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-947, must be received on or before July 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-947 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Driss Benmhend, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9525; e-mail address: benmhend.drissa@epa.gov.

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:

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-947. 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-947 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 (703) 305-5805.

3. Electronically. You may submit your comments electronically by e-mail to: “opp-docket@epa.gov,” 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-947. 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

Summary of Petition

The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. 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 0F6144 from BioTechnologies for Horticulture, Inc., 100 Independence Mall West, Philadelphia, PA 19106-2399, 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 1-methylcyclopropene (1-MCP).

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, BioTechnologies for Horticulture, Inc. (BTH) has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by BioTechnologies for Horticulture, Inc. 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.

BioTechnologies for Horticulture, Inc.

0F6144

A. Product Name and Proposed Use Practices

1-MCP has a non-toxic mode of action. 1-MCP acts as an inhibitor of the natural plant hormone ethylene by blocking the attachment of ethylene to the ethylene receptor in flowers and post-harvested fruits and vegetables thereby counteracting many of the deleterious effects of ethylene. 1-MCP works by blocking the effects from both internal and external sources of ethylene. 1-MCP does not function by directly harming target organisms.

1-MCP is very effective at counteracting many of the undesirable effects of ethylene on harvested fruits and vegetables, like accelerating ripening and softening of climacteric fruit, accelerated de-greening and softening of non-climacteric fruit, accelerated senescence and loss of green color in fresh cut vegetables, russet spotting of lettuce, abscission of leaves, and physiological disorders in fruits.

1-MCP treatments of post-harvested fruit and vegetables will occur indoors in enclosed areas, and are expected to occur mostly in commercial food storage facilities, a number of which are controlled atmosphere facilities which utilize relatively low levels of oxygen and relatively high levels of carbon dioxide.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. EthylBloc® technology is a powdered end-use product containing 0.14% 1-MCP active ingredient. 1-MCP is released as a gas when EthylBloc® product is added to water. EPA has classified 1-MCP as a plant growth regulator structurally related to naturally occurring plant-containing materials, and eligible for a reduced data set requirement. 1-MCP is regulated by the EPA's Biopesticides and Pollution Prevention Division (BPPD), and EthylBloc® is currently registered to BTH for indoor use on flowers, potted plants, and bedding (EPA Reg. No. 71297-1).

2. Magnitude of residue at the time of harvest the method used to determine the residue. Estimates of residues of 1-MCP found in foodstuffs following treatment with EthylBloc® are projected to be extremely low, below reasonable quantifiable concentrations. Low concentrations of 1-MCP passively diffuse in and out of plant tissues and, like naturally occurring ethylene, bind to ethylene receptors. A reasonable worst case estimate of 1-MCP present in plant tissue at any one time can be calculated by assuming that all ethylene receptors in the plant are occupied by 1-MCP. The concentration of ethylene binding sites in plant vegetative tissue range from 1.9 x 10^-9 to 6.8 x 10^-9 moles/kilograms (mol/kg) fresh weight for the leaf portion of plants, and 3.2 x 10^-11 to 7.0 x 10^-11 mol/kg fresh weight for the edible portion of plants (e.g., apple pulp and tomato fruit). An estimate of 1-MCP residues (molecular weight 54 g/mole) in the leaf and edible portions of plants can be determined as follows:

Leaf:

6.8 x 10^-9 moles/kg x 54 g/mole x 1.0 (100% sites) = 0.00000037 g/kg (0.37 parts per billion (ppb))

Edible portion:

7.0 x 10^-11 moles/kg x 54 g/mole x 1.0 (100% sites) = 0.000000004 g/kg (0.004 ppb)

Assuming that 1-MCP occupies all ethylene binding sites in a plant, the quantitative estimates indicate that only 0.37 ppb 1-MCP residues could be retained in the plant tissue, and considerably less than this (0.004 ppb) could be retained in the edible portion of the fruit. In addition, these calculations may have overestimated the actual residue concentrations that consumers would be potentially exposed to, since there would be a finite time between post-harvest treatment of fruits and vegetables and the arrival of the food commodities at the consumer's table. This additional time period would allow 1-MCP to diffuse off ethylene receptors and out of the plant tissue. Given that the estimates of 1-MCP residues would conservatively range between 0.004 and 0.4 ppb, standard residue methods, which normally have a limit of detection of about 10 ppb, will not have the sensitivity to measure 1-MCP residues. The detection limit for the analysis of 1-MCP in the end-use EthylBloc® formulation is 10 ppb (MRID 444647-02). The predicted residues of 1-MCP in food are low and well below reasonable analytical detection limits.

Further evidence of very low predicted 1-MCP residue levels is obtained from preliminary studies that measured airborne 1-MCP concentrations in food chambers having sizes of approximately one cubic meter or greater. The collective results of these studies indicate that 1-MCP remains present in the air at or near nominal levels over the 6 to 24 hr exposure periods, and imply that 1-MCP does not non-specifically bind to the food in the storage rooms. This supports the above arguments that very low residues of 1-MCP would be expected on food treated with 1-MCP. Even if one assumed a 10% deposition rate of the airborne 1-MCP on the stored food, which is the variability of the measured results, only 0.9 ppb 1-MCP would be calculated to be on/in the apples. Finally, in the extreme worst case, if one assumed that all (100%) of the 1-MCP in the chamber was on the food, which is not possible given the above measurements of 1-MCP in the storage room air, then only 9 ppb 1-MCP would be calculated to be in/on the apples.

Overall, there is no reasonable expectation of detectable residues of 1-MCP on food commodities following post-harvest treatment with EthylBloc®.

3. Analytical method. 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 of 1-MCP is not applicable, as this document proposes an exemption from the requirement of a tolerance.

C. Mammalian Toxicological Profile

1. Acute toxicity. Since 1-MCP is a gas at room temperature, most acute toxicity studies were conducted with EthylBloc® end-use product. EthylBloc® exhibits low acute toxicity. The rat oral LD₅₀ is greater than 5,000 milligrams/kilograms (mg/kg) product, and the rabbit dermal LD₅₀ is greater than 2,000 mg/kg product. In addition, EthylBloc® is not a skin sensitizer in guinea pigs, shows no dermal irritation in rabbits, and shows mild-to-moderate ocular irritation in rabbits. No mortalities or any toxic effects were observed in a rat acute inhalation toxicity study conducted with 165 parts per million (ppm) 1-MCP in the air.

2. Genotoxicity. Short-term assays for genotoxicity consisting of a bacterial reverse mutation assay (Ames test), a mouse lymphoma forward mutation assay, and a mouse in vivo micronucleus assay have been conducted using EthylBloc® end-use product as the test material. These studies showed a lack of genotoxicity for EthylBloc®/1-MCP.

3. Other tests. No additional mammalian toxicity testing has been conducted. BTH has requested waivers from the requirements to submit further mammalian toxicity studies on the basis of the favorable toxicological profile for EthylBloc®, its non-toxic mode of action (i.e., ethylene receptor binding), its low use rates (30-1,000 ppb v/v 1-MCP in air), its predicted low residue levels (0.004-0.4 ppb), and the predicted insignificant levels of exposure based on the confined nature of the proposed use (i.e., indoor use in enclosed chambers some of which will contain very low oxygen levels which absolutely necessitates no entry). No data were found in the literature that would indicate EthylBloc® or 1-MCP has any adverse effects on mammals or wildlife. No incidents of hypersensitivity or any other adverse effects have been observed in individuals handling the material over the past several years.

D. Aggregate Exposure

1. Dietary exposure. Any dietary exposure resulting from application of 1-MCP would be through food consumption.

i. Food. Residues in treated fruits and vegetables are predicted to be low (i.e., 0.004-0.4 ppb). Residues would be expected to continue to decline while treated food items remain in storage, and after food is removed from storage and before consumption. Cooking and/or processing would be expected to further lower the residues on treated food.

ii. Drinking water. Since 1-MCP would only be used indoors in enclosed storage areas, there is little if any potential for drinking water exposure.

2. Non-dietary exposure. EthylBloc® is to be used only indoors in enclosed commercial treatment areas. EthylBloc® is currently registered for use on flowers also for use indoors and in enclosed areas. Non-dietary exposure to 1-MCP via lawn care, topical treatments, etc., is not expected to occur. Thus, the potential for non-occupational exposure to the general population is virtually non-existent.

E. Cumulative Exposure

EPA is required to consider the potential for cumulative effects of 1-MCP and other substances that have a common mechanism of toxicity. Consideration of a common mode of toxicity is not appropriate given that there is no indication of mammalian toxicity for 1-MCP and no information that indicates toxic effects, if any, would be cumulative with any other compounds. Since 1-MCP exhibits a non-toxic mode of action in post-harvested fruits and vegetables, it is appropriate to consider only the potential risks of 1-MCP in this exposure assessment.

F. Safety Determination

1. U.S. population. Since there are no anticipated residues in drinking water or from other non-occupational sources, and no reliable information exists on cumulative effects due to a common mechanism of toxicity, the aggregate exposure to 1-MCP is adequately represented by the dietary route. The lack of toxicity of 1-MCP (administered as EthylBloc® end-use product) has been demonstrated by the results of acute toxicity testing in mammals in which EthylBloc® end-use product caused no adverse effects when dosed orally or dermally, and when 1-MCP was administered via inhalation. Anticipated residues in consumed treated fruits and vegetables are predicted to be low, below reasonable levels of analytical detection. Moreover, 1-MCP exhibits close similarity to the naturally occurring plant hormone ethylene, and to other plant-based, naturally occurring cyclopropene and cyclopropane derivatives. Thus, dietary exposure to 1-MCP should pose negligible risks to human health.

2. Infants and children. Based on the lack of toxicity and low exposure, there is a reasonable certainty that no harm to infants, children, or adults will result from aggregate exposure to 1-MCP residues. Exempting 1-MCP from the requirement of tolerances should pose no significant risk to humans or the environment.

G. Effects on the Immune and Endocrine Systems

BTH has no information to suggest that 1-MCP will adversely affect the immune or endocrine systems.

H. Existing Tolerances

There are no other established U.S. tolerances or exemptions from tolerances for 1-MCP.

I. International Tolerances

No maximum residue levels have been established for phosphorous 1-MCP by Codex Alimentarius Commission.