
[Federal Register Volume 77, Number 70 (Wednesday, April 11, 2012)]
[Rules and Regulations]
[Pages 21670-21676]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8355]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0086; FRL-9343-3]


Acibenzolar-S-methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
acibenzolar-S-methyl in or on berry, low growing, subgroup 13-07G. The 
Interregional Research Project No. 4 (IR-4) requested the tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 11, 2012. Objections and 
requests for hearings must be received on or before June 11, 2012, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2011-0086. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; email address: jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
OCSPP test guidelines referenced in this document electronically, go 
to: http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.''

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

[[Page 21671]]

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-2011-0086 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 June 11, 2012. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0086, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 6, 2011 (76 FR 39358) (FRL-8875-6), 
EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 0E7818) 
by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The 
petition requested that 40 CFR part 180 be amended by establishing a 
tolerance for residues of the fungicide acibenzolar-S-methyl, 
benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester, in or on low 
growing berry subgroup 13-07G at 0.15 parts per million (ppm), and by 
amending the tolerance expression to read, ``tolerances are established 
for residues of acibenzolar-S-methyl, benzo(1,2,3)thiadiazole-7-
carbothioic acid-S-methyl ester, including its metabolites and 
degradates, in or on the commodity(s) listed. Compliance with the 
tolerance level is to be determined by measuring only those 
acibenzolar-S-methyl residues convertible to benzo(1,2,3)thiadiazole-7-
carboxylic acid (CGA-210007), expressed as the stoichiometric 
equivalent of acibenzolar-S-methyl. That notice referenced a summary of 
the petition prepared by Syngenta Crop Protection, Inc., the 
registrant, which is available in the docket, http://www.regulations.gov.
    One comment on the notice of filing was received. EPA's response to 
this comment is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has 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 their 
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.
    Acibenzolar-S-methyl showed no significant toxicity in a battery of 
acute toxicity tests. Considerable skin sensitizing (contact 
allergenic) potential was demonstrated in a dermal sensitization study 
in guinea pigs.
    In subchronic and chronic oral studies in rats, dogs and mice, 
signs of mild regenerative hemolytic anemia were consistently observed 
in all three species. Additional toxic effects observed in these same 
studies included decreases in body weight, body weight gain and/or food 
consumption. In a 28-day dermal study in rats, no systemic or dermal 
effects were observed at dose levels up to 1,000 milligrams/kilogram/
day (mg/kg/day), the limit dose. No neurotoxic effects were observed at 
any dose in a subchronic neurotoxicity study in rats.
    Prenatal and postnatal toxicity data are available including 
developmental toxicity studies in rats and rabbits, a developmental 
neurotoxicity (DNT) study in rats, and a 2-generation reproduction 
toxicity study in rats. 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. In the rat developmental 
toxicity study, treatment related visceral malformations and skeletal 
variations were observed in fetuses at 200 mg/kg/day, the no observed 
adverse effect level (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 (HDT). 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. 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 HDT.
    Acibenzolar-S-methyl was classified by the Agency as ``not likely'' 
to be a human carcinogen based on negative carcinogenicity studies in 
male and female rats and mice and generally negative results in an 
acceptable battery of mutagenicity studies.
    An immunotoxicity study required as part of new 40 CFR part 158 
data requirements for registration of a pesticide has been submitted 
and is being reviewed by the Agency. Based on a preliminary review, the 
study is

[[Page 21672]]

acceptable and indicates no evidence of immunotoxicity.
    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 
``Acibenzolar-S-methyl Human Health Risk Assessment for Proposed Use of 
Acibenzolar-S-methyl on Low Growing Berries Crop Subgroup 13-07G, dated 
February 23, 2012'', on pages 28-33 in docket ID number EPA-HQ-OPP-
2011-0086-0007.

B. Toxicological Points of Departure (POD)/Levels of Concern (LOC)

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological POD and LOC 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 the following table.

    Table--Summary of Toxicological Doses and Endpoints for Acibenzolar-S-methyl for Use in Human Health Risk
                                                   Assessments
----------------------------------------------------------------------------------------------------------------
                                      Point of       Uncertainty/FQPA  RfD, PAD, LOC for         Study and
       Exposure/scenario             departure        safety factors    risk assessment    toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General           NOAEL = 8.2 mg/kg/ UFA = 10x........  aRfD = 0.082 mg/   Developmental
 Population).                     day.              UFH = 10x........   kg/day.            Neurotoxicity
                                                    FQPA SF = 1x.....  aPAD = 0.082 mg/    Toxicity--Rat.
                                                                        kg/day.           Developmental LOAEL =
                                                                                           82 mg/kg/day based on
                                                                                           changes in brain
                                                                                           morphometrics in the
                                                                                           cerebellum in
                                                                                           offspring.
                                                                                          Maternal LOAEL = was
                                                                                           not observed.
                                                                                          NOAEL = 326.2 mg/kg/
                                                                                           day HDT.
Chronic Dietary (Females 13-49   NOAEL = 8.2 mg/kg/ UFA = 10x........  aRfD = 0.082 mg/   Developmental
 years & Young Children).         day.              UFH = 10x........   kg/day.            Neurotoxicity
                                                    FQPA SF = 1x.....  aPAD = 0.082 mg/    Toxicity--Rat.
                                                                        kg/day.           Developmental LOAEL =
                                                                                           82 mg/kg/day based on
                                                                                           changes in brain
                                                                                           morphometrics in the
                                                                                           cerebellum in
                                                                                           offspring.
                                                                                          Maternal LOAEL = was
                                                                                           not observed.
                                                                                          NOAEL = 326.2 mg/kg/
                                                                                           day HDT.
Chronic Dietary (Adult Males     NOAEL = 25 mg/kg/  UFA = 10x........  cRfD = 0.25 mg/kg/ Chronic Toxicity--Dog;
 and Females 50+ yrs).            day.              UFH = 10x........   day.               Co-critical; Chronic/
                                                    FQPA SF = 1x.....  cPAD = 0.25 mg/kg/  Cancer--Rat & Mouse,
                                                                        day.               Reproduction
                                                                                           Toxicity--Rat.
                                                                                          LOAEL = 105 mg/kg/day
                                                                                           based on hemolytic
                                                                                           anemia with
                                                                                           compensatory
                                                                                           response.
Incidental Oral................  NOAEL = 8.2 mg/kg/ UFA = 10x........  Occupational LOC   Developmental
                                  day.              UFH = 10x........   for MOE = 100.     Neurotoxicity
                                                                                           Toxicity--Rat.
                                                                                          Developmental LOAEL =
                                                                                           82 mg/kg/day based on
                                                                                           changes in brain
                                                                                           morphometrics in the
                                                                                           cerebellum in
                                                                                           offspring.
                                                                                          Maternal LOAEL = was
                                                                                           not observed.
                                                                                          NOAEL = 326.2 mg/kg/
                                                                                           day HDT.
Dermal Short (1-30 days) and     NOAEL= 8.2 mg/kg/  UFA = 10x........  Occupational LOC   Developmental
 Intermediate (1-6 months) Term.  day.              UFH = 10x........   for MOE = 100.     Neurotoxicity
DAF = 40%......................                                                            Toxicity--Rat.
                                                                                          Developmental LOAEL =
                                                                                           82 mg/kg/day based on
                                                                                           changes in brain
                                                                                           morphometrics in the
                                                                                           cerebellum in
                                                                                           offspring.
                                                                                          Maternal LOAEL = was
                                                                                           not observed.
                                                                                          NOAEL = 326.2 mg/kg/
                                                                                           day HDT.
Inhalation Short (1-30 days)     NOAEL= 8.2 mg/kg/  UFA = 10x........  Occupational LOC   Developmental
 and Intermediate (1-6 months)    day.              UFH = 10x........   for MOE = 100.     Neurotoxicity
 Term.                                                                                     Toxicity--Rat.
                                                                                          Developmental LOAEL =
                                                                                           82 mg/kg/day based on
                                                                                           changes in brain
                                                                                           morphometrics in the
                                                                                           cerebellum in
                                                                                           offspring.
                                                                                          Maternal LOAEL = was
                                                                                           not observed.
                                                                                          NOAEL = 326.2 mg/kg/
                                                                                           day HDT.
                                --------------------------------------------------------------------------------
Cancer (all routes)............                         A ``not likely'' human carcinogen.
----------------------------------------------------------------------------------------------------------------
Point of Departure = A data point or an estimated point that is derived from observed dose-response data and
  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant
  human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF =
  uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
  sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD =
  population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level
  of concern. DAF = Dermal Absorption Factor. Since no inhalation absorption data are available, toxicity by the
  inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure (100%
  absorption factor). mg/kg/day = milligram/kilogram/day. HDT = highest dose tested.


[[Page 21673]]

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 Sec.  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. In estimating acute dietary exposure, EPA 
used food consumption information from the U.S. Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
performed a refined (probabilistic) acute dietary exposure analysis for 
the general population and all population subgroups. The acute analysis 
assumed a distribution of residues based on field trial data. Empirical 
and Dietary Exposure Evaluation Model (DEEM) default processing factors 
were used to modify the field trial data. Maximum screening-level 
percent crop treated (PCT) estimates were used for commodities for 
which data were available. If no PCT data were available, 100 PCT was 
assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, the chronic analysis 
incorporated tolerance level residues and 100 PCT assumptions were 
used. DEEM default and empirical processing factors were used to modify 
the tolerance values.
    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 PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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. EPA did not use PCT data in 
assessing chronic exposure.
    2. Dietary exposure from drinking water. The residues of concern 
for drinking water are acibenzolar-S-methyl, benzo(1,2,3) thiadiazole-
7-carbothioic acid-S-methyl ester, convertible to 
benzo(1,2,3)thiadiazole-7-carboxylic acid (CGA-210007). The Agency used 
screening level water exposure models in the dietary exposure analysis 
and risk assessment for acibenzolar-S-methyl and CGA-210007 in drinking 
water. These simulations 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.
    Based on Tier II Pesticide Root Zone Model/Exposure Analysis 
Modeling System and Screening Concentration in Ground Water (SCI-GROW) 
models, the estimated drinking water concentrations (EDWCs) of 
acibenzolar-S-methyl and CGA-210007 for acute exposures are estimated 
to be 0.72 and 20.02 parts per billion (ppb), respectively, for surface 
water and 0.0000125 and 0.0812 ppb, respectively, for ground water. 
EDWCs of acibenzolar-S-methyl and CGA-210007 for chronic exposures for 
non-cancer assessments are estimated to be 0.02 and 8.09 ppb, 
respectively, for surface water and 0.0000125 and 0.0812 ppb, 
respectively, for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. CGA-210007 drinking water 
residues were included in the dietary exposure assessment as 
acibenzolar-S-methyl equivalents. CGA 210007 residues were converted to 
acibenzolar-S-methyl equivalents based on molecular weight (MW), i.e., 
(MW of acibenzolar (210) / MW of CGA 210007 (180) x EDWC for CGA 
210007). The acute analysis incorporated the entire time distribution 
of estimated drinking water concentrations adjusted to account for CGA-
210007. For chronic dietary risk assessment, the water concentration of 
value 9.44 ppb was used to assess the contribution of CGA 210007 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 currently registered for the following uses 
that could result in residential exposures: Turfgrass use on sodfarms, 
golf courses, collegiate athletic fields, and lawns around commercial 
and industrial buildings. Residential exposure was assessed for adult 
handlers and for adult and child post-application activities. Exposure 
for adult and child golfers was used to aggregate adult post-
application dermal exposure with dietary and drinking water exposure. 
The aggregate exposure assessment for children combines dermal and 
incidental oral post-application exposure with food and water 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

[[Page 21674]]

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 SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicity database for acibenzolar-S-methyl includes adequate 
developmental toxicity studies in rats and rabbits, a DNT study in 
rats, and a 2-generation reproduction toxicity study in rats. As 
discussed in Unit III.A., several of these studies indicate that the 
young are quantitatively and qualitatively more sensitive to 
acibenzolar-S-methyl. Nonetheless, there are no residual uncertainties 
with regard to prenatal and/or postnatal toxicity since the NOAELs and 
the LOAELs have been identified for all effects of concern, a clear 
dose response has been well defined, and the PODs selected for risk 
assessment are protective of the fetal/offspring effects.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for acibenzolar-S-methyl is complete 
except for finalization of EPA's review of an immunotoxicity study. 
Recent changes to 40 CFR part 158 require immunotoxicity testing (OPPTS 
Guideline 870.7800) for pesticide registration and tolerance 
establishment. An immunotoxicity study has been submitted to EPA and is 
currently under review. The study is acceptable and preliminary review 
results show no evidence of immunotoxicty. In the absence of a 
completed assessment of the immunotoxicity study at this time, EPA 
evaluated available acibenzolar-S-methyl toxicity data to determine 
whether an additional database uncertainty factor is needed to account 
for potential immunotoxicity. There are no indications in the available 
studies that organs associated with immune function, such as the thymus 
and spleen, are affected by acibenzolar-S-methyl and acibenzolar-S-
methyl does not belong to a class of chemicals (e.g., the organotins, 
heavy metals, or halogenated aromatic hydrocarbons) that would be 
expected to be immunotoxic. Therefore, EPA does not believe that the 
ultimate findings of the submitted immunotoxicity study will result in 
a POD lower than those already selected for acibenzolar-S-methyl risk 
assessment, and an additional database uncertainty factor is not needed 
to account for the lack of this study.
    ii. There is concern for increased qualitative and/or quantitative 
susceptibility following in utero exposure to acibenzolar-S-methyl 
based on developmental toxicity and developmental neurotoxicity studies 
in rats. However, for the reasons noted above, the degree of concern 
for the increased susceptibility seen in these studies is low.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary risk assessment is conservative and will not 
underestimate dietary and/or non-dietary residential exposure to 
acibenzolar-S-methyl. The acute analysis assumed a distribution of 
residues based on field trial data and maximum PCT estimates were used 
for commodities for which data were available. The chronic dietary food 
exposure assessment was performed based on 100 PCT and tolerance-level 
residues. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to acibenzolar-S-
methyl in drinking water. EPA used similarly conservative assumptions 
to assess post-application exposure of children as well as incidental 
oral exposure of toddlers. 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 35% of the aPAD for children 3-5 
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 11% of the cPAD 
for children 1-2 and children 3-5 years old, the population groups 
receiving the greatest exposure. Based on the explanation in Unit 
III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of acibenzolar-S-methyl is not expected.
    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).
    Acibenzolar-S-methyl is currently registered for uses that could 
result in short-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term residential exposures to acibenzolar-S-
methyl.
    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 700 for females 
13-49 years old from handler activities, and 1,600 for females 13-49 
years old, and 800-1,000 for children 1-2 and 6-12 years old, 
respectively, from post-application exposure. Because EPA's LOC for 
acibenzolar-S-methyl is a MOE of 100 or below, these short-term 
aggregate 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).
    An intermediate-term adverse effect was identified; however, 
acibenzolar-S-methyl is not registered for any use patterns that would 
result in intermediate-term residential exposure.

[[Page 21675]]

Intermediate-term risk is assessed based on intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess intermediate-term 
risk), no further assessment of intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for acibenzolar-S-methyl.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, acibenzolar-S-methyl is not expected to pose a cancer risk 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

    Adequate enforcement methodology (High-performance liquid 
chromatography with ultraviolent detection (HPLC/UV) Method AG-617A) is 
available to enforce the tolerance expression. This method has 
undergone a successful tolerance method validation by the Agency.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for acibenzolar-S-methyl in or 
on berry, low growing, subgroup 13-07G.

C. Response to Comments

    One comment was received from a private citizen who opposed 
authorization by EPA to allow ``all of these toxic chemicals since this 
Agency does not test their reaction with thousands of other chemicals 
that are already present * * *.''
    The Agency has received this same comment on numerous previous 
occasions. Refer to Federal Register of January 7, 2005, 70 FR 1349 for 
the Agency's response to this comment.

V. Conclusion

    Therefore, a tolerance is established for residues of acibenzolar-
S-methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester, 
including its metabolites and degradates, in or on the berry, low 
growing, subgroup 13-07G at 0.15 ppm. Compliance with the tolerance 
level specified is to be determined by measuring only those 
acibenzolar-S-methyl residues convertible to benzo(1,2,3)thiadiazole-7-
carboxylic acid (CGA-210007), expressed as the stoichiometric 
equivalent of acibenzolar-S-methyl.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children From Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions To Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination With Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

[[Page 21676]]

List of Subjects in 40 CFR Part 180

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

    Dated: March 27, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. Section 180.561 is amended by revising paragraph (a) to read as 
follows:


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

    (a) General. Tolerances are established for residues of 
acibenzolar-S-methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid-S-
methyl ester, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only those 
acibenzolar-S-methyl residues convertible to benzo(1,2,3)thiadiazole-7-
carboxylic acid (CGA-210007), expressed as the stoichiometric 
equivalent of acibenzolar-S-methyl, in or on the following raw 
agricultural commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana \1\..................................................        0.1
Berry, low growing, subgroup 13-07G.........................        0.15
Onion, bulb, subgroup 3-07A.................................        0.1
Spinach.....................................................        1.0
Tomato, paste...............................................        3.0
Vegetable, brassica, leafy, group 5.........................        1.0
Vegetable, cucurbit, group 9................................        2.0
Vegetable, fruiting, group 8................................        1.0
Vegetable, leafy, group 4...................................        0.25
------------------------------------------------------------------------
\1\ There are no United States registrations for banana.

* * * * *
[FR Doc. 2012-8355 Filed 4-10-12; 8:45 am]
BILLING CODE 6560-50-P


