[Federal Register Volume 67, Number 79 (Wednesday, April 24, 2002)]
[Notices]
[Pages 20121-20124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9655]
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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:
[email protected].
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: [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 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
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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