[Federal Register Volume 79, Number 35 (Friday, February 21, 2014)]
[Rules and Regulations]
[Pages 9861-9866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03734]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0775 and EPA-HQ-OPP-2013-0008; FRL-9905-87]


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 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 February 21, 2014. Objections and 
requests for hearings must be received on or before April 22, 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 in this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0775 and EPA-HQ-OPP-2013-
0008, 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), EPA West 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; telephone 
number: (703) 305-7090; email address: [email protected].

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

[[Page 9862]]

proper receipt by EPA, you must identify the docket ID number EPA-HQ-
OPP-2012-0775 and/or EPA-HQ-OPP-2013-0008 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 April 22, 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-2012-0775 and/or 
EPA-HQ-OPP-2013-0008, 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 November 7, 2012 (77 FR 66781) (FRL-
9367-5) (EPA-HQ-OPP-2012-0775), 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 2E8065) 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, including its metabolites and 
degradates, in or on sugarcane, cane at 0.03 parts per million (ppm); 
sugarcane, molasses at 0.075 ppm; and sugarcane, refined sugar at 0.045 
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. There were no comments received in response 
to the notice of filing.
    In the Federal Register of February 27, 2013 (78 FR 13295) (FRL-
9380-2) (EPA-HQ-OPP-2013-0008), 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 2F8139) 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, including its metabolites and 
degradates, in or on crayfish at 0.01 ppm. In the Federal Register of 
December 30, 2013 (78 FR 79359) (FRL-9903-69) (EPA-HQ-OPP-2013-0008) 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing a revision to the original pesticide petition 
(PP 2F8139) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The revised petition requested that 40 
CFR 180.649 be amended by establishing tolerances for residues of the 
herbicide, saflufenacil, including its metabolites and degradates, in 
or on fish-freshwater finfish and fish-shellfish crustacean at 0.01 ppm 
instead of ``crayfish at 0.01 ppm'' based on the Agency's evaluation of 
the data supporting the original petition. That document referenced a 
summary of the petition prepared by BASF Corporation, the registrant, 
which is available in the docket, http://www.regulations.gov. There 
were no comments received in response to the notice of filing.
    In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2) 
(EPA-HQ-OPP-2013-0008), 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 2F8129) 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 amending tolerances for residues of the 
herbicide, saflufenacil, including its metabolites and degradates, in 
or on rice, straw at 0.30 ppm and amend the current commodity 
definition ``Grain, cereal, forage, fodder and straw group 16'' to 
``Grain, cereal, forage, fodder and straw group 16 (except rice 
straw).'' That document referenced a summary of the petition prepared 
by BASF Corporation, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petitions, EPA has 
determined that the tolerance level of 0.03 ppm requested for 
sugarcane, cane is increased to 0.05 ppm; and the tolerance level of 
0.075 ppm requested for sugarcane, molasses is increased to 0.08 ppm. 
Additionally, tolerances requested for sugarcane, refined sugar and 
rice, straw are not being established at this time. 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.
    Saflufenacil has low acute toxicity via all routes of exposure. 
Subchronic and

[[Page 9863]]

chronic toxicity studies in rats, mice, and dogs identified the 
hematopoietic system as the primary target of saflufenacil. Consistent 
with its proposed mode of toxicity involving protoporphyrinogen IX 
oxidase (PPO) inhibition and subsequent disruption of heme 
biosynthesis, decreased hematological parameters were seen at about the 
same dose level [lowest-observed adverse-effect levels (LOAELs) of 13-
39 milligram/kilogram/day (mg/kg/day)] across species, except in the 
case of the dog, where the effects were seen at a slightly higher dose 
(LOAELs of 50-100 mg/kg/day). These effects occurred around the same 
dose level from short- through long-term exposures without increasing 
in severity. In line with findings that male rats achieve a greater 
systemic exposure than females, males were the most sensitive sex in 
mice and rats. Effects were also seen in the liver (increased weight, 
centrilobular fatty change, lymphoid infiltrate) in mice, the spleen 
(increased spleen 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 increasing in severity.
    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, 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.
    There is no evidence of neurotoxicity or immunotoxicity in the 
saflufenacil database.
    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 Fish, Crayfish, 
and Imported Sugarcane'' at p. 26 in 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 no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for saflufenacil used for 
human risk assessment is shown in Table 1 of this unit.

 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     Study and toxicological effects
                                      safety  factors      risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 500 mg/kg/    Acute RfD = 5.0 mg/  Acute Neurotoxicity Study (rat).
 including infants and children).   day.                  kg/day.             LOAEL = 2,000 mg/kg/day based on
                                   UFA = 10X...........  aPAD = 5.0 mg/kg/     decreased motor activity
                                   UFH = 10X...........   day.                 representing mild and transient
                                                                               systemic toxicity in male rats.
                                   FQPA SF = 1X
Chronic dietary (All populations)  NOAEL= 4.6 mg/kg/day  Chronic RfD = 0.046  Chronic/Carcinogenicity (mouse).
                                                          mg/kg/day.          LOAEL = 13.8 mg/kg/day based on
                                                                               decreased red blood cells,
                                                                               hemoglobin, hematocrit, and
                                                                               porphyria observed in the
                                                                               satellite group.
                                   UFA = 10X             cPAD = 0.046 mg/kg/
                                   UFH = 10X...........   day.
                                   FQPA SF = 1X
----------------------------------------------------------------------------------------------------------------

[[Page 9864]]

 
Cancer (Oral, dermal, inhalation)    Not likely carcinogenic to humans based on the lack of tumors in the mouse
                                              and rat carcinogenicity studies and lack of mutagenicity.
----------------------------------------------------------------------------------------------------------------
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 and chronic 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 both acute and chronic dietary exposure, EPA used the 
Dietary Exposure Evaluation Model--Food Consumption Intake Database 
(DEEM) which incorporates 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 assumed 100 percent crop treated 
(PCT), 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. 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.
    iii. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for saflufenacil. Tolerance level residues and/or 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 
SF 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

[[Page 9865]]

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.

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 18% of the cPAD for 
infants <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: [email protected].

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.

C. Revisions to Petitioned-for Tolerances

    EPA has increased the tolerance level requested by BASF Corporation 
in petition 2E8065 for sugarcane, cane from 0.03 ppm to 0.05 ppm based 
on the residue data for sugarcane and use of the Organization for 
Economic Co-operation and Development (OECD) tolerance calculation 
procedures. Also, based on the residue data for sugarcane and to 
account for concentrations of residues during processing, a tolerance 
of 0.08 ppm is required for residues in or on sugarcane, molasses. 
Residues did not concentrate in refined sugar, so the tolerance 
proposed for this commodity will not be established at this time. In 
addition, the proposed tolerances for rice straw in PP 2F8129 will not 
be established since rice straw is not a significant livestock item. 
Therefore, the associated request for a change in the commodity 
definition is not necessary.

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 and 
degradates in or on sugarcane, cane at 0.05 ppm and sugarcane, molasses 
at 0.08 ppm. Also, tolerances are established for residues of the 
parent, saflufenacil, in fish-freshwater finfish and fish-shellfish, 
crustacean at 0.01 ppm. Compliance with the sugarcane, cane and 
sugarcane, molasses 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-

[[Page 9866]]

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 
fish-freshwater finfish and fish-shellfish, crustacean tolerances are 
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.

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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of 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: February 11, 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. Add alphabetically the following commodities and footnote 2 to the 
table in paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in 
paragraph (a)(2).
    The amendments read as follows:


Sec.  180.649  Saflufenacil; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sugarcane, cane \2\........................................         0.05
Sugarcane, molasses \2\....................................         0.08
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    \2\ No U.S. registration as of February 21, 2014.
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fish-freshwater finfish....................................         0.01
Fish-shellfish, crustacean.................................         0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-03734 Filed 2-20-14; 8:45 am]
BILLING CODE 6560-50-P