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Cryolite (Gowan). April 24, 2002. Proposed new and modified tolerances. Federal Register.



Note from FAN's pesticide webmaster.

One of the weaknesses of the following petition is that there is no reference to EPA's September 5, 2001, updated risk assessment on inorganic fluoride.

EPA published this new risk assessment in the September 5, 2001, Federal Register in a petition for the first-time use of Sulfuryl fluoride as a fumigant for post-harvest food commodities. Because fluoride is the endpoint of toxicological concern for both Cryolite and Sufluryl fluoride, the September 5, 2001 fluoride assessment is a critical addition to the literature. It is also essential reading for understanding the risks associated with inorganic fluoride pesticides.

http://www.epa.gov/fedrgstr/EPA-PEST/2002/April/Day-24/p9655.htm


[Federal Register: April 24, 2002 (Volume 67, Number 79)]
[Notices]
[Page 20121-20124]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap02-95]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0007; FRL-6832-1]
 
Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number OPP-2002-0007, 
must be received on or before May 24, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-2002-0007 in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: By mail: Marilyn Mautz, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-6785; e-mail address: 
mautz.marilyn@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:


------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-2002-0007. 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 OPP-2002-0007 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: opp-docket@epa.gov, 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 OPP-2002-0007. 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

[[Page 20122]]

all of that information as CBI. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. In addition to one complete version of the comment that includes any 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public version of the official record. Information not marked 
confidential will be included in the public version of the official 
record without prior notice. If you have any questions about CBI or the 
procedures for claiming CBI, please consult the person identified under 
FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: April 9, 2002.
Debra Edwards,
Acting 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 Gowan Company, and represents the view of 
the Gowan Company. 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.

 Gowan Company

    EPA has received a pesticide petition from Gowan Company, P.O. Box 
5569, Yuma, AZ, 85366-5569 proposing, pursuant to section 408(d) of 
FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by: (1) Modifying 
the tolerance expression in 40 CFR 180.145 (a) General. from 
``Tolerances are established for combined residues of the insecticidal 
fluorine compounds cryolite and synthetic cryolite (sodium 
aluminofluoride) in or on the following commodities:'' to ``Tolerances 
are established for residues of fluoride arising from the use of the 
insecticidal fluorine compounds cryolite and synthetic cryolite (sodium 
aluminofluoride), in or on the following commodities:''; (2) renewing 
and removing the time limitations for potato and potato waste 
tolerances, as an amendment to petitions (December 5, 1997 62 FR 64294) 
(FRL-5756-5); (3) modifying the existing tolerances, for cucumber and 
kiwifruit to reflect the tolerance expression stated as residues of 
fluoride; (4) modifying existing tolerances for apricots, nectarines, 
kale, cranberry and plums (included in the tolerance modifications for 
plums is the relocation in 40 CFR 180.145 from (a)(1) to (a)(c)), as a 
followup to the Cryolite Reregistration Eligibility Decision, and as 
recommended by the Agency; and (5) establishing new tolerances for 
prunes and the berry group (Crop Group 13) as a follow-up to the 
Cryolite Reregistration Eligibility Decision, and as recommended by the 
Agency. The following specific actions are proposed:
Modify existing tolerances:
     Apricots from 7 ppm to 10 parts per million (ppm)
     Cucumber from 7 ppm to 4 ppm
     Cranberry from 7 ppm to 2 ppm
     Kale from 7 ppm to 35 ppm
     Kiwi from 15 ppm to 8 ppm
     Nectarines from 7 ppm to 10 ppm
     Plums from 7 ppm to 2 ppm (tolerance with regional registration)
Renew tolerances and remove time-limitation:
     Potatoes - 2 ppm
     Potatoes, waste from processing 22 ppm
Establish new tolerances:
     Berries (crop group 13) - 0.5 ppm (replaces separate existing 
tolerances for blackberries, blueberries, boysenberries, dewberries, 
loganberries, raspberries and youngberries
     Prunes - 7 ppm (tolerance with regional registration)
     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 cryolite in plants and 
animals was reviewed in the Cryolite Reregistration Eligibility 
Decision (RED) of 1996 and in the December 5, 1997 Federal Register. 
The nature of the residues in plants is understood. Plant residues are 
inorganic surface residues of cryolite, that are measured as total 
fluoride. Uptake and translocation of cryolite residues from soil is 
unlikely, due to the low water solubility of cryolite.
    2. Analytical method. Analytical methodology was reviewed in the 
Cryolite Reregistration Eligibility Decision of 1996 and in the 
December 5, 1997 Federal Register. An adequate analytical method 
(fluoride specific electrode) is available for enforcement purposes for 
plant and animal residues. The limit of quantitation is 0.05 ppm. EPA 
has previously concluded that, because cryolite is an inorganic ionic 
compound, the requirement for data using the multi-residue protocols in 
the Pesticide Analytical Manual (PAM) Vol. I is not applicable.
    3. Magnitude of residues. Magnitude of the residue studies have 
been reviewed in the 1996 cryolite RED, and in the December 5, 1997 
Federal Register. Magnitude of the residue studies have been conducted 
at the maximum label rates for the commodities. Results from the 
studies demonstrate that the highest fluoride

[[Page 20123]]

residues will not exceed the proposed tolerances, when the insecticide 
is applied following the label use directions.

B. Toxicological Profile

     The cryolite RED concluded that the toxicological data base was 
adequate for a reregistration eligibility decision. No additional 
toxicology requirements were specified in the RED. The cryolite residue 
of toxicological concern is fluoride; and health effects identified for 
fluoride in humans and animals are skeletal and dental fluorosis. 
Dental fluorosis (mottling of tooth enamel) is not considered to be an 
adverse effect. Further, the Agency has determined that although, 
fluoride accumulation is demonstrated in a number of studies, the 
accumulation itself is not considered an adverse effect.
    1. Acute toxicity. A rat acute oral toxicity study (MRID 00138096) 
showed an LD50 greater than 5,000 milligrams/kilogram (mg/
kg). A rabbit acute dermal toxicity study (MRID 00128107) demonstrated 
an LD50 of 2,100 mg/kg. An LC50 > 2.06 milligrams 
per liter( mg/L) and < 5.03 mg/L was seen in an acute inhalation study 
with rats (MRID 00128107).Technical cryolite is a moderate eye irritant 
in rabbits (MRID 00128106). Cryolite is not a skin irritant to rabbits 
(MRID 00128106) and is not a dermal sensitizer to guinea pigs (MRID 
00138097).
    2. Genotoxicty. Cryolite was negative in an Ames reverse mutation 
test (MRID 41838401) using Salmonella typhimurium with and without 
activation at dose levels of 167, 500, 1,670, 5,000, 7,500, and 10,000 
microgram/plate (g/plate). Cryolite was tested in an in vitro 
chromosome aberration assay (MRID 41838402) using human lymphocytes at 
100, 500, and 1,000 microgram milliliter (g/ml), with and 
without activation. The results were negative. Cryolite was also 
negative in an unscheduled DNA synthesis study (MRID 41838403) with rat 
hepatocytes at dose levels up to and including 50 g/mL.
    3. Reproductive and developmental toxicity--i. Reproductive 
toxicity. A two-generation rat reproduction study (MRID 43387501) was 
conducted with cryolite at dietary dose levels of 0, 200, 600, and 
1,800 ppm (representing 0, 14, 42, and 128 milligrams/kilogram/day (mg/
kg/day) for males and 0, 16, 49, and 149 mg/kg/day for females, 
respectively, during premating). The systemic toxicity no observed 
adverse effect level (NOAEL) was not determined. The lowest observed 
adverse effect level (LOAEL), for systemic toxicity was 200 ppm (15 mg/
kg/day) based on dental fluorosis. The NOAEL and LOAEL for reproductive 
toxicity were 600 and 1,800 ppm, respectively (46 and 138 mg/kg/day) 
based on decreased pup body weights.
    ii. Developmental toxicity. A developmental toxicity study was 
performed with cryolite in rats (MRID 00128112) at dose levels of 0, 
750, 1,500, and 3,000 mg/kg/day (gavage). The NOAEL for both 
developmental and maternal toxicity was 3,000 mg/kg/day. At this dose 
level, the only observation was whitening of the teeth of dams.
     A developmental toxicity study was conducted in female mice (MRID 
42297902) with cryolite at dose levels of 0, 30, 100, and 300 mg/kg/day 
(gavage). The NOAEL for maternal toxicity was 30 mg/kg/day and the 
LOAEL was 100 mg/kg/day, based on a single mortality in this group. 
Fetuses at 300 mg/kg/day exhibited bent ribs and bent limb bones. The 
NOAEL for developmental toxicity was 100 mg/kg/day. The LOAEL was 300 
mg/kg/day based on an increase in bent ribs and bent limbs.
     A range-finding developmental toxicity study in female rabbits 
(MRID 42297901), tested cryolite at dose levels of 0, 10, 30, 100, 300, 
and 1,000 mg/kg/day (gavage). The NOAEL for maternal toxicity was 
determined to be 10 mg/kg/day and the LOAEL was 30 mg/kg/day based on 
an increased incidence of soft stool and dark colored feces and 
decreased defecation and urination. The NOAEL for developmental 
toxicity was 30 mg/kg/day. The developmental LOAEL could not be 
assessed due to excessive maternal toxicity at dose levels of >30 mg/
kg/day.
    4. Subchronic toxicity. Cryolite was tested in a 28-day range-
finding feeding study in rats (MRID 00128109), at dose levels of 0, 
250, 500, 1,000, 2,000, 4,000, 10,000, 25,000, and 50,000 ppm in the 
diet (representing approximately 0, 25, 50, 100, 200, 400, 1,000, 
2,500, and 5,000 mg/kg/day). The only compound-related effect seen in 
this study was a change in coloration and physical property of the 
teeth. A NOAEL was not determined in this study. The LOAEL is 250 ppm 
(25 mg/kg/day) based on dental fluorosis.
     In a 90-day rat feeding study (MRID 00158000), cryolite was tested 
at dose levels of 0, 50, 5,000, and 50,000 ppm (corresponding to 0, 
3.8, 399.2 and 4,172.3 mg/kg/day in males and 0, 4.5, 455.9, and 
4,758.1 mg/kg/day in females). The NOAEL was 50 ppm (3.8 mg/kg/day) for 
effects other than fluoride accumulation. The LOAEL was 5,000 ppm 
(399.2 mg/kg/day) based on lesions observed in the stomach.
     Cryolite was tested in a 90-day dog feeding study (MRID 00157999) 
at dose levels of 0, 500, 10,000, and 50,000 ppm (corresponding to 0, 
17, 368, and 1,692 mg/kg/day). The NOAEL was 10,000 ppm (368 mg/kg/
day). The LOAEL was 50,000 ppm (1,692 mg/kg/day) for effects other than 
fluoride accumulation.
    5. Chronic toxicity. The Agency concluded in the cryolite RED that 
the available information does not support the regulation of cryolite 
insecticides as carcinogens. The Agency has classified cryolite as a 
Group ``D'' chemical not classifiable as to human carcinogenicity. 
Further, EPA has noted that fluoride has been the subject of a 
comprehensive review by the National Research Council (National Academy 
of Sciences Subcommittee of Health Effects of Ingested Fluoride) who 
concluded that, `` . . .the available laboratory data are insufficient 
to demonstrate a carcinogenic effect of fluoride in animals.'' and that 
`` . . . the weight of evidence from more than 50 epidemiological 
studies does not support the hypothesis of an association between 
fluoride exposure and increased cancer risk in humans.'' As stated in 
the cryolite RED, the Agency is in agreement with the conclusions 
reached by the National Academy of Science (NAS).
    The following specific chronic/oncogenicity studies are included in 
the cryolite toxicology data base:
     A 2-year bioassay in B6C3F1 mice (HED DOC No. 009682) was 
conducted by the National Toxicology Program (NTP) using sodium 
fluoride as the test material at dose levels of 0, 25, 100, and 175 
ppm, in water, representing 0, 2.4, 9.6, and 16.7 mg/kg/day in males 
and 0, 2.8, 11.3, and 18.8 mg/kg/day in females. The NOAEL was less 
than 25 ppm (2.4 mg/kg/day). The LOAEL was 25 ppm (2.4 mg/kg/day) based 
on attrition of the teeth in males, discoloration and mottling of the 
teeth in males and females and increased bone fluoride in both sexes. 
NTP considered that, there was ``no evidence'' of carcinogenic activity 
in male and female mice.
     A 2-year bioassay in F344/N rats (HED DOC No. 009682) also was 
conducted by the National Toxicology Program (NTP) using sodium 
fluoride as the test material at dose levels of 0, 25, 100, and 175 
ppm, in water, representing 0, 1.3, 5.2, and 8.6 mg/kg/day in males and 
0, 1.3, 5.5, and 9.5 mg/kg/day in females. Osteosarcoma of the bone was 
observed only in 1 male of 50 (1/50) in the 100 ppm group and in 3 of 
80 (3/80) males in the 175 ppm group. The NOAEL was less than 25 ppm 
(1.3 mg/kg/day). The LOAEL was 25 ppm (1.3 mg/kg/day) based on

[[Page 20124]]

mottling of teeth, dentine incisor dysplasia, increased serum, urine 
and bone fluoride levels in males and females and incisor odontoblast 
and incisor ameloblast degeneration in males.
     EPA concluded in the cryolite RED, that the NTP studies utilizing 
sodium fluoride in lieu of cryolite satisfy the guideline study 
requirements for both the rodent chronic feeding study and the rat 

carcinogenicity study. Fluoride has been identified as the residue of 
toxicological concern in cryolite and synthetic cryolite, and these 
compounds act as free fluoride.
     A 1-year chronic dog feeding study (MRID 42575101) was conducted 
with cryolite at dose levels of 0, 3,000, 10,000, and 30,000 ppm, 
representing 0, 95, 366, and 1,137 mg/kg/day in males and 0, 105, 387, 
and 1,139 mg/kg/day in females (in terms of fluoride the doses are 0, 
51, 198, and 614 mg F/kg/day for males and 0, 57, 209 and 615 mg F/kg/
day for females). The NOAEL was less than 3,000 ppm (95 mg/kg/day in 
males and 105 mg/kg/day in females). The LOAEL was 3,000 ppm based on 
increases in emesis, nucleated cells in males, renal lesions and a 
decrease in urine specific gravity in females.
    6. Animal metabolism. As noted in the RED, cryolite behaves 
toxicologically as free fluoride. That is, dissociation produces free 
fluoride ions which are assimilated into bone. There are numerous 
references in the open literature concerning the metabolism of cryolite 
and other fluoride salts. The National Research Council concluded in 
their 1993 comprehensive report titled Health Effects of Ingested 
Fluoride, 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. The active moiety of cryolite is free 
fluoride, which does not further metabolize.
    8. Endocrine disruption. No effects similar to those produced by 
naturally occurring estrogens, or other endocrine effects have been 
noted.

C. Aggregate Exposure

    1. Dietary exposure. A tier 3, partially refined, chronic 
DEEMTM analysis has been conducted for cryolite. In this 
assessment, the most highly exposed population subgroup was determined 
to be children 1-6 years old, at 0.0067 mg/kg/day, or 5.9% of the 
toxicological endpoint used for risk assessment. The estimated dietary 
exposure in this assessment for cryolite is below EPA's level of 
concern for chronic exposure for all population subgroups. Grapes and 
grape products are the largest contributors to dietary exposure 
estimates for all population subgroups. Lettuce was also a significant 
source of exposure for adult populations.
    i. Food. No acute endpoints have been identified for cryolite. For 
the chronic dietary exposure assessment, EPA has determined that the 
dose to be used for risk assessment for exposure to fluoride is 0.114 
mg F/kg/day, per the 1996 Cryolite RED. This value is used for all 
population subgroups, and is derived from a maximum acceptable amount 
of fluoride in drinking water recommended to the EPA by the Surgeon 
General as providing an adequate margin of safety for avoiding skeletal 
fluorosis (1996 Cryolite RED). Tolerance level residues were assumed in 
this assessment for all crops. The tolerance expression currently used 
in the Code of Federal Regulations (40 CFR 180.145) for all cryolite 
tolerances is described as ``the combined residues of the insecticidal 
fluorine compounds cryolite and synthetic cryolite (sodium aluminum 
fluoride) in or on the following agricultural commodities.'' For this 
assessment, the cryolite tolerances have all been converted into ppm as 
fluoride and the toxic endpoint is also expressed as ppm fluoride.
     Estimates of percent crop-treated data were incorporated into the 
assessment where they were available, or could be reasonably translated 
from related crops, but 100% crop-treated (%CT) was assumed for 
cranberries, mint, and berries. The estimates of percent crop-treated 
were taken from BEAD estimates in the 1996 RED. Experimental processing 
factors were used for mint, oil, grape raisins, grape juice, juice 
concentrate; and for citrus juices, juice concentrates, and citrus 
peel. For all other commodities DEEMTM default process 
factors were used.
    ii. Drinking water. The cryolite RED concludes that use of cryolite 
should have negligible impacts on fluoride levels in ground and surface 
water. However, fluoride is intentionally supplemented to drinking 
water for prevention of dental caries, and may also be present at 
natural background levels. Levels of fluoride in/on food from the 
agricultural use of cryolite plus fluoride levels in U.S. drinking 
water supplies, results in a daily intake of fluoride of approximately 
0.064 mg/kg/day for the most highly exposed population subgroup, 
children 1-6 years old. This is 56% of the dose used for chronic risk 
assessment (0.114 mg/kg/day), which represents a level, which provides 
no known or anticipated adverse health effect as determined by the 
Surgeon General. For the U.S. population, the exposure estimate is 
0.060 mg/kg/day (53% of the dose used for risk assessment).
    2. Non-dietary exposure. Non-dietary exposure to cryolite is 
anticipated to be negligible.

D. Cumulative Effects

     EPA has not determined, that any pesticidal substance has a common 
mechanism of toxicity with cryolite.

E. Safety Determination

    1. U.S. population. For the U.S. population, the combined exposure 
estimate to fluoride from the agricultural use of cryolite plus 
drinking water is 0.060 mg/kg/day.
    2. Infants and children. Levels of fluoride in/on food from the 
agricultural use of cryolite plus fluoride levels in U.S. drinking 
water supplies results in a daily intake of fluoride of approximately 
0.064 mg/kg/day for the most highly exposed population subgroup, 
children 1-6 years old.

F. International Tolerances

     No Canadian, Codex or other international tolerances currently 
exist for cryolite.
[FR Doc. 02-9655 Filed 4-23-02; 8:45 am]
BILLING CODE 6560-50-S

Fluoride Action Network (FAN)
An international coalition working to end the fluoridation of public drinking water and to minimize exposure to fluoride.

FAN'S Index on CRYOLITE:
A source for further information on Cryolite.

FAN'S List of Pesticides:
Inorganic Fluoride and Organofluorine
E-Mail FAN's pesticide webmaster
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