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Dichlorvos (DDVP, Vapona) - Revocation of Food Additive Tolerance--Final Rule 11/93

40 CFR Part 185
[OPP-300237A; FRL-4188-7]
RIN No. 2070-AC18
Dichlorvos; Revocation of Food Additive Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This document revokes the food additive regulation
for residues of the pesticide dichlorvos (2,2-dichlorovinyl
dimethyl phosphate), also known as DDVP, in or on packaged or
bagged nonperishable processed food 120 days after the publication
of this document. This action is being taken because the Agency
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 regulation becomes effective March 10,
1994.

ADDRESSES: Written objections, requests for a hearing, and/or
requests of stays identified by document control number, [OPP-
300237A], must be submitted to: Hearing Clerk (1900), Environmental
Protection Agency, Rm. 3708, 401 M St., SW., Washington, DC
20460. A copy of any objections, hearing requests, or other
related documents filed with the Hearing Clerk should be submitted
to: OPP Docket, Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis
Hwy., Arlington, VA, 22202

FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi, Special
Review and Reregistration Division (7508W), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location
and telephone number: Special Review Branch, Crystal Station
#1, 3rd Floor, Rm. WF31L1, 2800 Jefferson Davis Hwy., Arlington,
VA, (703)-308-8028.

SUPPLEMENTARY INFORMATION:

I. Introduction

   Dichlorvos (DDVP) is an insecticide registered under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
for use on a number of sites, including a variety of food crops,
stored and processed foods, as well as for domestic use in and
around homes and in commercial, institutional, and industrial
buildings.
   A food additive regulation of 0.5 part per million (ppm)
for residues of dichlorvos in or on packaged or bagged nonperishable
processed food has been established under section 409 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) and is codified
in 40 CFR 185.1900.
   A petition submitted to the Agency in May 1989 by the State
of California, Natural Resource Defense Council, Public Citizen,
AFL-CIO, and several individuals requested that EPA revoke food
additive regulations for a number of chemicals, one of which
was dichlorvos. The petitioners claimed that these regulations
violated the Delaney Clause in section 409 of the FFDCA. The
Delaney Clause provides that a food additive regulation may
not be approved for a food additive if it "is found to induce
cancer when ingested by man or animal, or if it is found, after
tests which are appropriate for the evaluation of the safety
of food additives, to induce cancer in man or animal, * * *."
(21 U.S.C. 348(c)).
   In responding to the petition, EPA interpreted the Delaney
Clause as subject to an exception for pesticide uses which posed
no greater than a de minimis cancer risk (56 FR 7750, Feb. 25,
1991). Although EPA concluded that several of the challenged
regulations met this de minimis standard, EPA found that the
dichlorvos food additive regulation did not. Therefore, in the
Federal Register of October 3, 1991 (56 FR 50190), EPA proposed
to revoke the food additive for packaged or bagged nonperishable
processed food. Several comments were received in response to
the notice of proposed revocation. These comments are presented
in this document along with EPA's responses.
   Subsequent to the issuance of the proposal to revoke the
dichlorvos food additive regulation, the Court of Appeals for
the Ninth Circuit rejected EPA's de minimis interpretation.
Les v. Reilly, 968 F.2d 985 (9th Cir. 1992), cert. denied, 113
S. Ct. (1993). That decision became effective in March 1993.

II. Responses to Comments

A. AMVAC Chemical Corp.
   EPA received extensive comments from AMVAC Chemical Corp.,
the holder of the FIFRA registration for the manufacturing product
dichlorvos. Each of AMVAC's comments, however, concerns the
magnitude of the risk posed by dichlorvos and its attendant
benefits. Because the Court's holding in Les v. Reilly renders
such issues irrelevant in determining whether a section 409
regulation is permissible under the Delaney Clause, EPA believes
no response is necessary. Nonetheless, for the completeness
of the record, EPA's responses to comments are provided below.
   1. Comment. AMVAC claims that EPA's change in position between
its initial response to the California petition and its Final
Order regarding the level of risk posed by dichlorvos was insufficiently
justified. AMVAC also believes that EPA inappropriately relied
on a reexamination of data and instead should have waited for
submission of new data. AMVAC cited two judicial decisions requiring
administrative agencies to provide an explanation of the basis
for any change in existing regulations or policies. (See Motor
Vehicles Manufacturers'Association v. State Farm Mutual Automobile
Insurance Co., 463 U.S. 29 (1983) (recision of rule held arbitrary
and capricious where Agency did not present an adequate basis
and explanation); Pacific Legal Foundation v. Department of
Transportation, 593 F.2d 1338 (D.C. Cir. 1979), cert. denied,
444 U.S. 830 (1979) (revision of rule upheld where sufficient
explanation provided by Agency)).
   Response. EPA agrees that when an administrative agency adopts
a change in course by revoking a rule it must supply a "reasoned
analysis." (See Rust v. Sullivan, 111 S. Ct. 1759, 1769 (1991);
Chevron USA, Inc. v. NRDC, 467 U.S. 837, 862-864 (1984)). However,
in the present situation EPA did not change a position which
had the status of a final rule, but merely changed a preliminary
decision in an ongoing administrative process. EPA's initial
decision that the risk posed by dichlorvos might be de minimis
was in an order to which objections were filed pursuant to procedures
in the FFDCA, 21 U.S.C. 348(f). EPA changed its decision regarding
the level of risk posed by dichlorvos based on a reexamination
of the relevant data in response to the objections filed.
   In any event, EPA's change in position was adequately explained
in the proposed rule to revoke dichlorvos. EPA's original position
was that new residue data were likely to show that the risk
posed by dichlorvos was de minimis. The basis for this position
was that the existing risk estimate was made using tolerance
levels as the measure of residue levels in foods and that "tolerance
residue levels generally overestimate likely dietary exposure."
(55 FR 17568, April 25, 1990). EPA changed its position following
a reexamination of the residue data used to establish the tolerance.
(56 FR 7775, Feb. 25, 1991). That reexamination showed that
dichlorvos residues may exceed the tolerance, and thus the tolerance
may have been established at too low a level. Accordingly, EPA
concluded that "the current risk estimate may be understated."
Id. Thus, EPA changed its position because an examination of
the data on dichlorvos residues showed that EPA's initial general
assumption concerning the relationship between tolerance levels
and actual residues was not necessarily accurate for dichlorvos.
   2. Comment. AMVAC stated that because EPA has "no conclusive
evidence" showing that the risks of dichlorvos are greater
than de minimis, there is not sufficient evidence in the record
to support EPA's decision.
   Response. First, the burden of showing the safety of a food
additive regulation lies with the proponent of the regulation
to allow the additive in food (40 CFR 179.91; Environmental
Defense Fund v. Department of Health, Education, and Welfare,
428 F.29 1083, 1092 n.27 (D.C. Cir. 1970)). Second, the risk
posed by dichlorvos when assessed at the tolerance level (the
legal level) exceeds a de minimis risk. Data for the aerosol
application indicate the potential for over-tolerance residues,
and this has been substantiated by over-tolerance dichlorvos
residues found in two treated samples in a recent market basket
study conducted by AMVAC in late 1992. Thus, the record in this
case adequately supports EPA's decision.
   3. Comment. AMVAC stated that because EPA examined the benefits
involved in pesticide usage in adopting a de minimis exception
to the Delaney Clause, EPA is required to consider the benefits
of an individual pesticide in applying the de minimis exception.
   Response. On several occasions, courts have expressly rejected
the argument that application of a de minimis exception allows
the balancing of risks and benefits. Public Citizen v. Federal
Trade Commission, 869 F.29 1541, 1557 (D.C. Cir. 1989); Alabama
Power Co. v. Costle, 636 F.29 323, 361 (D.C. Cir. 1979). EPA's
consideration of benefits in the context of deciding whether
or not to interpret the Delaney Clause as containing a de minimis
exception was not inconsistent with those decisions. EPA considered
the benefits of pesticides and Congressional views of those
benefits in evaluating whether a de minimis exception was consistent
with the legislative design for the regulation of pesticides.
Legislative design is one of several factors relevant to whether
a statute allows for a de minimis exception. Alabama Power,
636 F.2d at 360.
   EPA has not considered the benefits of a pesticide in determining
whether the risks posed by a particular use falls within the
de minimis exception to the Delaney Clause.
   4. Comment. AMVAC states that EPA should consider less burdensome
alternatives including lowering the permissible tolerance level
and changing dichlorvos use patterns prior to revoking the dichlorvos
food additive regulation. As authority for this proposition,
AMVAC cites Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th
Cir. 1991).
   Response. The cited case involved the Toxic Substances Control
Act, which contains explicit statutory language relating to
least burdensome alternatives. Id. at 1214-1215. This matter
involves the application of a de minimis exception to an otherwise
zero-risk provision. There is no statutory requirement in the
Delaney Clause to consider less burdensome alternatives. Moreover,
as noted above, interpreting a statute as containing a de minimis
risk exception does not give EPA the authority to consider cost
factors in applying such a de minimis exception to determine
if there is a less burdensome alternative. To the extent EPA
is under an obligation to consider whether different use patterns
would present a de minimis risk, the lack of data on residue
levels at different use rates precludes such consideration.
   5. Comment. AMVAC believes that residue levels of dichlorvos
are significantly lower than those assumed by EPA in its risk
assessment. AMVAC states that the residue data that the Agency
relied on are "outdated" because the aerosol application used
does not reflect current methods of application. AMVAC cited
two reasons why over-tolerance residues occurred: (1) the inefficient
(old) method of atomization and (2) the nonvolatility of the
solvents used in the (old) formulation compared to the volatile
solvents currently used.
   Response. The level of dichlorvos used in the risk assessment
for estimating exposure due to dietary intake of treated processed
commodities, packaged and bagged, may overestimate the actual
residues in these food items. However, when the dietary risk
was estimated, the only residue data available to the Agency
were those purportedly "outdated" data to which AMVAC alluded.
As noted below, the additional residue data submitted to the
Agency in late 1991 are limited in size and scope and therefore
were not used. The Agency can only base its decisions on the
data at hand.
   6. Comment. To support its contention that residue levels
of dichlorvos are significantly lower, AMVAC submitted the results
of a market basket survey. Food products were exposed to dichlorvos
from as few as one treatment to as many as 11 treatments (average
of 2.5 treatments per commodity). Treatment frequency varied
from once per week to once every 5 or 6 weeks (average treatment
internal of 3.45 weeks). AMVAC asserted that the residue levels
observed should represent the maximum levels that could be found
in commercial facilities and that the average values would be
at least an order of magnitude lower.
   Response. Currently, the product labels permit an unspecified
number of aerosol treatments. It also specifies no waiting period
for treated commodities to be shipped and sold after treatment.
Market basket samples were collected days after treatment. Thus,
the residue levels observed in the treated processed commodities
do not necessarily reflect the maximum label use conditions.
In addition, AMVAC's submission contained adequate analytical
data only for a few types of processed commodities permitted
on the product label. The Agency is not convinced that the dietary
exposure estimates should be revised based upon this weak data
base.
   7. Comment. AMVAC contends that the Agency incorporated dichlorvos
residue reduction factors only for rice, wheat, barley, rye,
and possibly oats containing foods in its dietary exposure assessment,
but allowance for residue reduction was not made for any of
the several dried fruits, sugar products, or soybean products.
AMVAC believes that, based on the hydrolytic instability of
dichlorvos, the Agency should allow for residue reduction in
packaged and bagged processed agricultural commodities that
are cooked before consumption.
   Response. The Agency agrees that some reduction in residues
occurs with cooking and, as the registrant points out, some
reduction factors were used for cooked rice and other small
grains. However, no further adjustments in the exposure assessment
will be made until data on processing/cooking factors are submitted,
reviewed, and found valid.
   8. Comment. AMVAC estimated the percent of site treated (bagged
or packaged, nonperishable processed food) to be about 0.7 percent,
an order of magnitude below EPA's estimate. It used two assumptions
that account for its lower estimate: (1) the percent of processed
food packaged in materials susceptible to dichlorvos residues,
and (2) the percent of foodstuffs present on the day of treatment.
In referring to "materials susceptible to dichlorvos residues,"
AMVAC appears to mean packaging material which allows dichlorvos
to penetrate the package, resulting in residues. AMVAC contends
that glass and metal containers would not result in residues.
   Response. EPA's estimate of site treated was 7.5 percent.
That figure was based on a survey of food processors which showed
that, on average, 7.5 percent of food processors used dichlorvos.
Significantly, the greatest use was by processors of grains
and sugars (20 percent), the two commodities which represent
the majority of the estimated risk of dichlorvos.
   EPA has serious reservations about whether the 7.5-percent
figure is adequately supported by the above-noted survey. The
food additive regulation for dichlorvos in question covers bagged
and packaged nonperishable processed food. Such food could be
exposed to dichlorvos in several locations-in a food-processing
plant, in a dry grocery warehouse, or in a food-handling establishment
such as a supermarket. The survey of food processors purports
to measure only usage in food-processing plants.
   Based on figures submitted by AMVAC concerning the pounds
of dichlorvos applied and the total cubic feet of warehouses
and processing plants nationwide, the percent of site treated
would be in the range of 5 to 10 percent. AMVAC, however, has
contended that the percent of site treated should be reduced
by the percentage of foods in dry grocery warehouses which are
in metal or glass containers and by the percent of food likely
to be in the warehouse on the day of treatment.
   AMVAC contends that glass and metal containers would protect
foods from exposure to dichlorvos. Even assuming that is true,
EPA finds AMVAC's analysis to be flawed. Although admitting
that the percentage of foods in glass and metal "is difficult
to determine" and that it could obtain little or no data on
the issue, AMVAC estimated that 90 percent of the food in warehouses
is packaged in glass or metal containers. AMVAC reached this
conclusion through use of a U.S. Department of Commerce survey
of manufacturers that reports the dollar value of products by
industry. AMVAC appears to have divided the dollar value of
products for industries which produce food which could be in
flexible packaging, as opposed to glass or metal, by the dollar
value of products for industries which could have products in
food warehouses to compute a percentage of food in warehouses
which could be in flexible packaging. According to AMVAC, this
calculation showed 20 percent of the food in warehouses could
be in flexible packaging. AMVAC further reduced this percentage
by half because AMVAC reasoned that not all of this food would
be in flexible packaging. AMVAC's basis for this latter reduction
is not clear.
   AMVAC's proposed reduction of the percent of site treated
to reflect AMVAC's estimate of the percent of food in warehouses
which is in flexible packaging fails to take into account that
EPA, in deriving a risk estimate for dichlorvos, only included
those commodities in its exposure assessment which EPA judged
to be likely to be packaged in bags and packages. Certainly,
some of the commodities selected by EPA are packaged in glass
or metal containers as well as in more flexible materials. However,
EPA has no data to make a computation of the percentage breakdown
between the various container types, and AMVAC's information
is certainly not commodity specific. Moreover, as mentioned
above, the two commodities which account for the bulk of the
risk in the dichlorvos risk estimate are sugar and processed
grains, two commodities which EPA believes are generally packaged
in flexible materials.
   EPA finds AMVAC's proposed reduction of the percent of site
treated by the likelihood of a food being in the warehouse on
the day the warehouse is treated with dichlorvos to be similarly
unsubstantiated. AMVAC calculated that only 4.8 percent of the
food in warehouses is present on the day of treatment. Whether
or not that figure is correct, AMVAC has not adequately documented
its assumption that only food present on the day of treatment
is susceptible to dichlorvos residues. AMVAC suggests that residues
from past treatments of dichlorvos dissipate and do not contaminate
food introduced after the treatments. This maybe true, but the
data to substantiate that assumption have not been submitted
to EPA. For all of the above reasons, EPA concludes there is
no reason to lower its estimate of the percent of crop treated
by dichlorvos.
B. Other Comments
   1. Comment. Three commenters (Millers' National Federation,
Grocery Manufacturers' Association (GMA), and National Food
Processors Association) stated that it was not good policy to
take an action which would render foods which are legally treated
with pesticides as adulterated. GMA argued that EPA's action
would hurt consumer confidence in the safety of the food supply
and EPA should withdraw the proposed revocation or bar the use
of dichlorvos entirely.
   Response. EPA agrees the best policy is to act consistently
under the various regulatory provisions. This policy concern,
however, does not justify leaving the DDVP regulation in place.
In any event, EPA plans, under FIFRA, to cancel products containing
dichlorvos on packaged and bagged nonperishable processed foods.
   2. Comment. Two commenters (Millers' National Federation
and American Spice Trade Association) objected to the revocation
of this dichlorvos food additive regulation on the grounds that
it would disrupt Integrated Pest Management (IPM) programs causing
greater quantities of less effective pesticides to be used at
the expense of the environment and the user.
   Response. EPA supports the use of IPM programs, but does
not believe the effect of this revocation on such programs is
an appropriate consideration under the Delaney Clause.

III. Order
   EPA has concluded that this food additive regulation must
be revoked because DDVP induces cancer in animals and the Delaney
Clause bars the establishment of regulations for such pesticides.
DDVP has been shown in a 2-year bioassay in Fischer 344 rats
to cause statistically significant increases, with a positive
dose-related trend, in leukemia in males at 2 dose levels. (Ref.
1) The results of this study show that DDVP induces cancer in
animals. In its weight of the evidence evaluation, EPA considered
the historical evidence on leukemia in Fischer 344 rats (Ref.
2), other tumors reported in the study involving Fischer 344
rats, several additional cancer studies in mice and rats (Ref.
3), results of the transplantable rat mononuclear cell leukemia
model (Ref. 4), mutagenicity data (Ref. 5), and structure activity
information (Ref. 6). Much of this information supports EPA's
conclusion that results of the Fischer 344 rat study are significant
and, to the extent any of the information did not confirm the
results of that rat study, none of that information is of such
weight that it affects EPA's determination that the increased
incidence of leukemia in male rats was the result of exposure
to the test compound.

IV. Timing of Order
   EPA proposed to make this revocation take effect 120 days
after the revocation decision is final and published in the
Federal Register. This proposal took into consideration that
dichlorvos may still be legally used on packaged and bagged
nonperishable processed foods under FIFRA. Processed foods treated
with dichlorvos will necessarily become adulterated as a result
of the revocation of the dichlorvos food additive regulation,
even though the use of dichlorvos when it was applied was consistent
with both the FIFRA registration and the FFDCA regulation. The
120-day period was chosen because EPA had preliminary data indicating
that dichlorvos residues would be nondetectable after 60 days.
   Two commenters (Millers' National Federation and American
Spice Trade Association) urged EPA to delay the revocation for
2 years-the period of time necessary for all food treated prior
to the revocation decision to clear the market. They argued
that EPA should not rely on preliminary data on degradation
in establishing the effective date. EPA shares the concerns
of these commenters, but believes that the 120-day period is
reasonable given that it is twice the length of time that the
preliminary data suggest is needed for the degradation of residues.
Accordingly, this order contains as an effective date for the
revocation 120 days from the publication of this rule.

V. 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 December 10, 1993. 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 December 27,
1993.

B. Effective Date and Stays of Effective Date
   This final rule shall become effective March 10, 1993. 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 December 10, 1993. 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 and
the specific food additive regulation(s) 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(s) for which
the stay is sought for such time as is required to review the
stay petition, if necessary. 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 as to the regulation(s) to which the stay is requested
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.

VI. Other Regulatory Requirements

A. Executive Order 12291
   As explained in the proposal published in the Federal Register
of October 3, 1991 (56 FR 50190), EPA determined, pursuant to
the requirements of E.O. 12291, that the revocation of the food
additive tolerance is not a major regulatory action, i.e., it
will not have an annual effect on the economy of at least $100
million, will not cause a major increase in prices, and will
not have a significant adverse effect on competition or the
ability of U.S. enterprises to compete with foreign enterprises.
The Agency's best judgment is that the total impact of this
rule may be as high as $50 million per year.
   This rule has been reviewed by the Office of Management and
Budget (OMB) as required under section 3 of E.O. 12291.

B. Regulatory Flexibility Act
   This 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 have a minor economic
impact on a small number of small businesses, small governments,
or small organizations. The reasons for this conclusion are
discussed in the October 3, 1991, proposal.
   The Delaney Clause does not give EPA the authority to consider
economic impact. Accordingly, I certify that this rule does
not require a separate regulatory flexibility analysis under
the Regulatory Flexibility Act.

C. Paperwork Reduction Act

   This 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.

VII. References for DDVP

   All references cited in section VII of this preamble are
available for viewing in the Office of Pesticide Program's Public
Docket under control number 260053C. 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, regardless
of affiliation. Disclosure of the references identified by an
MRID number are subject to the limitations imposed by section
10 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). Visitors are required to sign an "Affirmation of Non-
multinational Status" form prior to viewing any references
identified by an MRID number.
   Copies of the references also are available by writing to:
Freedom of Information Office (A101), 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.

References

   1.Two-year Gavage Study of Dichlorvos in F344 Rats (Southern
Research Institute, Study No. 05049, May 23, 1983, sponsored
by the National Toxicology Program), PWG Report, May 30, 1986.
MRID 006019.
   2. Haseman et al., JNCI 75:975-984, 1985.
   3. See EPA, Office of Pesticide Programs, "4th Peer Review
of Dichlorvos" (9/18/89). PWG Dichlorvos Two Year B6C3F1 Mouse
Corn Oil Gavage Study. (Southern Research Institute; Study Numbers:
05049 Test 02. NTP C# 00113B, May 23, 1983; sponsored by National
Toxicology Program) PWG May 14, 1986. NTP Technical Report No.
342, "A Review of the Interpretation of the NTP Toxicology
and Carcinogenesis Studies of Dichlorvos," June 30, 1988, by
John H. Mennear, Ph.D., Professor of Toxicology, Campbell University,
Buies Creek, North Carolina.
   4. The transcript of the NTP panel of experts meeting of
July 14, 1987.
   5. See Memorandum, from Judith Hauswirth to George La Rocca,
EPA, Office of Pesticide Programs, "First Peer Review of Dichlorvos
(DDVP)" (Sept. 25, 1987).
   6. Same as item 5 of these references.

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: October 22, 1993.

Victor J. Kimm,

Acting Assistant Administrator for Prevention, Pesticides and

Toxic Substances.

   Therefore, 40 CFR part 185 is 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.

   2. By revising . 185.1900 to read as follows:
 185.1900   2,2-Dichlorovinyl dimethyl phosphate.
   A tolerance that expires on March 10, 1994, is established
as follows: The food additive 2,2-dichlorovinyl dimethyl phosphate
may be present as a residue from application as an insecticide
on packaged or bagged nonperishable processed food (see: 21
CFR 170.3(j)) in an amount in such food not in excess of 0.5
part per million (ppm). To assure safe use of the insecticide,
its label and labeling shall conform to the label and labeling
registered by the U.S.Environmental Protection Agency, and the
usage employed shall conform to such label and labeling.

[FR Doc. 93-27607 Filed 11-9-93; 8:45 am]