[Federal Register: September 11, 2009 (Volume 74, Number 175)]
[Rules and Regulations]
[Page 46683-46689]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11se09-3]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0352; FRL-8430-4]
Saflufenacil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of saflufenacil and its metabolites and degradates in or on various
plant and livestock commodities. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 11, 2009. Objections and
requests for hearings must be received on or before November 10, 2009,
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-2008-0352. 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: Kathryn Montague, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-1243; e-mail address:
montague.kathryn@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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance
[[Page 46684]]
regulations at 40 CFR part 180 through the Government Printing Office's
e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS
Harmonized Guidelines referenced in this document, go directly to the
guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2008-0352 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before November 10, 2009.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0352, 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. Petition for Tolerance
In the Federal Register of June 13, 2008 (73 FR 33814) (FRL-8367-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7322) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research
Triangle Park, NC 27709-3528. The petition requested that 40 CFR part
180 be amended by adding a section for the herbicide saflufenacil and
establishing tolerances therein for combined residues of saflufenacil
(aka BAS 800 H), N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-
(trifluromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)benzyl]-N-isopropyl-N-
methylsulfamide plus its metabolite M800H11, N-[2-chloro-5-(2,6-dioxo-
4(trifluormethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N'-
isopropylsulfamide, and its metabolite M800H35, (N-[4-chloro-2-fluoro-
5-({[(isopropylamino)sulfonyl]amino{time} carbonyl)phenyl]urea), in or
on legume vegetables (group 06), citrus fruits (group 10), pome fruits
(group 11), stone fruits (group 12), tree nuts (group 14), pistachio,
cereal grains (group 15), undelinted cotton seed, cotton gin
byproducts, and grape at 0.03 parts per million (ppm); foliage of
legume vegetables (group 07); forage, fodder and straw of cereal grains
(group 16); and sorghum stover at 0.1 ppm; almond hulls at 0.2 ppm; and
sunflower seed at 0.7 ppm. The petition also requested that tolerances
be established for residues of saflufenacil, M800H11 and M800H35 on
animal kidney at 0.02 ppm and animal liver at 0.8 ppm, although the
proposed tolerance levels for kidney and liver were not specified in
the company's notice of filing. That notice referenced a summary of the
petition prepared by BASF Corporation, the registrant, which is
available to the public in the docket, http://www.regulations.gov.
Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
revised the tolerance levels for almond hulls and sunflower seed;
determined that a tolerance for sorghum stover is unnecessary;
determined that tolerances are required for additional livestock
commodities; and revised the tolerance expression for plant and
livestock commodities. EPA also revised commodity terms, as necessary,
to agree with the Agency's Food and Feed Commodity Vocabulary. The
reasons for these changes are explained in Unit IV.D.
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 the petitioned-for
tolerances for residues of saflufenacil, including its metabolites and
degradates, on the plant commodities almond, hulls at 0.10 ppm; cotton,
gin byproducts at 0.10 ppm; cotton, undelinted seed at 0.03 ppm; fruit,
citrus, group 10 at 0.03 ppm; fruit, pome, group 11 at 0.03 ppm; fruit,
stone, group 12 at 0.03 ppm; grain, cereal, forage, fodder and straw
group 16 at 0.10 ppm; grain, cereal, group 15 at 0.03 ppm; grape at
0.03 ppm; nut, tree, group 14 at 0.03 ppm; pistachio at 0.03 ppm;
sunflower, seed at 1.0 ppm; vegetable, foliage of legume, group 7 at
0.10 ppm; and vegetable, legume, group 6 at 0.03 ppm; and on the
livestock commodities cattle, fat at 0.01 ppm; cattle, liver at 0.80
ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts, except liver at
0.02 ppm; goat, fat at 0.01 ppm; goat, liver at 0.80 ppm; goat, meat at
0.01 ppm; goat, meat byproducts, except liver at 0.02 ppm; hog, fat at
0.01 ppm; hog, liver at 0.80 ppm; hog, meat at 0.01 ppm; hog, meat
byproducts, except liver at 0.02 ppm; horse, fat at 0.01 ppm; horse,
liver at 0.80 ppm; horse, meat at 0.01 ppm; horse, meat byproducts,
except liver at 0.02 ppm; milk at 0.01 ppm; sheep, fat at 0.01 ppm;
sheep, liver at 0.80 ppm; sheep, meat at 0.01 ppm; and sheep, meat
byproducts, except liver at 0.02 ppm. EPA's assessment of exposures and
risks associated with establishing tolerances follows.
[[Page 46685]]
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-term 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. These effects
also occurred around the same dose level from the short-term through
long-term exposures without increasing in severity. 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.
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. Revised Human-Health
Risk Assessment for Proposed Uses in/on Legume Vegetables (Crop Group
06), the Foliage of Legume Vegetables (Crop Group 07), Citrus Fruits
(Crop Group 10), Pome Fruits (Crop Group 11), Stone Fruits (Crop Group
12), Tree Nuts (Crop Group14), Cereal Grains (Crop Group 15), Forage,
Fodder and Straw of Cereal Grains (Crop Group 16), Grapes, Cotton, and
Sunflower, page 45 in docket ID number EPA-HQ-OPP-2008-0352.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
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
greater than that 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 can be found at http://www.regulations.gov in the
document Saflufenacil. Revised Human-Health Risk Assessment for
Proposed Uses in/on Legume Vegetables (Crop Group 06), the Foliage of
Legume Vegetables (Crop Group 07), Citrus Fruits (Crop Group 10), Pome
Fruits (Crop Group 11), Stone Fruits (Crop Group 12), Tree Nuts (Crop
Group14), Cereal Grains (Crop Group 15), Forage, Fodder and Straw of
Cereal Grains
[[Page 46686]]
(Crop Group 16), Grapes, Cotton, and Sunflower, page 27 in docket ID
number EPA-HQ-OPP-2008-0352.
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. No other tolerances have been established for
saflufenacil. 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.
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 Intakes by Individuals
(CSFII). As to residue levels in food, EPA assumed that residues are
present in all commodities at the tolerance level and that 100% of
commodities are treated with saflufenacil. Dietary Exposure Evaluation
Model (DEEM\(TM)\) 7.81 default concentration factors were used to
estimate residues of saflufenacil in processed commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used the same
assumptions (tolerance-level residues, 100% crop treated, and
DEEM\(TM)\ 7.81 default concentration factors) as in the acute exposure
assessment.
iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA classified saflufenacil as ``not likely to be
carcinogenic to humans;'' therefore, an exposure assessment to evaluate
cancer risk is unnecessary for this chemical.
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 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) models, 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 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 website 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 and a two-generation reproduction
toxicity 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.
iv. The dose used to evaluate chronic dietary risks (4.6
milligrams/kilogram/day (mg/kg/day)) is lower than the NOAELS for
fetal/offspring effects in the developmental and reproduction studies
(5 mg/kg/day in the rat developmental study, 50 mg/kg/day in the rabbit
developmental study, and 15 mg/kg/day in the rat reproduction study)
and is, therefore, protective of the developmental and offspring
effects observed in these studies and
v. Residential exposures are not expected, since there are no
residential uses proposed for saflufenacil.
[[Page 46687]]
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 adequate to assess the
prenatal and postnatal toxicity of saflufenacil. In accordance with 40
CFR part 158 Toxicology Data requirements, an immunotoxicity study
(870.7800) is required for saflufenacil. In the absence of specific
immunotoxicity studies, EPA has evaluated the available saflufenacil
toxicity data to determine whether an additional database uncertainty
factor is needed to account for potential immunotoxicity. An increase
in spleen weight, an organ of the immune system, was seen in rats in
the 90-day oral toxicity study. This effect 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. There were no other effects on
immune system organs observed in toxicity studies with saflufenacil,
and saflufenacil does not belong to a class of chemicals (e.g., the
organotins, heavy metals, or halogenated aromatic hydrocarbons) that
would be expected to be immunotoxic. Based on these considerations, EPA
does not believe that conducting immunotoxicity testing will result in
a point of departure lower than those already selected for
saflufenacil, and an additional database uncertainty factor is not
needed to account for potential immunotoxicity.
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. There is evidence of increased quantitative and qualitative
susceptibility of offspring in the developmental and reproduction
studies for saflufenacil; however, 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 groundwater and surface water modeling
used to assess exposure to saflufenacil in drinking water. Residential
exposure to saflufenacil is not expected. 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 pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute 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 28% 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-term/intermediate-term risk. Short-term and intermediate-
term aggregate exposures take into account short-term or intermediate-
term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Saflufenacil is not
registered for any use patterns that would result in residential
exposure. Therefore, the short-term and intermediate-term aggregate
risk is the sum of the risk from exposure to saflufenacil through food
and water and will not be greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S. population. Saflufenacil is
classified as ``not likely to be carcinogenic to humans'' and is,
therefore, not expected to pose a cancer risk.
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 saflufenacil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry (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
There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) established for residues of saflufenacil and its metabolites in
crops or livestock commodities. The residue definition and tolerances
being established by this rule are harmonized with MRLs being
established concurrently by Canada and Australia.
C. Response to Comments
EPA received one comment in response to the petition notice of
filing. The commenter, a private citizen, expressed strong objections
to ``genetically engineered foods.'' The commenter's objections are not
relevant to this petition, since the tolerances for saflufenacil do not
involve genetically altered herbicide-tolerant crops.
D. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition, EPA has
revised the tolerance levels for almond hulls and sunflower seed;
determined that a tolerance for sorghum stover is unnecessary;
determined that tolerances are required for additional livestock
commodities; and revised the tolerance expression for plant and
livestock commodities. EPA also revised commodity terms, as necessary,
to agree with the Agency's Food and Feed Commodity Vocabulary.
EPA increased the tolerance on sunflower seed from 0.7 ppm to 1.0
ppm based on analysis of the field trial data using the Agency's
Tolerance Spreadsheet in accordance with the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data. The tolerance on almond
hulls was decreased from 0.2 ppm to 0.10 ppm, based on the results of
field trials showing that all residues were less than the limit of
quantitation (LOQ) (0.025 ppm for each analyte) at the proposed
preharvest interval (PHI) of 7 days. The
[[Page 46688]]
tolerance level was determined by adding the LOQs for saflufenacil and
its two regulated analytes and rounding up to 0.10 ppm. EPA determined
that a separate tolerance on sorghum stover is unnecessary, since
sorghum stover is included in crop group 16 (grain, cereal, forage,
fodder and straw group).
The petitioner proposed tolerances for saflufenacil and its
metabolites M800H11 and M800H35 on animal kidney at 0.02 ppm and on
animal liver at 0.80 ppm. EPA determined that M800H11 and M800H35
should be excluded from the tolerance expression for livestock
commodities based on the low potential for exposure to these
metabolites from the proposed uses. Data from the cattle feeding study
with saflufenacil indicate that tolerances are needed for residues of
saflufenacil at 0.80 ppm in liver and at 0.02 ppm in the meat
byproducts, except liver, of cattle, goats, horses, hogs, and sheep.
EPA is also establishing tolerances at the method LOQ (0.01 ppm) for
fat, meat, and milk, because feeding levels in the cattle feeding study
were not high enough (i.e., 10X) to demonstrate conclusively that
detectable residues would not occur in these livestock commodities.
Although the commodity terms proposed in the petition itself were
largely in accordance with the Agency's Food and Feed Commodity
Vocabulary, many were incorrectly specified in the Notice of Filing:
legume vegetables (group 06); citrus fruits (group 10); pome fruits
(group 11); stone fruits (group 12); tree nuts (group 14); cereal
grains (group 15); undelinted cotton seed; cotton gin byproducts;
foliage of legume vegetables (group 07); forage, fodder and straw of
cereal grains (group 16); almond hulls; and sunflower seed. EPA has
corrected these commodity terms to read: vegetable, legume, group 6;
fruit, citrus, group 10; fruit, pome, group 11; fruit, stone, group 12;
nut, tree, group 14; grain, cereal, group 15; cotton, undelinted seed;
cotton, gin byproducts; vegetable, foliage of legume, group 7; grain,
cereal, forage, fodder and straw group 16; almond, hulls; and
sunflower, seed.
Finally, EPA is revising the tolerance expressions for plant and
livestock commodities to clarify the chemical moieties that are covered
by the tolerances and specify how compliance with the tolerances is to
be measured. The revised tolerance expressions make clear that the
tolerances cover ``residues of saflufenacil, including its metabolites
and degradates,'' and that compliance with the tolerance levels will be
determined, for livestock commodities, by measuring only saflufenacil;
and for plant commodities, by measuring only the sum of saflufenacil,
2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-
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(2H)-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.
V. Conclusion
Therefore, tolerances are established for residues of saflufenacil,
including its metabolites and degradates, on the plant commodities
almond, hulls at 0.10 ppm; cotton, gin byproducts at 0.10 ppm; cotton,
undelinted seed at 0.03 ppm; fruit, citrus, group 10 at 0.03 ppm;
fruit, pome, group 11 at 0.03 ppm; fruit, stone, group 12 at 0.03 ppm;
grain, cereal, forage, fodder and straw group 16 at 0.10 ppm; grain,
cereal, group 15 at 0.03 ppm; grape at 0.03 ppm; nut, tree, group 14 at
0.03 ppm; pistachio at 0.03 ppm; sunflower, seed at 1.0 ppm; vegetable,
foliage of legume, group 7 at 0.10 ppm; and vegetable, legume, group 6
at 0.03 ppm; and on the livestock commodities cattle, fat at 0.01 ppm;
cattle, liver at 0.80 ppm; cattle, meat at 0.01 ppm; cattle, meat
byproducts, except liver at 0.02 ppm; goat, fat at 0.01 ppm; goat,
liver at 0.80 ppm; goat, meat at 0.01 ppm; goat, meat byproducts,
except liver at 0.02 ppm; hog, fat at 0.01 ppm; hog, liver at 0.80 ppm;
hog, meat at 0.01 ppm; hog, meat byproducts, except liver at 0.02 ppm;
horse, fat at 0.01 ppm; horse, liver at 0.80 ppm; horse, meat at 0.01
ppm; horse, meat byproducts, except liver at 0.02 ppm; milk at 0.01
ppm; sheep, fat at 0.01 ppm; sheep, liver at 0.80 ppm; sheep, meat at
0.01 ppm; and sheep, meat byproducts, except liver at 0.02 ppm.
Compliance with the tolerance levels for plant commodities will be
determined by measuring only the sum of saflufenacil, 2-chloro-5-[3,6-
dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-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(2H)-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. Compliance
with the tolerance levels for livestock commodities will be determined
by measuring only saflufenacil.
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 (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 section 408(d) of FFDCA, 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 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, 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
[[Page 46689]]
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 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 (NTTAA), 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: September 2, 2009.
Debra Edwards,
Director, Office of Pesticide Programs.
0
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 added to read as follows:
Sec. 180.649 Saflufenacil; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
saflufenacil, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-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(2H)-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
the commodities.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls........................................ 0.10
Cotton, gin byproducts............................... 0.10
Cotton, undelinted seed.............................. 0.03
Fruit, citrus, group 10.............................. 0.03
Fruit, pome, group 11................................ 0.03
Fruit, stone, group 12............................... 0.03
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
Pistachio............................................ 0.03
Sunflower, seed...................................... 1.0
Vegetable, foliage of legume, group 7................ 0.10
Vegetable, legume, group 6........................... 0.03
------------------------------------------------------------------------
(2) Tolerances are established for residues of saflufenacil,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only saflufenacil, 2-chloro-5-[3,6-
dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-
fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide, in or on the
commodities.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.......................................... 0.01
Cattle, liver........................................ 0.80
Cattle, meat......................................... 0.01
Cattle, meat byproducts, except liver................ 0.02
Goat, fat............................................ 0.01
Goat, liver.......................................... 0.80
Goat, meat........................................... 0.01
Goat, meat byproducts, except liver.................. 0.02
Hog, fat............................................. 0.01
Hog, liver........................................... 0.80
Hog, meat............................................ 0.01
Hog, meat byproducts, except liver................... 0.02
Horse, fat........................................... 0.01
Horse, liver......................................... 0.80
Horse, meat.......................................... 0.01
Horse, meat byproducts, except liver................. 0.02
Milk................................................. 0.01
Sheep, fat........................................... 0.01
Sheep, liver......................................... 0.80
Sheep, meat.......................................... 0.01
Sheep, meat byproducts, except liver................. 0.02
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E9-21826 Filed 9-10-09; 8:45 am]
BILLING CODE 6560-50-S