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cryolite (Kryocide) Pesticide Tolerance and Animal Feed Additive Regulation 4/93

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   
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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:

                                                                              
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                           Commodity                              Parts per   
                                                                   million    
------------------------------------------------------------------------------
                                                                              
Potato waste, process (wet or dry).............................         22.0  
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[FR Doc. 93-10578 Filed 5-4-93; 8:45 am]
BILLING CODE 6560-50-F