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Occlusion Bodies of the Granulosis Virus of Cydia Pomenella; Exemption from the Requirement of a Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: August 16, 1995 (Volume 60, Number 158)]
[Rules and Regulations]
[Page 42449-42450]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au95-16]
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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: opp-docket@epamail.epa.gov. 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: hollis.linda@epamail.epa.gov.
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-Docket@epamail.epa.gov
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