
[Federal Register Volume 78, Number 243 (Wednesday, December 18, 2013)]
[Rules and Regulations]
[Pages 76561-76566]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29963]



[[Page 76561]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0431; FRL-9402-4]


Endothall; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
endothall in or on apple and apple, pomace. United Phosphorus, Inc. 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective December 18, 2013. Objections and 
requests for hearings must be received on or before February 18, 2014, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0431, 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), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 703-305-5447; email 
address: Rossi.Lois@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0431 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 
February 18, 2014. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0431, 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.htm.
    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 July 25, 2012 (77 FR 43562) (FRL-9353-
6), 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 
2F8023) by United Phosphorus, Inc., 630 Freedom Business Center, Suite 
402 King of Prussia, PA 19406. The petition requested that 40 CFR 
180.293 be amended by establishing tolerances for residues of the 
herbicide, endothall, mono (N,N-dimethylalkylamine) salt of endothall, 
and the dipotassium salt of endothall, in or on apples at 0.05 parts 
per million (ppm), and apple, pomace at 0.15 ppm. That document 
referenced a summary of the petition prepared by United Phosphorus, 
Inc., the registrant, which is available in the docket, EPA-HQ-OPP-
2012-0431 at 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 proposed definition for apple pomace to ``apple, wet 
pomace'' and updated the current tolerance expression so that 
metabolites and degradates of endothall are included. The reasons for 
these changes are explained in Unit IV.D.

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. . . 
.''

[[Page 76562]]

    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 endothall including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with endothall 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.
    Endothall is a caustic chemical with toxicity being the result of a 
direct degenerative effect on tissue. By acute exposure, endothall is a 
skin sensitizer and an extreme irritant by the acute oral and ocular 
routes of administration. The most sensitive effect of endothall 
following chronic oral administration is direct irritation of the 
gastrointestinal system. This effect was evident in several species and 
in several studies. The dog is particularly sensitive to endothall 
toxicity. Endothall caused gastric epithelial hyperplasia in dogs 
treated with an oral dose of 6.5 mg/kg/day for 52 weeks (a dose level 
that was one order of magnitude lower than doses associated with 
clinical signs of toxicity (subdued behavior, poor condition, thin 
appearance and distended abdomen). Besides gastric irritant effects, 
decreased body weight in the dog was also a sensitive effect following 
13 weeks of endothall administration. The decreased body weights were 
most likely attributable to the constant and direct irritation of the 
gastric lining. In the rat, gastric irritation was noted at a dose 
level that was 1 to 2 orders of magnitude lower than doses resulting in 
kidney lesions. Proliferative lesions of the gastric epithelium were 
observed in F1 parental male and female rats treated orally with 2 mg/
kg/day endothall in a 2-generation reproduction study (a NOAEL was not 
identified). In a developmental rat study, pregnant rats exhibited 
decreased body weight and decreased body weight was also noted in a 90-
day dietary study in the rat.
    Dermally, endothall destroys the stratum corneum and then the 
underlying viable epidermis. In the 21-day dermal rat study, systemic 
toxicity (hematology and clinical chemistry alterations) was noted at a 
dose level that was one order of magnitude greater than that causing 
dermal irritation. Available studies clearly demonstrate that local 
irritation (portal of entry effect) is the most sensitive and initial 
effect, occurring at dose levels lower than those associated with 
systemic toxicity.
    Acute inhalation toxicity of endothall is low; however, nasal and 
pulmonary toxicity were evident in the 5-day and 28-day inhalation 
toxicity studies in the rat including rales, labored respiration, pale 
lungs (gross necropsy), increased absolute and relative lung weights, 
subacute inflammation, alveolar proteinosis, and nasal hemorrhage 
inflammation, erosion, and ulceration.
    Endothall does not cause pre-natal toxicity following in utero 
exposure to rats nor pre-and postnatal toxicity following exposures to 
rats for two generations. In the developmental mouse study, there was 
severe maternal toxicity (i.e., greater than 30% mortality) at the 
highest dose tested; at this dose level, a slight increase in vertebral 
and rib malformations was observed in the offspring indicating that 
these effects were most likely secondary to severe maternal toxicity. 
The hazard data for endothall indicate no evidence of quantitative or 
qualitative increased susceptibility of rat fetuses exposed in utero to 
endothall in the developmental toxicity studies. In addition, no 
evidence of quantitative or qualitative increased susceptibility of rat 
fetuses or neonates was observed in the 2-generation reproduction 
study.
    Available studies showed no evidence of neurotoxicity and do not 
indicate potential Immunotoxicity. Endothall does not belong to the 
class of compounds (e.g., the organotins, heavy metals, or halogenated 
aromatic hydrocarbons) that would be expected to be toxic to the immune 
system. Endothall is classified as ``not likely to be carcinogenic to 
humans'' based on lack of evidence of carcinogenicity in mice or rats. 
It has no mutagenic potential.
    Specific information on the studies received and the nature of the 
adverse effects caused by endothall as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Endothall. Human Health Risk 
Assessment to support proposed Use on Apples'' at 30-34 in docket ID 
number EPA-HQ-OPP-2012-0431.

B. Toxicological Points of Departure/Levels of Concern

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

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     Table 1--Summary of Toxicological Doses and Endpoints for Endothall Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/Scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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Acute dietary (General population    An appropriate endpoint attributable to a single dose was not available
 including Females 13-50 years of     from any study, including the prenatal development toxicity study in rats.
 age, infants and children).          An acute RfD was not established.
                                    ----------------------------------------------------------------------------
Chronic dietary (All populations)..  LOAEL = 2 mg/kg/day     Chronic RfD = 0.007 mg/ Rat 2-generation
                                      (NOAEL not              kg/day.                 reproduction study
                                      determined).           cPAD = 0.007 mg/kg/day   proliferative lesions of
                                     UF = 300x.............                           the gastric epithelium
                                     FQPA SF = 3x..........                           (both sexes)
Incidental oral short-term (1 to 30  Offspring NOAEL = 9.4   Residential LOC for     Rat 2-generation
 days).                               mg/kg/day.              MOE = 100.              reproduction study LOAEL =
                                                                                      60 mg/kg/day based on
                                                                                      decreased pup body weight
                                                                                      (both sexes) on Day 0 F1
                                                                                      and F2 generations Body
                                                                                      Weights were also
                                                                                      similarly decreased in the
                                                                                      dams throughout the study.
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Dermal short-term (1 to 30 days)     In the 21 day dermal toxicity study, severe dermal effects were observed at
 And Intermediate-term (1 to 6        30 mg/kg/day (lowest dose tested). The NOAEL for dermal irritation was not
 months).                             established due to Erythema, edema and fissuring and sloughing off of skin
                                      at the lowest tested (30 mg/kg/day) endothall is caustic dermally because
                                      it is an acid. Since undiluted endothal is so toxic at the portal of entry
                                      (e.g., skin), quantification of systemic toxicity and risk is not
                                      necessary to show that direct exposure to endothall poses unacceptable
                                      risk. Protection against any potential dermal effects from direct exposure
                                      is addressed with precautionary labeling recommending the use of gloves
                                      and other personal protection which limits contact of the material with
                                      the handler's body. The 30 mg/kg/day dose from the 21 day dermal study was
                                      used as a point of reference in assessing potential risk to swimmers from
                                      dermal exposure.
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Inhalation short-term (1 to 30       Inhalation (or oral)    LOC for MOE = 30......  Subchronic inhalation
 days).                               study NOAEL = 0.001                             toxicity study LOAEL =
                                      mg/kg/day (inhalation                           0.005 based on clinical
                                      absorption rate =                               signs (rales and labored
                                      100%).                                          respiration) observed
                                     UFA = 3x\c\x..........                           acutely (0-1 hr post
                                     UFH = 10xx............                           dosing and prior to next
                                     FQPA SF = 1x..........                           exposure).
                                    ----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..                Classified as a ``Not Likely'' human carcinogen
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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. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS =  use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to endothall, EPA considered exposure under the petitioned-for 
tolerances as well as all existing endothall tolerances in 40 CFR 
180.293. EPA assessed dietary exposures from endothall 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.
    No such effects were identified in the toxicological studies for 
endothall; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FID) Version 3.16 which uses 
food consumption data from the U.S. Department of Agriculture`s 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA), conducted from 2003-2008. As to residue levels 
in food, EPA used average percent crop treated (PCT) estimates for 
endothall, average field trial residues for all existing and new uses, 
and DEEM 7.81 default and crop specific processing factors and 
conservative drinking water estimates to obtain accurate residue data.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that endothall does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Percent crop treated (PCT) 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.

[[Page 76564]]

    The Agency estimated the PCT for new and existing uses as follows: 
Apple 62%, apple fresh market 76%, apple processing 37%, apple juice 
40%, barley for grain 36%, corn for grain 19%, dry beans 32%, grape 
95%, grape fresh market 99%, grape processing 94%, green peas 43%, oats 
for grain 7%, peanut for nuts 42%, rice 100%, sorghum for grain 15%, 
soybean for beans 9%, strawberry 90%, strawberry fresh market 88%, 
strawberry processing 100%, sugar beet for sugar 37%, sugarcane for 
sugar 54%, watermelon 33%, and wheat for grain 14%.
    Because endothall will be applied to water in irrigation canals, 
EPA estimates the percent crop treated for endothall by estimating the 
percent of the crop that is irrigated. This will serve as an upper 
bound for crops that may be exposed to endothall in irrigation water. 
EPA uses two methods to estimate percent crop irrigated. The first 
method, where data on irrigated production is available, is an estimate 
of the share of total production that is irrigated. Estimates from this 
method are provided for barley, corn, dry edible beans, oats, peanuts, 
rice, sorghum, soybeans, sugar beets, sugarcane, and wheat. For these 
crops, data on irrigated production is from the 2007 Census of 
Agriculture. Where data on irrigated production are not available, EPA 
estimates the percent crop irrigated by determining the percentage of 
United States production of a crop that is grown in 17 western states 
where endothall may be used. The 17 western states are Arizona, 
California, Colorado, Idaho, Kansas, Montana, Nebraska, Nevada, New 
Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, 
Washington, and Wyoming. These states are the states where large scale 
water projects are predominate, and where other chemicals are used in 
canals for weed control. These types of irrigation projects are 
relatively rare in other parts of the country. Data on the share of the 
crop grown in the 17 western states are from USDA/NASS data.
    These estimates are conservative because they are the equivalent of 
assuming 100% of irrigated crops are irrigated with water from 
endothall-treated canals. This assumption is being made despite the 
fact that all irrigation canals may not be treated with endothall, even 
in some areas with surface water delivery systems and other areas with 
crops (even in the heavily irrigated areas of the West), not being 
irrigated.
    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. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which endothall may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for endothall in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of endothall. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Simple First-Order Degradation the estimated 
drinking water concentrations (EDWCs) of endothall for chronic 
exposures for non-cancer assessments are estimated to be 31 ppb for 
surface water and ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    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). A product containing 
endothall is currently registered for uses that could result in 
residential exposures which include aquatic applications on ponds, 
lakes and garden pools. There is a potential for exposure from 
registered uses for homeowners who apply endothall products to control 
aquatic weeds and algae in ponds and garden pools. For residential 
handlers, exposure scenarios are only considered to be short-term in 
nature due to the episodic uses associated with homeowner products. 
There is also a potential for exposure to adults and children from 
contacting water treated with endothall through swimming, wading, water 
skiing, etc. Only short-term exposures are expected since these 
scenarios are expected to be only episodic.
    Endothall registered use patterns and current labeling indicate 
three likely residential handler exposure scenarios: (1) applying 
granules by hand for treating garden pools, (2) applying granules by 
cup for treating ponds and lakes, and (3) applying granules by spoon 
for treating ponds and lakes. For post-application exposures, the 
Agency quantitatively assessed inhalation and incidental oral (water 
ingestion) from the aquatic use (adult and children). Since endothall 
is caustic dermally because it is an acid the Agency determined 
quantification of systemic toxicity and risk resulting from dermal 
exposure is not appropriate. Though swimmers could be exposed to 
endothall, EPA did not conduct a formal quantitative assessment for 
this scenario because the maximum concentration of endothall in 
swimming water is 5 ppm, and this dilutes out very rapidly. In 
comparison, in the dermal toxicity study, the concentration that caused 
irritation was substantially higher (2000 ppm). Therefore exposures to 
endothall in water would not likely result in any irritation to the 
skin. 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 endothall to share a common mechanism of toxicity 
with any other substances, and endothall does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that endothall does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common

[[Page 76565]]

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. There was no indication of 
increased susceptibility of rats or mice in utero and or postnatal 
exposure in the developmental and reproductive toxicity studies.
    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 3X. That decision is based on the following 
findings:
    i. The toxicity database for endothall is complete, with the 
exception of the immunotoxicity study, which is a toxicology data 
requirement of the revised 40 CFR Part 158. However, endothall does not 
belong to the class of compounds (e.g., the organotins, heavy metals, 
or halogenated aromatic hydrocarbons) that would be expected to be 
toxic to the immune system and the available studies showed no evidence 
of potential immunotoxicity.
    ii. There is no indication that endothall is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that endothall results in increased 
susceptibility in utero in rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties in the endothall database 
in regard to dietary (food and drinking water) and residential 
exposures. Though the chronic dietary exposure and risk assessment was 
partially refined by using percent crop treated data, the dietary food 
assessment is still very conservative since field trial rather than 
monitoring data were used as the residue input, and default as well as 
measured processing factors were used for some commodities. Also, the 
drinking water inputs were based on modeled surface water values from 
the scenario which provides the highest estimated environmental 
concentration and will not underestimate chronic exposure to residues 
of endothall present in drinking water. Residential exposure estimates 
are based on conservative, health-protective assumptions that also 
ensure exposures are not underestimated.
    v. Although all of the above factors support the conclusion that 
removal of the FQPA factor would be safe for children, an additional 3X 
FQPA factor is being retained because a LOAEL established in the two-
generation reproduction study was used for assessing chronic dietary 
risks. A 3X factor (as opposed to a 10X) was determined to be adequate 
since the severity of the lesions were minimal to mild indicating that 
LOAEL did not far exceed the NOAEL.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and therefore no acute dietary endpoint was selected. 
Endothall is not expected to pose an acute dietary risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
endothall from food and water will utilize 90% of the cPAD for infants 
(1-2 years old) which is the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
endothall is not expected.
    3. Short-term risk: Short-term aggregate exposure takes into 
account adult and children's post-application inhalation and oral 
exposure (from swimming in water bodies treated with endothall) 
combined with the chronic dietary exposure from the mostly highly 
exposed adult (General US population) and children's (all children 1-2 
years old) subpopulations respectively, to determine aggregate exposure 
and risk. The Agency has determined that it is appropriate to aggregate 
chronic exposure through food and water with short-term residential 
exposures to endothall.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1200 and 210 for 
the most highly exposed subgroups of adults and children, respectively.
    Because EPA's level of concern for endothall is a MOE of 100 or 
below, these MOEs are not of concern. As discussed in Unit III.C.3., 
the risk to swimmers from dermal exposure to endothall is very low.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, endothall is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to endothall residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (GC with microcoulometric nitrogen 
detection and a confirmatory HPLC/MSD method) is available to enforce 
the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint

[[Page 76566]]

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 endothall.

C. Response to Comments

    There were no comments on the petition to establish endothall 
tolerance on apples and apple pomace. The comment posted in the 
Endothall Docket, EPA-HQ-OPP-2012-0431-0005 was published within the 
incorrect docket and is irrelevant to this action.

D. Revisions to Petitioned-For Tolerances

    The proposed commodity definition for apple pomace is being revised 
to ``apple, wet pomace'' to reflect the Agency's correct commodity 
definition. In addition EPA is revising the tolerance expression in 40 
CFR 180.293(a)(1) for food commodities to clarify the chemical moieties 
that are covered by the tolerances and specify how compliance with the 
tolerances is to be measured. The revised tolerance expression makes 
clear that the tolerances cover ``residues of endothall, including its 
metabolites and degradates,'' and that compliance with the tolerance 
levels will be determined, for food commodities, by measuring only 
endothall (7-oxabicyclo [2.2.1] heptanes-2,3-dicarboxylic acid) and its 
mono-methyl ester. EPA has determined that it is reasonable to make 
this change final without prior proposal and opportunity for comment, 
because public comment is not necessary, in that the change has no 
substantive effect on the tolerance, but rather is merely intended to 
clarify the legal effect of tolerances as Provided in FFDCA section 
408(a)(3).

V. Conclusion

    Therefore, tolerances are established for residues of endothall and 
its mono-methyl ester, in or on apple at 0.05 ppm and apple, wet pomace 
at 0.15 ppm.

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) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: December 9, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.293 revise paragraph (a)(1) introductory text and add, 
alphabetically, the following commodities to the table to read as 
follows:


Sec.  180.293  Endothall; tolerances for residues.

    (a) General. (1) Tolerances are established for the residues of 
endothall, 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 endothall (7-
oxabicylco [2.2.1] heptanes-2,3-dicarboxylic acid) and its mono-methyl 
ester.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple......................................................         0.05
Apple, wet pomace..........................................         0.15
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-29963 Filed 12-17-13; 8:45 am]
BILLING CODE 6560-50-P


