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[Federal Register Volume 66, Number 116 (Friday, June 15, 2001)]
[Notices]
[Pages 32618-32621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15150]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-1030; FRL-6788-2]

Notice of Filing a Pesticide Petition to Establish a Tolerance 
fora Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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: (703) 308-6742; e-mail address: 
[email protected].

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:

[[Page 32619]]

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         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 (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-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 (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], 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.

[[Page 32620]]

Dated: ---------------------------------------------------------------

  
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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

[[Page 32621]]

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.
[FR Doc. 01-15150 Filed 6-14-01; 8:45 am]
BILLING CODE 6560-50-S
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