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51738 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations
that Executive Order 13132, entitled Parts per the Internet and will be publicly
Commodity
Federalism (64 FR 43255, August 10, million available only in hard copy form.
1999) and Executive Order 13175, Publicly available docket materials are
entitled Consultation and Coordination * * * * * available either in the electronic docket
with Indian Tribal Governments (65 FR Pistachio ................................... 0.05 at http://www.regulations.gov, or, if only
* * * * *
67249, November 9, 2000) do not apply available in hard copy, at the OPP
to this final rule. In addition, this final Public Docket, in Rm. S4400, One
* * * * *
rule does not impose any enforceable Potomac Yard (South Bldg.), 2777 S.
[FR Doc. E820625 Filed 9408; 8:45 am]
duty or contain any unfunded mandate Crystal Dr., Arlington, VA. The Docket
BILLING CODE 656050S
as described under Title II of the Facility is open from 8:30 a.m. to 4 p.m.,
Unfunded Mandates Reform Act of 1995 Monday through Friday, excluding legal
(UMRA) (Public Law 1044). holidays. The Docket Facility telephone
ENVIRONMENTAL PROTECTION
This action does not involve any number is (703) 3055805.
AGENCY
technical standards that would require FOR FURTHER INFORMATION CONTACT:
Agency consideration of voluntary 40 CFR Part 180 Joanne I. Miller, Registration Division
consensus standards pursuant to section (7505P), Office of Pesticide Programs,
[EPAHQOPP2007-0366; FRL83776]
12(d) of the National Technology Environmental Protection Agency, 1200
Transfer and Advancement Act of 1995 Pyraflufen-ethyl; Time-Limited Pennsylvania Ave., NW., Washington,
(NTTAA), Public Law 104113, section Pesticide Tolerances DC 204600001; telephone number:
12(d) (15 U.S.C. 272 note). 703-305-6224; e-mail address:
AGENCY: Environmental Protection miller.joanne@epa.gov.
VII. Congressional Review Act Agency (EPA).
SUPPLEMENTARY INFORMATION:
ACTION: Final rule.
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides I. General Information
SUMMARY: This regulation establishes
that before a rule may take effect, the permanent tolerances for residues of A. Does this Action Apply to Me?
agency promulgating the rule must pyraflufen-ethyl in or on grass, forage, You may be potentially affected by
submit a rule report to each House of group 17; and grass, hay, group 17; this action if you are an agricultural
the Congress and to the Comptroller establishes time-limited tolerances for producer, food manufacturer, or
General of the United States. EPA will milk; cattle, meat byproducts; goat, meat pesticide manufacturer. Potentially
submit a report containing this rule and byproducts; horse, meat byproducts and affected entities may include, but are
other required information to the U.S. sheep, meat byproducts, and revises the not limited to:
Senate, the U.S. House of existing tolerances for soybean, forage;
Representatives, and the Comptroller ˇ Crop production (NAICS code 111).
soybean, hay; wheat, forage and wheat, ˇ Animal production (NAICS code
General of the United States prior to hay. Nichino America, Inc. requested
publication of this final rule in the 112).
these tolerances under the Federal Food, ˇ Food manufacturing (NAICS code
Federal Register. This final rule is not Drug, and Cosmetic Act (FFDCA). The
a ``major rule'' as defined by 5 U.S.C. 311).
time-limited tolerances expire on ˇ Pesticide manufacturing (NAICS
804(2). October 15, 2012. code 32532).
DATES: This regulation is effective This listing is not intended to be
List of Subjects in 40 CFR Part 180
September 5, 2008. Objections and exhaustive, but rather provides a guide
Environmental protection, requests for hearings must be received for readers regarding entities likely to be
Administrative practice and procedure, on or before November 4, 2008, and affected by this action. Other types of
Agricultural commodities, Pesticides must be filed in accordance with the entities not listed in this unit could also
and pests, Reporting and recordkeeping instructions provided in 40 CFR part be affected. The North American
requirements. 178 (see also Unit I.C. of the Industrial Classification System
SUPPLEMENTARY INFORMATION). (NAICS) codes have been provided to
Dated: August 25, 2008.
ADDRESSES: EPA has established a assist you and others in determining
Lois Rossi, docket for this action under docket whether this action might apply to
Director, Registration Division, Office of identification (ID) number EPAHQ certain entities. If you have any
Pesticide Programs. OPP2007-0366. To access the questions regarding the applicability of
ITherefore, 40 CFR chapter I is electronic docket, go to http:// this action to a particular entity, consult
amended as follows: www.regulations.gov, select ``Advanced the person listed under FOR FURTHER
Search,'' then ``Docket Search.'' Insert INFORMATION CONTACT.
PART 180--[AMENDED] the docket ID number where indicated
and select the ``Submit'' button. Follow B. How Can I Access Electronic Copies
the instructions on the regulations.gov of this Document?
I 1. The authority citation for part 180
continues to read as follows: website to view the docket index or In addition to accessing an electronic
access available documents. All copy of this Federal Register document
Authority: 21 U.S.C. 321(q), 346a and 371.
documents in the docket are listed in through the electronic docket at http://
I 2. Section 180.474 is amended in the docket index available in www.regulations.gov, you may access
paragraph (a)(1) by alphabetically regulations.gov. Although listed in the this Federal Register document
adding the commodity pistachio to the index, some information is not publicly electronically through the EPA Internet
hsrobinson on PROD1PC76 with RULES
table to read as follows: available, e.g., Confidential Business under the ``Federal Register'' listings at
Information (CBI) or other information http://www.epa.gov/fedrgstr. You may
§180.474 Tebuconazole; tolerances for whose disclosure is restricted by statute. also access a frequently updated
residues.
Certain other material, such as electronic version of 40 CFR part 180
(a) General. (1) * * * copyrighted material, is not placed on through the Government Printing
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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 51739
Office's pilot e-CFR site at http:// requested that 40 CFR 180.585 be study conducted to determine residues
www.gpoaccess.gov/ecfr. amended by establishing tolerances for of the E-9 metabolite in milk and cattle
residues of the herbicide, pyraflufen- tissues.
C. Can I File an Objection or Hearing
ethyl, ethyl 2-chloro-5-(4-chloro-5-
Request? III. Aggregate Risk Assessment and
difluoromethoxy-1-methyl-1H-pyrazol-3 Determination of Safety
Under section 408(g) of FFDCA, as -yl)-4-fluorophenoxyacetate; and its acid
amended by FQPA, any person may file metabolite, E-1, 2-chloro-5-4-chloro-5- Section 408(b)(2)(A)(i) of FFDCA
an objection to any aspect of this difluoromethoxy-(1-methyl-1H-pyrazol- allows EPA to establish a tolerance (the
regulation and may also request a 3-yl)-4-fluorophenoxyacetic acid, legal limit for a pesticide chemical
hearing on those objections. The EPA expressed in terms of the parent in or on residue in or on a food) only if EPA
procedural regulations which govern the food commodities: Soybeans, forage at determines that the tolerance is ``safe.''
submission of objections and requests 0.05 parts per million (ppm); soybean, Section 408(b)(2)(A)(ii) of FFDCA
for hearings appear in 40 CFR part 178. hay at 0.10 ppm; grass, forage, crop defines ``safe'' to mean that ``there is a
You must file your objection or request group 17 at 1.0 ppm; and grass, hay, reasonable certainty that no harm will
a hearing on this regulation in crop group 17 at 1.2 ppm. result from aggregate exposure to the
accordance with the instructions pesticide chemical residue, including
In the Federal Register of June 13,
provided in 40 CFR part 178. To ensure all anticipated dietary exposures and all
2008 (73 FR 33814) (FRL83673), EPA
proper receipt by EPA, you must other exposures for which there is
issued a second notice pursuant to reliable information.'' This includes
identify docket ID number EPAHQ
section 408(d)(3) of FFDCA, 21 U.S.C. exposure through drinking water and in
OPP2007-0366 in the subject line on
346a(d)(3), announcing the filing of a residential settings, but does not include
the first page of your submission. All
pesticide petition (PP 7F7190) by occupational exposure. Section
requests must be in writing, and must be
Nichino America, Inc., 4550 New 408(b)(2)(C) of FFDCA requires EPA to
mailed or delivered to the Hearing Clerk
Linden Hill Road, Suite 501, give special consideration to exposure
on or before November 4, 2008
In addition to filing an objection or Wilmington, DE 19808. The petition of infants and children to the pesticide
hearing request with the Hearing Clerk requested that 40 CFR 180.585 be chemical residue in establishing a
as described in 40 CFR part 178, please amended by establishing new tolerances tolerance and to ``ensure that there is a
submit a copy of the filing that does not for residues of the herbicide, pyraflufen- reasonable certainty that no harm will
contain any CBI for inclusion in the ethyl, ethyl 2-chloro-5-(4-chloro-5- result to infants and children from
public docket that is described in difluoromethoxy-1-methyl-1H-pyrazol- aggregate exposure to the pesticide
ADDRESSES. Information not marked
3-yl)-4-fluorophenoxyacetate, and its chemical residue....''
confidential pursuant to 40 CFR part 2 acid metabolite, E-1, 2-chloro-5-(4- Consistent with the factors specified
may be disclosed publicly by EPA chloro-5-difluoromethoxy-1-methyl-1H- in FFDCA section 408(b)(2)(D), EPA has
without prior notice. Submit your pyrazol-3-yl)-4-fluorophenoxyacetic reviewed the available scientific data
copies, identified by docket ID number acid, expressed in terms of the parent, and other relevant information in
EPAHQOPP2007-0366, by one of the in or on food commodities grass, forage, support of this action. EPA has
following methods: group 17 at 1.0 ppm; grass, hay, group sufficient data to assess the hazards of
ˇ Federal eRulemaking Portal: http:// 17 at 1.4 ppm; milk at 0.02 ppm; cattle, and to make a determination on
www.regulations.gov. Follow the on-line meat byproducts at 0.02 ppm; goat, meat aggregate exposure for the petitioned-for
instructions for submitting comments. byproducts at 0.02 ppm; horse, meat tolerances for residues of pyraflufen-
ˇ Mail: Office of Pesticide Programs byproducts at 0.02 ppm; and sheep, ethyl and its metabolite expressed in
(OPP) Regulatory Public Docket (7502P), meat byproducts at 0.02 ppm, and by terms of the parent on grass, forage,
Environmental Protection Agency, 1200 revising existing tolerances for residues group 17 at 1.0 ppm; grass, hay, group
Pennsylvania Ave., NW., Washington, of the herbicide, pyraflufen-ethyl, ethyl 17 at 1.4 ppm; milk at 0.02 ppm; cattle,
DC 204600001. 2-chloro-5-(4-chloro-5-difluoromethoxy- meat byproducts at 0.02 ppm; goat, meat
ˇ Delivery: OPP Regulatory Public 1-methyl-1H-pyrazol-3-yl)-4- byproducts at 0.02 ppm; horse, meat
Docket (7502P), Environmental fluorophenoxyacetate, and its acid byproducts at 0.02 ppm; and sheep,
Protection Agency, Rm. S4400, One metabolite, E-1, 2-chloro-5-(4-chloro-5- meat byproducts at 0.02 ppm, and by
Potomac Yard (South Bldg., 2777 S. difluoromethoxy-1-methyl-1H-pyrazol- revising existing tolerances for soybean,
Crystal Dr., Arlington, VA. Deliveries 3-yl)-4-fluorophenoxyacetic acid, forage to 0.05 ppm; soybean, hay to 0.10
are only accepted during the Docket's expressed in terms of the parent, in or ppm; wheat, forage to 0.02 ppm; and
normal hours of operation (8:30 a.m. to on food commodities soybean, seed to wheat, hay to 0.01 ppm. EPA's
4 p.m., Monday through Friday, 0.05 ppm; soybean, hay to 0.10 ppm; assessment of exposures and risks
excluding legal holidays). Special wheat, forage to 0.02 ppm; and wheat, associated with establishing these
arrangements should be made for hay to 0.01 ppm.These notices tolerances follows.
deliveries of boxed information. The referenced a summary of the petition
prepared by Nichino America, Inc., the A. Toxicological Profile
Docket Facility telephone number is
(703) 3055805. registrant, which is available to the EPA has evaluated the available
public in the docket, http:// toxicity data and considered its validity,
II. Petition for Tolerances www.regulations.gov. There were no completeness, and reliability as well as
In the Federal Register of June 27, comments received in response to the the relationship of the results of the
2007 (72 FR 35237) (FRL81334), EPA notices of filing. Tolerances for milk at studies to human risk. EPA has also
issued a notice pursuant to section 0.02 ppm; cattle, meat byproducts at considered available information
408(d)(3) of FFDCA, 21 U.S.C. 0.02 ppm; goat, meat byproducts at 0.02 concerning the variability of the
hsrobinson on PROD1PC76 with RULES
346a(d)(3), announcing the filing of a ppm; horse, meat byproducts at 0.02 sensitivities of major identifiable
pesticide petition (PP 7F7190) by ppm; and sheep, meat byproducts at subgroups of consumers, including
Nichino America, Inc., 4550 New 0.02 ppm expire on October 15, 2012. A infants and children. Specific
Linden Hill Road, Suite 501, time limitation been imposed because of information on the studies received and
Wilmington, DE 19808. The petition the requirement for a cattle feeding the nature of the toxic effects caused by
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51740 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations
pyraflufen-ethyl as well as the no- population adjusted dose (cPAD). The Continuing Surveys of Food Intake by
observed-adverse-effect-level (NOAEL) aPAD and cPAD are calculated by Individuals (CSFII). As to residue levels
and the lowest-observed-adverse-effect- dividing the POD by all applicable UFs. in food, the following assumptions were
level (LOAEL) from the toxicity studies. Aggregate short-, intermediate-, and made for the chronic exposure
Pyraflufen-ethyl has low to moderate chronic-term risks are evaluated by assessments: 100 percent crop treated
toxicity from acute exposure and it is comparing food, water, and residential (PCT) and tolerance-level residues for
not a dermal sensitizer. The liver, exposure to the POD to ensure that the pyraflufen-ethyl on all treated crops
kidney, and possibly the hematopoietic margin of exposure (MOE) called for by except corn, cottonseed, potato, soybean
system are the target organs for the product of all applicable UFs is not and wheat for which one half of the
pyraflufen-ethyl in the rat and/or the exceeded. This latter value is referred to combined Levels of Quantification
mouse. There is no evidence of as the Level of Concern (LOC). (LOQs) for the parent and the metabolite
increased sensitivity to the young in For non-threshold risks, the Agency were used since all field trial data were
developmental and reproductive studies assumes that any amount of exposure less than the LOQ.
with pyraflufen-ethyl. Pyraflufen-ethyl will lead to some degree of risk. Thus, iii. Cancer. For the cancer dietary
was not shown to be mutagenic in a the Agency estimates risk in terms of the exposure assessment EPA used the food
battery of tests. Pyraflufen-ethyl was probability of an occurrence of the consumption data from the USDA 1994
classified as ``Likely to be carcinogenic adverse effect greater than that expected 1996 and 1998 Continuing Surveys of
to humans'' based on male mouse in a lifetime. For more information on Food Intake by Individuals (CSFII). As
hepatocellular adenomas, carcinomas the general principles EPA uses in risk to residue levels in food, the following
and/or hepatoblastomas (combined) characterization and a complete assumptions were made for the chronic
observed in the mouse carcinogenicity description of the risk assessment exposure assessments: 100 percent crop
study. process, see http://www.epa.gov/ treated (PCT) and tolerance-level
Specific information on the studies pesticides/factsheets/riskassess.htm. residues for pyraflufen-ethyl on all
received and the nature of the toxic A summary of the toxicological treated crops except corn, cottonseed,
effects caused by pyraflufen-ethyl as endpoints for pyraflufen-ethyl used for potato, soybean and wheat for which
well as the no-observed-adverse-effect- human risk assessment can be found at one-half of the combined LOQs for the
level (NOAEL) and the lowest-observed- http://www.regulations.gov in document parent and the metabolite were used
adverse-effect-level (LOAEL) from the Pyraflufen-ethyl: Human Health Risk since all field trial data were less than
toxicity studies can be found at http:// Assessment for Pyraflufen-ethyl: the LOQ.
www.regulations.gov in document Proposed New Use on Pasture and 2. Dietary exposure from drinking
Pyraflufen-ethyl: Human Health Risk Rangeland Grasses (PP#7F7190) and water. The Agency used screening level
Assessment for Pyraflufen-ethyl: Amendment to Allow Early Season water exposure models in the dietary
Proposed New Use on Pasture and Postemergence Broadcast Uses to Corn exposure analysis and risk assessment
Rangeland Grasses (PP 7F7190) and (excluding sweet corn), Soybeans and
Amendment to Allow Early Season for pyraflufen-ethyl in drinking water.
Wheat at page 13 in docket ID number These simulation models take into
Postemergence Broadcast Uses to Corn EPAHQOPP2007-0366. Also, a
(excluding sweet corn), Soybeans and account data on the physical, chemical,
summary of the toxicological endpoints and fate/transport characteristics of
Wheat at page 13 in docket ID number for pyraflufen-ethyl used for human risk
EPAHQOPP20070366. pyraflufen-ethyl. Further information
assessment is discussed in Unit III.B. of regarding EPA drinking water models
B. Toxicological Endpoints the final rule published in the Federal used in pesticide exposure assessment
Register of April 30, 2003 (68 FR 23046) can be found at http://www.epa.gov/
For hazards that have a threshold (FRL73009).
below which there is no appreciable oppefed1/models/water/index.htm.
risk, a toxicological point of departure C. Exposure Assessment Based on the First Index Reservoir
(POD) is identified as the basis for 1. Dietary exposure from food and Screening Tool (FIRST) and Screening
derivation of reference values for risk feed uses. In evaluating dietary Concentration in Ground Water (SCI-
assessment. The POD may be defined as exposure to pyraflufen-ethyl, EPA GROW) models, the estimated drinking
the highest dose at which no adverse considered exposure from the water concentrations (EDWCs) of
effects are observed (the NOAEL) in the petitioned-for tolerances as well as all pyraflufen-ethyl for acute exposures are
toxicology study identified as existing pyraflufen-ethyl tolerances in estimated to be 1,247 parts per trillion
appropriate for use in risk assessment. 40 CFR 180.585. EPA assessed dietary (ppt) for surface water and 1.8 ppt for
However, if a NOAEL cannot be exposures from pyraflufen-ethyl in food ground water. Chronic exposures for
determined, the lowest dose at which as follows: cancer assessments are estimated to be
adverse effects of concern are identified i. Acute exposure. Quantitative acute 281 ppt for surface water and 1.8 ppt for
(the LOAEL) or a Benchmark Dose dietary exposure and risk assessments ground water
(BMD) approach is sometimes used for are performed for a food-use pesticide, Modeled estimates of drinking water
risk assessment. Uncertainty/safety if a toxicological study has indicated the concentrations were directly entered
factors (UFs/safety factors) are used in possibility of an effect of concern into the dietary exposure model. For
conjunction with the POD to take into occurring as a result of a 1day or single chronic dietary risk assessment, the
account uncertainties inherent in the exposure. water concentration value of 281 ppt
extrapolation from laboratory animal No such effects were identified in the was used to assess the contribution to
data to humans and in the variations in toxicological studies for pyraflufen- drinking water.
sensitivity among members of the ethyl; therefore, a quantitative acute 3. From non-dietary exposure. The
human population as well as other dietary exposure assessment is term ``residential exposure'' is used in
hsrobinson on PROD1PC76 with RULES
unknowns. Safety is assessed for acute unnecessary. this document to refer to non-
and chronic dietary risks by comparing ii. Chronic exposure. In conducting occupational, non-dietary exposure
aggregate food and water exposure to the chronic dietary exposure assessment (e.g., for lawn and garden pest control,
the pesticide to the acute population EPA used the food consumption data indoor pest control, termiticides, and
adjusted dose (aPAD) and chronic from the USDA 19941996 and 1998 flea and tick control on pets).
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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 51741
Pyraflufen-ethyl is currently susceptibility of young rats in the and no acute dietary endpoint was
registered on the following residential reproduction study with pyraflufen- selected. Therefore, pyraflufen-ethyl is
non-dietary sites that could result in ethyl. EPA concluded there are no not expected to pose an acute risk.
residential exposures: airports, residual uncertainties for pre- and/or 2. Chronic risk. Using the exposure
nurseries, ornamental turf, golf courses, postnatal exposure. assumptions described in this unit for
roadsides, railroads, non-crop land, and 3. Conclusion. EPA has determined chronic exposure, EPA has concluded
uncultivated agricultural areas. The risk that reliable data show the safety of that chronic exposure to pyraflufen-
assessment was conducted using the infants and children would be ethyl from food and water will utilize
following residential exposure adequately protected if the FQPA SF less than 1% of the cPAD for all
assumptions: adults and children may were reduced to 1X. That decision is population groups. Based on the
be exposed to residues of pyraflufen- based on the following findings: explanation in Unit III.C.3., regarding
ethyl through short-term post- i. The toxicity database for pyraflufen- residential use patterns, chronic
application contact with treated areas ethyl is complete. residential exposure to residues of
which may include residential/ ii. There is no indication that pyraflufen-ethyl is not expected.
recreational areas. pyraflufen-ethyl is a neurotoxic 3. Short-term risk. Pyraflufen-ethyl is
4. Cumulative effects from substances chemical and there is no need for a currently registered for use(s) that could
with a common mechanism of toxicity. developmental neurotoxicity study or result in short-term residential exposure
Section 408(b)(2)(D)(v) of FFDCA additional UFs to account for and the Agency has determined that it
requires that, when considering whether neurotoxicity. is appropriate to aggregate chronic
to establish, modify, or revoke a iii. There is no evidence that exposure through food and water with
tolerance, the Agency consider pyraflufen-ethyl results in increased short-term residential exposures to
``available information'' concerning the susceptibility in in utero rats or rabbits pyraflufen-ethyl.
cumulative effects of a particular in the prenatal developmental studies or Short-term aggregate exposure takes
pesticide's residues and ``other in young rats in the 2generation into account short-term residential
substances that have a common reproduction study. exposure plus chronic exposure to food
mechanism of toxicity.'' iv. There are no residual uncertainties and water (considered to be a
EPA has not found pyraflufen-ethyl to identified in the exposure databases. background exposure level). A short-
share a common mechanism of toxicity The dietary food exposure assessments term risk aggregate assessment was not
with any other substances, and were performed based on 100% of the performed for adults because no handler
pyraflufen-ethyl does not appear to crop treated and a conservative estimate exposure is expected and post-
produce a toxic metabolite produced by of residues in food. EPA made application inhalation exposure is
other substances. For the purposes of conservative (protective) assumptions in expected to be negligible (and there are
this tolerance action, therefore, EPA has the ground and surface water modeling no dermal endpoints of concern). A
assumed that pyraflufen-ethyl does not used to assess exposure to pyraflufen- short-term aggregate risk assessment
have a common mechanism of toxicity ethyl in drinking water. EPA used was performed for infants and children
with other substances. For information similarly conservative assumptions to because there is a potential for oral post-
regarding EPA's efforts to determine assess post-application exposure of application exposure resulting from
which chemicals have a common children as well as incidental oral contact with treated areas which may
mechanism of toxicity and to evaluate exposure of toddlers. These assessments include residential/recreational areas.
the cumulative effects of such will not underestimate the exposure and Short-term aggregate exposure takes into
chemicals, see EPA's website at http:// risks posed by pyraflufen-ethyl. account residential exposure plus
www.epa.gov/pesticides/cumulative. chronic exposure to food and water.
E. Aggregate Risks and Determination of
Short term aggregate risk is based on
D. Safety Factor for Infants and Safety
children's incidental oral exposure
Children EPA determines whether acute and (from residential post-application
1. In general. Section 408(b)(2)(C) of chronic pesticide exposures are safe by treatment) and dietary exposure (food
FFDCA provides that EPA shall apply comparing aggregate exposure estimates and drinking water). The anticipated
an additional tenfold (10X) margin of to the aPAD and cPAD. The aPAD and exposure level for children, 1-2 years
safety for infants and children in the cPAD represent the highest safe (the highest exposed population) is
case of threshold effects to account for exposures, taking into account all below EPA's level of concern, with a
prenatal and postnatal toxicity and the appropriate SFs. EPA calculates the Margin of Exposure (MOE) greater than
completeness of the database on toxicity aPAD and cPAD by dividing the POD by 60,000.
and exposure unless EPA determines all applicable UFs. For linear cancer 4. Intermediate-term risk.
based on reliable data that a different risks, EPA calculates the probability of Intermediate-term aggregate exposure
margin of safety will be safe for infants additional cancer cases given the takes into account intermediate-term
and children. This additional margin of estimated aggregate exposure. Short-, residential exposure plus chronic
safety is commonly referred to as the intermediate-, and chronic-term risks exposure to food and water (considered
FQPA safety factor (SF). In applying this are evaluated by comparing the to be a background exposure level).
provision, EPA either retains the default estimated aggregate food, water, and Pyraflufen-ethyl is not registered for
value of 10X, or uses a different residential exposure to the POD to any use patterns that would result in
additional safety factor when reliable ensure that the MOE called for by the intermediate-term residential exposure.
data available to EPA support the choice product of all applicable UFs is not No residential handler exposure is
of a different factor. exceeded. expected and post-application
2. Prenatal and postnatal sensitivity. 1. Acute risk. An acute aggregate risk inhalation exposure is expected to be
hsrobinson on PROD1PC76 with RULES
There is no evidence of increased assessment takes into account exposure negligible. Post-application exposure to
susceptibility of rat or rabbit fetuses estimates from acute dietary infants and children over the
following in utero exposure in the consumption of food and drinking intermediate term duration (1 to 6)
developmental studies with pyraflufen- water. No adverse effect resulting from months is not likely based on the use
ethyl. There is no evidence of increased a single-oral exposure was identified pattern. Therefore, the intermediate-
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51742 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations
term aggregate risk is the sum of the risk Environmental Science Center, 701 This final rule directly regulates
from exposure to pyraflufen-ethyl Mapes Rd., Ft. Meade, MD 207555350; growers, food processors, food handlers,
through food and water, which has telephone number: (410) 3052905; e- and food retailers, not States or tribes,
already been addressed, and will not be mail address: residuemethods@epa.gov. nor does this action alter the
greater than the chronic aggregate risk. relationships or distribution of power
B. International Residue Limits
5. Aggregate cancer risk for U.S. and responsibilities established by
population. The aggregate cancer risk There are currently no established
Congress in the preemption provisions
assessment for the general population Codex, Canadian or Mexican maximum
of section 408(n)(4) of FFDCA. As such,
takes into account exposure estimates residue limits, for residues of
pyraflufen-ethyl in/on grass, milk, meat the Agency has determined that this
form dietary consumption of pyraflufen- action will not have a substantial direct
ethyl from food, residential, and drink byproducts, soybean and wheat.
effect on States or tribal governments,
water sources. Exposures from V. Conclusion on the relationship between the national
residential uses are based on the
Therefore, permanent tolerances are government and the States or tribal
lifetime average daily dose and assume
an exposure period of 5 days per year established for residues of pyraflufen- governments, or on the distribution of
and 50 years of exposure in a lifetime ethyl and its metabolite expressed in power and responsibilities among the
(70 years). Average food plus water terms of the parent on grass, forage, various levels of government or between
group 17 at 1.0 ppm; grass, hay, group the Federal Government and Indian
source dietary exposure was used.
17 at 1.4 ppm. Time-limited tolerances tribes. Thus, the Agency has determined
Estimated cancer risk for the U.S.
are established for milk at 0.02 ppm; that Executive Order 13132, entitled
population includes infants and
cattle, meat byproducts at 0.02 ppm; Federalism (64 FR 43255, August 10,
children. The aggregate cancer risk
goat, meat byproducts at 0.02 ppm; 1999) and Executive Order 13175,
estimate for pyraflufen-ethyl is 2.9 x
horse, meat byproducts at 0.02 ppm; entitled Consultation and Coordination
10-6. This risk estimate is based, in part,
and sheep, meat byproducts at 0.02 with Indian Tribal Governments (65 FR
on the conservative assumption that
ppm. Existing tolerances are revised for 67249, November 9, 2000) do not apply
100% of all crops for which pyraflufen-
soybean, forage to 0.05 ppm; soybean,
ethyl is registered or proposed for to this final rule. In addition, this final
hay to 0.10 ppm; wheat, forage to 0.02
registration are treated. Additional rule does not impose any enforceable
ppm; and wheat, hay to 0.01 ppm.
refinement using Percent Crop Treated duty or contain any unfunded mandate
estimates would result in a lower VI. Statutory and Executive Order as described under Title II of the
estimate of cancer risk. Reviews Unfunded Mandates Reform Act of 1995
EPA generally considers cancer risks This final rule establishes tolerances (UMRA) (Public Law 1044).
in the range of 1 in 1 million (1 x 10-6) under section 408(d) of FFDCA in
or less to be negligible. The precision This action does not involve any
response to a petition submitted to the technical standards that would require
which can be assumed for cancer risk Agency. The Office of Management and