information on the studies received and the nature of the
adverse effects caused by fomesafen 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 titled ``Fomesafen: Draft Human
Health Risk Assessment for Registration Review and for the Section 3
Registration Action on Tuberous and Corm Vegetables (Crop Group 1C),
Legume Vegetable (Crop Group 6) and Low Growing Berry (Except
Cranberry) (Crop Group 13-07G)'' on pages 36-45 in docket ID number
EPA-HQ-OPP-2015-0629.
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
[[Page 5314]]
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for fomesafen used for
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Fomesafen for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 No toxic effects of fomesafen attributable to a single dose and specific to
years of age). females of ages 13-49 were found in the database.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population NOAEL = 100 mg/kg/ Acute RfD = 1 mg/kg/ Acute neurotoxicity test in rats.
including infants and children). day. day. LOAEL = 250 mg/kg/day based on
UFA = 10x........... aPAD = 1 mg/kg/day. decreased motor activity
UFH = 10x........... (horizontal and vertical activity
FQPA SF = 1x........ and time in central quadrant) in
males.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 1 mg/kg/day. Chronic RfD = 0.01 Subchronic toxicity in the dog.
UFA = 10x........... mg/kg/day. LOAEL = 25 mg/kg/day based on
UFH = 10x........... cPAD = 0.01 mg/kg/ hematology (decreased hemoglobin
FQPA SF = 1x........ day.. and hematocrit concentrations and
erythrocyte count and increased
platelet count and prothrombin
time).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: The Agency has classified Fomesafen as ``Not Likely to be
Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fomesafen, EPA considered exposure under the petitioned-for
tolerances as well as all existing fomesafen tolerances in 40 CFR
180.433. EPA assessed dietary exposures from fomesafen 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.
Such effects were identified for fomesafen. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption data from the
U.S. Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA assumed tolerance level residues and 100
percent crop treated (PCT).
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used 2003-2008 food consumption data from the USDA's
NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance level
residues and 100 PCT.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fomesafen 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 PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
fomesafen. Tolerance level residues and 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 fomesafen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fomesafen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Pesticide in Water Calculator (PWC) model (Version
1.52) the estimated drinking water concentrations (EDWCs) of fomesafen
for acute exposures are estimated to be 168 parts per billion (ppb) and
for chronic exposures are estimated to be 125 ppb. These modeled
estimates of drinking water concentrations were directly entered into
the dietary exposure model.
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).
Fomesafen 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
[[Page 5315]]
substances that have a common mechanism of toxicity.''
EPA has not found fomesafen to share a common mechanism of toxicity
with any other substances, and fomesafen does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fomesafen 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://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 Food Quality
Protection Act Safety Factor (FQPA 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 no evidence of
increased susceptibility of rat fetuses to in utero exposure to
fomesafen. Post-implantation loss was observed in the rat developmental
toxicity study. However, as the etiology of the effect is unknown, it
is considered to be a part of both a maternal and fetal effect. The 2-
generation reproduction study in rats did not show evidence of
increased susceptibility to fomesafen. Although the developmental
toxicity study in rabbits was classified as unacceptable due to
mortality from bacterial infections, there was adequate information to
show that there was no evidence of increased susceptibility of rabbit
fetuses due to the treatment with fomesafen.
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 toxicology database for fomesafen is complete and sufficient
for assessing potential susceptibility to infants and children.
Although the developmental toxicity study in rabbits was classified
unacceptable due to mortality from bacterial infections, there was no
evidence of increased susceptibility of rabbit fetuses due to the
treatment with fomesafen. Therefore, the lack of an acceptable
developmental toxicity study in non-rodents is not considered a data
gap.
ii. There is no need for a developmental neurotoxicity study or a
need to retain the FQPA SF to account for the lack of such study.
Decreased motor activity (horizontal and vertical activity and time in
central quadrant) was observed in male rats in the acute neurotoxicity
screening battery. In the subchronic neurotoxicity test, neither
general systemic toxicity nor neurotoxicity was observed at the highest
dose tested. All points of departure used in the risk assessment are
protective of potential neurotoxicity.
iii. There is no evidence that fomesafen results in increased
susceptibility in in utero rats in the prenatal developmental studies
or in young rats in the 2-generation reproduction study. Although the
developmental toxicity study in rabbits was classified as unacceptable
due to mortality from bacterial infections, there was adequate
information to show that there was no evidence of increased
susceptibility of rabbit fetuses due to the treatment with fomesafen.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to fomesafen in drinking water. These assessments
will not underestimate the exposure and risks posed by fomesafen.
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fomesafen will occupy 2.9% of the aPAD for all infants less than 1-
years old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fomesafen from food and water will utilize 70% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for fomesafen.
3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Both short- and intermediate-term adverse effects were identified;
however, fomesafen is not registered for any use patterns that would
result in either short- or intermediate-term residential exposure.
Short- and intermediate-term risk is assessed based on short- and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- 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 either short- or intermediate-term risk), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for fomesafen.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fomesafen 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 fomesafen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate residue analytical methods are available for the purpose
of fomesafen tolerance enforcement for plant commodities. A high
performance liquid chromatography method with tandem mass spectrometry
detection (LC/MS/MS) method (GRM045.01A) has
[[Page 5316]]
previously been submitted as an enforcement method. The method uses
extraction procedures similar to previous methods, SPE cleanup
procedures, and the final determination step by LC/MS/MS for analysis
of fomesafen residues. The validated limit of quantitation (LOQ) of the
method is 0.02 ppm.
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 MRLs for fomesafen.
C. Response to Comments
Two comments were received in response to the notice of filing. The
first was related to a different chemical, azoxystrobin, and is
therefore not relevant to this action. The second was from the Center
for Biological Diversity and centered primarily around impacts on
endangered and threatened species. This comment is not relevant to the
Agency's evaluation of safety of the fomesafen tolerances under section
408 of the FFDCA, which requires the Agency to evaluate the potential
harms to human health, not effects on the environment.
V. Conclusion
Therefore, tolerances are established for residues of fomesafen,
including its metabolites and degradates, in or on the following
commodities: Berry, low growing, subgroup 13-07G, except cranberry at
0.02 ppm; vegetable, legume, group 6 at 0.05 ppm; and vegetable,
tuberous and corm, subgroup 1C at 0.025 ppm. In addition, the following
existing tolerances are removed as unnecessary since they are
superseded by the newly established tolerances: Bean, dry at 0.05 ppm;
bean, lima, succulent at 0.05 ppm; bean, snap, succulent at 0.05 ppm;
pea, succulent at 0.025 ppm; potato at 0.025 ppm; soybean at 0.05 ppm;
and soybean, vegetable, succulent at 0.05 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); 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 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: January 25, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.433, amend the table in paragraph (a) by:
0
i. Removing the commodities ``Bean, dry''; ``Bean, lima, succulent'';
and ``Bean, snap, succulent'';
0
ii. Adding alphabetically the commodity ``Berry, low growing, subgroup
13-07G, except cranberry'';
0
iii. Removing the commodities ``Pea, succulent''; ``Potato'';
``Soybean''; and ``Soybean, vegetable, succulent''; and
[[Page 5317]]
0
iv. Adding alphabetically the commodities ``Vegetable, legume, group
6'' and ``Vegetable, tuberous and corm, subgroup 1C''.
The additions read as follows:
Sec. 180.433 Fomesafen; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Berry, low growing, subgroup 13-07G, except cranberry...... 0.02
* * * * *
Vegetable, legume, group 6................................. 0.05
Vegetable, tuberous and corm, subgroup 1C.................. 0.025
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-02344 Filed 2-6-18; 8:45 am]
BILLING CODE 6560-50-P
