[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]
BILLING CODE 6550-50-F