Document ID: EPA-HQ-OPP-2014-0124-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Saflufenacil
Posted Date: 2014-09-03T04:00Z

[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Rules and Regulations]
[Pages 52215-52220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20947]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0622 and EPA-HQ-OPP-2014-0124; FRL-9912-91]

Saflufenacil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and revises tolerances for 
residues of saflufenacil in or on multiple commodities which are 
identified and discussed later in this document. BASF Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective September 3, 2014. Objections and 
requests for hearings must be received on or before November 3, 2014, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2013-0622 and EPA-HQ-OPP-2014-
0124, are available at http://www.regulations.gov or at the Office of 
Pesticide Programs Regulatory Public Docket (OPP Docket) in the 
Environmental Protection Agency Docket Center (EPA/DC), West William 
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC 20460-0001. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805. Please review 
the visitor instructions and additional information about the docket 
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID numbers EPA-HQ-OPP-2013-0622 and EPA-HQ-OPP-2014-0124 in the 
subject line on the first page of your submission. All objections and 
requests for a hearing must be in writing, and must be received by the 
Hearing Clerk on or before November 3, 2014. Addresses for mail and 
hand delivery of objections and hearing requests are provided in 40 CFR 
178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0622 and EPA-
HQ-OPP-2014-0124, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of October 25, 2013 (78 FR 63938) (FRL-
9901-96), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3F8192) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR 
180.649 be amended by establishing tolerances for residues of the 
herbicide saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(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 
grass, forage at 15 parts per million (ppm); grass, hay at 20 ppm; 
grass, seed screenings at 0.9 ppm; and grass, straw at 1.5 ppm and 
revising the livestock commodity tolerances for (cattle, goat, horse, 
and sheep): Fat from 0.01 ppm to 0.05 ppm; liver from 2.5 ppm to 45 
ppm; and meat byproducts, except liver from 0.05 ppm to 0.5 ppm; hog, 
fat from 0.01 ppm to 0.05 ppm; hog, liver from 0.80 ppm to 45 ppm; and 
hog, meat byproducts, except liver from 0.02 ppm to 0.5 ppm.
    The same Federal Register document of October 25, 2013, also 
announced

[[Page 52216]]

BASF Corporation's filing of a pesticide petition (PP 3F8185) that 
requested 40 CFR 180.649 be amended by revising tolerances for 
saflufenacil and its metabolites in or on barley, grain from 0.10 ppm 
to 1.0 ppm; barley, straw from 0.10 ppm to 15.0 ppm; barley, bran from 
0.10 ppm to 1.53 ppm; wheat, grain from 0.10 ppm to 0.6 ppm; and wheat, 
straw from 0.10 ppm to 6.0 ppm, included under the existing tolerances 
for ``Grain, cereal, group 15'' and ``Grain, cereal, forage, fodder and 
straw group 16.'' In addition, BASF Corporation requested to amend the 
existing commodity definition, ``Grain, cereal, forage, fodder and 
straw group 16'' to ``Grain, cereal, forage, fodder and straw, group 
16, except barley, rice and wheat straw'' as well as amend the 
commodity definition, ``Grain, cereal, group 15'' to ``Grain, cereal, 
group 15, except barley and wheat.''
    Finally, in the Federal Register of February 25, 2014 (79 FR 10458) 
(FRL-9906-77), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 4F8229) by BASF Corporation. The petition requested that 
40 CFR 180.649 be amended by establishing tolerances for residues of 
the herbicide saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-
4-(trifluoromethyl)-1(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 
olive at 0.03 ppm. These documents referenced summaries of the 
petitions prepared by BASF Corporation, the petitioner, which are 
available in the dockets, http://www.regulations.gov. There were no 
comments received in response to these notices of filings.
    Based upon review of the supporting data, EPA has made 
modifications to the proposed tolerances which include:
    1. Rounding the proposed tolerance for barley, bran.
    2. Revising the commodity definition for crop group 16.
    3. Decreasing the proposed tolerances for grass, seed screenings 
and grass, straw.
    4. Increasing the existing tolerance for residues in or on grain, 
aspirated fractions.
    5. Making several changes to the proposed livestock tolerances.
    The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for saflufenacil, including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with saflufenacil 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. In the Federal Register of February 21, 2014 (79 FR 9861) 
(FRL-9905-87), EPA published a final rule establishing tolerances for 
residues of the herbicide saflufenacil and its metabolites in or on 
sugarcane, fish, and shellfish commodities based on EPA's conclusion 
that aggregate exposure to saflufenacil is safe for the general 
population, including infants and children. Since that rulemaking, 
there have been no additional tolerance actions for saflufenacil, nor 
has the toxicity profile for saflufenacil changed. 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 are discussed in that rulemaking which can be found in the 
docket under docket ID numbers EPA-HQ-OPP-2012-0775 and EPA-HQ-OPP-
2013-0008.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the lowest dose at which the 
LOAEL are identified. Uncertainty/safety factors (UFs) are used in 
conjunction with the POD to calculate a safe exposure level--generally 
referred to as a population-adjusted dose (PAD) or a reference dose 
(RfD)--and a safe margin of exposure (MOE). For non-threshold risks, 
the Agency assumes that any amount of exposure will lead to some degree 
of risk. Thus, the Agency estimates risk in terms of the probability of 
an occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the 
toxicological endpoints for saflufenacil used for human risk assessment 
is discussed in Unit III.B. of the February 21, 2014 Federal Register 
final rule.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to saflufenacil, EPA considered exposure under the petitioned-
for tolerances as well as all existing saflufenacil tolerances in 40 
CFR 180.649. EPA assessed dietary exposures from saflufenacil in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for saflufenacil. In estimating acute dietary exposure, EPA used food

[[Page 52217]]

consumption information from the United States Department of 
Agriculture National Health and Nutrition Examination Survey, What We 
Eat in America, (USDA NHANES/WWEIA, 2003-2008). As to residue levels in 
food, EPA assumed 100 percent crop treated (PCT), Dietary Exposure 
Evaluation Model (DEEM) 7.81 default processing factors, and tolerance-
level or higher (i.e., tolerance levels adjusted to take into account 
metabolite levels) residues for all foods.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA, 2003-2008. As to residue levels in food, EPA made the same 
assumptions (adjusted tolerance-level residues and 100 PCT) as in the 
acute dietary exposure assessment.
    iii. Cancer. As indicated in the February 21, 2014 Federal Register 
final rule preamble for saflufenacil, EPA has concluded that 
saflufenacil does not pose a cancer risk to humans. Therefore, a 
dietary exposure assessment for the purpose of assessing cancer risk is 
unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for saflufenacil. Tolerance-level residues (or higher) and 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for 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 Tier 1 Rice Model and Tier II Pesticide Root Zone 
Model Ground Water (PRZM GW), the estimated drinking water 
concentrations (EDWCs) of saflufenacil for acute exposures are 
estimated to be 133 parts per billion (ppb) for surface water and 69.2 
ppb for ground water. Chronic exposures for non-cancer assessments are 
estimated to be 120 ppb for surface water and 51.5 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 133 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 120 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Saflufenacil is not registered for any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found 
saflufenacil to share a common mechanism of toxicity with any other 
substances, and saflufenacil does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that saflufenacil does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. Increased fetal 
susceptibility was observed in the developmental toxicity studies in 
the rat and rabbit and in the 2-generation reproduction study in the 
rat. Developmental effects (decreased fetal body weights and increased 
skeletal variations in rats and increased liver porphyrins in rabbits) 
occurred at doses that were not maternally toxic in the developmental 
studies, indicating increased quantitative susceptibility. In the 2-
generation reproductive toxicity study in rats, the reported offspring 
effects were more severe than the maternal effects at the same dose 
level, indicating evidence for increased qualitative susceptibility. An 
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 occurred at the same dose level as 
maternal decrements in food intake, body weight, body-weight gain, and 
changes in hematological parameters and organ weights indicative of 
anemia.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for saflufenacil is complete.
    ii. There is no indication that saflufenacil is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. The concern for increased susceptibility following prenatal or 
postnatal exposure is low because 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 reproductive toxicity 
study. Further, the dose-response relationship for the effects of 
concern is also well characterized and being used for assessing risks. 
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. The chronic point of departure used for risk 
assessment is protective of any developmental and offspring effects 
observed in these studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to saflufenacil in drinking water. These assessments 
will not underestimate the exposure and risks posed by saflufenacil.

[[Page 52218]]

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to saflufenacil will occupy <1% of the aPAD for infants less than 1-
year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
saflufenacil from food and water will utilize 20% of the cPAD for 
infants less than 1-year old, the population group receiving the 
greatest exposure. There are no residential uses for saflufenacil.
    3. Short and intermediate-term risk. Short and intermediate-term 
aggregate exposure takes into account short and intermediate-term 
residential exposures plus chronic exposure to food and water 
(considered to be a background exposure level). Because there is no 
short or intermediate-term residential exposure and chronic dietary 
exposure has already been assessed under the appropriately protective 
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short or intermediate-term risk is 
necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short-term risk for saflufenacil.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, saflufenacil is not expected to pose a cancer risk to humans.
    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 methods ``D0603/02'' and ``L0073/01'' (liquid 
chromatography/mass spectroscopy/mass spectroscopy (LC-MS/MS)) are 
available to enforce the tolerance expression. These 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; email address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are MRLs established for residues of saflufenacil, measuring 
the levels of the parent only and not residues of the metabolites, as 
follows: 0.01 ppm in or on cereal grains, which includes barley, corn, 
and wheat; 0.05 ppm for maize fodder (dry), sorghum straw and fodder, 
dry; 0.05 ppm for barley straw and fodder, dry; 0.05 ppm for wheat 
straw and fodder, dry; 0.01 mammalian fats (except milk fats), which 
includes cattle, goat, hog, horse, and sheep; and 0.3 edible offal 
mammalian, which includes cattle, goat, hog, horse, and sheep.
    Harmonization between the Codex MRLs for cereal grains and the U.S. 
tolerances for barley, grain and wheat, grain and between the Codex MRL 
for barley straw and fodder, dry and the U.S. tolerance for barley, 
straw and between the Codex MRL for wheat straw and fodder, dry and the 
U.S. tolerance for wheat, straw is not possible as the U.S. use pattern 
(harvest-aide/burndown application) results in significantly higher 
residues than the Codex use pattern (pre-emergence application). The 
higher residues translate into higher residues of saflufenacil in 
animal byproducts than are covered by the corresponding Codex MRLs for 
livestock commodities under the Codex use pattern; therefore, U.S. 
tolerances for livestock commodities cannot be harmonized with Codex 
MRLs for corresponding livestock commodities.
    The U.S. tolerances for crop groups 15 and 16 are not harmonized 
with the Codex MRLs for cereal grains and straw and fodder because the 
compliance with the Codex MRLs involve measurement of residues of the 
parent only and not the metabolites, whereas the U.S. tolerance 
requires measurement of both, in order to be harmonized with Canadian 
tolerances.

C. Revisions to Petitioned-for Tolerances

    EPA is making several revisions to the petitioned-for tolerances. 
These include the following. First, the petitioned value for barley 
bran is being rounded from 1.53 ppm to 1.5 ppm to be consistent with 
the current Organization for Economic Cooperation and Development 
(OECD) tolerance-calculation procedure. Second, the commodity 
definition ``Grain, cereal, forage, fodder, and straw group 16 (except 
barley, wheat and rice straw)'' is being revised to ``Grain, cereal, 
forage, fodder and straw group 16 (except barley and wheat straw)'' as 
the new use pattern (harvest aid/desiccant) was not proposed for rice. 
Third, the petitioner requested tolerance values for grass straw and 
seed screenings were based on data from trials in which the samples 
were harvested at a significantly shorter preharvest interval (PHI) 
than that listed on the label. Additional residue data reflecting the 
actual PHI listed on the label showed lower residue levels; therefore, 
the tolerance values for grass straw and seed screenings are being 
decreased. Fourth, the existing tolerance of 10 ppm for residues in or 
on grain, aspirated fractions is being increased to 50 ppm as a result 
of the new tolerances for cereal grains and based on available residues 
data. Finally, EPA is making several revisions to the proposed 
livestock tolerances which include:
    1. Decreasing the proposed tolerances for cattle, goat, sheep, hog 
and horse fat from 0.05 ppm to 0.04 ppm and meat byproducts (except 
liver) from 0.05 ppm to 0.03 ppm.
    2. Increasing the tolerances proposed for cattle, goat, sheep and 
horse liver from 45 ppm to 50 ppm.
    3. Decreasing the tolerance proposed for hog liver from 45 ppm to 
2.0 ppm.
    4. Establishing tolerances for cattle, goat, sheep and horse meat 
at 0.02 ppm.

[[Page 52219]]

    5. Retaining the currently established tolerances for hog, fat or 
hog, meat byproducts (except liver), instead of increasing them as 
requested.
    The tolerances being set for residues in livestock differ from the 
petitioned-for tolerances due to differences in calculation methods of 
the maximum reasonably balanced diets (MRBDs) with the results of the 
ruminant feeding study. It also appears that the petitioner over-
estimated residues in hog commodities as a result of using the cattle 
MRDB.

 V. Conclusion

    Therefore, tolerances are established for residues of saflufenacil, 
including its metabolites and degradates, as set forth in the 
regulatory text. Compliance with the plant tolerances is to be 
determined by measuring 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 livestock tolerances is to be determined by measuring only 
saflufenacil, 2-chloro-5-[3,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-
1(2H)-pyrimidinyl)-4-fluoro-N-[[methyl(1-
methylethyl)amino]sulfonyl]benzamide.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this 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 FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This 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 FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 25, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.649:
0
a. Remove the commodities ``Grain, aspirated fractions,'' ``Grain, 
cereal, forage, fodder and straw group 16,'' and ``Grain, cereal, group 
15'' in the table in paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in 
paragraph (a)(1).
0
c. Revise the following commodities in the table in paragraph (a)(2).
    The amendments read as follows:

Sec.  180.649  Saflufenacil; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Barley, bran............................................            1.5
Barley, grain...........................................            1.0
Barley, straw...........................................           15
 
                                * * * * *
Grain, aspirated grain fractions........................           50
Grain, cereal, forage, fodder and straw group 16 (except            0.10
 barley and wheat straw)................................
Grain, cereal, group 15 (except barley and wheat grain).            0.03
 
                                * * * * *
Grass, forage...........................................           15
Grass, hay..............................................           20
Grass, seed screenings..................................            0.15
Grass, straw............................................            0.15
 
                                * * * * *
Olive...................................................            0.03
 
                                * * * * *
Wheat, grain............................................            0.60
Wheat, straw............................................            6.0
------------------------------------------------------------------------

* * * * *
    (2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Cattle, fat.............................................            0.04

[[Page 52220]]

 
Cattle, liver...........................................           50
Cattle, meat............................................            0.02
Cattle, meat byproducts, except liver...................            0.30
 
                                * * * * *
Goat, fat...............................................            0.04
Goat, liver.............................................           50
Goat, meat..............................................            0.02
Goat, meat byproducts, except liver.....................            0.30
 
                                * * * * *
Hog, liver..............................................            2.0
 
                                * * * * *
Horse, fat..............................................            0.04
Horse, liver............................................           50
Horse, meat.............................................            0.02
Horse, meat byproducts, except liver....................            0.30
 
                                * * * * *
Sheep, fat..............................................            0.04
Sheep, liver............................................           50
Sheep, meat.............................................            0.02
Sheep, meat byproducts, except liver....................            0.30
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-20947 Filed 9-2-14; 8:45 am]
BILLING CODE 6560-50-P