Quizalofop Ethyl; Pesticide Tolerances, 86581-86586 [2016-28873]
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Federal Register / Vol. 81, No. 231 / Thursday, December 1, 2016 / Rules and Regulations
residues of Muscodor albus strain SA–
13 and the volatiles produced on
rehydration. Therefore, an exemption
from the requirement of a tolerance is
established for residues of Muscodor
albus strain SA–13 and the volatiles
produced on rehydration in or on all
food commodities when used in
accordance with label directions and
good agricultural practices.
B. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes because EPA
is establishing an exemption from the
requirement of a tolerance without any
numerical limitation.
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C. Revision to the Requested Tolerance
Exemption
One modification has been made to
the requested tolerance exemption.
When MBI first submitted this petition
in 2014, it described the pesticide
chemical as ‘‘sterile grain inoculated
with Muscodor albus strain SA–13.’’
After conducting a review of this
petition and evaluating a tolerance
exemption established in 2005 for
another strain of Muscodor albus (QST
20799) (70 FR 56569), which has the
same mode of action as Muscodor albus
strain SA–13, EPA is changing the
pesticide chemical name to ‘‘Muscodor
albus strain SA–13 and the volatiles
produced on rehydration.’’ This revision
better reflects the possible residues that
may occur on food commodities and the
data/information submitted to support
the petition.
IV. Statutory and Executive Order
Reviews
This action establishes a tolerance
exemption under FFDCA section 408(d)
in response to a petition submitted to
EPA. 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
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‘‘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 exemption in this action,
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. As a result,
this action does not alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
EPA 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, EPA 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
EPA’s 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).
V. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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86581
Dated: November 15, 2016.
Jack Housenger,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1340 to subpart D to read
as follows:
■
§ 180.1340 Muscodor albus strain SA–13
and the volatiles produced on rehydration;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Muscodor albus strain SA–13 and the
volatiles produced on rehydration in or
on all food commodities when used in
accordance with label directions and
good agricultural practices.
[FR Doc. 2016–28884 Filed 11–30–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0412; FRL–9950–89]
Quizalofop Ethyl; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of quizalofop
ethyl in or on crayfish and rice grain.
Nissan Chemical Industries, Ltd.
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
December 1, 2016. Objections and
requests for hearings must be received
on or before January 30, 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–2015–0412, is
available at https://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.,
DATES:
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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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/test-guidelines-pesticidesand-toxic-substances.
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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–2015–0412 in the subject line on
the first page of your submission. All
objections and requests for a hearing
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must be in writing, and must be
received by the Hearing Clerk on or
before January 30, 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–
2015–0412, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of August 26,
2015 (80 FR 51759) (FRL–9931–74),
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 5F8367) by Lewis
and Harrison, LLC, 122 C St. NW., Suite
505, Washington, DC 20001 (on behalf
of Nissan Chemical Industries, Ltd., 7–
1, 3-chome, Kanda-Nishiki-cho,
Chiyoda-ku, Tokyo 101–0054, Japan).
The petition requested that 40 CFR
180.441 be amended by establishing
tolerances for residues of the herbicide
quizalofop-p-ethyl ester, ethyl-(R)-(2-(4((6-chloroquinoxalin-2yl)oxy)phenoxy)propanoate), and its
acid metabolite quizalofop-P, R-(2-(4((6-quinoxalin-2yl)oxy)phenoxy)propanoic acid, and the
S enantiomers of both the ester and the
acid, all expressed as quizalofop-P-ethyl
ester, in or on crayfish at 0.04 parts per
million (ppm) and rice, grain at 0.05
ppm. That document referenced a
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summary of the petition prepared by
Nissan Chemical Industries, Ltd., the
registrant, which is available in the
docket, https://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 changed
the tolerance expression for rice grain
and corrected the commodity definition
for crayfish. The reasons for these
changes are 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 quizalofop ethyl,
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with quizalofop ethyl
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.
Quizalofop ethyl is a 50/50 racemic
mixture of R- and S-enantiomers.
Quizalofop-P-ethyl, the purified R-
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enantiomer, is the pesticidally-active
isomer. Since the toxicological profiles
of quizalofop ethyl and quizalofop-Pethyl are similar, the available toxicity
studies are adequate to support both
compounds. For the purposes of this
final rule, both quizalofop ethyl and
quizalofop-P-ethyl are collectively
referred to as ‘‘quizalofop ethyl’’.
Quizalofop ethyl has very low acute
toxicity via the oral, dermal, and
inhalation routes of exposure, is not an
eye or skin irritant, and is not a skin
sensitizer. There were no adverse effects
observed in the oral toxicity studies that
could be attributable to a single-dose
exposure.
Repeated-dose toxicity studies
indicate the liver as the target organ, as
evidenced by increased liver weights
and histopathological changes.
Following oral administration,
quizalofop ethyl is rapidly excreted via
urine and feces. In the subchronic oral
toxicity rat study, effects of decreased
body weight gains, increased liver
weight, and centrilobular liver cell
enlargement were observed. In the
subchronic oral toxicity dog study, an
increased incidence of testicular
atrophy was observed. In the combined
chronic toxicity/carcinogenicity study
in rats, an increased incidence of
centrilobular liver cell enlargement was
observed in both sexes and mild anemia
in males.
No dermal toxicity effects were
observed in the subchronic dermal
toxicity rabbit study at up to the limit
dose. Subchronic inhalation toxicity is
assumed to be equivalent to oral
toxicity. In the chronic oral toxicity dog
study, no toxicity effects were observed
at the highest dose tested (HDT).
In the rat and rabbit developmental
toxicity studies, maternal effects
including decreased body weight gains
and food consumption were observed;
no developmental effects were observed
at up to the HDT. In the two-generation
reproduction toxicity study in rats,
maternal effects including decreased
body weight and body weight gains
were observed at the same dose level
that resulted in prenatal and postnatal
effects (decreased percentage of pups
born alive and decreased pup weights).
Although tumors were observed in
male and female mice after exposure to
quizalofop, the overall evidence for
carcinogenicity is weak, as discussed in
supporting documents. Additionally,
the point of departure used for
establishing the chronic reference dose
for quizalofop is significantly lower
(30X) than the dose that induced tumors
in male and female mice. EPA has
determined that quantification of cancer
risk using a non-linear approach would
adequately account for all chronic
toxicity, including carcinogenicity,
which could result from exposure to
quizalofop ethyl.
Quizalofop ethyl does not show
evidence of neurotoxicity, based on no
evidence of neurotoxicity or
neuropathology in the available
toxicology studies. There was also no
evidence of adverse effects on the
functional development of pups
observed in the rat reproduction toxicity
study. Quizalofop ethyl showed no
evidence of immunotoxicity.
Specific information on the studies
received and the nature of the adverse
effects caused by quizalofop ethyl as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document,
86583
‘‘Quizalofop-P-ethyl. Human Health
Risk Assessment in Support of the
Proposed New Use on Rice’’ in docket
ID number EPA–HQ–OPP–2015–0412.
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 the NOAEL and the
LOAEL are identified. Uncertainty/
safety factors (UF) 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 nonthreshold 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 https://
www.epa.gov/pesticides-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for quizalofop ethyl used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR QUIZALOFOP ETHYL FOR USE IN HUMAN HEALTH
RISK ASSESSMENT
Point of departure and
uncertainty/safety factors
Exposure/scenario
Acute dietary (all populations) .......
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Chronic dietary (all populations) ....
RfD, PAD, LOC for risk
assessment
Study and
toxicological effects
No hazard attributable to a single-dose exposure was identified.
NOAEL = 0.9 mg/kg/day ..............
UFA = 10x .....................................
UFH = 10x .....................................
FQPA SF = 1x ..............................
Chronic RfD = 0.009 mg/kg/day ...
cPAD = 0.009 mg/kg/day .............
Combined Chronic Toxicity/Carcinogenicity Rat Study
LOAEL = 3.7 mg/kg/day based on
mild anemia in males and increased number of liver masses
and centrilobular enlargement
of the liver in both sexes
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day.
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).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to quizalofop ethyl, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing quizalofop ethyl tolerances in
40 CFR 180.441. EPA assessed dietary
exposures from quizalofop ethyl 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 one-day or
single exposure. No such effects were
identified in the toxicological studies
for quizalofop ethyl; 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 2003–2008 National
Health and Nutrition Examination
Survey, What We Eat in America
(NHANES/WWEIA). As to residue levels
in food, EPA incorporated tolerancelevel residues, 100 percent crop treated
(PCT) for all commodities, and default
processing factors for all processed
commodities except sunflower oil.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that quizalofop ethyl 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. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for quizalofop ethyl. Tolerance level
residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for quizalofop ethyl in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
quizalofop ethyl. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide.
Based on the Modified Tier 1 Rice
Model and Pesticide Root Zone Model
Ground Water (PRZM GW) model, the
estimated drinking water concentrations
(EDWCs) of quizalofop ethyl for chronic
exposures for non-cancer assessments
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are estimated to be 127 parts per billion
(ppb) for surface water and 89 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration value of 127 ppb
was used to assess the contribution to
drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Quizalofop ethyl is not registered for
any specific use patterns that would
result in residential exposure.
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 quizalofop ethyl to
share a common mechanism of toxicity
with any other substances, and
quizalofop ethyl does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that quizalofop ethyl does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
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
Food Quality Protection Act Safety
Factor (FQPA SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
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data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
As summarized in Unit III.A., results
from the rat and rabbit developmental
toxicity and the two-generation rat
reproduction toxicity studies indicated
no qualitative or quantitative evidence
of increased susceptibility in developing
fetuses or in the offspring following
prenatal and/or postnatal exposure to
quizalofop ethyl.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for quizalofop
ethyl is complete.
ii. There is no indication that
quizalofop ethyl is a neurotoxic
chemical and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no qualitative or
quantitative evidence that quizalofop
ethyl results in increased susceptibility
in in utero rats or rabbits in the prenatal
developmental studies or in young rats
in the two-generation reproduction
study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to quizalofop
ethyl in drinking water. These
assessments will not underestimate the
exposure and risks posed by quizalofop
ethyl.
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. Since there are no residential
uses for quizalofop ethyl, the aggregate
risk assessment only includes exposure
estimates from dietary consumption of
food and drinking water.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
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Federal Register / Vol. 81, No. 231 / Thursday, December 1, 2016 / Rules and Regulations
consumption of food and drinking
water. No adverse effect resulting from
a single-dose exposure was identified
and no acute dietary endpoint was
selected. Therefore, quizalofop ethyl 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 quizalofop
ethyl from food and water will utilize
97% of the cPAD for all infants less than
1 year old, the population group
receiving the greatest exposure.
3. Short- and intermediate-term risk.
Short- and intermediate-term aggregate
exposure takes into account short- and
intermediate-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). Because there are no
residential uses, quizalofop ethyl is not
expected to pose short- or intermediateterm risk.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
quizalofop ethyl is not expected to pose
a cancer risk to humans.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to quizalofop
ethyl residues.
IV. Other Considerations
jstallworth on DSK7TPTVN1PROD with RULES
A. Analytical Enforcement Methodology
Adequate enforcement methodologies
(Modified Meth-147, liquid
chromatography-mass spectrometry/
mass spectrometry (LC-MS/MS) for
plant commodities including rice;
Modified BASF Method Number D1416
(LC-MS/MS) for crustaceans; and AMR515-86, AMR-623-86, AMR-627-86,
AMR-845-87, and AMR-846-87, all High
Performance Liquid Chromotography
(HPLC) methods using ultraviolet
detection for livestock commodities) are
available to enforce the tolerance
expression.
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
VerDate Sep<11>2014
13:50 Nov 30, 2016
Jkt 241001
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 quizalofop ethyl.
C. Revisions to Petitioned-For
Tolerances
EPA changed the proposed tolerance
expression for rice grain from the
detection of ‘‘quizalofop-P-ethyl and its
acid metabolite quizalofop-P, and the S
enantiomers of both the ester and the
acid, all expressed as quizalofop-P-ethyl
ester’’ to ‘‘quizalofop ethyl residues
convertible to 2-methoxy-6chloroquinoxaline, expressed as the
stoichiometric equivalent of quizalofop
ethyl’’ to match the expression of the
other existing plant commodities since
the same common moiety analytical
method is used for enforcement. EPA
also changed the proposed commodity
name from ‘‘crayfish’’ to the correct
definition of ‘‘fish-shellfish,
crustacean’’.
V. Conclusion
Therefore, tolerances are established
for residues of quizalofop ethyl in or on
fish-shellfish, crustacean at 0.04 ppm
and rice, grain at 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
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86585
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).
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86586
Federal Register / Vol. 81, No. 231 / Thursday, December 1, 2016 / Rules and Regulations
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: November 10, 2016.
Michael Goodis,
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. In § 180.441:
■ a. Add alphabetically the commodity
in the table in paragraph (a)(1).
■ b. Add paragraph (a)(3).
The additions read as follows:
■
§ 180.441 Quizalofop ethyl; tolerances for
residues.
(a) * * *
(1) * * *
Parts per
million
*
*
*
Rice, grain ............................
*
*
*
*
*
0.05
*
*
*
*
*
*
(3) Tolerances are established for
residues of the herbicide quizalofop-Pethyl, including its metabolites and
degradates, in or on the commodities in
the following table. Compliance with
the tolerance levels specified in the
following table is to be determined by
measuring quizalofop ethyl and
quizalofop acid, expressed as the
stoichiometric equivalent of quizalofop
ethyl, in or on the commodity.
Parts per
million
Fish-shellfish, crustacean .....
jstallworth on DSK7TPTVN1PROD with RULES
Commodity
0.04
*
*
*
*
[FR Doc. 2016–28873 Filed 11–30–16; 8:45 am]
BILLING CODE 6560–50–P
VerDate Sep<11>2014
13:50 Nov 30, 2016
SUPPLEMENTARY INFORMATION:
Review of Foreign Ownership Policies
for Broadcast, Common Carrier and
Aeronautical Radio Licensees
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
In this Report and Order, the
Federal Communications Commission
(Commission) extends its streamlined
foreign ownership rules and procedures
that apply to common carrier and
certain aeronautical licensees under
Section 310(b)(4) of the
Communications Act of 1934, as
amended (the ‘‘Act’’) to broadcast
licensees, with certain modifications to
tailor them to the broadcast context. The
Commission also reforms the
methodology used by both common
carrier and broadcast licensees that are,
or are controlled by, U.S. public
companies to assess compliance with
the 20 percent foreign ownership limit
in Section 310(b)(3), and the 25 percent
foreign ownership benchmark in
Section 310(b)(4) of the Act, in order to
reduce regulatory burdens on applicants
and licensees. Finally, the Commission
makes certain technical corrections and
clarifications to its foreign ownership
rules.
Jkt 241001
Effective January 30, 2017,
except for the amendments to 47 CFR
1.5000 through 1.5004, 25.105, 73.1010
and 74.5 which will be effective upon
approval of information collection
requirements by the Office of
Management and Budget (OMB). The
Commission will publish a separate
document in the Federal Register
announcing the effective date of these
rule changes.
ADDRESSES: Federal Communications
Commission, 445 12th Street SW.,
Washington, DC 20554. The
Commission will seek comments from
the Office of Management and Budget
(OMB), other Federal agencies and the
general public on the Paperwork
Reduction Act (PRA) information
collection requirements contained
herein in a separate notice to be
published in Federal Register.
FOR FURTHER INFORMATION CONTACT:
Kimberly Cook or Francis Gutierrez,
Telecommunications and Analysis
Division, International Bureau, FCC,
(202) 418–1480 or via email to
Kimberly.Cook@fcc.gov,
Francis.Gutierrez@fcc.gov. On PRA
DATES:
*
*
[GN Docket No. 15–236; FCC 16–128]
SUMMARY:
PART 180—[AMENDED]
Commodity
47 CFR Parts 1, 25, 73 and 74
matters, contact Cathy Williams, Office
of the Managing Director, FCC, (202)
418–2918 or via email to
Cathy.Williams@fcc.gov.
FEDERAL COMMUNICATIONS
COMMISSION
PO 00000
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Fmt 4700
Sfmt 4700
This is a
summary of the Commission’s Report
and Order in GN Docket No. 15–236,
FCC 16–128, adopted September 29,
2016 and released on September 30,
2016. The full text of the Report and
Order is available for inspection and
copying during normal business hours
in the FCC Reference Center, 445 12th
Street SW., Washington, DC 20554. The
document also is available for download
over the Internet at https://
transition.fcc.gov/Daily_Releases/Daily_
Business/2016/db0930/FCC-16128A1.pdf.
Synopsis of Report and Order
1. The Report and Order modifies the
foreign ownership filing and review
process for broadcast licensees by
extending the streamlined rules and
procedures developed for foreign
ownership reviews for common carrier
and certain aeronautical licensees under
Section 310(b)(4) of the
Communications Act of 1934, as
amended (the ‘‘Act’’), to the broadcast
context with certain limited
exceptions.1 Recognizing the difficulty
U.S. public companies face in
ascertaining their foreign ownership,
this Report and Order also reforms the
methodology used by both common
carrier and broadcast licensees that are,
or are controlled by, U.S. public
companies to assess compliance with
the foreign ownership limits in Sections
310(b)(3) and 310(b)(4) of the Act,
respectively. In particular, the reformed
methodology provides a framework for
a publicly traded licensee or controlling
U.S. parent to ascertain its foreign
ownership using information that is
‘‘known or reasonably should be
known’’ to the company in the ordinary
1 For ease of reference, this Report and Order
refers to broadcast, common carrier, aeronautical en
route and aeronautical fixed radio station
applicants and licensees (including broadcast
permittees) and to common carrier spectrum lessees
collectively as ‘‘licensees’’ unless the context
warrants otherwise. This Report and Order also
uses the term ‘‘common carrier’’ or ‘‘common
carrier licensees’’ to encompass common carrier,
aeronautical en route and aeronautical fixed radio
station applicants and licensees unless the context
applies only to common carrier licensees.
‘‘Spectrum lessees’’ are defined in Section 1.9003
of Part 1, Subpart X (‘‘Spectrum Leasing’’). 47 CFR
1.9003. This Report and Order also refers to
aeronautical en route and aeronautical fixed
licensees collectively as ‘‘aeronautical’’ licensees. In
using this shorthand, this Report and Order does
not include other types of aeronautical radio station
licenses issued by the Commission.
E:\FR\FM\01DER1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 231 (Thursday, December 1, 2016)]
[Rules and Regulations]
[Pages 86581-86586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28873]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0412; FRL-9950-89]
Quizalofop Ethyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
quizalofop ethyl in or on crayfish and rice grain. Nissan Chemical
Industries, Ltd. requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 1, 2016. Objections and
requests for hearings must be received on or before January 30, 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-2015-0412, is available at https://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.,
[[Page 86582]]
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
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.
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-2015-0412 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 30, 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-2015-0412, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), 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
5F8367) by Lewis and Harrison, LLC, 122 C St. NW., Suite 505,
Washington, DC 20001 (on behalf of Nissan Chemical Industries, Ltd., 7-
1, 3-chome, Kanda-Nishiki-cho, Chiyoda-ku, Tokyo 101-0054, Japan). The
petition requested that 40 CFR 180.441 be amended by establishing
tolerances for residues of the herbicide quizalofop-p-ethyl ester,
ethyl-(R)-(2-(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoate), and
its acid metabolite quizalofop-P, R-(2-(4-((6-quinoxalin-2-
yl)oxy)phenoxy)propanoic acid, and the S enantiomers of both the ester
and the acid, all expressed as quizalofop-P-ethyl ester, in or on
crayfish at 0.04 parts per million (ppm) and rice, grain at 0.05 ppm.
That document referenced a summary of the petition prepared by Nissan
Chemical Industries, Ltd., the registrant, which is available in the
docket, https://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 changed
the tolerance expression for rice grain and corrected the commodity
definition for crayfish. The reasons for these changes are 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 quizalofop ethyl, including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with quizalofop
ethyl 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.
Quizalofop ethyl is a 50/50 racemic mixture of R- and S-
enantiomers. Quizalofop-P-ethyl, the purified R-
[[Page 86583]]
enantiomer, is the pesticidally-active isomer. Since the toxicological
profiles of quizalofop ethyl and quizalofop-P-ethyl are similar, the
available toxicity studies are adequate to support both compounds. For
the purposes of this final rule, both quizalofop ethyl and quizalofop-
P-ethyl are collectively referred to as ``quizalofop ethyl''.
Quizalofop ethyl has very low acute toxicity via the oral, dermal,
and inhalation routes of exposure, is not an eye or skin irritant, and
is not a skin sensitizer. There were no adverse effects observed in the
oral toxicity studies that could be attributable to a single-dose
exposure.
Repeated-dose toxicity studies indicate the liver as the target
organ, as evidenced by increased liver weights and histopathological
changes. Following oral administration, quizalofop ethyl is rapidly
excreted via urine and feces. In the subchronic oral toxicity rat
study, effects of decreased body weight gains, increased liver weight,
and centrilobular liver cell enlargement were observed. In the
subchronic oral toxicity dog study, an increased incidence of
testicular atrophy was observed. In the combined chronic toxicity/
carcinogenicity study in rats, an increased incidence of centrilobular
liver cell enlargement was observed in both sexes and mild anemia in
males.
No dermal toxicity effects were observed in the subchronic dermal
toxicity rabbit study at up to the limit dose. Subchronic inhalation
toxicity is assumed to be equivalent to oral toxicity. In the chronic
oral toxicity dog study, no toxicity effects were observed at the
highest dose tested (HDT).
In the rat and rabbit developmental toxicity studies, maternal
effects including decreased body weight gains and food consumption were
observed; no developmental effects were observed at up to the HDT. In
the two-generation reproduction toxicity study in rats, maternal
effects including decreased body weight and body weight gains were
observed at the same dose level that resulted in prenatal and postnatal
effects (decreased percentage of pups born alive and decreased pup
weights).
Although tumors were observed in male and female mice after
exposure to quizalofop, the overall evidence for carcinogenicity is
weak, as discussed in supporting documents. Additionally, the point of
departure used for establishing the chronic reference dose for
quizalofop is significantly lower (30X) than the dose that induced
tumors in male and female mice. EPA has determined that quantification
of cancer risk using a non-linear approach would adequately account for
all chronic toxicity, including carcinogenicity, which could result
from exposure to quizalofop ethyl.
Quizalofop ethyl does not show evidence of neurotoxicity, based on
no evidence of neurotoxicity or neuropathology in the available
toxicology studies. There was also no evidence of adverse effects on
the functional development of pups observed in the rat reproduction
toxicity study. Quizalofop ethyl showed no evidence of immunotoxicity.
Specific information on the studies received and the nature of the
adverse effects caused by quizalofop ethyl 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 https://www.regulations.gov in document, ``Quizalofop-P-ethyl. Human Health
Risk Assessment in Support of the Proposed New Use on Rice'' in docket
ID number EPA-HQ-OPP-2015-0412.
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 the NOAEL and the LOAEL are identified.
Uncertainty/safety factors (UF) 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 https://www.epa.gov/pesticides-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for quizalofop ethyl used
for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Quizalofop Ethyl for Use in Human Health Risk
Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and
factors assessment toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)...... No hazard attributable to a single-dose exposure was identified.
--------------------------------------------------------------------------
Chronic dietary (all populations).... NOAEL = 0.9 mg/kg/day.. Chronic RfD = 0.009 mg/ Combined Chronic
UFA = 10x.............. kg/day. Toxicity/
UFH = 10x.............. cPAD = 0.009 mg/kg/day. Carcinogenicity Rat
FQPA SF = 1x........... Study
LOAEL = 3.7 mg/kg/day
based on mild anemia
in males and increased
number of liver masses
and centrilobular
enlargement of the
liver in both sexes
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
milligram/kilogram/day. 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).
[[Page 86584]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to quizalofop ethyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing quizalofop ethyl
tolerances in 40 CFR 180.441. EPA assessed dietary exposures from
quizalofop ethyl 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 one-day or single exposure. No such effects were
identified in the toxicological studies for quizalofop ethyl;
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 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA incorporated
tolerance-level residues, 100 percent crop treated (PCT) for all
commodities, and default processing factors for all processed
commodities except sunflower oil.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that quizalofop ethyl 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.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for quizalofop ethyl. Tolerance level residues and/
or 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for quizalofop ethyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of quizalofop ethyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Modified Tier 1 Rice Model and Pesticide Root Zone
Model Ground Water (PRZM GW) model, the estimated drinking water
concentrations (EDWCs) of quizalofop ethyl for chronic exposures for
non-cancer assessments are estimated to be 127 parts per billion (ppb)
for surface water and 89 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 127 ppb was used to assess
the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Quizalofop ethyl is
not registered for any specific use patterns that would result in
residential exposure.
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 quizalofop ethyl to share a common mechanism of
toxicity with any other substances, and quizalofop ethyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
quizalofop ethyl does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
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 Food Quality
Protection Act Safety Factor (FQPA 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. As summarized in Unit
III.A., results from the rat and rabbit developmental toxicity and the
two-generation rat reproduction toxicity studies indicated no
qualitative or quantitative evidence of increased susceptibility in
developing fetuses or in the offspring following prenatal and/or
postnatal exposure to quizalofop ethyl.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for quizalofop ethyl is complete.
ii. There is no indication that quizalofop ethyl is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no qualitative or quantitative evidence that
quizalofop ethyl results in increased susceptibility in in utero rats
or rabbits in the prenatal developmental studies or in young rats in
the two-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to quizalofop ethyl in drinking water. These
assessments will not underestimate the exposure and risks posed by
quizalofop ethyl.
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. Since there are no residential uses for quizalofop
ethyl, the aggregate risk assessment only includes exposure estimates
from dietary consumption of food and drinking water.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary
[[Page 86585]]
consumption of food and drinking water. No adverse effect resulting
from a single-dose exposure was identified and no acute dietary
endpoint was selected. Therefore, quizalofop ethyl 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
quizalofop ethyl from food and water will utilize 97% of the cPAD for
all infants less than 1 year old, the population group receiving the
greatest exposure.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Because there are no
residential uses, quizalofop ethyl is not expected to pose short- or
intermediate-term risk.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, quizalofop ethyl is not expected to pose a cancer risk to
humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to quizalofop ethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies (Modified Meth-147, liquid
chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) for plant
commodities including rice; Modified BASF Method Number D1416 (LC-MS/
MS) for crustaceans; and AMR-515-86, AMR-623-86, AMR-627-86, AMR-845-
87, and AMR-846-87, all High Performance Liquid Chromotography (HPLC)
methods using ultraviolet detection for livestock commodities) are
available to enforce the tolerance expression.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for quizalofop ethyl.
C. Revisions to Petitioned-For Tolerances
EPA changed the proposed tolerance expression for rice grain from
the detection of ``quizalofop-P-ethyl and its acid metabolite
quizalofop-P, and the S enantiomers of both the ester and the acid, all
expressed as quizalofop-P-ethyl ester'' to ``quizalofop ethyl residues
convertible to 2-methoxy-6-chloroquinoxaline, expressed as the
stoichiometric equivalent of quizalofop ethyl'' to match the expression
of the other existing plant commodities since the same common moiety
analytical method is used for enforcement. EPA also changed the
proposed commodity name from ``crayfish'' to the correct definition of
``fish-shellfish, crustacean''.
V. Conclusion
Therefore, tolerances are established for residues of quizalofop
ethyl in or on fish-shellfish, crustacean at 0.04 ppm and rice, grain
at 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 86586]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 10, 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. In Sec. 180.441:
0
a. Add alphabetically the commodity in the table in paragraph (a)(1).
0
b. Add paragraph (a)(3).
The additions read as follows:
Sec. 180.441 Quizalofop ethyl; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Rice, grain............................................ 0.05
* * * * *
------------------------------------------------------------------------
* * * * *
(3) Tolerances are established for residues of the herbicide
quizalofop-P-ethyl, including its metabolites and degradates, in or on
the commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring quizalofop ethyl and quizalofop acid, expressed as the
stoichiometric equivalent of quizalofop ethyl, in or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Fish-shellfish, crustacean............................. 0.04
------------------------------------------------------------------------
* * * * *
[FR Doc. 2016-28873 Filed 11-30-16; 8:45 am]
BILLING CODE 6560-50-P
