trifluralin (Treflan) Revocation of Food Additive Regulation 1/96
[Federal Register: January 26, 1996 (Volume 61, Number 18)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 185
Trifluralin; Revocation of Food Additive Regulation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is revoking the food additive regulation (FAR) for
residues of the herbicide trifluralin in peppermint oil and spearmint
oil. 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 foods containing peppermint and
spearmint oil. Therefore, this FAR is not required.
EFFECTIVE DATE: This final rule becomes effective January 26, 1996.
ADDRESSES: Written objections, requests for a hearing, and/or requests
of stays identified by the document control number, OPP-300394A, must
be submitted by February 26, 1996, and comments on all of the above
must be submitted by March 11, 1996 to the OPP docket: Public Response
and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Hand deliver to: Rm. 1132, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA.
Information submitted as a filing 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 filings 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 (non-CBI) filings 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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: firstname.lastname@example.org. 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-300394A]. 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: Niloufar Nazmi, Special Review
Branch (7508W), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Crystal Mall #2, Rm. 1113,
1921 Jefferson Davis Hwy., Arlington, VA, (703)-308-8028; e-mail:
EPA is revoking the FAR for residues of the herbicide trifluralin
in peppermint oil and spearmint oil (40 CFR 185.5900).
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 Federal Food, Drug, and
Cosmetic Act (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 U.S.
Department of Agriculture (USDA). EPA can establish a tolerance in
response to a petition (FFDCA sections 408(d)(1) and 409(b)(1)) or on
its own initiative (FFDCA sections 408(e) and 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 of the act, which pertains to
food additives" (21 U.S.C. 348). Maximum residue regulations established under
section 409 of the act are commonly referred to as food additive regulations
(hereafter 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
level 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
In the Federal Register of July 14, 1993 (58 FR 37862) EPA issued a
final order, hereafter referred to as 1993 Order", that was subject
to objections and requests for a hearing and that revoked the
trifluralin FAR for peppermint oil and spearmint oil. The 1993 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. In the
Federal Register of June 30, 1994 (59 FR 33684), EPA issued a final
order (hereafter referred to as 1994 Order") denying DowElanco's
objections and requests for a hearing and a stay of the revocation. 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 FAR for trifluralin (as well as for benomyl), 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 (58 FR 7470, Feb. 5,
1993). 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.
In the Federal Register of July 28, 1995 (60 FR 38781), EPA issued
a proposed rule to revoke the FAR for trifluralin on peppermint and
spearmint oils. In the same proposed rule, EPA proposed to withdraw its
Order dated July 14, 1993 (58 FR 37862), to the extent that it revoked
the FAR for trifluralin in peppermint oil and spearmint oil. Today's
document contains a final rule revoking the trifluralin FAR and
responds to comments on the July 28, 1995 proposal
II. Revocation of the Food Additive Regulations for Trifluralin in
Peppermint Oil and Spearmint Oil
EPA has determined that no section 409 FAR 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. The proposed rule for this action was published in
the Federal Register of July 28, 1995 (60 FR 38781). The Federal
Register document and all the supporting documents are in the OPP
docket number 300394.
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. Chewing gum is a ready-to-eat food
with the highest concentration of peppermint and spearmint oils. The
information available to EPA shows that trifluralin residues are
diluted during manufacturing so that there is no concentration over the
RAC tolerance in the ready-to-eat chewing gum. Thus, no section 409 FAR
is needed for peppermint oil and spearmint oil, and EPA is revoking the
existing FAR. (60 FR 38781)
III. Response to Comments
EPA received comments on the proposed revocation of the trifluralin
FAR. All the commenters support the basis for the revocation of the
referenced FAR. In addition, many of the commenters raise other issues
that EPA believes are not relevant to EPA's conclusion that mint oils
are not ready-to-eat commodities and that as a result, the section 409
FAR covering residues of trifluralin in mint oils are not necessary.
However, the following are brief responses to these comments.
The National Food Processor's Association (NFPA), the American Crop
Protection Association (ACPA), DowElanco, and Gowan Co. submitted
comments in support of the revocation of the proposed FAR and the
withdrawal of the July 14, 1993 Order. However, NFPA, ACPA, and
DowElanco contend that there are other controlling legal reasons why
the 1993 and 1994 Orders must be withdrawn.
The commenters contend that once it has been determined that
trifluralin residues in mint oil are subject to the section 402 flow-
through provision, the 1993 and 1994 Orders must be withdrawn because
those Orders purported to revoke the FAR on the grounds that the
pesticide induces cancer" within the meaning of the Delaney clause.
The commenters contend that, as a matter of law, EPA is precluded from
revoking a section 409 FAR under the safety standard in section 409(c)
if EPA has determined, as it has here, that the FAR is not needed to
prevent the adulteration of processed food.
According to the commenters, the flow-through provision prohibits
EPA from determining that an agricultural pesticide in a processed food
is unsafe," notwithstanding the provisions of section 409, if the pesticide
residue has been removed to the extent possible in good manufacturing practice
and the level of the residue in the processed food when ready to eat is not
greater than the applicable section 408 tolerance. Thus, the commenters reason
that since EPA has decided that trifluralin residues in mint oil are likely
to fall within the protection of the flow-through provision, EPA is
barred from revoking the trifluralin FAR on grounds that the pesticide
induces cancer" within the meaning of the Delaney clause in section
409 of the FFDCA. On June 10, 1995, NFPA separately filed a petition
with EPA raising this same issue.
As will be explained in more detail in EPA's response to the June
10, 1995 NFPA petition, the commenters' argument is without any legal
basis. The commenters misunderstand the relationship between a section
409 FAR and the flow-through provision. As a result of the flow-through
provision, a FAR only has legal effect as to residues of the pesticide
in processed food that exceed the residue levels qualifying under the
flow-through provision. Thus, a finding that a pesticide does not meet
the safety standard under section 409 and a revocation of a FAR based
on such a finding has no effect on residues of the pesticide that are
in compliance with the flow-through provision. Such a lack of safety
finding under section 409(c) does not render pesticide residues in
compliance with the flow-through provision unsafe. If a section 409 FAR
is revoked, residues still retain the same legal safe harbor they
always had under the flow-through provision. Accordingly, the flow-
through provision contains no bar to the revocation of a section 409
FAR on safety grounds.
DowElanco further requests that the Agency explicitly acknowledge
that DowElanco and other adversely affected parties will not be
precluded from challenging any induce cancer" finding for
trifluralin in any future FFDCA tolerance revocation actions. DowElanco
insists that without such an acknowledgement, today's Notice will not
resolve the underlying controversy in the Dupont and DowElanco v.
Browner litigation. In addition, DowElanco urges that the EPA should
use today's Notice to clarify its position on chemicals classified as
Group C carcinogens with quantification by the Reference Dose approach
(or found not to be quantifiable). DowElanco further argues that by
using the Reference Dose approach for quantifying risk, EPA is
recognizing that the carcinogenic risk is so uncertain that it is
disregarded for evaluating risk.
EPA believes that there are no additional trifluralin tolerances or
FARs that are likely to be revoked on grounds that trifluralin
induces cancer." The trifluralin Reregistration Eligibility
Document, which will soon be issued by EPA, indicates that there are no
section 409 FARs needed for this chemical. Therefore, EPA does not
foresee a situation that would result in any hearings under the FFDCA
on whether trifluralin induces cancer." However, as explained below,
EPA will consider future hearing requests raising any evidence relevant
and material to a finding that trifluralin induces cancer" within
the meaning of the Delaney clause when that finding serves as the basis
for an order issued by EPA under the authority of sections 408 and 409
of the FFDCA.
EPA believes that precluding review of issues that could have and
should have been raised in prior proceedings is an appropriate and
essential policy and legal position for the Agency to take in FFDCA
proceedings because it ensures that such Agency decisions are accorded
finality. In the interest of administrative efficiency and economy,
final determinations in such administrative proceedings deserve to be
treated with the same finality as final determinations in judicial
proceedings. Further, under section 409 of the FFDCA, the only way to
prevent EPA from according finality to a section 409(f) order, and the
legal and factual basis for that order, is to file objections within
the time period specified, Nader v. EPA, 859 F.2d 747 (9th Cir. 1988),
cert. denied, 490 U.S. 1931 (1989; and CNI v. Young, 773 F2.d 1356
EPA found, in its 1990 and 1991 Orders, that trifluralin induces
cancer" but that because the trifluralin cancer risks were de minimis,
EPA would retain the trifluralin FAR that was the subject of NRDC's
petition. However, because EPA retained the FAR, and because this was
the first proceeding of this nature under section 409 of the FFDCA,
proponents of the FAR and chemicals, including DowElanco, may not have
understood that their failure to raise objections to the cancer finding
at that time could result in that finding being accorded finality by
EPA. Given that such circumstances are not likely to be repeated, EPA
believes it is appropriate to assure DowElanco that EPA will not assert
in future FFDCA proceedings that the issue of whether trifluralin
induces cancer" must or will be accorded finality based on EPA's
1990 and 1991 Orders.
Because EPA is providing the assurances requested by commenters,
EPA believes there should be no objections to an EPA final order
withdrawing the 1993 and 1994 Orders.
IV. Procedural Matters
A. Filing of Objections and Requests for Hearings
Any person adversely affected by this final rule may file written
objections to the final rule, and may include with any such objection a
written request for an evidentiary hearing on the objection. Such
objections must be submitted to the Hearing Clerk on or before February
26, 1996. A copy of the objections and hearing requests filed with the
Hearing Clerk shall be submitted to the Office of Pesticide Programs
Docket Room. Regulations applicable to objections and requests for
hearings are set out at 40 CFR parts 178 and 179. Those regulations
require, among other things, that objections specify with particularity
the provisions of the final rule objected to, the basis for the
objections, and the relief sought. Additional requirements as to the
form and manner of the submission of objections are set out at 40 CFR
178.25. The Administrator will respond as set forth in 40 CFR 178.30,
178.35, and/or 178.37 to objections that are not accompanied by a
request for evidentiary hearing.
A person may include with any objection a written request for an
evidentiary hearing on the objection. A hearing request must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on each such issue, and a summary of any
evidence relied upon by the requestor. Additional requirements as to
the form and manner of submission of requests for an evidentiary
hearing are set out at 40 CFR 178.27. Under 40 CFR 178.32(c), the
Administrator, where appropriate, will make rulings on any issues
raised by an objection if such issues must be resolved prior to
determining whether a request for an evidentiary hearing should be
granted. The Administrator will respond to requests for evidentiary
hearings as set forth in 40 CFR 178.30, 178.32, 178.35, 178.37, and/or
179.20. Under 40 CFR 178.32(b), a request for an evidentiary hearing on
an objection will be granted if the objection and request have been
properly submitted and if the Administrator determines that the
material submitted show: (1) There is a genuine and substantial issue
of fact for resolution at a hearing; (2) 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; and (3)
Resolution of one or more of the factual issues in the manner sought by the
person requesting the hearing would be adequate to justify the action
Any person wishing to comment on any objections or requests for a
hearing may submit such comments to the Hearing Clerk on or before
March 11, 1996.
A record has been established for this rulemaking under docket
number [OPP-300394A] (including 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-300394A], 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:
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.
B. Effective Date
EPA is making this final rule effective January 26, 1996 given the
lack of adverse comments on EPA's proposed action. In addition, if EPA
does not receive objections to this Order, this Order and the factual
and legal basis for this Order become final and are not judicially
reviewable. See section 409(g)(1), 21 U.S.C. 348(g)(1), and Nader v.
EPA: 859 F.2d 747 (9th Cir. 1988), cert. denied, 490 U.S. 1931 (1989).
C. Request for Stays of Effective Date
A person filing objections to this final rule may submit with the
objections a petition to stay the effective date of this final rule.
Such stay petitions must be submitted to the Hearing Clerk on or before
February 26, 1996. A copy of the stay request filed with the Hearing
Clerk shall be submitted to the Office of Pesticide Programs Docket
Room. A stay may be requested for a specific time period or for an
indefinite time period. The stay petition must include a citation to
this final rule, the length of time for which the stay is requested,
and a full statement of the factual and legal grounds upon which the
petitioner relies for the stay. In determining whether to grant a stay,
EPA will consider the criteria set out in the Food and Drug
Administration's regulations regarding stays of administrative
proceedings at 21 CFR 10.35. Under those rules, a stay will be granted
if it is determined that: (1) The petitioner will otherwise suffer
irreparable injury; (2) The petitioner's case is not frivolous and is
being pursued in good faith; (3) The petitioner has demonstrated sound
public policy grounds supporting the stay; and (4) The delay resulting
from the stay is not outweighed by public health or other public
Under FDA's criteria, EPA may also grant a stay if EPA finds such
action is in the public interest and in the interest of justice.
Any person wishing to comment on any stay request may submit such
comments and objections to a stay request, to the Hearing Clerk, on or
before March 11, 1996. Any subsequent decisions to stay the effect of
this Order, based on a stay request filed, will be published in the
Federal Register, along with EPA's response to comments on the stay
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 final 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 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 Order 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,
Reporting and recordkeeping.
Dated: January 19, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Therefore, 40 CFR part 185 is amended as follows:
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.