01-15150. 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 control number PF-1030, must be received on or before July 16, 2001.

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-1030 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Dennis McNeilly, Insecticide-Rodenticide Branch, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 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” “Regulation 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-1030. 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-1030 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 [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-1030. 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

Dated:

 

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.

Dow AgroSciences

PP 62719-EUP-UL

EPA has received an Experimental Use Permit Request and associated temporary tolerance pesticide petition (62719-EUP-UL) from Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a temporary tolerance for residues of fluoride in or on the raw agricultural commodity walnuts at 12 parts per million (ppm) and sulfuryl fluoride (SF) in or on raisins at 0.0032 ppm and to establish an exemption from the requirement of a tolerance for fluoride in or on raisins. 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 support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism of SF is adequately understood for the purpose of this tolerance. Potential residues of SF fluoride and its degradation product fluoride and sulfate were investigated. Residues of SF in treated commodities are transient and rapidly decrease to very low (parts per billion (ppb) or non-detectable levels. Residues of fluoride and sulfate resulting from the fumigation of commodities with SF were measurable and predictable. Sulfate as a terminal residue of SF is not considered of toxicological significance due to its natural abundance and pervasiveness in living systems.

2. Analytical method. Analytical methods have been developed and validated to determine the residues of sulfuryl fluoride in walnuts and raisins. The SF method is based on gas chromatography/electron capture detector (GC-ECD) with a limit of quantitation (LOQ) of 4.7 ppb in walnuts and 3.2 ppb in raisins. The fluoride method utilizes a fluoride specific electrode. The fluoride ion method was validated with an LOQ of 2.2 ppm in raisins and 1.9 ppm in walnuts.

3. Magnitude of residues. Residue data in support of the proposed temporary tolerances for SF and the degradate of interest, fluoride in walnuts and raisins have been generated. SF residues in raisins, 1-day post fumigation were all below the LOQ with all but two of the measurements were below the LOD of 1.1 ppb (mg/kg). Fluoride residues in raisins measured 4 days-post fumigation were all less than the LOQ with about half of the observations below the Limit of detection (LOD) of 0.75 ppm. The SF residues in walnuts rapidly decreased to levels ranging from <LOQ to 61.8 ppb at three fumigation temperatures tested, demonstrating the transient nature of the SF residue. Fluoride residues in walnuts measured 4 days-post fumigation at three temperatures ranged from 2.9 ppm to 8.0 ppm.

On the basis of the residues of fluoride that were evaluated, a tolerance of 12.0 ppm is supported in walnuts for fluoride. The rapid and complete dissipation of SF residues from both walnuts and raisins supports tolerances for SF for walnuts and raisins at 2 ppm and 0.0032 ppm, respectively. In addition, the low concentrations of fluoride found in raisins which are indistinguishable from background levels of fluoride in that commodity, supports an exemption from from the requirement of a tolerance for fluoride in raisins under the USEPA's Threshold of Regulation Policy-Deciding Whether a Pesticide with a Food Use Pattern Needs a Tolerance.

B. Toxicological Profile

1. Acute toxicity. The acute LC₅₀ for SF is 642 ppm (1,088 milligrams/kilogram body weight) for CD-1 mice exposed for 4 hours.

2. Genotoxicty. Genetic toxicity did not occur when SF was tested in multiple in vivo and in vitro tests.

3. Reproductive and developmental toxicity. Sulfuryl fluoride did not have any effects on reproductive parameters at dose levels that induced treatment-related effects in parental rats and rabbits. In addition, a teratogenic potential for SF was not demonstrated in either rats or rabbits at dose levels that induced maternal toxicity.

4. Subchronic toxicity. Several 2-week repeated dose inhalation studies indicate for mice a no observed adverse effect level NOAEL of 30 ppm and for rat, rabbit, and beagle dog a NOAEL of 100 ppm.

5. Chronic toxicity. The lowest reported chronic NOAEL for SF is 5 ppm based on a 2-year inhalation study with Fischer 344 rats and the parental NOAEL in a 2-generation rat reproduction study. There was no evidence of carcinogenicity in 2-year rat and 18-month mouse studies.

6. Animal metabolism. Rats fed a diet that had been fumigated by SF at a rate of 2 pounds/1,000 cu ft (containing fluoride levels of 19 ppm above the control level of 36 ppm) for 66 days experienced an increase in the fluoride content of their bones. The National Research Council, in their 1993 report on fluoride concluded that fluoride is readily absorbed by the gut and rapidly becomes associated with teeth and bones. The remaining fluoride is eliminated almost exclusively by the kidneys with the rate of renal clearance related directly to urinary pH.

7. Metabolite toxicology. Clinical symptoms of acute fluoride poisoning in humans are characterized by nausea, vomiting, diarrhea, abdominal pain, and paresthesia. The frequently cited “probably toxic dose,” the dose which should trigger therapeutic intervention and hospitalization, is 5 mg/kg bwt calculated for the lowest third percentile of the infant population. Five to 10 grams of sodium fluoride is considered the certainly lethal dose (CLD) for a 70 kg adult (32 to 64 mg fluoride per kg body weight). One quarter of the CLD can be ingested without producing serious acute toxicity and is known as the safely tolerated dose, i.e., 8 to 16 mg of fluoride per kg of body weight. The Council on Dental Therapeutics of the American Dental Association recommends that “no more than 264 mg of NaF (120 mg F) be dispensed at any one time” in dental treatments to prevent the accidental poisoning of an infant weighing as little as 10 kg. EPA (Cryolite RED decision, August 1996) determined a Maximum Concentration Limit Goal (MCLG) of 0.114 mg/kg/day for fluoride which provides protection from any known or anticipated adverse health effects. The MCLG has been reviewed and supported by the Surgeon General. The National Toxicology Program (NTP) has concluded that there was “no evidence” of carcinogenic activity in male or female mice administered sodium fluoride in drinking water for 2-years.

8. Endocrine disruption. There is no evidence from any studies to suggest that SF or fluoride are endocrine disrupters.

C. Aggregate Exposure

1. Dietary exposure. The Dietary Exposure Evaluation Model (DEEM), version 7.075, of Novigen Sciences, Inc. was used to estimate the dietary exposure to the U.S. population and critical sub-populations resulting from the use of SF on walnuts and raisins. The highest potential acute exposures to SF were to children ages 1-6 years totaling 0.00008 mg/kg-bwt/day. The highest potential acute exposure to fluoride was to children ages 1-6 years with a highest estimated exposure of 0.003 mg/kg-bwt/day. The highest potential chronic exposures to SF was to children ages 1-6 years resulting from the consumption of walnuts totaling 0.000002 mg/kg-bwt/day. Likewise, the highest potential chronic exposure to fluoride was to children ages 1-6 years with a highest estimated exposure of 0.00004 mg/kg-bwt/day.

i. Food. Food tolerances as inorganic fluorine compounds exist to support the uses of Cryolite (insecticide) on various food and feed commodities in the U.S. EPA, in the 1996 Cryolite RED document conservatively estimates that the “high-end dietary exposures to fluoride due to all sources and routes, (including the fluorination of water and the potential for fluoride residues resulting from the uses of Cryolite) are approximately 0.085 mg/kg-bwt/day.

ii. Drinking water. There is no anticipated exposure of SF to drinking water. As a public health tool to aid in the prevention of dental caries, fluoride is added to some domestic water supplies at generally 0.8 to 1.0 ppm.

2. Non-dietary exposure. Sulfuryl fluoride (as Vikane specialty gas fumigant) is presently used to fumigate homes and other structures to control wood infesting insects. The existing Vikane use patterns and exposed populations are not expected to overlap with the intended post-harvest uses of ProFume on stored walnuts and raisins.

D. Cumulative Effects

The primary degradation product of SF is fluoride. The toxicity of fluoride in various forms has been extensively reviewed and is used as an additive in treated water supplies, tooth pastes, mouth rinses, and other treatments for the prevention of dental caries. It is also prescribed in therapeutic amounts for the treatment of osteoporosis. Fluoride is naturally present in both food and water in varying amounts, and has been added to public water supplies to fight dental caries. The recommended concentration of fluoride (usually as fluorosilicic acid) in treated water supplies is 0.8 to 1.0 ppm. The Third Report on Nutrition Monitoring in the U.S. says that:

Food contributes only small amounts of fluoride and monitoring the diet for fluoride intake is not very useful for current public health concerns. The sub-population most susceptible to fluoride is children. For this reason a number of studies have attempted to quantify the fluoride intake from a variety of sources. The total daily intake of fluoride from water (used to prepare formula, juices, and other foods) for infants ages birth to 9-months ranged to 1.73 mg with means from 0.29 to 0.38 mg. Assuming a body weight of 10 kg, these amounts are equivalent to 0.03 to 0.04 mg/kg/day. These levels of dietary exposure in combination with the potential dietary exposures that the proposed uses of ProFume on stored walnuts and raisins would represent (chronic dietary exposures of 0.00004 mg/kg-bwt/day) are considerably lower than the USEPA MCLG for fluoride of 0.114 mg/kg-bwt/day.

E. Safety Determination

1. U.S. population. Aggregate risk from exposure to SF would be minimal because of its rapid dissipation from any fumigated commodity and because it is not expected to be present at the time of food consumption. The SF residues in fumigated foods are expected to be non-detectable at the point of food consumption. Furthermore, if residues were considered as high as 2.0 ppm, the Margin of Exposure to the most sensitive population (children) is estimated to be greater than 300,000 (acute) or greater than 1,000,000 for chronic exposures. Exposure to fluoride, the residue of interest for SF, can occur from foods, water, and, dental treatments. The additional fluoride residues in raisins fumigated with SF are indistinguishable from the natural levels of fluoride already present and would therefore also fall within the EPA Threshold of Regulation Policy. Alternatively, fluoride in walnuts are expected to contribute to the fluoride that is ingested, but at a levels far below other sources, especially treated water and dentrifices. Chronic exposure to fluoride in walnuts and raisins (0.00004 mg/kg/day) is much lower than the EPA MCLG of 0.114 mg/kg-bwt/day calculated for exposure to fluorinated water. In addition there is no directly applicable scientific documentation of adverse medical effects at levels of fluorine below 0.23 mg/kg/day.

2. Infants and children. Acute exposure from a single day consumption of raisins and walnuts would be approximately 0.003 mg/kg/day for a child age 1-6 years. This value is approximately 10,000 times lower than the generally accepted toxic dose, and approximately 2,500 times lower than the accepted safe dose.

F. International Tolerances

There is no Codex maximum residue level established for residues of fluoride on any food or feed crop.