01-10122. Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

DATES:

Comments, identified by docket control number PF-1009, must be received on or before May 25, 2001.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1009 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Joanne Miller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

Categories	NAICS codes	Examples of potentially affected entities
Industry	111	Crop production
	112	Animal production
	311	Food manufacturing
	32532	Pesticide manufacturing

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an official record for this action under docket control number PF-1009. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1009 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number PF-1009. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Make sure to submit your comments by the deadline in this notice.

7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects

• Environmental protection
• Agricultural commodities
• Feed additives
• Food additives
• Pesticides and pests
• Reporting and recordkeeping requirements

April 9, 2001.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

The petitioner summary of the pesticide is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the view of the petitioner. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Dow AgroSciences LLC

PP 0F6089

EPA has received a pesticide petition (0F6089) from Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of cyhalofop-butyl in or on the raw agricultural commodity rice grain, rice hull, rice bran, and polished rice at 0.03 parts per million (ppm) for grain and 8.0 ppm for straw. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism of cyhalofop-butyl in plants (rice) is adequately understood for the purposes of this tolerance. A rotational crop study showed no carryover of significant cyhalofop-butyl related residues in representative test crops.

2. Analytical method. An analytical method has been developed and validated to determine the residues of total cyhalofop and the diacid metabolite in rice grain, straw and processed products. The method was based on capillary gas chromatography with mass selective detection (GC/MSD) indicating limits of detection (LOD) and quantitation (LOQ) for each analyte at 0.005-0.006 μg/g and 0.01-0.02 μg/g, respectively.

3. Magnitude of residues. Metabolism studies in livestock at exaggerated doses of cyhalofop-butyl (nominal concentration equivalent to 10 ppm in the diet) indicated that about 87-90% of the administered dose was eliminated in the excreta. The low levels of residues (0.001-0.08 ppm) in fat and edible tissues, milk or eggs demonstrate that residues due to cyhalofop-butyl would not accumulate in the animals.

B. Toxicological Profile

1. Acute toxicity. The acute toxicity of cyhalofop-butyl is low. The oral and dermal LD_50s were greater than 5,000 milligram/kilogram (mg/kg), and the inhalation LC₅₀ was greater than 5 mg/L. In addition, cyhalofop-butyl induced only minimal ocular and dermal irritation, and did not cause dermal sensitization.

2. Neurotoxicity. Cyhalofop-butyl has been shown to have no neurotoxicologic potential based on acute and subchronic studies.

3. Genotoxicty. Genetic toxicity did not occur when cyhalofop-butyl was tested in multiple in vivo and in vitro tests.

4. Reproductive and developmental toxicity. Cyhalofop-butyl did not have any effects on reproductive parameters at dose levels that induced treatment-related effects in parental rats. In addition, a teratogenic potential for cyhalofop-butyl was not demonstrated in either rats or rabbits at dose levels that induced maternal toxicity.

5. Subchronic and chronic toxicity, and oncogenicity. Cyhalofop-butyl caused increases in liver and kidney weights, microscopic hepatocellular hypertrophy, renal tubular microscopic effects, and distended gallbladders when given at sufficiently high dose levels to the appropriate species for 13 weeks. Similar increases in liver and kidney weights, hepatocellular hypertrophy, and renal effects were also observed in chronic toxicity studies in rodents. In addition, mice had liver inflammation (microgranulomas). Chronic toxicity in dogs was limited to decreased body weight and the occurrence of concretions in the gallbladder.

Using the Guidelines for Carcinogen Risk Assessment published September 24, 1986 (51 FR 33992), it is proposed that cyhalofop and cyhalofop-butyl be classified as Group E for carcinogenicity (no evidence of carcinogenicity) based on the results of carcinogenicity studies in two species. Dow AgroSciences LLC believes that there was no evidence of carcinogenicity in an 18-mouse feeding study and a 24-month rat feeding study at all dosages tested.

6. Animal metabolism. Orally administered cyhalofop-butyl is rapidly absorbed, metabolized and excreted in the rat and dog. Once absorbed, cyhalofop-butyl is hydrolyzed to the acid metabolite (cyhalofop) with no significant quantities of unchanged parent compound present in the plasma, tissues or excreta.

7. Metabolite toxicology. Cyhalofop-butyl is rapidly hydrolyzed from the butyl ester to the acid in plants and the environment. Rats and dogs have also been shown to rapidly hydrolyze the ester to the acid. Mammalian toxicity studies that will test specifically the acid (cyhalofop) in animals are not necessary since the animals in the toxicity studies with the butyl ester have already been exposed to large quantities of the acid. Plant metabolism studies have shown the diacid to be the major metabolite thus analyzed in the samples from crop field trials. This metabolite is more polar and less lipid soluble than the acid and, therefore, would be expected to be less toxic than the acid. Processing of the harvested crop does not result in any residues that are not formed in animals, so additional toxicity studies on residues are not required.

8. Endocrine disruption. There is no evidence from any of the studies to suggest that cyhalofop-butyl is an endocrine disrupter.

C. Aggregate Exposure

Based on the rapid degradation of cyhalofop-butyl and its high tendency to sorb to soils, no surface water or ground water contamination is expected. This agrees with EPA Tier I modeling carried out on cyhalofop-butyl. Therefore, drinking water will not be a significant route of exposure. Dietary exposure is very low as previously mentioned. In addition, a rotational crop study showed no carryover of cyhalofop-butyl related residues in any representative test crop. There are no residential uses for this compound. As a result, the only potential for exposure is dietary, which is acceptable. Therefore, aggregation of exposures is not necessary.

D. Cumulative Effects

The potential for cumulative effects of cyhalofop-butyl, cyhalofop-acid and other substances that have a common mechanism of toxicity is also considered. There is no reliable information to indicate that toxic effects produced by cyhalofop-butyl, cyhalofop-acid and cyhalofop-diacid would be cumulative with those of any other pesticide chemical. Thus, it is appropriate to consider only the potential risks of cyhalofop-butyl and cyhalofop-acid in an aggregate exposure assessment.

E. Safety Determination

1. U.S. population. Using the conservative exposure assumptions described above, and based on the completeness and reliability of the toxicity data, aggregate exposure to cyhalofop-butyl, as determined under the guidance of the FQPA, will utilize no more than 1.3% of the reference dose (RfD) from the dietary exposure for all subgroups of the U.S. population. Generally, and under the FQPA, EPA has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Therefore, there is a reasonable certainty that no harm will result from exposure to cyhalofop-butyl residues.

2. Infants and children. Data from developmental toxicity studies in rats and rabbits and a multigeneration reproduction study in the rat are considered in assessing the potential for additional sensitivity of infants and children to residues of cyhalofop-butyl. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from pesticide exposure during prenatal development. Reproduction studies provide information relating to effects from exposure of both parents to the pesticide on the reproductive capability and potential systemic toxicity of mating animals and on various parameters associated with the well-being of offspring. FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base. Based on the current toxicological data requirements, the data base for cyhalofop-butyl relative to prenatal and postnatal effects for children is complete. Overall, cyhalofop-butyl had no effect on reproduction or embryo-fetal development at any dosage tested. Further, for cyhalofop-butyl, the no observed adverse effect level (NOAEL) in the chronic mouse study (0.3 mg/kg/day), which was used to calculate the RfD (0.003 mg/kg/day), is already lower than the NOAELs from the developmental studies in rats and rabbits. Therefore, an additional FQPA uncertainty factor is not needed and the RfD at 0.003 mg/kg/day is appropriate for assessing risk to infants and children. Using the conservative exposure assumptions previously described, the percent RfD utilized by the potential aggregate exposure to residues of cyhalofop-butyl on rice is about 1.3% for non-nursing infants, the most sensitive population subgroup. Therefore, based on the completeness and reliability of the toxicity data and the conservative exposure assessment, Dow AgroSciences LLC concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to cyhalofop-butyl on rice.

F. International Tolerances

There is no Codex maximum residue level established for residues of cyhalofop-butyl, cyhalofop-acid and cyhalofop-diacid on any food or feed crop.