[Federal Register Volume 59, Number 23 (Thursday, February 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2445]
[[Page Unknown]]
[Federal Register: February 3, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 185 and 186
[FAP 3H5659/R2021; FRL-4738-3]
RIN 2070-AB78
Food/Feed Additive Regulations for Hexakis
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes or increases tolerances for the
combined residues of the miticide hexakis (2-methyl-2-phenylpropyl)
distannoxane and its organotin metabolites calculated as hexakis (2-
methyl-2-phenylpropyl) distannoxane in or on the food commodity citrus
oil and the feed commodities dried citrus pulp, dried apple pomace, and
raisin waste. The regulation to establish maximum permissible levels
for residues of the miticide was requested in a petition submitted by
E.I. Du Pont de Nemours & Co., Inc.
EFFECTIVE DATE: This regulation becomes effective February 3, 1994.
ADDRESSES: Written objections, identified by the document control
number, [FAP 3H5659/R2021], may be submitted to: Hearing Clerk (A-110),
Environmental Protection Agency, Rm. 3708, 401 M St., SW., Washington,
DC 20460.
FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr.,
Product Manager (PM) 19, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 207, CM #2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202, (703)-305-6386.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 21, 1993
(58 FR 54355), EPA issued a notice announcing that E.I. Du Pont de
Nemours & Co., Inc., had submitted a food/feed additive petition (FAP
3H5659) to EPA proposing to amend 40 CFR parts 185 and 186, under
section 409 of the FFDCA, 21 U.S.C. 348, by establishing a tolerance in
or on citrus oil and increasing tolerances in or on dried citrus pulp,
dried apple pomace, and raisin waste for the combined residues of
hexakis (2-methyl-2-phenylpropyl) distannoxane and its organotin
metabolites calculated as hexakis (2-methyl-2-phenylpropyl)
distannoxane. The Agency has determined that citrus oil may be a human
food, and a tolerance in or on citrus oil must be included in 40 CFR
185.3550.
Tolerances exist for residues in citrus fruits, apples, and grapes
(40 CFR 180.362). Studies submitted in support of the reregistration of
hexakis (2-methyl-2-phenylpropyl) distannoxane showed that it
concentrates during the processing of these commodities. The Agency
requested that Du Pont submit a food additive petition that proposed
tolerances that would be adequate for the increased concentrations of
residues.
The data submitted in the petition and other relevant material have
been evaluated. The pesticide is considered useful for the purpose for
which the tolerances are sought and capable of achieving its intended
physical or technical effect. The toxicological data considered in
support of the proposed tolerances include the following:
1. A subchronic rat feeding study (data requirements satisfied by
the chronic rat study) with a no-observed-effect level (NOEL) of 50
parts per million (ppm) and a lowest-effect level (LEL) of 100 ppm,
based on increased BUN.
2. A 21-day rabbit dermal toxicity study with systemic NOEL greater
than 5 milligrams (mg)/kilogram (kg) of body weight/day and dermal NOEL
of 0.05 mg/kg of body weight/day, based on erythema and edema.
3. A chronic rat feeding/carcinogenicity study with NOEL of 100 ppm
(equivalent to 5 mg/kg of body weight/day) and LEL of 600 ppm
(equivalent to 30 mg/kg of body weight/day), based on increased
alkaline phosphatase and testes weight. Under the study conditions
carcinogenic potential was not demonstrated.
4. A chronic dog feeding study with NOEL of 5 mg/kg of body weight/
day and LEL of 15 mg/kg of body weight/day, based on vomiting and
diarrhea.
5. A mouse carcinogenicity study with NOEL of 100 ppm (equivalent
to 15 mg/kg of body weight/day) and LEL of 300 ppm (equivalent to 45
mg/kg of body weight/day) based on decreased body weights. Under the
study conditions carcinogenic potential was not demonstrated.
6. A rat developmental toxicity study with maternal NOEL of 15 mg/
kg of body weight/day and maternal LEL of 30 mg/kg of body weight/day,
based on postimplantation loss and decreased body weight. The
developmental NOEL was 30 mg/kg of body weight/day.
7. A rabbit developmental toxicity study with a maternal/
developmental NOEL of 1 mg/kg of body weight/day and a maternal/
developmental LEL of 5 mg/kg of body weight/day, based on slightly
decreased maternal body weight/intrauterine mortality. Maternal death
resulted at 10 mg/kg of body weight/day.
8. A two-generation rat reproduction study with maternal/
reproductive NOEL of 75 ppm (5.2 mg/kg of body weight/day in males and
5.98 mg/kg of body weight/day in females) and maternal/reproductive LEL
of 250 ppm (17.4 mg/kg of body weight/day in males and 20.3 mg/kg of
body weight/day in females), based on decreased maternal body weight
and food consumption and decreased pup body weight during lactation.
9. The Ames gene mutation assay was negative up to cytotoxic
levels.
10. Several other mutagenicity studies that were all negative.
These include a Chinese hamster ovary cell mutation assay, a human
lymphocyte assay for chromosomal aberration, and an unscheduled DNA
synthesis assay.
11. A general metabolism study in rats shows that bioaccumulation
is low, with the highest levels found in the liver, heart, and kidneys.
Most is excreted unchanged within 72 hours in the feces.
The reference dose (RfD) based on the two-generation rat
reproduction study (NOEL of 5.2 mg/kg of body weight/day for reduced
body weight and food consumption in both sexes of pups of the first and
second generations) and using a 100-fold uncertainty factor is
calculated to be 0.05 mg/kg of body weight/day. The theoretical maximum
residue contribution (TMRC) from existing tolerances is calculated to
be 0.068104 mg/kg of body weight/day. The current action will not
increase the TMRC, and no dietary risk exposure analysis was conducted.
Published tolerances for meat and milk will cover any secondary
residues that may result from use as feed items.
Adequate gas chromatographic analytical methods are available in
the Pesticide Analytical Manual, Vol. II (PAM II), for enforcement
purposes. There are currently no actions pending against continued
registration of this chemical.
Based on the above information considered by the Agency, the
tolerances established by amending 40 CFR 185.3550 and 186.3550 would
protect the public health and use of the pesticide would be safe.
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 with the Hearing Clerk, at the address given above.
40 CFR 178.20. 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 fee prescribed
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, the requestor's contentions on each such issue, and a
summary of any evidence relied upon by the objector. 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; the
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 this rule 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 185 and 186
Environmental protection, Food additives, Feed additives,
Pesticides and pests.
Dated: January 24, 1994.
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 185--[AMENDED]
1. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
b.In Sec. 185.3550, by revising the table therein to read as
follows:
Sec. 185.3550 Hexakis.
* * * * *
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Parts per
Food million
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Citrus oil................................................. 140
Prunes, dried.............................................. 20.0
Raisins.................................................... 20
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PART 186--[AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 348.
b.In Sec. 186.3550, in paragraph (a) by revising the table therein
to read as follows:
Sec. 186.3550 Hexakis (2-methyl-2-phenylpropyl)distannoxane.
(a) * * *
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Parts per
Commodity million
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Apple pomace, dried........................................ 100
Citrus pulp, dried......................................... 100
Grape pomace, dried........................................ 100
Raisin waste............................................... 80
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[FR Doc. 94-2445 Filed 2-2-94; 8:45 am]
BILLING CODE 6560-50-F
