[Federal Register Volume 60, Number 145 (Friday, July 28, 1995)]
[Proposed Rules]
[Pages 38781-38783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18621]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 185

[OPP-300394; FRL-4969-9]
RIN 2070-AC18


Trifluralin; Revocation of Food Additive Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke tolerances for residues of the 
herbicide trifluralin in or on peppermint oil and spearmint oil, and to 
withdraw a prior final rule revoking those tolerances. EPA is taking 
this action because peppermint oil and spearmint oil are not ready-to-
eat commodities, and residues of trifluralin are not likely to 
concentrate in ready-to-eat forms of peppermint and spearmint oil. 
Therefore, food additive tolerances are not required. In addition, 
after the tolerances are revoked pursuant to this action, the basis for 
the prior revocation will be eliminated.

DATES: Written comments, identified by the document control number 
[OPP-300394], must be received on or before August 28, 1995.

ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA. Information submitted as a 
comment concerning this document may be claimed confidential by marking 
any part or all of that information as ``Confidential Business 
Information'' (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 without prior notice. All written comments will be 
available for public inspection in Rm. 1132 at the address given above, 
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. 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-300394]. No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
proposed 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: Jean M. Frane, Policy and 
Special Projects Staff (7501C), Environmental Protection Agency, 401 M 
St., SW., Washington, D.C. 20460. Office location and telephone number: 
Crystal Mall #2, Rm. 1113, 1921 Jefferson Davis Hwy., Arlington, VA, 
(703)-305-5944; e-mail: [email protected].


[[Page 38782]]


SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA is proposing two separate actions in this document. First, EPA 
proposes to revoke the food additive regulations (FARs) for residues of 
the herbicide trifluralin in or on peppermint oil and spearmint oil (40 
CFR 185.5900). Second, EPA proposes to withdraw its Order dated July 
14, 1993 (58 FR 37862) to the extent that it revoked the food additive 
regulations for trifluralin in or on peppermint oil and spearmint oil.

A. Statutory Background

    The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et 
seq., authorizes the establishment by regulation of maximum permissible 
levels of pesticides in foods. Such regulations are commonly referred 
to as ``tolerances.'' Without such a tolerance or an exemption from the 
requirement of a tolerance, a food containing a pesticide residue is 
``adulterated'' under section 402 of the FFDCA and may not be legally 
moved in interstate commerce. 21 U.S.C. 331, 342. EPA was authorized to 
establish pesticide tolerances under Reorganization Plan No. 3 of 1970. 
5 U.S.C. App. at 1343 (1988). Monitoring and enforcement of pesticide 
tolerances are carried out by the U.S. Food and Drug Administration 
(FDA) and the United States Department of Agriculture (USDA). EPA can 
establish a tolerance in response to a petition (FFDCA 408(d)(1), 
409(b)(1)), or on its own initiative (FFDCA 408(e), 409(d)).
    The FFDCA has separate provisions for tolerances for pesticide 
residues on raw agricultural commodities (RACs) and tolerances on 
processed food. For pesticide residues in or on RACs, EPA establishes 
tolerances, or exemptions from tolerances when appropriate, under 
section 408 of the act. 21 U.S.C. 346a. EPA regulates pesticide 
residues in processed foods under section 409, which pertains to ``food 
additives.'' 21 U.S.C. 348. Maximum residue regulations established 
under section 409 are commonly referred to as food additive regulations 
(hereinafter referred to as ``FARs''). Section 409 FARs are needed, 
however, only for certain pesticide residues in processed food. Under 
section 402(a)(2) of the FFDCA, a pesticide residue in processed food 
generally will not render the food adulterated if the residue results 
from application of the pesticide to a RAC and the residue in the 
processed food when ready to eat is below the RAC tolerance. This 
exemption in section 402(a)(2) is commonly referred to as the ``flow-
through'' provision because it allows the section 408 raw food 
tolerance to flow through to the processed food forms. Thus, a section 
409 food additive regulation is only necessary to prevent foods from 
being deemed adulterated when the concentration of the pesticide 
residue in a processed food when ready to eat is greater than the 
tolerance prescribed for the RAC, or if the processed food itself is 
treated or comes in contact with a pesticide.

B. Regulatory Background

    On July 14, 1993, EPA issued a final order, subject to objections 
and requests for a hearing, revoking the trifluralin FARs for 
peppermint oil and spearmint oil (58 FR 37862, hereinafter referred to 
as ``1993 Order''). This Order was issued in response to the decision 
by the U.S. Court of Appeals, Ninth Circuit, in the case of Les v. 
Reilly, 968 F.2d 985 (9th Cir. 1992), cert. denied, 113 S.Ct. 1361 
(1993). DowElanco, the manufacturer of trifluralin, filed objections to 
the revised Order, as well as requests for a hearing on and a stay of, 
the revocation Order. On June 30, 1994, EPA issued a final order 
denying DowElanco's objections and requests for a hearing and a stay of 
the revocation (59 FR 33684, hereinafter referred to as ``1994 
Order''). On July 14, 1994, DowElanco filed an action in the U.S. Court 
of Appeals, D.C. Circuit for review of EPA's 1993 Order, and moved for 
summary reversal or, in the alternative, an emergency stay of the 
revocation. E.I. DuPont DeNemours and Co., et al. v. EPA, Civ. Action 
No. 94-1504 (D.C. Cir.). On August 24, 1994, the Court denied 
DowElanco's motion for summary reversal, but issued an emergency stay 
of the revocation. In the Federal Register of September 12, 1994 (59 FR 
46768), EPA reinstated the FARs for trifluralin (as well as for the 
other pesticides involved in the litigation), and they are currently in 
effect.
    On September 11, 1992, the National Food Processors Association 
(NFPA) and other organizations filed a petition with EPA challenging, 
among other things, EPA's interpretation of the phrase ``ready to eat'' 
in the Delaney Clause. (Petition to the Environmental Protection 
Agency, Office of Pesticide Programs, Concerning EPA's Pesticide 
Concentration Policy (1992)) (hereinafter cited as ``NFPA petition''). 
The petition requested that EPA apply the term ``ready to eat'' in the 
flow-through provision according to what NFPA asserts is its plain 
meaning. EPA sought public comment on the petition (Federal Register of 
Feb. 5, 1993 (58 FR 7470)). In the Federal Register of June 14, 1995 
(60 FR 31300), EPA issued a partial response to the NFPA petition, 
addressing the ``ready to eat'' policy. In that response, EPA agreed 
that the term ``ready to eat'' food has a common-sense meaning of food 
which is consumed without further preparation and stated its intention 
to apply that interpretation in future actions.

II. Revocation of the Food Additive Regulations for Trifluralin in 
Peppermint Oil and Spearmint Oil

    EPA has reviewed the trifluralin FARs for peppermint oil and 
spearmint oil. EPA has determined that no section 409 tolerance is 
necessary for mint oils because they are not ``ready to eat'' processed 
foods, and because ready to eat foods containing mint oils are unlikely 
to have trifluralin residues greater than the RAC tolerances for 
peppermint hay and spearmint hay.
    As noted above, under FFDCA section 402(a)(2), processed foods 
containing pesticide residues are not deemed adulterated if the level 
of pesticide residues in the processed food ``when ready to eat is not 
greater than the tolerance prescribed for the raw agricultural 
commodity.'' EPA believes that the common-sense meaning of the term 
``ready to eat'' food is food ready for consumption without further 
preparation. Mint oils are not consumed ``as is'' but are used as a 
flavoring in other foods. As such, peppermint oil and spearmint oil are 
not ``ready to eat.''
    Mint oils are used as flavoring agents in foods such as beverages, 
ice cream, candy and chewing gum. The maximum amounts used are listed 
in a February 1965 article in Food Technology (``Recent Progress in the 
Consideration of Flavoring Ingredients Under the Food Additives 
Amendment, III. GRAS Substances,'' Richard L. Hall and Bernard L. 
Oser). The highest concentrations of peppermint oil and spearmint oil 
in foods are in chewing gum at 8,300 ppm and 6,200 ppm, respectively. 
These equate to dilution factors of 120 and 160, respectively. Using 
these dilution factors and the mint oil tolerances of 2 ppm or the 
maximum levels observed from a 1 x rate (i.e., about 1.2 ppm), maximum 
residues of trifluralin in the ready-to-eat food will be on the order 
of 0.010 to 0.02 ppm. These are lower than the RAC tolerances of 0.05 
ppm. Thus, no section 409 tolerances are needed for peppermint oil and 
spearmint oil, and EPA proposes to revoke the existing food additive 
regulations.

III. Withdrawal of the July 14, 1993 Order With Respect to 
Trifluralin

    EPA proposes to withdraw those aspects of EPA's July 1993 Order and 
EPA's June 1994 Order revoking the 

[[Page 38783]]
trifluralin peppermint and spearmint oil FARs on grounds that 
trifluralin ``induces cancer'' within the meaning of the Delaney 
clause. As EPA states in this proposal, the trifluralin peppermint and 
spearmint oil FARs are no longer necessary. Ideally, EPA would prefer 
to have reached the conclusions announced in this proposal with respect 
to trifluralin residues in mint oils sooner. However, EPA has only 
recently been able to complete and release its revised policy 
interpreting the phrase ``ready to eat,'' a reinterpretation that 
provides alternative grounds for revoking the trifluralin mint FARs. 
EPA had an obligation in 1993 to respond promptly to the Ninth 
Circuit's order in Les v. Reilly. Moreover, EPA did not believe it 
would be appropriate to delay its response to the Les Court's order 
until it had vetted the many issues raised in NFPA's petition, a 
petition that was filed many years after the petition that was the 
subject of Les.
    Given that other, less controversial grounds for revoking these 
FARs have recently become available, EPA is taking this opportunity to 
revoke the FARs on these grounds. EPA believes that there is no need to 
continue to litigate the legality of its 1993 and 1994 Orders relating 
to trifluralin where there are less controversial grounds available to 
achieve the revocation of the mint FARs. Therefore, EPA will inform the 
Court in DuPont v. EPA that it is proposing these revocations.
    If EPA receives no adverse comments on its notice proposing the 
revocation of the trifluralin mint FARs on alternative grounds, EPA 
will issue a final order revoking the FARs. EPA will also request that 
the D.C. Circuit Court remand the 1993 and 1994 Orders with respect to 
trifluralin so that EPA may likewise issue a final order withdrawing 
the trifluralin-related aspects of those Orders.

IV. Procedural Matters

A. Comments

    Interested persons may comment on the following: EPA's 
determination that peppermint oil and spearmint oil are not ready to 
eat commodities; and EPA's proposal to withdraw the 1993 Order with 
respect to revocation of the trifluralin FARs.
    If EPA receives no adverse comments on the revocation of the FARs 
for trifluralin in mint oils, it will issue a final order, effective 
upon publication, subject to objections and requests for a hearing. If 
a party does not submit comments on this proposal, EPA believes that it 
would be appropriate to deny objections or a request for a hearing from 
that party.
    Written comments must bear a notation indicating the document 
control number, [OPP-300394]. All written comments filed in response to 
this notice will be available for public inspection in Rm. 1132 at the 
address given above from 8 a.m. and 4:30 p.m., Monday through Friday, 
except legal holidays.
     A record has been established for this rulemaking under docket 
number [OPP-300394] (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 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.
    Electronic comments can be sent directly to EPA at:

    opp-D[email protected].


    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 rulemaking, 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.

V. Regulatory Requirements

A. Executive Order 12866

    Under Executive Order 12866, 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 the order, a ``significant regulatory action'' 
is 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, and the environment, public health or safety, of 
State, local, or tribal governments or communities''; (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 the Executive Order. EPA has 
determined that this proposed rule is not a ``significant'' action 
under E.O. 12866. EPA is taking this action because it has determined 
that the food additive regulation for trifluralin is not needed. 
Therefore, the Agency expects that no economic impact will result.

B. Regulatory Flexibility Act

    The proposed regulatory action has been reviewed under the 
Regulatory Flexibility Act of 1980, and, as stated above, EPA expects 
that it will not have any economic impacts, including impacts on small 
entities.

C. Paperwork Reduction Act

    This proposal does not contain any information collection 
requirements subject to review by the Office of Management and Budget 
under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.

List of Subjects in 40 CFR Part 185

    Environmental protection, Administrative practice and procedures, 
Agricultural commodities, Food additives, Pesticides and pests, Records 
and recordkeeping.

    Dated: July 24, 1995.

Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, it is proposed that 40 CFR part 185 be amended as 
follows:

PART 185--[AMENDED]

    1. The authority citation for part 185 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 348.

Sec. 185.5900   [Removed]

    2. By removing Sec. 185.5900 Trifluralin.

[FR Doc. 95-18621 Filed 7-27-95; 8:45 am]
BILLING CODE 6560-50-F