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. Start Printed Page 21974
Comments, identified by docket control number PF-992, must be received on or before June 1, 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-992 in the subject line on the first page of your response.Start Further Info
FOR FURTHER INFORMATION CONTACT:
By mail: Carol E. Frazer, PhD., Biopesticides and Pollution Prevention Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-8810; e-mail address: frazer.carol @epa.gov.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 code||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,” “Regulatations and Proposed Rules“ 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-992. 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-992 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-992. 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. Start Printed Page 21975
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: April 19, 2001.
Janet L. Andersen,
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. The summary of the petition was prepared by the petitioner and represents the view of the petitioners. 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.
EPA has received a pesticide petition 0G6222 from Nutra-Park Inc., formerly known as JP BioRegulators, Inc., 3230 Deming Way, Suite 125, Middleton, WI 53562, through Interregional Research Project Number 4 (IR-4), Technology Centre of New Jersey, Rutgers University, 681 U.S. Highway #1 South, proposing pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 USC 346a(d), to amend 40 CFR part 180 to establish an amendment/expansion of an existing tolerance exemption for the biochemical pesticide Lysophosphatidylethanolamine, also known as Lyso-PE and LPE.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Nutra-Park Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Nutra-Park Inc. 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.
A. Product Name and Proposed Use Practices
Lysophosphatidylethanolamine, a specific type of phospholipid, is used to enhance the ripening and shelf life of the following fruits: Apples, citrus, cranberries, grapes, nectarines, peaches, pears, strawberries, tomatoes, blueberries, peppers, and cherries. Phospholipid enhances ethylene production thus stimulating and promoting ripening, but does not enhance respiration so that fruit stays firmer and has a longer shelf life.
Lysophosphatidylethanolamine is sprayed at the rate of 12-500 ppm of active ingredient. Application rate will be 50-200 gallons per acre. Preharvest applications are made May through October and post-harvest application, by dipping fruit in solution and air drying, is extended into December. Treatment is made either 2 weeks prior to harvest or within 1-4 weeks after harvest.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. The active ingredient is lysophosphatidylethanolamine, a specific type of phospholipid. The mechanism by which phospholipid enhances ripening is as a growth regulator. It has been observed empirically that phospholipid stimulates ethylene production, but not respiration of plant tissues although the exact mechanism is not fully understood. Phospholipid is present in all cells in all organisms. It is part of cell membranes. About 50% of the cell membrane is composed of lipid of which the major constituent is phospholipid. Lyso-PE (a specific member of the phospholipid group) is present in high quantities in food products containing egg yolk and meat. In dried egg yolk, Lyso-PE constitutes 2% of the lipids present. Lyso-PE is also found in egg solids, cow's milk, corn grains, corn starch, oats and wheat which are exempted from regulation under section 25(b)(2) of FIFRA.
2. Magnitude of residue at the time of harvest and method used to determine the residue. This section is not applicable, as this proposes a temporary exemption from the requirement of a tolerance.
3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed . An analytical method for residues is not applicable, as this proposes a temporary exemption from the requirement of a tolerance.
C. Mammalian Toxicological Profile
Waivers for toxicology studies have been requested for phospholipid. Phospholipid is a fat found in food consumed by humans and animals, and is non-toxic to humans and animals. Sufficient data exist to assess the hazards of phospholipid and to make a determination on aggregate exposure, consistent with section 408 (c)(2), for the exemptions from the requirement of a tolerance. The exposures, including dietary exposure, and risks associated with establishing the requested exemption from the requirement of a tolerance follows.
Phospholipid is present in all cells in all organisms. It is part of the cell membranes. Lyso-PE (a specific phospholipid) is present in high quantities in food products containing egg yolk and meat. In dried egg yolk, the Lyso-PE constitutes 2% of the fat present. Egg solids are widely used in food products. In the USA, about 18 billion eggs are broken per year to produce egg white and egg solids. Because of this, all acute toxicity, genotoxicity, and subchronic toxicity studies normally required for biochemical pesticides are waived.
D. Aggregate Exposure
Phospholipid is present in all cells in all organisms. It is a part of the cell membrane. Phospholipid is present in high quantities in food products containing egg yolk and meat.
1. Dietary exposure—i. Food. It is anticipated that residues of phospholipid will be negligible in treated raw agricultural commodities. Due to the product's lack of mammalian toxicity, any exposure, if it occurred, will not be harmful to humans.
ii. Drinking water. It is not anticipated that residues of phospholipid will occur in drinking water.
2. Non-dietary exposure. Nutra-Park Inc. is not aware of any non-dietary exposures.
E. Cumulative Exposure
There is no anticipated potential for cumulative effects of phospholipid since it does not have a mode of Start Printed Page 21976toxicity. No cumulative effects are expected with other substances.
F. Safety Determination
1. U.S. population. The lack of toxicity of phospholipid is demonstrated by the above summary. Based on this information, the aggregate exposure to phospholipid over a lifetime should not pose appreciable risks to human health. There is a reasonable certainty that no harm will result from aggregate exposure to phospholipid residues. Exempting phospholipid from the requirement of a temporary tolerance should be considered safe and pose insignificant risk.
Egg solids are widely used in food products. In dried egg yolk, 2% of the lipids are Lyso-PE.
2. Infants and children. Egg yolks are used in a variety of foods including baby food and infant formula. Lyso-PE is also present in human breast milk. There is a reasonable certainty that no harm will result to infants and children from aggregate exposure to phospholipid residues.
G. Effects on the Immune and Endocrine Systems
Nutra-Park Inc. has no information to suggest that phospholipid will adversely affect the immune or endocrine systems.
H. Existing Tolerances
A temporary tolerance exemption on apples, citrus, cranberries, grapes, nectarines, peaches, pears, strawberries and tomatoes in conjunction with Experimental Use Permits for lysophosphatidylethanolamine is currently in effect (63 FR 32131) June 12, 1998, and has been extended to June 2003.
I. International Tolerances
Nutra-Park Inc. is not aware of any international tolerances of this biochemical.End Supplemental Information
[FR Doc. 01-11000 Filed 5-1-01; 8:45 am]
BILLING CODE 6560-50-S