[Federal Register Volume 60, Number 26 (Wednesday, February 8, 1995)]
[Rules and Regulations]
[Pages 7456-7457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2821]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4314/R2104; FRL-4932-4]
RIN 2070-AB78
1,4-Dimethylnaphthalene; Exemption from the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA establishes an exemption from the requirement for a
tolerance for residues of the potato sprout inhibitor 1,4-
dimethylnaphthalene from the postharvest application to potatoes. D-I-
1-4, Inc., requested this exemption.
EFFECTIVE DATE: This regulation becomes effective February 8, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4314/R2104], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., 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. 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 March 30, 1994 (59 FR 14854), which announced that
D-I-1-4, Inc., 15401 Cartwright Rd., Boise, ID 83703, had submitted
pesticide petition (PP) 4F4314 to EPA requesting that the
Administrator, pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish an exemption
from the requirement of a tolerance for the plant growth regulator 1,4-
dimethylnaphthalene for use on potatoes (post- harvest).
There were no comments received in response to this notice of
filing. The data submitted in the petition and all other relevant
material have been evaluated. The toxicological data considered in
support of the exemption from the requirement of a tolerance include:
1. A rat acute oral study with an LD50 of 2,730 milligrams
(mg)/kilogram (kg).
2. A rabbit acute dermal study with an LD50 greater than 2
grams (g)/kg.
3. A rat acute inhalation study with an LD50 greater than 4.16
mg/Liter (L).
4. A rabbit primary eye irritation study with moderate irritation
that dissipated by day 14.
5. A rabbit primary dermal irritation study with moderate
irritation that dissipated by day 14.
6. A guinea pig dermal sensitization study with no apparent
sensitization.
7. An Ames mutagenicity study that was negative in the presence and
absence of metabolic activation homogenate.
8. An in vitro test for unscheduled DNA synthesis in rat liver
primary cell culture that was negative.
9. A in vivo micronucleus assay that was negative.
10. No hypersensitivity Incidents were reported.
1,4-Dimethylnaphthalene has been classified as a biochemical as
defined by 40 CFR 158.65. Biochemical pesticides are distinguished by
their unique nontoxic mode of action, low use volume, target
specificity, and natural occurrence. 1,4-Dimethylnaphthalene is
naturally occurring in potatoes at levels between 1 and 10 ppm. When
conditions are right for sprouting, the potato metabolizes 1,4-
dimethylnaphthalene to a low enough level so that sprouting can occur.
1,4-Dimethylnaphthalene is applied to potatoes at a 2.5 ppm level up to
4 applications as a plant growth regulator during the storage season,
which generally runs from October to August, to keep 1,4-
dimethylnaphthalene at a sufficient concentration in the potato to
continue to inhibit sprouting.
The results of the toxicity studies provided, the low-volume use
pattern, and the fact that use of the product will not increase levels
of 1,4-dimethylnaphthalene above levels normally found in potatoes are
sufficient to demonstrate that there are no foreseeable human health
hazards likely to arise from the use of the product as a potato sprout
inhibitor. Because no enforcement residue level is established by this
exemption, the requirement for an analytical method for enforcement
purposes is not applicable to this exemption request.
1,4-Dimethylnaphthalene is considered useful for the purposes for
which the exemption is sought. Based on the information and data
considered, the Agency concludes that the establishment of a tolerance
is not necessary to protect the public health. Therefore, the exemption
from requirement of a tolerance is 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 [[Page 7457]] 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).
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
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
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: January 27, 1995.
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 subpart D, by adding new Sec. 180.1142, to read as follows:
Sec. 180.1142 1,4-Dimethylnaphthalene; exemption from the requirement
of tolerance.
An exemption from the requirement of a tolerance is established for
residues of the plant growth regulator 1,4-dimethylnaphthalene when
applied post harvest to potatoes in accordance with good agricultural
practices.
[FR Doc. 95-2821 Filed 2-7-95; 8:45 am]
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