Document ID: EPA-HQ-OPP-2014-0613-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Endothall
Posted Date: 2016-11-21T05:00Z

[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Rules and Regulations]
[Pages 83163-83169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27984]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2014-0613; FRL-9953-97]

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 multiple commodities which are identified and 
discussed later in this document. United Phosphorus, Inc. requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective November 21, 2016. Objections and 
requests for hearings must be received on or before January 20, 2017 
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-2014-0613, 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: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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-2014-0613 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 
January 20, 2017. 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-2014-0613, 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 December 17, 2014 (79 FR 75110) (FRL-
9918-90), 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 
4F8293) 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 amending tolerances for residues of the herbicide 
endothall, in or on cattle, fat from 0.01 to 0.05 parts per million 
(ppm); cattle, kidney from 0.20 to 0.06 ppm; cattle, liver from 0.10 to 
0.05 ppm; cattle, meat from 0.03 to 0.05 ppm; goat, fat from 0.005 to 
0.05 ppm; goat, kidney from 0.15 to 0.06 ppm; goat, meat from 0.015 to 
0.05 ppm; hog, fat from 0.005 to 0.05 ppm; hog, kidney from 0.10 to 
0.06 ppm; hog, meat

[[Page 83164]]

from 0.01 to 0.05 ppm; milk from 0.03 to 0.01 ppm; poultry, fat from 
0.015 to 0.05 ppm; poultry, meat from 0.015 to 0.05 ppm; poultry, meat 
byproducts from 0.2 to 0.05 ppm; sheep, fat from 0.005 to 0.05 ppm; 
sheep, kidney from 0.15 to 0.06 ppm; and sheep, meat from 0.015 to 0.05 
ppm. That document referenced a summary of the petition prepared by 
United Phosphorus, Inc., 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 
adjusted the proposed tolerance for ruminant kidney from 0.06 to 0.05. 
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 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 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 orally with endothall for 52 weeks (a no observed adverse 
effect level (NOAEL) was not determined). 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 endothall in a 2-generation reproduction study (a 
NOAEL for the parental effects 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 toxicity study, 
severe dermal effects were observed at the lowest dose tested. 
Available studies clearly demonstrate that local irritation (portal of 
entry effect) is the most sensitive and initial effect.
    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 2-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 in Support of Registration Review, and the Petition to Re-
evaluate Tolerances for Livestock, and Remove the Restriction that 
Prohibits Livestock from Drinking Treated Water'' in docket ID number 
EPA-HQ-OPP-2014-0613.

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

[[Page 83165]]

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 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Endothall 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
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Acute dietary....................   An appropriate endpoint attributable to a single dose was not available from
                                                    any study. An acute RfD was not established.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  LOAEL= 2 mg/kg/day..  Chronic RfD = 0.007  Rat 2-generation reproduction
                                   UFA = 10x...........   mg/kg/day.           study.
                                   UFH = 10x...........  cPAD = 0.007 mg/kg/  LOAEL = 2 mg/kg/day based on
                                   FQPA SF.............   day.                 proliferative lesions of the
                                   UFL = 3x............                        gastric epithelium (both sexes).
                                  ------------------------------------------------------------------------------
Short-term Incidental oral (1 to   Offspring NOAEL= 9.4  Residential........  Rat 2-generation reproduction
 30 days).                          mg/kg/day.           LOC for MOE = 100..   study.
                                   UFA = 10x...........  Occupational = N/A.  LOAEL = 60 mg/kg/day based on
                                   UFH = 10x...........                        decreased pup body weight (both
                                   FQPA SF = 1x........                        sexes) on Day 0 in F1 and F2
                                                                               generations.
                                  ------------------------------------------------------------------------------
Short-term Inhalation (1 to 30     NOAEL = 0.001 mg/L..  Residential LOC for  Subchronic inhalation toxicity
 days).                            Residential HEC =      MOE = 30.            study (MRID 47872201).
                                    0.00049 mg/L (HED =                       Residential acute scenario: LOAEL
                                    0.0143 mg/kg/day).                         = 0.005 mg/L based on clinical
                                   Inhalation (or oral)                        signs (rales and labored
                                    study NOAEL =                              respiration) observed acutely (0-
                                    0.001mg/L mg/kg/day                        1 hr postdosing and prior to next
                                    (inhalation                                exposure).
                                    absorption rate =
                                    100%).
                                   UFA = 3x............
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)                 Classified as a ``Not Likely'' 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. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. HEC = Human
  Equivalent Concentration.

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 food consumption data from the USDA National 
Health and Nutrition Examination Survey, What We Eat in America, 
(NHANES/WWEIA), conducted from 2003-2008. As to residue levels in food, 
average residue values have been used for all crops. The residue and 
processing data used in this assessment are from residue field trials 
and processing studies designed to produce maximum residues for the 
purpose of setting tolerances. All treatments in the field trials with 
irrigated crops were performed by overhead irrigation (i.e. are sprayed 
on the crops). The processing data available were translated to the 
important processed commodities of all crops. Where data were not 
available, DEEM default processing factors were used.
    Anticipated residues of meat, milk, poultry, and eggs have been 
estimated by using the maximum or average residues in feed stuffs as 
well as the maximum allowed 5 ppm concentration of endothall in 
livestock drinking water. Tolerance level residues were used for 
finfish and shellfish.
    EPA used average percent crop treated (PCT) data for alfalfa, 
cotton, and potato, the crops to which endothall is directly applied, 
as well as PCT data for irrigated crops.
    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

[[Page 83166]]

purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (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.
    The Agency estimated the PCT for existing uses as follows for 
irrigated crops: Apple 78%, fresh market apple 84%, processing apple 
49%, apple juice 22%, canned apple 55%, barley for grain 40%, corn for 
grain 21%, dry beans 35%, grape 97%, fresh market grape 99%, processed 
grape 96%, green peas 42%, oats for grain 8%, peanut for nuts 34%, rice 
100%, sorghum for grain 19%, soybean for beans 12%, strawberry 92%, 
fresh market strawberry 90%, processed strawberry 100%, sugarbeet for 
sugar 37%, sugarcane for sugar 54%, watermelon 38%, wheat for grain 
13%. For direct uses of endothall, PCT estimates used include alfalfa 
1%, cotton 1%, and potatoes 2.5%.
    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 to 7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum 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. 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. This represents a conservative estimate 
of high-end chronic exposure from endothall from the use most likely to 
generate the highest exposures (treatment of a reservoir).
    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).
    Endothall is currently registered for the following uses that could 
result in residential exposures: Aquatic applications. EPA assessed 
residential exposure using the following assumptions: There are no 
registered residential uses resulting in residential handler exposure 
to endothall. Therefore, a quantitative residential handler exposure 
assessment was not performed. Residential post-application exposure/
risk estimates were assessed for certain scenarios. The scenarios, 
routes of exposure and lifestages assessed include inhalation exposure 
during recreational swimming (both adults and children 3 to < 6 years 
old) and ingestion of water during recreational swimming (both adults 
and children 3 to < 6 years old.) The assessment of these lifestages is 
health protective for the exposures and risk estimates for any other 
potentially exposed lifestages. 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

[[Page 83167]]

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. There is no evidence of 
quantitative or qualitative increased susceptibility following prenatal 
exposure to rats or rabbits in developmental toxicity studies, and pre- 
and post-natal exposure to rats in the 2-generation reproduction study.
    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 for all scenarios except the chronic dietary 
assessment. For the assessment of risk following chronic dietary 
exposure, the FQPA Safety Factor for increased susceptibility to 
infants and children is reduced to 3X because a lowest observed adverse 
effect level (LOAEL) established in the 2-generation reproduction study 
was used for assessing chronic dietary risks. Since a LOAEL was used, a 
3X FQPA Safety Factor in the form of UFL is retained for 
chronic exposure scenarios. A 3X factor (as opposed to a 10X) was 
determined to be adequate since the severity of the lesions observed at 
the LOAEL were minimal to mild, and therefore the true NOAEL for this 
study is likely to be very near the LOAEL value. For assessments other 
than the chronic dietary assessment, the FQPA safety factor was reduced 
to 1X for the following reasons:
    i. The toxicity database is complete.
    ii. There are no concerns for neurotoxicity, and thus no need to 
retain the 10X for the lack of a developmental neurotoxicity study.
    iii. There is no indication of increased susceptibility of rats or 
rabbits in utero and/or postnatal exposure in the developmental and 
reproductive toxicity studies;
    iv. There are no residual uncertainties identified in the exposure 
databases. The residential post-application exposure assessments are 
based upon the 2012 Residential Standard Operating Procedures (SOPs). 
These assessments of exposure are not likely to underestimate exposure 
to endothall. There is no residual uncertainty in the exposure database 
for endothall with respect to dietary exposure. An adequate database 
with respect to both the nature and magnitude of residues expected in 
food has been provided. The chronic dietary food exposure assessment is 
conservative as field trial data along with 100% of crop treated 
assumptions for some commodities, and default processing factors for 
some commodities were used. Also, conservative modeled drinking water 
estimates of exposure were included in the assessments which are likely 
to exaggerate actual exposures from drinking water. These assessments 
will not underestimate the exposure and risks posed by endothall.

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 no acute dietary endpoint was selected. Therefore, 
endothall is not expected to pose an acute 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 children 
1 to 2 years of age, 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 short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Endothall 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 endothall.
    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 1,200 for adults 
and 210 for children. Because EPA's level of concern for endothall 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). Intermediate-term exposure is not expected to result from the 
residential uses of endothall. 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 
endothall.
    5. 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.
    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 endothall residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (GC with microcoulometric nitrogen 
detection for plants, Method KP-245R0 for livestock, and Method KP-
218R0 for

[[Page 83168]]

fish and plants) is available to enforce the tolerance expression.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
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 endothall.

C. Revisions to Petitioned-for Tolerances

    The registrant requested modification of tolerances for all 
livestock commodities at the LOQ of the enforcement method (0.01 ppm 
for milk, 0.05 ppm for the remaining commodities) with the exception of 
ruminant kidney for which a tolerance of 0.06 ppm was proposed based on 
residues of 0.051 ppm observed in the cow feeding study. Based on 
available data and calculations of anticipated residues, EPA has 
determined that 0.05 ppm would be sufficient to cover residues for all 
meat, poultry, and egg commodities, including ruminant kidney.

D. International Trade Considerations

    In this rulemaking, EPA is reducing the existing tolerances for 
cattle, goat, hog, and sheep kidney; cattle, liver; poultry, meat 
byproducts to 0.05 ppm and for milk to 0.01 ppm. The petitioner 
requested these reductions. EPA has determined that the reduction is 
appropriate based on available data and residue levels resulting from 
registered use patterns. In accordance with the World Trade 
Organization's (WTO) Sanitary and Phytosanitary Measures Agreement, EPA 
notified the WTO of the request to revise these tolerances. In this 
action, EPA is allowing the existing higher tolerances to remain in 
effect for 6 months following the publication of this rule in order to 
allow a reasonable interval for producers in the exporting countries to 
adapt to the requirements of these modified tolerances. On May 22, 
2017, those existing higher tolerances will expire, and the new reduced 
tolerances for ruminant kidney, cattle, liver and poultry, meat 
byproducts and milk will remain to cover residues of endothall on those 
commodities. Before that date, residues of endothall on those 
commodities would be permitted up to the higher tolerance levels; after 
that date, residues of endothall on ruminant kidney, cattle, liver and 
poultry, meat byproducts and milk will need to comply with the new 
lower tolerance levels. This reduction in tolerance is not 
discriminatory; the same food safety standard contained in the FFDCA 
applies equally to domestically produced and imported foods.

V. Conclusion

    Therefore, tolerances are amended for residues of endothall, in or 
on cattle, fat from 0.01 to 0.05 parts per million (ppm); cattle, 
kidney from 0.20 to 0.05 ppm; cattle, liver from 0.10 to 0.05 ppm; 
cattle, meat from 0.03 to 0.05 ppm; goat, fat from 0.005 to 0.05 ppm; 
goat, kidney from 0.15 to 0.05 ppm; goat, meat from 0.015 to 0.05 ppm; 
hog, fat from 0.005 to 0.05 ppm; hog, kidney from 0.10 to 0.05 ppm; 
hog, meat from 0.01 to 0.05 ppm; milk from 0.03 to 0.01 ppm; poultry, 
fat from 0.015 to 0.05 ppm; poultry, meat from 0.015 to 0.05 ppm; 
poultry, meat byproducts from 0.2 to 0.05 ppm; sheep, fat from 0.005 to 
0.05 ppm; sheep, kidney from 0.15 to 0.05 ppm; and sheep, meat from 
0.015 to 0.05 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 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).

[[Page 83169]]

List of Subjects in 40 CFR Part 180

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

    Dated: October 13, 2016.
Michael Goodis,
Acting 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. Amend the table in Sec.  180.293 paragraph (d) as follows:
0
a. Revise the entries for ``Cattle, fat'', ``Cattle, meat'', ``Goat, 
fat'', ``Goat, meat'', ``Hog, fat'', ``Hog, meat'', ``Poultry, fat'', 
``Poultry, meat'', ``Sheep, fat, and ``Sheep, meat'';
0
b. Add alphabetically footnotes for the entries ``Cattle, kidney \1\'', 
``Cattle, liver \1\'', ``Goat, kidney \1\'', ``Hog, kidney \1\'', 
``Milk'', ``Poultry, meat byproducts \1\'', and ``Sheep, kidney \1\''; 
and
0
c. Add alphabetically the entries for ``Cattle, kidney'', ``Cattle, 
liver'', ``Goat, kidney'', ``Hog, kidney'', ``Milk'', ``Poultry, meat 
byproducts'', and ``Sheep, kidney''.
    The revisions and additions read as follows:

Sec.  180.293  Endothall; tolerances for residues.

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cattle, fat.................................................        0.05
Cattle, kidney \1\..........................................        0.20
Cattle, kidney..............................................        0.05
Cattle, liver \1\...........................................        0.10
Cattle, liver...............................................        0.05
Cattle, meat................................................        0.05
 
                                * * * * *
Goat, fat...................................................        0.05
Goat, kidney \1\............................................        0.15
Goat, kidney................................................        0.05
 
                                * * * * *
Goat, meat..................................................        0.05
 
                                * * * * *
Hog, fat....................................................        0.05
Hog, kidney \1\.............................................        0.10
Hog, kidney.................................................        0.05
 
                                * * * * *
Hog, meat...................................................        0.05
Milk \1\....................................................        0.03
Milk........................................................        0.01
 
                                * * * * *
Poultry, fat................................................        0.05
 
                                * * * * *
Poultry, meat...............................................        0.05
Poultry, meat byproducts \1\................................        0.20
Poultry, meat byproducts....................................        0.05
 
                                * * * * *
Sheep, fat..................................................        0.05
Sheep, kidney \1\...........................................        0.15
Sheep, kidney...............................................        0.05
 
                                * * * * *
Sheep, meat.................................................        0.05
 
                                * * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on May 22, 2017.

[FR Doc. 2016-27984 Filed 11-18-16; 8:45 am]
 BILLING CODE 6560-50-P