
[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
