[Federal Register Volume 59, Number 46 (Wednesday, March 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5422]


[[Page Unknown]]

[Federal Register: March 9, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
 40 CFR Part 185

[OPP-300238A; FRL-4635-9]
RIN No. 2070-AB78

 

Dicofol; Revocation of Food Additive Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking the food additive tolerance for residues of 
the pesticide dicofol (1,1-bis[p-chlorophenyl)-2,2,2-trichloro-ethanol) 
in or on dried tea. This action is being taken because EPA has 
determined that this food additive regulation is inconsistent with the 
Delaney Clause in section 409 of the Federal Food, Drug, and Cosmetic 
Act.

EFFECTIVE DATE: This final rule is effective May 9, 1994.

ADDRESSES: Written objections, requests for a hearing, and/or requests 
of stays identified by the document control number, OPP-300238A, must 
be submitted by April 8, 1994 to: Hearing Clerk (1900), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. A copy of any 
objections and hearing requests filed with the Hearing Clerk shall be 
submitted 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 copy of objections and hearing requests to: Rm. 1132, 
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees 
accompanying objections shall be labeled ``Tolerance Petition Fees'' 
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP 
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.

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 
Jefferson Davis Hwy., Arlington, VA, Telephone: (703)-308-8028.

SUPPLEMENTARY INFORMATION:
I. Introduction and Background 
A. Introduction 
    Dicofol is used to control mites on tea grown outside of the United 
States. Although dicofol is not registered for use on tea in the U.S., 
a food additive regulation of 45 ppm (parts per million) has been 
established to cover residues on imported tea. In 1989, the State of 
California, Natural Resources Defense Council (NRDC), Public Citizen, 
the AFL-CIO, and others petitioned the EPA to revoke several food 
additive regulations, including dicofol on dried tea, arguing that the 
food additive regulations at issue violated the Delaney Clause in the 
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301 et seq). 
EPA proposed to revoke this food additive regulation (see the Federal 
Register of October 4, 1991 (56 FR 50466)) based on its determination 
that this food additive regulation is inconsistent with the Delaney 
Clause because dicofol induces cancer in animals and this regulation 
permitted exposure to dicofol residues posing a greater than de minimis 
cancer risk. Comments have been filed in response to EPA's preliminary 
determinations and are addressed in this document.
B. Statutory Background
    The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 301 et 
seq.) authorizes the establishment of the maximum permissible levels of 
pesticides in foods, which are referred to as ``tolerances'' (21 U.S.C. 
346(a), 348). Without such tolerances or exemptions from tolerances, a 
food containing pesticide residues is ``adulterated'' under section 402 
of the FFDCA and may not legally be moved in interstate commerce (21 
U.S.C. 342). Monitoring and enforcement are carried out by the Food and 
Drug Administration (FDA) and the United States Department of 
Agriculture (USDA).
    Under section 408 of the FFDCA, tolerances or exemptions from 
tolerances are established for pesticide residues in raw agricultural 
commodities (RAC). In setting these tolerances under the FFDCA, EPA 
must make a finding that the promulgation of the rule would ``protect 
the public health'' by considering, among other things, the following: 
the necessity for the production of an adequate, wholesome, and 
economical food supply; additional ways in which the consumer may be 
affected by the pesticide; and the usefulness of the pesticide for 
which a tolerance is being sought. (21 U.S.C. 346a(b)). EPA has 
interpreted section 409 as authorizing food additive regulations 
(sometimes referred to as section 409 tolerances) for pesticide 
residues in processed foods. Under EPA policy, a food additive 
regulation is needed if the concentration of the pesticide residue in a 
processed food, when ready to eat, may be greater than the tolerance 
prescribed for the RAC from which the processed food is derived, or if 
the processed food is treated or comes in contact with a pesticide, 
such as in storage facilities. If the pesticide residue level results 
from treatment of the RAC and is at or below the section 408 tolerance 
level of the RAC which is being processed, the ``flow-through'' 
provision of FFDCA section 402 provides that the section 408 tolerance 
covers the pesticide residues in both the RAC and resulting processed 
commodities.
    Before a food additive regulation may be established, section 409 
requires a finding that use of the pesticide will be ``safe'' (21 
U.S.C. 348(c)(3)). Relevant factors in this safety determination 
include: (1) the probable consumption of the pesticide or its 
metabolites; (2) the cumulative effect of the pesticide in the diet of 
man or animals, taking into account any related substances in the diet; 
and (3) appropriate safety factors to relate the animal data to the 
human risk evaluation. Section 409 also contains the Delaney Clause, 
which specifically provides that, with limited exceptions, no additive 
is deemed safe if it has been found to induce cancer in man or animals. 
(21 U.S.C. 348(c)(5)).
    Before a pesticide may be sold or distributed, it must be 
registered under the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA). To qualify for registration, a pesticide must, among other 
things, perform its intended function without causing ``unreasonable 
adverse effects on the environment.'' (7 U.S.C. 136a(c)(5)). The term 
``unreasonable adverse effects on the environment'' is defined as ``any 
unreasonable risk to man or the environment, taking into account the 
economic, social and environmental costs and benefits of the use of any 
pesticide.'' (7 U.S.C. 136(bb)).

C. Regulatory Background

    A food additive regulation of 45 parts per million (ppm) for 
dicofol residues in dried tea is codified at 40 CFR 185.410. There is 
no associated section 408 tolerance for any raw form of tea from which 
the dried tea is derived.
    As mentioned above, in 1989 EPA was petitioned to revoke certain 
food additive regulations, including dicofol on dried tea, on the 
grounds that the regulations were inconsistent with the Delaney Clause. 
EPA responded to the petition by stating the Agency would propose 
revocation unless adequate data on residues and processing were 
submitted to show the lifetime cancer risk for humans is no greater 
than de minimis (55 FR 17568, Apr. 25, 1990). Although additional data 
were submitted for dicofol on tea, EPA concluded the data submitted 
were not adequate to demonstrate a de minimis risk, and thus the Agency 
stated it would take action to revoke the food additive regulation for 
dicofol on dried tea (56 FR 7750, Feb. 25, 1991).
    EPA proposed to revoke the food additive regulation for tea in the 
Federal Register of October 4, 1991 (56 FR 50466). The proposal was 
issued because available data showed the food additive regulation for 
dicofol on dried tea was inconsistent with the Delaney Clause of the 
FFDCA, that is because dicofol induces cancer in animals and the 
regulation permitted exposure to dicofol residues posing a greater than 
de minimis cancer risk.
    In a separate notice, EPA also requested public comment on an EPA 
assessment of dicofol's carcinogenicity (56 FR 67269, Dec. 30, 1991). 
On December 4, 1991, EPA's Carcinogen Review and Verification Effort 
(CRAVE) met to discuss the carcinogenicity of dicofol. CRAVE made a 
tentative finding that dicofol should be classified in Group C 
(possible human carcinogen) under EPA's Cancer Assessment Guidelines, 
pending review by EPA's Office of Health and Environmental Assessment 
(OHEA). While there were differing conclusions about whether it would 
be appropriate to develop a quantitative estimate of human cancer risk, 
CRAVE, OHEA, and EPA's Office of Pesticide Programs all agreed that 
dicofol should be classified in Group C.
    On July 8, 1992, the Ninth Circuit court rejected EPA's 
interpretation of the Delaney Clause as subject to a de minimis 
exception and set aside EPA's order responding to the petition filed by 
the State of California and others. Les v. Reilly, 968 F, 2d 985 (9th 
Cir. 1992) cert. denied, 113 S. Ct. 1361 (1993). The court ruled that 
food additive regulations are barred for any pesticides that have been 
found to induce cancer in animals or humans, regardless of the level of 
risk.
    The manufacturers of dicofol, Rohm and Haas Co. and Makhteshim-Agan 
America, Inc. (MAA), recently petitioned EPA to establish a section 408 
tolerance for the raw agricultural commodity, ``plucked tea.'' EPA is 
currently reviewing this petition. In a related matter, EPA published a 
notice in the February 5, 1993 Federal Register requesting comments an 
a range of issues related to regulating pesticide residues in both raw 
and processed commodities. EPA's final position on several of these 
issues (such as determining when a food is ``ready-to-eat'' within the 
meaning of the Delaney Clause and coordinating tolerances in raw foods 
when Delaney bars residues in resulting processed foods) could affect 
the regulatory status of dicofol residues in or on various forms of 
tea.

II. Response to Comments

    Comments were submitted on both the proposed revocation and the 
CRAVE meeting minutes (Ref. 1) by both manufacturers of dicofol. These 
comments, which were submitted prior to the Ninth Circuit court's 
decision, generally criticize EPA's decision to revoke dicofol under a 
de minimis interpretation of the Delaney Clause. These comments address 
whether the risk associated with dicofol dietary exposure should be 
quantified, the magnitude of the risk posed to humans, and dicofol 
residues in various forms of tea. Because of the Ninth Circuit court's 
decision, the only issue relevant to today's final revocation is 
whether dicofol has been found to induce cancer in man or animals. 
However, for the completeness of EPA's record, the Agency has 
responded, at least briefly, to all significant comments. Moreover, as 
noted above, EPA may consider some of the information submitted in 
comments in future actions related to regulating dicofol residues in or 
on tea.
    Comment: In its submission dated October 25, 1991 (Ref. 2), Rohm 
and Haas Co. contends that EPA would not consider ``low end,'' or 
unquantified Group C, carcinogens as animal carcinogens if the data 
base and weight of the evidence used were insufficient. In support of 
their contention that dicofol met this exception to consideration under 
the Delaney Clause, they cite the following paragraph from EPA's policy 
notice on the Delaney Paradox:

    *  *  * a pesticide may be classified in Group C because the 
data on whether the chemical is an animal carcinogen are limited or 
uncertain, e.g., if the data are equivocal, unreliable, or subject 
to significant doubt, or if only benign tumors occurred. If the 
Agency determines that the weight of the evidence does not support 
treating the chemical as an animal carcinogen, the Agency will not 
treat the chemicals as falling within the Delaney clause bar. The 
Agency will, of course, in any such determination, set forth the 
reasons for its judgement. For example, a pesticide may be 
classified as belonging in Group C because the pesticide is 
associated with an increase in tumors in only one sex of one species 
with a lack of a clear dose/response relationship. Assuming that 
mutagenic data are negative and that structure/activity analysis 
shows no association with known carcinogens, the Agency generally 
would consider such a pesticide to be at the `low' end of the Group 
C range. It is doubtful that the Agency would require a 
quantification of the carcinogenic risk, and in such a case, the 
Delaney clause would not be deemed applicable.

(53 FR 4112-13, October 19, 1988). Rohm and Haas concludes their 
argument by saying that EPA made a final determination that the animal 
data on dicofol are limited and insufficient for risk assessment 
purposes.
    EPA's response: This comment raises the only issue that was not 
rendered irrelevant by the Les v. Reilly decision: whether dicofol 
induces cancer within the meaning of the Delaney Clause. EPA believes 
the quoted language from the Delaney paradox notice has only limited 
relevance here because that notice dealt primarily with EPA's 
interpretation of the Delaney Clause as subject to a de minimis 
exception. In any event, EPA does believe it is necessary to carefully 
examine pesticides classified in group C of the Cancer Assessment 
Guidelines to determine whether they meet the Delaney Clause's induce 
cancer standard. In construing the ``induce cancer'' standard as to 
animals, EPA continues to follow a weight of the evidence approach. As 
regards animal carcinogenicity, EPA, in general, agrees with FDA's 
explanation of the term ``induce cancer'':

    The carcinogenicity of a substance in animals is established 
when administration in adequately designed and conducted studies 
results in an increase in the incidence of one or more types of 
malignant (or, where appropriate, a combination of benign and 
malignant) neoplasms in treated animals compared to untreated 
animals maintained under identical conditions except for exposure to 
the test compound. Determination that the incidence of neoplasms 
increases as the result of exposure to the test compound requires a 
full biological, pathological, and statistical evaluation. 
Statistics assist in evaluating the biological conclusion, but a 
biological conclusion is not determined by the statistical results.

(52 FR 49577, Dec. 31, 1987).
    Dicofol has been shown to produce a statistically significant 
increase of hepatocellular adenomas and combined hepatocellular 
adenomas and carcinomas in male mice (B6C3F1) at two doses tested (Ref. 
3). There was also a statistically significant positive trend of 
adenomas and combined adenomas and carcinomas. Although the background 
incidence of hepatocellular adenomas in male B6C3F1 mice is generally 
high (Ref. 4), there were no hepatocellular adenomas in the concurrent 
control animals. In addition, as noted, there was a statistically 
significant increase for adenomas and combined adenomas and carcinomas 
at both tested doses, and there was a statistically significant 
positive trend for adenomas and combined adenomas and carcinomas. EPA 
believes combining adenomas and carcinomas is appropriate for this type 
of tumor. These study results show that dicofol induces cancer in 
animals. In its weight of the evidence determination, EPA considered 
two 2-year bioassays in two strains of rats which were negative as to 
carcinogenicity (Ref. 5), mutagenicity data (Ref. 6), and structure 
activity comparisons (Ref. 7). None of the information, including the 
negative cancer studies, is of such weight that it affects EPA's 
determination that the increased incidence of adenomas and combined 
adenomas and carcinomas in male mice was the result of exposure to the 
test compound.
    Comment. Substantial comments and data were presented by both 
manufacturers on the issue of whether dicofol residues on tea posed a 
de minimis cancer risk. Rohm and Haas presented analyses and data in 
support of their contention that a quantitative risk assessment was not 
appropriate for dicofol. MAA presented data regarding the residues of 
dicofol in both dried and brewed tea.
    EPA's response: The question of whether it is appropriate to do a 
quantitative cancer risk assessment for dicofol has proven a difficult 
one for EPA. As explained in the preamble of the proposed revocation, 
EPA's position on this issue has shifted several times. Following 
issuance of the proposal and in light of the new data supplied by Rohm 
and Haas, EPA has held two meetings of the CRAVE committee on dicofol 
and the Office of Pesticide Programs Cancer Assessment Peer Review 
Committee met to reconsider dicofol. Nonetheless, the issue of whether 
a quantitative cancer risk assessment for dicofol is appropriate has 
not been fully resolved. For the purpose of responding to comments, 
however, EPA is willing to state that, regardless of what risk numbers 
are calculated by a quantitative assessment, the weight of the 
qualitative evidence on cancer indicates that dicofol poses no greater 
than a negligible cancer risk to humans. Additionally, EPA has examined 
the residue data submitted by MAA and concluded that the anticipated 
residues of dicofol in brewed tea are 0.005 ppm. The previous risk 
assessment for dicofol on dried tea was based on the assumption of 45 
ppm dicofol in tea. Use of the newer, more realistic residue assumption 
in a quantitative risk assessment for dicofol would lower the estimated 
upper-bound lifetime cancer risk by approximately five orders of 
magnitude. All of this suggests that had the court allowed a de minimis 
interpretation in Les v. Reilly, EPA would not be finalizing this 
revocation.
    Comment: MAA argued that it was inappropriate for EPA to proceed 
with a revocation of a FFDCA tolerance before giving pesticide 
registrants a formal opportunity under FIFRA to produce data showing 
that the risks posed by the pesticide use are de minimis.
    EPA's response: This comment is made moot by the fact that MAA now 
has submitted residue data, which has been examined by EPA. 
Nonetheless, EPA would like to make clear that under the FFDCA the 
burden of establishing the safety of a food additive regulation rests 
with the proponent of the regulation. 40 CFR 179.91; Environmental 
Defense Fund v. Department of Health, Education, and Welfare, 428 F.2d 
1083, 1092 n.27 (D.C. Cir. 1971). Where EPA has insufficient data to 
support an existing FFDCA tolerance regulation, the fact that it had 
explicit authority under a separate statute to require submission of 
data does not require EPA to leave this inadequately supported 
regulation in force until it has requested and reviewed the 
information.
    Comment: The United Planters' Association of Southern India argues 
that the revocation of the section 409 tolerance for dicofol would have 
a severe economic impact on the tea growers and exporters of India 
since dicofol plays a crucial role in mite control. In addition, UPASI 
states that the growers will be faced with difficulty because they must 
choose not to treat the tea plants with dicofol or separate the dicofol 
treated teas from the rest in warehouses and on the fields.
    EPA's response: India is a large producer of tea, but less than 
one-third of the tea produced in India is exported to the U.S. EPA 
proprietary data (1987) indicate that alternative chemicals are used in 
India more than dicofol for control of mites; specifically, less than 
30% of tea grown in India is treated with dicofol. Availability of 
alternatives should eliminate the economic hardship that would 
otherwise be felt by growers and exporters. Even if the impact of not 
using dicofol were significant on current users, the impact on world 
tea markets and prices would probably be negligible because the percent 
of tea crop treated with dicofol and exported to the U.S. appears to be 
less than ten percent. In any event, under the Ninth Circuit Court's 
ruling of the Delaney Clause, consideration of benefits is not 
authorized.

III. Revocation of the Food Additive Regulation for Dicofol on 
Dried Tea

    EPA is revoking the food additive regulation of 45 ppm for residues 
of dicofol in dried tea based on EPA's determination that this food 
additive regulation is inconsistent with the Delaney Clause of the 
FFDCA because EPA has determined dicofol induces cancer in mice. EPA's 
proposal was based, in addition to the ``induce cancer'' finding, on 
the grounds that the cancer risk posed by dicofol on tea was greater 
than de minimis. The decision in Les v. Reilley, however, has clarified 
that the only issue involving cancer under the Delaney Clause is 
whether or not the pesticide induces cancer, not the magnitude of the 
cancer risk. Accordingly, EPA is not basing this revocation on the 
magnitude of dicofol's cancer risk.

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 April 8, 
1994. 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 objector. 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 requested.
    Any person wishing to comment on any objections or requests for a 
hearing may submit such comments to the Hearing Clerk on or before 
April 25, 1994.

B. Effective Date and Stays of Effective Date

    EPA proposed to make this revocation effective 30 days following 
publication in the Federal Register of this document. EPA received no 
comment on this issue other than speculation by Rohm and Haas and MAA 
that this would disrupt the tea market. EPA has extended the period 30 
days to allow for consideration of petitions regarding a stay of the 
effective date.
    This final rule shall become effective May 9, 1994. A copy of the 
stay request filed with the Hearing Clerk shall be submitted to the 
Office of Pesticide Programs Docket Room. 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 April 8, 1994. 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 
and the specific food additive regulation as to which the stay is 
sought, 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. If a petition for a stay is submitted, EPA will 
automatically stay the effective date of the final rule as to the 
particular regulation for which the stay is sought for such time as is 
required to review the stay petition. 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 
interests.
    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.
    If a stay petition is submitted, EPA will publish a notice of 
receipt in the Federal Register, stating that the effective date of 
this final rule is stayed pending EPA consideration of the stay 
request. Any affected person may submit objections to a stay request to 
the Hearing Clerk on or before 15 days from the publication in the 
Federal Register of the notice of receipt of a stay request. Any 
decision lifting the stay will be published in the Federal Register.

V. Other Regulatory Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to all the requirements of the Executive Order, i.e., 
Regulatory Impact Analysis, review by the Office of Management and 
Budget (OMB). Under section 3(f), the order defines ``significant'' as 
those actions likely to lead to 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 known 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 (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, EPA has determined 
that this rule is not ``significant'' and is therefore not subject to 
OMB review.

B. Regulatory Flexibility Act

    This rule has been reviewed under the Regulatory Flexibility Act of 
1989 (Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et seq.), and EPA has 
determined that any economic impact on small businesses, small 
governments, or small organizations would be minor since there are many 
sources of tea that are not treated with dicofol. The U.S.-based 
businesses most affected would be tea importers, who could turn to 
alternative sources for untreated tea. In support of this conclusion, 
the October 4, 1991 proposal stated that information shows that between 
1987 and 1991, there were no detections of dicofol in 11 samples tested 
by the FDA, and that the precentage of the tea crop treated appears to 
be only around 10 percent. EPA has no new information on sampling to 
show otherwise.
    Even if the Agency determined that significant economic impacts 
would occur with respect to small businesses, EPA would be revoking 
this food additive regulation because the Delaney Clause does not 
permit the consideration of economic factors. Thus there is no 
alternative course of action that would mitigate whatever economic 
impact, if any, might result from the revocation of the food additive 
regulations for dicofol on dried tea.

C. Paperwork Reduction Act

    This final rule 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.

VI. References

    All references and copies of Federal Register documents cited in 
section II of this document are available for viewing in the Office of 
Pesticide Program's Public Docket under control number 300238A. The 
docket is located in Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis 
Hwy., Arlington, VA, telephone: 703-305-5805. The docket is open from 8 
a.m. to 4:30 p.m., Monday through Friday, except legal holidays.
    Copies of the references without an associated Master Record 
Identification (MRID) number are available to any person. Disclosure of 
the references identified by an MRID number are subject to the 
limitations imposed by section 10 of FIFRA.
    Copies of the references also are available by writing to: Freedom 
of Information Office (A-101), U.S. Environmental Protection Agency, 
401 M St. SW., Washington, DC 20460. Disclosure of the references under 
the Freedom of Information Act are subject to the same limitations as 
outlined above.
    1. Schoeny, Rita, Summary Report, December 3-4 meeting of EPA's 
Carcinogen Risk Verification Effort (CRAVE), dated January 16, 1992.
    2. Comments submitted on the proposed revocation from Rohm and Haas 
Co. submitted by Robert H. Larkin of Rohm and Haas; dated October 25, 
1991.
    3. National Cancer Institute, 1978, Bioassay of Dicofol for 
Possible Carcinogenicity, CAS No. 115-32-2. Carcinogenisis Report 
Series 90-1978. As updated by letter from Dr. Maronpot of the National 
Toxicology Program to J.A. Moore, April 5, 1985.
    4. Haseman, J.K., J. Huff, G.A. Borman (1984). ``The Use of 
Historical Control Data in Carcinogenicity Studies in Rodents.'' 
Toxicol. Pathol., 12:126-135.
    5. Hazelton, G.A., D.C. Harris, 1989. Dicofol (Kelthane MF 
miticide). Twenty-four month dietary chronic oncogenicity test in rats. 
Rohm and Haas, #86R-190. March 29, 1989. MRID No. 411500-01.
    6. In Vitro Forward Mutation (CHO/HGPRT). MRID No. 40042049. In 
Vitro Cytogenetics (CHO). MRID No. 40042051.
    7. Brown, M.A., J.E. Casida (1987). ``Metabolism of a Dicofol 
Impurity alpha-chloro DDT, but not Dicifol or Dechlorodicofol, to DDE 
in Mice and a Liver Microsomal System.'' Xenobiotica., 17(10):1169-
1174. Accession No. 256328.

List of Subjects in 40 CFR Part 185

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Food additives, Pesticides and pests, 
Reporting and recordkeeping requirements.

    Dated: March 1, 1994.

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

    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. 185.410   [Removed]

    2. By removing Sec. 185.410 Bis(p-chlorophenyl)-2,2,2-
trichloroethanol.

[FR Doc. 94-5422 Filed 3-8-94; 8:45 am]
BILLING CODE 6560-50-F