[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10621-10625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4281]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0067; FRL-7701-8]


Sulfuryl Fluoride; Notice of Filing a Pesticide Petition to 
Establish Tolerances 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 identification (ID) number OPP-
2005-0067, must be received on or before April 4, 2005.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Suku Oonnithan, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: 703-605-0368; e-mail address:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

[[Page 10622]]

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2005-0067. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2005-0067. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2005-0067. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0067.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information

[[Page 10623]]

and Records Integrity Branch (PIRIB), Office of Pesticide Programs 
(OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0067. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is 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 docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed 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 
ID 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 FFDCA 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 25, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

PP 3F6573

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
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 a pesticide petition (PP 3F6573) from Dow 
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 
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 by 
establishing tolerances for residues of:
    1. Fluoride in or on the following raw agricultural commodities: 
Animal feed at 130 parts per million (ppm), beef, meat at 40 ppm; 
cheese, post harvest at 5 ppm; cocoa bean, post harvest at 12 ppm; 
coconut, post harvest at 40 ppm; coffee, post harvest at 12 ppm; 
cottonseed, post harvest at 13 ppm; egg at 850 ppm; ginger, post 
harvest at 13 ppm; grain, cereal, forage, fodder and straw group 16, 
post harvest at 130 ppm; grass, forage, fodder and hay group 17, post 
harvest at 130 ppm; ham at 20 ppm; herbs and spices group 19, post 
harvest at 50 ppm; milk at 3 ppm; nut, pine, post harvest at 10 ppm; 
other processed food at 70 ppm; peanut, post-harvest at 13 ppm; rice 
flour, post harvest at 98 ppm; and vegetable, legume, group 06, post 
harvest at 6 ppm.
    2. Sulfuryl fluoride in or on the following raw agricultural 
commodities: Animal feed at 2.0 ppm; beef, meat at 0.01 ppm; cheese, 
post harvest at 0.5 ppm; cocoa bean, post harvest at 0.8 ppm; coconut, 
post harvest at 1.0 ppm; coffee, post harvest at 0.8 ppm; cottonseed, 
post harvest at 0.2 ppm; egg at 0.7 ppm; ginger, post harvest at 0.2 
ppm; grain, cereal, forage, fodder and straw group 16, post harvest at 
2.0 ppm; grass, forage, fodder and hay group 17, post harvest at 2.0 
ppm; ham at 0.01 ppm; herbs and spices group 19, post harvest at 0.3 
ppm; milk at 1.5 ppm; nut, pine, post harvest at 3.0 ppm; other 
processed food at 1.2 ppm; peanut, post-harvest at 0.2 ppm; rice flour, 
post harvest at 0.08 ppm; and vegetable, legume, group 06, post harvest 
at 0.02 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 supports 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 8.0 ppb in grains and grain processed products 
and 4.0

[[Page 10624]]

ppb in all other commodities. The fluoride method utilizes a fluoride 
ion specific electrode. The fluoride ion method was validated with an 
LOQ of 0.5 ppm in grains and grain processed products and 1.0 ppm in 
all other commodities.
    3. Magnitude of residues. Cereal and small grains and their 
processed products were treated with sulfuryl fluoride at target doses 
ranging from 200 mg hr/L to 1500 mg hr/L. Sulfuryl fluoride dissipated 
rapidly with residues at less than the LOQ (with one exception), 
immediately following the 24-hr aeration. One sample (white corn) at 
the 1,500 mg hr/L dose showed a residue of 0.019 ppm after the 24-hr 
aeration interval. Fluoride ion residues measured in whole grains 
following the fumigations ranged from less than the LOQ to 1.8 ppm (200 
mg hr/L dose level) and from 1.0 to 7.5 ppm (1,500 mg hr/L dose level). 
The processing of sulfuryl fluoride-fumigated whole grain wheat 
containing fluoride ion at 1.19 ppm yielded flour, shorts, bran, 
middlings, impurities, and germ containing fluoride ion at 0.446 ppm, 
1.50 ppm, 3.05 ppm, 0.718 ppm, 1.07 ppm, and 5.74 ppm, respectively. 
The processing of fumigated whole grain corn containing fluoride ion at 
1.76 ppm produced flour, meal, grits, impurities, containing fluoride 
ion at 1.29 ppm, 1.37 ppm, 0.826 ppm, and 9.67 ppm. Fluoride ion was 
below the LOQ (0.3 ppm) 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 ppm, with residues generally following the order of wheat germ being 
greater than wheat flour, being greater than corn flour, being greater 
than corn meal. Finished food products and key ingredients were 
fumigated with sulfuryl fluoride (SF) in controlled exposures to 
determine the magnitude of sulfuryl fluoride and terminal fluoride 
anion. Most of the finished food products were fumigated in their 
retail packaging and also in open configuration (removed from packages) 
to compare residue levels resulting from those two packaging 
configurations. Portions (typically 200 - 2,000g) of each commodity 
were exposed in single, 24-hr fumigations to a SF concentration of 62.5 
mg/L (CT Product of 1,500 mg hr/L), at an exposure temperature of 30 C. 
Following fumigation and aeration, the commodities were analyzed to 
determine residue levels of sulfuryl fluoride and fluoride anion. The 
tested food commodities were exposed in a combination of packaged and 
open configuration. Sulfuryl fluoride was not present above the limit 
of quantitation (4 ppb) in twelve commodities fumigated in open 
configuration, nor in three commodities fumigated in packaged 
configuration. Only five of the fumigated commodities had SF residue 
levels that exceeded 1,000 ppb with the highest level being 1,864 ppb. 
The SF concentrations rapidly decayed in the tested commodities between 
post-fumigation Day 1 and Day 2. Fluoride ion was not present above the 
LOQ (1 ppm) in four commodities fumigated in open configuration, nor in 
seven commodities fumigated in packaged configuration. Thirty-five (of 
the 39) commodities fumigated with SF in the open configuration had 
quantifiable levels of fluoride which ranged from 1.03 to 754 ppm. The 
highest fluoride levels were 754 ppm in powdered eggs. Of the 20 
commodities fumigated in packaged configuration, 13 had quantifiable 
fluoride levels, but the fluoride concentrations were less than 12 ppm 
for all package-fumigated commodities with one exception. The 
comparative results of fluoride residues in commodities fumigated under 
packaged versus open fumigation conditions indicate that the packaging 
in most cases does function as a barrier that isolates the contents of 
the package from external SF atmospheres or at least attenuates the 
inner-package concentration of SF to which the commodities are exposed.
    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 four hours.
    2. Genotoxicity. 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 (NOEL) of 
30 ppm; for rat, rabbit, and beagle dog a NOEL of 100 ppm.
    5. Chronic toxicity. The lowest reported chronic NOEL for sulfuryl 
fluoride is 5 ppm based on a 2-year inhalation study with Fischer 344 
rats and the parental NOEL in a two-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 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 (NaF) 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 kilograms. 
The U.S. EPA (Cryolite Reregistration Eligibility Decision [RED], 8/96) 
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 sulfuryl fluoride or fluoride are endocrine disrupters.

[[Page 10625]]

C. Aggregate Exposure

    1. Dietary exposure. The Dietary Exposure Evaluation Model (DEEM), 
version 7.76, 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 0.00009 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 0.005 mg/kg/bwt/day.
    i. Food. Food tolerances as inorganic fluorine compounds exist to 
support the uses of Cryolite (insecticide) and ProFume on various food 
and feed commodities in the United States. The U.S. EPA, in the 2004 
ProFume registration decision, conservatively estimates that the 
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) could be as high as 0.0397 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 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 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 0.005 mg/
kg/bwt/day) are considerably lower than the U.S. EPA 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 150,000-fold 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 the U.S. EPA 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 (0.005 mg/kg/day) is much lower than the U.S. 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 0.005 
mg/kg/day for a child age 1 to 6 years. This value is much lower than 
the U.S. EPA 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. 05-4281 Filed 3-3-05; 8:45 am
BILLING CODE 6560-50-S