[Federal Register Volume 66, Number 225 (Wednesday, November 21, 2001)]
[Notices]
[Pages 58473-58477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28861]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1056; FRL-6811-7]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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

DATES:  Comments, identified by docket control number PF-1056, must be 
received on or before December 21, 2001.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1056 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 58474]]

I. General Information

A. Does this Action Apply to Me?

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

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

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-1056. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1056 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-1056. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

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

[[Page 58475]]

and pests, Reporting and recordkeeping requirements.

    Dated: November 8, 2001.
Peter Caulkins,
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 Gowan Company, P.O. Box 5569, Yuma, AZ 85366-
5569, the registrant, and represents the view of 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.

Interregional Research Project Number 4

0E6165

    EPA has received a pesticide petition (0E6165) from the 
Interregional Research Project Number 4 (IR-4), 681 US Highway #1 
South, North Brunswick, NJ 08902 proposing, pursuant to section 408(d) 
of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.145 by 
establishing a tolerance for residues of the insecticidal fluorine 
compounds cryolite and synthetic cryolite (sodium aluminum fluoride) in 
or on the raw agricultural commodities peppermint tops and spearmint 
tops at 50 parts per million (ppm). EPA has determined that the 
petition contains data or information regarding the elements set forth 
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
support granting of the petition. Additional data may be needed before 
EPA rules on the petition. This notice of filing contains a summary of 
the petition provided by Gowan Company, the registrant.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of the residue in 
plants is understood, and that plant residues are inorganic surface 
residues of cryolite which are measured as fluoride.
    2. Analytical method. Adequate methodology is available for data 
collection and tolerance enforcement. Methods for plant residues have 
undergone successful Agency validation and will be published in 
Pesticide Analytical Manual (PAM), Vol. II. Using these methods, total 
fluoride is determined using a pH/ion meter with a fluoride-specific 
electrode. The residue analytical method does not distinguish between 
naturally occurring fluoride and fluoride resulting from agricultural 
use of cryolite. Current Food and Drug Administration (FDA) multi-
residue screening protocols are not appropriate for inorganic fluoride 
residues.
    3. Magnitude of residues. A tolerance of 50 ppm is supported for 
fluoride in or on mint tops for the use pattern of 36 pounds active 
ingredient/acre per season of Gowan cryolite bait (20% granular).

B. Toxicological Profile

    1. Acute toxicity. A rat acute oral toxicity study showed a lethal 
dose (LD)50 greater than 5,000 milligrams/kilograms (mg/kg). 
A rabbit acute dermal toxicity study demonstrated an LD50 of 
2,100 mg/kg. A lethal concentration (LC)50 >2.06 milligram 
per liter (mg/L) and <5.03 mg/L was seen in an acute inhalation study 
with rats. Technical cryolite is a moderate eye irritant in rabbits. 
Cryolite is not a skin irritant to rabbits and is not a dermal 
sensitizer to guinea pigs.
    2. Genotoxicity. Cryolite was negative in an Ames reverse mutation 
test using Salmonella typhimurium with and without activation at dose 
levels of 167, 500, 1,670, 5,000, 7,500, and 10,000 g/plate. 
Cryolite was tested in an in vitro chromosome aberration assay using 
human lymphocytes at 100, 500, and 1,000 g/mL, with and 
without activation. The results were negative. Cryolite also was 
negative in an unscheduled DNA synthesis (UDS) study with rat 
hepatocytes at dose levels up to and including 50 g/mL.
    3. Developmental and reproductive toxicity. A developmental 
toxicity study was performed with cryolite in rats at dose levels of 0, 
750, 1,500, and 3,000 mg/kg/day (gavage). The no observed adverse 
effect level (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 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 lowest observed 
adverse effect level (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 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.
    A 2-generation rat reproduction study was conducted with cryolite 
at dietary dose levels of 0, 200, 600, and 1,800 ppm (representing 0, 
14, 42, and 128 mg/kg/day for males and 0, 16, 49, and 149 mg/kg/day 
for females, respectively, during premating). The systemic toxicity 
NOAEL was not determined. The 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.
    4. Subchronic toxicity. Cryolite was tested in a 28-day range-
finding feeding study in rats 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, 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. Fluoride accumulated at all dose 
levels in this study.
    Cryolite was tested in a 90-day dog feeding study 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. Fluoride accumulation occurred at all dose levels.
    A 21-day subchronic dermal toxicity study in rabbits is considered 
invalid because it is likely that cryolite was

[[Page 58476]]

ingested by the test animals during the study. For this reason, the 
systemic dermal NOAEL and LOAEL could not be determined from this 
study.
    5. Chronic toxicity. A 2-year bioassay in B6C3F1 mice 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 also was conducted by the 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 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. NTP 
considered that there was equivocal evidence of carcinogenic activity 
in male rats in this study and no evidence of carcinogenic activity in 
female rats.
    A 1-year chronic dog feeding study 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. Cryolite metabolism in animals manifests 
itself as free fluoride, that the qualitative nature of the residue is 
understood and that total fluoride is the residue of concern.
    7. Metabolite toxicology. 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.
    8. Endocrine disruption. The 2-generation rat reproduction study, 
the rat, rabbit, and mouse developmental studies, and the dog chronic 
studies summarized above did not demonstrate any effects with cryolite 
that are similar to those produced by naturally occurring estrogens, or 
other endocrine effects. No endocrine effects were determined in the 
rat and mouse (NTP) studies.

C. Aggregate Exposure

    1. Dietary exposure. For acute dietary exposure, no endpoint of 
concern could be found from which an acute dietary risk assessment (1 
day) should be conducted. There was no endpoint for acute dietary 
exposure, since acute toxicity in animal studies is absent until very 
high doses of cryolite were used.
    i. Food. The Agency has estimated chronic dietary exposure to 
cryolite using reassessed tolerances for all currently registered crops 
and percent of crop treated assumptions. The estimated dietary exposure 
to cryolite from all crops is approximately 0.020 mg/kg/day for the 
U.S. population, 0.024 mg/kg/day for children 1 to 6 years old, 0.015 
mg/kg/day for children 7 to 12 years old, and 0.028 mg/kg/day for 
nursing females 13+ years. For the highest exposed subgroup (females 20 
years old and over), the Agency estimated exposure of 0.038 mg/kg/day.
    A Tier 1 chronic dietary risk assessment based on the proposed 
tolerance of 50 ppm for mint top, the conservative assumption of 1 ppm 
(limit of detection) in mint oil, and 100 percent crop treated 
indicates that the additional exposure to fluoride caused by the 
proposed tolerance would be miniscule. The Tier 1 chronic assessment, 
performed with Novigen Sciences Inc. Dietary Exposure Evaluation (DEEM) 
software shows that the highest exposed populations, children 1 to 6 
years old and 7 to 12 years old, would be exposed to an additional 
0.000001 mg/kg/day. The total U.S. population and all other population 
subgroups would be exposed to less 1 x 10-6 mg/kg/day, which 
is the smallest value. Based on the results of this conservative model, 
additional exposure caused by the proposed tolerance would be 
negligible.
    ii. Drinking water. The Agency concluded that the use of cryolite 
should have negligible impacts on fluoride levels in ground and surface 
water. For this reason, the contribution of cryolite to potential 
exposure to fluoride from drinking water need not be considered in the 
aggregate risk assessment.
    However, fluoride is intentionally supplemented to drinking water 
for prevention of dental caries and may also be present at natural 
background levels. The U.S. Public Health Service recommends an optimal 
fluoride concentration of 0.7-1.2 mg/L to prevent dental caries and 
minimize dental fluorosis. Fluoride levels in public drinking water are 
regulated under the Safe Drinking Water Act. A maximum concentration 
limit (MCL) of 4.0 mg/L (0.114 mg/kg/day) has been established.
    EPA has previously estimated that levels of fluoride in/on food 
from the agricultural use of cryolite plus fluoride levels in U.S. 
drinking water supplies result in a daily dietary intake of fluoride of 
approximately 0.085 mg/kg/day. This is substantially less than the MCL 
of 4.0 mg/L (0.144 mg/kg/day), a level which provides no known or 
anticipated adverse health effect as determined by the Surgeon General.
    2. Non-dietary exposure. EPA previously concluded on December 5, 
1997 (62 FR 64294) (FRL-5756-5), that significant non-dietary 
(residential) exposure from the use of cryolite is not anticipated.

D. Cumulative Effects

    The residue of toxicological concern in cryolite is fluoride. 
However, current tolerances for insecticidal fluorine-containing 
compounds are limited to cryolite and synthetic cryolite. For this 
reason, consideration of potential cumulative effects of residues from 
pesticidal substances other than sodium aluminofluoride with a common 
mechanism of toxicity are not applicable.

E. Safety Determination

    1. U.S. population. As discussed above, non-dietary exposure to 
cryolite is negligible. For dietary exposure, EPA concluded that rather 
than establishing a traditional reference dose (RfD), a weight-of-the-
evidence risk assessment is a more appropriate approach for cryolite. 
The toxicological endpoint of

[[Page 58477]]

concern for dietary exposure to cryolite is skeletal fluorosis.
    EPA estimated that total dietary fluoride exposure, including food 
and drinking water, is 0.085 mg/kg/day. Of this total exposure, the 
dietary (food) contribution is about 0.020 mg/kg/day for the U.S. 
population and 0.028 mg/kg/day for the highest exposed subgroup 
(nursing females 13 years old and over). The proposed mint tolerances 
will contribute no more than 0.000001 mg/kg/day to total dietary 
exposure. Thus, the proposed tolerance would have essentially no effect 
on total fluoride exposure. The total exposure to fluoride from all 
sources is well below the MCL of 4.0 mg/L (0.114 mg/kg/day).
    2. Infants and children. EPA has previously concluded on December 
5, 1997 (62 FR 64294), that based on current data requirements, the 
data base relative to prenatal and postnatal toxicity is complete. This 
data taken together suggest minimal concern for developmental or 
reproductive toxicity and do not indicate any increased prenatal or 
postnatal sensitivity. Therefore, EPA concluded that reliable data 
support the weight-of-evidence risk assessment approach for the 
assessment of risks to infants and children associated with the use of 
cryolite and that an additional safety factor is not needed.

F. International Tolerances

    No Codex, European or other international tolerances are in effect 
for cryolite; thus potential dietary exposure to fluoride from the 
agricultural use of cryolite on crops would not include imported 
foodstuffs.
[FR Doc. 01-28861 Filed 11-20-01; 8:45 am]
BILLING CODE 6560-50-S