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 ID number OPP-2002-0214, must be received on or before October 25, 2002.

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 ID number OPP-2002-0214 in the subject line on the first page of your response.

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; bryceland.andrew@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,” “Regulations 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 ID number OPP-2002-0214. 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 ID number OPP-2002-0214 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: 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 ID number OPP-2002-0214. 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 Cosmetic 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

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 Certis USA LLC and represents the view of Certis USA LLC. 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.

Certis USA LLC

PP 2F6477

EPA has received a pesticide petition [2F6477] from Certis USA LLC 9145 Guild Road, Suite 175, Columbia, MD 21046, 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 ammonium bicarbonate.

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

1. The biochemical ammonium bicarbonate is proposed for use as an insect feeding attractant in the end use product olive fly attract and kill (A&K) target device; EPA registration pending. Ammonium bicarbonate acts as a feeding attractant to the olive fruit fly (Bactrocera oleae.) The end use product also contains the active ingredients lambda-cyhalothrin insecticide and the pheromone 1,7-dioxaspiro-(5,5)-undecane. The proposed use of the product is in olive orchards to control the olive fruit fly. The active ingredient, ammonium bicarbonate, is listed by the U.S. Food and Drug Administration as a direct food additive under 21 CFR 73.85, 163.110, 163.111, 163.112 and is listed as generally recognized as safe (GRAS) under 21 CFR 184.1135. It is exempt from the requirement of a tolerance under 40 CFR 180.1001(c) when used as an inert ingredient in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest.

2. The ammonium bicarbonate in the end use product, when exposed to air, decomposes and releases gaseous ammonia. Ammonia is a by-product of protein decomposition and as such is recognized by the olive fruit fly as a potential food source. The ammonia released from the end use product attracts the insects to the device. Ammonia per se is exempt from the requirement of a tolerance under 40 CFR 180.1003 when used as a fungicide applied to grapefruit, lemons, oranges and corn grain.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Ammonium bicarbonate, CAS number 1066-33-7, is also known as ammonium hydrogen carbonate. It is a naturally occurring mineral. It is a white, crystalline powder soluble in water but non-soluble in alcohol and acetone. It decomposes at 36 to 60 degrees centigrade to ammonia, carbon dioxide and water vapor. It has many applications including use in baking powders, fire-extinguishing mixtures, agricultural fertilizers and is used as a surfactant, suspending agent and dispersing agent in pesticide formulations.

2. Magnitude of residue at the time of harvest and method used to determine the residue. The end use product contains 4 grams of ammonium bicarbonate bound in a polymer. The polymer is attached to a cellulose card material which is approximately 19 centimeters (cm) by 20 cm in size. The card is suspended from olive tree limbs at a rate of 42 cards per acre of olive orchard resulting in 168 grams (0.37 pounds) of ammonium bicarbonate per acre of orchard. Being contained in the polymer and attached to the cellulose card there is little opportunity for the ammonium bicarbonate to come in contact with either the fruit or the soil. Upon application the end use product will be constantly exposed to sunlight and elevated temperatures which will continually release very small amounts of gaseous ammonia.

Ammonia is a naturally occurring compound which is a key intermediate in the nitrogen cycle. Under normal conditions, ammonia is essential for many biological processes. Ammonia may be released to the atmosphere by volatilization from numerous sources including: Decaying organic matter, animal livestock excreta, fertilization of soil, and burning of coal, wood, and other natural products. Because of its significance in natural cycles, ammonia is found at a local concentration in most environmental media. The half-life of atmospheric ammonia is estimated to be only a few days. In olive orchards atmospheric concentrations of ammonia will be present from the decay of organic matter and from the application of fertilizer to soil as ammonia, ammonium compounds or ammonia precursors (such as urea). Because ammonia, as ammonium ion, is the nutrient of choice for many plants, uptake of soil ammonia by living plants is an important fate process. The rate of uptake by plants varies with the growing season. At normal environmental concentrations, ammonia does not have a very long soil half-life. It is either rapidly taken up by plants, bioconverted by the microbial population, or volatilized to the atmosphere.

Under the conditions of use proposed and given the natural background levels of ammonia in the atmosphere and in the soil, no residues of ammonia or of ammonium bicarbonate are expected to occur in olive fruit from the use of the olive fly attract and kill (A&K) target device.

3. Residues in olive fruit are not expected from the use of the olive fly attract and kill target device; therefore, an analytical method is not needed.

C. Mammalian Toxicological Profile

Because toxicity studies in the scientific literature are limited for ammonium bicarbonate, data on the related ammonium salt, ammonium chloride, and on the carbonate salt, sodium bicarbonate, are discussed. The single dose LD₅₀ of ammonium chloride in the mouse and the rat, administered orally, is reported in scientific literature as 1,300 milligrams/kilogram (mg/kg) and 1,650 mg/kg, respectively. The single dose LD₅₀ of sodium bicarbonate in the mouse and rat, administered orally, is reported in scientific literature as 5,650 mg/kg and 3,400 mg/kg, respectively. For ammonia, the acute inhalation LC₅₀ in the rat exposed for a single period of 15 minutes, was reported in scientific literature as 17,401 parts per million (ppm). The acute inhalation LC₅₀ in the mouse exposed for a single period of 30 minutes was reported as 21,430 ppm.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Ammonium bicarbonate as used in the olive fly attract and kill target device will not come into direct contact with olives. Therefore, no residues of this compound are expected to occur in olives. Ammonium bicarbonate is listed by the U.S. Food and Drug Administration as a direct food additive and is commonly used as a leavening agent in baked goods.

There is some potential for the decomposition product ammonia gas to come into contact with growing olives. However, it is expected that levels of gaseous ammonia would be well below the normal background levels of atmospheric ammonia present in an area of crop production.

ii. Drinking water. Given the mode of application whereby the ammonium bicarbonate is bound in a polymer matrix attached to a cellulose card which is suspended from olive tree branches, there is little likelihood that residues of ammonium bicarbonate would occur in drinking water from this use.

2. Non-dietary exposure. When exposed to air, sun and elevated temperatures in an olive orchard, the ammonium bicarbonate will slowly decompose to ammonia, carbon dioxide, and water vapor. The total amount of ammonium bicarbonate applied per acre in the olive fly attract and kill target devices is 168 grams. Assuming the complete consumption of the ammonium bicarbonate during the growing season, the theoretical yield of ammonia would be equal to approximately 36.1 grams. Assuming that this amount of ammonia is distributed over an acre of olive orchard to a height of 15 feet at a single point in time, this is equal to a theoretical concentration of 3 parts per billion (ppb) of ammonia. But a more realistic scenario would take into account that the release of ammonia would occur over the 4-5 month period after application in the orchard resulting in a daily concentration that is approximately one hundred times less, i.e. 0.025 ppb. This concentration of ammonia would be well below the worldwide atmospheric background concentration of ammonia that has been estimated in scientific literature at approximately 1-3 ppb. Also by comparison, farmers can be exposed to ammonia when applying fertilizer. The ammonia concentration over a field during the application of gaseous anhydrous ammonia fertilizer was reported in scientific literature as high as 213 microgram/cubic meter (ug/m³) 300 ppb. This is ten thousand fold higher than the theoretical exposure from the olive fly attract and kill target device.

E. Cumulative Exposure

Because of the method of application and the low use rates of ammonium bicarbonate, little to no exposure is expected. Since ammonium bicarbonate is approved as a direct food additive and is listed as “Generally Recognized as Safe” by the U.S. Food and Drug Administration, there is no concern regarding the potential for cumulative effects of ammonium bicarbonate from the proposed use with other substances due to a common mechanism of action.

F. Safety Determination

1. U.S. population. Evidence of ammonium bicarbonate's low toxicity is demonstrated in the data reported for the related salts, ammonium chloride and sodium bicarbonate. The U.S. Food and Drug Administration has placed the following limitations on the maximum allowable levels of ammonium bicarbonate in processed foods: up to 3.2% in baked goods, grain, snack foods and reconstituted vegetables. This is the equivalent of 32,000 ppm of ammonium bicarbonate concentration in these foods.

Ammonium bicarbonate is exempt from the requirement of a tolerance under 40 CFR 180.1001(c) when it is used as a surfactant, suspending agent or dispensing agent in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. The amount of ammonium bicarbonate used in a pesticide formulation is not restricted by 40 CFR 180.1001(c). Therefore, any level of residue of ammonium bicarbonate in or on olives is currently acceptable when used for these purposes.

Given the method of application of ammonium bicarbonate where it is bound in a polymer within a discrete target device it is extremely unlikely for this compound to come into contact with and result in residues in or on olive fruit. Thus, aggregate exposure to ammonium bicarbonate from use in the olive fly attract and kill target device and any risk to human health will be negligible.

2. Infants and children. Given the low toxicity of the related salts ammonium chloride and sodium bicarbonate and the allowable levels of ammonium bicarbonate in processed foods, there is a reasonable certainty of no harm to children and infants from the use of the olive fly attract and kill target device in olive orchards.

G. Effects on the Immune and Endocrine Systems

Certis USA has no information to suggest that ammonium bicarbonate will adversely affect the immune or endocrine systems.

H. Existing Tolerances

Ammonium bicarbonate is exempt from the requirement of a tolerance under 40 CFR 180.1001(c) when used as an inert ingredient in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. Ammonia is exempt from the requirement of a tolerance under 40 CFR 180.1003 when used as a fungicide applied to grapefruit, lemons, oranges, and corn grain.

I. International Tolerances

There is no Codex maximum residue level (MRL) for ammonium bicarbonate. Canada has established permitted residue levels of ammonium bicarbonate in cocoa products and in unstandardized food products.