[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Rules and Regulations]
[Pages 58614-58620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24463]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0840; FRL-9933-27]


Acibenzolar-S-methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
acibenzolar-S-methyl in or on fruit, citrus, group 10-10 and fruit, 
pome, group 11-10. Syngenta Crop Protection, LLC requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 30, 2015. Objections and 
requests for hearings must be received on or before November 30, 2015, 
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-2014-0840, 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, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone

[[Page 58615]]

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 proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0840 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 30, 2015. 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-2014-0840, 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 
4F8269) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC. The petition requested that 40 CFR 180.561 be amended by 
establishing tolerances for residues of the fungicide, acibenzolar-S-
methyl, in or on pome fruit, crop group 11-10 at 0.03 parts per million 
(ppm) and citrus fruit, crop group 10-10 at 0.01 ppm. That document 
referenced a summary of the petition prepared by Syngenta Crop 
Protection, LLC, 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 petition, EPA has 
revised the tolerance for residues of acibenzolar-S-methyl in or on 
fruit, citrus, group 10-10 at 0.02 ppm. The reason for this change is 
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 acibenzolar-S-methyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with acibenzolar-S-
methyl 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 subchronic and chronic oral studies in rats, dogs and 
mice, signs of mild regenerative hemolytic anemia were consistently 
observed in all three species. These signs frequently included 
decreased erythrocyte counts, decreased hemoglobin, decreased 
hematocrit, increased reticulocyte counts, increased hemosiderosis in 
the spleen, liver and/or bone marrow, extramedullary hematopoiesis in 
the spleen, and increased spleen weights in both males and females. A 
compensatory response (increased erythrocyte production) regularly 
followed the initial anemia. Additional toxic effects observed in these 
same studies included decreases in body weight, body weight gain and/or 
food consumption. No other significant treatment-related effects of 
toxicological concern were observed in these subchronic and chronic 
oral studies. In a 28-day dermal study in rats, no systemic or dermal 
effects were observed at dose levels up to 1,000 milligram (mg)/
kilogram (kg)/day, the limit dose. No neurotoxic effects were observed 
at any dose in a subchronic neurotoxicity study in rats.

[[Page 58616]]

    Treatment-related developmental malformations, anomalies and 
variations were observed in a developmental toxicity study in rats at 
or below the no observable adverse effect level (NOAEL) for maternal 
toxicity. At the highest dose tested in this study (400 mg/kg/day), 
both maternal toxicity (hemorrhagic perineal discharge) and 
considerable developmental toxicity (including total litter 
resorptions, fetal malformations, anomalies and variations) were 
observed. The fetal malformations noted at this dose included 
treatment-related effects on nervous system tissues (hydrocephaly, 
craniorachisis and anophthalmia/microphthalmia). At the next lower dose 
tested (200 mg/kg/day), treatment-related visceral malformations and 
skeletal variations were demonstrated in the absence of significant 
maternal toxicity. A similar increased sensitivity of fetuses or pups 
(as compared to adults) was not observed in a developmental toxicity 
study in rabbits or in 2-generation and 1-generation (range-finding) 
studies in rats. In a dermal developmental toxicity study in rats, no 
maternal or developmental toxicity was observed at dose levels up to 
500 mg/kg/day, the highest dose tested.
    In a battery of mutagenicity studies, results were negative in all 
studies except in an in vitro chromosome aberration study in Chinese 
hamster ovary (CHO) cells, in which there was evidence of a clastogenic 
response in the absence of S-9 activation.
    In a 2-year chronic toxicity/carcinogenicity study in rats and an 
18-month carcinogenicity study in mice, acibenzolar-S-methyl was 
negative for carcinogenicity when administered at dose levels adequate 
for the testing of carcinogenic potential.
    Acibenzolar-S-methyl showed no significant toxicity in a battery of 
acute toxicity tests (Toxicity Category III or IV in all tests). 
Considerable skin sensitizing (contact allergenic) potential was 
demonstrated in a dermal sensitization study in guinea pigs for the 
technical grade material. The end-use product did not show dermal 
sensitization in guinea pigs.
    Specific information on the studies received and the nature of the 
adverse effects caused by acibenzolar-S-methyl as well as the NOAEL and 
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies can be found at http://www.regulations.gov in document titled 
``Acibenzolar-S-Methyl. A Human Health Risk Assessment to support 
Section 3 Use of Acibenzolar-S-Methyl Uses on Citrus Crop Group 10-10, 
and Pome Crop Group 11-10 at pages 39-44 in docket ID number EPA-HQ-
OPP-2014-0840.

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 
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 acibenzolar-S-methyl 
used for human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Acibenzolar-S-methyl 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 (Females 13-49       NOAEL = 8.2 mg/kg/    Acute RfD = 0.082    Developmental Neurotoxicity
 years old and children 1-12        day.                  mg/kg/day.           Toxicity--Rat.
 years old).                       UFA = 10x...........  aPAD = 0.082 mg/kg/  Developmental LOAEL = 82 mg/kg/day
                                   UFH = 10x...........   day.                 based on changes in brain
                                   FQPA SF = 1x........                        morphometrics in the cerebellum
                                                                               in offspring.
                                                                              Maternal NOAEL = 326.2 mg/kg/day
                                                                               (highest dose tested); no effects
                                                                               observed in maternal animals.
Chronic Dietary (Females 13-49     NOAEL = 8.2 mg/kg/    Chronic RfD = 0.082  Developmental Neurotoxicity
 years old and children 1-12        day.                  mg/kg/day.           Toxicity--Rat.
 years old).                       UFA = 10x...........  cPAD = 0.082 mg/kg/  Developmental LOAEL = 82 mg/kg/day
                                   UFH = 10x...........   day.                 based on changes in brain
                                   FQPA SF = 1x........                        morphometrics in the cerebellum
                                                                               in offspring.
                                                                              Maternal NOAEL = 326.2 mg/kg/day
                                                                               (highest dose tested); no effects
                                                                               observed in maternal animals.
Chronic Dietary (Males 12+ yrs.    NOAEL = 25 mg/kg/day  Chronic RfD = 0.25   Chronic Toxicity--Dog; Co-
 and Females 50+ yrs.).            UFA = 10x...........   mg/kg/day.           critical; Chronic/Cancer--Rat and
                                   UFH = 10x...........  cPAD = 0.25 mg/kg/    Mouse, Reproduction Toxicity--
                                   FQPA SF = 1x........   day.                 Rat.
                                                                              LOAEL = 105 mg/kg/day based on
                                                                               hemolytic anemia with
                                                                               compensatory response.
Incidental Oral..................  NOAEL = 8.2 mg/kg/    Occupational LOC     Developmental Neurotoxicity
                                    day.                  for MOE = 100.       Toxicity--Rat
                                   UFA = 10x...........                       Developmental LOAEL = 82 mg/kg/day
                                   UFH = 10x...........                        based on changes in brain
                                                                               morphometrics in the cerebellum
                                                                               in offspring.
                                                                              Maternal NOAEL = 326.2 mg/kg/day
                                                                               (highest dose tested); no effects
                                                                               observed in maternal animals.
----------------------------------------------------------------------------------------------------------------

[[Page 58617]]

 
Cancer (all routes)..............  EPA has determined that acibenzolar-S-methyl is not likely to be a human
                                    carcinogen.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. 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 acibenzolar-S-methyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing acibenzolar-S-methyl 
tolerances in 40 CFR 180.561. EPA assessed dietary exposures from 
acibenzolar-S-methyl 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 acibenzolar-S-methyl for females 13-49 years old and children 1-12 
years old. No acute endpoint was identified for the general population/
adults. In estimating acute dietary exposure, EPA used food consumption 
data from the U.S. Department of Agriculture's (USDA's) National Health 
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA) 2003-2008. A probabilistic assessment was performed for the 
acute analysis. Foods were classified as blended, partially blended, or 
non-blended. The acute analysis assumed a distribution of residues 
based on field-trial data for non-blended and partially blended 
commodities. For blended commodities, the mean field-trial values were 
used as a point estimate. A value of \1/2\ level of quantification 
(LOQ) was used for samples that contained less than LOQ residues. Time-
limited tolerance values were used (0.05 ppm) for the Experimental Use 
Permit (EUP) commodities, i.e., apple, pear, and grapefruit. Section 3 
tolerance-level residues were used for all other citrus and pome fruit 
commodities. Dietary Exposure Evaluation Model (DEEM) default 
processing factors were used for apple juice, cranberry juice, dried 
apples, dried pears, dried onion, dried banana, dried plantain, and 
dried tomato. Empirical processing factors were used for citrus juice 
(1.0), tomato paste (7.1), tomato puree (2.9), and tomato juice (1.0). 
Residues of acibenzolar-S-methyl did not concentrate in citrus juice or 
oil. The acute analysis used available maximum percent crop treated 
(MPCT) estimates and assumed 100 PCT for commodities for which no PCT 
data were available. Based on the lettuce metabolism data, a factor of 
1.5X was applied to estimates of acibenzolar-S-methyl residues to 
account for all of the residues of concern for dietary risk (including 
CGA-210007, CGA-323060 and CGA-324041).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA NHANES/
WEIA 2003-2008. A conservative chronic dietary exposure analysis was 
performed for the general U.S. population and various population 
subgroups. In the chronic dietary exposure analysis, tolerance-level 
residues were used and 100% CT was assumed for all commodities. 
Temporary tolerance values were used for apple, pear, and grapefruit, 
since they are higher that the new section 3 tolerances, and do not 
expire until 12/31/2015. Section 3 tolerance levels are used for all 
other crop group 10-10, and pome crop group 11-10 commodities. DEEM 
default processing factors were used for apple juice, dried apples, 
cranberry juice, dried apple, dried pears, dried onion, dried banana, 
dried plantain, and dried tomato. A processing factor was not used for 
tomato paste because a separate tolerance has been established for this 
processed commodity. In the submitted tomato processing study, 
processing factors of 1.0 and 2.9 were reported for tomato juice and 
tomato puree, respectively. These processing factors were used in the 
dietary exposure assessment. Residues of acibenzolar-S-methyl did not 
concentrate in citrus juice or oil based on a processing study, so a 
processing factor of 1.0 was used. A factor of 1.5X was applied to 
estimates of acibenzolar-S-methyl residues to account for all of the 
residues of concern for dietary risk (including CGA-210007, CGA-323060 
and CGA-324041).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that acibenzolar-S-methyl 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 information. 
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on 
the actual percent of food treated for assessing chronic dietary risk 
only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    For the acute dietary analysis, EPA estimated PCT for the following 
crops for which uses of acibenzolar-S-methyl are currently registered 
based on available MPCT estimates: Broccoli: 10%; cabbage: 2.5%; 
cauliflower: 10%; lettuce: 10%; peppers: 10%; spinach: 50%; and 
tomatoes: 10%.
    In the chronic dietary exposure analysis, 100% CT was assumed for 
all commodities.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses a maximum

[[Page 58618]]

PCT for acute dietary risk analysis. The maximum PCT figure is the 
highest observed maximum value reported within the recent 6 years of 
available public and private market survey data for the existing use 
and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for acibenzolar-S-methyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of acibenzolar-S-methyl. 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.
    Surface water estimated drinking water concentrations (EDWCs) were 
generated for the total residues of acibenzolar and CGA 210007 using 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) model for all proposed uses. Exposure in ground water due to 
leaching was assessed with the Pesticide Root Zone Model Ground Water 
(PRZM-GW). The EDWCs of acibenzolar-S-methyl for acute exposures are 
estimated to be 47.19 microgram per liter ([micro]g/L) for surface 
water (citrus) and 13.33 [micro]g/L for ground water. For chronic 
exposures (non-cancer) assessments the EDWC is 13.33 [micro]g/L for 
surface water (apple).
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 47.19 [micro]g/L was used 
to assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 13.33 [micro]g/L 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).
    Acibenzolar-S-methyl is not being registered for any specific use 
patterns that would result in residential exposure in this action. 
However, a revised post-application residential exposure assessment was 
conducted to update the residential exposures based on the 2012 revised 
Residential SOPs.
    There is the potential for post-application exposure for 
individuals exposed as a result of being in an environment that has 
been previously treated with acibenzolar-S-methyl. The quantitative 
exposure/risk assessment for residential post-application exposures is 
based on the following scenarios: Adult, 11 to <16 years old, and 6 to 
<11 years old dermal exposure from playing golf on treated golf courses 
(short-term dermal exposure).
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 acibenzolar-S-methyl to share a common mechanism 
of toxicity with any other substances, and acibenzolar-S-methyl does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has assumed 
that acibenzolar-S-methyl 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 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. In the rat developmental 
toxicity study, treatment-related visceral malformations and skeletal 
variations were observed in fetuses at 200 mg/kg/day, the NOAEL for 
maternal toxicity. In the developmental neurotoxicity study, offspring 
toxicity was observed at 82 mg/kg/day while no maternal toxicity was 
observed at 326 mg/kg/day, the highest dose tested. Additional 
developmental toxicity studies in rats and rabbits and reproduction 
studies in rats provided no indication of increased susceptibility of 
rat or rabbit fetuses or neonates compared to adult animals.
    3. Conclusion. The FQPA factor for increased susceptibility to 
infants and children is reduced to 1x based on the following 
considerations.
    i. The toxicology database for acibenzolar-S-methyl is complete and 
adequate for assessing increased susceptibility under FQPA. The pre- 
and postnatal toxicity database for acibenzolar-S-methyl includes 
developmental toxicity studies in rats and rabbits, a developmental 
neurotoxicity study (DNT) study in rats, and a 2-generation 
reproduction toxicity study in rats.
    ii. There is some evidence of potential neurotoxicity in a 
developmental neurotoxicity study. Although there were no treatment-
related offspring effects seen on survival, clinical signs, functional 
observational battery (FOB), developmental land marks, brain weights or 
neuropathology, significant morphometric changes (decreased thickness 
of the molecular layer of the cerebellum) were observed in male 
offspring on postnatal date (PND) 63 at 82 mg/kg/day. At the high dose, 
treatment-related offspring effects included decreased body weights, 
increased auditory startle response and increased thickness in the 
corpus

[[Page 58619]]

callosum in females. No effects were observed in maternal animals at 
the highest dose tested. However, in a subchronic neurotoxicity study 
in rats, no compound-related effects were observed in the FOB, motor 
activity, gross pathology or neuropathology at the highest doses (575/
628 mg/kg/day, male/female) tested.
    iii. Based on the developmental toxicity in rats and the 
developmental neurotoxicity studies in rats, there is concern for 
increased qualitative and/or quantitative susceptibility following in 
utero exposure to acibenzolar-S-methyl. However, the degree of concern 
for the increased susceptibility seen in these studies is low, as there 
are no residual uncertainties with regard to pre- and/or postnatal 
toxicity since (1) NOAELs and LOAELs have been identified for all 
effects of concern, (2) a clear dose response has been well defined, 
and (3) the points of departure selected for risk assessment are 
protective of the fetal/offspring effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The refined acute dietary assessment utilizes maximum 
percent crop treated estimates but is still considered conservative, 
since it is based on field trial data treated at the shorest preharvest 
interval and maximum use rate. The chronic dietary and residential risk 
assessments are also conservative. These assessments will not 
underestimate dietary and/or non-dietary residential exposure to 
acibenzolar-S-methyl. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
acibenzolar-S-methyl in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure. These assessments will 
not underestimate the exposure and risks posed by acibenzolar-S-methyl.

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 acibenzolar-S-methyl will occupy 33% of the aPAD for children 1-2 
years 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 
acibenzolar-S-methyl from food and water will utilize 13% of the cPAD 
for children 1-2 years old, the population group receiving the greatest 
exposure.
    3. Short-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). There is 
potential short-term exposure to acibenzolar-S-methyl via the dietary 
pathway and the residential pathway (golfing on treated golf courses). 
Using the exposure assumptions described in this unit for short-term 
exposures, EPA has concluded the combined short-term food, water, and 
residential exposures result in aggregate MOEs of 1,300 for children 6 
to <11 years old. Because EPA's level of concern for acibenzolar-S-
methyl is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Since the short- and intermediate-term PODs are the same and 
short-term exposure estimates are greater than their intermediate-term 
counterparts, the short-term aggregate risk assessment is protective of 
the intermediate-term aggregate exposure.
    5. Aggregate cancer risk for U.S. population. An aggregate cancer 
risk was not calculated because acibenzolar-S-methyl was classified as 
``not likely to be carcinogenic to humans''.
    6. 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 acibenzolar-S-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    HPLC/UV Method AG-617A is available for tolerance enforcement. The 
method consists of an initial hydrolysis with NaOH to convert 
acibenzolar-S-methyl to CGA-210007 followed by methanol extraction. 
Residues are then diluted with HCl and purified by a series of solid-
phase extraction steps. Prior to HPLC/UV analysis, residues are 
partitioned into ethyl acetate, dried down, and re-dissolved in 
phosphoric acid. This method has a LOQ of 0.02 ppm. The method includes 
optional detection via HPLC/MS, giving a means of residue confirmation.
    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: 
[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 acibenzolar-S-methyl.

C. Revisions to Petitioned-For Tolerances

    The tolerance level for fruit, citrus, group 10-10 (0.02 ppm) is 
being set at the LOQ of the enforcement method which is higher than the 
petitioned-for tolerance (0.01 ppm). The names of the crop groups for 
citrus and pome fruit are being corrected to fruit, citrus, group 10-10 
and fruit, pome, group 11-10.

V. Conclusion

    Therefore, tolerances are established for residues of acibenzolar-
S-methyl, fungicide, in or on fruit, citrus, group 10-10 at 0.02 ppm 
and fruit, pome, group 11-10 at 0.03 ppm.

VI. Statutory and Executive Order Reviews

    This action 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

[[Page 58620]]

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: September 4, 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.  180.561, is amended by adding alphabetically the entries 
for ``Fruit, citrus, group'', and ``Fruit, pome, group'' to the table 
in paragraph (a)(1) to read as follows:


Sec.  180.561  Acibenzolar-S-methyl; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, citrus, group 10-10.................................         0.02
Fruit, pome, group 11-10...................................         0.03
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-24463 Filed 9-29-15; 8:45 am]
 BILLING CODE 6560-50-P