[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Rules and Regulations]
[Pages 42449-42450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20307]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 2F4090/R2154; FRL-4966-9]
RIN 2070-AB78


Occlusion Bodies of the Granulosis Virus of Cydia Pomenella; 
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 of a 
pesticide tolerance for residues of the microbial pest control agent 
Occlusion Bodies of the Granulosis Virus of Cydia pomenella (codling 
moth) in or on all raw agricultural commodities. The University of 
California at Berkley requested this tolerance exemption in a petition 
submitted under the Federal Food, Drug and Cosmetic Act (FFDCA). This 
regulation eliminates the need to establish a maximum permissible level 
for residues of Cydia pomenella Granulosis Virus.

EFFECTIVE DATE: This regulation becomes effective on August 16, 1995.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 2F4090/R2154], may be submitted to: 
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
St., SW., Washington, DC 20460. Fees accompanying objections and 
hearing requests shall be labeled ``Tolerance Petition Fees'' and 
forwarded to: EPA Headquarters Accounting Operations Branch, OPP 
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. 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 copy of 
objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA 22202.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number [PP 
2F4090/R2154]. No Confidential Business Information (CBI) should be 
submitted through e-mail. Electronic copies of objections and hearing 
requests on this rule may be filed online at many Federal Depository 
Libraries. Additional information on electronic submissions can be 
found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Linda Hollis, Biopesticides 
and Pollution Prevention Division (7501W), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: Rm. 259, 1921 Jefferson Davis Hwy., Arlington, VA 
22202, (703)-308-8733; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 10, 1992 (57 
FR 24645), EPA issued a notice that The University of California, 
Berkley, CA 94720, had petitioned EPA under section 408 of the FFDCA, 
21 U.S.C. 346a, to establish an exemption from the requirement of a 
tolerance for residues of the microbial pest control agent Cydia 
pomonella Granulosis Virus in or on all raw agricultural commodities 
when used to control the codling moth.
    There were no comments received in response to the 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 the 
following: an acute toxicity/pathogenicity study, an acute dermal 
toxicity study, an acute intravenous toxicity study, a primary eye 
irritation study, and a cell culture assay.
    1. Acute Oral Toxicity/Pathogenicity in Rats, Guideline No. 152A-
10. Eighteen male and female rats were dosed by oral gavage with 5.0 mL 
Cydia pomonella granulosis inclusion bodies at a potency of 4 X 
1011 GIBs/mL. No abnormalities or toxicity were observed. A 
distinct clearance pattern was evident in the feces and heart/lungs 
through day 7 of the study. TOX CATEGORY IV.
    2. Acute Dermal Toxicity in Rabbits, Guideline No. 152A-11. Five 
male and female New Zealand rabbits were tested. One test animal 
displayed mild erythema and edema within 24 hours postdosing. No other 
signs of dermal irritation were noted. TOX CATEGORY IV.
    3. Acute Pulmonary Toxicity/Infectivity in Rats, Guideline No. 
152A-13. Thirty-four male and female Sprague-Dawley rats were dosed via 
intratracheal injection with 1.2 mL/kg GIBs/mL. Baculovirus Cydia 
pomonella was not toxic, infectious, or pathogenic to rats. TOX 
CATEGORY IV
    4. Primary Eye Irritation in Rabbits, Guideline No. 152A-14. Six 
New Zealand white rabbits were administered in a single dose of 0.1 mL 
Baculovirus Cydia pomonella into the conjunctival sac of both eyelids. 
Baculovirus Cydia pomonella was not irritating to rabbit eyes when 
compared to rabbits treated with sterile distilled water. Ocular 
irritation dissipated in both control and treated eyes by day 21. TOX 
CATEGORY II.
    5. Cell Culture Toxicity/Infectivity, Guideline No. 152A-16. Three 
human cell lines WI-38, WS1, and HepG2 were challenged with 2 X 
109 particles/mL of Cydia pomonella Granulosis Virus (CpGV) over a 
1-hour exposure and rinsed. No significant cytopathic or toxic effects 
were observed.
    The toxicology data provided are sufficient to demonstrate that 
there are no foreseeable human health hazards likely to arise from the 
Cydia pomonella Granulosis Virus in or on all raw agricultural 
commodities when applied in accordance with good agricultural 
practices.

Residue Chemistry Data

    Residue chemistry data are necessary only if the submitted 
toxicology studies indicate that additional Tier II or II toxicology 
data would be required as specified in 40 CFR 158.165(e). The submitted 
toxicology data for this use indicate that the product is of low 
mammalian toxicity; therefore, Tier II or III data were not required.
    Acceptable chemistry data are necessary only if the submitted 
toxicology studies indicate that additional Tier II or III toxicology 
data would be required as specified in 40 CFR 158.165(e). The submitted 
toxicology data for this use indicate that the product is of low 
mammalian toxicity; therefore, Tier II or III data were not required.
    Based on the information considered, the Agency concludes that the 
establishment of a tolerance for the active ingredient Occlusion Bodies 
of the Granulosis Virus of Cydia pomonella is not necessary to protect 
the public health. Therefore, 40 CFR part 180 is amended 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 

[[Page 42450]]
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 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 a genuine and 
substantial issue of fact; there is a reasonable possibility that 
available evidence identified by the requestor would, if established, 
resolve 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).
     A record has been established for this rulemaking under docket 
number [PP 2F4090/R2154] (including any objections and hearing requests 
submitted electronically as described below). A public version of this 
record, including printed, paper versions of electronic comments, which 
does not include any information claimed as CBI, is available for 
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Written objections and hearing requests, identified by the document 
control number [PP 2F4090/R2154], may be submitted to the Hearing Clerk 
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., 
Washington, DC 20460.
    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk can be sent directly to EPA at:
    opp-D[email protected]


    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any objections and hearing requests received 
electronically into printed, paper form as they are received and will 
place the paper copies in the official rulemaking record which will 
also include all objections and hearing requests submitted directly in 
writing. The official rulemaking record is the paper record maintained 
at the address in ``ADDRESSES'' at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the order defines a ``significant regulatory action'' as an action that 
is likely to result in 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 referred to 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 the rights and obligations of recipients 
thereof; 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 the 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: July 21, 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. 180.1148, to read as follows:


Sec. 180.1148   Occlusion Bodies of the Granulosis Virus of Cydia 
pomenella; tolerance exemption.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pest control agent Occlusion Bodies of the 
Granulosis Virus of Cydia pomonella (codling moth) in or on all raw 
agricultural commodities.

[FR Doc. 95-20307 Filed 8-15-95; 8:45 am]
BILLING CODE 6560-50-F