Florasulam; Pesticide Tolerance, 55073-55078 [E7-19219]
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Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Rules and Regulations
on or before November 27, 2007, and
must be filed in accordance with the
instructions provided in 40 CFR part
List of Subjects in 40 CFR Part 180
178 (see also Unit I.C. of the
Environmental protection,
SUPPLEMENTARY INFORMATION ).
Administrative practice and procedure,
ADDRESSES: EPA has established a
Agricultural commodities, Pesticides
docket for this action under docket
and pests, Reporting and recordkeeping identification (ID) number EPA–HQ–
requirements.
OPP–2006–0993. To access the
electronic docket, go to https://
Dated: September 21, 2007.
www.regulations.gov, select ‘‘Advanced
Lois Rossi,
Search,’’ then ‘‘Docket Search.’’ Insert
Director, Registration Division, Office of
the docket ID number where indicated
Pesticide Programs.
and select the ‘‘Submit’’ button. Follow
I Therefore, 40 CFR chapter I is
the instructions on the regulations.gov
amended as follows:
website to view the docket index or
access available documents. All
PART 180—[AMENDED]
documents in the docket are listed in
I 1. The authority citation for part 180
the docket index available in
continues to read as follows:
regulations.gov. Although listed in the
index, some information is not publicly
Authority: 21 U.S.C. 321(q), 346a and 371.
available, e.g., Confidential Business
I 2. Section 180.463 is amended by
Information (CBI) or other information
alphabetically adding the following
whose disclosure is restricted by statute.
commodities to the table in paragraph
Certain other material, such as
(a) to read as follows:
copyrighted material, is not placed on
the Internet and will be publicly
§ 180.463 Quinclorac; tolerances for
residues.
available only in hard copy form.
Publicly available docket materials are
(a) * * *
available in the electronic docket at
https://www.regulations.gov, or, if only
Commodity
Parts per million
available in hard copy, at the OPP
Barley, grain ...................
2.0 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.
[FR Doc. E7–19227 Filed 9–27–07; 8:45 am]
to 4 p.m., Monday through Friday,
BILLING CODE 6560–50–S
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
ENVIRONMENTAL PROTECTION
FOR FURTHER INFORMATION CONTACT:
AGENCY
Joanne I. Miller, Registration Division
(7505P), Office of Pesticide Programs,
40 CFR Part 180
Environmental Protection Agency, 1200
[EPA–HQ–OPP–2006–0993; FRL–8148–4]
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
Florasulam; Pesticide Tolerance
(703) 305–6224; e-mail address:
miller.joanne@epa.gov.
AGENCY: Environmental Protection
Agency (EPA).
SUPPLEMENTARY INFORMATION:
ACTION: Final rule.
I. General Information
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a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
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
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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;
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 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 EPA–
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HQ–OPP–2006–0993, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for 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-5methoxy(1,2,4)triazolo(1,5c)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, https://
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
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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-5methoxy(1,2,4)triazolo(1,5c)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
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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 noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
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-20060993 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 https://
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.
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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FLORASULAM FOR USE IN HUMAN RISK
ASSESSMENT
Point of Departure
Uncertainty
Factors/ FQPA
Safety Factors/
RfD, PAD, Level
of Concern for
Risk Assessment
Acute dietary
(Females 13–49 years of age) ................................................
N/A
N/A
No appropriate endpoint identified.
Acute dietary
(General population including infants and children) ................
N/A
N/A
No appropriate endpoint identified.
The effects observed 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.
NOAEL= 5 mg/kg/
day
UFA = 10X
UFH = 10X
l FQPA SF = 1X
cPAD = 0.05 mg/
kg/day
Chronic toxicity – dogs.
LOAEL = 50 mg/kg/day, based on
decreased body weights (17%), body
weight gains (68%), and food
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.
N/A
N/A
No appropriate endpoint identified.
28–day dermal toxicity study – rats.
LOAEL = not determined, no
systemic effect up to the limit dose
of 1,000 mg/kg/day.
NOAEL = 5 mg/
kg/day
IAF = 100%
UFA = 10X
UFH = 10X
FQPA SF = 1X
Residential LOC
for MOE = 100
(Residential)
90–day oral toxicity – dogs.
LOAEL = 50 mg/kg/day based on
increased incidence/severity of
hepatic vacuolation in both sexes.
Exposure/Scenario
Chronic dietary
(All populations) .......................................................................
Short-term dermal
(1 to 30 days) (Residential)
Inhalation Short-term (1-30 days)
Cancer (oral, dermal, inhalation)
Study and Toxicological Effects
‘‘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.
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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.
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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 treatmentrelated 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
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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
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used in pesticide exposure assessment
can be found at https://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 SCIGROW2 (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 nonoccupational, 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
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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 https://
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
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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.
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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.
rwilkins on PROD1PC63 with RULES
V. Conclusion
Therefore, the tolerance is established
for residues of florasulam, N-(2,6difluorophenyl)-8-fluoro-5methoxy(1,2,4)triazolo(1,5c)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.
VerDate Aug<31>2005
18:21 Sep 27, 2007
Jkt 211001
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
PO 00000
Frm 00067
Fmt 4700
Sfmt 4700
55077
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:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.633 is added to read as
follows:
I
§ 180.633 Florasulam; tolerances for
residues.
(a) General. Tolerances are
established for residues of the herbicide
florasulam N-(2,6-difluorophenyl)-8fluoro-5-methoxy(1,2,4)triazolo(1,5c)pyrimidine-2-sulfonamide in or on the
following commodities:
Commodity
Barley, grain ...................
Barley, hay ......................
Barley, straw ...................
Oat, forage ......................
Oat, grain ........................
Oat, hay ..........................
Oat, straw .......................
Rye, forage .....................
Rye, grain .......................
E:\FR\FM\28SER1.SGM
28SER1
Parts per million
0.01
0.05
0.05
0.05
0.01
0.05
0.05
0.05
0.01
55078
Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Rules and Regulations
Commodity
Parts per million
Rye, straw .......................
Wheat, forage .................
Wheat, grain ...................
Wheat, hay .....................
Wheat, straw ...................
0.05
0.05
0.01
0.05
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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0072; FRL–8148–2]
Tembotrione; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
rwilkins on PROD1PC63 with RULES
I. General Information
This regulation establishes
tolerances for combined residues of
tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione and its metabolite
(M5); 2-[2-chloro-4-(methylsulfonyl)-3[(2,2,2-trifluoroethoxy)methyl]benzoyl]4,6-dihydroxy-1,3-cyclohexanedione in
or on corn (field, sweet and pop) and
livestock commodities. Bayer
CropScience requested those tolerances
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–2006-0072. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
SUMMARY:
VerDate Aug<31>2005
18:21 Sep 27, 2007
Jkt 211001
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
https://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:
Eugene Wilson, Registration Division,
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305-6103; e-mail address:
wilson.eugene@epa.gov.
SUPPLEMENTARY 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.
PO 00000
Frm 00068
Fmt 4700
Sfmt 4700
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 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–2006-0072 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 EPA–
HQ–OPP–2006-0072, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
E:\FR\FM\28SER1.SGM
28SER1
]]>Agencies
[Federal Register Volume 72, Number 188 (Friday, September 28, 2007)]
[Rules and Regulations]
[Pages 55073-55078]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19219]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0993; FRL-8148-4]
Florasulam; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
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 https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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
EPA-
[[Page 55074]]
HQ-OPP-2006-0993, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for 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, https://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 https://
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 https://
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
----------------------------------------------------------------------------------------------------------------
Acute dietary N/A N/A No appropriate endpoint
(Females 13-49 years of age).......... identified.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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 https://
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 https://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.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.633 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
