Sulfuryl Fluoride; Notice of Filing a Pesticide Petition to Establish Tolerances for a Certain Pesticide Chemical in or on Food, 10621-10625 [05-4281]
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Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
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Dated: February 24, 2005.
Thomas P. Dunne,
Deputy Assistant Administrator, Office of
Solid Waste and Emergency Response.
[FR Doc. 05–4265 Filed 3–3–05; 8:45 am]
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10621
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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:oonnithan.suku@epa.gov.
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.
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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
https://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 https://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
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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 email 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
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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 https://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 opp-docket@epa.gov,
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
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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.
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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;
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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, postharvest 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, postharvest 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
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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 millfumigated 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, 24hr 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
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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 postfumigation 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,
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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 twogeneration 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). Onequarter 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.
E:\FR\FM\04MRN1.SGM
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Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
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
VerDate jul<14>2003
19:07 Mar 03, 2005
Jkt 205001
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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
10625
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
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–7875–9]
Draft Final Title VI Public Involvement
Guidance for EPA Assistance
Recipients Administering
Environmental Permitting Programs
(Draft Final Recipient Guidance)
Environmental Protection
Agency (EPA).
ACTION: Agency guidance.
AGENCY:
SUMMARY: EPA’s Office of Civil Rights is
soliciting comments on the Draft Final
Title VI Public Involvement Guidance
for EPA Assistance Recipients
Administering Environmental
Permitting Programs (Draft Final
Recipient Guidance). This guidance
significantly revises the previous Draft
Title VI Guidance for EPA Assistance
Recipients Administering
Environmental Permitting Programs
(Draft Recipient Guidance) issued for
public comment in June 2000. The
revisions made in this document reflect
and include public involvement
considerations suggested in comments
the Office of Civil Rights (OCR) received
on the Draft Recipient Guidance, at
public participation sessions OCR held
in various states over the last two years,
and from other public involvementrelated discussions and information.
This guidance has been developed for
recipients of EPA assistance that
implement environmental permitting
programs. It discusses various
approaches and suggests tools recipients
may wish to use to help enhance the
public involvement aspects of their
current permitting programs and reduce
potential issues related to Title VI of the
Civil Rights Act of 1964 (Title VI) and
EPA’s regulations implementing Title
VI.
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10621-10625]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4281]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:oonnithan.suku@epa.gov.
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 https://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 https://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 https://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 opp-docket@epa.gov,
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
