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sodium propionate Proposed Tolerance Actions 6/95

[Federal Register: June 28, 1995 (Volume 60, Number 124)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300389; FRL-4960-5]
Sodium Propionate, Methoprene, and Heliothis zea Npv; Proposed 
    Tolerance Actions
AGENCY: Environmental Protection Agency (EPA or "the Agency")
ACTION: Proposed rule.
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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: opp-docket@epamail.epa.gov. 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 
legal holidays.

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, poli.philip@epamail.epa.gov.

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 
seq.].

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 
larvae.

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 
active ingredient.

C. Heliothis zea NPV: Changes to the Existing Language Under 40 CFR 
180.1027

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:
                         opp-docket@epamail.epa.gov

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 
this document.

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.

IV. References

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 
Flexibility Act.

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 
recordkeeping requirements.

Dated: June 15, 1995.

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

Therefore, 40 CFR, chapter I, is proposed to be amended as follows:

PART 180--[AMENDED]

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. 
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 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 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.

PART 185--[AMENDED]

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).