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26304 Federal Register / Vol. 72, No.

89 / Wednesday, May 9, 2007 / Rules and Regulations

B. Analytical Method(s) government and the States or tribal § 174.452 Bacillus thuringiensis Vip3Aa19
governments, or on the distribution of protein in cotton; temporary exemption
A method for extraction and ELISA from the requirement of a tolerance.
analysis of the Vip3Aa19 protein in power and responsibilities among the
various levels of government or between Residues of Bacillus thuringiensis
cotton has been submitted and is under
the Federal Government and Indian Vip3Aa19 protein in cotton are
review by the Agency. For the
tribes. Thus, the Agency has determined temporarily exempt from the
temporary tolerance exemption, the
that Executive Order 13132, entitled requirement of a tolerance when used as
ELISA method described with the
Federalism (64 FR 43255, August 10, a plant-incorporated protectant (PIP) in
expression data is sufficient.
1999) and Executive Order 13175, the food and feed commodities of
C. Codex Maximum Residue Level entitled Consultation and Coordination cotton; vegetative-insecticidal protein in
No Codex maximum residue levels with Indian Tribal Governments (65 FR cotton seed, cotton oil, cotton meal,
exist for the PIP Bacillus thuringiensis 67249, November 6, 2000) do not apply cotton hay, cotton hulls, cotton forage,
Vip3Aa19 protein and the genetic to this rule. In addition, this rule does and cotton gin byproducts. This
material necessary for its production in not impose any enforceable duty or temporary exemption from the
cotton. contain any unfunded mandate as requirement of tolerance will permit the
described under Title II of the Unfunded use of the food commodities in this
VIII. Statutory and Executive Order Mandates Reform Act of 1995 (UMRA) section when treated in accordance with
Reviews (Public Law 104–4). the provisions of the experimental use
This final rule establishes a tolerance This action does not involve any permit (EUP) 67979–EUP–7, which is
under section 408(d) of FFDCA in technical standards that would require being issued in accordance with the
response to a petition submitted to the Agency consideration of voluntary provisions of the Federal Insecticide,
Agency. The Office of Management and consensus standards pursuant to section Fungicide, and Rodenticide Act
Budget (OMB) has exempted these types 12(d) of the National Technology (FIFRA), as amended (7 U.S.C. 136).
of actions from review under Executive Transfer and Advancement Act of 1995 This temporary exemption from the
Order 12866, entitled Regulatory (NTTAA), Public Law 104–113, section requirement of a tolerance expires and
Planning and Review (58 FR 51735, 12(d) (15 U.S.C. 272 note). is revoked May 1, 2008. However, if the
October 4, 1993). Because this rule has EUP is revoked, or if any experience
IX. Congressional Review Act with or scientific data on this pesticide
been exempted from review under
Executive Order 12866, this rule is not The Congressional Review Act, 5 indicate that the temporary tolerance
subject to Executive Order 13211, U.S.C. 801 et seq., generally provides exemption is not safe, this temporary
Actions Concerning Regulations That that before a rule may take effect, the exemption from the requirement of a
Significantly Affect Energy Supply, agency promulgating the rule must tolerance may be revoked at any time.
Distribution, or Use (66 FR 28355, May submit a rule report to each House of [FR Doc. E7–8951 Filed 5–8–07; 8:45 am]
22, 2001) or Executive Order 13045, the Congress and to the Comptroller BILLING CODE 6560–50–S
entitled Protection of Children from General of the United States. EPA will
Environmental Health Risks and Safety submit a report containing this rule and
Risks (62 FR 19885, April 23, 1997). other required information to the U.S. ENVIRONMENTAL PROTECTION
This final rule does not contain any Senate, the U.S. House of AGENCY
information collections subject to OMB Representatives, and the Comptroller
General of the United States prior to 40 CFR Part 180
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et publication of this final rule in the
[EPA–HQ–OPP–2006–0965; FRL–8124–2]
seq., nor does it require any special Federal Register. This final rule is not
considerations under Executive Order a ‘‘major rule’’ as defined by 5 U.S.C. Flufenacet; Pesticide Tolerance
12898, entitled Federal Actions to 804(2).
Address Environmental Justice in AGENCY: Environmental Protection
Minority Populations and Low-Income List of Subjects in 40 CFR Part 174 Agency (EPA).
Populations (59 FR 7629, February 16, Environmental protection, ACTION: Final rule.
1994). Administrative practice and procedure,
SUMMARY: This regulation establishes
Since tolerances and exemptions that Agricultural commodities, Pesticides
are established on the basis of a petition pesticide tolerances under the Federal
and pests, Reporting and recordkeeping
under section 408(d) of FFDCA, such as Food, Drug, and Cosmetic Act (FFDCA)
requirements.
the tolerance in this final rule, do not for combined residues of flufenacet and
require the issuance of a proposed rule, Dated: April 26, 2007. its metabolites containing the 4-fluoro-
the requirements of the Regulatory W. Michael McDavit, N-methylethyl benzenamine moiety in
Flexibility Act (RFA) (5 U.S.C. 601 et Acting Director, Biopesticides and Pollution
or on grass (forage, hay), sweet corn
seq.) do not apply. Prevention Division, Office of Pesticide (forage, kernel plus cob with husk
This final rule directly regulates Programs. removed, stover), wheat (bran, forage,
growers, food processors, food handlers grain, hay, straw), cattle kidney, goat
■Therefore, 40 CFR chapter I is
and food retailers, not States or tribes, kidney, hog kidney, horse kidney, and
amended as follows:
nor does this action alter the sheep kidney. Bayer Cropscience
relationships or distribution of power [PART 174—AMENDED] petitioned EPA to establish these
and responsibilities established by tolerances.
Congress in the preemption provisions ■ 1. The authority citation for part 174 DATES: This regulation is effective May
continues to read as follows:
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of section 408(n)(4) of FFDCA. As such, 9, 2007. Objections and requests for


the Agency has determined that this Authority: 7 U.S.C. 136-136y; 21 U.S.C. hearings must be received on or before
action will not have a substantial direct 346a and 371. July 9, 2007, and must be filed in
effect on States or tribal governments, ■ 2. Section 174.452 is revised to read accordance with the instructions
on the relationship between the national as follows: provided in 40 CFR part 178 (see also

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Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26305

Unit I.C. of the SUPPLEMENTARY be affected. The North American • Delivery: OPP Regulatory Public
INFORMATION). Industrial Classification System Docket (7502P), Environmental
ADDRESSES: EPA has established a (NAICS) codes have been provided to Protection Agency, Rm. S–4400, One
docket for this action under docket assist you and others in determining Potomac Yard (South Bldg.), 2777 S.
identification (ID) number EPA–HQ– whether this action might apply to Crystal Dr., Arlington, VA. Deliveries
OPP–2006–0965. All documents in the certain entities. If you have any are only accepted during the Docket’s
docket are listed in the index for the questions regarding the applicability of normal hours of operation (8:30 a.m. to
docket. Although listed in the index, this action to a particular entity, consult 4 p.m., Monday through Friday,
the person listed under FOR FURTHER excluding legal holidays). Special
some information is not publicly
INFORMATION CONTACT. arrangements should be made for
available, e.g., Confidential Business
deliveries of boxed information. The
Information (CBI) or other information B. How Can I Access Electronic Copies
Docket Facility telephone number is
whose disclosure is restricted by statute. of this Document?
(703) 305–5805.
Certain other material, such as In addition to accessing an electronic
copyrighted material, is not placed on copy of this Federal Register document II. Background and Statutory Findings
the Internet and will be publicly through the electronic docket at http:// In the Federal Register of December
available only in hard copy form. www.regulations.gov, you may access 20, 2006 (71 FR 76321) (FRL–8104–4),
Publicly available docket materials are this Federal Register document EPA issued a notice pursuant to section
available in the electronic docket at electronically through the EPA Internet 408(d)(3) of FFDCA, 21 U.S.C.
http://www.regulations.gov, or, if only under the ‘‘Federal Register’’ listings at 346a(d)(3), announcing the filing of a
available in hard copy, at the OPP http://www.epa.gov/fedrgstr. You may pesticide petition (PP 0F6095) by Bayer
Regulatory Public Docket in Rm. S– also access a frequently updated CropScience, 2 T.W. Alexander Dr.,
4400, One Potomac Yard (South Bldg.), electronic version of 40 CFR part 180 Research Triangle Park, NC 27709. The
2777 S. Crystal Dr., Arlington, VA. The through the Government Printing petition requested that 40 CFR 180.527
Docket Facility is open from 8:30 a.m. Office’s pilot e-CFR site at http:// be amended by establishing a tolerance
to 4 p.m., Monday through Friday, www.gpoaccess.gov/ecfr. for combined residues of the herbicide
excluding legal holidays. The Docket flufenacet (N-(4-fluorophenyl)-N-(1-
Facility telephone number is (703) 305– C. Can I File an Objection or Hearing methylethyl)-2-[[5-(trifluoromethyl)-
5805. Request? 1,3,4-thiadiazol-2-yl] oxy] acetamide
FOR FURTHER INFORMATION CONTACT: Jim Under section 408(g) of the FFDCA, as and its metabolites containing the 4-
Tompkins, Registration Division amended by the FQPA, any person may fluoro-N-methylethyl benzenamine
(7505P), Office of Pesticide Programs, file an objection to any aspect of this moiety in or on the food commodities:
Environmental Protection Agency, 1200 regulation and may also request a corn, sweet, forage at 0.4 parts per
Pennsylvania Ave., NW., Washington, hearing on those objections. The EPA million (ppm); corn, sweet, kernel plus
DC 20460–0001; telephone number: procedural regulations which govern the cob with husks removed at 0.05 ppm;
(703) 305–5697; e-mail address: submission of objections and requests corn, sweet, stover at 0.4 ppm; wheat,
tompkins.jim@epa.gov. for hearings appear in 40 CFR part 178. forage at 10.0 ppm; wheat, grain at 1.0
You must file your objection or request ppm; wheat, hay at 2.0 ppm; wheat,
SUPPLEMENTARY INFORMATION:
a hearing on this regulation in straw at 0.5 ppm; seed-grass, forage at
I. General Information accordance with the instructions 7.0 ppm; seed-grass, forage, regrowth at
provided in 40 CFR part 178. To ensure 0.1 ppm; seed-grass, hay, regrowth at 0.5
A. Does this Action Apply to Me?
proper receipt by EPA, you must ppm. That notice included a summary
You may be potentially affected by identify docket ID number EPA–HQ– of the petition prepared by Bayer
this action if you are an agricultural OPP–2006–0965 in the subject line on CropScience, the registrant. There were
producer, food manufacturer, or the first page of your submission. All no comments received in response to
pesticide manufacturer. Potentially requests must be in writing, and must be the notice of filing.
affected entities may include, but are mailed or delivered to the Hearing Clerk After completing a review of the
not limited to: on or before July 9, 2007. submitted data, the Agency determined
• Crop production (NAICS code 111), In addition to filing an objection or that additional tolerances are needed in
e.g., agricultural workers; greenhouse, hearing request with the Hearing Clerk connection with the petitioned-for
nursery, and floriculture workers; as described in 40 CFR part 178, please tolerances for wheat bran 0.80 ppm,
farmers. submit a copy of the filing that does not grass forage at 7.0 ppm, and grass hay
• Animal production (NAICS code contain any CBI for inclusion in the at 0.4 ppm, cattle kidney at 0.05 ppm,
112), e.g., cattle ranchers and farmers, public docket that is described in goat kidney at 0.05 ppm, hog kidney at
dairy cattle farmers, livestock farmers. ADDRESSES. Information not marked 0.05 ppm, horse kidney at 0.05 ppm,
• Food manufacturing (NAICS code confidential pursuant to 40 CFR part 2 and sheep kidney at 0.05 ppm. EPA
311), e.g., agricultural workers; farmers; may be disclosed publicly by EPA determined that tolerance levels are
greenhouse, nursery, and floriculture without prior notice. Submit your needed that differ from those proposed
workers; ranchers; pesticide applicators. copies, identified by docket ID number by the registrant for sweet corn forage at
• Pesticide manufacturing (NAICS EPA–HQ–OPP–2006–0965, by one of 0.45 ppm (0.4 ppm proposed) sweet
code 32532), e.g., agricultural workers; the following methods: corn stover at 0.30 ppm, (0.4 ppm
commercial applicators; farmers; • Federal eRulemaking Portal: http:// proposed) wheat forage at 6.0 ppm (10.0
greenhouse, nursery, and floriculture www.regulations.gov. Follow the on-line ppm proposed), wheat grain at 0.60 ppm
workers; residential users. instructions for submitting comments. (1.0 ppm proposed), wheat hay at 1.2
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This listing is not intended to be • Mail: Office of Pesticide Programs ppm (2.0 ppm proposed), and wheat
exhaustive, but rather provides a guide (OPP) Regulatory Public Docket (7502P), straw at 0.35 ppm (0.5 ppm proposed).
for readers regarding entities likely to be Environmental Protection Agency, 1200 EPA determined that tolerances are not
affected by this action. Other types of Pennsylvania Ave., NW., Washington, necessary for fat, meat, and meat
entities not listed in this unit could also DC 20460–0001. byproducts of cattle, goat, hog, horse,

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and sheep. Since permanent tolerances adverse-effect-level (NOAEL) and the occurring as a result of a 1–day or single
are being established for wheat and lowest-observed-adverse-effect-level exposure.
kidney of cattle, goat, hog, horse, and (LOAEL) from the toxicity studies can The Dietary Exposure Evaluation
sheep, emergency exemption tolerances be found at http://www.regulations.gov Model (DEEMTM) analysis evaluated the
for these commodities are being deleted. in the document, entitled Flufenacet: individual food consumption as
Section 408(b)(2)(A)(i) of FFDCA HED Human Health Risk Assessment for reported by respondents in the U.S.
allows EPA to establish a tolerance (the Uses on Wheat, Perennial Grasses Department of Agriculture (USDA)
legal limit for a pesticide chemical Grown for Seed and Sweet Corn which 1994–1996 and 1988 Nationwide
residue in or on a food) only if EPA is in the docket for this rule. Continuing Surveys of Food Intake by
determines that the tolerance is ‘‘safe.’’ Individuals (CSFII) and accumulated
Section 408(b)(2)(A)(ii) of FFDCA B. Toxicological Endpoints
exposure to the chemical for each
defines ‘‘safe’’ to mean that ‘‘there is a For hazards that have a threshold commodity. The following assumptions
reasonable certainty that no harm will below which there is no appreciable were made for the acute exposure
result from aggregate exposure to the risk, the dose at which no adverse assessments: Anticipated residues for
pesticide chemical residue, including effects are observed (the NOAEL) from many crops (field corn, soybean, sweet
all anticipated dietary exposures and all the toxicology study identified as corn, and wheat) were developed using
other exposures for which there is appropriate for use in risk assessment is field trial data. Anticipated residues for
reliable information.’’ This includes used to estimate the toxicological level livestock commodities were derived
exposure through drinking water and in of concern (LOC). However, the lowest
using available feeding and metabolism
residential settings, but does not include dose at which adverse effects of concern
studies in conjunction with the
occupational exposure. Section are identified (the LOAEL) is sometimes
anticipated dietary burden to ruminants,
408(b)(2)(C) of FFDCA requires EPA to used for risk assessment if no NOAEL
swine and poultry. Tolerance level
give special consideration to exposure was achieved in the toxicology study
residues were used to assess flufenacet
of infants and children to the pesticide selected. An uncertainty factor (UF) is
exposure from the remaining
chemical residue in establishing a applied to reflect uncertainties inherent
commodities (i.e., cereal grains other
tolerance and to ‘‘ensure that there is a in the extrapolation from laboratory
than wheat). Exposure estimates for all
reasonable certainty that no harm will animal data to humans and in the
commodities were further refined using
result to infants and children from variations in sensitivity among members
percent crop treated (PCT) data.
aggregate exposure to the pesticide of the human population as well as
Projected PCT data were used to refine
chemical residue. . . .’’ other unknowns.
anticipated residues for the new food
EPA performs a number of analyses to The linear default risk methodology
uses (sweet corn and wheat). Available
determine the risks from aggregate (Q*) is the primary method currently
processing data were used to refine
exposure to pesticide residues. For used by the Agency to quantify non-
anticipated residues for cereal grains
further discussion of the regulatory threshold hazards such as cancer. The
and corn. For all other processed
requirements of section 408 of the Q* approach assumes that any amount
commodities, DEEM (ver. 7.81) default
FFDCA and a complete description of of exposure will lead to some degree of
processing factors were assumed.
the risk assessment process, see http:// cancer risk, estimates risk in terms of
www.epa.gov/fedrgstr/EPA-PEST/1997/ the probability of occurrence of ii. Chronic exposure. In conducting
November/Day-26/p30948.htm. additional cancer cases. More the chronic dietary exposure assessment
information can be found on the general EPA used the Dietary Exposure
III. Aggregate Risk Assessment and Evaluation Model software with the
principles EPA uses in risk
Determination of Safety Food Commodity Intake Database
characterization at http://www.epa.gov/
Consistent with section 408(b)(2)(D) pesticides/health/human.htm. (DEEM-FCIDTM), which incorporates
of FFDCA, EPA has reviewed the A summary of the toxicological food consumption data as reported by
available scientific data and other endpoints for flufenacet used for human respondents in the USDA 1994–1996
relevant information in support of this risk assessment can be found in Table and 1998 CSFII, and accumulated
action. EPA has sufficient data to assess 4 (p.14) of the document, entitled exposure to the chemical for each
the hazards of and to make a Flufenacet: HED Human Health Risk commodity. The following assumptions
determination on aggregate exposure, Assessment for Uses on Wheat, were made for the chronic exposure
consistent with section 408(b)(2) of Perennial Grasses Grown for Seed and assessments: Anticipated residues for
FFDCA, for a tolerance for combined Sweet Corn which is in the docket for many crops (field corn, soybean, sweet
residues of flufenacet. EPA’s assessment this rule. corn, and wheat) were developed using
of exposures and risks associated with field trial data. Anticipated residues for
establishing the tolerance follows. C. Exposure Assessment livestock commodities were derived
1. Dietary exposure from food and using available feeding and metabolism
A. Toxicological Profile feed uses. Tolerances have been studies in conjunction with the
EPA has evaluated the available established (40 CFR 180.527) for the anticipated dietary burden to ruminants,
toxicity data and considered its validity, combined residues of flufenacet and its swine and poultry. Tolerance level
completeness, and reliability as well as metabolites, in or on a variety of raw residues were used to assess flufenacet
the relationship of the results of the agricultural commodities. Risk exposure from the remaining
studies to human risk. EPA has also assessments were conducted by EPA to commodities (i.e., cereal grains).
considered available information assess dietary exposures from flufenacet Exposure estimates for all commodities
concerning the variability of the in food from existing and proposed were further refined using PCT data.
sensitivities of major identifiable tolerances as follows: Projected PCT data were used to refine
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subgroups of consumers, including i. Acute exposure. Quantitative acute anticipated residues for the new food
infants and children. Specific dietary exposure and risk assessments uses (sweet corn and wheat). Available
information on the studies received and are performed for a food-use pesticide, processing data were used to refine
the nature of the toxic effects caused by if a toxicological study has indicated the anticipated residues for cereal grains
flufenacet as well as the no-observed- possibility of an effect of concern and corn. For all other processed

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commodities, DEEM (ver. 7.81) default same species and there are many weeds consumption information and
processing factors were assumed. and herbicides used to control those consumption information for significant
iii. Cancer. A cancer aggregate weeds which are common to the two subpopulations is taken into account
exposure assessment was not performed crops. Therefore the use of flufenacet on through EPA’s computer-based model
because flufenacet is not carcinogenic. field corn was used as the basis for for evaluating the exposure of
iv. Anticipated residue and PCT predicting flufenacet use on sweet corn. significant subpopulations including
information. Section 408(b)(2)(E) of EPA also analyzed other factors based several regional groups. Use of this
FFDCA authorizes EPA to use available on available information that included consumption information in EPA’s risk
data and information on the anticipated more recent usage of other acetamide assessment process ensures that EPA’s
residue levels of pesticide residues in herbicides on both field corn and sweet exposure estimate does not understate
food and the actual levels of pesticide corn, information on new products exposure for any significant
chemicals that have been measured in desired for sweet corn, including subpopulation group and allows the
food. If EPA relies on such information, flufenacet, to combat newly invasive Agency to be reasonably certain that no
EPA must pursuant section 408(f)(1) of weeds and resistant weeds, and regional population is exposed to
FFDCA require that data be provided 5 differences in importance of individual residue levels higher than those
years after the tolerance is established, herbicides between field corn and sweet estimated by the Agency. Other than the
modified, or left in effect, demonstrating corn. data available through national food
that the levels in food are not above the Chronic and acute dietary exposure consumption surveys, EPA does not
levels anticipated. Following the initial analyses for wheat were based on have available information on the
data submission, EPA is authorized to projected PCT when treated with regional consumption of food to which
require similar data on a time frame it flufenacet of an average of 1% and a flufenacet may be applied in a particular
deems appropriate. For the present maximum of 3%. These projected PCT area.
action, EPA will issue such Data Call- estimates were based on the following: 2. Dietary exposure from drinking
Ins for information relating to Emergency exemption uses have been water. The Agency lacks sufficient
anticipated residues as are required by issued for flufenacet on wheat for monitoring exposure data to complete a
section 408(b)(2)(E) of FFDCA and several years. EPA initially estimated comprehensive dietary exposure
authorized under section 408(f)(1) of the PCT for wheat based on recent PCTs analysis and risk assessment for
FFDCA. Such Data Call-Ins will be for winter wheat due to emergency flufenacet in drinking water. Because
required to be submitted no later than exemption usage. EPA later examined the Agency does not have
5 years from the date of issuance of this acres treated in individual states and comprehensive monitoring data,
tolerance. compared that information to the drinking water concentration estimates
Section 408(b)(2)(F) of FFDCA states treatment acres permitted under the are made by reliance on simulation or
that the Agency may use data on the emergency exemptions. EPA also modeling taking into account data on
actual percent of food treated for analyzed other factors based on the physical characteristics of
assessing chronic dietary risk only if the available information that included flufenacet. Further information
Agency can make the following usage of metribuzin on winter wheat regarding EPA drinking water models
findings: Condition 1, that the data used (since a new use is the combination used in pesticide exposure assessment
are reliable and provide a valid basis to metribuzin and flufenacet), current and can be found at http://www.epa.gov/
show what percentage of the food past Emergency Exemption requests for oppfeed1/models/water/index.
derived from such crop is likely to flufenacet in the Northwest and on the Based on the Pesticide Root Zone
contain such pesticide residue; East Coast to control resistant Italian Model/Exposure Analysis Modeling
Condition 2, that the exposure estimate ryegrass, and more recent usage data. System (PRZM/EXAMS) and Screening
does not underestimate exposure for any For all other commodities, PCT Concentrations in Groundwater (SCI-
significant subpopulation group; and estimates were based on a screening GROW) models, the estimated drinking
Condition 3, if data are available on level usage analysis of pesticide usage water concentrations (EDWCs) of
pesticide use and food consumption in data from the following sources: flufenacet (plus its degradate thiadione
a particular area, the exposure estimate • USDA-NASS (United States in surface water) for acute exposures are
does not understate exposure for the Department of Agriculture’s National estimated to be 8.64 parts per billion
population in such area. In addition, the Agricultural Statistics Service)— (ppb) for surface water and 0.10 ppb for
Agency must provide for periodic pesticide usage data from 1998 to 2003. ground water. The EECs for chronic
evaluation of any estimates used. To • NCFAP (National Center for Food exposures are estimated to be 2.23 ppb
provide for the periodic evaluation of and Agricultural Policy—pesticide for surface water and 0.10 ppb for
the estimate of PCT as required by usage data from 1997 and is only used ground water.
section 408(b)(2)(F) of FFDCA, EPA may if data is not available from the other 3. From non-dietary exposure. The
require registrants to submit data on sources. term ‘‘residential exposure’’ is used in
PCT. • Private pesticide market research— this document to refer to non-
The Agency used PCT information as pesticide usage data from 1998 to 2004. occupational, non-dietary exposure
follows: The Agency believes that the three (e.g., for lawn and garden pest control,
Chronic and acute dietary exposure conditions previously discussed have indoor pest control, termiticides, and
analyses for sweet corn were based on been met. With respect to Condition 1, flea and tick control on pets).
projected PCT when treated with EPA finds that the PCT information Flufenacet is not registered for use on
flufenacet of an average of 3% (used for described above for flufenacet on sweet any sites that would result in residential
chronic exposure assessment) and a corn, wheat, and grass forage and other exposure.
maximum of 10% (used for acute commodities with existing registrations 4. Cumulative effects from substances
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exposure assessment). These projected for flufenacet is reliable and has a valid with a common mechanism of toxicity.
PCT estimates were based on the basis. The Agency is reasonably certain Section 408(b)(2)(D)(v) of FFDCA
following. Flufenacet has been that the percentage of the food treated requires that, when considering whether
registered and used on field corn since is not likely to be an underestimation. to establish, modify, or revoke a
1998. Field corn and sweet corn are the As to Conditions 2 and 3, regional tolerance, the Agency consider

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‘‘available information’’ concerning the pup death in early lactation and Factor should be retained. The primary
cumulative effects of a particular cannibalism) were more severe than reason for retaining the additional safety
pesticide’s residues and ‘‘other those seen in the parental animals factor is that there is uncertainty
substances that have a common (increased liver weight and cytomegaly), regarding the protectiveness of selected
mechanism of toxicity.’’ although there was no difference in the RfDs because of a lack of comparative
Unlike other pesticides for which EPA NOAELs/LOAELS between parental susceptibility data for thyroid hormone
has followed a cumulative risk approach animals and offspring in that study. levels. Secondarily there is also some
based on a common mechanism of Increased susceptibility (qualitative and uncertainty due to the lack of a NOAEL
toxicity, EPA has not made a common quantitative) was seen in the in the DNT for the decrease in
mechanism of toxicity finding as to developmental neurotoxicity study in morphometric measurements and body
flufenacet and any other substances and rats. Decreased body weight was seen in weight effects in pups and the lack of
flufenacet does not appear to produce a pups at all dose levels, and additional data on comparative sensitivity to
toxic metabolite produced by other effects, including decreased motor neuropathologic lesions. Concerns with
substances. For the purposes of this activity, delayed developmental regard to these latter issues are more
tolerance action, therefore, EPA has not landmarks, and decreases in limited given dose response data on the
assumed that flufenacet has a common morphometric measurements were seen morphometric changes indicating that
mechanism of toxicity with other at mid and high doses. Morphometric these effects would not be expected at
substances. For information regarding measurements were not made at the low the low dose, the transient nature of the
EPA’s efforts to determine which dose. A slight decrease in body weight body weight effects seen at the low
chemicals have a common mechanism in mid and high dose dams during early dose, and the fact that neuropathologic
of toxicity and to evaluate the lactation may have been due to lesions were only seen at relatively high
cumulative effects of such chemicals, palatability of test substance and was doses.
see the policy statements released by not considered adverse.
EPA’s Office of Pesticide Programs The selection of 1.7 milligrams/ E. Aggregate Risks and Determination of
concerning common mechanism kilograms/day (mg/kg/day) as a LOAEL Safety
determinations and procedures for for the developmental neurotoxicity 1. Acute risk. Using the exposure
cumulating effects from substances study is considered to be a conservative assumptions discussed in this unit for
found to have a common mechanism on recommendation as to the decreased acute exposure, the acute dietary
EPA’s website at http://www.epa.gov/ body weight effect, because the decrease exposure from food plus drinking water
pesticides/cumulative. in pup body weight at that dose is to flufenacet will occupy 30% of the
transient, and a similar decrease was not aPAD for the U.S. population, 25% of
D. Safety Factor for Infants and
seen in the 2–generation reproduction the aPAD for females 13 years and older,
Children
study (decreased pup body weight seen 89% of the aPAD for all infants (< 1 year
1. In general. Section 408 of FFDCA in the 1–generation range-finding old), and 42% of the aPAD for children
provides that EPA shall apply an reproduction study occurred at higher 1–2 years old.
additional tenfold margin of safety for doses than those evaluated in the 2. Chronic risk. Using the exposure
infants and children in the case of developmental neurotoxicity study). assumptions described in this unit for
threshold effects to account for prenatal 3. Conclusion. Several factors chronic exposure, EPA has concluded
and postnatal toxicity and the weighed in favor of the conclusion that that exposure to flufenacet from food
completeness of the data base on no additional safety factor is needed to plus drinking water will utilize 2.9% of
toxicity and exposure unless EPA protect the safety of infants and the cPAD for the U.S. population, 9.2%
determines based on reliable data that a children. First, there was no evidence of of the cPAD for all infants (< 1 year old),
different margin of safety will be safe for increased susceptibility in the and 4.4% of the cPAD for children 1–
infants and children. Margins of safety developmental toxicity studies (rats and 2 years old. There are no residential
are incorporated into EPA risk rabbits), and qualitative susceptibility uses for flufenacet that result in chronic
assessments either directly through use seen in the rat reproduction study did residential exposure to flufenacet. EPA
of a MOE analysis or through using not raise concerns because the pup does not expect the aggregate exposure
uncertainty (safety) factors in death may be attributable to maternal to exceed 100% of the cPAD.
calculating a dose level that poses no cannibalism, and there was a clear 3. Short-term risk. Short-term
appreciable risk to humans. In applying NOAEL for the effect. Second, there are aggregate exposure takes into account
this provision, EPA either retains the also no additional residual uncertainties residential exposure plus chronic
default value of 10X when reliable data with respect to exposure data: exposure to food and water (considered
do not support the choice of a different • The dietary drinking water to be a background exposure level).
factor, or, if reliable data are available, assessment utilizes water concentration Flufenacet is not registered for use on
EPA uses a different additional safety values generated by models and any sites that would result in residential
factor value based on the use of associated modeling parameters which exposure. Therefore, the aggregate risk
traditional uncertainty factors and/or are designed to provide conservative, is the sum of the risk from food and
special FQPA safety factors, as health protective, high-end estimates of water, which do not exceed the
appropriate. water concentrations which will not Agency’s level of concern.
2. Prenatal and postnatal sensitivity. likely be exceeded. 4. Intermediate-term risk.
There is no indication of additional • Although the exposure assessment Intermediate-term aggregate exposure
susceptibility of young rats or rabbits from pesticide residues in food was takes into account residential exposure
following prenatal exposure to somewhat refined, the assessment is plus chronic exposure to food and water
flufenacet in the developmental toxicity based on reliable data and will not (considered to be a background
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studies. There was an indication of underestimate exposure/risk. exposure level).


qualitative susceptibility in the 2– • There are no residential uses for Flufenacet is not registered for use on
generation reproduction study. Effects flufenacet. any sites that would result in residential
seen in the offspring in the reproductive Nonetheless, for several reasons EPA exposure. Therefore, the aggregate risk
toxicity studies (including increased determined that the 10X FQPA Safety is the sum of the risk from food and

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Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26309

water, which do not exceed the Order 12866, entitled Regulatory responsibilities among the various
Agency’s level of concern. Planning and Review (58 FR 51735, levels of government.’’ This final rule
5. Aggregate cancer risk for U.S. October 4, 1993). Because this rule has directly regulates growers, food
population. Because flufenacet is been exempted from review under processors, food handlers, and food
classified as a ‘‘not likely’’ carcinogen, Executive Order 12866 due to its lack of retailers, not States. This action does not
the Agency does not expect exposure to significance, this rule is not subject to alter the relationships or distribution of
flufenacet to result in any cancer risk. Executive Order 13211, Actions power and responsibilities established
6. Determination of safety. Based on Concerning Regulations That by Congress in the preemption
these risk assessments, EPA concludes Significantly Affect Energy Supply, provisions of section 408(n)(4) of
that there is a reasonable certainty that Distribution, or Use (66 FR 28355, May FFDCA. For these same reasons, the
no harm will result to the general 22, 2001). This final rule does not Agency has determined that this rule
population, and to infants and children contain any information collections does not have any ‘‘tribal implications’’
from aggregate exposure to flufenacet subject to OMB approval under the as described in Executive Order 13175,
residues. Paperwork Reduction Act (PRA), 44 entitled Consultation and Coordination
IV. Other Considerations U.S.C. 3501 et seq., or impose any with Indian Tribal Governments (65 FR
enforceable duty or contain any 67249, November 6, 2000). Executive
A. Analytical Enforcement Methodology
unfunded mandate as described under Order 13175, requires EPA to develop
Adequate enforcement methodology Title II of the Unfunded Mandates an accountable process to ensure
(gas chromatographic/single ion mode Reform Act of 1995 (UMRA) (Public ‘‘meaningful and timely input by tribal
(GC/SIM) common moiety method) is Law 104–4). Nor does it require any officials in the development of
available to enforce the tolerance special considerations under Executive regulatory policies that have tribal
expression. The method may be Order 12898, entitled Federal Actions to implications.’’ ‘‘Policies that have tribal
requested from: Chief, Analytical Address Environmental Justice in implications’’ is defined in the
Chemistry Branch, Environmental Minority Populations and Low-Income Executive order to include regulations
Science Center, 701 Mapes Rd., Ft. Populations (59 FR 7629, February 16, that have ‘‘substantial direct effects on
Meade, MD 20755–5350; telephone 1994); or OMB review or any Agency one or more Indian tribes, on the
number: (410) 305–2905; e-mail address: action under Executive Order 13045, relationship between the Federal
residuemethods@epa.gov. entitled Protection of Children from Government and the Indian tribes, or on
B. International Residue Limits Environmental Health Risks and Safety the distribution of power and
Risks (62 FR 19885, April 23, 1997). responsibilities between the Federal
Flufenacet is not in the Codex system,
This action does not involve any Government and Indian tribes.’’ This
i.e., there are no established or pending
technical standards that would require rule will not have substantial direct
Codex MRLs for flufenacet. Therefore,
Agency consideration of voluntary effects on tribal governments, on the
there are no harmonization issues.
consensus standards pursuant to section relationship between the Federal
V. Conclusion 12(d) of the National Technology Government and Indian tribes, or on the
Therefore, the tolerances are Transfer and Advancement Act of 1995 distribution of power and
established for combined residues of (NTTAA), Public Law 104–113, section responsibilities between the Federal
flufenacet, (N-(4-fluorophenyl)-N-(1- 12(d) (15 U.S.C. 272 note). Since Government and Indian tribes, as
methylethyl)-2-[[5-(trifluoromethyl)- tolerances and exemptions that are specified in Executive Order 13175.
1,3,4-thiadiazol-2-yl] oxy] acetamide established on the basis of a petition Thus, Executive Order 13175 does not
and its metabolites containing the 4- under section 408(d) of FFDCA, such as apply to this rule.
fluoro-N-methylethyl benzenamine the tolerance in this final rule, do not
moiety, in or on grass forage at 7.0 ppm, require the issuance of a proposed rule, VII. Congressional Review Act
grass hay at 0.4 ppm, sweet corn forage the requirements of the Regulatory
The Congressional Review Act, 5
at 0.45, sweet corn kernel plus cob with Flexibility Act (RFA) (5 U.S.C. 601 et
U.S.C. 801 et seq., generally provides
husk removed at 0.05 ppm, sweet corn seq.) do not apply. In addition, the
that before a rule may take effect, the
stover at 0.30 ppm, wheat bran at 0.80 Agency has determined that this action
agency promulgating the rule must
ppm, wheat forage at 6.0 ppm, wheat will not have a substantial direct effect
submit a rule report, which includes a
grain at 0.60 ppm, wheat hay at 1.2 on States, on the relationship between
copy of the rule, to each House of the
ppm, wheat straw at 0.35 ppm, cattle the national government and the States,
or on the distribution of power and Congress and to the Comptroller General
kidney at 0.05 ppm, goat kidney at 0.05 of the United States. EPA will submit a
ppm, hog kidney at 0.05 ppm, horse responsibilities among the various
levels of government, as specified in report containing this final rule and
kidney at 0.05 ppm, and sheep kidney other required information to the U.S.
at 0.05 ppm. Section 18 emergency Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, Senate, the U.S. House of
exemption tolerances are deleted for Representatives, and the Comptroller
flufenacet in or on wheat (forage, grain, 1999). Executive Order 13132 requires
EPA to develop an accountable process General of the United States prior to
hay, straw) and fat, kidney, meat, and publication of this final rule in the
meat byproducts of cattle, goat, hog, to ensure ‘‘meaningful and timely input
by State and local officials in the Federal Register. This final rule is not
horse, and sheep. a ‘‘major rule’’ as defined by 5 U.S.C.
development of regulatory policies that
VI. Statutory and Executive Order have federalism implications.’’ ‘‘Policies 804(2).
Reviews that have federalism implications’’ is List of Subjects in 40 CFR Part 180
This final rule establishes a tolerance defined in the Executive order to
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under section 408(d) of FFDCA in include regulations that have Environmental protection,
response to a petition submitted to the ‘‘substantial direct effects on the States, Administrative practice and procedure,
Agency. The Office of Management and on the relationship between the national Agricultural commodities, Pesticides
Budget (OMB) has exempted these types government and the States, or on the and pests, Reporting and recordkeeping
of actions from review under Executive distribution of power and requirements.

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26310 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations

Dated: May 1, 2007. yl] oxy]acetamide, and its metabolites the instructions on the regulations.gov
Lois Rossi, containing the 4-fluoro-N-methylethyl web site to view the docket index or
Director, Registration Division, Office of benzenamine moiety, with regional access available documents. All
Pesticide Programs. registration. documents in the docket are listed in
■Therefore, 40 CFR chapter I is the docket index available in
Commodity Parts per million regulations.gov. Although listed in the
amended as follows:
index, some information is not publicly
Grass, forage ........ 7.0 available, e.g., Confidential Business
PART 180—AMENDED Grass, hay ............ 0.4
Information (CBI) or other information
■ 1. The authority citation for part 180 whose disclosure is restricted by statute.
continues to read as follows: (d) Indirect or inadvertent residues.
Tolerances are established for indirect Certain other material, such as
Authority: 21 U.S.C. 321(q), 346a and 371.
or inadvertent residues of the herbicide copyrighted material, is not placed on
flufenacet, N-(4-fluorophenyl)-N-(1- the Internet and will be publicly
■ 2. Section 180.527 is amended as available only in hard copy form.
follows: methylethyl)-2-[[5-(trifluoromethyl)-
■ i. By revising the section heading; 1,3,4-thiadiazol-2-yl]oxy]acetamide and Publicly available docket materials are
its metabolites containing the 4-fluoro- available in the electronic docket at
■ ii. By revising paragraph (a); http://www.regulations.gov,or, if only
■ iii. By removing the text of paragraph N-methylethyl benzenamine moiety in
or on the following raw agricultural available in hard copy, at the OPP
(b) and reserving with heading; Regulatory Public Docket in Rm. S-4400,
■ iv. By revising the introductory text of commodities when present therein as a
result of application of flufenacet to the One Potomac Yard (South Bldg.), 2777
paragraph (c) and adding commodities S. Crystal Dr., Arlington, VA. The
to the table; and growing crops in paragraph (a) of this
section. Docket Facility is open from 8:30 a.m.
■ v. By revising the introductory text of
to 4 p.m., Monday through Friday,
paragraph (d). * * * * * excluding legal holidays. The Docket
The amendments read as follows: [FR Doc. E7–8936 Filed 5–8–07; 8:45 am] telephone number is (703) 305-5805.
BILLING CODE 6560–50–S
§ 180.527 Flufenacet, N-(4-fluorophenyl)-N- FOR FURTHER INFORMATION CONTACT:
(1-methylethyl)-2-[[5-(trifluoromethyl)-1, 3, Sidney Jackson, Registration Division
4-thiadiazol-2-yl] oxy]acetamide and its (7505P), Office of Pesticide Programs,
metabolites containing the 4-fluoro-N- ENVIRONMENTAL PROTECTION
Environmental Protection Agency, 1200
methylethyl benzenamine tolerances for AGENCY
residues.
Pennsylvania Ave., NW., Washington,
40 CFR Part 180 DC 20460-0001; telephone number:
(a) General. Tolerances are (703) 305-7610; e-mail address:
established for the combined residues of [EPA–HQ–OPP–2005–0535; FRL–8127–2] jackson.sidney@epa.gov.
the herbicide flufenacet, N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5- Clethodim; Pesticide Tolerance SUPPLEMENTARY INFORMATION:
(trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] AGENCY: Environmental Protection I. General Information
oxy]acetamide and its metabolites Agency (EPA).
containing the 4-fluoro-N-methylethyl A. Does this Action Apply to Me?
ACTION: Final rule.
benzenamine moiety in or on the You may be potentially affected by
following commodities. SUMMARY: This regulation establishes this action if you are an agricultural
tolerances for combined residues of producer, food manufacturer, or
Commodity Parts per million clethodim and certain of its metabolites pesticide manufacturer. Potentially
in or on asparagus; flax, seed; herb, affected entities may include, but are
Cattle, kidney ........ 0.05 not limited to those engaged in the
Corn, field, forage 0.4 subgroup 19A; hop, dried cones; leafy
Corn, field, grain ... 0.05 greens subgroup 4A; safflower, meal; following activities:
Corn, field, stover 0.4 safflower, seed; sesame, seed; and • Crop production (NAICS code 111),
Corn, sweet, for- vegetable, legume, group 6, except e.g., agricultural workers; greenhouse,
age .................... 0.45 soybean. The Interregional Research nursery, and floriculture workers;
Corn, sweet, kernel Project Number 4 (IR-4) requested these farmers.
plus cob with tolerances under the Federal Food, • Animal production (NAICS code
husks removed .. 0.05 Drug, and Cosmetic Act (FFDCA). 112), e.g., cattle ranchers and farmers,
Corn, sweet, stover 0.30 dairy cattle farmers, livestock farmers.
DATES: This regulation is effective May
Goat, kidney ......... 0.05 • Food manufacturing (NAICS code
Hog, kidney ........... 0.05 9, 2007. Objections and requests for
311), e.g., agricultural workers; farmers;
Horse, kidney ........ 0.05 hearings must be received on or before
greenhouse, nursery, and floriculture
Sheep, kidney ....... 0.05 July 9, 2007, and must be filed in
workers; ranchers; pesticide applicators.
Soybean, seed ...... 0.1 accordance with the instructions • Pesticide manufacturing (NAICS
Wheat, bran .......... 0.80 provided in 40 CFR part 178 (see also
Wheat, forage ....... 6.0 code 32532), e.g., agricultural workers;
Unit I.C. of the SUPPLEMENTARY commercial applicators; farmers;
Wheat, grain ......... 0.60 INFORMATION).
Wheat, hay ........... 1.2 greenhouse, nursery, and floriculture
Wheat, straw ......... 0.35 ADDRESSES: EPA has established a workers; residential users.
docket for this action under docket This listing is not intended to be
(b) Section 18 emergency exemptions. identification (ID) number EPA–HQ– exhaustive, but rather to provide a guide
[Reserved] OPP–2005–0535. To access the for readers regarding entities likely to be
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(c) Tolerances with regional electronic docket, go to http:// affected by this action. Other types of
registrations. Tolerances are established www.regulations.gov, select ‘‘Advanced entities not listed in this unit could also
for combined residues of flufenacet, N- Search,’’ then ‘‘Docket Search.’’ Insert be affected. The North American
(4-fluorophenyl)-N-(1-methylethyl)-2- the docket ID number where indicated Industrial Classification System
[[5-(trifluoromethyl)-1, 3, 4-thiadiazol-2- and select the ‘‘Submit’’ button. Follow (NAICS) codes have been provided to

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