[Federal Register Volume 60, Number 45 (Wednesday, March 8, 1995)]
[Rules and Regulations]
[Pages 12702-12703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5655]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4328/R2112; FRL-4940-5]
RIN 2070-AB78
Pseudomonas Syringae; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes an exemption from the requirement for a
tolerance for residues of Pseudomonas syringae in or on all raw
agricultural commodities when applied postharvest in accordance with
good agricultural practices. EcoScience Corp. requested this exemption.
EFFECTIVE DATE: This regulation becomes effective March 8, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP4F4328/R2112], 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
requests 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 (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring a copy of objections and hearing
requests 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: Sheryl K. Reilly,
Biopesticides and Pollution Prevention Division (7501W), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460, (703)-308-
8265.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 11, 1994 (59
FR 24429), EPA issued a notice that the EcoScience Corp., One
Innovation Drive, Worcester, MA 01545, had submitted pesticide petition
PP 4F4328 to EPA proposing to amend 40 CFR part 180 by establishing a
regulation pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to exempt from the requirement
of a tolerance the residues of the biological control agent, Bio-Save
10, containing the active ingredient Pseudomonas syringae in or on
pears, apples, lemons, oranges, and grapefruit when applied postharvest
in accordance with good agricultural practices.
There were no comments received in response to the notice of
filing.
Pseudomonas syringae is naturally occurring and was originally
isolated from apples.
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 an acute oral
toxicity/pathogenicity study, an acute dermal toxicity study, an acute
pulmonary toxicity/pathogenicity study, an acute intravenous toxicity/
pathogenicity study, a primary eye irritation study, and a primary
dermal irritation study.
The results of these studies indicated that the organism was not
toxic to test animals when administered via oral, dermal, pulmonary, or
intravenous routes.
The active ingredient was not infective or pathogenic to test
animals in any of the studies. Minimal ocular irritation observed in
the eye irritation study dissipated within 5 days; very slight skin
irritation noted immediately following exposure to the compound
dissipated within 2 days. There have been no reports of
hypersensitivity related to the active ingredient. All of the toxicity
studies submitted are considered acceptable.
The toxicology data provided are sufficient to demonstrate that
there are no foreseeable human health hazards likely to arise from the
use of Pseudomonas syringae on all raw agricultural commodities when
applied postharvest in accordance with good agricultural practices.
Acceptable daily intake (ADI) and maximum permissible intake (MPI)
considerations are not relevant to this petition because the data
submitted demonstrated that this biological control agent is not toxic
to humans by dietary exposure. No enforcement actions are expected.
Therefore, the requirement for an analytical method for enforcement
purposes is not applicable to this exemption request. This is the first
exemption from the requirement of a tolerance for this biological
control agent.
Based on the information considered, the Agency concludes that
establishment of a tolerance is not necessary to protect the public
health. Therefore, the exemption from 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 to the regulation and may also request a hearing on
those objections. Objections and hearing requests must be filed 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 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 such issues, 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 genuine and substantial issue
of fact; there is reasonable possibility that available evidence
identified by the requestor would, if established, resolve
[[Page 12703]] one 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, Reporting and
recordkeeping requirements.
Dated: February 27, 1995.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
PART 180--[AMENDED]
Therefore, 40 CFR part 180 is amended as follows:
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. 180.1145, to read as follows:
Sec. 180.1145 Pseudomonas syringae; exemption from the requirement of
a tolerance.
Pseudomonas syringae is exempted from the requirement of a
tolerance on all raw agricultural commodities when applied postharvest
according to good agricultural practices.
[FR Doc. 95-5655 Filed 3-7-95; 8:45 am]
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