[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Rules and Regulations]
[Pages 42458-42460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20305]



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40 CFR Parts 180 and 185
40 CFR Parts 180 and 185

[OPP-300389A; FRL-4967-9]
RIN 2070-AB78


Sodium Propionate, Methoprene, and Heliothis zea NPV; Tolerance 
Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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 

[[Page 42459]]
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 
[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: [email protected].

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 178.32).
     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 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 

[[Page 42460]]
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.

Lois Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR, chapter I, 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. 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 following specifications:
    (1) The level of extraneous bacterial contamination of the final 
unformulated viral insecticide should not exceed 107 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 be demonstrated.
    (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.

PART 185--[AMENDED]

    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 rice hulls).

[FR Doc. 95-20305 Filed 8-15-95; 8:45 am]
BILLING CODE 6560-50-F