81_FR_83387 81 FR 83163 - Endothall; Pesticide Tolerances

81 FR 83163 - Endothall; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 224 (November 21, 2016)

Page Range83163-83169
FR Document2016-27984

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).

Federal Register, Volume 81 Issue 224 (Monday, November 21, 2016)
[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Rules and Regulations]
[Pages 83163-83169]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0613 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
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                                    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.
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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

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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: 
[email protected].

B. International Residue Limits

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



                                                                   Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Rules and Regulations                                        83163

                                                  defined by two lines parallel to the                    available at http://www.regulations.gov               proper receipt by EPA, you must
                                                  correlation regression line, offset at a                or at the Office of Pesticide Programs                identify docket ID number EPA–HQ–
                                                  distance of ±25 percent of the numerical                Regulatory Public Docket (OPP Docket)                 OPP–2014–0613 in the subject line on
                                                  emission limit value from the correlation               in the Environmental Protection Agency                the first page of your submission. All
                                                  regression line.
                                                     (6) What are the criteria to pass a RRA? To
                                                                                                          Docket Center (EPA/DC), West William                  objections and requests for a hearing
                                                  pass a RRA, you must meet the criteria                  Jefferson Clinton Bldg., Rm. 3334, 1301               must be in writing, and must be
                                                  specified in paragraphs (6)(i) through (iii) of         Constitution Ave. NW., Washington, DC                 received by the Hearing Clerk on or
                                                  this section. If your PM CEMS fails to meet             20460–0001. The Public Reading Room                   before January 20, 2017. Addresses for
                                                  these RRA criteria, it is out of control, with          is open from 8:30 a.m. to 4:30 p.m.,                  mail and hand delivery of objections
                                                  the following exception: If any of the PM               Monday through Friday, excluding legal                and hearing requests are provided in 40
                                                  CEMS response values resulting from your                holidays. The telephone number for the                CFR 178.25(b).
                                                  RRA are lower than the lowest PM CEMS                   Public Reading Room is (202) 566–1744,                  In addition to filing an objection or
                                                  response value of your existing correlation             and the telephone number for the OPP                  hearing request with the Hearing Clerk
                                                  curve, you may extend your correlation                                                                        as described in 40 CFR part 178, please
                                                  regression line to the point corresponding to
                                                                                                          Docket is (703) 305–5805. Please review
                                                                                                          the visitor instructions and additional               submit a copy of the filing (excluding
                                                  the lowest PM CEMS response value
                                                  obtained during the RRA; this extended                  information about the docket available                any Confidential Business Information
                                                  correlation regression line must then be used           at http://www.epa.gov/dockets.                        (CBI)) for inclusion in the public docket.
                                                  to determine if the RRA data meets the                  FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                Information not marked confidential
                                                  criteria specified in paragraphs (6)(i) through         Michael Goodis, Registration Division                 pursuant to 40 CFR part 2 may be
                                                  (iii) of this section.                                  (7505P), Office of Pesticide Programs,                disclosed publicly by EPA without prior
                                                     (i) For all three data points, the PM CEMS
                                                                                                          Environmental Protection Agency, 1200                 notice. Submit the non-CBI copy of your
                                                  response value can be no greater than the                                                                     objection or hearing request, identified
                                                  greatest PM CEMS response value used to                 Pennsylvania Ave. NW., Washington,
                                                                                                          DC 20460–0001; main telephone                         by docket ID number EPA–HQ–OPP–
                                                  develop your correlation curve.                                                                               2014–0613, by one of the following
                                                     (ii) For two of the three data points, the PM        number: (703) 305–7090; email address:
                                                                                                          RDFRNotices@epa.gov.                                  methods:
                                                  CEMS response value must lie within the PM
                                                                                                                                                                  • Federal eRulemaking Portal: http://
                                                  CEMS output range used to develop your                  SUPPLEMENTARY INFORMATION:
                                                  correlation curve.                                                                                            www.regulations.gov. Follow the online
                                                     (iii) At least two of the three sets of PM           I. General Information                                instructions for submitting comments.
                                                  CEMS and reference method measurements                                                                        Do not submit electronically any
                                                  must fall within the same specified area on             A. Does this action apply to me?                      information you consider to be CBI or
                                                  a graph of the correlation regression line as              You may be potentially affected by                 other information whose disclosure is
                                                  required for the RCA and described in                   this action if you are an agricultural                restricted by statute.
                                                  paragraph (5)(iii) of this section.                     producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                                  *      *     *       *      *                           pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                  [FR Doc. 2016–27849 Filed 11–18–16; 8:45 am]            list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                                  BILLING CODE 6560–50–P                                  Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                                                                                          not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                                                                                          provides a guide to help readers                      arrangements for hand delivery or
                                                  ENVIRONMENTAL PROTECTION                                determine whether this document                       delivery of boxed information, please
                                                  AGENCY                                                  applies to them. Potentially affected                 follow the instructions at http://
                                                                                                          entities may include:                                 www.epa.gov/dockets/contacts.html.
                                                  40 CFR Part 180                                            • Crop production (NAICS code 111).                  Additional instructions on
                                                  EPA–HQ–OPP–2014–0613; FRL–9953–97]                         • Animal production (NAICS code                    commenting or visiting the docket,
                                                                                                          112).                                                 along with more information about
                                                  Endothall; Pesticide Tolerances                            • Food manufacturing (NAICS code                   dockets generally, is available at http://
                                                                                                          311).                                                 www.epa.gov/dockets.
                                                  AGENCY:  Environmental Protection
                                                                                                             • Pesticide manufacturing (NAICS                   II. Summary of Petitioned-for Tolerance
                                                  Agency (EPA).
                                                                                                          code 32532).
                                                  ACTION: Final rule.                                                                                              In the Federal Register of December
                                                                                                          B. How can I get electronic access to                 17, 2014 (79 FR 75110) (FRL–9918–90),
                                                  SUMMARY:   This regulation establishes                  other related information?                            EPA issued a document pursuant to
                                                  tolerances for residues of endothall in or                                                                    FFDCA section 408(d)(3), 21 U.S.C.
                                                  on multiple commodities which are                          You may access a frequently updated
                                                                                                          electronic version of EPA’s tolerance                 346a(d)(3), announcing the filing of a
                                                  identified and discussed later in this                                                                        pesticide petition (PP 4F8293) by
                                                  document. United Phosphorus, Inc.                       regulations at 40 CFR part 180 through
                                                                                                          the Government Printing Office’s e-CFR                United Phosphorus, Inc., 630 Freedom
                                                  requested these tolerances under the                                                                          Business Center, Suite 402, King of
                                                  Federal Food, Drug, and Cosmetic Act                    site at http://www.ecfr.gov/cgi-bin/text-
                                                                                                          idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  Prussia, PA 19406. The petition
                                                  (FFDCA).                                                                                                      requested that 40 CFR 180.293 be
                                                                                                          40tab_02.tpl.
                                                  DATES: This regulation is effective                                                                           amended by amending tolerances for
                                                  November 21, 2016. Objections and                       C. How can I file an objection or hearing             residues of the herbicide endothall, in
                                                  requests for hearings must be received                  request?                                              or on cattle, fat from 0.01 to 0.05 parts
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  on or before January 20, 2017 and must                    Under FFDCA section 408(g), 21                      per million (ppm); cattle, kidney from
                                                  be filed in accordance with the                         U.S.C. 346a, any person may file an                   0.20 to 0.06 ppm; cattle, liver from 0.10
                                                  instructions provided in 40 CFR part                    objection to any aspect of this regulation            to 0.05 ppm; cattle, meat from 0.03 to
                                                  178 (see also Unit I.C. of the                          and may also request a hearing on those               0.05 ppm; goat, fat from 0.005 to 0.05
                                                  SUPPLEMENTARY INFORMATION).                             objections. You must file your objection              ppm; goat, kidney from 0.15 to 0.06
                                                  ADDRESSES: The docket for this action,                  or request a hearing on this regulation               ppm; goat, meat from 0.015 to 0.05 ppm;
                                                  identified by docket identification (ID)                in accordance with the instructions                   hog, fat from 0.005 to 0.05 ppm; hog,
                                                  number EPA–HQ–OPP–2014–0613, is                         provided in 40 CFR part 178. To ensure                kidney from 0.10 to 0.06 ppm; hog, meat


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                                                  83164            Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Rules and Regulations

                                                  from 0.01 to 0.05 ppm; milk from 0.03                   concerning the variability of the                     vertebral and rib malformations was
                                                  to 0.01 ppm; poultry, fat from 0.015 to                 sensitivities of major identifiable                   observed in the offspring indicating that
                                                  0.05 ppm; poultry, meat from 0.015 to                   subgroups of consumers, including                     these effects were most likely secondary
                                                  0.05 ppm; poultry, meat byproducts                      infants and children.                                 to severe maternal toxicity. The hazard
                                                  from 0.2 to 0.05 ppm; sheep, fat from                      Endothall is a caustic chemical with               data for endothall indicate no evidence
                                                  0.005 to 0.05 ppm; sheep, kidney from                   toxicity being the result of a direct                 of quantitative or qualitative increased
                                                  0.15 to 0.06 ppm; and sheep, meat from                  degenerative effect on tissue. By acute               susceptibility of rat fetuses exposed in
                                                  0.015 to 0.05 ppm. That document                        exposure, endothall is a skin sensitizer              utero to endothall in the developmental
                                                  referenced a summary of the petition                    and an extreme irritant by the acute oral             toxicity studies. In addition, no
                                                  prepared by United Phosphorus, Inc.,                    and ocular routes of administration. The              evidence of quantitative or qualitative
                                                  the registrant, which is available in the               most sensitive effect of endothall                    increased susceptibility of rat fetuses or
                                                  docket, http://www.regulations.gov.                     following oral administration is direct               neonates was observed in the 2-
                                                  There were no comments received in                      irritation of the gastrointestinal system.            generation reproduction study.
                                                  response to the notice of filing.                       This effect was evident in several                       Available studies showed no evidence
                                                     Based upon review of the data                        species and in several studies. The dog               of neurotoxicity and do not indicate
                                                  supporting the petition, EPA has                        is particularly sensitive to endothall                potential immunotoxicity. Endothall
                                                  adjusted the proposed tolerance for                     toxicity. Endothall caused gastric                    does not belong to the class of
                                                  ruminant kidney from 0.06 to 0.05. The                  epithelial hyperplasia in dogs treated                compounds (e.g., the organotins, heavy
                                                  reason for this change is explained in                  orally with endothall for 52 weeks (a no              metals, or halogenated aromatic
                                                  Unit IV.C.                                              observed adverse effect level (NOAEL)                 hydrocarbons) that would be expected
                                                                                                          was not determined). Besides gastric                  to be toxic to the immune system.
                                                  III. Aggregate Risk Assessment and
                                                                                                          irritant effects, decreased body weight               Endothall is classified as ‘‘not likely to
                                                  Determination of Safety
                                                                                                          in the dog was also a sensitive effect                be carcinogenic to humans’’ based on
                                                     Section 408(b)(2)(A)(i) of FFDCA                     following 13 weeks of endothall                       lack of evidence of carcinogenicity in
                                                  allows EPA to establish a tolerance (the                administration. The decreased body                    mice or rats. It has no mutagenic
                                                  legal limit for a pesticide chemical                    weights were most likely attributable to              potential.
                                                  residue in or on a food) only if EPA                    the constant and direct irritation of the                Specific information on the studies
                                                  determines that the tolerance is ‘‘safe.’’              gastric lining. In the rat, gastric irritation        received and the nature of the adverse
                                                  Section 408(b)(2)(A)(ii) of FFDCA                       was noted at a dose level that was 1 to               effects caused by endothall as well as
                                                  defines ‘‘safe’’ to mean that ‘‘there is a              2 orders of magnitude lower than doses                the no-observed-adverse-effect-level
                                                  reasonable certainty that no harm will                  resulting in kidney lesions. Proliferative            (NOAEL) and the lowest-observed-
                                                  result from aggregate exposure to the                   lesions of the gastric epithelium were                adverse-effect-level (LOAEL) from the
                                                  pesticide chemical residue, including                   observed in F1 parental male and female               toxicity studies can be found at
                                                  all anticipated dietary exposures and all               rats treated orally with endothall in a 2-            http:www.regulations.gov in document
                                                  other exposures for which there is                      generation reproduction study (a                      ‘‘Endothall: Human Health Risk
                                                  reliable information.’’ This includes                   NOAEL for the parental effects was not                Assessment in Support of Registration
                                                  exposure through drinking water and in                  identified). In a developmental rat                   Review, and the Petition to Re-evaluate
                                                  residential settings, but does not include              study, pregnant rats exhibited decreased              Tolerances for Livestock, and Remove
                                                  occupational exposure. Section                          body weight and decreased body weight                 the Restriction that Prohibits Livestock
                                                  408(b)(2)(C) of FFDCA requires EPA to                   was also noted in a 90-day dietary study              from Drinking Treated Water’’ in docket
                                                  give special consideration to exposure                  in the rat.                                           ID number EPA–HQ–OPP–2014–0613.
                                                  of infants and children to the pesticide                   Dermally, endothall destroys the
                                                                                                                                                                B. Toxicological Points of Departure/
                                                  chemical residue in establishing a                      stratum corneum and then the
                                                                                                                                                                Levels of Concern
                                                  tolerance and to ‘‘ensure that there is a               underlying viable epidermis. In the 21-
                                                  reasonable certainty that no harm will                  day dermal toxicity study, severe                        Once a pesticide’s toxicological
                                                  result to infants and children from                     dermal effects were observed at the                   profile is determined, EPA identifies
                                                  aggregate exposure to the pesticide                     lowest dose tested. Available studies                 toxicological points of departure (POD)
                                                  chemical residue . . . .’’                              clearly demonstrate that local irritation             and levels of concern to use in
                                                     Consistent with FFDCA section                        (portal of entry effect) is the most                  evaluating the risk posed by human
                                                  408(b)(2)(D), and the factors specified in              sensitive and initial effect.                         exposure to the pesticide. For hazards
                                                  FFDCA section 408(b)(2)(D), EPA has                        Acute inhalation toxicity of endothall             that have a threshold below which there
                                                  reviewed the available scientific data                  is low; however, nasal and pulmonary                  is no appreciable risk, the toxicological
                                                  and other relevant information in                       toxicity were evident in the 5-day and                POD is used as the basis for derivation
                                                  support of this action. EPA has                         28-day inhalation toxicity studies in the             of reference values for risk assessment.
                                                  sufficient data to assess the hazards of                rat including rales, labored respiration,             PODs are developed based on a careful
                                                  and to make a determination on                          pale lungs (gross necropsy), increased                analysis of the doses in each
                                                  aggregate exposure for endothall                        absolute and relative lung weights,                   toxicological study to determine the
                                                  including exposure resulting from the                   subacute inflammation, alveolar                       dose at which no adverse effects are
                                                  tolerances established by this action.                  proteinosis, and nasal hemorrhage                     observed (the NOAEL) and the lowest
                                                  EPA’s assessment of exposures and risks                 inflammation, erosion, and ulceration.                dose at which adverse effects of concern
                                                  associated with endothall follows.                         Endothall does not cause pre-natal                 are identified (the LOAEL). Uncertainty/
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                                                                          toxicity following in utero exposure to               safety factors are used in conjunction
                                                  A. Toxicological Profile                                rats nor pre-and postnatal toxicity                   with the POD to calculate a safe
                                                    EPA has evaluated the available                       following exposures to rats for 2-                    exposure level—generally referred to as
                                                  toxicity data and considered its validity,              generations. In the developmental                     a population-adjusted dose (PAD) or a
                                                  completeness, and reliability as well as                mouse study, there was severe maternal                reference dose (RfD)—and a safe margin
                                                  the relationship of the results of the                  toxicity (i.e., greater than 30%                      of exposure (MOE). For non-threshold
                                                  studies to human risk. EPA has also                     mortality) at the highest dose tested; at             risks, the Agency assumes that any
                                                  considered available information                        this dose level, a slight increase in                 amount of exposure will lead to some


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                                                                     Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Rules and Regulations                                                      83165

                                                  degree of risk. Thus, the Agency                                EPA uses in risk characterization and a                     A summary of the toxicological
                                                  estimates risk in terms of the probability                      complete description of the risk                         endpoints for endothall used for human
                                                  of an occurrence of the adverse effect                          assessment process, see http://                          risk assessment is shown in Table 1 of
                                                  expected in a lifetime. For more                                www.epa.gov/pesticides/factsheets/                       this unit.
                                                  information on the general principles                           riskassess.htm.
                                                      TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ENDOTHALL FOR USE IN HUMAN HEALTH RISK
                                                                                               ASSESSMENT
                                                                                                   Point of departure        RfD, PAD, LOC for
                                                           Exposure/scenario                        and uncertainty/                                                       Study and toxicological effects
                                                                                                                              risk assessment
                                                                                                     safety factors

                                                  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/            Chronic RfD = 0.007           Rat 2-generation reproduction study.
                                                                                                   day.                       mg/kg/day.                  LOAEL = 2 mg/kg/day based on proliferative lesions of the
                                                                                                 UFA = 10x                  cPAD = 0.007 mg/                gastric epithelium (both sexes).
                                                                                                 UFH = 10x                    kg/day.
                                                                                                 FQPA SF
                                                                                                 UFL = 3x

                                                  Short-term Incidental oral (1 to               Offspring NOAEL=           Residential ...............   Rat 2-generation reproduction study.
                                                    30 days).                                      9.4 mg/kg/day.           LOC for MOE = 100             LOAEL = 60 mg/kg/day based on decreased pup body weight
                                                                                                 UFA = 10x                  Occupational = N/A              (both sexes) on Day 0 in F1 and F2 generations.
                                                                                                 UFH = 10x
                                                                                                 FQPA SF = 1x

                                                  Short-term Inhalation (1 to 30                 NOAEL = 0.001 mg/          Residential LOC for           Subchronic inhalation toxicity study (MRID 47872201).
                                                    days).                                         L.                         MOE = 30.                   Residential acute scenario: LOAEL = 0.005 mg/L based on
                                                                                                 Residential HEC =                                          clinical signs (rales and labored respiration) observed acutely
                                                                                                   0.00049 mg/L                                             (0–1 hr postdosing and prior to next exposure).
                                                                                                   (HED = 0.0143
                                                                                                   mg/kg/day)
                                                                                                 Inhalation (or oral)
                                                                                                   study NOAEL =
                                                                                                   0.001mg/L mg/kg/
                                                                                                   day (inhalation ab-
                                                                                                   sorption rate =
                                                                                                   100%)
                                                                                                 UFA = 3x
                                                                                                 UFH = 10x
                                                                                                 FQPA SF = 1x

                                                  Cancer (Oral, dermal, inhala-                                                       Classified as a ‘‘Not Likely’’ human carcinogen.
                                                    tion).
                                                    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                                             ii. Chronic exposure. In conducting                   Where data were not available, DEEM
                                                     1. Dietary exposure from food and                            the chronic dietary exposure assessment                  default processing factors were used.
                                                  feed uses. In evaluating dietary                                EPA used the food consumption data                          Anticipated residues of meat, milk,
                                                  exposure to endothall, EPA considered                           from the USDA National Health and                        poultry, and eggs have been estimated
                                                  exposure under the petitioned-for                               Nutrition Examination Survey, What We                    by using the maximum or average
                                                  tolerances as well as all existing                              Eat in America, (NHANES/WWEIA),                          residues in feed stuffs as well as the
                                                  endothall tolerances in 40 CFR 180.293.                         conducted from 2003–2008. As to                          maximum allowed 5 ppm concentration
                                                  EPA assessed dietary exposures from                             residue levels in food, average residue                  of endothall in livestock drinking water.
                                                  endothall in food as follows:                                   values have been used for all crops. The                 Tolerance level residues were used for
                                                     i. Acute exposure. Quantitative acute                        residue and processing data used in this                 finfish and shellfish.
                                                  dietary exposure and risk assessments                           assessment are from residue field trials                    EPA used average percent crop treated
                                                  are performed for a food-use pesticide,                         and processing studies designed to                       (PCT) data for alfalfa, cotton, and potato,
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  if a toxicological study has indicated the                      produce maximum residues for the                         the crops to which endothall is directly
                                                  possibility of an effect of concern                             purpose of setting tolerances. All                       applied, as well as PCT data for irrigated
                                                  occurring as a result of a 1-day or single                      treatments in the field trials with                      crops.
                                                  exposure.                                                       irrigated crops were performed by                           iii. Cancer. Based on the data
                                                     No such effects were identified in the                       overhead irrigation (i.e. are sprayed on                 summarized in Unit III.A., EPA has
                                                  toxicological studies for endothall;                            the crops). The processing data available                concluded that endothall does not pose
                                                  therefore, a quantitative acute dietary                         were translated to the important                         a cancer risk to humans. Therefore, a
                                                  exposure assessment is unnecessary.                             processed commodities of all crops.                      dietary exposure assessment for the


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                                                  83166            Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Rules and Regulations

                                                  purpose of assessing cancer risk is                     proprietary market surveys, and the                   System (PRZM/EXAMS) and Simple
                                                  unnecessary.                                            National Pesticide Use Database for the               First-Order Degradation the estimated
                                                     iv. Anticipated residue and percent                  chemical/crop combination for the most                drinking water concentrations (EDWCs)
                                                  crop treated (PCT) information. Section                 recent 6 to 7 years. EPA uses an average              of endothall for chronic exposures for
                                                  408(b)(2)(E) of FFDCA authorizes EPA                    PCT for chronic dietary risk analysis.                non-cancer assessments are estimated to
                                                  to use available data and information on                The average PCT figure for each existing              be 31 ppb for surface water and ground
                                                  the anticipated residue levels of                       use is derived by combining available                 water. This represents a conservative
                                                  pesticide residues in food and the actual               public and private market survey data                 estimate of high-end chronic exposure
                                                  levels of pesticide residues that have                  for that use, averaging across all                    from endothall from the use most likely
                                                  been measured in food. If EPA relies on                 observations, and rounding to the                     to generate the highest exposures
                                                  such information, EPA must require                      nearest 5%, except for those situations               (treatment of a reservoir).
                                                  pursuant to FFDCA section 408(f)(1)                     in which the average PCT is less than                    Modeled estimates of drinking water
                                                  that data be provided 5 years after the                 one. In those cases, 1% is used as the                concentrations were directly entered
                                                  tolerance is established, modified, or                  average PCT and 2.5% is used as the                   into the dietary exposure model.
                                                  left in effect, demonstrating that the                  maximum PCT. EPA uses a maximum                          3. From non-dietary exposure. The
                                                  levels in food are not above the levels                 PCT for acute dietary risk analysis. The              term ‘‘residential exposure’’ is used in
                                                  anticipated. For the present action, EPA                maximum PCT figure is the highest                     this document to refer to non-
                                                  will issue such data call-ins as are                    observed maximum value reported                       occupational, non-dietary exposure
                                                  required by FFDCA section 408(b)(2)(E)                  within the recent 6 years of available                (e.g., for lawn and garden pest control,
                                                  and authorized under FFDCA section                      public and private market survey data                 indoor pest control, termiticides, and
                                                  408(f)(1). Data will be required to be                  for the existing use and rounded up to                flea and tick control on pets).
                                                  submitted no later than 5 years from the                the nearest multiple of 5%.                              Endothall is currently registered for
                                                  date of issuance of these tolerances.                      The Agency believes that the three                 the following uses that could result in
                                                     Section 408(b)(2)(F) of FFDCA states                 conditions discussed in Unit III.C.1.iv.              residential exposures: Aquatic
                                                  that the Agency may use data on the                     have been met. With respect to                        applications. EPA assessed residential
                                                  actual percent of food treated for                      Condition a, PCT estimates are derived                exposure using the following
                                                  assessing chronic dietary risk only if:                 from Federal and private market survey                assumptions: There are no registered
                                                     • Condition a: The data used are                     data, which are reliable and have a valid             residential uses resulting in residential
                                                  reliable and provide a valid basis to                   basis. The Agency is reasonably certain               handler exposure to endothall.
                                                  show what percentage of the food                        that the percentage of the food treated               Therefore, a quantitative residential
                                                  derived from such crop is likely to                     is not likely to be an underestimation.               handler exposure assessment was not
                                                  contain the pesticide residue.                          As to Conditions b and c, regional                    performed. Residential post-application
                                                     • Condition b: The exposure estimate                 consumption information and                           exposure/risk estimates were assessed
                                                  does not underestimate exposure for any                 consumption information for significant               for certain scenarios. The scenarios,
                                                  significant subpopulation group.                        subpopulations is taken into account                  routes of exposure and lifestages
                                                     • Condition c: Data are available on                 through EPA’s computer-based model                    assessed include inhalation exposure
                                                  pesticide use and food consumption in                   for evaluating the exposure of                        during recreational swimming (both
                                                  a particular area, the exposure estimate                significant subpopulations including                  adults and children 3 to < 6 years old)
                                                  does not understate exposure for the                    several regional groups. Use of this                  and ingestion of water during
                                                  population in such area. In addition, the               consumption information in EPA’s risk                 recreational swimming (both adults and
                                                  Agency must provide for periodic                        assessment process ensures that EPA’s                 children 3 to < 6 years old.) The
                                                  evaluation of any estimates used. To                    exposure estimate does not understate                 assessment of these lifestages is health
                                                  provide for the periodic evaluation of                  exposure for any significant                          protective for the exposures and risk
                                                  the estimate of PCT as required by                      subpopulation group and allows the                    estimates for any other potentially
                                                  FFDCA section 408(b)(2)(F), EPA may                     Agency to be reasonably certain that no               exposed lifestages. Further information
                                                  require registrants to submit data on                   regional population is exposed to                     regarding EPA standard assumptions
                                                  PCT.                                                    residue levels higher than those                      and generic inputs for residential
                                                     The Agency estimated the PCT for                     estimated by the Agency. Other than the               exposures may be found at http://
                                                  existing uses as follows for irrigated                  data available through national food                  www.epa.gov/pesticides/trac/science/
                                                  crops: Apple 78%, fresh market apple                    consumption surveys, EPA does not                     trac6a05.pdf.
                                                  84%, processing apple 49%, apple juice                  have available reliable information on                   4. Cumulative effects from substances
                                                  22%, canned apple 55%, barley for                       the regional consumption of food to                   with a common mechanism of toxicity.
                                                  grain 40%, corn for grain 21%, dry                      which endothall may be applied in a                   Section 408(b)(2)(D)(v) of FFDCA
                                                  beans 35%, grape 97%, fresh market                      particular area.                                      requires that, when considering whether
                                                  grape 99%, processed grape 96%, green                      2. Dietary exposure from drinking                  to establish, modify, or revoke a
                                                  peas 42%, oats for grain 8%, peanut for                 water. The Agency used screening level                tolerance, the Agency consider
                                                  nuts 34%, rice 100%, sorghum for grain                  water exposure models in the dietary                  ‘‘available information’’ concerning the
                                                  19%, soybean for beans 12%, strawberry                  exposure analysis and risk assessment                 cumulative effects of a particular
                                                  92%, fresh market strawberry 90%,                       for endothall in drinking water. These                pesticide’s residues and ‘‘other
                                                  processed strawberry 100%, sugarbeet                    simulation models take into account                   substances that have a common
                                                  for sugar 37%, sugarcane for sugar 54%,                 data on the physical, chemical, and fate/             mechanism of toxicity.’’
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  watermelon 38%, wheat for grain 13%.                    transport characteristics of endothall.                  EPA has not found endothall to share
                                                  For direct uses of endothall, PCT                       Further information regarding EPA                     a common mechanism of toxicity with
                                                  estimates used include alfalfa 1%,                      drinking water models used in pesticide               any other substances, and endothall
                                                  cotton 1%, and potatoes 2.5%.                           exposure assessment can be found at                   does not appear to produce a toxic
                                                     In most cases, EPA uses available data               http://www.epa.gov/oppefed1/models/                   metabolite produced by other
                                                  from United States Department of                        water/index.htm.                                      substances. For the purposes of this
                                                  Agriculture/National Agricultural                          Based on the Pesticide Root Zone                   tolerance action, therefore, EPA has
                                                  Statistics Service (USDA/NASS),                         Model/Exposure Analysis Modeling                      assumed that endothall does not have a


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                                                                   Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Rules and Regulations                                       83167

                                                  common mechanism of toxicity with                          iii. There is no indication of increased           residential exposure to residues of
                                                  other substances. For information                       susceptibility of rats or rabbits in utero            endothall is not expected.
                                                  regarding EPA’s efforts to determine                    and/or postnatal exposure in the                         3. Short-term risk. Short-term
                                                  which chemicals have a common                           developmental and reproductive                        aggregate exposure takes into account
                                                  mechanism of toxicity and to evaluate                   toxicity studies;                                     short-term residential exposure plus
                                                  the cumulative effects of such                             iv. There are no residual uncertainties            chronic exposure to food and water
                                                  chemicals, see EPA’s Web site at http://                identified in the exposure databases.                 (considered to be a background
                                                  www.epa.gov/pesticides/cumulative.                      The residential post-application                      exposure level).
                                                                                                          exposure assessments are based upon                      Endothall is currently registered for
                                                  D. Safety Factor for Infants and
                                                                                                          the 2012 Residential Standard Operating               uses that could result in short-term
                                                  Children
                                                                                                          Procedures (SOPs). These assessments                  residential exposure, and the Agency
                                                    1. In general. Section 408(b)(2)(C) of                of exposure are not likely to                         has determined that it is appropriate to
                                                  FFDCA provides that EPA shall apply                     underestimate exposure to endothall.                  aggregate chronic exposure through food
                                                  an additional tenfold (10X) margin of                   There is no residual uncertainty in the               and water with short-term residential
                                                  safety for infants and children in the                  exposure database for endothall with                  exposures to endothall.
                                                  case of threshold effects to account for                respect to dietary exposure. An                          Using the exposure assumptions
                                                  prenatal and postnatal toxicity and the                 adequate database with respect to both                described in this unit for short-term
                                                  completeness of the database on toxicity                the nature and magnitude of residues                  exposures, EPA has concluded the
                                                  and exposure unless EPA determines                      expected in food has been provided.                   combined short-term food, water, and
                                                  based on reliable data that a different                 The chronic dietary food exposure                     residential exposures result in aggregate
                                                  margin of safety will be safe for infants               assessment is conservative as field trial             MOEs of 1,200 for adults and 210 for
                                                  and children. This additional margin of                                                                       children. Because EPA’s level of
                                                                                                          data along with 100% of crop treated
                                                  safety is commonly referred to as the                                                                         concern for endothall is a MOE of 100
                                                                                                          assumptions for some commodities, and
                                                  FQPA Safety Factor (SF). In applying                                                                          or below, these MOEs are not of
                                                                                                          default processing factors for some
                                                  this provision, EPA either retains the                                                                        concern.
                                                                                                          commodities were used. Also,
                                                  default value of 10X, or uses a different                                                                        4. Intermediate-term risk.
                                                                                                          conservative modeled drinking water
                                                  additional safety factor when reliable                                                                        Intermediate-term aggregate exposure
                                                                                                          estimates of exposure were included in
                                                  data available to EPA support the choice                                                                      takes into account intermediate-term
                                                                                                          the assessments which are likely to
                                                  of a different factor.                                                                                        residential exposure plus chronic
                                                    2. Prenatal and postnatal sensitivity.                exaggerate actual exposures from
                                                                                                          drinking water. These assessments will                exposure to food and water (considered
                                                  There is no evidence of quantitative or                                                                       to be a background exposure level).
                                                  qualitative increased susceptibility                    not underestimate the exposure and
                                                                                                          risks posed by endothall.                             Intermediate-term exposure is not
                                                  following prenatal exposure to rats or                                                                        expected to result from the residential
                                                  rabbits in developmental toxicity                       E. Aggregate Risks and Determination of               uses of endothall. Intermediate-term risk
                                                  studies, and pre- and post-natal                        Safety                                                is assessed based on intermediate-term
                                                  exposure to rats in the 2-generation                                                                          residential exposure plus chronic
                                                  reproduction study.                                        EPA determines whether acute and
                                                                                                          chronic dietary pesticide exposures are               dietary exposure. Because there is no
                                                    3. Conclusion. EPA has determined
                                                                                                          safe by comparing aggregate exposure                  intermediate-term residential exposure
                                                  that reliable data show the safety of
                                                                                                          estimates to the acute PAD (aPAD) and                 and chronic dietary exposure has
                                                  infants and children would be
                                                                                                          chronic PAD (cPAD). For linear cancer                 already been assessed under the
                                                  adequately protected if the FQPA SF
                                                                                                          risks, EPA calculates the lifetime                    appropriately protective cPAD (which is
                                                  were reduced to 1X for all scenarios
                                                                                                          probability of acquiring cancer given the             at least as protective as the POD used to
                                                  except the chronic dietary assessment.
                                                                                                          estimated aggregate exposure. Short-,                 assess intermediate-term risk), no
                                                  For the assessment of risk following
                                                                                                          intermediate-, and chronic-term risks                 further assessment of intermediate-term
                                                  chronic dietary exposure, the FQPA
                                                                                                          are evaluated by comparing the                        risk is necessary, and EPA relies on the
                                                  Safety Factor for increased
                                                                                                          estimated aggregate food, water, and                  chronic dietary risk assessment for
                                                  susceptibility to infants and children is
                                                                                                          residential exposure to the appropriate               evaluating intermediate-term risk for
                                                  reduced to 3X because a lowest
                                                                                                          PODs to ensure that an adequate MOE                   endothall.
                                                  observed adverse effect level (LOAEL)
                                                                                                          exists.                                                  5. Aggregate cancer risk for U.S.
                                                  established in the 2-generation
                                                                                                             1. Acute risk. An acute aggregate risk             population. Based on the lack of
                                                  reproduction study was used for
                                                                                                          assessment takes into account acute                   evidence of carcinogenicity in two
                                                  assessing chronic dietary risks. Since a
                                                                                                          exposure estimates from dietary                       adequate rodent carcinogenicity studies,
                                                  LOAEL was used, a 3X FQPA Safety
                                                                                                          consumption of food and drinking                      endothall is not expected to pose a
                                                  Factor in the form of UFL is retained for
                                                                                                          water. No adverse effect resulting from               cancer risk to humans.
                                                  chronic exposure scenarios. A 3X factor                                                                          6. Determination of safety. Based on
                                                  (as opposed to a 10X) was determined                    a single oral exposure was identified
                                                                                                          and no acute dietary endpoint was                     these risk assessments, EPA concludes
                                                  to be adequate since the severity of the                                                                      that there is a reasonable certainty that
                                                  lesions observed at the LOAEL were                      selected. Therefore, endothall is not
                                                                                                          expected to pose an acute risk.                       no harm will result to the general
                                                  minimal to mild, and therefore the true                                                                       population, or to infants and children
                                                  NOAEL for this study is likely to be very                  2. Chronic risk. Using the exposure
                                                                                                          assumptions described in this unit for                from aggregate exposure to endothall
                                                  near the LOAEL value. For assessments                                                                         residues.
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  other than the chronic dietary                          chronic exposure, EPA has concluded
                                                  assessment, the FQPA safety factor was                  that chronic exposure to endothall from               IV. Other Considerations
                                                  reduced to 1X for the following reasons:                food and water will utilize 90% of the
                                                                                                          cPAD for children 1 to 2 years of age,                A. Analytical Enforcement Methodology
                                                    i. The toxicity database is complete.
                                                    ii. There are no concerns for                         the population group receiving the                      Adequate enforcement methodology
                                                  neurotoxicity, and thus no need to                      greatest exposure. Based on the                       (GC with microcoulometric nitrogen
                                                  retain the 10X for the lack of a                        explanation in Unit III.C.3., regarding               detection for plants, Method KP–245R0
                                                  developmental neurotoxicity study.                      residential use patterns, chronic                     for livestock, and Method KP–218R0 for


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                                                  83168            Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Rules and Regulations

                                                  fish and plants) is available to enforce                this action, EPA is allowing the existing             contain any information collections
                                                  the tolerance expression.                               higher tolerances to remain in effect for             subject to OMB approval under the
                                                     The methods may be requested from:                   6 months following the publication of                 Paperwork Reduction Act (PRA) (44
                                                  Chief, Analytical Chemistry Branch,                     this rule in order to allow a reasonable              U.S.C. 3501 et seq.), nor does it require
                                                  Environmental Science Center, 701                       interval for producers in the exporting               any special considerations under
                                                  Mapes Rd., Ft. Meade, MD 20755–5350;                    countries to adapt to the requirements of             Executive Order 12898, entitled
                                                  telephone number: (410) 305–2905;                       these modified tolerances. On May 22,                 ‘‘Federal Actions to Address
                                                  email address:                                          2017, those existing higher tolerances                Environmental Justice in Minority
                                                  residuemethods@epa.gov.                                 will expire, and the new reduced                      Populations and Low-Income
                                                  B. International Residue Limits                         tolerances for ruminant kidney, cattle,               Populations’’ (59 FR 7629, February 16,
                                                                                                          liver and poultry, meat byproducts and                1994).
                                                     In making its tolerance decisions, EPA               milk will remain to cover residues of                    Since tolerances and exemptions that
                                                  seeks to harmonize U.S. tolerances with                 endothall on those commodities. Before                are established on the basis of a petition
                                                  international standards whenever                        that date, residues of endothall on those             under FFDCA section 408(d), such as
                                                  possible, consistent with U.S. food                     commodities would be permitted up to                  the tolerance in this final rule, do not
                                                  safety standards and agricultural                       the higher tolerance levels; after that               require the issuance of a proposed rule,
                                                  practices. EPA considers the                            date, residues of endothall on ruminant               the requirements of the Regulatory
                                                  international maximum residue limits                    kidney, cattle, liver and poultry, meat               Flexibility Act (RFA) (5 U.S.C. 601 et
                                                  (MRLs) established by the Codex                         byproducts and milk will need to                      seq.), do not apply.
                                                  Alimentarius Commission (Codex), as                     comply with the new lower tolerance
                                                  required by FFDCA section 408(b)(4).                                                                             This action directly regulates growers,
                                                                                                          levels. This reduction in tolerance is not            food processors, food handlers, and food
                                                  The Codex Alimentarius is a joint                       discriminatory; the same food safety
                                                  United Nations Food and Agriculture                                                                           retailers, not States or tribes, nor does
                                                                                                          standard contained in the FFDCA                       this action alter the relationships or
                                                  Organization/World Health                               applies equally to domestically
                                                  Organization food standards program,                                                                          distribution of power and
                                                                                                          produced and imported foods.                          responsibilities established by Congress
                                                  and it is recognized as an international
                                                  food safety standards-setting                           V. Conclusion                                         in the preemption provisions of FFDCA
                                                  organization in trade agreements to                        Therefore, tolerances are amended for              section 408(n)(4). As such, the Agency
                                                  which the United States is a party. EPA                 residues of endothall, in or on cattle, fat           has determined that this action will not
                                                  may establish a tolerance that is                       from 0.01 to 0.05 parts per million                   have a substantial direct effect on States
                                                  different from a Codex MRL; however,                    (ppm); cattle, kidney from 0.20 to 0.05               or tribal governments, on the
                                                  FFDCA section 408(b)(4) requires that                   ppm; cattle, liver from 0.10 to 0.05 ppm;             relationship between the national
                                                  EPA explain the reasons for departing                   cattle, meat from 0.03 to 0.05 ppm; goat,             government and the States or tribal
                                                  from the Codex level. The Codex has not                 fat from 0.005 to 0.05 ppm; goat, kidney              governments, or on the distribution of
                                                  established a MRL for endothall.                        from 0.15 to 0.05 ppm; goat, meat from                power and responsibilities among the
                                                                                                          0.015 to 0.05 ppm; hog, fat from 0.005                various levels of government or between
                                                  C. Revisions to Petitioned-for Tolerances               to 0.05 ppm; hog, kidney from 0.10 to                 the Federal Government and Indian
                                                    The registrant requested modification                 0.05 ppm; hog, meat from 0.01 to 0.05                 tribes. Thus, the Agency has determined
                                                  of tolerances for all livestock                         ppm; milk from 0.03 to 0.01 ppm;                      that Executive Order 13132, entitled
                                                  commodities at the LOQ of the                           poultry, fat from 0.015 to 0.05 ppm;                  ‘‘Federalism’’ (64 FR 43255, August 10,
                                                  enforcement method (0.01 ppm for milk,                  poultry, meat from 0.015 to 0.05 ppm;                 1999) and Executive Order 13175,
                                                  0.05 ppm for the remaining                              poultry, meat byproducts from 0.2 to                  entitled ‘‘Consultation and Coordination
                                                  commodities) with the exception of                      0.05 ppm; sheep, fat from 0.005 to 0.05               with Indian Tribal Governments’’ (65 FR
                                                  ruminant kidney for which a tolerance                   ppm; sheep, kidney from 0.15 to 0.05                  67249, November 9, 2000) do not apply
                                                  of 0.06 ppm was proposed based on                       ppm; and sheep, meat from 0.015 to                    to this action. In addition, this action
                                                  residues of 0.051 ppm observed in the                   0.05 ppm.                                             does not impose any enforceable duty or
                                                  cow feeding study. Based on available                                                                         contain any unfunded mandate as
                                                                                                          VI. Statutory and Executive Order                     described under Title II of the Unfunded
                                                  data and calculations of anticipated
                                                                                                          Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                                  residues, EPA has determined that 0.05
                                                  ppm would be sufficient to cover                          This action establishes tolerances                  1501 et seq.).
                                                  residues for all meat, poultry, and egg                 under FFDCA section 408(d) in                            This action does not involve any
                                                  commodities, including ruminant                         response to a petition submitted to the               technical standards that would require
                                                  kidney.                                                 Agency. The Office of Management and                  Agency consideration of voluntary
                                                                                                          Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                                  D. International Trade Considerations                   of actions from review under Executive                12(d) of the National Technology
                                                    In this rulemaking, EPA is reducing                   Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                                  the existing tolerances for cattle, goat,               Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                                  hog, and sheep kidney; cattle, liver;                   October 4, 1993). Because this action
                                                                                                                                                                VII. Congressional Review Act
                                                  poultry, meat byproducts to 0.05 ppm                    has been exempted from review under
                                                  and for milk to 0.01 ppm. The petitioner                Executive Order 12866, this action is                   Pursuant to the Congressional Review
                                                  requested these reductions. EPA has                     not subject to Executive Order 13211,                 Act (5 U.S.C. 801 et seq.), EPA will
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  determined that the reduction is                        entitled ‘‘Actions Concerning                         submit a report containing this rule and
                                                  appropriate based on available data and                 Regulations That Significantly Affect                 other required information to the U.S.
                                                  residue levels resulting from registered                Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
                                                  use patterns. In accordance with the                    FR 28355, May 22, 2001) or Executive                  Representatives, and the Comptroller
                                                  World Trade Organization’s (WTO)                        Order 13045, entitled ‘‘Protection of                 General of the United States prior to
                                                  Sanitary and Phytosanitary Measures                     Children from Environmental Health                    publication of the rule in the Federal
                                                  Agreement, EPA notified the WTO of                      Risks and Safety Risks’’ (62 FR 19885,                Register. This action is not a ‘‘major
                                                  the request to revise these tolerances. In              April 23, 1997). This action does not                 rule’’ as defined by 5 U.S.C. 804(2).


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                                                                      Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Rules and Regulations                                                                   83169

                                                  List of Subjects in 40 CFR Part 180                                                                                        Parts per   and 101–45. Sections therein should
                                                                                                                                       Commodity
                                                    Environmental protection,                                                                                                 million    have been removed when the policy
                                                  Administrative practice and procedure,                                                                                                 migrated from FPMR parts 101–42 and
                                                                                                                          *              *              *               *         *      101–45 (with regards to items requiring
                                                  Agricultural commodities, Pesticides                                 Hog, meat ...................................              0.05
                                                  and pests, Reporting and recordkeeping                                                                                                 special handling) to FMR part 102–40.
                                                                                                                       Milk 1 ...........................................         0.03
                                                  requirements.                                                        Milk .............................................         0.01      GSA indicated in the preamble of
                                                     Dated: October 13, 2016.
                                                                                                                                                                                         FMR Change–2015–01; FPMR Case
                                                                                                                         *            *              *               *            *      2003–101–1; FMR Case 2003–102–4,
                                                  Michael Goodis,                                                      Poultry, fat ..................................            0.05   which was published in the Federal
                                                  Acting Director, Registration Division, Office                                                                                         Register at 80 FR 7352, on February 10,
                                                  of Pesticide Programs.                                                 *          *             *               *               *      2015, that these sections were migrating
                                                    Therefore, 40 CFR chapter I is                                     Poultry, meat ..............................               0.05
                                                                                                                       Poultry, meat byproducts 1 ..........                      0.20
                                                                                                                                                                                         from the FPMR to the FMR; but the
                                                  amended as follows:                                                                                                                    deletion of these superseded FPMR
                                                                                                                       Poultry, meat byproducts ............                      0.05
                                                                                                                                                                                         sections were not specifically
                                                  PART 180—[AMENDED]                                                     *           *              *               *             *      enumerated in the list of changes to be
                                                  ■ 1. The authority citation for part 180                             Sheep, fat ...................................             0.05   made. The end result is that, as of today,
                                                                                                                       Sheep, kidney 1 ...........................                0.15   there is overlapping policy in both the
                                                  continues to read as follows:                                        Sheep, kidney .............................                0.05   FPMR and the FMR and the remaining
                                                      Authority: 21 U.S.C. 321(q), 346a and 371.                                                                                         FPMR material is outdated and
                                                                                                                         *        *              *               *                *
                                                  ■  2. Amend the table in § 180.293                                                                                                     redundant. Therefore, to remove this
                                                                                                                       Sheep, meat ...............................                0.05
                                                  paragraph (d) as follows:                                                                                                              duplicative information, GSA is issuing
                                                  ■ a. Revise the entries for ‘‘Cattle, fat’’,                                                                                           a technical correction to FMR Change–
                                                                                                                            *             *              *             *          *
                                                  ‘‘Cattle, meat’’, ‘‘Goat, fat’’, ‘‘Goat,                                                                                               2015–01; FPMR Case 2003–101–1; FMR
                                                                                                                          1 This   tolerance expires on May 22, 2017.
                                                  meat’’, ‘‘Hog, fat’’, ‘‘Hog, meat’’,                                                                                                   Case 2003–102–4.
                                                  ‘‘Poultry, fat’’, ‘‘Poultry, meat’’, ‘‘Sheep,                        [FR Doc. 2016–27984 Filed 11–18–16; 8:45 am]
                                                  fat, and ‘‘Sheep, meat’’;                                                                                                              List of Subjects in 41 CFR Part 101–42
                                                                                                                       BILLING CODE 6560–50–P
                                                  ■ b. Add alphabetically footnotes for the                                                                                              and 101–45
                                                  entries ‘‘Cattle, kidney 1’’, ‘‘Cattle,                                                                                                  Disposition of personal property with
                                                  liver 1’’, ‘‘Goat, kidney 1’’, ‘‘Hog,                                GENERAL SERVICES                                                  special handling requirements; sale,
                                                  kidney 1’’, ‘‘Milk’’, ‘‘Poultry, meat                                ADMINISTRATION                                                    abandonment or destruction of personal
                                                  byproducts 1’’, and ‘‘Sheep, kidney 1’’;                                                                                               property.
                                                  and                                                                  41 CFR Parts 101–42 and 101–45
                                                  ■ c. Add alphabetically the entries for
                                                                                                                                                                                           Dated: November 9, 2016.
                                                  ‘‘Cattle, kidney’’, ‘‘Cattle, liver’’, ‘‘Goat,                       [FPMR-Amendment 2016–01; FPMR–                                    Denise Turner Roth,
                                                                                                                       TechAmdt–2016–01; Docket No. 2007–0001;                           Administrator of General Services.
                                                  kidney’’, ‘‘Hog, kidney’’, ‘‘Milk’’,                                 Sequence No. 6]
                                                  ‘‘Poultry, meat byproducts’’, and                                                                                                        For the reasons set forth in the
                                                  ‘‘Sheep, kidney’’.                                                   Federal Property Management                                       preamble, 41 CFR parts 101–42 and
                                                     The revisions and additions read as                               Regulations; Technical Amendments                                 101–45 is amended as follows:
                                                  follows:
                                                                                                                       AGENCY:  Office of Government-wide                                PART 101–42—DISPOSITION OF
                                                  § 180.293 Endothall; tolerances for                                  Policy, General Services Administration
                                                  residues.                                                                                                                              PERSONAL PROPERTY WITH
                                                                                                                       (GSA).                                                            SPECIAL HANDLNG REQUIREMENTS
                                                  *       *    *             *         *                               ACTION: Final rule.
                                                      (d) * * *
                                                                                                                       SUMMARY:    GSA is amending the Federal                           ■ 1. The authority for part 101–42 is
                                                                                                       Parts per       Property Management Regulations                                   revised to read as follows:
                                                                 Commodity                              million        (FPMR) to delete repetitive information                             Authority: Sec. 205(c), 63 Stat. 390; 40
                                                                                                                       that has already migrated to the Federal                          U.S.C. 486(c).
                                                     *              *              *               *            *      Management Regulation (FMR).                                      § 101–42.001—101–42.1102–10         [Removed]
                                                  Cattle,   fat ....................................            0.05   DATES: Effective: November 21, 2016.
                                                  Cattle,   kidney 1 ............................               0.20   FOR FURTHER INFORMATION CONTACT: Mr.                              ■ 2. Remove sections 101–42.001
                                                  Cattle,   kidney ..............................               0.05   Robert Holcombe, Director, Personal                               through 101–42.1102–10.
                                                  Cattle,   liver 1 ................................            0.10   Property Policy, at 202–501–3828, or
                                                  Cattle,   liver ..................................            0.05                                                                     PART 101–45—SALE,
                                                                                                                       email robert.holcombe@gsa.gov for
                                                  Cattle,   meat ................................               0.05                                                                     ABANDONMENT, OR DESTRUCTION
                                                                                                                       clarification of content. For information
                                                                                                                                                                                         OF PERSONAL PROPERTY
                                                    *             *              *               *              *      pertaining to the status or publication
                                                  Goat, fat ......................................              0.05   schedules, contact the Regulatory
                                                                                                                                                                                         ■ 3. The authority for part 101–45
                                                  Goat, kidney 1 .............................                  0.15   Secretariat Division (MVCB), 1800 F
                                                                                                                                                                                         continues to read as follows:
                                                  Goat, kidney ...............................                  0.05   Street NW., Washington, DC 20405, or
                                                                                                                       202–501–4755. Please cite FPMR–Tech                                 Authority: 40 U.S.C. 545 and 40 U.S.C.
                                                    *          *              *               *                 *      Amdt–2016–01; Technical                                           121(c).
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                                                  Goat, meat ..................................                 0.05   Amendments.                                                       § 101–45.001—101–45.004       [Removed]
                                                    *             *              *               *              *      SUPPLEMENTARY INFORMATION:
                                                                                                                                                                                         ■ 4. Remove sections 101–45.001
                                                  Hog, fat .......................................              0.05   Background                                                        through 101–45.004.
                                                  Hog, kidney 1 ...............................                 0.10
                                                  Hog, kidney .................................                 0.05     GSA is amending the FPMR to make                                [FR Doc. 2016–28010 Filed 11–18–16; 8:45 am]
                                                                                                                       editorial changes to FPMR Parts 101–42                            BILLING CODE 6820–14–P




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Document Created: 2018-02-14 08:33:43
Document Modified: 2018-02-14 08:33:43
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective 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).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation81 FR 83163 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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