Rimsulfuron; Pesticide Tolerances, 5942-5947 [2018-02676]
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Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Rules and Regulations
adopted on December 7, 1990 and
revised on December 4, 2006.
(B) Mojave Desert Air Quality
Management District.
(1) Rule 444, adopted on October 8,
1976 and amended on September 25,
2006.
(2) Rule 1106, Marine Coating
Operations, adopted on August 28, 2006
and amended on October 23, 2006.
(3) Previously approved on July 16,
2008 in paragraph (c)(350)(i)(B)(2) of
this section and now deleted with
replacement in (c)(498)(i)(B)(1), Rule
1106, adopted on August 28, 2006 and
amended on October 23, 2006.
*
*
*
*
*
(498) * * *
(i) * * *
(B) Mojave Desert Air Quality
Management District.
(1) Rule 1106, ‘‘Marine and Pleasure
Craft Coating Operations,’’ amended on
October 24, 2016.
[FR Doc. 2018–02669 Filed 2–9–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0516; FRL–9972–36]
Rimsulfuron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances, including tolerances with
regional registration, for residues of
rimsulfuron in or on multiple
commodities that are identified and
discussed later in this document. In
addition, this regulation removes
several previously established
tolerances that are superseded by this
final rule. 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 12, 2018. Objections and
requests for hearings must be received
on or before April 13, 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–2016–0516, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
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SUMMARY:
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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/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–2016–0516 in the subject line on
the first page of your submission. All
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objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before April 13, 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
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0516, 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 Thursday,
March 23, 2017 (82 FR 14846) (FRL–
9957–99), 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 6E8496) by
IR–4 Headquarters, Rutgers, The State
University of New Jersey, 500 College
Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40
CFR 180.478 be amended by
establishing tolerances for residues of
the herbicide rimsulfuron, N-[[(4,6dimethoxy-2-pyrimidinyl)amino]
carbonyl]-3-(ethylsulfonyl)-2pyridinesulfonamide, in or on Berry,
low growing, except strawberry,
subgroup 13–07H at 0.01 parts per
million (ppm); Fruit, citrus, group 10–
10 at 0.01 ppm; Fruit, pome, group 11–
10 at 0.01 ppm; Fruit, small, vine
climbing, except fuzzy kiwifruit,
subgroup 13–07F at 0.01 ppm; Fruit,
stone, group 12–12 at 0.01 ppm; Nut,
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tree, group 14–12 at 0.01 ppm;
Vegetable, tuberous and corm, subgroup
1C at 0.1 ppm; and tolerances with
regional restrictions in or on Fescue,
forage at 0.01 ppm; Fescue, hay at 0.01
ppm; Ryegrass, perennial, forage at 0.01
ppm; and Ryegrass, perennial, hay at
0.01 ppm. That document referenced a
summary of the petition prepared by E.
I. du Pont de Nemours and Company,
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 is
establishing tolerance levels that vary
from what the petition requested. The
reason for these changes are explained
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 rimsulfuron
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with rimsulfuron 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
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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 toxicity database indicates that
target organs for rimsulfuron are the
liver and kidney in the rat and dog,
along with the testis and blood in the
mouse and dog. In the mouse, the
stomach was also a target organ.
Adverse changes in body weight and
food consumption were observed in
rats, mice and dogs. In subchronic and
chronic toxicity studies in rats, toxic
effects included decreased body weight,
decreased body weight gain, increased
relative liver and absolute kidney
weights, and diuresis. In the subchronic
study in mice, increased red blood cell
and hemoglobin, and decreased body
weight gain and food efficiency were
observed. In the chronic study in mice,
decreased body weight, increased
incidences of dilation and cysts in the
glandular stomach, and degeneration of
the testicular artery and tunica
albuginea were observed. In the
subchronic study in dogs, diuresis was
indicated by urinary volume, platelet
concentration and kidney weights
accompanied by decreased urinary
osmolality. In the chronic study in dogs,
increased absolute liver and kidney
weights, increased seminiferous tubule
degeneration, and increased number of
spermatid giant cells present in
epididymides in males were observed.
In the developmental toxicity study in
rats, no toxicity was seen at the highest
dose tested (HDT). In the developmental
toxicity study in rabbits, and in the 2generation reproduction toxicity study
in rats, developmental/offspring toxicity
was seen in the presence of maternal/
systemic toxicity and at similar dose
levels. There is no quantitative or
qualitative evidence of increased
susceptibility following pre- and/or
post-natal exposures in the
developmental and reproduction
studies.
There is no indication in the database
that rimsulfuron is neurotoxic or
immunotoxic. Rimsulfuron is not
mutagenic and has been classified as
‘‘not likely to be carcinogenic to
humans,’’ based on the lack of evidence
for carcinogenicity in studies conducted
in rats and mice.
Specific information on the studies
received and the nature of the adverse
effects caused by rimsulfuron as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
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toxicity studies can be found at https://
www.regulations.gov in document
entitled, ‘‘SUBJECT: Rimsulfuron.
Human Health Risk Assessment in
Support of a Petition (PP#6E8496) for
the Establishment of Permanent
Tolerances on Tuberous and Corm
Vegetable Subgroup 1C, Small Vine
Climbing Fruit Except Fuzzy Kiwifruit
Subgroup 13–07F, Low Growing Berry
Except Strawberry Subgroup 13–07H,
Tolerances with Regional Registrations
for Ryegrass and Fescue and Crop Group
Conversions for Citrus Fruit Group 10–
10, Pome Fruit Group 11–10, Stone
Fruit Group 12–12, and Tree Nut Group
14–12,’’ dated May 5, 2017 at pp. 31–
34 in docket ID number EPA–HQ–OPP–
2016–0516.
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/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for rimsulfuron used for
human risk assessment is shown in
Table 1 of this unit.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR RIMSULFURON FOR
USE IN HUMAN HEALTH RISK ASSESSMENT
Exposure/scenario
Point of
departure and
uncertainty/safety
factors
Acute Dietary (All populations)
RfD, PAD, LOC
for risk
assessment
Study and toxicological effects
An endpoint attributable to a single dose was not identified in the database.
Chronic dietary (All populations)
NOAEL= 11.8 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.118
mg/kg/day.
cPAD = 0.118 mg/
kg/day
Combined Chronic/Carcinogenicity—Rat.
LOAEL = 121 mg/kg/day based on decreased body weight
gains and liver effects.
Cancer (Oral, dermal, inhalation).
Rimsulfuron is considered ‘‘not likely to be carcinogenic to humans’’ due to the absence of tumors in the available rat and mouse carcinogenicity studies.
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FQPA SF = Food Quality Protection Act Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect
level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, LOC = level of concern, 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 rimsulfuron, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing rimsulfuron tolerances in 40
CFR 180.478. EPA assessed dietary
exposures from rimsulfuron in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure. No such effects were
identified in the toxicological studies
for rimsulfuron; therefore, a quantitative
acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the United States Department of
Agriculture (USDA) 2003–2008 National
Health and Nutrition Examination
Survey, What We Eat in America
(NHANES/WWEIA). As to residue levels
in food, EPA assumed that rimsulfuron
residues were present at tolerance levels
in all commodities for which tolerances
have been established and currently
proposed, and 100 percent crop treated
(PCT) with rimsulfuron.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that rimsulfuron 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 or PCT
information in the dietary assessment
for rimsulfuron. Tolerance level
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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 rimsulfuron in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of rimsulfuron.
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.
Based on the Pesticides in Flooded
Applications Model (PFAM) and the
Wisconsin cranberry (worst case)
scenario to conduct an assessment of
surface water exposure to total toxic
residue (TTR) of rimsulfuron (PFAM
model was developed specifically for
regulatory applications to estimate
exposure for pesticides used in flooded
agriculture such as rice paddies and
cranberry bogs) and Pesticide Root Zone
Model Ground Water (PRZM GW) and
the Tier I assessment for applications of
rimsulfuron to corn in Wisconsin (worst
case), the estimated drinking water
concentrations (EDWCs) of rimsulfuron
for acute exposures are estimated to be
9.59 parts per billion (ppb) for surface
water and 22.2 ppb for ground water.
Chronic exposures for non-cancer
assessments are estimated to be 1.70
ppb for surface water and 19.7 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 19.7 ppb
was used to assess the contribution to
drinking water.
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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).
Rimsulfuron 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.’’
Rimsulfuron belongs to the class of
pesticides known as sulfonylureas
(SUs). The SUs share a core chemical
structure with varying degrees of
structural similarity. In addition, the
SUs share a pesticidal mode of action
(i.e., the inhibition of acetolactate
synthase (ALS)), although the function
of ALS in humans is unknown and the
relevance of this mode of action (MOA)
in humans in unclear. Based on toxicity
studies, the SUs do not share a common
toxicological profile; instead the target
organs vary among the class and are
often unspecific, such as changes in
body weight or general effects on the
liver. Further dividing the SUs into
subclasses based on the urea substituent
did not result in a clear association of
a target organ with any particular
substructure.
Based on the weight of the evidence,
considering the lack of common
toxicological profile of the SUs, the
uncertainty in the human relevance of
ALS inhibition, and the lack of
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mammalian MOA data, a testable
hypothesis for a common mechanism of
action cannot be identified. Therefore,
the Agency concludes that no common
mechanism of toxicity exists among
these pesticides and a cumulative risk
assessment (CRA) approach is not
appropriate for this class of pesticides.
For further explanation, see ‘‘SUBJECT:
Sulfonylureas: Screening Analysis of
Toxicological Profiles to Consider
Whether a Candidate Common
Mechanism Group Can Be Established’’,
dated 9/9/2015, found at https://
www.regulations.gov in docket ID
number EPA–HQ–OPP–2016–0516.
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-scienceand-assessing-pesticide-risks/
cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA 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.
In the developmental toxicity study in
rats, no developmental toxicity was seen
at the highest dose tested. In the
developmental toxicity study in rabbits
and in the 2-generation reproductive
study in rats, developmental and
offspring toxicity were seen only in the
presence of maternal/systemic toxicity.
There is no evidence of quantitative or
qualitative increased susceptibility
following pre- and/or postnatal
exposures to rimsulfuron.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
rimsulfuron is complete.
ii. There is no indication that
rimsulfuron is a neurotoxic chemical
and there is no need for a
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developmental neurotoxicity study or
increased SF to account for
neurotoxicity.
iii. There is no evidence that
rimsulfuron 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. No
acute toxicological endpoint was
identified. The chronic dietary food and
drinking water exposure assessment
utilizes tolerance-level residues and 100
PCT information for all commodities.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to rimsulfuron in drinking water. These
assessments will not underestimate the
exposure and risks posed by
rimsulfuron.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, rimsulfuron is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to rimsulfuron
from food and water will utilize 1.5% of
the cPAD for all infants less than 1 year
old, the population group receiving the
greatest exposure. There are no
residential uses for rimsulfuron.
Therefore, the chronic aggregate risk is
the same as the chronic dietary risk and
not of concern.
3. Short- and intermediate-term risks.
Short- and intermediate-term aggregate
exposures take into account short- and
intermediate-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). Because there is no
short- or intermediate-term residential
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exposure and chronic dietary exposure
has already been assessed under the
appropriately protective cPAD, no
further assessment of short- or
intermediate-term risk is necessary.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
rimsulfuron 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 rimsulfuron
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
DuPont method 15033 using highperformance liquid chromatography/
electrospray ionization tandem mass
spectrometry (HPLC/ESI–MS/MS), is
available for determination of residues
of rimsulfuron in petitioned-for
commodities.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established MRLs
for residues of rimsulfuron in/on any
commodity associated with this action.
C. International Trade Considerations
In this final rule, EPA is establishing
a crop subgroup tolerance for subgroup
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1C (vegetable, tuberous and corm,
subgroup 1C) at 0.10 ppm. This
subgroup includes the commodity
potato, for which a tolerance is
currently set at 0.1 ppm. Setting a new
tolerance at 0.10 ppm on potato as part
of subgroup 1C has a theoretically trade
restrictive effect on the import of
potatoes, resulting from rounding to
significant figures when quantifying
residues of rimsulfuron, compared with
the current tolerance of 0.1 ppm.
In accordance with the World Trade
Organization’s (WTO) Sanitary and
Phytosanitary Measures (SPS)
Agreement, EPA intends to promptly
publish this action with the WTO.
Although he subgroup 1C tolerance is
being established at 0.10 ppm and is
unlikely to impact trade, EPA is
establishing an expiration date for the
existing potato tolerance following
publication of this rule in order to
provide a six-month reasonable interval
for producers in exporting countries to
adapt the modified tolerance. Before
that date, residues of rimsulfuron on
potato will be permitted under the
current tolerance of 0.1 ppm; after that
date, residues will need to be in
compliance with the new 0.10 ppm
subgroup 1C tolerance level.
The tolerance level is appropriate
based on available data and residues
levels resulting from registered use
patterns. The tolerance level for all
subgroup 1C commodities is not
discriminatory; the same food safety
standard contained in the FFDCA
applies equally to domestically
produced and imported foods. None of
the other tolerance actions taken in this
rulemaking restrict permissible
pesticide residues below currently
allowed levels in the United States.
Any commodities listed in the
regulatory text of this document that are
treated with the pesticides subject to
this final rule, and that are in the
channels of trade following the
tolerance revocation, shall be subject to
FFDCA section 408(1)(5), as established
by FQPA. Under this unit, any residues
of these pesticides in or on such food
shall not render the food adulterated so
long as it is shown to the satisfaction of
the Food and Drug Administration that:
1. The residue is present as the result
of an application or use of the pesticide
at a time and in a manner that was
lawful under FIFRA.
2. The residue does not exceed the
level that was authorized at the time of
the application or use to be present on
the food under a tolerance or exemption
from tolerance. Evidence to show that
food was lawfully treated may include
records that verify the dates that the
pesticide was applied to such food.
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D. Revisions to Petitioned-For
Tolerances
EPA is establishing the tolerance level
for ‘‘Berry, low growing, except
strawberry, subgroup 13–07H’’ at 0.02
ppm, instead of 0.01 ppm as requested,
to fully account for residue loss in the
field trial samples during freezer storage
from the time of harvest to the time of
analysis. Concurrent storage stability
samples indicate that as much as half of
the residue present in the samples may
have been lost between the time of
harvest and the time of analysis;
therefore, 0.02 ppm (twice LOQ) was
selected as the appropriate tolerance for
subgroup 13–07H. In addition, the
tolerance for subgroup 1C is being
established as 0.10 ppm rather than 0.1
ppm to conform with the Agency’s
practice of using two significant figures.
V. Conclusion
Therefore, tolerances are established
for residues of rimsulfuron, N-[[(4,6dimethoxy-2-pyrimidinyl)amino]
carbonyl]-3-(ethylsulfonyl)-2pyridinesulfonamide, to be determined
by measuring only rimsulfuron, in or on
Berry, low growing, except strawberry,
subgroup 13–07H at 0.02 ppm; Fruit,
citrus, group 10–10 at 0.01 ppm; Fruit,
pome, group 11–10 at 0.01 ppm; Fruit,
small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F at 0.01 ppm;
Fruit, stone, group 12–12 at 0.01 ppm;
Nut, tree, group 14–12 at 0.01 ppm;
Vegetable, tuberous and corm, subgroup
1C at 0.10 ppm; and tolerances with
regional restriction on Fescue, forage at
0.01 ppm; Fescue, hay at 0.01 ppm;
Ryegrass, perennial, forage at 0.01 ppm;
and Ryegrass, perennial, hay at 0.01
ppm. In addition, the Agency is
removing the existing tolerances for
‘‘fruit, citrus, group 10’’, ‘‘fruit, pome,
group 11’’, ‘‘fruit, pome, group 12’’,
‘‘grape’’, ‘‘nut, tree, group 14’’, and
‘‘pistachio’’ since they are superseded
by the tolerances being established in
this action. Finally, the Agency is
establishing a six-month expiration date
for the existing ‘‘potato’’ tolerance at 0.1
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
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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); or Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
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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
Dated: January 22, 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 § 180.478:
i. Remove the entries for ‘‘Fruit, citrus
group 10’’; ‘‘Fruit, pome, group 11’’;
‘‘Fruit, stone, group 12’’; ‘‘Grape’’; ‘‘Nut,
tree, group 14’’; and ‘‘Pistachio’’ from
the table in paragraph (a).
■ ii. Add alphabetically the entries to
the table in paragraph (a) ‘‘Berry, low
■
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
■
growing, except strawberry, subgroup
13–07H’’; ‘‘Fruit, citrus, group 10–10’’;
‘‘Fruit, pome, group 11–10’’; ‘‘Fruit,
small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F’’; ‘‘Fruit,
stone, group 12–12’’; and ‘‘Nut, tree,
group 14–12’’.
■ iii. Revise the entry for ‘‘Potato’’ in the
table in paragraph (a).
■ iv. Add alphabetically the entry to the
table in paragraph (a) ‘‘Vegetable,
tuberous and corm, subgroup 1C’’.
■ v. Add footnote 1 to the table in
paragraph (a).
■ vi. Revise paragraph (c).
The additions and revisions read as
follows:
§ 180.478 Rimsulfuron; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
*
*
Berry, low growing, except strawberry, subgroup 13–07H .................................................................................................................
*
*
*
*
*
*
*
citrus, group 10–10 ....................................................................................................................................................................
pome, group 11–10 ....................................................................................................................................................................
small, vine climbing, except fuzzy kiwifruit, subgroup 13–07F ..................................................................................................
stone, group 12–12 ....................................................................................................................................................................
*
*
*
*
*
*
*
Nut, tree, group 14–12 ........................................................................................................................................................................
*
*
*
*
*
*
*
Potato 1 ................................................................................................................................................................................................
*
*
*
*
*
*
*
Vegetable, tuberous and corm, subgroup 1C .....................................................................................................................................
*
Fruit,
Fruit,
Fruit,
Fruit,
1 This
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances with regional
registrations, as defined in § 180.1(1),
are established for residues of the
herbicide rimsulfuron, including its
metabolites and degradates, in or on the
commodities in the following table.
Compliance with the tolerance levels
specific in the following table is to be
0.1
0.10
Parts per
million
Fescue, forage .....................................................................................................................................................................................
Fescue, hay .........................................................................................................................................................................................
Ryegrass, perennial, forage ................................................................................................................................................................
Ryegrass, perennial, hay .....................................................................................................................................................................
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0.01
determined by measuring only
rimsulfuron, N-[[(4,6-dimethoxy-2pyrimidinyl)amino] carbonyl]-3(ethylsulfonyl)-2-pyridinesulfonamide.
Commodity
*
0.01
0.01
0.01
0.01
tolerance expires on August 12, 2018.
*
*
0.02
*
*
*
[FR Doc. 2018–02676 Filed 2–9–18; 8:45 am]
BILLING CODE 6560–50–P
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0.01
0.01
0.01
]]>Agencies
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Rules and Regulations]
[Pages 5942-5947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02676]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0516; FRL-9972-36]
Rimsulfuron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances, including tolerances
with regional registration, for residues of rimsulfuron in or on
multiple commodities that are identified and discussed later in this
document. In addition, this regulation removes several previously
established tolerances that are superseded by this final rule.
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 12, 2018. Objections and
requests for hearings must be received on or before April 13, 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-2016-0516, 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:
[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-2016-0516 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 13, 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 notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0516, 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 Thursday, March 23, 2017 (82 FR 14846)
(FRL-9957-99), 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 6E8496) by IR-4 Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested that 40 CFR 180.478 be amended by
establishing tolerances for residues of the herbicide rimsulfuron, N-
[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]-3-(ethylsulfonyl)-2-
pyridinesulfonamide, in or on Berry, low growing, except strawberry,
subgroup 13-07H at 0.01 parts per million (ppm); Fruit, citrus, group
10-10 at 0.01 ppm; Fruit, pome, group 11-10 at 0.01 ppm; Fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm;
Fruit, stone, group 12-12 at 0.01 ppm; Nut,
[[Page 5943]]
tree, group 14-12 at 0.01 ppm; Vegetable, tuberous and corm, subgroup
1C at 0.1 ppm; and tolerances with regional restrictions in or on
Fescue, forage at 0.01 ppm; Fescue, hay at 0.01 ppm; Ryegrass,
perennial, forage at 0.01 ppm; and Ryegrass, perennial, hay at 0.01
ppm. That document referenced a summary of the petition prepared by E.
I. du Pont de Nemours and Company, 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 is
establishing tolerance levels that vary from what the petition
requested. The reason for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for rimsulfuron including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with rimsulfuron 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 toxicity database indicates that target organs for rimsulfuron
are the liver and kidney in the rat and dog, along with the testis and
blood in the mouse and dog. In the mouse, the stomach was also a target
organ.
Adverse changes in body weight and food consumption were observed
in rats, mice and dogs. In subchronic and chronic toxicity studies in
rats, toxic effects included decreased body weight, decreased body
weight gain, increased relative liver and absolute kidney weights, and
diuresis. In the subchronic study in mice, increased red blood cell and
hemoglobin, and decreased body weight gain and food efficiency were
observed. In the chronic study in mice, decreased body weight,
increased incidences of dilation and cysts in the glandular stomach,
and degeneration of the testicular artery and tunica albuginea were
observed. In the subchronic study in dogs, diuresis was indicated by
urinary volume, platelet concentration and kidney weights accompanied
by decreased urinary osmolality. In the chronic study in dogs,
increased absolute liver and kidney weights, increased seminiferous
tubule degeneration, and increased number of spermatid giant cells
present in epididymides in males were observed.
In the developmental toxicity study in rats, no toxicity was seen
at the highest dose tested (HDT). In the developmental toxicity study
in rabbits, and in the 2-generation reproduction toxicity study in
rats, developmental/offspring toxicity was seen in the presence of
maternal/systemic toxicity and at similar dose levels. There is no
quantitative or qualitative evidence of increased susceptibility
following pre- and/or post-natal exposures in the developmental and
reproduction studies.
There is no indication in the database that rimsulfuron is
neurotoxic or immunotoxic. Rimsulfuron is not mutagenic and has been
classified as ``not likely to be carcinogenic to humans,'' based on the
lack of evidence for carcinogenicity in studies conducted in rats and
mice.
Specific information on the studies received and the nature of the
adverse effects caused by rimsulfuron 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 entitled, ``SUBJECT: Rimsulfuron. Human
Health Risk Assessment in Support of a Petition (PP#6E8496) for the
Establishment of Permanent Tolerances on Tuberous and Corm Vegetable
Subgroup 1C, Small Vine Climbing Fruit Except Fuzzy Kiwifruit Subgroup
13-07F, Low Growing Berry Except Strawberry Subgroup 13-07H, Tolerances
with Regional Registrations for Ryegrass and Fescue and Crop Group
Conversions for Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Stone
Fruit Group 12-12, and Tree Nut Group 14-12,'' dated May 5, 2017 at pp.
31-34 in docket ID number EPA-HQ-OPP-2016-0516.
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-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for rimsulfuron used for
human risk assessment is shown in Table 1 of this unit.
[[Page 5944]]
Table 1--Summary of Toxicological Doses and Endpoints for Rimsulfuron 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 (All populations).. An endpoint attributable to a single dose was not identified in the database.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 11.8 mg/kg/ Chronic RfD = 0.118 Combined Chronic/Carcinogenicity--
day. mg/kg/day. Rat.
UFA = 10x........... cPAD = 0.118 mg/kg/ LOAEL = 121 mg/kg/day based on
UFH = 10x........... day. decreased body weight gains and
FQPA SF = 1x........ liver effects.
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Rimsulfuron is considered ``not likely to be carcinogenic to humans'' due to
the absence of tumors in the available rat and mouse carcinogenicity
studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose,
LOC = level of concern, 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 rimsulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing rimsulfuron tolerances in 40 CFR
180.478. EPA assessed dietary exposures from rimsulfuron in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for rimsulfuron; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA assumed that rimsulfuron residues were
present at tolerance levels in all commodities for which tolerances
have been established and currently proposed, and 100 percent crop
treated (PCT) with rimsulfuron.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that rimsulfuron 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 or PCT information in the dietary
assessment for rimsulfuron. 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 rimsulfuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of rimsulfuron. 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 Pesticides in Flooded Applications Model (PFAM) and
the Wisconsin cranberry (worst case) scenario to conduct an assessment
of surface water exposure to total toxic residue (TTR) of rimsulfuron
(PFAM model was developed specifically for regulatory applications to
estimate exposure for pesticides used in flooded agriculture such as
rice paddies and cranberry bogs) and Pesticide Root Zone Model Ground
Water (PRZM GW) and the Tier I assessment for applications of
rimsulfuron to corn in Wisconsin (worst case), the estimated drinking
water concentrations (EDWCs) of rimsulfuron for acute exposures are
estimated to be 9.59 parts per billion (ppb) for surface water and 22.2
ppb for ground water. Chronic exposures for non-cancer assessments are
estimated to be 1.70 ppb for surface water and 19.7 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 19.7 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).
Rimsulfuron 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.''
Rimsulfuron belongs to the class of pesticides known as
sulfonylureas (SUs). The SUs share a core chemical structure with
varying degrees of structural similarity. In addition, the SUs share a
pesticidal mode of action (i.e., the inhibition of acetolactate
synthase (ALS)), although the function of ALS in humans is unknown and
the relevance of this mode of action (MOA) in humans in unclear. Based
on toxicity studies, the SUs do not share a common toxicological
profile; instead the target organs vary among the class and are often
unspecific, such as changes in body weight or general effects on the
liver. Further dividing the SUs into subclasses based on the urea
substituent did not result in a clear association of a target organ
with any particular substructure.
Based on the weight of the evidence, considering the lack of common
toxicological profile of the SUs, the uncertainty in the human
relevance of ALS inhibition, and the lack of
[[Page 5945]]
mammalian MOA data, a testable hypothesis for a common mechanism of
action cannot be identified. Therefore, the Agency concludes that no
common mechanism of toxicity exists among these pesticides and a
cumulative risk assessment (CRA) approach is not appropriate for this
class of pesticides. For further explanation, see ``SUBJECT:
Sulfonylureas: Screening Analysis of Toxicological Profiles to Consider
Whether a Candidate Common Mechanism Group Can Be Established'', dated
9/9/2015, found at https://www.regulations.gov in docket ID number EPA-
HQ-OPP-2016-0516.
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 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. In the developmental
toxicity study in rats, no developmental toxicity was seen at the
highest dose tested. In the developmental toxicity study in rabbits and
in the 2-generation reproductive study in rats, developmental and
offspring toxicity were seen only in the presence of maternal/systemic
toxicity. There is no evidence of quantitative or qualitative increased
susceptibility following pre- and/or postnatal exposures to
rimsulfuron.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for rimsulfuron is complete.
ii. There is no indication that rimsulfuron is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or increased SF to account for neurotoxicity.
iii. There is no evidence that rimsulfuron 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. No acute toxicological endpoint was identified. The chronic
dietary food and drinking water exposure assessment utilizes tolerance-
level residues and 100 PCT information for all commodities. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to rimsulfuron in drinking water.
These assessments will not underestimate the exposure and risks posed
by rimsulfuron.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
rimsulfuron is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
rimsulfuron from food and water will utilize 1.5% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for rimsulfuron.
Therefore, the chronic aggregate risk is the same as the chronic
dietary risk and not of concern.
3. Short- and intermediate-term risks. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Because there is no
short- or intermediate-term residential exposure and chronic dietary
exposure has already been assessed under the appropriately protective
cPAD, no further assessment of short- or intermediate-term risk is
necessary.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, rimsulfuron 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 rimsulfuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, DuPont method 15033 using high-
performance liquid chromatography/electrospray ionization tandem mass
spectrometry (HPLC/ESI-MS/MS), is available for determination of
residues of rimsulfuron in petitioned-for commodities.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs for residues of rimsulfuron in/
on any commodity associated with this action.
C. International Trade Considerations
In this final rule, EPA is establishing a crop subgroup tolerance
for subgroup
[[Page 5946]]
1C (vegetable, tuberous and corm, subgroup 1C) at 0.10 ppm. This
subgroup includes the commodity potato, for which a tolerance is
currently set at 0.1 ppm. Setting a new tolerance at 0.10 ppm on potato
as part of subgroup 1C has a theoretically trade restrictive effect on
the import of potatoes, resulting from rounding to significant figures
when quantifying residues of rimsulfuron, compared with the current
tolerance of 0.1 ppm.
In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to promptly
publish this action with the WTO. Although he subgroup 1C tolerance is
being established at 0.10 ppm and is unlikely to impact trade, EPA is
establishing an expiration date for the existing potato tolerance
following publication of this rule in order to provide a six-month
reasonable interval for producers in exporting countries to adapt the
modified tolerance. Before that date, residues of rimsulfuron on potato
will be permitted under the current tolerance of 0.1 ppm; after that
date, residues will need to be in compliance with the new 0.10 ppm
subgroup 1C tolerance level.
The tolerance level is appropriate based on available data and
residues levels resulting from registered use patterns. The tolerance
level for all subgroup 1C commodities is not discriminatory; the same
food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods. None of the other tolerance
actions taken in this rulemaking restrict permissible pesticide
residues below currently allowed levels in the United States.
Any commodities listed in the regulatory text of this document that
are treated with the pesticides subject to this final rule, and that
are in the channels of trade following the tolerance revocation, shall
be subject to FFDCA section 408(1)(5), as established by FQPA. Under
this unit, any residues of these pesticides in or on such food shall
not render the food adulterated so long as it is shown to the
satisfaction of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA.
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates that the
pesticide was applied to such food.
D. Revisions to Petitioned-For Tolerances
EPA is establishing the tolerance level for ``Berry, low growing,
except strawberry, subgroup 13-07H'' at 0.02 ppm, instead of 0.01 ppm
as requested, to fully account for residue loss in the field trial
samples during freezer storage from the time of harvest to the time of
analysis. Concurrent storage stability samples indicate that as much as
half of the residue present in the samples may have been lost between
the time of harvest and the time of analysis; therefore, 0.02 ppm
(twice LOQ) was selected as the appropriate tolerance for subgroup 13-
07H. In addition, the tolerance for subgroup 1C is being established as
0.10 ppm rather than 0.1 ppm to conform with the Agency's practice of
using two significant figures.
V. Conclusion
Therefore, tolerances are established for residues of rimsulfuron,
N-[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]-3-(ethylsulfonyl)-2-
pyridinesulfonamide, to be determined by measuring only rimsulfuron, in
or on Berry, low growing, except strawberry, subgroup 13-07H at 0.02
ppm; Fruit, citrus, group 10-10 at 0.01 ppm; Fruit, pome, group 11-10
at 0.01 ppm; Fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 0.01 ppm; Fruit, stone, group 12-12 at 0.01 ppm;
Nut, tree, group 14-12 at 0.01 ppm; Vegetable, tuberous and corm,
subgroup 1C at 0.10 ppm; and tolerances with regional restriction on
Fescue, forage at 0.01 ppm; Fescue, hay at 0.01 ppm; Ryegrass,
perennial, forage at 0.01 ppm; and Ryegrass, perennial, hay at 0.01
ppm. In addition, the Agency is removing the existing tolerances for
``fruit, citrus, group 10'', ``fruit, pome, group 11'', ``fruit, pome,
group 12'', ``grape'', ``nut, tree, group 14'', and ``pistachio'' since
they are superseded by the tolerances being established in this action.
Finally, the Agency is establishing a six-month expiration date for the
existing ``potato'' tolerance at 0.1 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); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
[[Page 5947]]
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 22, 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. 180.478:
0
i. Remove the entries for ``Fruit, citrus group 10''; ``Fruit, pome,
group 11''; ``Fruit, stone, group 12''; ``Grape''; ``Nut, tree, group
14''; and ``Pistachio'' from the table in paragraph (a).
0
ii. Add alphabetically the entries to the table in paragraph (a)
``Berry, low growing, except strawberry, subgroup 13-07H''; ``Fruit,
citrus, group 10-10''; ``Fruit, pome, group 11-10''; ``Fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F''; ``Fruit,
stone, group 12-12''; and ``Nut, tree, group 14-12''.
0
iii. Revise the entry for ``Potato'' in the table in paragraph (a).
0
iv. Add alphabetically the entry to the table in paragraph (a)
``Vegetable, tuberous and corm, subgroup 1C''.
0
v. Add footnote 1 to the table in paragraph (a).
0
vi. Revise paragraph (c).
The additions and revisions read as follows:
Sec. 180.478 Rimsulfuron; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Berry, low growing, except strawberry, subgroup 13-07H.. 0.02
* * * * * * *
Fruit, citrus, group 10-10.............................. 0.01
Fruit, pome, group 11-10................................ 0.01
Fruit, small, vine climbing, except fuzzy kiwifruit, 0.01
subgroup 13-07F........................................
Fruit, stone, group 12-12............................... 0.01
* * * * * * *
Nut, tree, group 14-12.................................. 0.01
* * * * * * *
Potato 1................................................ 0.1
* * * * * * *
Vegetable, tuberous and corm, subgroup 1C............... 0.10
------------------------------------------------------------------------
1 This tolerance expires on August 12, 2018.
* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registrations, as defined in Sec. 180.1(1), are established
for residues of the herbicide rimsulfuron, including its metabolites
and degradates, in or on the commodities in the following table.
Compliance with the tolerance levels specific in the following table is
to be determined by measuring only rimsulfuron, N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino] carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Fescue, forage.......................................... 0.01
Fescue, hay............................................. 0.01
Ryegrass, perennial, forage............................. 0.01
Ryegrass, perennial, hay................................ 0.01
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-02676 Filed 2-9-18; 8:45 am]
BILLING CODE 6560-50-P
