[Federal Register Volume 59, Number 48 (Friday, March 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5723]
[[Page Unknown]]
[Federal Register: March 11, 1994]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180, 185, and 186
[PP 4F3103 and FAP 3H5654/P579; FRL-4763-5]
RIN 2070-AC18
Pesticide Tolerances for Methoprene
AGENCY: Environmental Protection Agency (EPA)
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes to establish tolerances for residues of
the insecticide methoprene in or on various agricultural commodities.
Zoecon Corp., A Sandoz Co., requested this proposed regulation to
establish the maximum permissible levels of methoprene in or on the
commodities. This document also proposes to delete certain obsolete
food additive tolerances for methoprene.
DATES: Comments, identified by the document control number, [PP 4F3103
and FAP 3H5654/P579] must be received on or before April 11, 1994.
ADDRESSES: By mail, submit written comments to: Public Document and
Freedom of Information Section, Field Operations Division (7506C),
Office of Pesticide Programs, 401 M St., SW., Washington, DC 20460. In
person, bring comments to: Rm.211, CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202, (703)-305-5412.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice. All
written comments will be available for public inspection in Rm. 1128C
at the address given below, from 8 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Phillip O. Hutton, Product
Manager (PM) 18, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460, (703)-305-
7690.
SUPPLEMENTARY INFORMATION: The Agency is proposing to delete an
expired, temporary food additive tolerance of 10 parts per million
(ppm) for residues of the insecticide methoprene (isopropyl (E,E)-11-
methoxy-3,7,11- trimethyl-2,4-dodecadienoate) in or on raisins, wheat
flour, macaroni (wheat), rice cereal, rye cereal, barley cereal, wheat
cereal, corn cereal, corn meal, grits, hominy, oat cereal, spices, dry
dog food, dried apples, dried apricots, dried peaches, and dried prunes
resulting from applications of methoprene in accordance with the
provisions of an experimental use permit that expired September 21,
1986. The tolerance was established under section 409 of the Federal,
Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, and appears in chapter I
of title 40 of the Code of Federal Regulations (40 CFR 185.4150(b)).
This temporary tolerance was established with issuance of an
experimental use permit (EUP) and expired on September 21, 1986. The
tolerance is obsolete, and EPA is proposing to remove it.
EPA issued a notice in the Federal Register of August 1, 1984 (49
FR 149), which announced that Zoecon Corp., 975 California Ave., Palo
Alto, CA, 94304, had submitted pesticide petition (PP) 4F3103 to EPA
proposing to establish tolerances under section 408 of the Federal,
Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, for the insecticide
methoprene in or on the following commodities: barley at 10.0 ppm,
buckwheat at 10.0 ppm, corn (all types) at 10.0 ppm, eggs at 2.0 ppm,
fat of cattle, goats, hogs, horses and sheep at 3.0 ppm, meat and meat
by-products of cattle, goats, hogs, horses, and sheep at 2.0 ppm, milk
at 2.0 ppm, millet at 10.0 ppm, milo (sorghum) at 10.0 ppm, oats at
10.0 ppm, poultry at 2.0 ppm, rice at 10.0 ppm, rye at 10.0 ppm,
sunflower at 10.0 ppm, and wheat at 10.0 ppm.
Subsequently, the Agency requested that Zoecon amend the petition
by proposing tolerances as follows: cereal grains Group XV (except
popcorn and sweet corn) at 5.0 ppm; eggs at 0.1 ppm; fat of cattle,
goats, hogs, horses, poultry, and sheep at 1.0 ppm; meat and meat by-
products of cattle, goats, hogs, horses, poultry, and sheep at 0.1 ppm;
and milk at 0.1 ppm. Sandoz Crop Protection Corp. acquired Zoecon Corp.
and amended the petition as follows: a tolerance of 5 ppm for cereal
grains Group XV (except popcorn and sweet corn); the tolerance for eggs
reduced to 0.1 ppm; the tolerance for fat of cattle, goats, hogs,
horses, and sheep reduced to 1.0 ppm; a tolerance for poultry fat of
1.0 ppm added; the tolerance for meat and meat by-products of cattle,
goats, hogs, horses, and sheep reduced to 0.1 ppm; a tolerance for meat
and meat by-products of poultry at 0.1 ppm added; and the tolerance for
milk reduced to 0.1 ppm.
EPA issued a notice in the Federal Register of July 20, 1988 (53 FR
27391), announcing that Sandoz Crop Protection Corp. had submitted
these tolerance requests to amend PP 4F3103. In addition, the Agency
requested that Zoecon submit a food additive petition for the proposed
tolerances of 25 ppm in or on rice hulls and 10.0 ppm for cereal grain
milled fractions (except flour and ricehulls). Zoecon submitted a food
additive petition requesting tolerances of 10.0 ppm for cereal grain
milled fractions (except flour and rice hulls) and 25 ppm in or on rice
hulls. The Agency designated this petition as food additive petition
(FAP) 3H5654.
Because tolerances for meat and meat by-products of cattle, goats,
hogs, horses, and sheep are currently established at 0.1 ppm, new
tolerances for these commodities are not necessary. There were no
comments received in response to the notices of filing.
The data submitted in support of the petitions and other relevant
material have been evaluated. The toxicological data considered in
support of the tolerances include the following:
1. An 18-month mouse feeding/carcinogenicity study using doses of
0, 250, 1,000, and 2,500 ppm (equivalent to doses of 0, 37.5, 150, and
375 milligrams/kilogram (mg/kg) of body weight (bwt)/day). The systemic
no-observed-effect level (NOEL) is 250 ppm (37.5 mg/kg/day) based on
liver pigmentation, and the systemic lowest-effect-level (LEL) is 1,000
ppm (150 mg/kg/day). There was no evidence of carcinogenicity at any
dose levels tested.
2. A 2-year rat feeding/carcinogenicity study using dietary
concentration of 0, 250, 100, and 5,000 ppm (equivalent to doses of 0,
12.5, 50, and 125 mg/kg bwt/day). The systemic NOEL is 1000 ppm (50 mg/
kg/day) based on liver pathology observed. There was no evidence of
carcinogenicity at any dose levels tested.
3. A three-generation mouse reproduction study with a NOEL of 2,500
ppm (125 mg/kg/day) for both reproductive and systemic effects.
4. A rabbit developmental toxicity study was negative for
developmental effects at all dose levels up to 2,000 mg/kg/day, the
highest dose tested. The NOEL for maternal toxicity and developmental
toxicity was 200 mg/kg/day, and the LEL for both maternal toxicity and
developmental toxicity was 2,000 mg/kg/day.
5. A mouse developmental toxicity study was negative for
developmental effects at all dose levels up to 600 mg/kg/day, the
highest dose tested. The NOEL for developmental toxicity was 600 mg/kg/
day.
Methoprene was not carcinogenic in either the mouse or rat chronic/
carcinogenic feeding studies. In the mouse study, the only effect noted
was a dark brown granular pigment in the cytoplasm of liver parenchymal
cells. This effect was pronounced at the 2,500 ppm level, still obvious
at the 1,000 ppm level, but was absent at the 250 ppm level. The effect
thus seemed dose related and linked to the administration of the
chemical. The tumor incidence in mice was not increased in this study.
The main toxicological effect seen in the rat chronic/carcinogenic
feeding study was liver pathology which consisted of slight portal
lymphocytic infiltration, slight to very slight bile duct
proliferation, and vacuolized hepatocytes. These findings were not
consistent and dose related. No increased occurrence of tumors was
observed in rats fed methoprene.
EPA concludes that methoprene did not induce cancer in rats or mice
and that no significant carcinogenic risk is posed by these tolerances.
The reference dose (RfD), based on the 18-month mouse chronic
feeding/carcinogenicity study (NOEL of 37.5 mg/kg bwt/day), and using a
hundredfold uncertainty factor, is calculated to be 0.4 mg/kg bwt/day.
The theoretical maximum residue contribution (TMRC) for the general
population from previously established tolerances and tolerances
established here is 0.016198 mg/kg bwt/day and utilizes 4% of the RfD.
The subgroup most highly exposed, nonnursing infants less than one year
old, has a TMRC from published and proposed uses of 0.045043 mg/kg bwt/
day, or 11.3% of the RfD.
The nature of the residue is adequately understood, and adequate
analytical methods for the enforcement of methoprene residues in milk,
meat, and animal fat have been published in the Pesticide Analytical
Manual, Vol. II.
The modifications raise tolerance levels for milk, eggs, and fat of
cattle, goats, hogs, horses, poultry, and sheep and for meat byproducts
of poultry. The modifications lower the tolerance level for poultry
meat. The tolerance level of 0.1 ppm for meat and meat byproducts of
cattle, goats, hogs, horses, and sheep remains unchanged.
The pesticide is considered useful for the purposes for which the
tolerances are sought and capable of achieving the intended physical or
technical effect. Based on the information and data considered, the
Agency concludes that the establishment of the tolerances will protect
the public health, and use of the pesticide in accordance with the
terms of the proposed food additive regulation would be safe.
Therefore, the tolerances and food/feed additive regulations are
established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this document in the Federal Register that the portion of this
rulemaking proposal for tolerances for raw agricultural commodities be
referred to an Advisory Committee in accordance with section 408(e) of
the Federal Food, Drug, and Cosmetic Act.
Interested persons are invited to submit written comments on the
proposed regulations. Comments must bear a notation indicating the
document control number, [PP 4F3103 and FAP 3H5654/P579]. All written
comments filed in response to this petition will be available in the
Public Docket and Freedom of Information Section, at the address give
above, from 8 a.m. to 4 p.m., Monday through Friday, except legal
holidays.
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 food
additive regulations or raising tolerance levels or food additive
regulations 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).
Because EPA proposes to reduce the tolerance for residues of
methoprene on poultry meat from 0.5 ppm to 0.1 ppm, an economic impact
assessment of the proposed reduction on business is needed to comply
with the requirements of the Regulatory Flexibility Act and Executive
Order 12866. The economic analysis concluded that there would be no
impact expected on businesses or other entities of any size by reducing
the poultry meat tolerance from 0.5 ppm to 0.1 ppm and that this
proposed rule is not a significant rule according to Executive Order
12866.
List of Subjects in 40 CFR Parts 180, 185, and 186
Environmental protection, Administrative practice and procedures,
Agriculture commodities, Food additives, Feed additives, Pesticides and
pests, Reporting and recordkeeping requirements.
Dated: March 3, 1994.
Stephanie R. Irene,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that chapter I of title 40 of the Code of
Federal Regulations be 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. By revising Sec. 180.359, to read as follows:
Sec. 180.359 Methoprene; tolerances for residues.
Tolerance are established for residues of the insect growth
regulator methoprene (isopropyl (E,E)-11-methoxy-3,7,11-trimethyl-2,4-
dodecadienoate) in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley..................................................... 5.0
Buckwheat.................................................. 5.0
Cattle, fat................................................ 1.0
Cattle, meat............................................... 0.1
Cattle, meat byproducts.................................... 0.1
Corn (except popcorn and sweetcorn)........................ 5.0
Eggs....................................................... 0.1
Goats, fat................................................. 1.0
Goats, meat................................................ 0.1
Goats, meat byproducts..................................... 0.1
Hogs, fat.................................................. 1.0
Hogs, meat................................................. 0.1
Hogs, meat byproducts...................................... 0.1
Horses, fat................................................ 1.0
Horses, meat............................................... 0.1
Horses, meat byproducts.................................... 0.1
Milk....................................................... 0.1
Millet..................................................... 5.0
Mushrooms.................................................. 1.0
Oats....................................................... 5.0
Peanuts.................................................... 2.0
Peanut hulls............................................... 40.0
Poultry, fat............................................... 1.0
Poultry, meat.............................................. 0.1
Poultry, meat byproducts................................... 0.1
Rice....................................................... 5.0
Rye........................................................ 5.0
Sheep, fat................................................. 1.0
Sheep, meat................................................ 0.1
Sheep, meat byproducts..................................... 0.1
Sorghum (milo)............................................. 5.0
Wheat...................................................... 5.0
------------------------------------------------------------------------
PART 185--[AMENDED]
2. 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. 185.4150, by revising paragraph (b), to read as follows:
Sec. 185.4150 Methoprene.
* * * * *
(b) A tolerance of 10 parts per million is established for residues
of isopropyl ((E,E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate) in
or on the food additive commodity cereal grain milled fractions (except
flour and rice hulls).
PART 186--[AMENDED]
3. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 348.
b. In Sec. 186.4150, by adding new paragraph (d), to read as
follows:
Sec. 186.4150 Methoprene.
* * * * *
(d) Tolerances are established for residues of the insect growth
regulator methoprene (isopropyl (E,E)-11-methoxy -3,7,11-trimethyl-2,4-
dodecadienoate) in or on the following feed additive commodities:
------------------------------------------------------------------------
Parts per
Feed million
------------------------------------------------------------------------
Cereal grain milled fractions (except flour and rice hulls) 10
Rice hulls................................................. 25
------------------------------------------------------------------------
[FR Doc. 94-5723 Filed 3-10-94; 8:45 am]
BILLING CODE 6560-50-F
