[Federal Register Volume 66, Number 116 (Friday, June 15, 2001)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15150]
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing a Pesticide Petition to Establish a Tolerance
fora Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
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
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:
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 potentially
Industry 111 Crop production
112 Animal production
311 Food 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
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
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
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
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
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
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
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.
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
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
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
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