[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Rules and Regulations]
[Pages 27256-27261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11553]
[[Page 27256]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0755; FRL-8872-7]
Saflufenacil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation revises or removes certain established
tolerances and establishes new tolerances for residues of saflufenacil
in or on multiple commodities which are identified and discussed later
in this document. BASF Corporation requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 11, 2011. Objections and
requests for hearings must be received on or before July 11, 2011, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0755. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
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 http://www.gpoaccess.gov/ecfr.
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-2010-0755 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 11, 2011. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0755, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 23, 2010 (75 FR 57942) (FRL-
8845-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
0F7744 and PP 0F7766) by BASF Corporation, 26 Davis Drive, P.O. Box
13528, Research Triangle Park, NC 27709-3528. The petitions requested
that 40 CFR 180.649 be amended by establishing tolerances for residues
of the herbicide saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-
dioxo-4-(trifluoromethyl)-1(2 H)-pyrimidinyl]-4-fluoro- N-[[methyl(1-
methylethyl)amino]sulfonyl]benzamide, and its metabolites N-[2-chloro-
5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2 H)-pyrimidinyl)-4-
fluorobenzoyl]- N-'isopropylsulfamide and N-[4-chloro-2-fluoro-5-
({[(isopropylamino)sulfonyl]amino{time} carbonyl)phenyl]urea,
calculated as the stoichiometric equivalent of saflufenacil, in or on
oilseeds, cottonseed subgroup 20C, gin byproducts at 3.5 parts per
million (ppm); oilseeds, cottonseed subgroup 20C, undelinted seed at
0.2 ppm; oilseeds, sunflower subgroup 20B, seed at 1.0 ppm; pea, vines
at 8.0 ppm; soybean, aspirated grain fractions at 4.52 ppm; soybean,
hulls at 0.42 ppm; soybean, seed at 0.1 ppm; vegetable, legume,
subgroup 6C, beans, dry at 0.5 ppm; and vegetable, legume, subgroup 6C,
peas, dry at 0.1 ppm (PP 0F7744); and in or on oilseeds, rapeseed
subgroup 20A, seed at 0.8 ppm (PP 0F7766). That notice referenced
[[Page 27257]]
summaries of the petitions prepared by BASF Corporation, the
registrant, which are available in the docket, http://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 proposed commodity terms and tolerance levels for several
commodities and determined that established tolerances for certain
livestock commodities should be increased. The reasons for these
changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 saflufenacil including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with saflufenacil
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.
Saflufenacil has low acute toxicity via the oral, dermal, and
inhalation routes of exposure. It is slightly irritating to the eye but
is neither a dermal irritant nor sensitizer.
Short-term, subchronic, and chronic toxicity studies in rats, mice,
and dogs identified the hematopoietic system as the target organ of
saflufenacil. Protoporphyrinogen oxidase inhibition in the mammalian
species may result in disruption of heme synthesis which in turn causes
anemia. In these studies, decreased hematological parameters [red blood
cells (RBC), hematocrit (Ht), mean corpuscular volume (MCV), mean
corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin
concentration (MCHC)] were seen at about the same dose level across
species, except in the case of the dog, where the effects were seen at
a slightly higher dose. These effects occurred around the same dose
level from the short- through long-term exposures without increasing in
severity. Effects were also seen in the liver (increased weight,
centrilobular fatty change, and lymphoid infiltrate) in mice, the
spleen (increased spleen weight and extramedullary hematopoiesis) in
rats, and in both these organs (increased iron storage in the liver and
extramedullary hematopoiesis in the spleen) in dogs. No dermal toxicity
was seen at the limit dose in a 28-day dermal toxicity study in rats.
Carcinogenicity studies in rats and mice showed no evidence of
increased incidence of tumors at the tested doses. Saflufenacil is
weakly clastogenic in the in vitro chromosomal aberration assay in V79
cells in the presence of S9 activation; however, the response was not
evident in the absence of S9 activation. It is neither mutagenic in
bacterial cells nor clastogenic in rodents in vivo. Saflufenacil is
classified as ``not likely to be carcinogenic to humans.''
Increased fetal and offspring susceptibility to saflufenacil were
observed in the developmental toxicity studies in the rat and rabbit
and in the 2-generation reproduction study in the rat. Developmental
effects such as decreased fetal body weights and increased skeletal
variations occurred at doses that were not maternally toxic in the
developmental study in rats, indicating increased quantitative
susceptibility. In rabbits, developmental effects such as increased
liver porphyrins were observed at doses that were not maternally toxic,
indicating increased quantitative susceptibility. In the 2-generation
reproduction study in rats, offspring effects such as increased number
of stillborn pups, decreased viability and lactation indices, decreased
pre-weaning body weight and/or body-weight gain, and changes in
hematological parameters were observed at a dose resulting in less
severe maternal toxicity (decreased food intake, body weight/weight
gain and changes in hematological parameters and organ weights
indicative of anemia), indicating increased qualitative susceptibility.
There was no evidence of neurotoxicity or neuropathology in the
toxicity database for saflufenacil. In the acute neurotoxicity study, a
decrease in motor activity was observed on the first day of dosing at
the limit dose in males only. The finding was not accompanied by any
other neuropathological changes and was considered a reflection of a
mild and transient general systemic toxicity and not a substance-
specific neurotoxic effect. In the subchronic neurotoxicity study,
systemic toxicity (anemia), but no evidence of neurotoxicity, was seen
in males and females.
There is no evidence of immunotoxity in the saflufenacil database.
The increase in spleen weight seen only in rats in the 90-day oral
toxicity study is attributable to an increased clearance of defective
RBCs (i.e., defective hemoglobin synthesis) and is thus an indication
of toxicity to the hematopoietic system rather than to the immune
system. In a recently submitted 28-day immunotoxicity study,
saflufenacil failed to induce toxicity specific to the immune system at
the highest dose tested (i.e., 52 milligrams/kilogram/bodyweight/day
(mg/kg bw/day)), indicating that saflufenacil does not directly target
the immune system at the dose levels being used for risk assessment.
Specific information on the studies received and the nature of the
adverse effects caused by saflufenacil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Saflufenacil. Human-Health Risk
Assessment for Proposed Uses in/on Vegetable, Legume, Subgroup 6C, pea
and bean (except soybean); Soybean; Rapeseed Subgroup 20A; Sunflower
Subgroup 20B; and Cottonseed Subgroup 20C'' at page 31 in docket ID
number EPA-HQ-OPP-2010-0755.
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
[[Page 27258]]
exposure to the pesticide. For hazards that have a threshold below
which there is no appreciable risk, the toxicological POD is used as
the basis for derivation of reference values for risk assessment. PODs
are developed based on a careful analysis of the doses in each
toxicological study to determine the dose at which no adverse effects
are observed (the NOAEL) and the lowest dose at which adverse effects
of concern are identified (the LOAEL). Uncertainty/safety factors are
used in conjunction with the POD to calculate a safe exposure level--
generally referred to as a population-adjusted dose (PAD) or a
reference dose (RfD)--and a safe margin of exposure (MOE). For non-
threshold risks, the Agency assumes that any amount of exposure will
lead to some degree of risk. Thus, the Agency estimates risk in terms
of the probability of an occurrence of the adverse effect expected in a
lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for saflufenacil used for
human risk assessment is shown in the following Table.
Table--Summary of Toxicological Doses and Endpoints for Saflufenacil for Use in Human Health Risk Assessment
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute dietary (General population NOAEL = 500 mg/kg/day.. Acute RfD = 5.0 mg/kg/ Acute Neurotoxicity
including infants and children). UFA = 10x.............. day. Study in the Rat.
UFH = 10x.............. aPAD = 5.0 mg/kg/day... LOAEL = 2,000 mg/kg/day
FQPA SF = 1x........... based on decreased
motor activity
representing mild and
transient systemic
toxicity in males. A
LOAEL was not
established for
females.
Chronic dietary (All populations)... NOAEL= 4.6 mg/kg/day... Chronic RfD = 0.046 mg/ Chronic/Carcinogenicity
UFA = 10x.............. kg/day. in the Mouse.
UFH = 10x.............. cPAD = 0.046 mg/kg/day. LOAEL = 13.8 mg/kg/day
FQPA SF = 1x........... based on decreased red
blood cells,
hemoglobin, and Ht and
porphyria observed in
the satellite group.
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Cancer (Oral, dermal, inhalation)... Classification: Not likely carcinogenic to humans based on the lack of
tumors in the mouse and rat carcinogenicity studies and lack of
mutagenicity.
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population-
adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to saflufenacil, EPA considered exposure under the petitioned-
for tolerances as well as all existing saflufenacil tolerances in 40
CFR 180.649. EPA assessed dietary exposures from saflufenacil 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 saflufenacil. In estimating acute dietary exposure, EPA used food
consumption information from the U.S. Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). The unrefined assessment assumed 100% crop treated
(CT), Dietrary Exposure Evaluation Model (DEEMTM 7.81)
default concentration factors, and tolerance-level residues for all
commodities, except cottonseed; sunflower subgroup 20B; soybean, seed;
vegetable, legume, subgroup 6C, pea and bean (except soybean); and
rapeseed subgroup 20A, for which the tolerance levels were multiplied
by a correction factor to account for a metabolite of concern which is
not included in the tolerance expression.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. Chronic dietary exposure was assessed using the same
food residue assumptions as in the acute dietary exposure assessment
discussed in Unit III.C.1.i.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that saflufenacil 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 saflufenacil. Tolerance level residues (or, for some
commodities, tolerance-level residues adjusted to account for an
additional metabolite of concern) and 100% CT were assumed for all food
commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for saflufenacil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of saflufenacil. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model/Ground Water (PRZM/GW), the estimated
drinking water concentrations (EDWCs) of saflufenacil for acute
exposures are estimated to be 37.3 parts per billion (ppb) for surface
water and 180 ppb for ground water. EDWCs for chronic exposures for
non-cancer assessments are estimated to be 23.8 ppb for surface water
and 173 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 180 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of
[[Page 27259]]
value 173 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). Saflufenacil 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 saflufenacil to share a common mechanism of
toxicity with any other substances, and saflufenacil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
saflufenacil 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 http://www.epa.gov/pesticides/cumulative.
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 saflufenacil includes rat and rabbit
developmental toxicity studies, a two-generation reproduction toxicity
study in rats, acute and subchronic neurotoxicity studies in rats, and
a 28-day immunotoxicity study in rats. As discussed in Unit III.A.,
there was evidence of quantitative susceptibility of fetuses to
saflufenacil exposure in the developmental toxicity studies in rats and
rabbits and evidence of qualitative susceptibility of offspring in the
rat reproduction study.
An analysis was performed to determine the degree of concern for
the effects observed in the developmental and reproduction toxicity
studies when considered in the context of all available toxicity data,
and to identify any residual uncertainties after establishing toxicity
endpoints and traditional UFs to be used in the risk assessment of
saflufenacil. The degree of concern is low and there are no residual
uncertainties for the increased susceptibility since:
i. Clear NOAELs/LOAELs were established for the developmental
effects seen in rats and rabbits as well as for the offspring effects
seen in the 2-generation reproduction study;
ii. Dose-response relationships for the effects of concern are well
characterized;
iii. None of the effects in the developmental or reproduction
studies were attributable to a single exposure and, therefore, are not
of concern for acute risk assessment; and
iv. The dose used to evaluate chronic dietary risks is lower than
the NOAELs for fetal/offspring effects in the developmental and
reproduction studies and is, therefore, protective of the developmental
and offspring effects observed in these studies.
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 saflufenacil is complete.
ii. There is no indication that saflufenacil is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. Although there is evidence of increased quantitative and
qualitative susceptibility of offspring in the developmental and
reproduction studies for saflufenacil, the degree of concern is low and
the Agency did not identify any residual uncertainties after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment of saflufenacil.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground- and surface water modeling used
to assess exposure to saflufenacil in drinking water. These assessments
will not underestimate the exposure and risks posed by saflufenacil.
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. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
saflufenacil will occupy less than 1% of the aPAD for all population
subgroups, including infants and children.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
saflufenacil from food and water will utilize 30% of the cPAD for
infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for saflufenacil.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure take into account short- or intermediate-term
residential exposure plus chronic exposure from food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however,
saflufenacil is not registered for any use patterns that would result
in short- or intermediate-term residential exposure. Short- and
intermediate-term risks are assessed based on short- or intermediate-
term residential exposure plus chronic dietary exposure. Because there
is no short- or intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short- and intermediate-term risk), no further assessment of
short- or intermediate-term risk is necessary, and EPA relies on the
chronic dietary risk
[[Page 27260]]
assessment for evaluating short- and intermediate-term risk for
saflufenacil.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, saflufenacil 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 saflufenacil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/mass
spectroscopy/mass spectroscopy (LC-MS/MS) methods D0603/02 (plants) and
L0073/01 (livestock)) is available to enforce the tolerance expression.
The methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail 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 U.N. 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 saflufenacil.
C. Revisions to Petitioned-For Tolerances
EPA has revised the proposed commodity terms as follows to agree
with the Agency's Food and Feed Commodity Vocabulary: ``oilseeds,
cottonseed subgroup 20C, gin byproducts'' was changed to ``cotton, gin
byproducts;'' ``oilseeds, cottonseed subgroup 20C, undelinted seed''
was changed to ``cottonseed subgroup 20C;'' ``oilseeds, sunflower
subgroup 20B, seed'' was changed to ``sunflower subgroup 20B;''
``soybean, aspirated grain fractions'' was changed to ``grain,
aspirated fractions;'' ``pea, vines'' was changed to ``pea, hay;'' and
``oilseeds, rapeseed subgroup 20A, seed'' was changed to ``rapeseed
subgroup 20A.''
EPA has also revised most of the proposed tolerance levels. Based
on analysis of the field trial data using the Agency's tolerance/MRL
calculator in accordance with the Agency's ``Guidance for Setting
Pesticide Tolerances Based on Field Trial Data,'' proposed tolerances
were revised for cotton, gin byproducts from 3.5 ppm to 0.45 ppm; for
pea, hay from 8.0 ppm to 17 ppm; and for rapeseed subgroup 20A from 0.8
ppm to 0.45 ppm. Proposed tolerances for grain, aspirated fractions and
soybean, seed were increased from 4.52 ppm to 10 ppm and 0.42 ppm to
0.50 ppm, respectively, based on processing factors (150x for aspirated
grain fractions and 6x for soybean hulls) derived from a soybean
processing study in conjunction with the highest average field trial
(HAFT) residue of 0.07 ppm from soybean residue studies. In addition,
EPA determined that separate tolerances were not needed for dry peas
and beans, proposed at 0.1 ppm and 0.5 ppm, respectively. A single
tolerance of 0.30 ppm on ``pea and bean, dried shelled, except soybean,
subgroup 6C'' was determined to be appropriate based on analysis of the
dry bean field trial data using the Agency's tolerance/MRL calculator.
Since residues were significantly lower in dried peas, they were not
used in calculating the subgroup 6C tolerance. Finally, based on
calculated livestock dietary burdens in light of the new tolerances and
data from a cattle feeding study, EPA has determined that established
tolerances for liver and meat byproducts, except liver, of cattle,
goats, horses, and sheep should be increased from 0.80 ppm to 2.5 ppm
and 0.02 ppm to 0.05 ppm, respectively.
In conjunction with establishing these tolerances, the existing
tolerance for ``vegetable, foliage of legume, group 7'' is being
revised to read ``vegetable, foliage of legume, group 7 (except pea,
hay)''; the existing tolerance for ``vegetable, legume, group 6'' at
0.03 ppm is being replaced with tolerances on ``vegetable, legume,
edible podded, subgroup 6A'' and ``pea and bean, succulent shelled,
subgroup 6B'' at the same level (0.03 ppm); and the existing tolerances
for ``sunflower, seed'' and ``cotton, undelinted seed,'' which are
superseded by tolerances on cottonseed subgroup 20C and sunflower
subgroup 20B, are being deleted.
V. Conclusion
Therefore, tolerances are established or revised for residues of
saflufenacil, including its metabolites and degradates, in or on the
commodities as codified in the regulatory text in Sec. 180.649(a)(1)
and (a)(2).
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA 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 final rule has been
exempted from review under Executive Order 12866, this final rule 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 final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act, 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 section 408(d) of FFDCA, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule 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 section 408(n)(4) of FFDCA. 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,
[[Page 27261]]
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 final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4).
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 of 1995, Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 3, 2011.
Lois Rossi,
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. Section 180.649 is amended as follows:
0
a. Revise the table in paragraph (a)(1).
0
b. In the table in paragraph (a)(2), revise the entries for cattle,
liver; cattle, meat byproducts, except liver; goat, liver; goat, meat
byproducts, except liver; horse, liver; horse, meat byproducts, except
liver; sheep, liver; and sheep, meat byproducts, except liver.
The revised texts read as follows:
Sec. 180.649 Saflufenacil; tolerances for residues.
(a) * * * (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls.............................................. 0.10
Cotton, gin byproducts..................................... 0.45
Cottonseed subgroup 20C.................................... 0.20
Fruit, citrus, group 10.................................... 0.03
Fruit, pome, group 11...................................... 0.03
Fruit, stone, group 12..................................... 0.03
Grain, aspirated fractions................................. 10
Grain, cereal, forage, fodder and straw group 16........... 0.10
Grain, cereal, group 15.................................... 0.03
Grape...................................................... 0.03
Nut, tree, group 14........................................ 0.03
Pea and bean, dried shelled, except soybean, subgroup 6C... 0.30
Pea and bean, succulent shelled, subgroup 6B............... 0.03
Pea, hay................................................... 17
Pistachio.................................................. 0.03
Rapeseed subgroup 20A...................................... 0.45
Sunflower subgroup 20B..................................... 1.0
Soybean, hulls............................................. 0.50
Soybean, seed.............................................. 0.10
Vegetable, foliage of legume, group 7 (except pea, hay).... 0.10
Vegetable, legume, edible podded, subgroup 6A.............. 0.03
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cattle, liver.............................................. 2.5
* * * * *
Cattle, meat byproducts, except liver...................... 0.05
* * * * *
Goat, liver................................................ 2.5
* * * * *
Goat, meat byproducts, except liver........................ 0.05
* * * * *
Horse, liver............................................... 2.5
* * * * *
Horse, meat byproducts, except liver....................... 0.05
* * * * *
Sheep, liver............................................... 2.5
* * * * *
Sheep, meat byproducts, except liver....................... 0.05
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2011-11553 Filed 5-10-11; 8:45 am]
BILLING CODE 6560-50-P