Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Florasulam,
[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]
ENVIRONMENTAL PROTECTION AGENCY
[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 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:
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General Information
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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.
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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.
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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: 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.
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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).
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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.
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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.
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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.
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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.
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Exposure Assessment
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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.
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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 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.
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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.
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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.
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Safety Factor for Infants and Children
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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.
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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.
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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.
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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.
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Acute risk. No acute dietary endpoint was identified; therefore, florasulam is not expected to pose an acute risk.
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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
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