[Federal Register Volume 67, Number 32 (Friday, February 15, 2002)]
[Notices]
[Pages 7156-7159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3661]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1068; FRL-6822-2]


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.

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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-1068, must be 
received on or before March 18, 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 
control number PF-1068 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis McNeilly, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-6742; and 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:

------------------------------------------------------------------------
                                                          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'' ``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 control number PF-1068. 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-1068 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-1068. Electronic comments

[[Page 7157]]

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: February 5, 2002.
Richard P. Kiegwin, Jr.,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's 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.

DowAgroSciences LLC

PP 1F6312

    EPA has received a pesticide petition (1F6312) from DowAgroSciences 
LLC, 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 tolerance for residues of:
    1. Fluoride in or on the following raw agricultural commodities: 
Date at 5 parts per million (ppm), fig at 5 ppm, plum, prune, dried at 
5 ppm, grape, raisin at 5 ppm, fruit, dried at 5 ppm, almond at 10 ppm, 
pecan at 23 ppm, pistachio at 18 ppm, walnut at 30 ppm, beechnut; 
butternut; cashew; chestnut; chinquapin; filbert; nut, brazil; nut, 
hickory; and nut, macadamia at 30 ppm, barley, grain at 10 ppm, corn, 
field, grain; and corn, pop, grain at 7 ppm, oat, grain at 17 ppm, 
rice, grain at 10 ppm, wheat, grain at 25 ppm, millet, grain; rice, 
wild, grain; sorghum, grain; and triticale, grain at 25 ppm and on the 
processed products corn, field, flour at 26 ppm, corn, field, grits at 
10 ppm, corn, field, meal at 28 ppm, corn, field, oil at 3 ppm, rice, 
brown at 14 ppm, rice, polished rice at 18 ppm, rice, bran at 31 ppm, 
rice, hulls at 35 ppm, wheat, bran at 40 ppm, wheat, flour at 10 ppm, 
wheat, germ at 98 ppm, wheat milled by products at 35 ppm, wheat, 
shorts at 38 ppm, corn, field, refined oil at 3 ppm.
    2. Sulfuryl fluoride in or on the following raw agricultural 
commodities: Date at 0.03 ppm, fig at 0.05 ppm, plum, prune, dried at 
0.01 ppm, grape, raisin at 0.01 ppm, fruit, dried at 0.05 ppm, almond 
at 0.2 ppm, pecan at 6.0 ppm, pistachio at 0.5 ppm, walnut at 6.0 ppm, 
beenut; butternut; cashew; chestnut; chinquapin; filbert; nut, brazil; 
nut, hickory; and nut, macadamia at 6.0 ppm, barley, grain at 0.01 ppm, 
corn, field, grain and corn, pop, grain at 0.04 ppm, oat, grain at 0.01 
ppm, rice, grain at 0.04 ppm, wheat, grain at 0.05 ppm, millet, grain; 
rice, wild, grain; sorghum, grain; triticale, grain at 0.05 ppm and on 
the processed products corn, field, flour at 0.01 ppm, corn, field, 
grits at 0.01 ppm, corn, field, meal at 0.01 ppm, corn, field, refined 
oil at 9.0 ppm, rice, brown at 0.01 ppm, rice, polished rice at 0.01 
ppm, rice, bran at 0.01 ppm, rice, hulls at 0.08 ppm, wheat, bran at 
0.01 ppm, wheat, flour at 0.03 ppm, wheat, germ at 0.01 ppm, wheat 
milled byproducts at 0.01 ppm, wheat, shorts at 0.01 ppm.
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 sulfuryl fluoride is 
adequately understood for the purposes of this tolerance. Potential 
residues of sulfuryl fluoride and its degradation product fluoride and 
sulfate were investigated. Residues of sulfuryl fluoride 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 sulfuryl 
fluoride were measurable and predictable. Sulfate as a terminal residue 
of sulfuryl fluoride 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 and fluoride 
in the listed commodities. The sulfuryl fluoride method is based on gas 
chromatography/electron capture detector (GC/ECD) with a limit of 
quantitation (LOQ) of 4.0 ppb in dried fruit, and tree nuts, and 8.0 
ppb in grains, and grain processed products.

[[Page 7158]]

 The fluoride method utilizes a fluoride ion specific electrode. The 
fluoride ion method was validated with a LOQ of 2.4 ppm in dried fruit, 
and tree nuts, and 0.5 ppm in grains, and grain processed products.
    3. Magnitude of residues. Residue data in support of the proposed 
temporary tolerances for sulfuryl fluoride and the degradate of 
interest, fluoride, in the listed commodities have been generated. Tree 
nuts (walnuts, pistachios, pecans, and almonds), and dried fruits 
(dates, figs, dried plums, and raisins) were treated with sulfuryl 
fluoride at target doses ranging from 200 milligrams hour/liter (mg hr/
L) to 1,500 mg hr/L. At the completion of a 24 aeration interval, 
following the single fumigation at 200 mg hr/L, sulfuryl fluoride 
residues were observed only in walnuts, pecans, and figs with average 
residues of 0.072 g/g, 0.046 g/g and 0.005 
g/g, respectively. The effect of multiple fumigations at 1,500 
mg hr/L per fumigation on residue levels indicated presence of sulfuryl 
fluoride residues in all of the commodities tested except in dried 
plums (no detectable residue). At the completion of a 24 aeration 
interval following each fumigation, sulfuryl fluoride average residue 
levels in the commodities were in the following order: Pecans (2.27-
5.16 g/g) >pistachios (0.036-0.29 g/g) >almonds 
(0.036-0.13 g/g) >figs (0.012-0.0141 g/g) >dates (ND-
0.007 g/g) >dried plums ND. Fluoride ion residues were 
measured after dissipation of sulfuryl fluoride residues (LOQ for both tree nuts and dried fruits. Only 
almonds contained measurable levels of fluoride ion with an average of 
3.4 g/g. For multiple fumigations (2-5 times) at 1,500 mg hr/L 
each fumigation, average fluoride ion levels in dried fruits were 
either not detected or g/g) near the LOQ. Fluoride ion residues 
were detected in tree nuts after each fumigation (3 fumigations). After 
the first fumigation, the average fluoride ion residues were 
approximately 4 g/g, 5 g/g, and 9 g/g in 
pistachios, almonds, and pecan, respectively. After the last 
fumigation, the fluoride ion levels increased to approximately 10 
g/g, 16 g/g, and 21 g/g in almonds, 
pistachios, and pecans, respectively. Vacuum fumigation of tree nuts 
(4-hour exposure, target CT product of 200 mg hr/L) resulted in higher 
SF levels in the commodity than from fumigations at NAP, however, 
fluoride levels remained low following vacuum fumigation, less than the 
method LOQ (2.4 g/g commodity).
    Cereal and small grains and their processed products were treated 
with sulfuryl fluoride at target doses ranging from 200 mg hr/L to 
1,500 mg hr/L. Sulfuryl fluoride dissipated rapidly with residues at 
g/g after the 24-hour aeration interval. Fluoride ion 
residues measured in whole grains following the fumigations ranged from 
g/g (200 mg hr/L dose level) and from 1.0 to 7.5 
g/g (1,500 mg hr/L dose level). The processing of sulfuryl 
fluoride-fumigated whole grain wheat containing fluoride ion at 1.19 
g/g yielded flour, shorts, bran, middlings, impurities, and 
germ containing fluoride ion at 0.446 g/g, 1.50 g/g, 
3.05 g/g, 0.718 g/g, 1.07 g/g, and 5.74 
g/g, respectively. The processing of fumigated whole grain 
corn containing fluoride ion at 1.76 g/g produced flour, meal, 
grits, impurities, containing fluoride ion at 1.29 g/g, 1.37 
g/g, 0.826 g/g, and 9.67 g/g. Fluoride ion 
was below the LOQ (0.3 g/g) in corn oil (dry-and wet-milled) 
and wet-milled starch. Fluoride ion residues were consistently higher 
in processed products than in the whole grains. Fluoride ion residues 
in mill-fumigated processed products (germ, flour, meal) ranged from 7 
to 90 g/g, with residues generally following the order of 
wheat germ >wheat flour >corn flour >corn meal.
    On the basis of the residues of fluoride and sulfuryl fluoride that 
were evaluated, the tolerances identified are supported for the listed 
commodities.

B. Toxicological Profile

    1. Acute toxicity. The acute LC50 for sulfuryl fluoride 
is 642 ppm (1,088 milligram/kilogram body weight (mg/kg/bwt) for CD-1 
mice exposed for 4 hours.
    2. Genotoxicty. Genetic toxicity did not occur when sulfuryl 
fluoride 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 sulfuryl fluoride 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 for rat, rabbit, and Beagle dog a NOAEL of 100 ppm.
    5. Chronic toxicity. The lowest reported chronic NOAEL for sulfuryl 
fluoride 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 
sulfuryl fluoride at a rate of 2 lb/1,000 cubic/feet (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 bwt). 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 kilograms. 
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 drinkingwater for 2 years.
    8. Endocrine disruption. There is no evidence from any studies to 
suggest

[[Page 7159]]

that sulfuryl fluoride or fluoride are endocrine disrupters.

C. Aggregate Exposure

    1. Dietary exposure. The Dietary Exposure Evaluation Model (DEEM), 
version 7.73, 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 sulfuryl fluoride under the conditions 
proposed. The highest potential chronic exposures to sulfuryl fluoride 
was to children ages 1 to 6 years resulting from the consumption of 
treated commodities totaling 0.000106 mg/kg/bwt/day. Likewise, the 
highest potential chronic exposure to fluoride was to children ages 1 
to 6 years with a highest estimated exposure of 0.002419 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. No toxicological 
endpoint attributable to a single exposure was identified in the 
available toxicology studies on sulfuryl fluoride or inorganic fluoride 
that would be applicable for an acute dietary exposure.
    ii. Drinking water. There is no anticipated exposure of sulfuryl 
fluoride 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 ppm 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.

D. Cumulative Effects

    The primary degradation product of sulfuryl fluoride is fluoride. 
The toxicity of fluoride in various forms has been extensively reviewed 
and is used as an additive in treated water supplies, toothpastes, 
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 ppm to 1.0 ppm. 
The third report on nutrition monitoring in the United States 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 would represent (chronic dietary exposures of 0.002419 
mg/kg/bwt/day) are considerably lower than EPA's MCLG for fluoride of 
0.114 mg/kg/bwt/day.

E. Safety Determination

    1. U.S. population. Aggregate risk from exposure to sulfuryl 
fluoride 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 sulfuryl fluoride residues in fumigated 
foods are expected to be non-detectable at the point of food 
consumption. Furthermore, if residues were considered as high as what 
is found immediately following the 24-hour aeration period, the margin 
of exposure to the most sensitive population (children) is estimated to 
be greater than 80,000 for chronic exposures. Exposure to fluoride, the 
residue of interest for sulfuryl fluoride, can occur from foods, water, 
and dental treatments. The additional fluoride residues in some 
commodities fumigated with sulfuryl fluoride are indistinguishable from 
the natural levels of fluoride already present and would therefore also 
fall within EPA's threshold of regulation policy. Alternatively, 
fluoride in other commodities are expected to contribute to the 
fluoride that is ingested, but at levels far below other sources, 
especially treated water and dentrifices. Chronic exposure to fluoride 
resulting from the proposed uses of ProFume (0.002419 mg/kg/day) is 
much lower than EPA's 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. Chronic exposure to fluoride from the 
consumption of ProFume treated commodities would be approximately 
0.002419 mg/kg/day for a child age 1 to 6 years. This value is much 
lower than EPA's MCLG of 0.114 mg/kg/bwt/day calculated for exposure to 
fluorinated water.

F. International Tolerances

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

[FR Doc. 02-3661 Filed 2-14-02; 8:45 am]
BILLING CODE 6560-50-S