PMEP Home Page Pesticide Active Ingredient Information Insecticides and Miticides abamectin (Agri-Mek) to buprofezin anagrapha falcifera (celery looper) anagrapha falcifera (celery looper) Exception of Tolerance Requirement 7/95

anagrapha falcifera (celery looper) Exception of Tolerance Requirement 7/95

40 CFR Part 180

[PP 4F4402/R2149; FRL-4963-6]
RIN 2070-AB78


Inclusion Bodies of Multi-Nuclear Polyhedrosis Virus of Anagrapha 
Falcifera; Exemption From the Requirement of a Tolerance 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Final rule.

----------------------------------------------------------------------- 

SUMMARY: This rule establishes an exemption from the requirement of a 
pesticide tolerance for residues of the microbial pest control agent 
inclusion bodies of the multi-nuclear polyhedrosis virus of Anagrapha 
falcifera (celery looper) in or on all raw agricultural commodities. 
Biosys requested this tolerance exemption that eliminates the need to 
establish a maximum permissible level for residues of Anagrapha 
falcifera multi-nuclear polyhedrosis virus. 

EFFECTIVE DATE: This regulation becomes effective July 19, 1995. 

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 4F4402/R2149], may be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. 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. 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 
4F4402/R2149]. 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), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: CS #1, 5th Floor, 2800 Crystal 
Drive, Crystal City, VA 22202, (703) 308-8733; e-mail: 
hollis.linda@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal 
Register of November 2, 1994 (59 FR 54902), which announced that Biosys, 
Palo Alto, CA 94303, had submitted a pesticide petition, PP 4F4402, 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), exempt 
from the requirement of a tolerance the residues of the microbial pest 
control agent inclusion bodies of the multi- nuclear polyhedrosis virus 
of Anagrapha falcifera in or on all raw agricultural commodities when 
used to control certain lepidopteran pest species.
No comments were received in response to the notice of filing. 

Residue Chemistry Data

Residue chemistry data are necessary only if the submitted toxicology 
studies indcate 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. 

Toxicology Data

Toxicology data considered in support of this exemption from the 
requirement of a tolerance were satisfied via data waivers from the open 
scientific literature with the exception of an acute oral toxicity 
study. Waivers include an acute dermal toxicity study in the guinea pig, 
an acute inhalation toxicity study in the rat, a primary eye irritation 
study in the rabbit, and a cell culture study. Findings from the open 
scientific literature showed no toxic, pathogenic, or adverse effects.
Reference Dose (RfD) and maximum permissible intake (MPI) considerations 
are not relevant to this petition because of this low toxicity and lack 
of pathogenicity or infectivity as reported in the open scientific 
literature.
Based on the information cited above, the Agency concludes that the 
establishment of a tolerance for the active ingredient Anagrapha 
falcifera multi-nuclear polyhedrosis virus 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 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 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 4F4402/R2149] (including 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 4F4402/R2149], 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, October 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: July 3, 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. 180.1149, to read as follows: 


Sec. 180.1149 Inclusion bodies of the multi-nuclear polyhedrosis virus 
of Anagrapha falcifera; exemption from the requirement of a tolerance.

The microbial pest control agent inclusion bodies of the multi- nuclear 
polyhedrosis virus of Anagrapha falcifera is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities 
when used to control certain lepidopteran pest species. 

[FR Doc. 95-17602 Filed 7-18-95; 8:45 am] BILLING CODE 6560-50-F

To Top

For more information relative to pesticides and their use in New York State, please contact the PMEP staff at:   5123 Comstock Hall Cornell University Ithaca, NY 14853-0901 (607) 255-1866

This site is supported, in part, by funding from the