[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27984]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Endothall; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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
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].
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
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
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
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
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
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some
degree of risk. Thus, the Agency estimates risk in terms of the
probability of an occurrence of the adverse effect expected in a
lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for endothall used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Endothall for Use in Human Health Risk Assessment
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
Acute dietary.................... An appropriate endpoint attributable to a single dose was not available from
any study. An acute RfD was not established.
Chronic dietary (All populations) LOAEL= 2 mg/kg/day.. Chronic RfD = 0.007 Rat 2-generation reproduction
UFA = 10x........... mg/kg/day. study.
UFH = 10x........... cPAD = 0.007 mg/kg/ LOAEL = 2 mg/kg/day based on
FQPA SF............. day. proliferative lesions of the
UFL = 3x............ gastric epithelium (both sexes).
Short-term Incidental oral (1 to Offspring NOAEL= 9.4 Residential........ Rat 2-generation reproduction
30 days). mg/kg/day. LOC for MOE = 100.. study.
UFA = 10x........... Occupational = N/A. LOAEL = 60 mg/kg/day based on
UFH = 10x........... decreased pup body weight (both
FQPA SF = 1x........ sexes) on Day 0 in F1 and F2
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
absorption rate =
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
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
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
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
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
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
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
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-
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:
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.
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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: October 13, 2016.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Amend the table in Sec. 180.293 paragraph (d) as follows:
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'';
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\'';
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) * * *
* * * * *
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
* * * * *
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