Environmental Protection Agency (EPA).
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.
Comments, identified by docket control number PF-1001, must be received on or before May 4, 2001.
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-1001 in the subject line on the first page of your response.Start Further Info
FOR FURTHER INFORMATION CONTACT:
By mail: Andrew Bryceland, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-6928; e-mail address: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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|
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-1001. 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 (703) 305-5805.
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-1001 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 (703) 305-5805.
3. Electronically. You may submit your comments electronically by e-mail to: email@example.com, 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-1001. 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. Start Printed Page 17893
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.Start List of Subjects
List of Subjects
- Environmental protection
- Agricultural commodities
- Feed additives
- Food additives
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: March 22, 2001.
Acting Director, Biopesticides and Pollution Prevention 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. This summary was prepared by Chemicals Laif and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner. 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.
Interregional Research Project Number 4 (IR-4)
EPA has received a pesticide petition 1E6251 from Interregional Research Project Number 4 (IR-4), Technology Centre of New Jersey, Rutgers University, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390, 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 to establish an exemption from the requirement of a tolerance for the biochemical pesticide Thymol in or on the raw agricultural comodities honey and beeswax.
A. Product Name and Proposed Use Practices
Thymol, the main component of the herb thyme and API LIFE VAR, has been shown to control varroa mites in bee hives. One tablet of API LIFE VAR (containing thymol) and weighing approximately 20 grams, is broken into two to three pieces and placed on the top bars of the frames over the brood chamber in the autumn after the honey harvest is complete. After 7 to 8 days the tablet is replaced with a fresh tablet. Then 7 to 8 days later the second tablet is replaced with a third tablet. The third tablet is left in the hive for 12 days, after which it is removed form the hive. The product label requires the thymol treatment to be discontinued at least 5 months (150 days) prior to harvesting honey.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. Thymol is mixed with other ingredients and then injected into a vermiculite tablet. The tablets containing 74.08% thymol are then sealed in a vapor proof pouch (bag). This is the end product.
2. Magnitude of residue at the time of harvest and method used to determine the residue. Residues in honey varied between 2 ppm and 48 ppm with average being 15 ppm. Residues were determined via gas chromatography using a flame ionization detector.
3. Analytical method. An analytical method for residues is not applicable, as this proposes an exemption from the requirement of a tolerance.
C. Mammalian Toxicological Profile
Thymol is not very toxic via the oral route. Thymol has an acute oral LD50 of 980 mg/kg in rats; 1,800 mg/kg in mice; and 880 mg/kg in guinea pigs. Thymol can cause eye irritation and with prolonged contact can cause skin irritation. Thymol is currently used as a flavoring agent in several foods and is a major constituent of thyme which is a commercially grown herb used for seasoning foods. Thymol is considered generally recognized as safe (GRAS) by the Food and Drug Administration. Thyme and thyme oil are exempted from pesticidal regulation under FIFRA section 25(b). Thyme oil contains at least 36% thymol.
D. Aggregate Exposure
1. Dietary exposure—i. Food. The potential dietary exposure of the general public to thymol residues resulting from its use in bee hives for the control of varroa mites is not expected to be significant. The public is exposed to thymol through its use as a direct food additive. Thymol is also a naturally occuring substance in lime honey and thyme (which is used to season many foods).
ii. Drinking water. It is not anticipated that residues of thymol will occur in drinking water due to its low application rate and because the use is considered an indoor use since it is placed inside bee hives.
2. Non-dietary exposure. There may be minor amounts of non-dietary esposure to thymol from use in mouth washes and medicines. Thyme oil (which contains at least 36% thymol) is classified as a GRAS substance for use as a flavoring agent in food (21 CFR 182.20) and was recently exempted from pesticide regulation under FIFRA section 25(b) because EPA views it as having minimal risk. Based on the small amount of thymol and thyme oil used in these instances, very minimal dietary exposure is expected.
E. Cumulative Exposure
Because of the low oral toxicity of thymol and because of the fact that its presence in the diet is, for the most part, as a naturally-occurring food ingredient, no cumulative mode of exposure is expected for thymol and other substance having a common mechanism of action.
F. Safety Determination
1. U.S. population. The use of products containing thymol, which is of low toxicity and is used in such low concentrations, is compatible with EPA's objectives to register reduced risk pesticides. Based on the low toxicity, there is reasonable certainty that no harm will result from aggregate exposure of the U.S. population, including infants and children, to residues from thymol. This includes all anticipated dietary exposures and all other exposures for which there is Start Printed Page 17894reliable information. There is an inconsequential increase in dietary exposure resulting from application to bee hives. Thymol is applied at low rates and with its proven low toxicity and its history of safe use, it does not pose a safety concern.
2. Infants and children. Based on the low toxicity of thymol, there is a reasonable certainty that no harm to children or adults will result from aggregate exposure to thymol. Exempting thymol from the requirement of a tolerance should pose no significant risk to humans.
G. Effects on the Immune and Endocrine Systems
Thymol is a naturally occurring biochemical. To date there is no evidence to suggest that thymol functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.
H. Existing Tolerances
There are no existing tolerances for thymol in the United States.
I. International Tolerances
There are no known approved CODEX maximum residue levels (MRLs) established for residues of thymol.End Supplemental Information
[FR Doc. 01-8280 Filed 4-3-01; 8:45 am]
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