80_FR_58803 80 FR 58614 - Acibenzolar-S-methyl; Pesticide Tolerances

80 FR 58614 - Acibenzolar-S-methyl; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 189 (September 30, 2015)

Page Range58614-58620
FR Document2015-24463

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).

Federal Register, Volume 80 Issue 189 (Wednesday, September 30, 2015)
[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Rules and Regulations]
[Pages 58614-58620]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                58614        Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations

                                                 Priority Mail Express & Priority Mail                    Global Reseller Expedited Package Services           USPS Electronic Postmark (EPM) Program
                                                    Contract 18                                             2                                                 Market Tests*
                                                 Priority Mail Express & Priority Mail                    Global Reseller Expedited Package Services           Metro Post
                                                    Contract 19                                             3                                                  International Merchandise Return Service
                                                 Priority Mail Express & Priority Mail                    Global Reseller Expedited Package Services             (IMRS)—Non-Published Rates
                                                    Contract 20                                             4                                                  Customized Delivery
                                                 Parcel Select & Parcel Return Service                    Global Expedited Package Services
                                                    Contract 3                                              (GEPS)—Non-Published Rates                        Shoshana M. Grove,
                                                 Parcel Select & Parcel Return Service                    Global Expedited Package Services                   Secretary.
                                                    Contract 5                                              (GEPS)—Non-Published Rates 2                      [FR Doc. 2015–24605 Filed 9–29–15; 8:45 am]
                                                 Parcel Select Contract 2                                 Global Expedited Package Services
                                                                                                                                                              BILLING CODE 7710–FW–P
                                                 Parcel Select Contract 3                                   (GEPS)—Non-Published Rates 3
                                                 Parcel Select Contract 4                                 Global Expedited Package Services
                                                 Parcel Select Contract 5                                   (GEPS)—Non-Published Rates 4
                                                 Parcel Select Contract 6                                 Global Expedited Package Services                   ENVIRONMENTAL PROTECTION
                                                 Parcel Select Contract 7                                   (GEPS)—Non-Published Rates 5
                                                 Parcel Select Contract 8
                                                                                                                                                              AGENCY
                                                                                                          Global Expedited Package Services
                                                 Parcel Select Contract 9                                   (GEPS)—Non-Published Rates 6
                                                 Priority Mail—Non-Published Rates                                                                            40 CFR Part 180
                                                                                                          Global Expedited Package Services
                                                 Priority Mail—Non-Published Rates 1                        (GEPS)—Non-Published Rates 7                      [EPA–HQ–OPP–2014–0840; FRL–9933–27]
                                                 First-Class Package Service Contract 16                  Priority Mail International Regional Rate
                                                 First-Class Package Service Contract 17                    Boxes—Non-Published Rates
                                                 First-Class Package Service Contract 18                                                                      Acibenzolar-S-methyl; Pesticide
                                                                                                          Outbound Competitive International                  Tolerances
                                                 First-Class Package Service Contract 19                    Merchandise Return Service
                                                 First-Class Package Service Contract 20                  Agreement with Royal Mail Group, Ltd.
                                                 First-Class Package Service Contract 21
                                                                                                                                                              AGENCY:  Environmental Protection
                                                                                                          Priority Mail International Regional Rate           Agency (EPA).
                                                 First-Class Package Service Contract 22                    Boxes Contracts
                                                 First-Class Package Service Contract 23                  Priority Mail International Regional Rate           ACTION: Final rule.
                                                 First-Class Package Service Contract 24                    Boxes Contracts 1
                                                 First-Class Package Service Contract 25                Inbound International*                                SUMMARY:  This regulation establishes
                                                 First-Class Package Service Contract 26                  International Business Reply Service                tolerances for residues of acibenzolar-S-
                                                 First-Class Package Service Contract 27                    (IBRS) Competitive Contracts                      methyl in or on fruit, citrus, group 10–
                                                 First-Class Package Service Contract 28                                                                      10 and fruit, pome, group 11–10.
                                                                                                          International Business Reply Service
                                                 First-Class Package Service Contract 29
                                                 First-Class Package Service Contract 30
                                                                                                            Competitive Contract 1                            Syngenta Crop Protection, LLC
                                                                                                          International Business Reply Service                requested these tolerances under the
                                                 First-Class Package Service Contract 31
                                                                                                            Competitive Contract 3                            Federal Food, Drug, and Cosmetic Act
                                                 First-Class Package Service Contract 32
                                                                                                          Inbound Direct Entry Contracts with                 (FFDCA).
                                                 First-Class Package Service Contract 33
                                                                                                            Customers
                                                 First-Class Package Service Contract 34
                                                                                                          Inbound Direct Entry Contracts with                 DATES:  This regulation is effective
                                                 First-Class Package Service Contract 35
                                                 First-Class Package Service Contract 36                    Foreign Postal Administrations                    September 30, 2015. Objections and
                                                 First-Class Package Service Contract 37                  Inbound Direct Entry Contracts with                 requests for hearings must be received
                                                 Priority Mail Express, Priority Mail & First-              Foreign Postal Administrations                    on or before November 30, 2015, and
                                                    Class Package Service Contract 1                      Inbound Direct Entry Contracts with                 must be filed in accordance with the
                                                 Priority Mail Express, Priority Mail & First-              Foreign Postal Administrations 1
                                                                                                                                                              instructions provided in 40 CFR part
                                                    Class Package Service Contract 2                      Inbound EMS
                                                                                                          Inbound EMS 2                                       178 (see also Unit I.C. of the
                                                 Priority Mail Express, Priority Mail & First-                                                                SUPPLEMENTARY INFORMATION).
                                                    Class Package Service Contract 3                      Inbound Air Parcel Post (at non-UPU rates)
                                                 Priority Mail Express, Priority Mail & First-            Royal Mail Group Inbound Air Parcel Post            ADDRESSES: The docket for this action,
                                                    Class Package Service Contract 4                        Agreement                                         identified by docket identification (ID)
                                                 Priority Mail & First-Class Package Service              Inbound Competitive Multi-Service                   number EPA–HQ–OPP–2014–0840, is
                                                    Contract 1                                              Agreements with Foreign                           available at http://www.regulations.gov
                                                 Priority Mail & First-Class Package Service                PostalOperators 1
                                                                                                                                                              or at the Office of Pesticide Programs
                                                    Contract 2                                          Special Services*
                                                                                                          Address Enhancement Services                        Regulatory Public Docket (OPP Docket)
                                                 Priority Mail & First-Class Package Service                                                                  in the Environmental Protection Agency
                                                    Contract 3                                            Greeting Cards, Gift Cards, and Stationery
                                                 Priority Mail & First-Class Package Service              International Ancillary Services                    Docket Center (EPA/DC), West William
                                                    Contract 4                                            International Money Transfer Service—               Jefferson Clinton Bldg., Rm. 3334, 1301
                                                 Priority Mail & First-Class Package Service                Outbound                                          Constitution Ave. NW., Washington, DC
                                                    Contract 5                                            International Money Transfer Service—               20460–0001. The Public Reading Room
                                                 Priority Mail & First-Class Package Service                Inbound                                           is open from 8:30 a.m. to 4:30 p.m.,
                                                    Contract 6                                            Premium Forwarding Service                          Monday through Friday, excluding legal
                                                 Priority Mail & First-Class Package Service              Shipping and Mailing Supplies
                                                                                                                                                              holidays. The telephone number for the
                                                    Contract 7                                            Post Office Box Service
                                                                                                          Competitive Ancillary Services                      Public Reading Room is (202) 566–1744,
                                                Outbound International*
                                                 Global Expedited Package Services (GEPS)               Nonpostal Services*                                   and the telephone number for the OPP
                                                    Contracts GEPS 3                                      Advertising                                         Docket is (703) 305–5805. Please review
                                                 Global Direct Contracts                                  Licensing of Intellectual Property other            the visitor instructions and additional
                                                 Global Direct Contracts 1                                  than Officially Licensed Retail Products          information about the docket available
mstockstill on DSK4VPTVN1PROD with RULES




                                                 Global Bulk Economy (GBE) Contracts                        (OLRP)                                            at http://www.epa.gov/dockets.
                                                 Global Plus Contracts                                    Mail Service Promotion
                                                                                                                                                              FOR FURTHER INFORMATION CONTACT:
                                                 Global Plus 1C                                           Officially Licensed Retail Products (OLRP)
                                                 Global Plus 2C                                           Passport Photo Service                              Susan Lewis, Registration Division
                                                 Global Reseller Expedited Package                        Photocopying Service                                (7505P), Office of Pesticide Programs,
                                                    Contracts                                             Rental, Leasing, Licensing or other Non-            Environmental Protection Agency, 1200
                                                 Global Reseller Expedited Package Services                 Sale Disposition of Tangible Property             Pennsylvania Ave. NW., Washington,
                                                    1                                                     Training Facilities and Related Services            DC 20460–0001; main telephone


                                           VerDate Sep<11>2014   17:12 Sep 29, 2015   Jkt 235001   PO 00000   Frm 00042   Fmt 4700   Sfmt 4700   E:\FR\FM\30SER1.SGM   30SER1


                                                             Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations                                        58615

                                                number: (703) 305–7090; email address:                  2014–0840, by one of the following                    reliable information.’’ This includes
                                                RDFRNotices@epa.gov.                                    methods:                                              exposure through drinking water and in
                                                SUPPLEMENTARY INFORMATION:                                • Federal eRulemaking Portal: http://               residential settings, but does not include
                                                                                                        www.regulations.gov. Follow the online                occupational exposure. Section
                                                I. General Information                                  instructions for submitting comments.                 408(b)(2)(C) of FFDCA requires EPA to
                                                A. Does this action apply to me?                        Do not submit electronically any                      give special consideration to exposure
                                                                                                        information you consider to be CBI or                 of infants and children to the pesticide
                                                   You may be potentially affected by                   other information whose disclosure is                 chemical residue in establishing a
                                                this action if you are an agricultural                  restricted by statute.                                tolerance and to ‘‘ensure that there is a
                                                producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   reasonable certainty that no harm will
                                                pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                 result to infants and children from
                                                list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 aggregate exposure to the pesticide
                                                Classification System (NAICS) codes is                  NW., Washington, DC 20460–0001.                       chemical residue. . . .’’
                                                not intended to be exhaustive, but rather                 • Hand Delivery: To make special
                                                provides a guide to help readers                                                                                 Consistent with FFDCA section
                                                                                                        arrangements for hand delivery or
                                                determine whether this document                                                                               408(b)(2)(D), and the factors specified in
                                                                                                        delivery of boxed information, please
                                                applies to them. Potentially affected                                                                         FFDCA section 408(b)(2)(D), EPA has
                                                                                                        follow the instructions at http://
                                                entities may include:                                                                                         reviewed the available scientific data
                                                                                                        www.epa.gov/dockets/contacts.html.
                                                   • Crop production (NAICS code 111).                                                                        and other relevant information in
                                                                                                        Additional instructions on commenting
                                                   • Animal production (NAICS code                                                                            support of this action. EPA has
                                                                                                        or visiting the docket, along with more
                                                112).                                                                                                         sufficient data to assess the hazards of
                                                                                                        information about dockets generally, is
                                                   • Food manufacturing (NAICS code                                                                           and to make a determination on
                                                                                                        available at http://www.epa.gov/
                                                311).                                                                                                         aggregate exposure for acibenzolar-S-
                                                                                                        dockets.
                                                   • Pesticide manufacturing (NAICS                                                                           methyl including exposure resulting
                                                code 32532).                                            II. Summary of Petitioned-For                         from the tolerances established by this
                                                                                                        Tolerance                                             action. EPA’s assessment of exposures
                                                B. How can I get electronic access to                                                                         and risks associated with acibenzolar-S-
                                                                                                           In the Federal Register of February
                                                other related information?                                                                                    methyl follows.
                                                                                                        11, 2015 (80 FR 7559) (FRL–9921–94),
                                                   You may access a frequently updated                  EPA issued a document pursuant to                     A. Toxicological Profile
                                                electronic version of EPA’s tolerance                   FFDCA section 408(d)(3), 21 U.S.C.
                                                regulations at 40 CFR part 180 through                  346a(d)(3), announcing the filing of a                   EPA has evaluated the available
                                                the Government Printing Office’s e-CFR                  pesticide petition (PP 4F8269) by                     toxicity data and considered its validity,
                                                site at http://www.ecfr.gov/cgi-bin/text-               Syngenta Crop Protection, LLC, P.O.                   completeness, and reliability as well as
                                                idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Box 18300, Greensboro, NC. The                        the relationship of the results of the
                                                40tab_02.tpl.                                           petition requested that 40 CFR 180.561                studies to human risk. EPA has also
                                                                                                        be amended by establishing tolerances                 considered available information
                                                C. How can I file an objection or hearing                                                                     concerning the variability of the
                                                request?                                                for residues of the fungicide,
                                                                                                        acibenzolar-S-methyl, in or on pome                   sensitivities of major identifiable
                                                  Under FFDCA section 408(g), 21                        fruit, crop group 11–10 at 0.03 parts per             subgroups of consumers, including
                                                U.S.C. 346a, any person may file an                     million (ppm) and citrus fruit, crop                  infants and children. In subchronic and
                                                objection to any aspect of this regulation              group 10–10 at 0.01 ppm. That                         chronic oral studies in rats, dogs and
                                                and may also request a hearing on those                 document referenced a summary of the                  mice, signs of mild regenerative
                                                objections. You must file your objection                petition prepared by Syngenta Crop                    hemolytic anemia were consistently
                                                or request a hearing on this regulation                 Protection, LLC, the registrant, which is             observed in all three species. These
                                                in accordance with the instructions                     available in the docket, http://                      signs frequently included decreased
                                                provided in 40 CFR part 178. To ensure                  www.regulations.gov. There were no                    erythrocyte counts, decreased
                                                proper receipt by EPA, you must                         comments received in response to the                  hemoglobin, decreased hematocrit,
                                                identify docket ID number EPA–HQ–                       notice of filing.                                     increased reticulocyte counts, increased
                                                OPP–2014–0840 in the subject line on                       Based upon review of the data                      hemosiderosis in the spleen, liver and/
                                                the first page of your submission. All                  supporting the petition, EPA has revised              or bone marrow, extramedullary
                                                objections and requests for a hearing                   the tolerance for residues of acibenzolar-            hematopoiesis in the spleen, and
                                                must be in writing, and must be                         S-methyl in or on fruit, citrus, group 10–            increased spleen weights in both males
                                                received by the Hearing Clerk on or                     10 at 0.02 ppm. The reason for this                   and females. A compensatory response
                                                before November 30, 2015. Addresses                     change is explained in Unit IV.C.                     (increased erythrocyte production)
                                                for mail and hand delivery of objections                                                                      regularly followed the initial anemia.
                                                and hearing requests are provided in 40                 III. Aggregate Risk Assessment and                    Additional toxic effects observed in
                                                CFR 178.25(b).                                          Determination of Safety                               these same studies included decreases
                                                  In addition to filing an objection or                    Section 408(b)(2)(A)(i) of FFDCA                   in body weight, body weight gain and/
                                                hearing request with the Hearing Clerk                  allows EPA to establish a tolerance (the              or food consumption. No other
                                                as described in 40 CFR part 178, please                 legal limit for a pesticide chemical                  significant treatment-related effects of
                                                submit a copy of the filing (excluding                  residue in or on a food) only if EPA                  toxicological concern were observed in
                                                any Confidential Business Information                   determines that the tolerance is ‘‘safe.’’            these subchronic and chronic oral
mstockstill on DSK4VPTVN1PROD with RULES




                                                (CBI)) for inclusion in the public docket.              Section 408(b)(2)(A)(ii) of FFDCA                     studies. In a 28-day dermal study in
                                                Information not marked confidential                     defines ‘‘safe’’ to mean that ‘‘there is a            rats, no systemic or dermal effects were
                                                pursuant to 40 CFR part 2 may be                        reasonable certainty that no harm will                observed at dose levels up to 1,000
                                                disclosed publicly by EPA without prior                 result from aggregate exposure to the                 milligram (mg)/kilogram (kg)/day, the
                                                notice. Submit the non-CBI copy of your                 pesticide chemical residue, including                 limit dose. No neurotoxic effects were
                                                objection or hearing request, identified                all anticipated dietary exposures and all             observed at any dose in a subchronic
                                                by docket ID number EPA–HQ–OPP–                         other exposures for which there is                    neurotoxicity study in rats.


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                                                58616           Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations

                                                   Treatment-related developmental                              evidence of a clastogenic response in                 toxicological points of departure (POD)
                                                malformations, anomalies and                                    the absence of S–9 activation.                        and levels of concern to use in
                                                variations were observed in a                                      In a 2-year chronic toxicity/                      evaluating the risk posed by human
                                                developmental toxicity study in rats at                         carcinogenicity study in rats and an 18-              exposure to the pesticide. For hazards
                                                or below the no observable adverse                              month carcinogenicity study in mice,                  that have a threshold below which there
                                                effect level (NOAEL) for maternal                               acibenzolar-S-methyl was negative for                 is no appreciable risk, the toxicological
                                                toxicity. At the highest dose tested in                         carcinogenicity when administered at                  POD is used as the basis for derivation
                                                this study (400 mg/kg/day), both                                dose levels adequate for the testing of               of reference values for risk assessment.
                                                maternal toxicity (hemorrhagic perineal                         carcinogenic potential.                               PODs are developed based on a careful
                                                discharge) and considerable                                        Acibenzolar-S-methyl showed no
                                                                                                                                                                      analysis of the doses in each
                                                developmental toxicity (including total                         significant toxicity in a battery of acute
                                                                                                                                                                      toxicological study to determine the
                                                litter resorptions, fetal malformations,                        toxicity tests (Toxicity Category III or IV
                                                anomalies and variations) were                                  in all tests). Considerable skin                      dose at which the NOAEL and the
                                                observed. The fetal malformations noted                         sensitizing (contact allergenic) potential            lowest dose at which adverse effects of
                                                at this dose included treatment-related                         was demonstrated in a dermal                          concern are identified (the LOAEL).
                                                effects on nervous system tissues                               sensitization study in guinea pigs for the            Uncertainty/safety factors are used in
                                                (hydrocephaly, craniorachisis and                               technical grade material. The end-use                 conjunction with the POD to calculate a
                                                anophthalmia/microphthalmia). At the                            product did not show dermal                           safe exposure level—generally referred
                                                next lower dose tested (200 mg/kg/day),                         sensitization in guinea pigs.                         to as a population-adjusted dose (PAD)
                                                treatment-related visceral malformations                           Specific information on the studies                or a reference dose (RfD)—and a safe
                                                and skeletal variations were                                    received and the nature of the adverse                margin of exposure (MOE). For non-
                                                demonstrated in the absence of                                  effects caused by acibenzolar-S-methyl                threshold risks, the Agency assumes
                                                significant maternal toxicity. A similar                        as well as the NOAEL and the lowest-                  that any amount of exposure will lead
                                                increased sensitivity of fetuses or pups                        observed-adverse-effect-level (LOAEL)                 to some degree of risk. Thus, the Agency
                                                (as compared to adults) was not                                 from the toxicity studies can be found                estimates risk in terms of the probability
                                                observed in a developmental toxicity                            at http://www.regulations.gov in                      of an occurrence of the adverse effect
                                                study in rabbits or in 2-generation and                         document titled ‘‘Acibenzolar-S-Methyl.               expected in a lifetime. For more
                                                1-generation (range-finding) studies in                         A Human Health Risk Assessment to                     information on the general principles
                                                rats. In a dermal developmental toxicity                        support Section 3 Use of Acibenzolar-S-               EPA uses in risk characterization and a
                                                study in rats, no maternal or                                   Methyl Uses on Citrus Crop Group 10–                  complete description of the risk
                                                developmental toxicity was observed at                          10, and Pome Crop Group 11–10 at                      assessment process, see http://
                                                dose levels up to 500 mg/kg/day, the                            pages 39–44 in docket ID number EPA–                  www.epa.gov/pesticides/factsheets/
                                                highest dose tested.                                            HQ–OPP–2014–0840.
                                                   In a battery of mutagenicity studies,                                                                              riskassess.htm.
                                                results were negative in all studies                            B. Toxicological Points of Departure/                    A summary of the toxicological
                                                except in an in vitro chromosome                                Levels of Concern                                     endpoints for acibenzolar-S-methyl used
                                                aberration study in Chinese hamster                               Once a pesticide’s toxicological                    for human risk assessment is shown in
                                                ovary (CHO) cells, in which there was                           profile is determined, EPA identifies                 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 and            RfD, PAD, LOC for
                                                         Exposure/scenario                                                                                            Study and toxicological effects
                                                                                                 uncertainty/safety         risk assessment
                                                                                                      factors

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




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                                                              Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations                                            58617

                                                     TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ACIBENZOLAR-S-METHYL FOR USE IN HUMAN
                                                                                   HEALTH RISK ASSESSMENT—Continued
                                                                                                  Point of
                                                                                               departure and            RfD, PAD, LOC for
                                                        Exposure/scenario                                                                                          Study and toxicological effects
                                                                                              uncertainty/safety         risk assessment
                                                                                                   factors

                                                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                                       tomato juice (1.0). Residues of                       residues of concern for dietary risk
                                                   1. Dietary exposure from food and                         acibenzolar-S-methyl did not                          (including CGA–210007, CGA–323060
                                                feed uses. In evaluating dietary                             concentrate in citrus juice or oil. The               and CGA–324041).
                                                                                                             acute analysis used available maximum                    iii. Cancer. Based on the data
                                                exposure to acibenzolar-S-methyl, EPA
                                                                                                             percent crop treated (MPCT) estimates                 summarized in Unit III.A., EPA has
                                                considered exposure under the
                                                                                                             and assumed 100 PCT for commodities                   concluded that acibenzolar-S-methyl
                                                petitioned-for tolerances as well as all
                                                                                                             for which no PCT data were available.                 does not pose a cancer risk to humans.
                                                existing acibenzolar-S-methyl tolerances
                                                                                                             Based on the lettuce metabolism data, a               Therefore, a dietary exposure
                                                in 40 CFR 180.561. EPA assessed dietary
                                                                                                             factor of 1.5X was applied to estimates               assessment for the purpose of assessing
                                                exposures from acibenzolar-S-methyl in
                                                                                                             of acibenzolar-S-methyl residues to                   cancer risk is unnecessary.
                                                food as follows:                                                                                                      iv. Anticipated residue and percent
                                                   i. Acute exposure. Quantitative acute                     account for all of the residues of
                                                                                                             concern for dietary risk (including                   crop treated information. Section
                                                dietary exposure and risk assessments                                                                              408(b)(2)(F) of FFDCA states that the
                                                are performed for a food-use pesticide,                      CGA–210007, CGA–323060 and CGA–
                                                                                                             324041).                                              Agency may use data on the actual
                                                if a toxicological study has indicated the                                                                         percent of food treated for assessing
                                                possibility of an effect of concern                            ii. Chronic exposure. In conducting                 chronic dietary risk only if:
                                                occurring as a result of a 1-day or single                   the chronic dietary exposure                             • Condition a: The data used are
                                                exposure. Such effects were identified                       assessment, EPA used the food                         reliable and provide a valid basis to
                                                for acibenzolar-S-methyl for females 13–                     consumption data from the USDA                        show what percentage of the food
                                                49 years old and children 1–12 years                         NHANES/WEIA 2003–2008. A                              derived from such crop is likely to
                                                old. No acute endpoint was identified                        conservative chronic dietary exposure                 contain the pesticide residue.
                                                for the general population/adults. In                        analysis was performed for the general                   • Condition b: The exposure estimate
                                                estimating acute dietary exposure, EPA                       U.S. population and various population                does not underestimate exposure for any
                                                used food consumption data from the                          subgroups. In the chronic dietary                     significant subpopulation group.
                                                U.S. Department of Agriculture’s                             exposure analysis, tolerance-level                       • Condition c: Data are available on
                                                (USDA’s) National Health and Nutrition                       residues were used and 100% CT was                    pesticide use and food consumption in
                                                Examination Survey, What We Eat in                           assumed for all commodities.                          a particular area, the exposure estimate
                                                America, (NHANES/WWEIA) 2003–                                Temporary tolerance values were used                  does not understate exposure for the
                                                2008. A probabilistic assessment was                         for apple, pear, and grapefruit, since                population in such area.
                                                performed for the acute analysis. Foods                      they are higher that the new section 3                In addition, the Agency must provide
                                                were classified as blended, partially                        tolerances, and do not expire until 12/               for periodic evaluation of any estimates
                                                blended, or non-blended. The acute                           31/2015. Section 3 tolerance levels are               used. To provide for the periodic
                                                analysis assumed a distribution of                           used for all other crop group 10–10, and              evaluation of the estimate of PCT as
                                                residues based on field-trial data for                       pome crop group 11–10 commodities.                    required by FFDCA section 408(b)(2)(F),
                                                non-blended and partially blended                            DEEM default processing factors were                  EPA may require registrants to submit
                                                commodities. For blended commodities,                        used for apple juice, dried apples,                   data on PCT.
                                                the mean field-trial values were used as                     cranberry juice, dried apple, dried                      For the acute dietary analysis, EPA
                                                a point estimate. A value of 1⁄2 level of                    pears, dried onion, dried banana, dried               estimated PCT for the following crops
                                                quantification (LOQ) was used for                            plantain, and dried tomato. A                         for which uses of acibenzolar-S-methyl
                                                samples that contained less than LOQ                         processing factor was not used for                    are currently registered based on
                                                residues. Time-limited tolerance values                      tomato paste because a separate                       available MPCT estimates: Broccoli:
                                                were used (0.05 ppm) for the                                 tolerance has been established for this               10%; cabbage: 2.5%; cauliflower: 10%;
                                                Experimental Use Permit (EUP)                                processed commodity. In the submitted                 lettuce: 10%; peppers: 10%; spinach:
                                                commodities, i.e., apple, pear, and                          tomato processing study, processing                   50%; and tomatoes: 10%.
                                                grapefruit. Section 3 tolerance-level                        factors of 1.0 and 2.9 were reported for                 In the chronic dietary exposure
                                                residues were used for all other citrus                      tomato juice and tomato puree,                        analysis, 100% CT was assumed for all
                                                and pome fruit commodities. Dietary                          respectively. These processing factors                commodities.
                                                Exposure Evaluation Model (DEEM)                             were used in the dietary exposure                        In most cases, EPA uses available data
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                                                default processing factors were used for                     assessment. Residues of acibenzolar-S-                from United States Department of
                                                apple juice, cranberry juice, dried                          methyl did not concentrate in citrus                  Agriculture/National Agricultural
                                                apples, dried pears, dried onion, dried                      juice or oil based on a processing study,             Statistics Service (USDA/NASS),
                                                banana, dried plantain, and dried                            so a processing factor of 1.0 was used.               proprietary market surveys, and the
                                                tomato. Empirical processing factors                         A factor of 1.5X was applied to                       National Pesticide Use Database for the
                                                were used for citrus juice (1.0), tomato                     estimates of acibenzolar-S-methyl                     chemical/crop combination for the most
                                                paste (7.1), tomato puree (2.9), and                         residues to account for all of the                    recent 6–7 years. EPA uses a maximum


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                                                58618        Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations

                                                PCT for acute dietary risk analysis. The                concentration value of 47.19 mg/L was                 D. Safety Factor for Infants and
                                                maximum PCT figure is the highest                       used to assess the contribution to                    Children
                                                observed maximum value reported                         drinking water. For chronic dietary risk                 1. In general. Section 408(b)(2)(C) of
                                                within the recent 6 years of available                  assessment, the water concentration of                FFDCA provides that EPA shall apply
                                                public and private market survey data                   value 13.33 mg/L was used to assess the               an additional tenfold (10X) margin of
                                                for the existing use and rounded up to                  contribution to drinking water.                       safety for infants and children in the
                                                the nearest multiple of 5%.                                3. From non-dietary exposure. The                  case of threshold effects to account for
                                                   The Agency believes that the three
                                                                                                        term ‘‘residential exposure’’ is used in              prenatal and postnatal toxicity and the
                                                conditions discussed in Unit III.C.1.iv.
                                                                                                        this document to refer to non-                        completeness of the database on toxicity
                                                have been met. With respect to
                                                                                                        occupational, non-dietary exposure                    and exposure unless EPA determines
                                                Condition a, PCT estimates are derived
                                                                                                        (e.g., for lawn and garden pest control,              based on reliable data that a different
                                                from Federal and private market survey
                                                                                                        indoor pest control, termiticides, and                margin of safety will be safe for infants
                                                data, which are reliable and have a valid
                                                                                                        flea and tick control on pets).                       and children. This additional margin of
                                                basis. The Agency is reasonably certain
                                                that the percentage of the food treated                    Acibenzolar-S-methyl is not being                  safety is commonly referred to as the
                                                is not likely to be an underestimation.                 registered for any specific use patterns              FQPA Safety Factor (SF). In applying
                                                As to Conditions b and c, regional                      that would result in residential                      this provision, EPA either retains the
                                                consumption information and                             exposure in this action. However, a                   default value of 10X, or uses a different
                                                consumption information for significant                 revised post-application residential                  additional safety factor when reliable
                                                subpopulations is taken into account                    exposure assessment was conducted to                  data available to EPA support the choice
                                                through EPA’s computer-based model                                                                            of a different factor.
                                                                                                        update the residential exposures based
                                                for evaluating the exposure of                                                                                   2. Prenatal and postnatal sensitivity.
                                                                                                        on the 2012 revised Residential SOPs.
                                                significant subpopulations including                                                                          In the rat developmental toxicity study,
                                                                                                           There is the potential for post-                   treatment-related visceral malformations
                                                several regional groups. Use of this                    application exposure for individuals
                                                consumption information in EPA’s risk                                                                         and skeletal variations were observed in
                                                                                                        exposed as a result of being in an                    fetuses at 200 mg/kg/day, the NOAEL
                                                assessment process ensures that EPA’s
                                                                                                        environment that has been previously                  for maternal toxicity. In the
                                                exposure estimate does not understate
                                                                                                        treated with acibenzolar-S-methyl. The                developmental neurotoxicity study,
                                                exposure for any significant
                                                                                                        quantitative exposure/risk assessment                 offspring toxicity was observed at 82
                                                subpopulation group and allows the
                                                Agency to be reasonably certain that no                 for residential post-application                      mg/kg/day while no maternal toxicity
                                                regional population is exposed to                       exposures is based on the following                   was observed at 326 mg/kg/day, the
                                                residue levels higher than those                        scenarios: Adult, 11 to <16 years old,                highest dose tested. Additional
                                                estimated by the Agency.                                and 6 to <11 years old dermal exposure                developmental toxicity studies in rats
                                                   2. Dietary exposure from drinking                    from playing golf on treated golf courses             and rabbits and reproduction studies in
                                                water. The Agency used screening-level                  (short-term dermal exposure).                         rats provided no indication of increased
                                                water exposure models in the dietary                       Further information regarding EPA                  susceptibility of rat or rabbit fetuses or
                                                exposure analysis and risk assessment                   standard assumptions and generic                      neonates compared to adult animals.
                                                for acibenzolar-S-methyl in drinking                    inputs for residential exposures may be                  3. Conclusion. The FQPA factor for
                                                water. These simulation models take                     found at http://www.epa.gov/pesticides/               increased susceptibility to infants and
                                                into account data on the physical,                      trac/science/trac6a05.pdf.                            children is reduced to 1x based on the
                                                chemical, and fate/transport                                                                                  following considerations.
                                                                                                           4. Cumulative effects from substances                 i. The toxicology database for
                                                characteristics of acibenzolar-S-methyl.                with a common mechanism of toxicity.
                                                Further information regarding EPA                                                                             acibenzolar-S-methyl is complete and
                                                                                                        Section 408(b)(2)(D)(v) of FFDCA                      adequate for assessing increased
                                                drinking water models used in pesticide                 requires that, when considering whether
                                                exposure assessment can be found at                                                                           susceptibility under FQPA. The pre-
                                                                                                        to establish, modify, or revoke a                     and postnatal toxicity database for
                                                http://www.epa.gov/oppefed1/models/
                                                                                                        tolerance, the Agency consider                        acibenzolar-S-methyl includes
                                                water/index.htm.
                                                   Surface water estimated drinking                     ‘‘available information’’ concerning the              developmental toxicity studies in rats
                                                water concentrations (EDWCs) were                       cumulative effects of a particular                    and rabbits, a developmental
                                                generated for the total residues of                     pesticide’s residues and ‘‘other                      neurotoxicity study (DNT) study in rats,
                                                acibenzolar and CGA 210007 using the                    substances that have a common                         and a 2-generation reproduction toxicity
                                                Pesticide Root Zone Model/Exposure                      mechanism of toxicity.’’                              study in rats.
                                                Analysis Modeling System (PRZM/                            EPA has not found acibenzolar-S-                      ii. There is some evidence of potential
                                                EXAMS) model for all proposed uses.                     methyl to share a common mechanism                    neurotoxicity in a developmental
                                                Exposure in ground water due to                         of toxicity with any other substances,                neurotoxicity study. Although there
                                                leaching was assessed with the Pesticide                and acibenzolar-S-methyl does not                     were no treatment-related offspring
                                                Root Zone Model Ground Water                            appear to produce a toxic metabolite                  effects seen on survival, clinical signs,
                                                (PRZM–GW). The EDWCs of                                 produced by other substances. For the                 functional observational battery (FOB),
                                                acibenzolar-S-methyl for acute                          purposes of this tolerance action,                    developmental land marks, brain
                                                exposures are estimated to be 47.19                     therefore, EPA has assumed that                       weights or neuropathology, significant
                                                microgram per liter (mg/L) for surface                  acibenzolar-S-methyl does not have a                  morphometric changes (decreased
                                                water (citrus) and 13.33 mg/L for ground                common mechanism of toxicity with                     thickness of the molecular layer of the
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                                                water. For chronic exposures (non-                      other substances. For information                     cerebellum) were observed in male
                                                cancer) assessments the EDWC is 13.33                   regarding EPA’s efforts to determine                  offspring on postnatal date (PND) 63 at
                                                mg/L for surface water (apple).                         which chemicals have a common                         82 mg/kg/day. At the high dose,
                                                   Modeled estimates of drinking water                  mechanism of toxicity and to evaluate                 treatment-related offspring effects
                                                concentrations were directly entered                    the cumulative effects of such                        included decreased body weights,
                                                into the dietary exposure model. For                    chemicals, see EPA’s Web site at http://              increased auditory startle response and
                                                acute dietary risk assessment, the water                www.epa.gov/pesticides/cumulative.                    increased thickness in the corpus


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                                                             Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations                                        58619

                                                callosum in females. No effects were                    exposure from food and water to                       Prior to HPLC/UV analysis, residues are
                                                observed in maternal animals at the                     acibenzolar-S-methyl will occupy 33%                  partitioned into ethyl acetate, dried
                                                highest dose tested. However, in a                      of the aPAD for children 1–2 years old,               down, and re-dissolved in phosphoric
                                                subchronic neurotoxicity study in rats,                 the population group receiving the                    acid. This method has a LOQ of 0.02
                                                no compound-related effects were                        greatest exposure.                                    ppm. The method includes optional
                                                observed in the FOB, motor activity,                      2. Chronic risk. Using the exposure                 detection via HPLC/MS, giving a means
                                                gross pathology or neuropathology at                    assumptions described in this unit for                of residue confirmation.
                                                the highest doses (575/628 mg/kg/day,                   chronic exposure, EPA has concluded                      The method may be requested from:
                                                male/female) tested.                                    that chronic exposure to acibenzolar-S-               Chief, Analytical Chemistry Branch,
                                                   iii. Based on the developmental                      methyl from food and water will utilize               Environmental Science Center, 701
                                                toxicity in rats and the developmental                  13% of the cPAD for children 1–2 years                Mapes Rd., Ft. Meade, MD 20755–5350;
                                                neurotoxicity studies in rats, there is                 old, the population group receiving the               telephone number: (410) 305–2905;
                                                concern for increased qualitative and/or                greatest exposure.                                    email address: residuemethods@
                                                quantitative susceptibility following in                  3. Short-term risk. Short-term                      epa.gov.
                                                utero exposure to acibenzolar-S-methyl.                 aggregate exposure takes into account
                                                However, the degree of concern for the                                                                        B. International Residue Limits
                                                                                                        short-term residential exposure plus
                                                increased susceptibility seen in these                  chronic exposure to food and water                       In making its tolerance decisions, EPA
                                                studies is low, as there are no residual                (considered to be a background                        seeks to harmonize U.S. tolerances with
                                                uncertainties with regard to pre- and/or                exposure level). There is potential short-            international standards whenever
                                                postnatal toxicity since (1) NOAELs and                 term exposure to acibenzolar-S-methyl                 possible, consistent with U.S. food
                                                LOAELs have been identified for all                     via the dietary pathway and the                       safety standards and agricultural
                                                effects of concern, (2) a clear dose                    residential pathway (golfing on treated               practices. EPA considers the
                                                response has been well defined, and (3)                 golf courses). Using the exposure                     international maximum residue limits
                                                the points of departure selected for risk               assumptions described in this unit for                (MRLs) established by the Codex
                                                assessment are protective of the fetal/                 short-term exposures, EPA has                         Alimentarius Commission (Codex), as
                                                offspring effects.                                      concluded the combined short-term                     required by FFDCA section 408(b)(4).
                                                   iv. There are no residual uncertainties              food, water, and residential exposures                The Codex Alimentarius is a joint
                                                identified in the exposure databases.                   result in aggregate MOEs of 1,300 for                 United Nations Food and Agriculture
                                                The refined acute dietary assessment                    children 6 to <11 years old. Because                  Organization/World Health
                                                utilizes maximum percent crop treated                   EPA’s level of concern for acibenzolar-               Organization food standards program,
                                                estimates but is still considered                       S-methyl is a MOE of 100 or below,                    and it is recognized as an international
                                                conservative, since it is based on field                these MOEs are not of concern.                        food safety standards-setting
                                                trial data treated at the shorest                         4. Intermediate-term risk.                          organization in trade agreements to
                                                preharvest interval and maximum use                     Intermediate-term aggregate exposure                  which the United States is a party. EPA
                                                rate. The chronic dietary and residential               takes into account intermediate-term                  may establish a tolerance that is
                                                risk assessments are also conservative.                 residential exposure plus chronic                     different from a Codex MRL; however,
                                                These assessments will not                              exposure to food and water (considered                FFDCA section 408(b)(4) requires that
                                                underestimate dietary and/or non-                       to be a background exposure level).                   EPA explain the reasons for departing
                                                dietary residential exposure to                         Since the short- and intermediate-term                from the Codex level.
                                                acibenzolar-S-methyl. EPA made                          PODs are the same and short-term                         The Codex has not established a MRL
                                                conservative (protective) assumptions in                exposure estimates are greater than their             for acibenzolar-S-methyl.
                                                the ground and surface water modeling                   intermediate-term counterparts, the
                                                used to assess exposure to acibenzolar-                                                                       C. Revisions to Petitioned-For
                                                                                                        short-term aggregate risk assessment is               Tolerances
                                                S-methyl in drinking water. EPA used                    protective of the intermediate-term
                                                similarly conservative assumptions to                   aggregate exposure.                                     The tolerance level for fruit, citrus,
                                                assess post-application exposure. These                   5. Aggregate cancer risk for U.S.                   group 10–10 (0.02 ppm) is being set at
                                                assessments will not underestimate the                  population. An aggregate cancer risk                  the LOQ of the enforcement method
                                                exposure and risks posed by                             was not calculated because acibenzolar-               which is higher than the petitioned-for
                                                acibenzolar-S-methyl.                                   S-methyl was classified as ‘‘not likely to            tolerance (0.01 ppm). The names of the
                                                                                                        be carcinogenic to humans’’.                          crop groups for citrus and pome fruit are
                                                E. Aggregate Risks and Determination of
                                                                                                          6. Determination of safety. Based on                being corrected to fruit, citrus, group
                                                Safety
                                                                                                        these risk assessments, EPA concludes                 10–10 and fruit, pome, group 11–10.
                                                   EPA determines whether acute and
                                                                                                        that there is a reasonable certainty that             V. Conclusion
                                                chronic dietary pesticide exposures are
                                                                                                        no harm will result to the general
                                                safe by comparing aggregate exposure                                                                            Therefore, tolerances are established
                                                                                                        population, or to infants and children
                                                estimates to the acute PAD (aPAD) and                                                                         for residues of acibenzolar-S-methyl,
                                                                                                        from aggregate exposure to acibenzolar-
                                                chronic PAD (cPAD). For linear cancer                                                                         fungicide, in or on fruit, citrus, group
                                                                                                        S-methyl residues.
                                                risks, EPA calculates the lifetime                                                                            10–10 at 0.02 ppm and fruit, pome,
                                                probability of acquiring cancer given the               IV. Other Considerations                              group 11–10 at 0.03 ppm.
                                                estimated aggregate exposure. Short-,
                                                                                                        A. Analytical Enforcement Methodology                 VI. Statutory and Executive Order
                                                intermediate-, and chronic-term risks
                                                are evaluated by comparing the                            HPLC/UV Method AG–617A is                           Reviews
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                                                estimated aggregate food, water, and                    available for tolerance enforcement. The                This action establishes tolerances
                                                residential exposure to the appropriate                 method consists of an initial hydrolysis              under FFDCA section 408(d) in
                                                PODs to ensure that an adequate MOE                     with NaOH to convert acibenzolar-S-                   response to a petition submitted to the
                                                exists.                                                 methyl to CGA–210007 followed by                      Agency. The Office of Management and
                                                   1. Acute risk. Using the exposure                    methanol extraction. Residues are then                Budget (OMB) has exempted these types
                                                assumptions discussed in this unit for                  diluted with HCl and purified by a                    of actions from review under Executive
                                                acute exposure, the acute dietary                       series of solid-phase extraction steps.               Order 12866, entitled ‘‘Regulatory


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                                                58620        Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations

                                                Planning and Review’’ (58 FR 51735,                     VII. Congressional Review Act                         SUMMARY:The Comprehensive
                                                October 4, 1993). Because this action                      Pursuant to the Congressional Review            Environmental    Response,
                                                has been exempted from review under                     Act (5 U.S.C. 801 et seq.), EPA will               Compensation, and Liability Act of 1980
                                                Executive Order 12866, this action is                   submit a report containing this rule and (‘‘CERCLA’’ or ‘‘the Act’’), as amended,
                                                not subject to Executive Order 13211,                   other required information to the U.S.             requires that the National Oil and
                                                entitled ‘‘Actions Concerning                           Senate, the U.S. House of                          Hazardous Substances Pollution
                                                Regulations That Significantly Affect                                                                      Contingency Plan (‘‘NCP’’) include a list
                                                                                                        Representatives, and the Comptroller
                                                Energy Supply, Distribution, or Use’’ (66                                                                  of national priorities among the known
                                                                                                        General of the United States prior to
                                                FR 28355, May 22, 2001) or Executive                                                                       releases or threatened releases of
                                                                                                        publication of the rule in the Federal
                                                Order 13045, entitled ‘‘Protection of                                                                      hazardous substances, pollutants or
                                                                                                        Register. This action is not a ‘‘major
                                                Children from Environmental Health                                                                         contaminants throughout the United
                                                                                                        rule’’ as defined by 5 U.S.C. 804(2).
                                                Risks and Safety Risks’’ (62 FR 19885,                                                                     States. The National Priorities List
                                                April 23, 1997). This action does not                   List of Subjects in 40 CFR Part 180                (‘‘NPL’’) constitutes this list. The NPL is
                                                contain any information collections                        Environmental protection,                       intended primarily to guide the
                                                subject to OMB approval under the                       Administrative practice and procedure,             Environmental Protection Agency (‘‘the
                                                Paperwork Reduction Act (PRA) (44                       Agricultural commodities, Pesticides               EPA’’ or ‘‘the agency’’) in determining
                                                U.S.C. 3501 et seq.), nor does it require                                                                  which sites warrant further
                                                                                                        and pests, Reporting and recordkeeping
                                                any special considerations under                                                                           investigation. These further
                                                                                                        requirements.
                                                Executive Order 12898, entitled                                                                            investigations will allow the EPA to
                                                ‘‘Federal Actions to Address                               Dated: September 4, 2015.                       assess the nature and extent of public
                                                Environmental Justice in Minority                       Susan Lewis,                                       health and environmental risks
                                                Populations and Low-Income                              Director, Registration Division, Office of         associated with the site and to
                                                Populations’’ (59 FR 7629, February 16,                 Pesticide Programs.                                determine what CERCLA-financed
                                                1994).                                                     Therefore, 40 CFR chapter I is                  remedial action(s), if any, may be
                                                   Since tolerances and exemptions that                 amended as follows:                                appropriate. This rule adds five sites to
                                                are established on the basis of a petition                                                                 the General Superfund section of the
                                                under FFDCA section 408(d), such as                     PART 180—[AMENDED]                                 NPL.
                                                the tolerance in this final rule, do not                                                                   DATES: The document is effective on
                                                require the issuance of a proposed rule,                ■ 1. The authority citation for part 180
                                                                                                                                                           October 30, 2015.
                                                the requirements of the Regulatory                      continues to read as follows:
                                                                                                                                                           ADDRESSES: Contact information for the
                                                Flexibility Act (RFA) (5 U.S.C. 601 et                     Authority: 21 U.S.C. 321(q), 346a and 371.      EPA Headquarters:
                                                seq.), do not apply.
                                                                                                        ■ 2. In § 180.561, is amended by adding               • Docket Coordinator, Headquarters;
                                                   This action directly regulates growers,
                                                                                                        alphabetically the entries for ‘‘Fruit,            U.S. Environmental Protection Agency;
                                                food processors, food handlers, and food
                                                retailers, not States or tribes, nor does               citrus, group’’, and ‘‘Fruit, pome, group’’ CERCLA Docket Office; 1301
                                                                                                        to the table in paragraph (a)(1) to read           Constitution Avenue NW., William
                                                this action alter the relationships or
                                                                                                        as follows:                                        Jefferson Clinton Building West, Room
                                                distribution of power and
                                                                                                                                                           3334, Washington, DC 20004, 202/566–
                                                responsibilities established by Congress
                                                                                                        § 180.561 Acibenzolar-S-methyl;                    0276.
                                                in the preemption provisions of FFDCA                   tolerances for residues.                              The contact information for the
                                                section 408(n)(4). As such, the Agency
                                                                                                           (a) * * *                                       regional dockets is as follows:
                                                has determined that this action will not                                                                      • Holly Inglis, Region 1 (CT, ME, MA,
                                                have a substantial direct effect on States                 (1) * * *
                                                                                                                                                           NH, RI, VT), U.S. EPA, Superfund
                                                or tribal governments, on the                                                                              Records and Information Center, 5 Post
                                                                                                                                               Parts per
                                                relationship between the national                                   Commodity                   million    Office Square, Suite 100, Boston, MA
                                                government and the States or tribal                                                                        02109–3912; 617/918–1413.
                                                governments, or on the distribution of                                                                        • Ildefonso Acosta, Region 2 (NJ, NY,
                                                power and responsibilities among the                        *          *        *            *        *    PR, VI), U.S. EPA, 290 Broadway, New
                                                various levels of government or between                 Fruit, citrus, group 10–10 .........          0.02 York, NY 10007–1866; 212/637–4344.
                                                the Federal Government and Indian                       Fruit, pome, group 11–10 .........            0.03
                                                                                                                                                              • Lorie Baker (ASRC), Region 3 (DE,
                                                tribes. Thus, the Agency has determined                                                                    DC,  MD, PA, VA, WV), U.S. EPA,
                                                that Executive Order 13132, entitled                        *          *        *            *        *
                                                                                                                                                           Library, 1650 Arch Street, Mailcode
                                                ‘‘Federalism’’ (64 FR 43255, August 10,                                                                    3HS12, Philadelphia, PA 19103; 215/
                                                1999) and Executive Order 13175,                        *      *       *     *     *
                                                                                                        [FR Doc. 2015–24463 Filed 9–29–15; 8:45 am]        814–3355.
                                                entitled ‘‘Consultation and Coordination                                                                      • Jennifer Wendel, Region 4 (AL, FL,
                                                                                                        BILLING CODE 6560–50–P
                                                with Indian Tribal Governments’’ (65 FR                                                                    GA, KY, MS, NC, SC, TN), U.S. EPA, 61
                                                67249, November 9, 2000) do not apply                                                                      Forsyth Street SW., Mailcode 9T25,
                                                to this action. In addition, this action                                                                   Atlanta, GA 30303; 404/562–8799.
                                                                                                        ENVIRONMENTAL PROTECTION
                                                does not impose any enforceable duty or
                                                                                                        AGENCY                                                • Todd Quesada, Region 5 (IL, IN, MI,
                                                contain any unfunded mandate as                                                                            MN, OH, WI), U.S. EPA Superfund
                                                described under Title II of the Unfunded                40 CFR Part 300                                    Division Librarian/SFD Records
                                                Mandates Reform Act (UMRA) (2 U.S.C.                                                                       Manager SRC–7J, Metcalfe Federal
                                                1501 et seq.).                                          [EPA–HQ–SFUND–2015–0136, 0137, 0138,               Building, 77 West Jackson Boulevard,
mstockstill on DSK4VPTVN1PROD with RULES




                                                   This action does not involve any                     0140, and 0141; FRL–9934–75–OSWER]                 Chicago, IL 60604; 312/886–4465.
                                                technical standards that would require                                                                        • Brenda Cook, Region 6 (AR, LA,
                                                Agency consideration of voluntary                       National Priorities List                           NM, OK, TX), U.S. EPA, 1445 Ross
                                                consensus standards pursuant to section                 AGENCY: Environmental Protection                   Avenue, Suite 1200, Mailcode 6SFTS,
                                                12(d) of the National Technology                        Agency (EPA).                                      Dallas, TX 75202–2733; 214/665–7436.
                                                Transfer and Advancement Act                            ACTION: Final rule.
                                                                                                                                                              • Preston Law, Region 7 (IA, KS, MO,
                                                (NTTAA) (15 U.S.C. 272 note).                                                                              NE), U.S. EPA, 11201 Renner Blvd.,


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Document Created: 2015-12-15 09:32:05
Document Modified: 2015-12-15 09:32:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 58614 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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