[Federal Register Volume 60, Number 26 (Wednesday, February 8, 1995)]
[Proposed Rules]
[Pages 7511-7513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2731]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 185 and 186
[FAP 3H5673, 4H5695, 4H5696/P591; FRL-4915-1]
RIN 2070-AC18
Food and Feed Additive Regulations for d-Limonene, Dihydro-5-
Pentyl-2(3H)-Furanone, and Dihydro-5-Heptyl-2(3H)-Furanone
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA proposes to establish food/feed additive regulations for
residues of the insecticides d-limonene, dihydro-5-pentyl-2(3H)-
furanone, and dihydro-5-heptyl-2(3H)-furanone when used as active
ingredients in insect- repellent tablecloths and in insect-
[[Page 7512]] repellent strips used in food/feed-handling
establishments. Rod Products Co. requested these regulations.
DATES: Comments, identified by the document control number, [FAP
3H5673, 4H5695, 4H5696/P591], must be received on or before March 10,
1995.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202. 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. 1132 at the address given above, from 8 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Robert A. Forrest, Product
Manager (PM 14), Registration Division (7505C), 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 a notice, published in the
Federal Register of October 21, 1993 (58 FR 54356), which announced
that Rod Products Co., 4600 Glencoe Ave., No. 4, Marina del Rey, CA
90292-6363, had submitted to EPA food/feed additive petitions (FAPs)
3H5673, 4H5695, and 4H5696, which requested that the Administrator,
pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 348, amend 40 CFR parts 185 and 186 by establishing
regulations for residues of d-limonene, dihydro-5-pentyl-2(3H)-
furanone, and dihydro-5-heptyl-2(3H)-furanone when used as active
ingredients in insect-repellent tablecloths used in food/feed-handling
establishments. The registrant subsequently requested the addition of
insect repellent strips used in food/feed-handling establishments.
d-Limonene is listed under 21 CFR 182.60 as generally recognized as
safe (GRAS) when used as a synthetic flavoring substance and adjuvant
in accordance with good manufacturing practice.
Dihydro-5-pentyl-2(3H)-furanone and dihydro-5-heptyl-2(3H)-furanone
are approved for use as direct food additives and are listed under 21
CFR 172.515 as synthetic flavoring substances and adjuvants which may
be safely used in food provided they are used in the minimum quantity
required to produce their intended effect and are otherwise used in
accordance with all the principles of good manufacturing practice.
The information submitted in the petitions and all other relevant
material have been evaluated. Data on the oral toxicity of d-limonene
was summarized in the National Toxicology Program (NTP) 2-year bioassay
and comprehensive literature review. The systemic toxicity of d-
limonene is comparatively low; effects are observed only at relatively
high doses even after long-term exposure. Effects at high doses in
laboratory animals would include reduced body weight gain, sometimes
with clinical signs (lethargy, excess salivation, nausea/vomiting),
skeletal variations in fetuses, maternal decreases in body weight gain,
and dermal irritation. D-limonene is not carcinogenic or mutgenic or a
developmental toxicant.
The toxciological data considered in support of the product
registrations included the following product-specific studies utilizing
all three insecticides in combination as the test material: acute oral
toxicity in the rat, acute dermal toxicity in the rabbit, primary eye
irritation in the rabbit, acute inhalation toxicity in the rat, primary
dermal irritation, and guinea pig sensitization. The Agency has
concluded that these formulations were of minimal toxicological
concern.
The Agency does not anticipate that significant oral exposure would
occur from the use of these products. Based on the small amount that
theoretically might be ingested if one ate food in contact with the
insect repellent tablecloth, or chewed on the cloth itself, and on the
apparent nontoxicity of very low amounts of these chemicals when
ingested orally, the Agency considers the potential toxicity hazard
from the insect repellent tablecloth to be minimal. The Agency also
considers the potential toxicity hazard from the use of the insect
repellent strip to be minimal given the assessment of the oral hazard
associated with the active ingredients in the insect repellent strip,
and the very limited direct food/feed contact as a result of its use.
There are currently no actions pending against the continued
registration of the chemicals.
The pesticides are considered capable of achieving the intended
physical or technical effect. Based on the information and data
considered, the Agency has determined that establishing food/feed
additive regulations by amending 40 CFR parts 185 and 186 will be safe.
Therefore, it is proposed that they be 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 this rulemaking proposal
be referred to an Advisory Committee in accordance with section 408(e)
of the FFDCA.
Interested persons are invited to submit written comments on the
proposed regulations. Comments must bear a notation indicating the
document control number, [FAP 3H5673, 4H5695, 4H5696/P591]. All written
comments filed in response to these petitions will be available in the
Public Response and Program Resources Branch, at the address given
above from 8 a.m. to 4 p.m., Monday through Friday, except legal
holidays.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to all the requirements of the Executive Order (i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB)). Under section 3(f), the order defines ``significant'' as
those actions likely to lead to a rule (1) having an annual effect on
the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also known as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
[[Page 7513]] that this rule is not ``significant'' and is therefore
not subject to OMB review. 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, or establishing or raising food
additive regulations 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, Administrative practice and procedure,
Agricultural commodities, Feed additives, Food additives, Pesticides
and pests, Reporting and recordkeeping requirements.
Dated: January 24, 1995.
Lois Rossi,
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 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. By adding new Sec. 185.1975, 185.1985, and 185.3775, to read as
follows:
Sec. 185.1975 Dihydro-5-heptyl-2(3H)-furanone.
The food additive dihydro-5-heptyl-2(3H)-furanone, may be safely
used in accordance with the following conditions:
(a) It is used in combination with the active ingredients d-
limonene and dihydro-5-pentyl-2(3H)-furanone in insect-repellent
tablecloths and in insect-repellent strips used in food-handling
establishments.
(b) To assure safe use of the insecticide, its label and labeling
shall conform to that registered by the U.S. Environmental Protection
Agency, and it shall be used in accordance with such label and
labeling.
Sec. 185.1985 Dihydro-5-pentyl-2(3H)-furanone.
The food additive dihydro-5-pentyl-2(3H)-furanone may be safely
used in accordance with the following conditions:
(a) It is used in combination with the active ingredients d-
limonene and dihydro-5-heptyl-2(3H)-furanone in insect-repellent
tablecloths and in insect-repellent strips used in food-handling
establishments.
(b) To assure safe use of the insecticide, its label and labeling
shall conform to that registered by the U.S. Environmental Protection
Agency, and it shall be used in accordance with such label and
labeling.
Sec. 185.3775 d-Limonene.
The food additive d-limonene may be safely used in accordance with
the following conditions:
(a) It is used with the active ingredients dihydro-5-pentyl-2(3H)-
furanone and dihydro-5-heptyl-2(3H)-furanone in insect-repellent
tablecloths and in insect-repellent strips used in food-handling
establishments.
(b) To assure safe use of the insecticide, its label and labeling
shall conform to that registered by the U.S. Environmental Protection
Agency, and it shall be used in accordance with such label and
labeling.
PART 186--[AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
b. By adding new Secs. 186.1975, 186.1985, and 186.3775, to read as
follows:
Sec. 186.1975 Dihydro-5-heptyl-2(3H)-furanone.
The feed additive dihydro-5-heptyl-2(3H)-furanone may be safely
used in accordance with the following conditions:
(a) It is used in combination with the active ingredients d-
limonene and dihydro-5-pentyl-2(3H)-furanone in insect-repellent
tablecloths and in insect-repellent strips used in feed-handling
establishments.
(b) To assure safe use of the insecticide, its label and labeling
shall conform to that registered by the U.S. Environmental Protection
Agency, and it shall be used in accordance with such label and
labeling.
Sec. 186.1985 Dihydro-5-pentyl-2(3H)-furanone.
The feed additive dihydro-5-pentyl-2(3H)-furanone may be safely
used in accordance with the following conditions:
(a) It is used in combination with the active ingredients d-
limonene and dihydro-5-heptyl-2(3H)-furanone in insect-repellent
tablecloths and in insect-repellent strips used in feed-handling
establishments.
(b) To assure safe use of the insecticide its label and labeling
shall conform to that registered by the U.S. Environmental Protection
Agency, and it shall be used in accordance with such label and
labeling.
Sec. 186.3775 d-Limonene.
The feed additive d-limonene may be safely used in accordance with
the following conditions:
(a) It is used with the active ingredients dihydro-5-pentyl-2(3H)-
furanone and dihydro-5-heptyl-2(3H)-furanone in insect repellent
tablecloths and in insect-repellent strips used in feed-handling
establishments.
(b) To assure safe use of the insecticide, its label and labeling
shall conform to that registered by the U.S. Environmental Protection
Agency, and it shall be used in accordance with such label and
labeling.
[FR Doc. 95-2731 Filed 2-7-95; 8:45 am]
BILLING CODE 6560-50-F