00-3220. Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals 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 certain pesticide chemicals in or on various food commodities.

DATES:

Comments, identified by docket control number PF-915, must be received on or before March 13, 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-915 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Peg Perreault, Registration Support Branch, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 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-915. 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-915 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, Ariel Rios Bldg., 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-915. 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 supports 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: January 27, 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.

BAYER Corporation

PP 8F4940

EPA has received a pesticide petition (PP 8F4940) from BAYER Corporation, 8400 Hawthorn Road, P.O. Box 4913, Kansas City, MO 64120-0013 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 imidacloprid in or on the raw agricultural commodities (RAC): citrus fruit, citrus pulp, dried and the leafy petiole subgroup (4-B) at 0.7, 5.0, and 6.0 parts per million (ppm), respectively. 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 nature of the imidacloprid residue in plants is adequately understood. The residues of concern are combined residues of imidacloprid and it metabolites containing the 6-chloropyridinyl moiety, all calculated as imidacloprid.

2. Analytical method. The analytical method is a common moiety method for imidacloprid and its metabolites containing the 6-chloropyridinyl moiety using a permanganate oxidation, silyl derivatization, and capillary gas chromatography mass spectrometry (GC/MS) selective ion monitoring. This method has successfully passed a petition method validation in EPA labs. There is a confirmatory method specifically for imidacloprid and several metabolites utilizing GC/MS and high performance liquid chromotography using ultra-violet detection (HPLC-UV) which has been validated by EPA as well. Imidacloprid and its metabolites are stable for at least 24 months in the commodities when frozen.

3. Magnitude of residues—i. Citrus. Forty-three residue crop field trials (23 foliar applications and 20 soil applications) were conducted to evaluate the quantity of imidacloprid expected in citrus from Admire 2, Flowable and Provado 1.6 applications. These trials were conducted in EPA Regions III, VI, and X. Imidacloprid residues in citrus whole fruit (oranges, grapefruit, and lemons) were quantitated by GC using a MS detector. The limit of quantitation (LOQ) was 0.05 ppm. The highest average field trial (HAFT) was 0.61 ppm in oranges. A processing study at 5 times the maximum recommended label use rate was conducted to evaluate the quantity of imidacloprid and metabolite residue in orange processed commodities following treatment of orange trees with Admire 2F. Harvested whole oranges were processed into dried pulp, oil, molasses, and juice using procedures which simulated commercial orange processing practices. Imidacloprid and metabolite residues in orange whole fruit and orange processed commodities were quantitated by GC using a MS detector. Total residue of imidacloprid and metabolites in orange whole fruit was 0.19 ppm. EPA's Table 1 - RAC and processed commodities and feedstuffs derived from crops lists dried pulp, oil, and juice as processed commodities. The processing study showed a total residue for imidacloprid and metabolites of 1.42 ppm (7.5x concentration) in dried pulp and no concentration of total residue of imidacloprid and metabolites in both orange juice and oil (0.05 ppm).

ii. Leaf petioles subgroup vegetables. Twelve residue crop field trials on celery were conducted to evaluate the quantity of imidacloprid expected in members of the leaf petiole vegetable subgroup from Admire 2 Flowable applications. These trials, which compared plant drench, soil sidedress and in-furrow at transplant applications, were conducted in EPA Regions III, V, VI, X, and XI. Imidacloprid residues in untrimmed celery stalks were quantitated by using a GC/MC. The LOQ was 0.05 ppm. Total residue values ranged from 0.13 to 5.62 ppm.

B. Toxicological Profile

1. Acute toxicity. The acute oral LD₅₀ values for imidacloprid technical ranged from 424 - 475 milligrams/kilograms/body weight (mg/kg/bwt) in the rat. The acute dermal LD₅₀ was greater than 5,000 mg/kg in rats. The 4-hour rat inhalation LC₅₀ was 69 mg/m³ air (aerosol). Imidacloprid was not irritating to rabbit skin or eyes. Imidacloprid did not cause skin sensitization in guinea pigs.

2. Genotoxicity. Extensive mutagenicity studies conducted to investigate point and gene mutations, DNA damage and chromosomal aberration, both using in vitro and in vivo test systems show imidacloprid to be non-genotoxic.

3. Reproductive and developmental toxicity. A 2-generation rat reproduction study gave a no-observed adverse effect level (NOAEL) of 100 ppm (8 mg/kg/bwt). Rat and rabbit developmental toxicity studies were negative at doses up to 30 mg/kg/bwt and 24 mg/kg/bwt, respectively.

4. Subchronic toxicity. Ninety-day feeding studies were conducted in rats and dogs. The NOAELs for these tests were 14 mg/kg bwt/day (150 ppm) and 5 mg/kg bwt/day (200 ppm) for the rat and dog studies, respectively.

5. Chronic toxicity. A 2-year rat feeding/carcinogenicity study was negative for carcinogenic effects under the conditions of the study and had a NOAEL of 100 ppm (5.7 mg/kg/bwt in male and 7.6 mg/kg/bwt female) for noncarcinogenic effects that included decreased bwt gain in females at 300 ppm and increased thyroid lesions in males at 300 ppm and females at 900 ppm. A 1-year dog feeding study indicated a NOAEL of 1,250 ppm (41 mg/kg/bwt). A 2-year mouse carcinogenicity study that was negative for carcinogenic effects under conditions of the study and had a NOAEL of 1,000 ppm (208 mg/kg/day). Imidacloprid has been classified under “Group E” (no evidence of carcinogenicity) by EPA's OPP/HED's Reference Dose (RfD) Committee. There is no cancer risk associated with exposure to this chemical. The RfD based on the 2-year rat feeding/carcinogenic study with a NOAEL of 5.7 mg/kg/bwt and 100-fold uncertainty factor, is calculated to be 0.057 mg/kg/bwt.

6. Animal metabolism. The metabolism of imidacloprid in rats was reported in seven studies. Data in these studies show that imidacloprid was rapidly absorbed and eliminated in the excreta (90% of the dose within 24 hours), demonstrating no biologically significant differences between sexes, dose levels, or route of administration. Elimination was mainly renal (70-80% of the dose) and fecal (17-25%). The major part of the fecal activity originated in the bile. Total body accumulation after 48 hours consisted of 0.5% of the radioactivity with the liver, kidney, lung, skin and plasma being the major sites of accumulation. Therefore, bioaccumulation of imidacloprid is low in rats. Maximum plasma concentration was reached between 1.1 and 2.5 hours. Two major routes of biotransformation were proposed for imidacloprid. The first route included an oxidative cleavage of the parent compound rendering 6-chloronicotinic acid and its glycine conjugate. Dechlorination of this metabolite formed the 6-hydroxynicotinic acid and its mercapturic acid derivative. The second route included the hydroxylation followed by elimination of water from the parent compound.

7. Metabolite toxicology. Several metabolites of imidacloprid have been investigated for acute toxicity and genotoxicity. No evidence for genotoxicity was found, and acute toxicity values for all metabolites studied ranged from slightly more toxic to significantly less toxic than parent imidacloprid.

8. Endocrine disruption. The toxicology data base for imidacloprid is current and complete. Studies in this data base include evaluation of the potential effects on reproduction and development, and an evaluation of the pathology of the endocrine organs following short-term or long-term exposure. These studies revealed no primary endocrine effects due to imidacloprid.

C. Aggregate Exposure

1. Dietary exposure—i. Food. For purposes of assessing the potential acute and chronic dietary exposure, Bayer has estimated exposure based on the theoretical maximum residue contribution (TMRC). The TMRC is obtained by using a model which multiplies the tolerance level residue for each commodity by consumption data. The consumption data, based on the NFCS 1989-92 data base, estimates the amount of each commodity and products derived from the commodities that are eaten by the U.S. population and various population subgroups.

a. Acute. For acute dietary exposure the model calculates a margin of exposure (MOE) by dividing the estimated human exposure into the NOAEL from the appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. EPA has determined that a NOAEL of 24 mg/kg/day from a developmental toxicity study in rabbits should be used to assess acute toxicity.

The MOE for imidacloprid derived from previously established tolerances, pending tolerances, plus the proposed use on citrus and the leaf petiole subgroup would be 366 for the U.S. population (48 contiguous States), 323 for non-nursing infants, 101 for children (ages 1-6 years), 420 for children (ages 7-12 years), 622 for males 13+ years, and 554 for females 13+ years at the 99.9 percentile. These MOEs do not exceed EPA's level of concern for acute dietary exposure.

b. Chronic. For purposes of assessing the potential chronic dietary exposure, the model uses the RfD which EPA has determined to be 0.057 mg/kg/day. This is based on the 2-year rat feeding/carcinogenic study with a NOAEL of 5.7 mg/kg/bwt and 100-fold uncertainty factor. In conducting this exposure assessment, very conservative assumptions (100% of all commodities contain imidacloprid residues and those residues are at the level of the tolerance) result in a large overestimate of human exposure.

Using these conservative assumptions, the TMRC for imidacloprid derived from previously established tolerances, pending tolerances, plus the proposed use on citrus and leaf petiole subgroup would be 0.008149 mg/kg bwt/day (14.3% of the RfD) for the U.S. population (48 contiguous States) and 0.018367 mg/kg bwt/day (32.2% of the RfD) for the most highly exposed population subgroup, children (1-6 years old). Therefore, chronic dietary exposure from the existing and proposed uses will not exceed the RfD for any subpopulation, including infants and children.

ii. Drinking water. EPA has determined that imidacloprid is persistent and could potentially leach into groundwater. However, there is no established maximum contamination level (MCL) or health advisory levels established for imidacloprid in drinking water. EPA's “Pesticides in Groundwater Database” has no entry for imidacloprid. In addition, Bayer is not aware of imidacloprid being detected in any ponds, lakes, streams, etc. from its use in the United States. Groundwater monitoring studies conducted in California, Michigan, and Long Island over the past 2 years have found maximum concentrations to be only 0.0001, 0.0002, and 0.0019 milligrams/liter (mg/L), respectively. Therefore, contributions to the dietary burden from residues of imidacloprid in water would be inconsequential.

2. Non-dietary exposure—i. Residential turf. Bayer has conducted an exposure study to address the potential exposures of adults and children from contact with imidacloprid treated turf. The population considered to have the greatest potential exposure from contact with pesticide treated turf soon after pesticides are applied are young children. Margins of safety (MOS) of 7,587 - 41,546 for 10-year old children and 6,859 - 45,249 for 5-year old children were estimated by comparing dermal exposure doses to the imidacloprid NOAEL of 1,000 mg/kg/day established in a 15-day dermal toxicity study in rabbits. The estimated safe residue levels of imidacloprid on treated turf for 10-year old children ranged from 5.6 - 38.2 g/cm² and for 5-year old children from 5.1 - 33.5 g/cm². This compares with the average imidacloprid transferable residue level of 0.080 g/cm² present immediately after the sprays have dried. These data indicate that children can safely contact imidacloprid-treated turf as soon after application as the spray has dried.

ii. Termiticide. Imidacloprid is registered as a termiticide. Due to the nature of the treatment for termites, exposure would be limited to that from inhalation and was evaluated by EPA's Occupational and Residential Exposure Branch (OREB) and Bayer. Data indicate that the MOS for the worst case exposures for adults and infants occupying a treated building who are exposed continuously (24 hours/day) are 8.0 x 107 and 2.4 x 108, respectively; exposure can thus be considered negligible.

iii. Tobacco smoke. Studies have been conducted to determine residues in tobacco and the resulting smoke following treatment. Residues of imidacloprid in cured tobacco following treatment were a maximum of 31 ppm (7 ppm in fresh leaves). When this tobacco was burned in a pyrolysis study, only 2% of the initial residue was recovered in the resulting smoke (main stream plus side stream). This would result in an inhalation exposure to imidacloprid from smoking of approximately 0.0005 mg per cigarette. Using the measured subacute rat inhalation NOAEL of 5.5 mg/m³, it is apparent that exposure to imidacloprid from smoking (direct and/or indirect exposure) would not be significant.

iv. Pet treatment. Human exposure from the use of imidacloprid to treat dogs and cats for fleas has been addressed by EPA's OREB who have concluded that due to the fact that imidacloprid is not an inhalation or dermal toxicant and that while dermal absorption data are not available, imidacloprid is not considered to present a hazard via the dermal route.

D. Cumulative Effects

No other chemicals having the same mechanism of toxicity are currently registered, therefore, there is no risk from cumulative effects from other substances with a common mechanism of toxicity.

E. Safety Determination

1. U.S. population. Using the conservative exposure assumptions described under aggregate exposure and based on the completeness and reliability of the toxicity data, it can be concluded that total aggregate exposure to imidacloprid from all current uses including those currently proposed will utilize little more than 14.3% of the RfD for the U.S. population from food, water, and non-occupational sources. EPA generally has no concern for exposures below 100% of the RfD, because the RfD represents the level at or below which daily aggregate exposure over a lifetime will not pose appreciable risks to human health. In addition, the MOEs for all population groups does not exceed EPA's level of concern for acute dietary exposure. Thus, it can be concluded that there is a reasonable certainty that no harm will result from aggregate exposure to imidacloprid residues.

2. Infants and children. In assessing the potential for additional sensitivity of infants and children to residues of imidacloprid, the data from developmental studies in both rat and rabbit and a 2-generation reproduction study in the rat have been considered. The developmental toxicity studies evaluate potential adverse effects on the developing animal resulting from pesticide exposure of the mother during prenatal development. The reproduction study evaluates effects from exposure to the pesticide on the reproductive capability of mating animals through two generations, as well as any observed systemic toxicity.

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 effects and the completeness of the toxicity data base. Based on current toxicological data requirements, the toxicology database for imidacloprid relative to prenatal and postnatal effects is complete. Further for imidacloprid, the NOAEL of 5.7 mg/kg/bwt from the 2-year old rat feeding/ carcinogenic study, which was used to calculate the RfD (discussed above), is already lower than the NOAELs from the developmental studies in rats and rabbits by a factor of 4.2 to 17.5 times. Since a 100-fold uncertainty factor is already used to calculate the RfD, it is surmised that an additional uncertainty factor is not warranted and that the RfD at 0.057 mg/kg bwt/day is appropriate for assessing aggregate risk to infants and children.

Using the conservative exposure assumptions described above under aggregate exposure, Bayer has determined from a chronic dietary analysis that the percent of the RfD utilized by aggregate exposure to residues of imidacloprid ranges from 9.3% for nursing infants up to 32.2% for children (1-6 years old). EPA generally has no concern for exposure below 100% of the RfD. In addition, the MOEs for all infant and children population groups do not exceed EPA's level of concern for acute dietary exposure. Therefore, based on the completeness and reliability of the toxicity data and the conservative exposure assessment, there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the residues of imidacloprid, including all anticipated dietary exposure and all other non-occupational exposures

F. International Tolerances

No CODEX maximum residue levels have been established for residues of Imidacloprid on any crops at this time.