heliothis zea NPV (Heliothis) Tolerance Actions 8/95
Date: Wed, 16 Aug 1995 09:37:50 -0400
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Sodium Propionate, Methoprene, and Heliothis zea NPV; Tolera X-Comment:
U.S. EPA FEDERAL REGISTER PESTICIDE documents
[Federal Register: August 16, 1995 (Volume 60, Number 158)] [Rules and
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
40 CFR Parts 180 and 185
40 CFR Parts 180 and 185
Sodium Propionate, Methoprene, and Heliothis zea NPV; Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: For each of the pesticides subject to the actions listed in this
rule, EPA has completed the reregistration process and issued a
Reregistration Eligibility Document (RED). In the reregistration process,
all information to support a pesticide's continued registration is reviewed
for adequacy and, when needed, supplemented with new scientific studies.
Based on the RED tolerance assessments for the pesticide chemicals subject
to this rule, EPA is taking the following tolerance actions: amending the
exemptions from the requirement of a tolerance for methoprene; revoking
exemptions for sodium propionate; and making wording changes to the
exemption from the requirement of a tolerance for Heliothis zea NPV. With
this rule to amend the exemptions from the requirement of tolerances for
methoprene, the Agency is correcting its position in the RED, which stated
that the exemptions should be revoked. The Agency believes that exemptions
from the requirement of tolerances for these uses are appropriate.
EFFECTIVE DATE: This regulation becomes effective on August 16, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [OPP-300389A], 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
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@example.com. 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 [OPP-300389A]. 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: Philip Poli, Special Review and
Reregistration Division (7505W), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location and telephone number:
Crystal Station #1, 3rd Floor, 2800 Crystal Drive, Arlington, VA 22202,
(703)-308-8038; e-mail: firstname.lastname@example.org.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 28, 1995 (60 FR
33383), EPA issued a proposed rule (FRL-4960-5) affecting 40 CFR 180.2,
180.1015, 180.1027, 180.1033, and 185.4150 regarding various chemicals and
tolerance actions the Agency proposed to take. Specifically, EPA proposed
actions regarding the following chemicals: Methoprene, the revision of the
methoprene regulation in 40 CFR 180.1033 to reflect changed uses and the
revocation of the methoprene regulation in 40 CFR 185.4150; sodium
propionate, the revocation of exemptions under 40 CFR 180.2(a) and
180.1015; and Heliothis zea NPV, the amendment of 40 CFR 180.1027 to better
reflect the current viral identification and testing technology.
There were no comments or requests for referral to an advisory committee
received in response to the proposed rule.
The data submitted with the proposal and other relevant material have been
evaluated and discussed in the proposed rule. Based on the data and
information considered, the Agency concludes that the regulations issued in
this document will protect the public health. Therefore, the regulations
are 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 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
A record has been established for this rulemaking under docket number [OPP-
300389A] (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 [OPP-300389A], may be submitted to the Hearing Clerk (1900),
Environmental Protection Agency, Rm. 3708, 401 M St., SW., Washington, DC
A copy of electronic objections and hearing requests filed with the Hearing
Clerk can be sent directly to EPA at:
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
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
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 Parts 180 and 185
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests, Reporting
and recordkeeping requirements.
Dated: August 8, 1995.
Director, Special Review and Reregistration Division, Office of Pesticide
Therefore, 40 CFR, chapter I, 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. Section 180.2 is revised to read as follows:
Sec. 180.2 Pesticide chemicals considered safe.
(a) As a general rule, pesticide chemicals other than benzaldehyde (when
used as a bee repellant in the harvesting of honey), ferrous sulfate, lime,
lime-sulfur, potassium carbonate, potassium polysulfide, potassium sorbate,
sodium carbonate, sodium chloride, sodium hypochlorite, sodium polysulfide,
sodium sesquicarbonate, sorbic acid, sulfur, and when used as plant
desiccants, sodium metasilicate (not to exceed 4 percent by weight in
aqueous solution) and when used as postharvest fungicide, citric acid,
fumaric acid, oil of lemon, oil of orange, and sodium benzoate are not for
the purposes of section 408(a) of the Act generally recognized as safe.
(b) Upon written request, the Registration Division will advise interested
persons whether a pesticide chemical should be considered as poisonous or
deleterious, or one not generally recognized by qualified experts, as safe.
(c) The training and experience necessary to qualify experts to evaluate
the safety of pesticide chemicals for the purposes of section 408(a) of the
Act are essentially the same as training and experience necessary to
qualify experts to serve on advisory committees prescribed by section
408(g) of the Act. (See Sec. 180.11.)
Sec. 180.1015 [Removed]
c. Section 180.1015 is removed.
d. Section 180.1027 is revised to read as follows:
Sec. 180.1027 Nuclear polyhedrosis virus of Heliothis zea; exemption from
the requirement of a tolerance.
(a) For the purposes of this section, the viral insecticide must be
produced with an unaltered and unadulterated inoculum of the single-
embedded Heliothis zea nuclear polyhedrosis virus (HzSNPV). The identity of
the seed virus must be assured by periodic checks.
(b) Each lot of active ingredient of the viral insecticide shall have the
(1) The level of extraneous bacterial contamination of the final
unformulated viral insecticide should not exceed 10<SUP>7 colonies per gram
as determined by an aerobic plate on trypticase soy agar.
(2) Human pathogens, e.g., Salmonella, Shigella, or Vibrio, must be absent.
(3) Safety to mice as determined by an intraperitoneal injection study must
(4) Identity of the viral product, as determined by the most sensitive and
standardized analytical technique, e.g., restriction endonuclease and/or
SDS-PAGE analysis, must be demonstrated.
(c) Exemptions from the requirement of a tolerance are established for the
residues of the microbial insecticide Heliothis zea NPV, as specified in
paragraphs (a) and (b) of this section, in or on all agricultural
commmodities including: corn, cottonseed, beans, lettuce, okra, peppers,
sorghum, soybeans, and tomatoes.
e. Section 180.1033 is revised to read as follows:
Sec. 180.1033 Methoprene; exemption from the requirement of a tolerance.
Methoprene is exempt from the requirement of a tolerance in or on all raw
agricultural commodities when used to control mosquito larvae including
pastures, rice fields, vineyards, date palm orchards, nut orchards, berry
orchards, and fruit orchards.
2. In part 185:
a. The authority citation for part 185 continues to read as follows:
Authority: 21 U.S.C. 348.
b. Section 185.4150 is revised to read as follows:
Sec. 185.4150 Methoprene.
A tolerance of 10 parts per million is established for residues of
isopropyl (E,E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate) in or on
the food additive commodity cereal grain milled fractions (except flour and
[FR Doc. 95-20305 Filed 8-15-95; 8:45 am] BILLING CODE 6560-50-F