[Federal Register Volume 59, Number 206 (Wednesday, October 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26468]


[[Page Unknown]]

[Federal Register: October 26, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 8F3689/R2081; FRL-4912-8]
RIN 2070-AB78

 

Pesticide Tolerances for Aluminum Tris(O-Ethylphosphonate)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
fungicide fosetyl-Al, aluminum tris(O-ethylphosphonate), in or on pome 
fruit at 10 parts per million (ppm). This regulation to establish the 
maximum permissible level of residues of the fungicide in or on this 
commodity was requested in petitions submitted by Rhone-Poulenc Ag Co.

DATES: This regulation becomes effective October 26, 1994.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 8F3689/R2081], may be submitted to: 
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
St., Washington, DC 20460. A copy of any objections and hearing request 
filed with the Hearing Clerk should be identified by the document 
control number and submitted to: Public Response and Program Resources 
Branch, Field Operations Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington 
DC 20450. In person, bring copy of objections and hearing request to: 
Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, 1921 
Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
Box 360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, Product 
Manager (PM) 22, Registration Division, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: Rm. 229, CM #2, 1921 Jefferson Davis Hwy., Arlington, 
VA 22202, (703)- 305-5540.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of October 20, 1988 (53 FR 41238), which announced 
that Rhone-Poulenc Ag Co., P.O. Box 12014, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709, had submitted a pesticide tolerance 
petition (PP 8F3689), and a food/feed additive petition (FAP 8H5567) to 
EPA requesting that the Administrator, pursuant to sections 408(d) and 
409 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(d), establish a tolerance for the fungicide fosetyl-Al, aluminum 
tris(O-ethylphosphonate), in or on pome fruit at 10 ppm and pome fruit 
juice and pome fruit pomace (wet and dry) at 12 ppm, respectively. 
Subsequently, the Agency reviewed an apple-processing study and 
concluded that section 409 tolerances for pome fruit juice and pome 
fruit pomace were unnecessary, and the food/feed additive petition was 
withdrawn.
    EPA issued a notice, published in the Federal Register of August 3, 
1994 (59 FR 39568), which announced that EPA was reissuing the 
pesticide petition (PP 8F3689) for the fungicide, aluminum tris(O-
ethylphosphonate), in or on pome fruit at 10 ppm. EPA reissued the 
petition because more than 5 years had passed since the first notice of 
filing.
    There were no comments or requests for referral to an advisory 
committee received in response to these notices of filing.
    The data submitted in the petitions and all other relevant material 
have been evaluated. The toxicology data considered in support of the 
tolerances include:
    1. A rat acute oral study with an LD50 of 5.4 grams (g)/
kilogram (kg).
    2. A mouse acute oral study with an LD50 of 3.4 gm/kg.
    3. A 90-day rat-feeding study with a no-observed-effect level 
(NOEL) of 5,000 ppm (500 milligrams (mg)/kg/day).
    4. A 90-day dog feeding study with a NOEL of 10,000 ppm (250 mg/kg/
day).
    5. A 21-day rabbit dermal study with a NOEL of 1.5 g/kg/day [the 
highest dose tested (HDT)].
    6. A carcinogenicity study in mice with no carcinogenic effects 
observed at any dose level under the conditions of the study (the 
highest dose tested was 2,857/4,286 mg/kg body weight (bwt)/day).
    7. A rat chronic feeding/carcinogenicity study with a NOEL of 8,000 
ppm (400 mg/kg bwt/day) for systemic effects (carcinogenic effects 
observed are discussed below).
    8. A 2-year dog feeding study with a NOEL of 10,000 ppm (250 mg/kg 
bwt/day) and a Lowest Effect Level (LEL) of 20,000 ppm (500 mg/kg bwt/
day) based on a slight degenerative effects on the testes.
    9. A reproduction study in rats with a NOEL of 300 mg/kg bwt/day 
and a LEL of 600 mg/kg bwt/day based on effects on animal weights in 
some groups and urinary tract changes in some groups.
    10. Teratology studies in rabbits and rats with teratogenic NOELs 
of 500 mg/kg/day and 1,000 mg/kg/day, respectively.
    11. Ames mutagenicity assays, E. coli phage induction tests, 
micronucleus tests in mice, DNA repair tests using E. coli, and 
Saccharomyces cervisiae yeast assay that were negative.
    As stated in a notice, published in the Federal Register of 
November 2, 1983 (48 FR 50532), carcinogenic effects were noted in the 
rat chronic feeding/carcinogenicity study. In this study, Charles River 
CD rats were dosed with aluminum tris(O-ethylphosphonate) at levels of 
0, 2,000, 8,000, and 40,000/30,000 ppm (0, 100, 400, and 2,000/1,500 
mg/kg bwt/day). The 40,000 ppm dose was reduced to 30,000 ppm after 2 
weeks following observations of staining of the abdominal fur and red 
coloration of the urine at 40,000 ppm (2,000 mg/kg bwt/day).
    The highest dose level of the chemical tested in the male Charles 
River CD-1 rats (2,000/1,500 mg/kg bwt/day) in this study appears to 
approximate a maximum tolerated dose (MTD) based on the finding of 
urinary bladder hyperplasia at this dose. Similarly, an MTD level 
appeared to be satisfied in the female Charles River CD-1 rats at the 
high-dose level of 2,000 mg/kg bwt/day, during the first 2 weeks of the 
carcinogenicity/chronic feeding study, before the dose level was 
reduced to 1,500 mg/kg bwt/day.
    The study demonstrated a significantly elevated incidence of 
urinary bladder tumors (adenomas and carcinomas combined) at the 
highest dose level tested (2,000/1,500 mg/kg) in male Charles River CD-
1 rats. The tumors were mainly seen in surviving males at the time of 
terminal sacrifice. The original pathological diagnosis of these tumors 
was independently confirmed by another consulting pathologist, who also 
reported an elevated incidence of urinary bladder hyperplasia in high-
dose male rats. No increase in the incidence of urinary bladder tumors 
was observed in female rats.
    In 1986, the Health Effects Division Peer Review Committee for 
Carcinogenicity of the Office of Pesticide Programs concluded that the 
available data provided limited evidence of the carcinogenicity of 
fosetyl-Al in male rats and classified the pesticide as a Category C 
carcinogen (possible human carcinogen with limited evidence of 
carcinogenicity in animals) in accordance with proposed Agency 
guidelines, published in the Federal Register of November 23, 1984 (49 
FR 46294). The Health Effects Division Peer Review Committee for 
Carcinogenicity determined that a quantitative risk assessment was not 
appropriate for the following reasons:
    1. The carcinogenic response observed with this chemical was 
confined solely to the high-dose males at one site (urinary bladder) in 
rats.
    2. The tumor response was primarily due to an increase in benign 
tumors.
    3. The tumors were seen only in surviving animals at the time of 
terminal sacrifice.
    4. The carcinogenic effects were observed only at unusually high 
doses which exceed the commonly used limit dose of 1,000 mg/kg/day 
recommended as an upper-limiting dose for bioassays.
    5. The chemical was not carcinogenic when administered in the diet 
to Charles River CD-1 mice at dose levels ranging from 2,500 to 30,000 
ppm (357 to 4,286 mg/kg bwt/day).
    6. Fosetyl-Al was not mutagenic in eight well conducted genotoxic 
assays.
    In 1993, the Health Effects Division Peer Review Committee (PRC) 
for Carcinogenicity revisited the carcinogenicity classification of 
fosetyl-Al due to a recent 90-day feeding study of fosetyl-Al in rats 
which showed a strong association between the presence of uroliths in 
the urinary bladder and the incidence of urinary bladder tumors in 
treated rats. The PRC concluded that fosetyl-Al is not amenable to 
classification using the current Agency cancer guidelines. Based on a 
mechanistic evaluation of the only tumors seen, those that occurred at 
exceptionally high doses in the bladder of male rats, it appears that 
humans are not likely to be exposed to doses of fosetyl-Al that produce 
the urinary tract toxicity that precedes and seems to lead to the tumor 
response in rats. In particular, anticipated human dietary and 
occupational exposures to fosetyl-Al are far below the NOEL in rats for 
the apparent urinary tract tumor precursors (stone formation and 
attendant epithelial irritation). These effects are produced in rats at 
extremely high doses, under conditions not anticipated to occur outside 
of the experimental laboratory. The PRC concludes that pesticidal use 
of fosetyl-Al is unlikely to pose a carcinogenic hazard to humans. 
Therefore, the standard risk assessment approach of using the Reference 
Dose (RfD) based on systemic toxicity was applied to fosetyl-Al.
    Using a 100-fold safety factor and the NOEL of 250 mg/kg bwt/day 
determined by the most sensitive species from the 2-year dog feeding 
study, the RfD is 3.0 mg/kg bwt/day. The theoretical maximum residue 
contribution (TMRC) from the established and proposed tolerances is 
0.058818 mg/kg bwt/day and utilizes 2 percent of the RfD for the 
overall U. S. population. For exposure of the most highly exposed 
subgroup in the population, nonnursing infants, the TMRC is 0.130051 
mg/kg bwt/day and utilizes 4 percent of the RfD. Previous tolerances 
have been established for fosetyl-Al, aluminum tris(O-
ethylphosphonate), in asparagus, avocadoes, brassica vegetable crop 
group, caneberries, citrus, cucurbit vegetables group, dried hops, dry 
bulb onions, fresh ginseng root, leafy vegetables crop group, 
pineapples, pineapple forage and fodder, and strawberries.
    The metabolism of aluminum tris(O-ethylphosphonate) in plants is 
adequately understood. There is no reasonable expectation of secondary 
residues occurring in milk, eggs, and meat of livestock or poultry as a 
result of this use on pome fruit. Based on an apple-processing study, a 
concentration of fosetyl-Al into process fractions did not occur and 
food/feed additive tolerances are not needed in conjunction with these 
uses on pome fruit.
    An adequate analytical method, gas-liquid chromatography, is 
available for enforcement purposes. 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 (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: Rm. 242, CM 
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703-305-4432).
    The pesticide is considered useful for the purposes for which the 
tolerances are sought. Based on the information and data considered, 
the Agency concludes that the establishment of the tolerances will 
protect the public health. Therefore, the tolerances are established as 
set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections and/or request a hearing with the Hearing Clerk, at 
the address given above (40 CFR 178.20). A copy of the objections and/
or hearing requests filed with the Hearing Clerk should be submitted to 
the OPP docket for this rulemaking. The objections submitted must 
specify the provisions of the regulation 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 on 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).
    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 Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Recording and 
recordkeeping requirements.

Dated: September 30, 1994.

Daniel M. Barolo,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

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

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

    2. In Sec. 180.415, by amending paragraph (a) in the table therein 
by adding and alphabetically inserting the following entry, to read as 
follows:


Sec. 180.415   Aluminum tris(O-ethylphosphonate); tolerances for 
residues.

    (a) *  *  *

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                                                              Parts per 
                         Commodity                             million  
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                                  *****                                 
Pome fruit.................................................           10
                                                                        
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[FR Doc. 94-26468 Filed 10-25-94; 8:45 am]
BILLING CODE 6560-50-F