00-18519. 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-953, must be received on or before August 21, 2000.

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-953 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Mary L. Waller, 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-953. 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-953 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-953. 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 Comestic 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

Dated: July 10, 2000.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

The petitioner summary of the pesticide petition 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.

Novartis Crop Protection, Inc.

PP 9F5044

EPA has received a pesticide petition PP 9F5044 from Novartis Crop Protection, Inc., 410 Swing Road, Greensboro, NC 27419 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of mefenoxam or CGA329351, (R)-2-(2,6-dimethylphenyl)-methoxyacetylamino-propionic acid methyl ester in or on the raw agricultural commodity rape seed (canola) at 0.05 parts per million (ppm). 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 support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. Novartis believes the studies supporting this mefenoxam petition well characterize metabolism in plants and animals. The metabolism profile supports the use of an analytical enforcement method that accounts for combined residues of mefenoxam and its metabolites which contain the 2,6-dimethylaniline (DMA) moiety.

2. Analytical method. Novartis has submitted a practical analytical method involving extraction, filtration, acid reflux, steam distillation, and solid phase cleanup with analysis by confirmatory gas chromatography using nitrogen/phosphorous (N/P) detection. A total residue method is used for determination of the combined residues of mefenoxam and its metabolites which contain the 2,6-dimethylaniline DMA moiety. The limit of quantitation (LOQ) for the method is 0.05 ppm.

3. Magnitude of residues—i. Crops. This petition is supported by six field residue trials that were analyzed in concordance with the OPPTS guidelines based on expected reduced residues and environmental benefits of seed applications. The six trials accounting for approximately 84% of commercial U.S. canola production (agricultural statistics, 1991), were conducted in Georgia (2%), Minnesota (16%), North Dakota (53%), South Dakota (2%), Idaho (6%), and Washington (5%). No residues <0.05 ppm of mefenoxam were detected as 2,6-DMA in canola seed at either the 1x or 3x treatment rate.

ii. Animals. As there were no detectable residues found with a 1x or 3x treatment regime, there is no expected impact on the dietary intake of livestock in association with this petition. Existing tolerances in 40 CFR part 180 are adequate to support the approval of this requested tolerance in the opinion of Novartis Crop Protection.

B. Toxicological Profile

1. Acute toxicity. The toxicological endpoints for mefenoxam are discussed in B.4. of the Federal Register notice of July 25, 1997, (62 FR 40084) (FRL-5726-4). The acute toxicity profile can be summarized as follows:

Rat acute oral study with a LD₅₀ value of 490 milligrams/kilograms (mg/kg). Rat acute dermal study with a LD₅₀ >2,000 mg/kg. Rat inhalation study with a LC₅₀ >2.29 milligram/liter (mg/L) air. Primary eye irritation study in rabbit showing mefenoxam as severely irritating. Primary dermal irritation study in rabbit showing mefenoxam as slightly irritating. Skin sensitization studies in guinea pigs (Maximization and Buehler Test) showing mefenoxam is not a sensitizer.

2. Genotoxicty. The toxicological endpoints for mefenoxam are discussed in Unit B.4. of the Federal Register notice of July 25, 1997 (62 FR 40084). The genotoxicity profile can be summarized as follows:

In vitro gene mutation test: Ames test-negative. In vitro chromosomal aberration test: Chinese hamster ovary (CHO)-negative. In vitro gene mutation tests: Ames tests (3 independent studies)-negative; gene mutation in mouse lymphoma cells-negative; reverse mutation in Saccharomyces cerevisiae-negative. In vitro chromosomal aberration tests: Chinese hamster bone marrow cytogenetic test-negative. DNA repair study in rat hepatocytes-negative.

3. Reproductive and developmental toxicity. The toxicological endpoints for mefenoxam are discussed in B.4. of the Federal Register notice of July 25, 1997 (62 FR 40084). The reproductive and developmental toxicity profile can be summarized as follows:

Teratology study in rats with a maternal no observed adverse effect level (NOAEL) of 10 mg/kg based on reduced body weight (bwt) gain. The fetuses remained entirely unaffected at the highest dose tested (HDT), 250 mg/kg. Teratology study in rabbits with a maternal NOAEL of 150 mg/kg based on bwt loss. The developmental NOAEL was greater than or equal to the HDT, 300 mg/kg. Three-generation reproduction study in rats with a NOAEL of 1,250 ppm, which was the HDT. The treatment had no effect on reproduction or fertility. Dominant lethal study in mouse-negative.

4. Subchronic toxicity. The toxicological endpoints for mefenoxam are discussed in Unit IV.B. of the Federal Register notice of July 25, 1997 (62 FR 40084). The subchronic toxicity profile can be summarized as follows:

A 28-day cumulative toxicity study in rats with a NOAEL of 50 mg/kg based on liver changes. A 90-day subchronic dietary toxicity study in rats with a NOAEL of 250 ppm based on liver changes. A 90-day subchronic dietary toxicity study in dogs with a NOAEL of 250 ppm based on changes in blood biochemistry and hematology indicative of functional liver changes. A 21-day dermal toxicity study in rats with a NOAEL equal to or higher than the limit dose of 1,000 mg/kg. No local or systemic signs of toxicity were found. A 6-month dietary toxicity study in dogs with a NOAEL of 250 ppm based on changes in blood biochemistry indicative of hepatocellular damage.

5. Chronic toxicity The toxicological endpoints for mefenoxam are discussed in B.4. of the Federal Register notice of July 25, 1997 (62 FR 40084). The chronic toxicity profile can be summarized as follows:

A 24-month combined chronic toxicity/carcinogenicity study conducted in rats with a NOAEL of 250 ppm based on liver changes. No evidence of oncogenicity was seen. A 24-month oncogenicity study conducted in mice with a NOAEL of 250 ppm based on liver changes. No evidence of oncogenicity was seen.

6. Animal metabolism. The rat and goat rapidly metabolize and excrete via the same metabolic pathways as plants. Urinary metabolites are polar, primarily gucuronide and other conjugates. The parent compound is not retained in animal tissues nor secreted in milk.

7. Metabolite toxicology. Metabolites are considered to be of equal or less toxicity than the parent material.

8. Endocrine disruption. Mefenoxam does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system. Furthermore, supporting developmental toxicity studies in rats and rabbits, and a reproduction study in rats gave no indication of any effects on endocrine function related to development and reproduction. Subchronic and chronic treatment did not induce any morphological changes in endocrine organs and tissues.

C. Aggregate Exposure

1. Dietary exposure—i. Food. For the purposes of assessing the potential dietary exposure under the proposed tolerance, Novartis Crop Protection has estimated aggregate exposure from all crops for which tolerances are established or proposed (i.e., rape seed).

a. Chronic exposure. Under the conservative exposure assumption of residue levels being at tolerance level, less than 15% of the reference dose (RfD) will be utilized by the U.S. general population. EPA generally has no concern for exposures below 100% of the RfD. Therefore, based on the completeness and reliability of the toxicity data supporting this petition, Novartis Crop Protection believes that there is a reasonable certainty that no harm will result from aggregate exposure to residues arising from this requested use, including anticipated dietary exposure and all other types of non-occupational exposures. From toxicity studies supporting the registration of mefenoxam, the active ingredient is classified as a Group “E” compound (evidence of noncarcinogenicty for humans). There was no evidence of carcinogenicity in a 24-month feeding trial in mice nor in a 24-month feeding study in rats at the dosage levels tested. The doses tested were adequate for identifying a cancer risk.

b. Acute exposure. The risk from acute dietary exposure to mefenoxam is considered to be very low. The NOAEL in a 28-day study was 50 mg/kg, which is 6-fold higher than the chronic NOAEL. Since chronic exposure assessment did not result in any unacceptable exposure for even the most impacted population subgroup, it is anticipated that also the acute exposure will be in an acceptable range. Calculations show that with the most exposed group (non-nursing infants) only 26% of the acute RfD will be utilized; the requested tolerance for rape seed (i.e., canola does not add any measurable contribution to this exposure according to our analysis).

ii. Drinking water. Novartis Crop Protection anticipates the potential exposure from residues of drinking water to be insignificant due to the proposed seed treatment use pattern associated with this petition.

2. Non-dietary exposure. Given the seed treatment use pattern proposed in this petition, there are no anticipated non-dietary exposures resulting from this requested tolerance. Mefenoxam is registered for use as a product for use on turf and ornamentals for control of soil-borne diseases. However, the product is not used residentially by homeowners and the potential exposure to the general public from turf and ornamentals is thought to be negligible.

D. Cumulative Effects

Novartis Crop Protection believes that consideration of a common mechanism of toxicity is not appropriate at this time since there is no information to indicate that toxic effects produced by mefenoxam would be cumulative with those of any other chemicals.

E. Safety Determination

1. U.S. population—i. Acute risk. The risk from acute dietary exposure to mefenoxam is considered to be very low. The NOAEL in a 28-day study was 50 mg/kg, which is 6-fold higher than the chronic NOAEL. Since chronic exposure assessment did not result in any unacceptable exposure for even the most impacted population subgroup, it is anticipated that also the acute exposure will be in an acceptable range. Again, the requested tolerance on rape seed (i.e., canola) was found not to contribute any measurable additional impact on acute exposure to mefenoxam so that for the general population less than 15% of the acute RfD is utilized.

ii. Chronic risk. Under the conservative exposure assumptions of residue levels being at tolerance level, less than 10% of the RfD will be utilized by the U.S. general population. Use on canola does not measurably contribute to this exposure, particularly given that no detectable residues were found even when 3x the use rate was utilized. Therefore, based on the completeness and reliability of the toxicity data supporting this petition, Novartis Crop Protection believes that there is a reasonable certainty that no harm will result from aggregate exposure to residues of mefenoxam taking into account dietary and non-occupational exposures.

2. Infants and children. There is no indication that mefenoxam interferes with the prenatal or neonatal development, even when experimental animals were exposed to very high doses leading to maternal toxicity. Infants and children are not expected to show any particular sensitivity to mefenoxam.

i. Acute risk. The risk from acute dietary exposure to mefenoxam is considered to be very low. The NOAEL in a 28-day study was 50 mg/kg, which is 6-fold higher than the chronic NOAEL. According to our analysis there is no measurable impact of the requested tolerance on the exposure to mefenoxam. The utilization of the acute RfD from the most exposed group is 26% (non-nursing infants).

ii. Chronic risk. Calculated on the basis of the theoretical maximum residue contribution (TMRC) for mefenoxam, utilization of RfD from dietary exposure of children is estimated as: 4.3% for nursing infants, 14% for non-nursing infants, 21% for 1 to 6 years old, and 12% for children 7 to 12 years old.

F. International Tolerances

There are no Codex maximum residue levels established for CGA329351.