Federal Register

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 186

[PP 9F3739 and FAP 1H5604/R1190; FRL-4579-1]

RIN 2070-AB78

Pesticide Tolerance and Animal Feed Additive Regulation for
Fluoride Compounds

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 186

[PP 9F3739 and FAP 1H5604/R1190; FRL-4579-1]

RIN 2070-AB78

Pesticide Tolerance and Animal Feed Additive Regulation for
Fluoride Compounds

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.
..
————————————————————
SUMMARY: This regulation establishes a 3-year time-limited tolerance
for residues of cryolite and/or synthetic cryolite (sodium aluminum
fluoride) in or on the raw agricultural commodity potatoes at
2.0 parts per million (ppm) and a 3-year time-limited feed additive
regulation for residues of the insecticide cryolite and/or synthetic
cryolite (sodium aluminum fluoride) in the commodity processed
potato waste (wet or dry) at 22.0 ppm. These regulations to
establish a maximum permissible level for residues of the insecticide
compounds in or on the commodities were requested in petitions
submitted by Atochem North America, Inc. (formally Pennwalt
Corp.)

EFFECTIVE DATE: These regulations become effective May 5, 1993.

ADDRESSES: Written objections, identified by the document control
number, [PP 9F3739 and FAP 1H5604/R1190], may be submitted to:
Hearing Clerk (A-110), Environmental Protection Agency, rm.
3708, 401 M St., St., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: By mail: Robert A. Forrest,
Product Manager (PM) 14, Registration Division, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 219, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA 22202, (703)-305-6600.

SUPPLEMENTARY INFORMATION: EPA issued notices as follows regarding
petitions submitted by Atochem North America, Inc., 3 Parkway,
rm. 619, Philadelphia, PA 19102:

1. PP 9F3739. Appearing in the Federal Register of March
23, 1989 (54 FR 12009), the petition requested that the Administrator,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 346a(d)) propose to establish a tolerance for
residues of cryolite and/or synthetic cryolite in or on the
raw agricultural commodity (RAC) Irish potatoes at 1.5 ppm.
EPA subsequently issued notice of filing of PP 1F3959 in the
Federal Register of April 3, 1991 (56 FR 13643), stating that
Atochem North America, Inc., proposed to increase the tolerance
from 1.5 ppm to 2.0 ppm and change the RAC Irish potatoes to
the more appropriate designation, potatoes. PP 1F3959 had been
intended as an amendment to PP 9F3739, but was published as
an initial filing. The April 3, 1991 notice reflects the current
amendment.
2. FAP 1H5604. Appearing in the Federal Register of April
3, 1991 (56 FR 13643), the petition requested that the Administrator,
pursuant to section 409(c)(1) of the Federal Food, Drug, and

Cosmetic Act (FFDCA), 21 U.S.C. 348(c)(1), propose to establish
a tolerance for residues of cryolite and/or synthetic cryolite
in the animal feed potato waste at 22.0 ppm resulting from the
application of the compounds to growing potatoes. For consistency,
the commodity potato waste is corrected to read potato waste
(wet or dry) in the final rule.
There were no comments received in response to these notices
of filing.
The data submitted in the petitions and all other relevant
material have been evaluated. The pesticide is considered useful
for the purposes for which the tolerances are sought and considered
capable of achieving the intended physical or technical effect.
The toxicological data considered in support of the tolerances
include the following:
1. A 2-year rat bioassay conducted by the National Toxicology
Program (NTP) using sodium fluoride as the test material in
which mottling; dentine incisor dysplasia; and incisor odontoblast
and ameloblast degeneration of teeth were observed at the lowest
dose tested, 25 ppm (1.3 mg/kg/day). Levels tested were 0, 25,
100, and 175 ppm.
Osteosarcoma of the bone was observed in one male in the
100-ppm group (mid-dose) and in three males in the 175 ppm group
(highest dose tested). NTP considers this to be equivocal evidence
of carcinogenicity in male F344/N rats. No evidence was seen
in female rats.
The currently available information does not support the
regulation of cryolite insecticides as carcinogens at this time.
The U.S. Department of Health and Human Servcies (USDHHS), Public
Health Service, concluded in its 1991 “Review of Fluoride Benefits
and Risks” that “Taken together, the two animal studies available
at this time fail to establish an association between fluoride
and cancer.” The two studies examined by USDHHS consisted of
the NTP study using male and female rats and mice and one conducted
by Procter and Gamble. A total of eight individual sex/species
groups (four sex/species groups from each study) were examined.
The National Academy of Science is currently examining all available
data on fluoride, including the NTP studies, with a report expected
to be issued April 1993.

The NTP study utilizing sodium fluoride as the test material
in lieu of cryolite or synthetic cryolite satisfies the guideline
study requirement 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 the available data show that these compounds act
as free fluoride. Due to an abundance of data on the effects
of fluoride on humans, additional data are not required to define
a no-observed-effect-level (NOEL) in rats for the effects of
fluoride on teeth.
2. A 2-year mouse bioassay conducted by the NTP utilizing
sodium fluoride as the test material with mottling, discoloration,
and attrition of teeth observed at the lowest dose tested, 25
ppm (2.4 mg/kg). The bioassay was negative for carcinogenic
effects under the conditions of the study. Levels tested were
0, 25, 100, and 175 ppm.
This study utilizing sodium fluoride in lieu of cryolite
or synthetic cryolite as the test material satisfies the guideline
study requirement for a mouse carcinogenicity study for the
reason described above under item one.
3. A developmental toxicity study in rats with developmental
and maternal no-observable-effect levels (NOELs) at greater
than 3,000 mg/kg/day (highest dose tested).
4. A developmental toxicity study in mice with a developmental
no-observable-effect level (NOEL) of 100 mg/kg/day with a lowest-
effect level (LEL) of 300 mg/kg/day based on increased incidents
of bent ribs and bent rib bones. The maternal NOEL was 30 mg/kg/day
with a LEL of 100 mg/kg/day based on increased mortality and
reddened mucosa in the glandular portion of the stomach. The
guideline study requirement for a developmental toxicity study
in a nonrodent species is waived.
5. A 28-day range-finding study in rats with the only compound-
related effect being a change in coloration and physical property
of the teeth.
6. A supplemental 90-day rat-feeding study at dose levels
of 0, 50, 5,000, and 50,000 ppm in which stomach lesions were
observed at the 5,000-ppm dose level.
7. A supplemental 90-day dog feeding study at dose levels
of 0, 500, 10,000, and 50,000 ppm with systemic effects (fluoride
accumulation in the bone) seen at the 500-ppm dose level.
8. Genotoxicity studies including an Ames test (negative),
an in vitro assay in human lymphocytes (negative), and an unscheduled
DNA synthesis in rat hepatocytes (negative).
9. Open literature studies showing that human and animal
metabolism of cryolite and/or synthetic cryolite manifests itself
as normal free fluoride metabolism, i.e., dissociation occurs,
producing free fluoride ions which are assimilated into bone.
Desirable toxicological data currently lacking and the projected
dates for completion of these studies are as follows: (1) 1-
year nonrodent feeding study, May 1994; (2) two-generation rat
reproduction study, June 1993.
Although there are significant data gaps for cryolite and/or
synthetic cryolite, the available toxicity data are considered
adequate to support the time-limited tolerance and feed additive
regulation. The additional dietary exposure to fluoride resulting
from the use of cryolite and/or synthetic cryolite on potatoes
is considered negligible when compared to the total dietary
exposure to fluoride from noninsecticidal sources such as drinking
water, toothpaste, dental fluoride application, and the naturally
occurring background levels in addition to that resulting from
the current established pesticide tolerances for the compounds.
The current established tolerances for the use of cryolite
and/or synthetic cryolite provide for an exposure of 0.029 mg
of fluoride per kg/day (.054 mg/kg/day of cryolite and/or synthetic
cryolite), and the current maximum contaminant level (MCL) of
4.0 ppm established for the use of sodium fluoride in drinking
water provides for an exposure of 0.266 mg of fluoride per kg/day
(based on consumption of 2 liters of water per day by a 60-kg
person) for a total of 0.285 mg/kg/day. As a result of this
regulation, the total maximum estimated dietary exposure will
be 0.2862 mg/kg/day of fluoride, or an increase of 0.0012 mg/kg/day
(0.4 percent) fluoride. As stated in the Federal Register of
May 11, 1979 (44 FR 27932-27954), the “Agency will generally
consider as insignificant an increase in the theoretical maximum
residue concentration of 1.0 percent or less.” For purposes
of this rule, this is interpreted to include the estimated dietary
exposure resulting from nonpesticidal uses.
This percent increase in the dietary exposure is even less
when the background levels of fluoride are taken into consideration.
Fluoride is ubiquitous and may be present in soils and foodstuffs
that have not been treated with cryolite and/or synthetic cryolite.
Data submitted in support of the subject petition show background
levels of fluoride in untreated potatoes ranged from 0.14 ppm
to 0.31 ppm and are consistent with the ranges reported in the
open literature. Levels of fluoride found in the treated potatoes
ranged from 0.18 ppm to 0.94 ppm. The residue analytical method
used for enforcing the subject tolerance cannot distinguish
between the naturally occurring fluoride and the fluoride resulting
from use of cryolite and/or synthetic cryolite.
The metabolism of the subject insecticides in plants and
animals is adequately understood. The residue of concern in
or on plants resulting from the application of these insecticides
is cryolite and/or synthetic cryolite. Only surface residues
of the insecticides per se may be expected to occur on the treated
plants. The residue of concern in animals is total fluoride.
An adequate analytical method (fluoride-specific electrode)
is available for enforcement purposes for the RAC potatoes and
potato waste. Because the subject compounds are inorganic compounds,
the requirement for data using the multiresidue protocols in
PAM Vol. I is not applicable.
Because of the long lead time from establishing these tolerances
to publication of the enforcement methodology in the Pesticide
Analytical Manual, Vol. II, the analytical methodology is being
made available in the interim to anyone interested in pesticide
enforcement when requested from: Calvin Furlow, Public Information
Branch, Field Operations Division (H7506C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 1128, CM
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703-305-
5232).
There is no reasonable expectation of finite residues of
cryolite or synthetic cryolite occurring in the meat, milk,
poultry, and eggs of animals fed potato waste processed from
the treated potatoes and 40 CFR 180.6(a)(3) applies. Thus, secondary
tolerances are not necessary at this time in meat, milk, poultry,
and eggs.
Because of the lack of a chronic dog feeding study, and a
two-generation rat reproduction study, the Agency is limiting
the period of time that the regulations are to be in effect.
Should the Agency find that these data are acceptable, it will
reassess the tolerance for potatoes, and if appropriate, will
establish a permanent tolerance for potatoes and a permanent
feed additive regulation for processed potato waste (wet or
dry). There are no regulatory actions pending against the continued
registration of these insecticidal compounds.
Based on the above information, the Agency concludes that
the establishment of the section 408 regulation will protect
the public health, and use of the pesticide in accordance with
the section 409 regulation will be safe. Based on the currently
available information, there has been shown no association between
fluoride and cancer and thus the pesticide has not been found
to induce cancer in man or animals. Therefore, the tolerance
and feed additive regulation are established as set forth below.
Residues not in excess of 2.0 ppm remaining in or on the
raw agricultural commodity potatoes and 22.0 ppm remaining in
or on the processed animal feed potato waste after expiration
of the time-limited tolerances will not be considered actionable
if the pesticide is legally applied during the term of, and
in accordance with, provisions of the tolerance and the feed
additive regulation.
Any person adversely affected by these regulations may, within
30 days after publication of this document in the Federal Register,
file written objections with the Hearing Clerk, at the address
given above (40 CFR 178.20). The objections submitted must specify
the provisions of the regulations deemed objectionable and the
grounds for the objections (40 CFR 178.25). Each objection must
be accompanied by the fees provided by 40 CFR 180.33(i). If
a hearing is requested, the objections must include a statement
of the factual issue(s) on which a hearing is requested, and
the requestor’s contentions on each such issue, and a summary
of the evidence relied upon by the objection (40 CFR 178.27).
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following:
There is a genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of
such issues in favor of the requestor, taking into account uncontested
claims or facts to the contrary; and resolution of the factual
issue(s) in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32).
The Office of Management and Budget has exempted these rules
from the requirements of section 3 of Executive Order 12291.
Pursuant to the requirements of the Regulatory Flexibility
Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances
or raising tolerance levels or establishing exemptions from
tolerance requirements do not have a significant economic impact
on a substantial number of small entities. A certification statement
to this effect was published in the Federal Register of May
4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Parts 180 and 186

Administrative practice and procedure, Agricultural commodities,
Animal feeds, Pesticides and pests, Recording and recordkeeping
requirements.

Dated: April 22, 1993.

Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, chapter I of title 40 of the Code of Federal Regulations
is amended as follows:

PART 180-[AMENDED]

1. In part 180:
a. The authority citation for part 180 continues to read
as follows:

Authority: 21 U.S.C. 346a and 371.

b. In . 180.145, by adding new paragraph (c), to read as
follows:

. 180.145   Fluorine compounds; tolerances for residues.
*     *     *     *     *
(c) A time-limited tolerance to expire May 6, 1996 is established
for residues of the insecticidal fluorine compounds cryolite
and synthetic cryolite (sodium aluminum fluoride) in or on the
raw agricultural commodity as follows:

————————————————————–+—————
Commodity                           |  Parts per
|   million
————————————————————–+—————
|
Potatoes…………………………………………….. |         2.0
————————————————————–+—————

PART 186-[AMENDED]

2. In part 186:
a. The authority citation continues to read as follows:

Authority: 21 U.S.C. 348.

b. By adding new . 186.3375, to read as follows:

. 186.3375   Fluorine compounds.

A time-limited tolerance to expire on May 6, 1996, is established
for residues of the insecticidal fluorine compounds cryolite
and synthetic cryolite (sodium aluminum fluoride) in the following
processed animal feed resulting from application of the compounds
to growing crops:

——————————————————————————
Commodity                              Parts per
million
——————————————————————————

Potato waste, process (wet or dry)………………………..         22.0
——————————————————————————

[FR Doc. 93-10578 Filed 5-4-93; 8:45 am]
BILLING CODE 6560-50-F