Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Tebufenozide,
[Federal Register: September 24, 2004 (Volume 69, Number 185)]
[Rules and Regulations]
[Page 57216-57223]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se04-14]
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0209; FRL-7680-9]
Tebufenozide; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of tebufenozide in or on tuberous and corm vegetables (except potato) subgroup 1D, grape, citrus (crop group 10), and citrus oil and indirect or inadvertent combined residues of tebufenozide, benzoic acid, 3,5- dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1-(1,1dimethylethyl)-2-[4-(1- hydroxyethyl)benzoyl]hydrazide in or on forage, fodder, hay and straw of cereal grain; forage, fodder, straw and hay of non-grass animal feed; forage, fodder and hay of grass and foliage of legume vegetables. Dow AgroSciences and Interregional Research Project Number 4 (IR-4) requested these tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 24, 2004. Objections and requests for hearings must be received on or before November 23, 2004.
ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP-2004-0209. All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket/.
Although listed in the index, some information is not publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305- 5805.
FOR FURTHER INFORMATION CONTACT: Joseph M. Tavano, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 305-6411; e-mail address: tavano.joseph@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:
Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 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 provides a guide for readers regarding entities likely to be
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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 and Other Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
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Background and Statutory Findings
In the Federal Register of March 19, 2001 (66 FR 15443-15459) (FRL- 6766-7), 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 0F6176) by Rohm and Haas, 100 Independence Mall West, Philadelphia, PA 19106, which has been subsequently purchased by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268. The petition requested that 40 CFR 180.482 be amended by establishing a tolerance for residues of the insecticide tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1- dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, in or on citrus (crop group 10) and citrus oil at 0.80 and 10 parts per million (ppm), respectively. That notice included a summary of the petition prepared by Rohm and Haas, the registrant at the time. There were no comments received in response to the notice of filing.
In the Federal Register of March 12, 2003 (68 FR 11846-11850) (FRL- 7295-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 2E6397 and PP 2E 6413), by Interregional Research Project Number 4 (IR- 4), 681 U.S. Highway 1, South Brunswick, NJ 08902. The petitions requested that 40 CFR 180.482 be amended by establishing tolerances for residues of the insecticide, tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, in or on grape at 3.0 ppm (PP 2E6413) and vegetable, tuberous and corm (except potato) subgroup 1D at 0.01 ppm (PP 2E6397). That notice included a summary of the petition prepared by IR-4. There were no comments received in response to the notice of filing.
In the Federal Register of January 28, 2004 (69 FR 4147-4151) (FRL- 7335-9), 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 7F4824), by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268. The petition requested that 40 CFR 180.482 be amended by establishing tolerances for indirect or inadvertent combined residues of tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4- ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1- (1,1dimethylethyl)-2-[4-(1-hydroxyethyl)benzoyl]hydrazide in or on forage, fodder, hay and straw of cereal grain; forage, fodder, straw and hay of non-grass animal feed; forage, fodder and hay of grass and foliage of legume vegetables at 0.5, 0.5, 0.5, and 0.1 ppm, respectively. That notice included a summary of the petition prepared by Dow AgroSciences, the registrant. One comment was received in response to this notice. The commentator stated that there should be a zero tolerance since the data supporting the tolerance was too old. EPA, however, believes that the data submitted in 1999 are still relevant and reliable. The submitted studies were conducted pursuant to EPA regulations and guidelines and the commentor has offered no reason as to why the data from these studies is unreliable.
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....''
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL- 5754-7).
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Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of tebufenozide on tuberous and corm vegetables (except potato) subgroup 1D, grape, citrus (crop group 10), and citrus oil at 0.015, 3.0, 0.80, and 15.0 ppm and indirect or inadvertent combined residues of tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1-(1,1dimethylethyl)-2-
[4-(1-hydroxyethyl)benzoyl] hydrazide in or on forage, fodder, hay and straw of ceral grain; forage, fodder, straw and hay of non-grass animal feed; forage, fodder and hay of grass and foliage of legume vegetables at 1.0, 1.0, 1.0, and 0.20 ppm. EPA'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. The nature of the toxic effects caused by tebufenozide as well as the no-observed-adverse-effect-level (NOAEL) and the lowest- observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of October 21, 1999 (64 FR 56690-56697) (FRL-6382-6).
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Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest
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dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used: ``Traditional uncertainty factors;'' the ``special FQPA safety factor;'' and the ``default FQPA safety factor.'' By the term ``traditional uncertainty factor,'' EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term ``special FQPA safety factor'' refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The ``default FQPA safety factor'' is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10-\5\), one in a million (1 X 10-\6\), or one in ten million (1 X 10-\7\). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ``point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer= point of departure/exposures) is calculated.
A summary of the toxicological endpoints for tebufenozide used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of October 21, 1999 ( 64 FR 56690- 56697) (FRL-6382-6).
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Exposure Assessment
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Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.482) for the residues of tebufenozide, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from tebufenozide in food as follows:
i. Acute exposure. Acute dietary 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. An appropriate endpoint attributable to a single dose was not identified. This risk is considered to be negligible.
ii. Chronic exposure. In conducting the chronic dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates food consumption data as reported by respondents in the U.S. Department of Agriculture 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: For the tolerances established in this action it was assumed that 100% of the crops would be treated with tebufenozide. Percent crop treated (PCT) estimates were used for some already existing tolerances. No anticipated residues were used.
iii. Cancer. Tebufenozide has been classified as a Group E ``No evidence of carcinogenicity for humans.'' Thus, tebufenozide is considered to pose at most a negligible risk of cancer and a quantitative exposure assessment for assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue.
Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group.
Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information in Table 1 of this unit as follows:
Estimates of PTC were used for the following crops. In all cases the maximum estimate was used.
Table 1.--Percent Crop Treated
Commodity
Average
Maximum
Almonds
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