

[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]

 
Florasulam; Pesticide Tolerance

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 
EPA-

[[Page 55074]]

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
----------------------------------------------------------------------------------------------------------------
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 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.

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
