Prosulfuron; Pesticide Tolerances, 31471-31476 [2017-14315]
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Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 2, 2017.
Michael L. Goodis,
Director, Registration Division, Office of
Pesticide Programs.
forage; grain, cereal, forage, fodder, and
straw, group 16, hay; grain, cereal,
forage, fodder, and straw, group 16,
straw; and grain, cereal, group 15.
Syngenta Crop Protection, LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
This regulation is effective July
7, 2017. Objections and requests for
hearings must be received on or before
September 5, 2017, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0218, is
■ 2. In § 180.613, add alphabetically the
available at https://www.regulations.gov
following commodities ‘‘Pea and bean,
or at the Office of Pesticide Programs
succulent shelled, subgroup 6B’’; ‘‘Pea
and bean, dried shelled, except soybean, Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
subgroup 6C’’; and ‘‘Vegetable, legume,
Docket Center (EPA/DC), West William
edible podded, subgroup 6A’’ to the
Jefferson Clinton Bldg., Rm. 3334, 1301
table in paragraph (a)(1) to read as
Constitution Ave. NW., Washington, DC
follows:
20460–0001. The Public Reading Room
§ 180.613 Flonicamid; tolerances for
is open from 8:30 a.m. to 4:30 p.m.,
residues.
Monday through Friday, excluding legal
(a) * * *
holidays. The telephone number for the
(1) * * *
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Parts per Docket is (703) 305–5805. Please review
Commodity
million
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
*
*
*
*
*
Pea and bean, succulent shelled,
FOR FURTHER INFORMATION CONTACT:
subgroup 6B ..............................
7.0 Michael L. Goodis, Registration Division
Pea and bean, dried shelled, ex(7505P), Office of Pesticide Programs,
cept soybean, subgroup 6C ......
3.0
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
*
*
*
*
*
DC 20460–0001; main telephone
Vegetable, legume, edible podded, subgroup 6A .....................
4.0 number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
*
*
*
*
*
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Authority: 21 U.S.C. 321(q), 346a and 371.
*
*
*
*
I. General Information
*
[FR Doc. 2017–14339 Filed 7–6–17; 8:45 am]
A. Does this action apply to me?
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0218; FRL–9962–97]
asabaliauskas on DSKBBXCHB2PROD with RULES
Prosulfuron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of prosulfuron in
or on grain, cereal, forage, fodder, and
straw, group 16, stover; grain, cereal,
forage, fodder, and straw, group 16,
SUMMARY:
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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).
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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–2016–0218 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 September 5, 2017. 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–
2016–0218, 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 May 19,
2016 (81 FR 31581) (FRL–9946–02),
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 6F8455) by
Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC 27419. The
petition requested that 40 CFR 180.481
be amended by establishing tolerances
for residues of the herbicide
prosulfuron, (N-[[(4-methoxy-6-methyl1,3,5-triazin-2-yl)amino]carbonyl]-2(3,3,3trifluoropropyl)benzenesulfonamide), in
or on grain, cereal, forage, fodder, and
straw, group 16, fodder at 0.01 parts per
million (ppm); grain, cereal, forage,
fodder, and straw, group 16, forage at
0.10 ppm; grain, cereal, forage, fodder,
and straw, group 16, hay at 0.20 ppm;
grain, cereal, forage, fodder, and straw,
group 16, straw at 0.02 ppm; and grain,
cereal, group 15 at 0.01 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. 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 commodity definition from grain,
cereal, forage, fodder, and straw, group
16, fodder to grain, cereal, forage,
fodder, and straw, group 16, stover. The
reason for this change is explained in
Unit IV.C.
asabaliauskas on DSKBBXCHB2PROD with RULES
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
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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 prosulfuron
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with prosulfuron 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 most
prevalent effect observed across species
and study durations following
administration of prosulfuron was
decreased body weight observed in
subchronic and chronic oral toxicity
studies in rats and dogs. Additionally,
subchronic and chronic oral toxicity
studies in dogs showed decreased
hematological parameters and hepatic
toxicity. Evidence of neurotoxicity was
observed in an acute neurotoxicity
study but not in the subchronic
neurotoxicity study. The neurological
effects seen in the acute neurotoxicity
study were transient, affecting primary
sensorimotor and gait functions. In a
developmental range-finding study in
rabbits, ataxia, hypoactivity, and
neuropathology were observed starting
at doses of 150 mg/kg/day. However,
these potential signs of neurotoxicity
were not consistent with findings in the
two main developmental studies in
rabbits where there were no signs of
neurotoxicity observed up to 200 mg/kg/
day. Additionally, other repeated dosing
studies in the rat, mouse, and dog did
not show evidence of neurotoxicity.
There is no evidence that prosulfuron is
an immunotoxic chemical. Prosulfuron
is classified as ‘‘Not Likely to Be
Carcinogenic to Humans’’ based on the
lack of evidence of carcinogenicity in
mice and rats and no concern for
mutagenicity. Prosulfuron has low acute
toxicity by the oral, dermal, and
inhalation routes of exposure, it is not
considered an eye or skin irritant and it
is not a skin sensitizer.
There was no evidence from the
developmental and reproductive studies
of increased susceptibility in rat or
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rabbit fetuses. In the first of two rabbit
developmental studies, there were no
signs of maternal or developmental
toxicity. The second rabbit (tested using
higher doses than the first) and the rat
developmental studies showed doserelated increases in small fetuses and
skeletal effects but these occurred at
maternally toxic doses. In the
reproductive study in rats, decreases in
body weights were noted for both the
adults of the P0 and P1 generations and
for the F1 and F2 pups.
Specific information on the studies
received and the nature of the adverse
effects caused by prosulfuron 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 document
Prosulfuron. Human Health Risk
Assessment in Support of a Section 3
Petition for the Expansion of Crop
Groups 15 and 16 to Include Permanent
Tolerances for Residues of Prosulfuron
in Rice, pages 9–12 in docket ID number
EPA–HQ–OPP–2016–0218.
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://
www2.epa.gov/pesticide-scienceandassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for prosulfuron used for
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human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROSULFURON FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Acute dietary (Females 13–49
years of age) (General population including infants and
children).
Chronic dietary (All populations)
Cancer (Oral, dermal, inhalation).
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
NOAEL = 10 mg/kg/
day.
UFA = 10x
UFH = 10x FQPA SF
= 1x
NOAEL = 5.3 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.1 mg/
kg/day.
aPAD = 0.1 mg/kg/
day
Acute Neurotoxicity Study—Rat
MRID 43387703
LOAEL = 250 mg/kg/day based on abnormal gait in females.
Chronic RfD = 0.053
mg/kg/day.
cPAD = 0.053 mg/
kg/day
Subchronic Oral Toxicity Study—Dog
MRID 42685230
LOAEL = 54 mg/kg/day based on decreased feed efficiency,
hematological findings and hepatotoxicity in both sexes.
Study and toxicological effects
Prosulfuron is classified as ‘‘Not Likely to Be Carcinogenic to Humans’’ based on the lack of evidence of carcinogenicity in mice and rats and no concern for mutagenicity.
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).
asabaliauskas on DSKBBXCHB2PROD with RULES
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to prosulfuron, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing prosulfuron tolerances in 40
CFR 180.481. EPA assessed dietary
exposures from prosulfuron 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
prosulfuron. In estimating acute dietary
exposure, EPA used food consumption
information from the United States
Department of Agriculture (USDA)
Nationwide Health and Nutrition
Examination Survey, What We Eat In
America (NHANES/WWEIA) conducted
from 2003–2008. As to residue levels in
food, the acute dietary analysis was
obtained from the Dietary Exposure
Evaluation Model using the Food
Commodity Intake Database (DEEM–
FCID; version 3.18) and assumed 100
percent crop treated (PCT) and
tolerance-level residues.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used the food
consumption data from the USDA
NHANES/WWEIA conducted from
2003–2008. As to residue levels in food,
the chronic dietary analysis was
obtained from the DEEM–FCID; version
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3.18 database and assumed 100 PCT and
tolerance-level residues.
iii. Cancer. EPA has concluded that
prosulfuron 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 prosulfuron. Tolerance-level
residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening-level
water exposure models in the dietary
exposure analysis and risk assessment
for prosulfuron in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of prosulfuron.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www2.epa.gov/pesticidescienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the Tier 1 Rice Model and
Pesticide Root Zone Model Ground
Water (PRZM GW), the estimated
drinking water concentrations (EDWCs)
of prosulfuron for both acute exposures
and chronic exposures for non-cancer
assessments are estimated to be 37 parts
per billion (ppb) for both surface water
and ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute and chronic dietary risk
assessment, the water concentration
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value of 37 ppb was used to assess the
contribution to drinking water.
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).
Prosulfuron is not registered for any
specific use patterns that would result
in residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found prosulfuron to
share a common mechanism of toxicity
with any other substances, and
prosulfuron does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that prosulfuron 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 Web site 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
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.
The prenatal and postnatal toxicity
database for prosulfuron includes a
developmental toxicity study in the rat,
two developmental toxicity studies and
a range-finding developmental study in
the rabbit, and a 2-generation
reproduction toxicity study in the rat.
There was no evidence of increased
susceptibility of fetuses or offspring in
any of these studies.
There were no maternal or fetal effects
observed at any dose in the first of two
rabbit developmental toxicity studies. In
the second rabbit study and in the rat
developmental toxicity study, a doserelated increase in small fetuses and
skeletal effects was observed, but only
in the presence of maternal toxicity
(decreased body weight gain in the rat
study; and increases in abortions,
decreases in food consumption and
decreased mean body weight gain in the
rabbit study).
In the developmental range-finding
study in rabbits, ataxia, hypoactivity,
and neuropathology were observed
starting at doses of 150 mg/kg/day.
However, these potential signs of
neurotoxicity were not consistent with
findings in the two main developmental
studies in rabbits where there were no
signs of neurotoxicity observed up to
200 mg/kg/day. In the 2-generation
reproduction study in the rat, decreases
in body weight were observed in the F1
and F2 offspring but these occurred at
doses in which parental toxicity was
also observed. There was no evidence of
neurotoxicity to fetuses or offspring
observed in any of the developmental or
reproduction toxicity studies.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the Food Quality
Protection Act Safety Factor (FQPA SF)
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were reduced to 1x. That decision is
based on the following findings:
i. The toxicity database for
prosulfuron is complete.
ii. Although there was evidence of
neurotoxicity in the acute neurotoxicity
study and the range-finding
developmental toxicity rabbit study, the
selected endpoints are protective of
these effects since they were seen at
dose levels in excess of those where
systemic toxicity occurred and at doses
at least 15–fold higher than the noobserved adverse effect levels (NOAELs)
selected for risk assessment. Concern is
also low since no neurotoxicity was
observed in the rest of the prosulfuron
toxicological database, including the
subchronic neurotoxicity study in rats.
iii. As discussed in Unit III.D.2., there
is no evidence that prosulfuron results
in increased susceptibility in in utero
rats or rabbits in the prenatal
developmental studies or in young rats
in the 2-generation reproduction study.
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 prosulfuron
in drinking water. These assessments
will not underestimate the exposure and
risks posed by prosulfuron.
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
prosulfuron will occupy 6.4% of the
aPAD for all infants (< 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 prosulfuron
from food and water will utilize 3.9% of
the cPAD for all infants (< 1 years old),
the population group receiving the
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greatest exposure. There are no
residential uses for prosulfuron.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
A short-term adverse effect was
identified; however, prosulfuron is not
registered for any use patterns that
would result in short-term residential
exposure. Short-term risk is assessed
based on short-term residential
exposure plus chronic dietary exposure.
Because there is no short-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the POD used to assess short-term risk),
no further assessment of short-term risk
is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating short-term risk for
prosulfuron.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
An intermediate-term adverse effect
was identified; however, prosulfuron is
not registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
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 intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for
prosulfuron.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
prosulfuron is not expected to pose a
cancer risk to humans.
6. 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 prosulfuron
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
Method AG–590C (a high performance
liquid chromatography method with
column switching and ultraviolet (UV)
detection), is available to enforce the
tolerance expression.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (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 a MRL
for prosulfuron.
asabaliauskas on DSKBBXCHB2PROD with RULES
C. Revisions to Petitioned-For
Tolerances
EPA has revised the commodity
definition from ‘‘grain, cereal, forage,
fodder, and straw, group 16, fodder’’ to
‘‘grain, cereal, forage, fodder, and straw,
group 16, stover’’ to be consistent with
the general food and feed commodity
vocabulary EPA uses for tolerances and
exemptions.
V. Conclusion
Therefore, tolerances are established
for residues of prosulfuron, (N-[[(4methoxy-6-methyl-1,3,5-triazin-2yl)amino]carbonyl]-2-(3,3,3trifluoropropyl)benzenesulfonamide),
including its metabolites and
degradates, in or on grain, cereal, forage,
fodder, and straw, group 16, stover at
0.01 ppm; grain, cereal, forage, fodder,
and straw, group 16, forage at 0.10 ppm;
grain, cereal, forage, fodder, and straw,
group 16, hay at 0.20 ppm; grain, cereal,
forage, fodder, and straw, group 16,
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17:43 Jul 06, 2017
Jkt 241001
straw at 0.02 ppm; and grain, cereal,
group 15 at 0.01 ppm.
In addition, EPA has revised the
tolerance expression to clarify (1) that,
as provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
degradates of prosulfuron not
specifically mentioned; and (2) that
compliance with the specified tolerance
levels is to be determined by measuring
only the specific compounds mentioned
in the tolerance expression. EPA has
determined that it is reasonable to make
this change final without prior proposal
and opportunity for comment, because
public comment is not necessary, in that
the change has no substantive effect on
the tolerance, but rather is merely
intended to clarify the existing tolerance
expression.
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). 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
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
31475
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: June 8, 2017.
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 § 180.481, paragraph (a) is
revised to read as follows:
■
§ 180.481 Prosulfuron; tolerances for
residues.
(a) General. Tolerances are
established for residues of prosulfuron,
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07JYR1
31476
Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations
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
prosulfuron (N-[[(4-methoxy-6-methyl1,3,5-triazin-2-yl)amino]carbonyl]-2(3,3,3-trifluoropropyl)
benzenesulfonamide) in or on the
commodity.
Commodity
Grain, cereal, forage, fodder,
and straw, group 16, forage ....................................
Grain, cereal, forage, fodder,
and straw, group 16, hay ..
Grain, cereal, forage, fodder,
and straw, group 16, stover .....................................
Grain, cereal, forage, fodder,
and straw, group 16, straw
Grain, cereal, group 15 ........
*
*
*
*
eligible petitioners in lieu of Amtrak to
operate not more than three longdistance routes (as defined in 49 U.S.C.
24102), and operated by Amtrak on the
date of enactment of the Passenger Rail
Reform and Investment Act of 2015
(title XI of the Fixing America’s Surface
Transportation (FAST) Act, Pub. L. 114–
94, 129 Stat. 1312, 1660–1664 (2015)).
The final rule establishes a petition,
notification, and bid process by which
Parts per
FRA will evaluate, and ultimately
million
select, bids to provide passenger rail
service over particular long-distance
routes. The final rule also, among other
0.10 things, addresses FRA’s execution of a
contract with the winning bidder
0.20 awarding the right and obligation to
provide intercity passenger rail service
over the route, along with an operating
0.01
subsidy, subject to the 49 U.S.C. 24405
0.02 grant conditions and such performance
0.01 standards as the Secretary of
Transportation (Secretary) may require.
*
b. Procedural History
[FR Doc. 2017–14315 Filed 7–6–17; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
Federal Railroad Administration
49 CFR Part 269
[Docket No. FRA–2016–0023; Notice No. 4]
RIN 2130–AC60
Competitive Passenger Rail Service
Pilot Program
Federal Railroad
Administration (FRA), Department of
Transportation (DOT).
ACTION: Final rule.
AGENCY:
This final rule implements a
pilot program for competitive selection
of eligible petitioners in lieu of Amtrak
to operate not more than three longdistance routes operated by Amtrak. The
final rule is required by statute.
DATES: This final rule is effective on
September 5, 2017.
FOR FURTHER INFORMATION CONTACT:
Brandon White, Office of Railroad
Policy and Development, FRA, 1200
New Jersey Ave. SE., Washington, DC
20590, (202) 493–1327, or Zeb Schorr,
Office of Chief Counsel, FRA, 1200 New
Jersey Ave. SE., Mail Stop 10,
Washington, DC 20590, (202) 493–6072.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSKBBXCHB2PROD with RULES
SUMMARY:
I. Background
a. Executive Summary of Final Rule
This final rule implements a pilot
program for competitive selection of
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17:43 Jul 06, 2017
Jkt 241001
By notice of proposed rulemaking
(NPRM) published on June 22, 2016 (81
FR 40624), FRA proposed a competitive
passenger rail service pilot program in
response to a statutory mandate in
section 11307 of the FAST Act. In
response to a request for a public
hearing, FRA held a public hearing on
September 7, 2016. FRA also extended
the comment period for the NPRM to
October 7, 2016 to allow time for
interested parties to submit written
comments in response to information
provided at the public hearing.
FRA received comments from the
American Association of Private
Railroad Car Owners, the Association of
Independent Passenger Rail Operators,
the National Association of Railroad
Passengers, Herzog Transit Services,
Corridor Capital, Iowa Pacific Holdings,
Florida East Coast Industries, Erie
Lackawanna Railroad, the North
Carolina Department of Transportation,
the National Railroad Passenger
Corporation (Amtrak), the Brotherhood
of Maintenance of Way Employees
Division/International Brotherhood of
Teamsters, the Brotherhood of Railroad
Signalmen, the International
Association of Sheet Metal, Air, Rail,
and Transportation Workers/Mechanical
Division, the Transportation Trades
Department of the American Federation
of Labor-Congress of Industrial
Organizations, and one individual.
Comments are addressed in the
preamble. Some comments were
generally supportive of the NPRM, and
other comments were generally
unsupportive of the NPRM.
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Fmt 4700
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c. Timelines Established by the Final
Rule
The final rule establishes deadlines
for filing petitions, filing bids, and the
execution of contract(s) with winning
bidders.
As to the filing of petitions, § 269.7(b)
of the final rule requires the filing of a
petition with FRA no later than 180
days after the effective date of the final
rule implementing the pilot program
(petition window). In the NPRM, FRA
proposed a 60 day petition window
from the publication of the final rule.
Several commenters stated the proposed
60 day petition window should be
extended to 120 or 180 days. Other
commenters stated the petition window
should remain 60 days. Still other
commenters stated the petition window
should be eliminated and the pilot
program should remain available
indefinitely.
After careful consideration of these
comments, the final rule establishes a
180 day petition window, balancing the
need for sufficient time to produce
quality petitions and bids with the
desire to encourage competition and
efficiently use Federal and Amtrak
resources. This extended time period
will ensure an eligible petitioner has an
adequate amount of time to file a
petition. It is important to also note the
final rule establishes the effective date
of the final rule as the trigger for the 180
day period (rather than the date the final
rule is published, as proposed in the
NPRM). This change effectively gives
eligible petitioners 60 more days (in
addition to the 180 days) to file a
petition. The final rule does not adopt
the suggestion of some commenters that
the pilot program be ‘‘evergreen.’’ First,
the FAST Act does not require the pilot
program to remain available
indefinitely. Second, an evergreen pilot
program may unduly burden the FRA
and Amtrak by imposing an indefinite
regulatory burden to maintain program
readiness. Finally, FRA believes
competition is best fostered by a limited
duration petition window allowing FRA
to evaluate multiple bidders competing
for the same route.
When an eligible petitioner files a
petition, under § 269.9(a) of the final
rule, FRA will notify the petitioner and
Amtrak of receipt of the petition, and
publish a notice of receipt in the
Federal Register, not later than 30 days
after receipt. See 49 U.S.C.
24711(b)(1)(B)(i).
Section 269.9(b) of the final rule
addresses the filing of bids. This section
requires both the bidder and Amtrak, if
Amtrak so chooses, to submit complete
bids to FRA not later than 120 days after
E:\FR\FM\07JYR1.SGM
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Agencies
[Federal Register Volume 82, Number 129 (Friday, July 7, 2017)]
[Rules and Regulations]
[Pages 31471-31476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14315]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0218; FRL-9962-97]
Prosulfuron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
prosulfuron in or on grain, cereal, forage, fodder, and straw, group
16, stover; grain, cereal, forage, fodder, and straw, group 16, forage;
grain, cereal, forage, fodder, and straw, group 16, hay; grain, cereal,
forage, fodder, and straw, group 16, straw; and grain, cereal, group
15. Syngenta Crop Protection, LLC requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 7, 2017. Objections and
requests for hearings must be received on or before September 5, 2017,
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-2016-0218, 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 L. 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:
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/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-2016-0218 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
September 5, 2017. 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-2016-0218, 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.
[[Page 31472]]
II. Summary of Petitioned-For Tolerance
In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-
02), 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
6F8455) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.481 be amended by
establishing tolerances for residues of the herbicide prosulfuron, (N-
[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-
trifluoropropyl)benzenesulfonamide), in or on grain, cereal, forage,
fodder, and straw, group 16, fodder at 0.01 parts per million (ppm);
grain, cereal, forage, fodder, and straw, group 16, forage at 0.10 ppm;
grain, cereal, forage, fodder, and straw, group 16, hay at 0.20 ppm;
grain, cereal, forage, fodder, and straw, group 16, straw at 0.02 ppm;
and grain, cereal, group 15 at 0.01 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. 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 commodity definition from grain, cereal, forage, fodder,
and straw, group 16, fodder to grain, cereal, forage, fodder, and
straw, group 16, stover. The reason for this change is 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 prosulfuron including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with prosulfuron 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 most prevalent effect observed across species and study
durations following administration of prosulfuron was decreased body
weight observed in subchronic and chronic oral toxicity studies in rats
and dogs. Additionally, subchronic and chronic oral toxicity studies in
dogs showed decreased hematological parameters and hepatic toxicity.
Evidence of neurotoxicity was observed in an acute neurotoxicity study
but not in the subchronic neurotoxicity study. The neurological effects
seen in the acute neurotoxicity study were transient, affecting primary
sensorimotor and gait functions. In a developmental range-finding study
in rabbits, ataxia, hypoactivity, and neuropathology were observed
starting at doses of 150 mg/kg/day. However, these potential signs of
neurotoxicity were not consistent with findings in the two main
developmental studies in rabbits where there were no signs of
neurotoxicity observed up to 200 mg/kg/day. Additionally, other
repeated dosing studies in the rat, mouse, and dog did not show
evidence of neurotoxicity. There is no evidence that prosulfuron is an
immunotoxic chemical. Prosulfuron is classified as ``Not Likely to Be
Carcinogenic to Humans'' based on the lack of evidence of
carcinogenicity in mice and rats and no concern for mutagenicity.
Prosulfuron has low acute toxicity by the oral, dermal, and inhalation
routes of exposure, it is not considered an eye or skin irritant and it
is not a skin sensitizer.
There was no evidence from the developmental and reproductive
studies of increased susceptibility in rat or rabbit fetuses. In the
first of two rabbit developmental studies, there were no signs of
maternal or developmental toxicity. The second rabbit (tested using
higher doses than the first) and the rat developmental studies showed
dose-related increases in small fetuses and skeletal effects but these
occurred at maternally toxic doses. In the reproductive study in rats,
decreases in body weights were noted for both the adults of the
P0 and P1 generations and for the F1
and F2 pups.
Specific information on the studies received and the nature of the
adverse effects caused by prosulfuron 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 document Prosulfuron. Human Health Risk
Assessment in Support of a Section 3 Petition for the Expansion of Crop
Groups 15 and 16 to Include Permanent Tolerances for Residues of
Prosulfuron in Rice, pages 9-12 in docket ID number EPA-HQ-OPP-2016-
0218.
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://www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for prosulfuron used for
[[Page 31473]]
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Prosulfuron 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 NOAEL = 10 mg/kg/day Acute RfD = 0.1 mg/ Acute Neurotoxicity Study--Rat
years of age) (General UFA = 10x........... kg/day. MRID 43387703
population including infants and UFH = 10x FQPA SF = aPAD = 0.1 mg/kg/ LOAEL = 250 mg/kg/day based on
children). 1x. day. abnormal gait in females.
Chronic dietary (All populations) NOAEL = 5.3 mg/kg/ Chronic RfD = 0.053 Subchronic Oral Toxicity Study--
day. mg/kg/day. Dog
UFA = 10x........... cPAD = 0.053 mg/kg/ MRID 42685230
UFH = 10x........... day. LOAEL = 54 mg/kg/day based on
FQPA SF = 1x........ decreased feed efficiency,
hematological findings and
hepatotoxicity in both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Prosulfuron is classified as ``Not Likely to Be Carcinogenic to Humans''
based on the lack of evidence of carcinogenicity in mice and rats and no
concern for mutagenicity.
----------------------------------------------------------------------------------------------------------------
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 prosulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing prosulfuron tolerances in 40 CFR
180.481. EPA assessed dietary exposures from prosulfuron 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 prosulfuron. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) Nationwide Health and Nutrition
Examination Survey, What We Eat In America (NHANES/WWEIA) conducted
from 2003-2008. As to residue levels in food, the acute dietary
analysis was obtained from the Dietary Exposure Evaluation Model using
the Food Commodity Intake Database (DEEM-FCID; version 3.18) and
assumed 100 percent crop treated (PCT) and tolerance-level residues.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, the
chronic dietary analysis was obtained from the DEEM-FCID; version 3.18
database and assumed 100 PCT and tolerance-level residues.
iii. Cancer. EPA has concluded that prosulfuron 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 prosulfuron. Tolerance-level residues and/or 100
PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for prosulfuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of prosulfuron. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Tier 1 Rice Model and Pesticide Root Zone Model Ground
Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of
prosulfuron for both acute exposures and chronic exposures for non-
cancer assessments are estimated to be 37 parts per billion (ppb) for
both surface water and ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute and chronic dietary
risk assessment, the water concentration value of 37 ppb was used to
assess the contribution to drinking water.
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). Prosulfuron is not
registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found prosulfuron to share a common mechanism of
toxicity with any other substances, and prosulfuron does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
prosulfuron 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 Web site at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulativeassessment-risk-pesticides.
[[Page 31474]]
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for prosulfuron includes a developmental toxicity
study in the rat, two developmental toxicity studies and a range-
finding developmental study in the rabbit, and a 2-generation
reproduction toxicity study in the rat. There was no evidence of
increased susceptibility of fetuses or offspring in any of these
studies.
There were no maternal or fetal effects observed at any dose in the
first of two rabbit developmental toxicity studies. In the second
rabbit study and in the rat developmental toxicity study, a dose-
related increase in small fetuses and skeletal effects was observed,
but only in the presence of maternal toxicity (decreased body weight
gain in the rat study; and increases in abortions, decreases in food
consumption and decreased mean body weight gain in the rabbit study).
In the developmental range-finding study in rabbits, ataxia,
hypoactivity, and neuropathology were observed starting at doses of 150
mg/kg/day. However, these potential signs of neurotoxicity were not
consistent with findings in the two main developmental studies in
rabbits where there were no signs of neurotoxicity observed up to 200
mg/kg/day. In the 2-generation reproduction study in the rat, decreases
in body weight were observed in the F1 and F2
offspring but these occurred at doses in which parental toxicity was
also observed. There was no evidence of neurotoxicity to fetuses or
offspring observed in any of the developmental or reproduction toxicity
studies.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
Food Quality Protection Act Safety Factor (FQPA SF) were reduced to 1x.
That decision is based on the following findings:
i. The toxicity database for prosulfuron is complete.
ii. Although there was evidence of neurotoxicity in the acute
neurotoxicity study and the range-finding developmental toxicity rabbit
study, the selected endpoints are protective of these effects since
they were seen at dose levels in excess of those where systemic
toxicity occurred and at doses at least 15-fold higher than the no-
observed adverse effect levels (NOAELs) selected for risk assessment.
Concern is also low since no neurotoxicity was observed in the rest of
the prosulfuron toxicological database, including the subchronic
neurotoxicity study in rats.
iii. As discussed in Unit III.D.2., there is no evidence that
prosulfuron results in increased susceptibility in in utero rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study.
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 prosulfuron in drinking water. These assessments
will not underestimate the exposure and risks posed by prosulfuron.
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 prosulfuron will occupy 6.4% of the aPAD for all infants (< 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
prosulfuron from food and water will utilize 3.9% of the cPAD for all
infants (< 1 years old), the population group receiving the greatest
exposure. There are no residential uses for prosulfuron.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
A short-term adverse effect was identified; however, prosulfuron is
not registered for any use patterns that would result in short-term
residential exposure. Short-term risk is assessed based on short-term
residential exposure plus chronic dietary exposure. Because there is no
short-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of short-term risk is necessary, and EPA relies on
the chronic dietary risk assessment for evaluating short-term risk for
prosulfuron.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
An intermediate-term adverse effect was identified; however,
prosulfuron is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no 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 intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
prosulfuron.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, prosulfuron is not expected to pose a cancer risk to humans.
6. 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 prosulfuron residues.
[[Page 31475]]
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, Method AG-590C (a high
performance liquid chromatography method with column switching and
ultraviolet (UV) detection), is available to enforce the tolerance
expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (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 a MRL for prosulfuron.
C. Revisions to Petitioned-For Tolerances
EPA has revised the commodity definition from ``grain, cereal,
forage, fodder, and straw, group 16, fodder'' to ``grain, cereal,
forage, fodder, and straw, group 16, stover'' to be consistent with the
general food and feed commodity vocabulary EPA uses for tolerances and
exemptions.
V. Conclusion
Therefore, tolerances are established for residues of prosulfuron,
(N-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-
trifluoropropyl)benzenesulfonamide), including its metabolites and
degradates, in or on grain, cereal, forage, fodder, and straw, group
16, stover at 0.01 ppm; grain, cereal, forage, fodder, and straw, group
16, forage at 0.10 ppm; grain, cereal, forage, fodder, and straw, group
16, hay at 0.20 ppm; grain, cereal, forage, fodder, and straw, group
16, straw at 0.02 ppm; and grain, cereal, group 15 at 0.01 ppm.
In addition, EPA has revised the tolerance expression to clarify
(1) that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of prosulfuron not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression. EPA has determined that it is reasonable to make
this change final without prior proposal and opportunity for comment,
because public comment is not necessary, in that the change has no
substantive effect on the tolerance, but rather is merely intended to
clarify the existing tolerance expression.
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). 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: June 8, 2017.
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. 180.481, paragraph (a) is revised to read as follows:
Sec. 180.481 Prosulfuron; tolerances for residues.
(a) General. Tolerances are established for residues of
prosulfuron,
[[Page 31476]]
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 prosulfuron (N-[[(4-methoxy-6-
methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-trifluoropropyl)
benzenesulfonamide) in or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Grain, cereal, forage, fodder, and straw, group 16, 0.10
forage.................................................
Grain, cereal, forage, fodder, and straw, group 16, hay. 0.20
Grain, cereal, forage, fodder, and straw, group 16, 0.01
stover.................................................
Grain, cereal, forage, fodder, and straw, group 16, 0.02
straw..................................................
Grain, cereal, group 15................................. 0.01
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-14315 Filed 7-6-17; 8:45 am]
BILLING CODE 6560-50-P