[Federal Register Volume 59, Number 88 (Monday, May 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11232]
[[Page Unknown]]
[Federal Register: May 9, 1994]
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DEPARTMENT OF THE TREASURY
40 CFR Part 185
[OPP-300238B; FRL-4780-8]
RIN 2070-AB78
Pesticides; Stay of Effective Date for Order Revoking Food
Additive Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule; Stay of effective date.
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SUMMARY: EPA is staying the effective date of a final rule revoking the
food additive regulation for dicofol (1,1-bis[p-chlorophenyl]-2,2,2-
trichloroethanol) in or on dried tea, which was published in the
Federal Register of March 9, 1994. EPA received petitions to stay the
May 9, 1994 effective date for the stated final rule. As allowed in the
March 9, 1994 final rule, EPA is staying the effective date
indefinitely in order to review the petition and determine whether to
grant the petition for a stay and if so, for what length of time. EPA
is allowing 15 days for public comment on the petition requesting a
stay of the effective date, which is available in the OPP public docket
and is summarized in this document. Any decision associated with this
action will be published in the Federal Register.
DATES: This stay is effective May 9, 1994. Any affected person may
submit comments on the stay request summarized in this document on or
before May 24, 1994.
ADDRESSES: Comments, identified by the document control number, [OPP-
300238B], may be submitted to: Hearing Clerk (1900), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: Niloufar Nazmi, Special Review Branch
(7508W), Special Review and Reregistration Division, Office of
Pesticide Programs, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: 3rd Floor, Westfield Building, 2800
Crystal Drive, Arlington, VA, Telephone: (703) 308-8208.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 9, 1994 (59
FR 10993), EPA issued a final rule revoking the food additive
regulation for dicofol on dried tea (hereinafter referred to as the
``final rule'') based on the determination that this food additive
regulation is inconsistent with the Delaney Clause in section 409 of
the Federal Food, Drug and Cosmetic Act (FFDCA). In the final rule, EPA
set an expiration date of May 9, 1994.
Any person adversely affected was given a 30-day opportunity to:
(1) file written objections to the order, (2) file a written request
for an evidentiary hearing on the objection, and (3) file a petition
for a stay of the effective date. EPA stated that if any petition for a
stay were received, the Agency would stay the May 9, 1994 effective
date of the final rule for such time as is required to review and make
a determination on the stay petition. If the stay petition is denied,
the final rule will be effective 30 days after date of publication of
the petition denial in the Federal Register.
Makhteshim-Agan of North America, Inc., and Rohm and Haas Co.
(together ``the Dicofol Task Force'') filed an objection to the final
rule, a request for an evidentiary hearing on the factual issues raised
in the objections, and a stay of the final rule pending final
resolution of the issues. In addition, the National Agricultural
Chemical Association (NACA) submitted a separate objection.
Outlined below are summaries of the petition to stay the effective
date of the March 9, 1994 final rule and other objections which EPA has
received. Full copies of the stay requests or objections may be viewed
or ordered from the OPP Docket under the document control number, OPP-
300238B]. The OPP Docket is located in Rm. 1128, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA, telephone (703)-305-5805.
The basis for the stay petition is that the Dicofol Task Force will
allegedly suffer irreparable injury if a stay is not granted. They
contend they have satisfied the four criteria outlined in the final
rule for granting a stay.
First, according to the Task Force, not only will there be impacts
from the loss of dicofol on tea, other uses of dicofol will suffer
because products containing dicofol will be tarnished by being labeled
``carcinogenic.''
Second, the Task Force asserts that their case is not frivolous and
is being pursued in good faith since EPA's decision to revoke the food
additive regulation for dicofol on dried tea is insupportable on
factual and legal grounds.
They cite the following reasons. The Task Force argues that EPA has
failed to apply the appropriate standard for determining whether
dicofol ``induces cancer'' within the meaning of the Delaney Clause
because EPA has not followed the Food and Drug Administration's
rigorous standard in determining whether a substance induces cancer. In
addition, the Task Force asserts that a proper evaluation of all the
relevant biological and statistical information would lead to the
conclusion that the weight-of-the-evidence does not support a finding
that dicofol induces cancer in man or animals. The Dicofol Task Force
further argues that, even assuming that dicofol induces cancer in
animals, the food additive regulation ``poses essentially no risk, or
at most a negligible risk,'' to consumers of tea beverages.
Third, the Task Force contends that the growers and the general
public will suffer irreparable injury from the impact resulting from
this revocation and the labeling of dicofol as a pesticide that
``induces cancer.'' They argue that since there are not many
alternative pesticides available, the revocation will result in the use
of less effective, environmentally unsafe, and more costly products.
Finally, the Task Force argues that because EPA has stated in
public notices that the use of dicofol poses no more that a negligible
risk, a delay resulting from a stay is not outweighed by any public
health or other public interest.
NACA's objections state that NACA and its members, which include
the Task Force, are adversely affected by EPA's interpretation of the
Delaney Clause because EPA's interpretation is not consistent with the
language of FFDCA or with the current state of scientific knowledge of
carcinogenicity. Furthermore, NACA argues that it is affected by other
procedural deficiencies in the adoption of the Final Rule,
specifically, EPA's failure to conduct a weight-of-the-evidence
evaluation on the issue of whether dicofol ``induces cancer'' in
animals based on tests ``which are appropriate for the evaluation of
the safety of food additives.''
NACA also requests that EPA withdraw the Final Rule and provide an
adequate opportunity for the submission of comments, and conduct a
proper weight of the evidence evaluation to determine whether dicofol
triggers the ``induce cancer'' standard of the Delaney Clause. NACA
urges the EPA to apply a standard to determining when a pesticide is
found to ``induce cancer that is in accord with current data evaluation
standards, current scientific knowledge of carcinogenicity, and FDA
precedent.''
Any comments regarding the requests for stay of the May 9, 1994
effective date for the food additive regulation for dicofol on dried
tea, identified by the document control number OPP-300238B, may be
forwarded within 15 days of publication of this Federal Register to the
Hearing Clerk at the address marked in the section ``Addresses''
section above in this document.''
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Authority: 21 U.S.C. 346a and 348.
Dated: May 4, 1994.
Victor J. Kimm,
Acting Assistant Administrator for Prevention, Pesticides, and Toxic
Substances.
PART 185--[AMENDED]
Therefore, the effective date of May 9, 1994, of the final rule
published at page 10993 in the Federal Register of March 9, 1994,
removing Sec. 185.410 Bis(p-chlorophenyl)-2,2,2-trichloroethanol is
stayed indefinitely.
[FR Doc. 94-11232 Filed 5-5-94; 3:41 pm]
BILLING CODE 6560-50-F