Florasulam; Pesticide Tolerance

[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Rules and Regulations]
[Page 55073-55078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se07-14]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0993; FRL-8148-4]

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for florasulam in or
on barley, grain at 0.01 ppm, barley, hay at 0.05 ppm, barley straw at
0.05 ppm, oat, grain at 0.01 ppm, oat, forage at 0.05 ppm, oat, hay at
0.05 ppm, oat, straw at 0.05 ppm, rye, grain at 0.01 ppm, rye, forage
at 0.05 ppm, rye, straw at 0.05 ppm, wheat, grain at 0.01 ppm, wheat,
forage at 0.05 ppm, wheat, hay at 0.05 ppm, and wheat, straw at 0.05
ppm. Dow AgroSciences LLC requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 28, 2007. Objections and
requests for hearings must be received on or before November 27, 2007,
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-2006-0993. To access the
electronic docket, go to http://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 in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory 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 those
engaged in the following activities:
• Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide 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
http://www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0993 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 as required by 40 CFR part 178 on or
before November 27, 2007.
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 this copy, identified by docket ID number

[[Page 55074]]

EPA-HQ-OPP-2006-0993, by one of the following methods:
• Federal eRulemaking Portal: http://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 Tolerance

In the Federal Register of January 24, 2007 (72 FR 3132) (FRL-8110-
9), 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
6F7061) by Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis,
IN 46268. The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for residues of the herbicide florasulam N-
(2,6-difluorophenyl)-8-fluoro-5-methoxy(1,2,4)triazolo(1,5-
c)pyrimidine-2-sulfonamide, in or on barley, grain at 0.01 parts per
million (ppm), barley, forage at 0.05 ppm, barley, hay at 0.05 ppm,
barley straw at 0.05 ppm, oats, grain at 0.01 ppm, oats, forage at 0.05
ppm, oats, hay at 0.05 ppm, oats, straw at 0.05 ppm, rye, grain at 0.01
ppm, rye, forage at 0.05 ppm, rye, hay at 0.05 ppm, rye, straw at 0.05
ppm, triticale, grain at 0.01 ppm, triticale, forage at 0.05 ppm,
triticale, hay at 0.05 ppm, triticale, straw at 0.05 ppm, wheat, grain
at 0.01 ppm, wheat, forage at 0.05 ppm, wheat, hay at 0.05 ppm, and
wheat, straw at 0.05 ppm. That notice referenced a summary of the
petition prepared by Dow AgroSciences, LLC, the registrant, which is
available to the public in the docket, http://www.regulations.gov.
Comments were received on the notice of filing. B. Sachau commented
that there are health implications listed for this chemical and a new
pesticide should not be approved because the safety tests required by
the EPA are insufficient. EPA's response to these comments is discussed
in Unit IV.C. of this document
EPA is not establishing the proposed tolerances for barley, forage
and rye, hay because EPA does not consider these items to be
significant food commodities as noted in Table 1 of the OPPTS 860
guidelines. EPA is also not establishing the proposed tolerances for
triticale. Triticale is covered by the tolerance for wheat as specified
in 40 CFR 180.1(g).

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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for residues of florasulam, N-(2,6-difluorophenyl)-8-fluoro-5-
methoxy(1,2,4)triazolo(1,5-c)pyrimidine-2-sulfonamide, on barley, grain
at 0.01 ppm, barley, hay at 0.05 ppm, barley, straw at 0.05 ppm, oat,
grain at 0.01 ppm, oat, forage at 0.05 ppm, oat, hay at 0.05 ppm, oat,
straw at 0.05 ppm, rye, grain at 0.01 ppm, rye, forage at 0.05 ppm,
rye, straw at 0.05 ppm, wheat, grain at 0.01 ppm, wheat, forage at 0.05
ppm, wheat, hay at 0.05 ppm, and wheat, straw at 0.05 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance 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 adverse effects caused by florasulam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov. The human health risk assessment document
is available in the docket established by this action, which is described
under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0993 in that
docket.

B. Toxicological Endpoints

For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from 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) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC 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
risks by comparing aggregate 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 LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see
http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

A summary of the toxicological endpoints for florasulam used for
human risk assessment is shown in Table 1 of this unit.

[[Page 55075]]

Table 1.--Summary of Toxicological Dose and Endpoints for Florasulam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Uncertainty
Factors/ FQPA
Point of Safety Factors/
Exposure/Scenario Departure RfD, PAD, Level Study and Toxicological Effects
of Concern for
Risk Assessment
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Acute dietary N/A N/A No appropriate endpoint
(Females 13-49 years of age).......... identified.
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Acute dietary N/A N/A No appropriate endpoint
(General population including infants identified. The effects observed
and children)........................ in an acute neurotoxicity study
were seen at a very high dose
2,000 mg/kg/day) that is
considered not applicable to human
exposure.
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Chronic dietary NOAEL= 5 mg/kg/ UFA = 10X Chronic toxicity - dogs.
(All populations)..................... day UFH = 10X LOAEL = 50 mg/kg/day, based on
l FQPA SF = 1X decreased body weights (17%), body
cPAD = 0.05 mg/kg/ weight gains (68%), and food
day consumption in the females;
adverse liver alterations; slight
vacuolation of the zona
reticularis and zona fasciculate
in the adrenal gland (fatty
change) in both sexes.
----------------------------------------------------------------------------------------------------------------
Short-term dermal N/A N/A No appropriate endpoint
(1 to 30 days) (Residential).......... identified. 28-day dermal toxicity
study - rats.
LOAEL = not determined, no
systemic effect up to the limit
dose of 1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-term (1-30 days) NOAEL = 5 mg/kg/ UFA = 10X 90-day oral toxicity - dogs.
day UFH = 10X LOAEL = 50 mg/kg/day based on
IAF = 100% FQPA SF = 1X increased incidence/severity of
Residential LOC hepatic vacuolation in both sexes.
for MOE = 100
(Residential)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ``Not likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose
(a = acute, c = chronic). RfD = reference dose. N/A = not applicable. LOC = level of concern. MOE = margin of
exposure.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to florasulam, EPA considered exposure under the petitioned-
for tolerances . EPA assessed dietary exposures from florasulam 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
florasulam; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Method (DEEM-FCID)
and the food consumption data from the USDA 1994-1996, and 1998 CSFII.
As to residue levels in food, EPA assumed all foods for which there are
tolerances were treated and contain tolerance-level residues.
iii. Cancer. There were no treatment-related tumors observed in
carcinogenicity studies in rats and mice. Because EPA has concluded
that florasulam is not a carcinogen, a cancer exposure assessment was
not needed.
iv. Anticipated residue and percent crop treated (PCT) information.
The chronic analyses assumed tolerance level residues, 100% crop
treated (CT), and DEEM \TM\ default processing factors for all
registered and proposed commodities. For those processed commodities in
the DEEM-FCID \TM\ residue list which were not in DEEM \TM\, a
processing factor of 1 was assumed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for florasulam in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
florasulam. Further information regarding EPA drinking water models

[[Page 55076]]

used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.

The 5-OH degradate formed by demethylation of florasulam is by far
the predominant environmental residue reaching maximum levels of 70% of
applied material in the hydrolysis and metabolism (soil, aquatic)
studies. This degradate is assumed to be of comparable toxicity to the
parent. On this basis, the residues of concern in drinking water are
the parent and 5-OH degradate. The Agency determined separate estimated
drinking water concentrations (EDWCs) for these two compounds using
FIRST (FQPA Index Reservoir Screening Tool) and SCI-GROW2 (Screening
Concentration in Ground Water) models.
The modeled water residues were incorporated in the DEEM-FCID into
the food categories ``water, direct, all sources'' and ``water,
indirect, all sources.'' To arrive at the total EDWC, the maximum
chronic surface water value for the parent was added to the maximum
chronic surface water value for the major degradate. For the parent,
the chronic aerial spray value (16.8 ppTr) was higher than the ground
spray value. For the degradate, the ground spray value was the higher
of the two (217.5 ppTr). Adding the 2 values (16.8 + 217.5) results in
the total chronic EDWC of 234 ppTr, or 0.234 ppb. This information can
be found under docket identification (ID) number EPA-HQ-OPP-2006-0993.
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).
Florasulam is not registered for use on any sites that would result
in residential exposure. Therefore, a residential exposure assessment
was not conducted.
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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to florasulam and any other
substances and florasulam does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that florasulam has 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 http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional (``10X'') tenfold 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. In applying
this provision, EPA either retains the default value of 10X when
reliable data do not support the choice of a different factor, or, if
reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility and no residual uncertainties with regard to
pre- and/or postnatal toxicity following in utero exposure to rats or
rabbits and pre and/or post-natal exposures to rats.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for florasulam is complete.
ii. There is no indication that florasulam 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 florasulam results in increased
susceptibility following in utero exposure to 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% CT and tolerance-level residues. Conservative ground and
surface water modeling estimates were used. These assessments will not
underestimate the dietary exposure and risks posed by florasulam. There
are no registered or proposed residential uses of florasulam.

E. Aggregate Risks and Determination of Safety

Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
1. Acute risk. No acute dietary endpoint was identified; therefore,
florasulam is not expected to pose an acute risk.
2. Chronic risk. The chronic dietary exposure analysis included
both food and drinking water. The general U.S. population and all
population subgroups have risk estimates that are below the level of
concern. The most highly exposed population subgroup is children (1-2
years) which utilizes < 1% of the cPAD. The general U.S. population
utilizes < 1% of the cPAD. There are no residential uses for florasulam
that result in chronic residential exposure to florasulam.
3. Short-term risk/Intermediate-term risk. Short-term aggregate
exposure takes into account residential exposure plus chronic exposure
to food and water (considered to be a background exposure level).
Intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Florasulam is not registered for use on any sites that would result
in residential exposure. Therefore, short-term and intermediate-term
aggregate risk assessments were not conducted.
4. Aggregate cancer risk for U.S. population. Exposure to
florasulam did not result in a treatment-related increase in tumor
formation in rats or mice; therefore, florasulam is not expected to
pose a cancer risk.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to florasulam residues.

[[Page 55077]]

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (capillary gas chromatography with
mass selective detection (GC/MSD) 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

Maximum residue levels (MRLs) are established in Canada for
residues of florasulam in barley, oats, and wheat grain at 0.01 ppm. No
harmonization issues exist since the same tolerance level is
recommended for the use in the United States. There are no Codex MRLs.

C. Response to Comments

One comment was received in response to the notice of filing from
B. Sachau, 15 Elm St., Florham Park, NJ 07932. The commenter objected
to the sale or use of this product and the acceptance of anything
except a zero tolerance. The commenter also indicated health
implications from this chemical. However, the comment contained no
scientific data or evidence to rebut the Agency's conclusion that there
is a reasonable certainty that no harm will result from aggregate
expose to florasulam, including all anticipated dietary exposure and
all other exposures for which there is reliable information. The
commenter also questioned the rigor of the safety testing submitted on
florasulam; however, the comment was in the form of a conclusory
statement and provided no supporting documentation or rationale for the
position taken.

V. Conclusion

Therefore, the tolerance is established for residues of florasulam,
N-(2,6-difluorophenyl)-8-fluoro-5-methoxy(1,2,4)triazolo(1,5-
c)pyrimidine-2-sulfonamide, in or on barley, grain at 0.01 ppm, barley,
hay at 0.05 ppm, barley, straw at 0.05 ppm, oat, grain at 0.01 ppm,
oat, forage at 0.05 ppm, oat, hay at 0.05 ppm, oat, straw at 0.05 ppm,
rye, grain at 0.01 ppm, rye, forage at 0.05 ppm, rye, straw at 0.05
ppm, wheat, grain at 0.01 ppm, wheat, forage at 0.05 ppm, wheat, hay at
0.05 ppm, and wheat, straw at 0.05 ppm.

VI. Statutory and Executive Order Reviews

This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866, this 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 6, 2000) do not apply to this rule. In addition, This
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: September 23, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.

• Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

• 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

• 2. Section 180.633 is added to read as follows:

Sec. 180.633 Florasulam; tolerances for residues.

(a) General. Tolerances are established for residues of the
herbicide florasulam N-(2,6-difluorophenyl)-8-fluoro-5-
methoxy(1,2,4)triazolo(1,5-c)pyrimidine-2-sulfonamide in or on the
following commodities:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Barley, grain........................................ 0.01
Barley, hay.......................................... 0.05
Barley, straw........................................ 0.05
Oat, forage.......................................... 0.05
Oat, grain........................................... 0.01
Oat, hay............................................. 0.05
Oat, straw........................................... 0.05
Rye, forage.......................................... 0.05
Rye, grain........................................... 0.01

[[Page 55078]]

Rye, straw........................................... 0.05
Wheat, forage........................................ 0.05
Wheat, grain......................................... 0.01
Wheat, hay........................................... 0.05
Wheat, straw......................................... 0.05
------------------------------------------------------------------------

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]

[FR Doc. E7-19219 Filed 9-27-07; 8:45 am]
BILLING CODE 6560-50-S

Notices For
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Florasulam; Pesticide Tolerance

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