heliothis zea NPV (Heliothis) Proposed Tolerance Actions 6/95
[Federal Register: June 28, 1995 (Volume 60, Number 124)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Sodium Propionate, Methoprene, and Heliothis zea Npv; Proposed
AGENCY: Environmental Protection Agency (EPA or "the Agency")
ACTION: Proposed rule.
SUMMARY: For each of the pesticides subject to the actions listed in
this proposed 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 proposed rule,
EPA is proposing the following tolerance actions: to amend the
exemptions from the requirement of a tolerance for methoprene; to
revoke exemptions for sodium propionate; and make wording changes to
the exemption from the requirement of a tolerance for Heliothis zea
NPV. With this proposal 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.
DATES: Written comments, identified by the OPP document control number
[OPP-300389], must be received on or before July 28, 1995.
ADDRESSES: By mail, submit comments to Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person,
deliver comments to Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: email@example.com. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number "OPP-300389." No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
document may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found in Unit
III of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of the comment that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA [[Page 33384]] without prior notice. All written comments will
be available for public inspection in Rm. 1132 at the Virginia address
given above from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
FOR FURTHER INFORMATION CONTACT: By mail: Philip Poli, Special Review
and Reregistration Division (7508W), Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location, telephone
number, and e-mail address: Crystal Station #1, 3rd floor, 2800 Crystal
Drive, Arlington, VA, (703) 308-8038, firstname.lastname@example.org.
I. Legal Authorization
The Federal Food, Drug, and Cosmetic Act (FFDCA) [21 U.S.C. 301 et
seq.] authorizes the establishment of tolerances (maximum legal residue
levels) and exemptions from the requirement of a tolerance for residues
of pesticide chemicals in or on raw agricultural commodities pursuant
to section 408 [21 U.S.C. 346(a)]. Without such tolerances or
exemptions, a food containing pesticide residues is considered to be
"adulterated" under section 402 of the FFDCA, and hence may not
legally be moved in interstate commerce [21 U.S.C. 342]. To establish a
tolerance or an exemption under section 408 of the FFDCA, EPA must make
a finding that the promulgation of the rule would "protect the public
health" [21 U.S.C. 346a(b)]. For a pesticide to be sold and
distributed the pesticide must not only have appropriate tolerances
under the FFDCA, but also must be registered under the Federal
Insecticide, Fungicide, and Rodenticide Act [FIFRA, 7 U.S.C. 136 et
In 1988, Congress amended FIFRA and required EPA to review and
reassess the potential hazards arising from currently registered uses
of pesticides registered prior to November 1, 1984. As part of this
process, the Agency must determine whether a pesticide is eligible for
reregistration and if any subsequent actions are required to fully
attain reregistration status. EPA has chosen to include in the
reregistration process a reassessment of existing tolerances or
exemptions from the need for a tolerance. Through this reassessment
process, EPA can determine whether a tolerance must be amended,
revoked, or established, or whether an exemption from the requirement
of one or more tolerances must be amended or is necessary.
The procedure for establishing, amending, or repealing tolerances
or exemptions from the requirement of tolerances is set forth in the
Code of Federal Regulations 40 CFR parts 177 through 180. The
Administrator of EPA or any person may initiate an action proposing to
establish, amend, revoke, or exempt a tolerance for a pesticide
registered for food uses. The proposal must explain the grounds for
such a proposed action and will be published as a public notice. Each
petition or request for a new tolerance, an amendment to an existing
tolerance, or a new exemption from the requirement of a tolerance must
be accompanied by a fee or a request for a waiver of such fee. Current
Agency policy on tolerance actions identified during the reregistration
process is to administratively process without requiring payment of a
fee tolerance actions for revision or revocation of an established
tolerance, or if the proposed exemption from the requirement of a
tolerance requires the concurrent revocation of an approved tolerance.
Comments submitted in response to the Agency's published proposals are
reviewed; the Agency then publishes its final determination regarding
the specific tolerance actions.
II. Chemical-Specific Information and Proposed Actions
A. Methoprene: Amendment to 40 CFR 180.1033 and Revocation of Exemption
under 40 CFR 185.4150
1. Regulatory background. Methoprene was first registered under
FIFRA in 1975; a Registration Standard was issued in February 1982.
Subsequent to the issuance of the Registration Standard, methoprene was
reclassified by EPA from a conventional to a biochemical pesticide
based on its mode of action and chemical structure. The Reregistration
Eligibility Document (RED) for methoprene was issued in March 1991. At
the time of the RED, a number of sites were registered for mosquito
control. For these sites, which included both food and non-food,
exemptions from the requirement of tolerances had been established. In
the RED, the Agency recommended that these exemptions be revoked based
on the following rationale:
The mosquito vector control uses that were exempt from the
requirement of a tolerance under 40 CFR 180.1033 and 185.4150 are
now considered non-food uses. Thus, the exemptions are no longer
applicable and will be revoked.
Subsequent to the issuance of the RED, other mosquito vector
control uses were added to the methoprene label; these included
vineyards, date palm orchards, nut orchards, berry orchards, and fruit
orchards. No tolerances or exemptions from the requirement of
tolerances were established.
2. Proposed action. Amendment to 40 CFR 180.1033. The 1991 RED
document erroneously reclassifies many of the mosquito vector control
uses for food sites as non-food, and recommends that the exemptions
from the requirements of a tolerance be revoked because they are
unnecessary. The Agency has reviewed its position and determined that
the exemptions for all food sites should remain or be established.
Because methoprene exhibited low toxicity and showed no oncogenic
potential in chronic feeding studies (Ref. 1), and because methoprene
has low potential for exposure when used as a mosquito larvae control,
the Agency is proposing that methoprene be exempt from the requirement
of a tolerance in or on all raw agricultural commodities, including
pastures, rice fields, vineyards, date palm orchards, nut orchards,
berry orchards, and fruit orchards, when used to control mosquito
With this proposal, the Agency is acknowledging its error in the
RED and is also amending the RED determination that the mosquito vector
control uses are non-food. The Agency believes that these uses are
indeed food uses, and as such, should have the appropriate clearances
for residues on food under the Federal Food, Drug, and Cosmetic Act.
Revocation of exemption under 40 CFR 185.4150(a). Revoke this
exemption, deleting paragraph (a), because the Agency no longer
requires tolerances for potable water.
B. Sodium Propionate: Revocation of Exemptions under 40 CFR Sections
180.2(a) and 180.1015
1. Regulatory background. EPA first registered propionic acid-
containing products in the early 1970's. The currently registered
products are used as fungicides and bactericides, and have been used
for both human food and animal feed. In 1975, EPA exempted sodium
propionate from tolerances for residues following post-harvest
application in grains or hays (40 CFR 180.1023). Sodium propionate is
also exempt from the requirement of a tolerance when applied (as an
inert ingredient) to growing crops or to raw agricultural commodities
after harvest as described in 40 CFR 180.1001(c). Sodium propionate is
Generally Recognized As Safe (GRAS) (21 CFR part 1081), by the Food and
Drug Admininstration (FDA) for use in food.
The Reregistration Eligibility Document (RED) was issued for
propionic acid and its salts in 1991. The [[Page 33385]] RED document
recommended revoking the exemption from the requirement of tolerances
for all active ingredients containing sodium and calcium propionate
since no pesticide products contain these pesticides. There are no
exemptions from the requirement of tolerances for calcium propionate
listed in the 40 CFR.
2. Proposed action. The Agency is proposing to revoke the
exemptions for sodium propionate under 40 CFR 180.1015 and 180.1027
since there are no registrations for pesticide products containing this
C. Heliothis zea NPV: Changes to the Existing Language Under 40 CFR
1. Regulatory background. Heliothis zea NPV was first registered by
the Agency in 1975 as a microbial pesticide for use on cotton and
tobacco to control the cotton bollworm and the tobacco budworm. In June
1984, the Registration Standard entitled "Guidance for the
Reregistration of Pesticide Products Containing Nuclear Polyhedrosis
Virus of Heliothis Zea as the Active Ingredient" (NTIS No. PB85134393)
was issued for Heliothis zea NPV, which summarized the available data
supporting its registration and concluded that additional scientific
data were needed to evaluate this microbial pesticide. The
Reregistration Eligibility Document (RED) was issued for Heliothis zea
NPV in December 1990. In this document, the Agency conducted a thorough
review of the scientific data base and all relevant information
supporting the reregistration of Heliothis zea NPV, including the data
submitted in response to the Registration Standard. The Agency
concluded as a result of the reregistration review that the exemption
from the requirement for a tolerance on all agricultural commodities
continues to be appropriate.
2. Proposed action. To better reflect the current viral
identification and testing technology, the Agency is at this time
proposing to amend the existing language of 40 CFR 180.1027. As
specified in the Pesticide Assessment Guideline, Subdivision O, Residue
Chemistry, the use of a pesticide on tobacco does not require a
tolerance or an exemption from the requirement of a tolerance, so the
commodity tobacco will no longer be listed under Sec. 180.1027(c).
III. Public Comment Procedures
Interested persons are invited to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by [insert date 30 days after date of publication in the
Federal Register]. Comments must bear a notation indicating the
document control number. Three copies of the comments should be
submitted to either location listed under ADDRESSES.
Information submitted as a comment concerning this document may be
claimed confidential by marking any or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of a comment that does
not contain CBI must be submitted for inclusion in the public record.
Information not marked confidential may be disclosed publicly by EPA
without prior notice.
A record has been established for this proposal under docket number
"OPP-300389" (including comments and data 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 Rm. 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.
Electronic comments can be sent directly to EPA at:
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this proposal, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments 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 comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ADDRESSES at the beginning of
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this proposed rule in the Federal Register that this rulemaking
proposal be referred to an Advisory Committee in accordance with
section 408(e) of the FFDCA.
To satisfy requirements for analysis specified by Executive Order
12866 and the Regulatory Flexibility Act, EPA has analyzed the impacts
of this proposal. This analysis is available for public inspection in
Rm. 1132 at the Virginia address given above.
U.S. Environmental Protection Agency. Reregistration Eligibility
Document for Isopropyl (2E,4E)-11-Methoxy-3,7,11-Trimethyl-2,4
Dodecadienoate (Referred to as Methoprene). Case 0030. March 1991.
V. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 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 entitlements, 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 this Executive Order, it has been
determined that this proposed rule is not a "significant regulatory
action," because it does not meet any of the regulatory-significance
criteria listed above.
B. Regulatory Flexibility Act
This proposed rule has been reviewed under the Regulatory
Flexibility Act of 1980 [Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et
seq.] and EPA has determined that it will not have a significant
economic impact on a substantial number of small businesses, small
governments, or small organizations. [[Page 33386]]
Accordingly, I certify that this proposed rule does not require a
separate regulatory flexibility analysis under the Regulatory
C. Paperwork Reduction Act
This proposed regulatory action does not contain any information
collection requirements subject to review by OMB under the Paperwork
Reduction Act of 1980, 44 U.S.C. 3501 et seq.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: June 15, 1995.
Director, Special Review and Reregistration Division, Office of
Therefore, 40 CFR, chapter I, is proposed to be amended as follows:
1. In part 180:
a. The authority citation for part 180 would continue to read as follows:
Authority: 21 U.S.C. 346a and 371.
b. 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 repellent 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 post-harvest fungicides, 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) are
essentially the same as training and experience necessary to qualify experts
to serve on advisory committees prescribed by section 408(g). (See Sec.
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 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
(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 residue of the microbial insecticide Heliothis zea NPV, as
specified in paragraphs (a) and (b) of this section, in or on all
agricultural commodities 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 180 would continue 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).