Pyraflufen-ethyl; Time-Limited Pesticide Tolerances, 51738-51743 [E8-20515]
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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. 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 this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 25, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.474 is amended in
paragraph (a)(1) by alphabetically
adding the commodity pistachio to the
table to read as follows:
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I
§180.474 Tebuconazole; tolerances for
residues.
(a) General. (1) * * *
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Parts per
million
Commodity
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Pistachio ...................................
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0.05
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[FR Doc. E8–20625 Filed 9–4–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007-0366; FRL–8377–6]
Pyraflufen-ethyl; Time-Limited
Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
permanent tolerances for residues of
pyraflufen-ethyl in or on grass, forage,
group 17; and grass, hay, group 17;
establishes time-limited tolerances for
milk; cattle, meat byproducts; goat, meat
byproducts; horse, meat byproducts and
sheep, meat byproducts, and revises the
existing tolerances for soybean, forage;
soybean, hay; wheat, forage and wheat,
hay. Nichino America, Inc. requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA). The
time-limited tolerances expire on
October 15, 2012.
DATES: This regulation is effective
September 5, 2008. Objections and
requests for hearings must be received
on or before November 4, 2008, 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: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007-0366. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
SUMMARY:
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the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Public Docket, in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Joanne I. Miller, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
703-305-6224; e-mail address:
miller.joanne@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. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
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Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
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C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2007-0366 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before November 4, 2008
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 that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2007-0366, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg., 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerances
In the Federal Register of June 27,
2007 (72 FR 35237) (FRL–8133–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 7F7190) by
Nichino America, Inc., 4550 New
Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition
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requested that 40 CFR 180.585 be
amended by establishing tolerances for
residues of the herbicide, pyraflufenethyl, ethyl 2-chloro-5-(4-chloro-5difluoromethoxy-1-methyl-1H-pyrazol-3
-yl)-4-fluorophenoxyacetate; and its acid
metabolite, E-1, 2-chloro-5-4-chloro-5difluoromethoxy-(1-methyl-1H-pyrazol3-yl)-4-fluorophenoxyacetic acid,
expressed in terms of the parent in or on
food commodities: Soybeans, forage at
0.05 parts per million (ppm); soybean,
hay at 0.10 ppm; grass, forage, crop
group 17 at 1.0 ppm; and grass, hay,
crop group 17 at 1.2 ppm.
In the Federal Register of June 13,
2008 (73 FR 33814) (FRL–8367–3), EPA
issued a second notice pursuant to
section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 7F7190) by
Nichino America, Inc., 4550 New
Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition
requested that 40 CFR 180.585 be
amended by establishing new tolerances
for residues of the herbicide, pyraflufenethyl, ethyl 2-chloro-5-(4-chloro-5difluoromethoxy-1-methyl-1H-pyrazol3-yl)-4-fluorophenoxyacetate, and its
acid metabolite, E-1, 2-chloro-5-(4chloro-5-difluoromethoxy-1-methyl-1Hpyrazol-3-yl)-4-fluorophenoxyacetic
acid, expressed in terms of the parent,
in or on food commodities grass, forage,
group 17 at 1.0 ppm; grass, hay, group
17 at 1.4 ppm; milk at 0.02 ppm; cattle,
meat byproducts at 0.02 ppm; goat, meat
byproducts at 0.02 ppm; horse, meat
byproducts at 0.02 ppm; and sheep,
meat byproducts at 0.02 ppm, and by
revising existing tolerances for residues
of the herbicide, pyraflufen-ethyl, ethyl
2-chloro-5-(4-chloro-5-difluoromethoxy1-methyl-1H-pyrazol-3-yl)-4fluorophenoxyacetate, and its acid
metabolite, E-1, 2-chloro-5-(4-chloro-5difluoromethoxy-1-methyl-1H-pyrazol3-yl)-4-fluorophenoxyacetic acid,
expressed in terms of the parent, in or
on food commodities soybean, seed to
0.05 ppm; soybean, hay to 0.10 ppm;
wheat, forage to 0.02 ppm; and wheat,
hay to 0.01 ppm.These notices
referenced a summary of the petition
prepared by Nichino America, Inc., the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notices of filing. Tolerances for milk at
0.02 ppm; cattle, meat byproducts at
0.02 ppm; goat, meat byproducts at 0.02
ppm; horse, meat byproducts at 0.02
ppm; and sheep, meat byproducts at
0.02 ppm expire on October 15, 2012. A
time limitation been imposed because of
the requirement for a cattle feeding
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study conducted to determine residues
of the E-9 metabolite in milk and cattle
tissues.
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 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 the petitioned-for
tolerances for residues of pyraflufenethyl and its metabolite expressed in
terms of the parent on grass, forage,
group 17 at 1.0 ppm; grass, hay, group
17 at 1.4 ppm; milk at 0.02 ppm; cattle,
meat byproducts at 0.02 ppm; goat, meat
byproducts at 0.02 ppm; horse, meat
byproducts at 0.02 ppm; and sheep,
meat byproducts at 0.02 ppm, and by
revising existing tolerances for soybean,
forage to 0.05 ppm; soybean, hay to 0.10
ppm; wheat, forage to 0.02 ppm; and
wheat, hay to 0.01 ppm. EPA’s
assessment of exposures and risks
associated with establishing these
tolerances 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. Specific
information on the studies received and
the nature of the toxic effects caused by
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pyraflufen-ethyl as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies.
Pyraflufen-ethyl has low to moderate
toxicity from acute exposure and it is
not a dermal sensitizer. The liver,
kidney, and possibly the hematopoietic
system are the target organs for
pyraflufen-ethyl in the rat and/or the
mouse. There is no evidence of
increased sensitivity to the young in
developmental and reproductive studies
with pyraflufen-ethyl. Pyraflufen-ethyl
was not shown to be mutagenic in a
battery of tests. Pyraflufen-ethyl was
classified as ‘‘Likely to be carcinogenic
to humans’’ based on male mouse
hepatocellular adenomas, carcinomas
and/or hepatoblastomas (combined)
observed in the mouse carcinogenicity
study.
Specific information on the studies
received and the nature of the toxic
effects caused by pyraflufen-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
Pyraflufen-ethyl: Human Health Risk
Assessment for Pyraflufen-ethyl:
Proposed New Use on Pasture and
Rangeland Grasses (PP 7F7190) and
Amendment to Allow Early Season
Postemergence Broadcast Uses to Corn
(excluding sweet corn), Soybeans and
Wheat at page 13 in docket ID number
EPA–HQ–OPP–2007–0366.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs/safety factors) are used in
conjunction with the POD to take into
account uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
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population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and
chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
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 greater than that 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/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for pyraflufen-ethyl used for
human risk assessment can be found at
https://www.regulations.gov in document
Pyraflufen-ethyl: Human Health Risk
Assessment for Pyraflufen-ethyl:
Proposed New Use on Pasture and
Rangeland Grasses (PP#7F7190) and
Amendment to Allow Early Season
Postemergence Broadcast Uses to Corn
(excluding sweet corn), Soybeans and
Wheat at page 13 in docket ID number
EPA–HQ–OPP–2007-0366. Also, a
summary of the toxicological endpoints
for pyraflufen-ethyl used for human risk
assessment is discussed in Unit III.B. of
the final rule published in the Federal
Register of April 30, 2003 (68 FR 23046)
(FRL–7300–9).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to pyraflufen-ethyl, EPA
considered exposure from the
petitioned-for tolerances as well as all
existing pyraflufen-ethyl tolerances in
40 CFR 180.585. EPA assessed dietary
exposures from pyraflufen-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 1–day or single
exposure.
No such effects were identified in the
toxicological studies for pyraflufenethyl; 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 1994–1996 and 1998
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Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, the following assumptions were
made for the chronic exposure
assessments: 100 percent crop treated
(PCT) and tolerance-level residues for
pyraflufen-ethyl on all treated crops
except corn, cottonseed, potato, soybean
and wheat for which one half of the
combined Levels of Quantification
(LOQs) for the parent and the metabolite
were used since all field trial data were
less than the LOQ.
iii. Cancer. For the cancer dietary
exposure assessment EPA used the food
consumption data from the USDA 1994–
1996 and 1998 Continuing Surveys of
Food Intake by Individuals (CSFII). As
to residue levels in food, the following
assumptions were made for the chronic
exposure assessments: 100 percent crop
treated (PCT) and tolerance-level
residues for pyraflufen-ethyl on all
treated crops except corn, cottonseed,
potato, soybean and wheat for which
one-half of the combined LOQs for the
parent and the metabolite were used
since all field trial data were less than
the LOQ.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for pyraflufen-ethyl in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
pyraflufen-ethyl. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
pyraflufen-ethyl for acute exposures are
estimated to be 1,247 parts per trillion
(ppt) for surface water and 1.8 ppt for
ground water. Chronic exposures for
cancer assessments are estimated to be
281 ppt for surface water and 1.8 ppt 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 281 ppt
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).
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Pyraflufen-ethyl is currently
registered on the following residential
non-dietary sites that could result in
residential exposures: airports,
nurseries, ornamental turf, golf courses,
roadsides, railroads, non-crop land, and
uncultivated agricultural areas. The risk
assessment was conducted using the
following residential exposure
assumptions: adults and children may
be exposed to residues of pyraflufenethyl through short-term postapplication contact with treated areas
which may include residential/
recreational areas.
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 pyraflufen-ethyl to
share a common mechanism of toxicity
with any other substances, and
pyraflufen-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 pyraflufen-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 website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence of increased
susceptibility of rat or rabbit fetuses
following in utero exposure in the
developmental studies with pyraflufenethyl. There is no evidence of increased
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susceptibility of young rats in the
reproduction study with pyraflufenethyl. EPA concluded there are no
residual uncertainties for pre- and/or
postnatal exposure.
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 pyraflufenethyl is complete.
ii. There is no indication that
pyraflufen-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 evidence that
pyraflufen-ethyl results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% of the
crop treated and a conservative estimate
of residues in food. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to pyraflufenethyl in drinking water. EPA used
similarly conservative assumptions to
assess post-application exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by pyraflufen-ethyl.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases 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 POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. No adverse effect resulting from
a single-oral exposure was identified
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51741
and no acute dietary endpoint was
selected. Therefore, pyraflufen-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 pyraflufenethyl from food and water will utilize
less than 1% of the cPAD for all
population groups. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of
pyraflufen-ethyl is not expected.
3. Short-term risk. Pyraflufen-ethyl is
currently registered for use(s) 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
pyraflufen-ethyl.
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). A shortterm risk aggregate assessment was not
performed for adults because no handler
exposure is expected and postapplication inhalation exposure is
expected to be negligible (and there are
no dermal endpoints of concern). A
short-term aggregate risk assessment
was performed for infants and children
because there is a potential for oral postapplication exposure resulting from
contact with treated areas which may
include residential/recreational areas.
Short-term aggregate exposure takes into
account residential exposure plus
chronic exposure to food and water.
Short term aggregate risk is based on
children’s incidental oral exposure
(from residential post-application
treatment) and dietary exposure (food
and drinking water). The anticipated
exposure level for children, 1-2 years
(the highest exposed population) is
below EPA’s level of concern, with a
Margin of Exposure (MOE) greater than
60,000.
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).
Pyraflufen-ethyl is not registered for
any use patterns that would result in
intermediate-term residential exposure.
No residential handler exposure is
expected and post-application
inhalation exposure is expected to be
negligible. Post-application exposure to
infants and children over the
intermediate term duration (1 to 6)
months is not likely based on the use
pattern. Therefore, the intermediate-
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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations
term aggregate risk is the sum of the risk
from exposure to pyraflufen-ethyl
through food and water, which has
already been addressed, and will not be
greater than the chronic aggregate risk.
5. Aggregate cancer risk for U.S.
population. The aggregate cancer risk
assessment for the general population
takes into account exposure estimates
form dietary consumption of pyraflufenethyl from food, residential, and drink
water sources. Exposures from
residential uses are based on the
lifetime average daily dose and assume
an exposure period of 5 days per year
and 50 years of exposure in a lifetime
(70 years). Average food plus water
source dietary exposure was used.
Estimated cancer risk for the U.S.
population includes infants and
children. The aggregate cancer risk
estimate for pyraflufen-ethyl is 2.9 x
10-6. This risk estimate is based, in part,
on the conservative assumption that
100% of all crops for which pyraflufenethyl is registered or proposed for
registration are treated. Additional
refinement using Percent Crop Treated
estimates would result in a lower
estimate of cancer risk.
EPA generally considers cancer risks
in the range of 1 in 1 million (1 x 10-6)
or less to be negligible. The precision
which can be assumed for cancer risk
estimates is best described by rounding
to the nearest integral order of
magnitude on the log scale; for example,
risks falling between 3.16 x 10-7 and
3.16 x 10-6 are expressed as risks in the
range of 1 x 10-6. Considering the
precision with which cancer hazard can
be estimated, the conservativeness of
low-dose linear extrapolation, and the
rounding procedure described above,
cancer risk should generally not be
assumed to exceed the benchmark LOC
of the range of 1 x 10-6 until the
calculated risk exceeds approximately 3
x 10-6. Since the calculated cancer risk
for pyraflufen-ethyl does not exceed this
level, estimated cancer risk is
considered to be negligible.
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 pyraflufenethyl residues.
hsrobinson on PROD1PC76 with RULES
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(Gas Chromatography and Mass
Spectrometry (GC/MS)) is available to
enforce the tolerance expression. The
method may be requested from: Chief,
Analytical Chemistry Branch,
VerDate Aug<31>2005
19:20 Sep 04, 2008
Jkt 214001
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
There are currently no established
Codex, Canadian or Mexican maximum
residue limits, for residues of
pyraflufen-ethyl in/on grass, milk, meat
byproducts, soybean and wheat.
V. Conclusion
Therefore, permanent tolerances are
established for residues of pyraflufenethyl and its metabolite expressed in
terms of the parent on grass, forage,
group 17 at 1.0 ppm; grass, hay, group
17 at 1.4 ppm. Time-limited tolerances
are established for milk at 0.02 ppm;
cattle, meat byproducts at 0.02 ppm;
goat, meat byproducts at 0.02 ppm;
horse, meat byproducts at 0.02 ppm;
and sheep, meat byproducts at 0.02
ppm. Existing tolerances are revised for
soybean, forage to 0.05 ppm; soybean,
hay to 0.10 ppm; wheat, forage to 0.02
ppm; and wheat, hay to 0.01 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, 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.
PO 00000
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Fmt 4700
Sfmt 4700
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. 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 this final rule in the
Federal Register. This final rule 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.
E:\FR\FM\05SER1.SGM
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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations
Dated: August 25, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
*
*
*
*
*
[FR Doc. E8–20515 Filed 9–4–08; 8:45 am]
BILLING CODE 6560–50–S
Therefore, 40 CFR chapter I is
amended as follows:
I
DEPARTMENT OF COMMERCE
PART 180—[AMENDED]
National Oceanic and Atmospheric
Administration
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.585 is amended by
revising paragraph (a) to read as follows:
I
§ 180.585 Pyraflufen-ethyl; tolerances for
residues.
(a) General. Tolerances are
established for residues of the herbicide,
pyraflufen-ethyl, ethyl 2-chloro-5-(4chloro-5-difluoromethoxy-1-methyl-1Hpyrazol-3-yl)-4-fluorophenoxyacetate,
and its acid metabolite, E-1, 2-chloro-5(4-chloro-5-difluoromethoxy-1-methyl1H-pyrazol-3-yl)-4-fluorophenoxyacetic
acid, expressed in terms of the parent in
or on the following food commodities:
Parts per
million
Commodity
hsrobinson on PROD1PC76 with RULES
Cattle, meat byproducts ........
Corn, field, forage ................
Corn, field, grain
Corn, field, stover .................
Cotton, gin byproducts ........
Cotton,
undelinted
seed ..............
Goat, meat byproducts ........
Grass, forage,
group 17 ........
Grass, hay,
group 17 ........
Horse, meat byproducts ........
Milk ...................
Potato ...............
Sheep, meat byproducts ........
Soybean, forage
Soybean, hay ....
Soybean, seed ..
Wheat, forage ...
Wheat, grain .....
Wheat, hay .......
Wheat, straw .....
VerDate Aug<31>2005
Expiration/
revocation
date
0.02
10/15/12
0.01
0.01
None
None
0.01
None
1.5
None
0.04
None
0.02
10/15/12
1.0
None
1.4
None
0.02
0.02
0.02
10/15/12
10/15/12
None
0.02
0.05
0.10
0.01
0.02
0.01
0.01
0.01
10/15/12
None
None
None
None
None
None
None
50 CFR Part 648
[Docket No. 070717340–8451–02]
RIN 0648–XK16
Fisheries of the Northeastern United
States; Atlantic Mackerel, Squid, and
Butterfish Fisheries; Closure of the
Directed Butterfish Fishery
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
SUMMARY: NMFS announces that the
directed fishery for butterfish in the
Exclusive Economic Zone (EEZ) will be
closed effective 0001 hours, September
5, 2008. Vessels issued a Federal permit
to harvest butterfish may not retain or
land more than 250 lb (0.11–mt) of
butterfish per trip for the remainder of
the year (through December 31, 2008).
This action is necessary to prevent the
fishery from exceeding its domestic
annual harvest (DAH) of 500 mt and to
allow for effective management of this
stock.
Effective 0001 hours, September
5, 2008, through 2400 hours, December
31, 2008.
FOR FURTHER INFORMATION CONTACT: Don
Frei, Fishery Management Specialist,
978–281–9221, Fax 978–281–9135.
SUPPLEMENTARY INFORMATION:
Regulations governing the butterfish
fishery are found at 50 CFR part 648.
The regulations require specifications
for maximum sustainable yield, initial
optimum yield, allowable biological
catch, domestic annual harvest (DAH),
domestic annual processing, joint
venture processing, and total allowable
levels of foreign fishing for the species
managed under the Atlantic Mackerel,
Squid, and Butterfish Fishery
Management Plan. The procedures for
DATES:
19:20 Sep 04, 2008
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PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
51743
setting the annual initial specifications
are described in § 648.21.
The 2008 specification of DAH for
butterfish was set at 500 mt (73 FR
18443, April 4, 2008).
Section 648.22 requires NMFS to
close the directed butterfish fishery in
the EEZ when 80 percent of the total
annual DAH has been harvested. If 80
percent of the butterfish DAH is
projected to be landed prior to October
1, a 250–lb (0.11–mt) incidental
butterfish possession limit is put in
effect for the remainder of the year, and
if 80 percent of the butterfish DAH is
projected to be landed on or after
October 1, a 600–lb (0.27–mt) incidental
butterfish possession limit is put in
effect for the remainder of the year.
NMFS is further required to notify, in
advance of the closure, the Executive
Directors of the Mid-Atlantic, New
England, and South Atlantic Fishery
Management Councils; mail notification
of the closure to all holders of butterfish
permits at least 72 hr before the effective
date of the closure; provide adequate
notice of the closure to recreational
participants in the fishery; and publish
notification of the closure in the Federal
Register. The Administrator, Northeast
Region, NMFS, based on dealer reports
and other available information, has
determined that 80 percent of the DAH
for butterfish in 2008 fishing year will
be harvested. Therefore, effective 0001
hours, September 5, 2008, the directed
fishery for butterfish fishery is closed
and vessels issued Federal permits for
butterfish may not retain or land more
than 250 lb (0.11 mt) of butterfish
during a calendar day. The directed
fishery will reopen effective 0001 hours,
January 1, 2009, when the 2009 DAH
becomes available.
Classification
This action is required by 50 CFR part
648 and is exempt from review under
Executive Order 12866.
Authority: 16 U.S.C. 1801 et seq.
Dated: September 2, 2008.
Allan D. Risenhoover,
Director, Office of Sustainable Fisheries,
National Marine Fisheries Service.
[FR Doc. E8–20600 Filed 9–2–08; 4:15 pm]
BILLING CODE 3510–22–S
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]]>Agencies
[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Rules and Regulations]
[Pages 51738-51743]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20515]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0366; FRL-8377-6]
Pyraflufen-ethyl; Time-Limited Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes permanent tolerances for residues
of pyraflufen-ethyl in or on grass, forage, group 17; and grass, hay,
group 17; establishes time-limited tolerances for milk; cattle, meat
byproducts; goat, meat byproducts; horse, meat byproducts and sheep,
meat byproducts, and revises the existing tolerances for soybean,
forage; soybean, hay; wheat, forage and wheat, hay. Nichino America,
Inc. requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA). The time-limited tolerances expire on October 15,
2012.
DATES: This regulation is effective September 5, 2008. Objections and
requests for hearings must be received on or before November 4, 2008,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0366. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the OPP
Public Docket, in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-305-6224; e-mail address:
miller.joanne@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.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing
[[Page 51739]]
Office's pilot e-CFR site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2007-0366 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before November 4, 2008
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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0366, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg., 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted
during the Docket's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket Facility
telephone number is (703) 305-5805.
II. Petition for Tolerances
In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7190) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be
amended by establishing tolerances for residues of the herbicide,
pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate; and its acid
metabolite, E-1, 2-chloro-5-4-chloro-5-difluoromethoxy-(1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms of the
parent in or on food commodities: Soybeans, forage at 0.05 parts per
million (ppm); soybean, hay at 0.10 ppm; grass, forage, crop group 17
at 1.0 ppm; and grass, hay, crop group 17 at 1.2 ppm.
In the Federal Register of June 13, 2008 (73 FR 33814) (FRL-8367-
3), EPA issued a second notice pursuant to section 408(d)(3) of FFDCA,
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7190) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be
amended by establishing new tolerances for residues of the herbicide,
pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate, and its acid
metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms of the
parent, in or on food commodities grass, forage, group 17 at 1.0 ppm;
grass, hay, group 17 at 1.4 ppm; milk at 0.02 ppm; cattle, meat
byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, meat
byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm, and by
revising existing tolerances for residues of the herbicide, pyraflufen-
ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetate, and its acid metabolite, E-1, 2-
chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetic acid, expressed in terms of the parent, in or on
food commodities soybean, seed to 0.05 ppm; soybean, hay to 0.10 ppm;
wheat, forage to 0.02 ppm; and wheat, hay to 0.01 ppm.These notices
referenced a summary of the petition prepared by Nichino America, Inc.,
the registrant, which is available to the public in the docket, https://
www.regulations.gov. There were no comments received in response to the
notices of filing. Tolerances for milk at 0.02 ppm; cattle, meat
byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, meat
byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm expire
on October 15, 2012. A time limitation been imposed because of the
requirement for a cattle feeding study conducted to determine residues
of the E-9 metabolite in milk and cattle tissues.
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 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 the petitioned-for tolerances for residues of pyraflufen-
ethyl and its metabolite expressed in terms of the parent on grass,
forage, group 17 at 1.0 ppm; grass, hay, group 17 at 1.4 ppm; milk at
0.02 ppm; cattle, meat byproducts at 0.02 ppm; goat, meat byproducts at
0.02 ppm; horse, meat byproducts at 0.02 ppm; and sheep, meat
byproducts at 0.02 ppm, and by revising existing tolerances for
soybean, forage to 0.05 ppm; soybean, hay to 0.10 ppm; wheat, forage to
0.02 ppm; and wheat, hay to 0.01 ppm. EPA's assessment of exposures and
risks associated with establishing these tolerances 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. Specific information on the studies received and the nature
of the toxic effects caused by
[[Page 51740]]
pyraflufen-ethyl as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies.
Pyraflufen-ethyl has low to moderate toxicity from acute exposure
and it is not a dermal sensitizer. The liver, kidney, and possibly the
hematopoietic system are the target organs for pyraflufen-ethyl in the
rat and/or the mouse. There is no evidence of increased sensitivity to
the young in developmental and reproductive studies with pyraflufen-
ethyl. Pyraflufen-ethyl was not shown to be mutagenic in a battery of
tests. Pyraflufen-ethyl was classified as ``Likely to be carcinogenic
to humans'' based on male mouse hepatocellular adenomas, carcinomas
and/or hepatoblastomas (combined) observed in the mouse carcinogenicity
study.
Specific information on the studies received and the nature of the
toxic effects caused by pyraflufen-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 Pyraflufen-ethyl: Human Health Risk
Assessment for Pyraflufen-ethyl: Proposed New Use on Pasture and
Rangeland Grasses (PP 7F7190) and Amendment to Allow Early Season
Postemergence Broadcast Uses to Corn (excluding sweet corn), Soybeans
and Wheat at page 13 in docket ID number EPA-HQ-OPP-2007-0366.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs/
safety factors) are used in conjunction with the POD to take into
account uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. Safety is
assessed for acute and chronic dietary risks by comparing aggregate
food and water exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and chronic-term risks are evaluated
by comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
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
greater than that 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/factsheets/riskassess.htm.
A summary of the toxicological endpoints for pyraflufen-ethyl used
for human risk assessment can be found at https://www.regulations.gov in
document Pyraflufen-ethyl: Human Health Risk Assessment for Pyraflufen-
ethyl: Proposed New Use on Pasture and Rangeland Grasses
(PP7F7190) and Amendment to Allow Early Season Postemergence
Broadcast Uses to Corn (excluding sweet corn), Soybeans and Wheat at
page 13 in docket ID number EPA-HQ-OPP-2007-0366. Also, a summary of
the toxicological endpoints for pyraflufen-ethyl used for human risk
assessment is discussed in Unit III.B. of the final rule published in
the Federal Register of April 30, 2003 (68 FR 23046) (FRL-7300-9).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyraflufen-ethyl, EPA considered exposure from the
petitioned-for tolerances as well as all existing pyraflufen-ethyl
tolerances in 40 CFR 180.585. EPA assessed dietary exposures from
pyraflufen-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 1-day or single exposure.
No such effects were identified in the toxicological studies for
pyraflufen-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 1994-1996
and 1998 Continuing Surveys of Food Intake by Individuals (CSFII). As
to residue levels in food, the following assumptions were made for the
chronic exposure assessments: 100 percent crop treated (PCT) and
tolerance-level residues for pyraflufen-ethyl on all treated crops
except corn, cottonseed, potato, soybean and wheat for which one half
of the combined Levels of Quantification (LOQs) for the parent and the
metabolite were used since all field trial data were less than the LOQ.
iii. Cancer. For the cancer dietary exposure assessment EPA used
the food consumption data from the USDA 1994-1996 and 1998 Continuing
Surveys of Food Intake by Individuals (CSFII). As to residue levels in
food, the following assumptions were made for the chronic exposure
assessments: 100 percent crop treated (PCT) and tolerance-level
residues for pyraflufen-ethyl on all treated crops except corn,
cottonseed, potato, soybean and wheat for which one-half of the
combined LOQs for the parent and the metabolite were used since all
field trial data were less than the LOQ.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pyraflufen-ethyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of pyraflufen-ethyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at https://www.epa.gov/oppefed1/models/water/
index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of pyraflufen-ethyl for
acute exposures are estimated to be 1,247 parts per trillion (ppt) for
surface water and 1.8 ppt for ground water. Chronic exposures for
cancer assessments are estimated to be 281 ppt for surface water and
1.8 ppt 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 281 ppt 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).
[[Page 51741]]
Pyraflufen-ethyl is currently registered on the following
residential non-dietary sites that could result in residential
exposures: airports, nurseries, ornamental turf, golf courses,
roadsides, railroads, non-crop land, and uncultivated agricultural
areas. The risk assessment was conducted using the following
residential exposure assumptions: adults and children may be exposed to
residues of pyraflufen-ethyl through short-term post-application
contact with treated areas which may include residential/recreational
areas.
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 pyraflufen-ethyl to share a common mechanism of
toxicity with any other substances, and pyraflufen-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
pyraflufen-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 website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat or rabbit fetuses following in utero
exposure in the developmental studies with pyraflufen-ethyl. There is
no evidence of increased susceptibility of young rats in the
reproduction study with pyraflufen-ethyl. EPA concluded there are no
residual uncertainties for pre- and/or postnatal exposure.
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 pyraflufen-ethyl is complete.
ii. There is no indication that pyraflufen-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 evidence that pyraflufen-ethyl results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% of the crop treated and a conservative estimate of residues in
food. EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to pyraflufen-ethyl in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by pyraflufen-ethyl.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute 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,
pyraflufen-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
pyraflufen-ethyl from food and water will utilize less than 1% of the
cPAD for all population groups. Based on the explanation in Unit
III.C.3., regarding residential use patterns, chronic residential
exposure to residues of pyraflufen-ethyl is not expected.
3. Short-term risk. Pyraflufen-ethyl is currently registered for
use(s) 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 pyraflufen-ethyl.
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). A short-term risk
aggregate assessment was not performed for adults because no handler
exposure is expected and post-application inhalation exposure is
expected to be negligible (and there are no dermal endpoints of
concern). A short-term aggregate risk assessment was performed for
infants and children because there is a potential for oral post-
application exposure resulting from contact with treated areas which
may include residential/recreational areas. Short-term aggregate
exposure takes into account residential exposure plus chronic exposure
to food and water. Short term aggregate risk is based on children's
incidental oral exposure (from residential post-application treatment)
and dietary exposure (food and drinking water). The anticipated
exposure level for children, 1-2 years (the highest exposed population)
is below EPA's level of concern, with a Margin of Exposure (MOE)
greater than 60,000.
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).
Pyraflufen-ethyl is not registered for any use patterns that would
result in intermediate-term residential exposure. No residential
handler exposure is expected and post-application inhalation exposure
is expected to be negligible. Post-application exposure to infants and
children over the intermediate term duration (1 to 6) months is not
likely based on the use pattern. Therefore, the intermediate-
[[Page 51742]]
term aggregate risk is the sum of the risk from exposure to pyraflufen-
ethyl through food and water, which has already been addressed, and
will not be greater than the chronic aggregate risk.
5. Aggregate cancer risk for U.S. population. The aggregate cancer
risk assessment for the general population takes into account exposure
estimates form dietary consumption of pyraflufen-ethyl from food,
residential, and drink water sources. Exposures from residential uses
are based on the lifetime average daily dose and assume an exposure
period of 5 days per year and 50 years of exposure in a lifetime (70
years). Average food plus water source dietary exposure was used.
Estimated cancer risk for the U.S. population includes infants and
children. The aggregate cancer risk estimate for pyraflufen-ethyl is
2.9 x 10-6. This risk estimate is based, in part, on the
conservative assumption that 100% of all crops for which pyraflufen-
ethyl is registered or proposed for registration are treated.
Additional refinement using Percent Crop Treated estimates would result
in a lower estimate of cancer risk.
EPA generally considers cancer risks in the range of 1 in 1 million
(1 x 10-6) or less to be negligible. The precision which can
be assumed for cancer risk estimates is best described by rounding to
the nearest integral order of magnitude on the log scale; for example,
risks falling between 3.16 x 10-7 and 3.16 x 10-6
are expressed as risks in the range of 1 x 10-6. Considering
the precision with which cancer hazard can be estimated, the
conservativeness of low-dose linear extrapolation, and the rounding
procedure described above, cancer risk should generally not be assumed
to exceed the benchmark LOC of the range of 1 x 10-6 until
the calculated risk exceeds approximately 3 x 10-6. Since
the calculated cancer risk for pyraflufen-ethyl does not exceed this
level, estimated cancer risk is considered to be negligible.
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 pyraflufen-ethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Gas Chromatography and Mass
Spectrometry (GC/MS)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no established Codex, Canadian or Mexican
maximum residue limits, for residues of pyraflufen-ethyl in/on grass,
milk, meat byproducts, soybean and wheat.
V. Conclusion
Therefore, permanent tolerances are established for residues of
pyraflufen-ethyl and its metabolite expressed in terms of the parent on
grass, forage, group 17 at 1.0 ppm; grass, hay, group 17 at 1.4 ppm.
Time-limited tolerances are established for milk at 0.02 ppm; cattle,
meat byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse,
meat byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm.
Existing tolerances are revised for soybean, forage to 0.05 ppm;
soybean, hay to 0.10 ppm; wheat, forage to 0.02 ppm; and wheat, hay to
0.01 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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.
[[Page 51743]]
Dated: August 25, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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. Section 180.585 is amended by revising paragraph (a) to read as
follows:
Sec. 180.585 Pyraflufen-ethyl; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide, pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-
difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate, and
its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms
of the parent in or on the following food commodities:
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Cattle, meat byproducts....................... 0.02 10/15/12
Corn, field, forage........................... 0.01 None
Corn, field, grain............................ 0.01 None
Corn, field, stover........................... 0.01 None
Cotton, gin byproducts........................ 1.5 None
Cotton, undelinted seed....................... 0.04 None
Goat, meat byproducts......................... 0.02 10/15/12
Grass, forage, group 17....................... 1.0 None
Grass, hay, group 17.......................... 1.4 None
Horse, meat byproducts........................ 0.02 10/15/12
Milk.......................................... 0.02 10/15/12
Potato........................................ 0.02 None
Sheep, meat byproducts........................ 0.02 10/15/12
Soybean, forage............................... 0.05 None
Soybean, hay.................................. 0.10 None
Soybean, seed................................. 0.01 None
Wheat, forage................................. 0.02 None
Wheat, grain.................................. 0.01 None
Wheat, hay.................................... 0.01 None
Wheat, straw.................................. 0.01 None
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-20515 Filed 9-4-08; 8:45 am]
BILLING CODE 6560-50-S
