Document ID: EPA-HQ-OPP-2014-0640-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Saflufenacil
Posted Date: 2015-11-25T05:00Z

[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Rules and Regulations]
[Pages 73663-73667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29889]

[[Page 73663]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0640; FRL-9936-71]

Saflufenacil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
saflufenacil in or on pomegranate. BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 25, 2015. Objections and 
requests for hearings must be received on or before January 25, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0640, is 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: Susan Lewis, Director, 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/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0640 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 
January 25, 2016. 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-2014-0640, 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 February 11, 2015, (80 FR 7559) (FRL-
9921-94), 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) 
4F8305 by BASF Corporation, 26 Davis Drive, 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, in or on pomegranate at 
0.03 parts per million (ppm). That document referenced a summary of the 
petition prepared by BASF Corporation, the registrant, which is 
available 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.

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

[[Page 73664]]

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.
    The effects observed following repeated oral exposures to 
saflufenacil are consistent with the proposed mode of toxicity 
involving inhibition of protoporphyrinogen oxidase (PPO) in mammals, 
resulting in disruption of heme biosynthesis. Toxicological effects 
from subchronic and chronic toxicity studies in rats, mice and dogs 
consisted of decreased hematological parameters (RBC, Ht, MCV, MCH, and 
MCHC) at approximately the same dose level (13-39 mg/kg/day), except in 
the case of the dog, where the effects were seen at a slightly higher 
dose (50-100 mg/kg/day). In line with the absorption, distribution, 
metabolism, and excretion (ADME) findings suggesting that male rats 
achieve a greater systemic exposure than females, males were the most 
sensitive sex in mice and rats, with LOAELs approximately 3-4X lower 
than their female counterparts. The hematological effects resulting 
from oral exposures to saflufenacil occurred around the same dose level 
from short- through long-term exposures without increasing in severity. 
Toxic effects were also seen in the liver (increased organ weight, 
centrilobular fatty change, lymphoid infiltrate) in mice, the spleen 
(increased organ weight and extramedullary hematopoiesis) in rats, and 
in both of 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 short- through long-term 
exposures without a progression in severity.
    Evidence for increased pre- and/or postnatal susceptibility was 
noted from the developmental toxicity studies in the rat and rabbit and 
in the 2-generation reproduction study in the rat. Decreased fetal body 
weights and increased skeletal variations occurred at doses (20 mg/kg/
day) that were not maternally toxic in the developmental study in rats. 
Similarly, in rabbits, increased liver porphyrins in fetuses were 
observed at doses (200 mg/kg/day) that were not maternally toxic. In 
the 2-generation reproductive toxicity study in rats, there was 
evidence of increased qualitative susceptibility based on an increased 
number of stillborn pups, decreased pup viability and lactation 
indices, decreased pre-weaning body-weight and/or body-weight gain, and 
changes in hematological parameters at the same dose level as less 
severe maternal effects consisting of decrements in food intake, body-
weight, body-weight gain, and changes in organ weights and 
hematological parameters indicative of anemia.
    In an acute neurotoxicity (ACN) study in rats, a decrease in motor 
activity was observed on the day of dosing at the limit dose (2,000 mg/
kg/day) in males only. However, the finding was not accompanied by any 
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 (SCN) study, 
systemic toxicity (anemia) was seen at 1,000 ppm (66.2 mg/kg/day) and 
1,350 ppm (101 mg/kg/day) in males and females, respectively. There was 
no evidence of neurotoxicity or neuropathology in either the acute or 
subchronic neurotoxicity study.
    In a 28-day dermal toxicity study in rats, saflufenacil did not 
induce any type of dermal or systemic toxicity up to the limit dose of 
1,000 mg/kg bw/day.
    Based on the results of acute toxicity studies, saflufenacil was 
ranked low for acute toxicity via the oral, dermal, and inhalation 
route of exposure. It was not classified as a dermal irritant or dermal 
sensitizer.
    In a 28-day immunotoxicity study in mice, saflufenacil failed to 
induce toxicity specific to the immune system at the highest dose 
tested (i.e., 52 mg/kg bw/day).
    Saflufenacil was 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 was neither mutagenic in bacterial cells nor clastogenic in rodents 
in vivo. Carcinogenicity studies in rats and mice showed no evidence of 
increased incidence of tumors at the tested doses. Saflufenacil is 
classified as ``not likely carcinogenic to humans.''
    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 document Saflufenacil. ``Human Health Risk 
Assessment in Support of Tolerances for Residues in/on Pomegranate'' 
pgs. 26-30 in docket ID number EPA-HQ-OPP-2014-0640.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for saflufenacil used for 
human risk assessment is shown in Table 1 of this unit.

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 Table 1--Summary of Toxicological Doses and Endpoints for Saflufenacil for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                      Point of departure
         Exposure/scenario            and  uncertainty/      RfD, PAD, LOC for risk     Study and toxicological
                                        safety factors             assessment                   effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population   NOAEL = 500 mg/kg bw.  Acute RfD = 5 mg/kg.......  Acute Neurotoxicity Study
 including infants and children).   UFA = 10x............  aPAD = 5 mg/kg............   (rat). LOAEL = 2,000 mg/
                                    UFH = 10x............                               kg bw based on decreased
                                    FQPA SF = 1x.........                               motor activity
                                                                                        representing mild and
                                                                                        transient systemic
                                                                                        toxicity in males.
Chronic dietary (All populations).  NOAEL = 4.6 mg/kg/day  Chronic RfD = 0.046mg/kg/   Chronic/Carcinogenicity
                                    UFA =10x.............   day.                        (mouse). LOAEL = 13.8 mg/
                                    UFH = 10x............  cPAD = 0.046 mg/kg/day....   kg bw/day based on
                                    FQPA SF = 1x.........                               decreased red blood
                                                                                        cells, hemoglobin,
                                                                                        hematocrit, and
                                                                                        porphyria observed in
                                                                                        the satellite group.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to saflufenacil, EPA considered exposure under the petitioned-
for tolerances as well as all existing saflufenacil tolerances in 40 
CFR 180.649. EPA assessed dietary exposures from saflufenacil in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for saflufenacil. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008). 
As to residue levels in food, EPA used an unrefined approach by 
assuming that 100% of the crop is treated and that residues are present 
at the tolerance-level or at tolerance-levels adjusted to account for 
the residues of concern for risk assessment for all foods. EPA also 
used default processing factors using the Dietary Exposure Evaluation 
Model (DEEM) 7.8.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the same conservative assumptions that were used 
for the acute dietary assessment noted above.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that saflufenacil does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for saflufenacil. Tolerance-level residues and/or 
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier 1 Rice Model and 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.
    The EDWCs for 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of

[[Page 73666]]

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. As discussed in III.A., 
there is evidence of increased pre- and/or postnatal susceptibility in 
the developmental toxicity studies in the rat and rabbit and in the 2-
generation reproduction study in the rat. 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 are also well characterized and 
being used for assessing risks. The point of departure for risk 
assessments would be protective of the developmental and offspring 
effects.
    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 was no evidence of neurotoxicity or neuropathology in the 
acute and subchronic neurotoxicity study. The decrease in motor 
activity observed in the acute neurotoxicity study on the day of dosing 
at the limit dose (2,000 mg/kg/day) in males is considered a reflection 
of a mild and transient general systemic toxicity and not a substance-
specific neurotoxic effect. No neurotoxic effects were seen in the sub-
chronic neurotoxicity study.
    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 are also well characterized and being used for assessing risks. 
The POD for risk assessments would be protective of the developmental 
and offspring effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to saflufenacil in drinking water. These assessments 
will not underestimate the exposure and risks posed by saflufenacil.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. 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 infants 
(<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 all 
infants (<1-year old) the population group receiving the greatest 
exposure. There are no residential uses for saflufenacil.
    3. Short-term and intermediate-term risk. Short-term aggregate 
exposure takes into account short-term residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level). Intermediate-term aggregate exposure takes into 
account intermediate-term residential exposure plus chronic exposure to 
food and water. Since there are no registered or proposed residential 
uses for saflufenacil that would result in short or intermediate-term 
residential exposures, 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 and 
intermediate-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 methodology (liquid chromatography/mass 
spectroscopy/mass spectroscopy (LC/MS/MS) Method D0603/02) is available 
to enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
email address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for saflufenacil on pomegranate. Therefore, 
harmonization of MRLs and U.S. tolerances is not an issue at this time.

C. Response to Comments

    EPA received two comments to the docket, EPA-HQ-OPP-2014-0640; 
however, only one of these public submissions was in response to the 
Notice of Filing for PP# 4F8305, while the remaining comment pertained 
to an unrelated petition in the Federal Register notice. For PP# 
4F8305, the commenter stated that they are in support of actions to set 
tolerance levels for pesticides on the food we eat and that we are 
taking a step in the right direction by making it safer for human 
consumption by placing more regulations on pesticide chemicals.
    EPA agrees with the commenter and will continue to regulate 
pesticides

[[Page 73667]]

under the legal framework provided by the Federal Insecticide, 
Fungicide, Rodenticide Act (FIFRA) and Section 408 of the Federal Food, 
Drug and Cosmetic Act (FFDCA), which allows EPA to assess the risk of 
pesticides and set tolerance levels for those pesticides on food 
commodities as deemed necessary to protect human health while still 
providing tools for growers so that they can meet the ever-growing food 
demands of this country and others.

V. Conclusion

    Therefore, tolerances are established for residues 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, in or on 
pomegranate at 0.03 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

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: November 17, 2015.
Susan Lewis,
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, add alphabetically the entry to the table in 
paragraph (a)(1) to read as follows:

Sec.  180.649  Saflufenacil; tolerances for residues.

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

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Pomegranate............................................            0.03
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-29889 Filed 11-24-15; 8:45 am]
 BILLING CODE 6560-50-P