[Federal Register Volume 61, Number 42 (Friday, March 1, 1996)]
[Proposed Rules]
[Pages 8174-8183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4836]
[[Page 8173]]
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Part V
Environmental Protection Agency
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40 CFR Part 180
_______________________________________________________________________
Pesticide Tolerances, Proposed Revocations; Proposed Rule
Federal Register / Vol. 61, No. 42 / Friday, March 1, 1996 / Proposed
Rules
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[[Page 8174]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300415; FRL-5351-6]
RIN 2070-AB18
Pesticide Tolerances; Proposed Revocations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA announces its decision on whether to propose revocation of
41 section 408 tolerances for 22 pesticides. Under EPA's policy
concerning the coordination of its authorities under sections 408 and
409 of the Federal Food, Drug and Cosmetic Act (FFDCA), EPA proposes to
revoke the following nine section 408 tolerances: dicofol on apples,
grapes, and plums; mancozeb on oats and wheat; propargite on apples and
figs; simazine on sugarcane; and triadimefon on wheat. These proposed
revocations are one of a series of actions being taken in response to a
decision of the Ninth Circuit Court of Appeals regarding the Delaney
clause in section 409 of the Federal Food, Drug and Cosmetic Act
(FFDCA). EPA proposes to leave the remaining tolerances in place.
DATES: Written comments, identified by the docket number [OPP-300415],
must be received on or before May 30, 1996.
ADDRESSES: By mail, submit comments to: Public Response Section, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring comments to: OPP Docket, Public Information Branch,
Field Operations Division, Rm. 1132, Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA. The telephone number for the OPP docket is
(703) 305-5805. Information submitted as a comment concerning this
document may be claimed confidential by marking any part or all of that
information as ``Confidential Business Information'' (CBI). Information
so marked will not be disclosed except in accordance with procedures
set forth in 40 CFR part 2 and in section 10 of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA). For questions
related to disclosure of materials, contact the OPP Docket at the
telephone number given above. A copy of the comment that does not
contain CBI must be submitted for inclusion in the public record.
Information not marked confidential may be disclosed publicly by EPA
without prior notice. All written comments will be available for public
inspection in the OPP Docket, Rm. 1132 at the Virginia address given
above, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number [OPP-300415]. No CBI should be submitted through e-mail.
Electronic comments on this proposed rule may be filed online at many
Federal Depository Libraries. Additional information on electronic
submissions can be found in [OPP-300415]. of this document.
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: Crystal Station #1, 2800 Crystal Drive, Arlington,
VA. Telephone 703-308-8028, [email protected]niloufar@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents:
I. Introduction
II. Background
A. Statutory Background
B. EPA's Policy Concerning Coordination of Its Authorities
Under Sections 408 and 409 of the FFDCA
C. Regulatory Background
III. Today's Action
IV. Determination of the Need for a Section 409 FAR
A. Pesticide Uses that Do Not Need a Section 409 FAR
B. Pesticide Uses Previously Found Not to Need Any Section 409
FARs
C. Additional Pesticide Uses Found Not to Need Any Section 409
FARs
D. Pesticide Uses that Need a Section 409 FAR
V. Delaney Clause Determinations for Needed Section 409 FARs
VI. Proposed Revocations
VII. Consideration of Comments
VIII. Public Docket
IX. Regulatory Requirements
I. Introduction
In this notice, EPA announces its decision whether 41 section 408
tolerances for 22 pesticides should be revoked under EPA's policy
concerning the coordination of its authorities under sections 408 and
409 of FFDCA. For those tolerances that EPA has determined should be
revoked, EPA is in this notice proposing revocation.
II. Background
A. Statutory Background
The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 301 et
seq.) authorizes the establishment of maximum permissible levels of
pesticides in foods, which are referred to as ``tolerances'' (21 U.S.C.
346a, 348). Without such a tolerance or an exemption from a tolerance,
a food containing a pesticide residue is ``adulterated'' under section
402 of the FFDCA and may not be legally moved in interstate commerce
(21 U.S.C. 342). Monitoring and enforcement of pesticide residues are
carried out by the U.S. Food and Drug Administration (FDA) and the U.S.
Department of Agriculture (USDA).
The FFDCA governs tolerances for raw agricultural commodities
(RACs) and processed foods separately. For pesticide residues in or on
RACs, EPA establishes tolerances, or exemptions from tolerances when
appropriate, under section 408. For processed foods, food additive
regulations (FARs) setting maximum permissible levels of pesticide
residues are established under section 409. Section 409 FARs are
needed, however, only for certain pesticide residues in processed food.
Under section 402(a)(2) of the FFDCA, no section 409 FAR is required
for pesticide residues carrying from raw to processed food if the
residue in the processed food, when ready to eat, is equal to or below
the section 408 tolerance for that pesticide in or on the RAC from
which it was derived, and all other conditions of section 402(a)(2) are
met. 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 form. Thus, a section
409 FAR is necessary to prevent foods from being deemed adulterated
when the concentration of the pesticide residue in a processed food
carrying over from the RAC is greater than the tolerance prescribed for
the RAC, or if the processed food itself is treated or comes in contact
with a pesticide.
To establish a tolerance regulation under section 408, EPA must
find that the regulation would ``protect the public health.'' 21 U.S.C.
346a(b). In reaching this determination, EPA is directed to consider,
among other things, the ``necessity for the production of an adequate,
wholesome, and economical food supply.'' Id. If a food additive
regulation must be established, section 409 of the FFDCA requires that
the use of the pesticide will be ``safe'' (21 U.S.C. 348(c)(3)).
Section 409 also contains the
[[Page 8175]]
Delaney clause, which specifically provides that, with little
exception, ``no additive shall be deemed safe if it has been found to
induce cancer when ingested by man or animal'' (21 U.S.C. 348(c)(3)).
B. EPA's Policy Concerning Coordination Of Its Authorities Under
Sections 408 and 409 of the FFDCA
EPA traditionally has followed a policy of coordinating its
authorities under section 408 and section 409 of the FFDCA. Thus, if
use of a pesticide would result in residues in a RAC needing a section
408 tolerance and residues in a processed food needing a section 409
FAR, EPA would not approve either the section 408 tolerance or the
section 409 FAR if EPA could not approve both. Similarly, EPA would not
approve a FIFRA registration for a use of a pesticide if all needed
tolerances and FARs connected with that use could not be approved.
In September 1992, the National Food Processors' Association (NFPA)
and other food-related organizations filed a petition with EPA
challenging the legality of EPA's coordination policy. In a policy
statement issued on January 25, 1996, (61 FR 2378) EPA for the most
part rejected the NFPA's arguments concerning the coordination policy.
EPA will continue to coordinate its actions under sections 408 and 409.
Where a pesticide needs a section 409 FAR but such FAR cannot be
granted because of the Delaney clause, EPA generally will not grant, or
allow to continue, the associated section 408 tolerance.
The critical issue in the application of the coordination policy is
whether there is a likelihood of residues exceeding the section 408
tolerance in ready-to-eat (RTE) processed food. If there is such a
likelihood of over-tolerance residues, EPA believes it is a reasonable
interpretation of section 408 to conclude that the section 408
tolerance does not meet the statutory standard under section 408
(``protect the public health'') and thus must be revoked. The criteria
EPA follows in determining the likelihood that residues in processed
food will exceed the section 408 tolerance are called the concentration
policy. Until recently, EPA's concentration policy had focused almost
entirely on the results of food processing studies and concentration
factors derived from those studies. Concentration factors measure the
ratio between residue levels in the processed food and the precursor
raw crop (e.g., a concentration factor of 2 indicates that residues in
the processed food are twice the level of residues in the raw crop).
However, in responding to the NFPA petition on June 14, 1995 (60 FR
31300), EPA announced it would consider a far greater range of
information in making the determination concerning the likelihood of
residues in processed food exceeding the section 408 tolerance.
C. Regulatory Background
1. Les v. Reilly. On May 25, 1989, the State of California, the
Natural Resources Defense Council (NRDC), Public Citizen, the AFL-CIO,
and several individuals filed a petition requesting that EPA revoke
several food additive regulations. The petitioners argued that these
food additive regulations should be revoked because they violated the
Delaney clause.
EPA responded to the petition by revoking certain food additive
regulations, but retained several others on the grounds that the
Delaney clause provides an exception for pesticide residues posing de
minimis risk; EPA denied the petition with respect to the food additive
regulations determined to fall under this exception. EPA's response was
challenged by the petitioners in the U.S. Court of Appeals, Ninth
Circuit. On July 8, 1992, the court ruled in Les v. Reilly, 968 F.2d
985 (9th Cir.), cert. denied, 113 S.Ct. 1361 (1993), that the Delaney
clause barred the establishment of a food additive regulation for
pesticides which ``induce cancer'' no matter how infinitesimal the
risk. In response to the court's decision in Les v. Reilly, EPA has
taken steps to identify and revoke all section 409 FARs for pesticides
which ``induce cancer.'' On March 30, 1994, EPA issued a list of
pesticide uses which potentially could be affected by the court's
decision. (59 FR 14980) (Note that, for the purpose of today's
document, this list has been superseded by Appendices to the court-
approved settlement in California v. Browner.) EPA has taken the
following actions in response to Les v. Reilly:
(1) Revoked certain FARs of six pesticides that were the subject of
the original NRDC petition. (58 FR 37862, July 14, 1993; 58 FR 59663,
November 10, 1993; and 59 FR 10993, March 9, 1994-a number of these
actions have been challenged in court or have been stayed).
(2) Proposed to revoke 26 FARs for seven pesticides (59 FR 33941,
July 1, 1994).
(3) Proposed to revoke six FARs for four pesticides (60 FR 3607,
January 18, 1995).
(4) Proposed to revoke two FARs for two pesticides as inconsistent
with the Delaney clause and proposed to revoke 34 other FARs for 16
pesticides because the FARs were not needed to prevent the adulteration
of food (60 FR 49142, September 21, 1995).
Having completed review (at least through the stage of issuing a
proposed action) of the section 409 FARs identified as potentially
inconsistent with the Delaney clause, EPA, in this notice, has focused
its attention on the application of the coordination policy to the
section 408 tolerances. Specifically, EPA is focusing on the section
408 tolerances associated with the section 409 FARs considered in the
July 1994, January 1995, and September 21, 1995 notices, as well as
several other section 408 tolerances identified previously as
potentially affected by EPA's coordination policy. Today's notice
announces decisions on 41 section 408 tolerances of 22 pesticides.
These pesticides are summarized in Table 1 of Unit III of this
document. EPA is proposing to revoke 9 section 408 tolerances for 5
pesticides and is proposing not to revoke the remaining 31 section 408
tolerances. The one remaining section 408 tolerance was previously
revoked.
2. California v. Browner. In a court approved settlement, entered
on February 9, 1995, in the case of California v. Browner, EPA agreed
to make decisions regarding pesticides that may be affected by the
Delaney clause. This settlement agreement includes appendices listing
pesticides and uses upon which EPA must make decisions, and a timetable
for making the decisions. The settlement required EPA to rule on the
NFPA petition that challenged a number of policies under which EPA
administers its tolerance-setting program. This proposal complies with
the timeframes in the California v. Browner settlement.
On June 14, 1995, EPA published a partial response to the NFPA
petition (60 FR 31300). The Agency concluded that some changes were
warranted to its policies concerning application of the Delaney clause.
On January 25, 1996 (61 FR 2378) EPA completed its response to the NFPA
petition by reaffirming its coordination policy. Today's proposals are
in accordance with EPA's responses to the NFPA petition.
III. Today's Action
In the California v. Browner settlement, EPA agreed to make
decisions by April, 1997 concerning whether 81 section 408 tolerances
violated EPA policies regarding the coordination of its authority under
sections 408 and 409. The settlement recognized that these policies
might be modified by EPA's response to the NFPA petition. Today's
notice announces EPA's decisions regarding 41
[[Page 8176]]
of those tolerances (See Table 1 of this document.) EPA has treated the
California v. Browner consent decree as the equivalent of a petition
under section 408(e) requesting the reexamination of the legality,
under the coordination policy, of the tolerances listed in the
appendices to the decree. This notice, in effect, acts on the petition
by proposing revocation of those tolerances that EPA has determined do
not meet the statutory standard under section 408 and by proposing not
to initiate a revocation proceeding against those tolerances to which
EPA has found the coordination policy is inapplicable. EPA is seeking
comment on both the proposed revocations and its proposed decisions not
to revoke and will issue a final order following the receipt and review
of such comments.
Table 1.--Section 408 Raw Food Tolerances in this Notice.
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Proposed
Pesticide Crop CFR Cite Decisions
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Acephate.................... Cottonseed..... 180.108 Retain
Alachlor.................... Sunflower seed. 180.249 Previously
revoked
Benomyl..................... Citrus......... 180.294 Retain
.......................... Rice........... 180.294 Retain
Captan...................... Grapes......... 180.103 Retain
.......................... Tomatoes....... 180.103 Retain
Carbaryl.................... Pineapples..... 180.169 Retain
Dicofol..................... Apples......... 180.163 Revoke
.......................... Grapes......... 180.163 Revoke
.......................... Plums.......... 180.163 Revoke
.......................... Tomatoes....... 180.163 Retain
Diflubenzuron............... Soybeans....... 180.377 Retain
Dimethipin.................. Cottonseed..... 180.406 Retain
Ethylene Oxide.............. Whole spices 180.151 Retain
(direct
treatment).
Iprodione................... Peanuts........ 180.399 Retain
.......................... Rice........... 180.399 Retain
Lindane..................... Tomatoes....... 180.133 Retain
Mancozeb.................... Barley......... 180.176 Retain
.......................... Grapes......... 180.176 Retain
.......................... Oats........... 180.176 Revoke
.......................... Rye............ 180.176 Retain
.......................... Wheat.......... 180.176 Revoke
Maneb....................... Grapes......... 180.110 Retain
Methomyl.................... Wheat.......... 180.253 Retain
Norflurazon................. Grapes......... 180.356 Retain
Oxyfluorfen................. Cottonseed..... 180.381 Retain
.......................... Peppermint..... 180.381 Retain
.......................... Spearmint...... 180.381 Retain
.......................... Soybeans....... 180.381 Retain
PCNB........................ Tomatoes....... 180.319 Retain
Permethrin.................. Tomatoes....... 180.378 Retain
Propargite.................. Apples......... 180.259 Revoke
.......................... Figs........... 180.259 Revoke
.......................... Grapes......... 180.259 Retain
.......................... Plums.......... 180.259 Retain
Simazine.................... Sugarcane...... 180.213 Revoke
Thiodicarb.................. Cottonseed..... 180.407 Retain
.......................... Soybeans....... 180.307 Retain
Triadimefon................. Grapes......... 180.410 Retain
.......................... Wheat.......... 180.410 Revoke
.......................... Pineapple...... 180.410 Retain
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In reviewing these 41 section 408 tolerances under its coordination
policy, EPA's first step was to determine whether the section 409 FARs
for such tolerances were needed. If a section 409 FAR is not needed in
connection with a section 408 tolerance, the coordination policy would
not be triggered because it only addresses the appropriate action to be
taken where approvals are needed under both sections 408 and 409.
If EPA determined that a section 409 FAR is needed, EPA then
determined whether a section 409 FAR for the pesticide in question
would comply with the Delaney clause. If a needed section 409 FAR would
violate the Delaney clause, EPA applied its coordination policy and
has, where appropriate, proposed in this notice the revocation of each
section 408 tolerance for which the Delaney clause bars the
establishment or maintenance of a section 409 FAR.
IV. Determination of the Need For a Section 409 FAR
Because the coordination policy has no application to section 408
tolerances that do not need section 409 FARs, EPA has first examined
whether each of the 41 section 408 tolerances need FARs under current
Agency policies. The determination whether a section 409 FAR is needed
to prevent a food from being considered adulterated primarily involves
application of EPA's concentration policy. EPA applies the
concentration policy to examine the likelihood that use of a pesticide
on a raw agricultural commodity will result in residues in a processed
food exceeding the section 408 tolerance.
A. Pesticide Uses that Do Not Need a Section 409 FAR
EPA has determined that its coordination policy does not warrant
revoking 31 of the 41 section 408 tolerances because no section 409 FAR
is needed for these tolerances. EPA has concluded that section 409 FARs
are not needed principally for one of three reasons. First, for several
pesticide/processed food combinations, EPA has received new processing
studies indicating that residues in processed food are not likely to
exceed the section 408 tolerance. Second, application of EPA's new
concentration policy has shown that, for several of the pesticide uses,
residues in processed food are not likely to exceed the section 408
tolerance. Third, several processing byproducts have been dropped from
EPA's list of significant animal feed items and therefore FARs are no
longer needed for these processed commodities. See 60 FR 49144.
In a proposed revocation published September 21, 1995 (60 FR
49142), EPA explained which of these factors applied to several of the
section 409 FARs associated with section 408 tolerances addressed in
this notice. Those FARs are listed in this unit with a cross-reference
to the earlier notice. EPA has also evaluated additional pesticide uses
having section 408 tolerances to determine where section 409 FARs would
be needed. This notice includes explanations of EPA's conclusions
regarding whether section 409 FARs are, or are not needed. A fuller
explanation as to each pesticide use is included in the public docket.
B. Pesticide Uses Previously Found Not to Need Any Section 409 FARs
On September 21, 1995, EPA proposed to revoke the following FARs on
the ground that no section 409 FAR was needed to prevent processed food
from being considered adulterated: (1) Acephate on cottonseed hulls and
cottonseed meal; (2) benomyl on dried citrus pulp and rice hulls; (3)
carbaryl on pineapple bran; (4) diflubenzuron on soybean hulls and
soybean soapstock; (5) dimethipin on cottonseed hulls; (6) iprodione on
peanut soapstock, rice bran and rice hulls; (7) mancozeb on milled
fractions of barley, oats, rye and wheat; (8) propargite on dried apple
pomace and dried grape pomace; (9) thiodicarb on cottonseed hulls and
[[Page 8177]]
soybean hulls; and (10) triadimefon on wet and dry grape pomace and
raisin waste. 60 FR 49142, September 21, 1995).
Based on these determinations, EPA concludes that the following 10
section 408 tolerances have or need no other section 409 FARs and thus
there is no reason under the coordination policy to revoke these
tolerances: (1) Acephate on cottonseed; (2) benomyl on citrus; (3)
carbaryl on pineapple; (4) diflubenzuron on soybeans; (5) dimethipin on
cottonseed, (6) iprodione on peanuts and rice; (7) thiodicarb on
cottonseed and soybeans; and (8) triadimefon on grapes.
It should be noted that unless all needed section 409 FARs can be
approved, EPA will apply the coordination policy to revoke the
underlying section 408 tolerance for the RAC. This means that even if
EPA can determine that one section 409 FAR is not needed by application
of the factors noted above, but other section 409 FARs continue to be
needed, the coordination policy applies. For example, in the list
above, propargite no longer requires a FAR on dried apple pomace
because it is not a significant animal feed, but does require a FAR on
wet apple pomace. Since the FAR on wet apple pomace is needed and
violates the Delaney clause (see Unit IV.D. of this document), EPA is
proposing to revoke the section 408 tolerance for propargite on apples.
C. Additional Pesticide Uses Found Not to Need Any Section 409 FARs
1. Recent processing studies-- a. oxyfluorfen on soybeans. This use
has a section 409 FAR for soybean oil. Based on a new processing study,
EPA has determined that the concentration factor for oxyfluorfen
residues in soybean oil compared to soybeans is less than one.
Therefore, EPA concludes that residues in soybean oil are unlikely to
exceed the section 408 tolerance and no section 409 FAR is needed for
soybean oil. Oxyfluorfen on soybeans has or needs no other section 409
FARs.
b. Benomyl on rice. This use was previously identified as needing
a section 409 FAR for rice bran. Based on a new processing study, EPA
has determined that the concentration factor for benomyl residues in
rice bran compared to rice is less than one. Therefore, no section 409
FAR is needed for rice bran. As noted above, EPA determined in the
September 1995 notice that no section 409 FAR is needed for benomyl on
rice hulls. Benomyl on rice has or needs no other section 409 FARs.
c. Propargite on plums. This use was previously identified as
needing a section 409 FAR for prunes. Based on a new processing study,
EPA has determined that the concentration factor for propargite on
prunes compared to plums is less than one. Therefore, no section 409
FAR is needed for prunes. Propargite on plums has or needs no other
section 409 FARs.
2. Revised concentration policy. EPA's concentration policy is used
to determine whether a section 409 FAR is necessary. EPA's
determination focuses on the likelihood that residue levels in the
processed food will exceed the associated section 408 tolerance level.
In determining the likelihood of tolerance exceedance, EPA now
considers the averaging of residue values that results from the
blending of crops (highest average field trial or HAFT), average
concentration factor (from multiple processing studies), and the
dilution of residues that occurs when a not ready-to-eat processed food
is made into ready-to-eat food. Below EPA explains which of those
factors resulted in the determination that section 409 FARs are not
needed for the following section 408 tolerances.
a. Captan on grapes. This use has section 409 FARs for pre-harvest
treatment of grapes and post-harvest treatment of raisins.
Pre-harvest treatment of grapes. EPA has reconsidered the
available grape/raisin processing studies and has determined that only
those studies that involve washing the fruit after it has been dried in
the field reflect current processing practices. When those data which
include a washing step were used to evaluate the need for a section 409
FAR for raisins, the average concentration factor for residues of
captan per se on washed raisins is less than one. Therefore, no section
409 FAR is needed for residues from pre-harvest treatment. The Captan
Task Force has petitioned EPA to revoke the section 409 FAR to the
extent it is premised on pre-harvest treatment of grapes and EPA will
be acting on that petition shortly.
Post-harvest treatment of raisins. EPA has received a petition from
the Captan Task Force requesting revocation of the section 409 FAR
covering the post-harvest treatment of raisins because, they claim,
captan is not used on drying raisins and the FAR is outdated and
erroneous. EPA agrees with the Petitioner and will shortly publish its
formal determination that no FAR is needed for post-harvest treatment
in a final rule.
Grape juice. After examining 17 processing studies, EPA has
determined that the average concentration factor in juice is less than
one. Therefore, this FAR is not needed. Captan on grapes has or needs
no other section 409 FARs.
b. Mancozeb on barley and rye. There are section 409 FARs for
residues of mancozeb on bran, flour and milled fractions as an animal
feed.
Flours of barley and rye. After examining several processing
studies involving mancozeb residues on grains, EPA has determined that
the average concentration factor for the processing of flours is less
than one. Therefore, the section 409 FARs are not needed for these
flours.
Brans of barley and rye. The use of mancozeb on barley and rye
have section 409 FARs for bran. On May 19, 1993, EPA published the
receipt of a petition requesting the revocation of brans of barley and
rye on the basis that they are not needed (58 FR 29318). EPA has
determined that rye bran is not a significant human food item. EPA has
also determined that both rye and barley bran are not RTE foods and
that once they are prepared to their RTE forms, mancozeb residues are
unlikely to exceed the section 408 tolerances for rye and barley
grains. Therefore, the section 409 FARs for mancozeb on brans of barley
and rye are not needed and EPA will soon be publishing a Federal
Register notice revoking them.
Mancozeb on barley and rye has or needs no other section 409 FARs.
c. Methomyl on wheat. This use does not have a section 409 FAR for
wheat bran but was previously identified as needing one. EPA has
multiplied the HAFT by the average concentration factor to calculate
the expected residue levels in bran. The data show that residues in
bran are not likely to significantly exceed the section 408 tolerance
and therefore a section 409 FAR for bran is not required. Methomyl on
wheat has or needs no other section 409 FARs.
d. Oxyfluorfen on cottonseed, peppermint, and spearmint. The uses
of oxyfluorfen on cottonseed, peppermint, and spearmint have section
409 FARs for oils produced from these crops. EPA has determined that
cottonseed oil, peppermint oil, and spearmint oils are not RTE human
foods and once in their RTE forms, the residues of oxyfluorfen are
unlikely to exceed the section 408 tolerances. EPA will soon be acting
on a petition requesting revocation of these FARs on these grounds.
Oxyfluorfen on cottonseed, peppermint, and spearmint have or need no
other section 409 FARs.
The Agency believes that most refined oils (e.g., soybean oil,
olive oil) should be considered RTE commodities based on their
availability to the general public in typical grocery stores and
subsequent use on salads. The latter use
[[Page 8178]]
is very similar to condiments, which the Agency noted in its June 1995
response to the NFPA petition should be considered RTE foods. In this
notice, EPA for the first time makes a RTE determination for cottonseed
oil. Unlike most other refined oils, cottonseed oil has very limited
availability in grocery stores. The National Cottonseed Products
Association (NCPA) has estimated that only 0.1% of all U.S. cottonseed
oil production is sold at the grocery store level. NCPA has informed
the Agency that most cottonseed oil is used by the snack food industry.
As an example, it is a good frying medium for production of potato
chips. Based on its almost exclusive use by the food processing
industry, the Agency has determined that cottonseed oil is not ready to
eat. As noted above, EPA believes that most other refined oils should
be considered ready to eat. The Agency is requesting public comment and
information on whether oils such as soybean, peanut, olive and corn
should be considered ready to eat.
e. Propargite on grapes. This use has a section 409 FAR for
raisins. EPA has multiplied the HAFT by the average concentration
factor to calculate the expected residue levels in raisins. The data
show that residues in raisins are not likely to exceed the section 408
tolerance for grapes and therefore a section 409 FAR is not needed. EPA
will soon be publishing a Federal Register notice revoking this FAR.
The section 409 FAR for dry grape pomace was proposed for revocation in
September 21, 1995. Propargite on grapes has or needs no other section
409 FARs.
3. Insignificant animal feeds. As explained above, several
processing byproducts (including tomato pomace, dried grape pomace, and
raisin waste) have been dropped from EPA's list of significant animal
feed items and therefore their section 409 FARs are not needed. Table 2
of this unit lists section 408 tolerances with the corresponding animal
feeds that do not need section 409 FARs: (1) Captan on grapes does not
need a raisin waste FAR; (2) captan on tomatoes does not need a dry
tomato pomace FAR; (3) dicofol on grapes does not need a dry grape
pomace or a raisin waste FAR; (4) dicofol on tomatoes does not need a
dry/wet tomato pomace FAR; (5) lindane on tomatoes does not need a dry
tomato pomace FAR; (6) mancozeb on grapes does not need a raisin waste
FAR; (7) maneb on grapes does not need a raisin waste FAR; (8)
norflurazon on grapes does not need a raisin waste FAR; (9) PCNB on
tomatoes does not need a dry tomato pomace FAR; (10) permethrin on
tomatoes does not need dry/ wet tomato pomace FAR; and (11)Propargite
on grapes does not need a raisin waste FAR. If no other section 409
FARs are needed, the coordination policy does not require revocation of
the section 408 tolerances.
4. Other-- a. Alachlor on sunflower seeds. This tolerance was
revoked on August 3, 1994 (59 FR 39464).
b. Ethylene oxide on raw whole spices. Ethylene oxide is used as
direct treatment of raw whole spices and processed ground spices.
Ethylene oxide has both a section 408 tolerance (raw whole spices) and
a section 409 FAR (processed ground spices). The FAR, however, is
needed only for direct treatment of processed ground spices and not
because of any concern that treatment of raw whole spices will lead to
residues in processed spices at a level exceeding the section 408
tolerance. The residues of ethylene oxide in processed ground spices
from treatment of whole raw spices are not expected to exceed the
section 408 tolerance.
c. Triadimefon on pineapple. Pure pineapple bran is no longer
considered a significant feed item and has been dropped from the list
of significant feed items in the Agency's Residue Chemistry Guidelines.
However, EPA has added pineapple process residue to this table of
significant feed items because the Agency has determined that the
material typically fed to livestock is pineapple process residue. This
feed item consists of tops (minus crowns), bottoms, trimmings, pulp
(remaining after squeezing for juice), and, in some cases, cull
pineapples. Since the processing study for triadimefon in pineapples
shows that residues do not concentrate in the process residue, a
section 409 FAR is not needed. Triadimefon on pineapple has or needs no
other section 409 FARs.
Table 2 below summarizes the section 408 raw food tolerances that
EPA is not proposing to revoke under its coordination policy.
Table 2.--Section 408 Raw Food Tolerances Being Proposed for Retention
------------------------------------------------------------------------
Raw commodity
Pesticide ----------------------------------
Crop CFR cite
------------------------------------------------------------------------
Acephate............................. Cottonseed............. 180.108
Benomyl.............................. Citrus................. 180.294
................................... Rice................... 180.294
Captan............................... Grapes................. 180.103
................................... Tomatoes............... 180.103
Carbaryl............................. Pineapples............. 180.169
Dicofol.............................. Tomatoes............... 180.163
Diflubenzuron........................ Soybeans............... 180.377
Dimethipin........................... Cottonseed............. 180.406
Ethylene Oxide....................... Whole spices (direct 180.151
treatment).
Iprodione............................ Peanuts................ 180.399
................................... Rice................... 180.399
Lindane.............................. Tomatoes............... 180.133
Mancozeb............................. Barley................. 180.176
................................... Grapes................. 180.176
................................... Rye.................... 180.176
Maneb................................ Grapes................. 180.110
Methomyl............................. Wheat.................. 180.253
Norflurazon.......................... Grapes................. 180.356
Oxyfluorfen.......................... Cottonseed............. 180.381
................................... Peppermint............. 180.381
................................... Spearmint.............. 180.381
................................... Soybeans............... 180.381
PCNB................................. Tomatoes............... 180.319
Permethrin........................... Tomatoes............... 180.378
Propargite........................... Grapes................. 180.259
...................................
Plums.................. 180.259
Thiodicarb........................... Cottonseed............. 180.407
................................... Soybeans............... 180.407
Triadimefon.......................... Grapes................. 180.410
................................... Pineapple.............. 180.410
------------------------------------------------------------------------
D. Pesticide Uses that Need a Section 409 FAR
EPA has determined that under its revised concentration policy the
pesticide uses listed in this unit need section 409 FARs to prevent the
adulteration of processed food.
In analyzing the need for section 409 FARs, EPA has taken into
account not only existing section 408 tolerances but also available
residue data bearing on whether the current section 408 tolerance
should be revised under existing tolerance-setting policies. EPA has
received large amounts of residue data as part of the reregistration
program. Review of these data shows that, in several instances, the
existing section 408 tolerance is set either too high or too low.
Tolerance adjustments would normally be accomplished through the
reregistration program.
EPA, however, sees no reason to wait until these tolerances are
formally revised to determine whether the pesticide concentrates for
the purpose of applying the coordination policy. EPA has decided that
it should base its concentration decision upon the most recent data on
residues in raw crops. If
[[Page 8179]]
those data indicate that section 408 tolerances should be adjusted, EPA
has used the adjusted section 408 tolerance level as the basis for its
determination of whether a section 409 FAR is needed. The basis for
EPA's determination that the tolerance should be adjusted is in the
docket.
In two cases (dicofol/plums and mancozeb/oats), the level of
residues in the processed food is between the current section 408
tolerance and an adjusted lower 408 tolerance. If EPA were to make its
determination of the need for a section 409 FAR based on the current
higher tolerance, EPA might in this notice decide that revocation was
not warranted only to have to revise that determination in the near
future once the overall tolerance reassessment for the pesticide is
complete. Once the overall tolerance reassessment for the pesticide is
complete, EPA would take the identical action proposed here: EPA would
explain why the tolerance needed to be lowered but then propose to
revoke the existing tolerance because amending the existing tolerance
would not be consistent with the coordination policy.
In two other cases (dicofol/apples and propargite/apples), the
level of residues in the processed food is higher than both the current
and adjusted section 408 tolerances. In this case, adjusting the
tolerance is irrelevant to the need for a section 409 FAR. Nonetheless,
in all situations where a tolerance needs to be adjusted (whether
raised or lowered), EPA believes the focus of the coordination policy
analysis should be the tolerance value that would be set taking into
account the most current data.
1. Dicofol on apples. The current section 408 tolerance for dicofol
on apples is 5 ppm (40 CFR 180.163). Evaluation of new residue data
indicates that the tolerance should be raised to 7 ppm.
This use needs a section 409 FAR for wet apple pomace. When apples
are processed, residues may concentrate in both wet and dried apple
pomace, with a greater potential concentration in dried apple pomace. A
section 409 FAR for dried apple pomace would therefore cover the lower
level of residues in wet apple pomace. In years past EPA often did not
establish a separate section 409 FAR for wet apple pomace, which tended
to obscure the fact that wet pomace itself was regarded by EPA as a
significant animal feed. More recently, tolerance listings for apple
pomace have included both wet and dried pomace, either with a single
tolerance level based on the dried apple pomace or separate tolerance
levels.
EPA determined in its June 1994 revision to the Residue Chemistry
Guidelines Table II (June 8, 1994; 59 FR 29603) and reaffirmed in
September 1995 (September 21, 1995; 60 FR 49150) that dried apple
pomace is not a significant animal feed. FARs for dried apple pomace
will eventually be revoked because they are not needed. However,
without a FAR for dried pomace, wet apple pomace needs a FAR. Under the
criteria of both the June 1994 and the September 1995 Table II, wet
apple pomace is considered a significant animal feed. This is not a new
determination by EPA; however, the decision to remove dried apple
pomace highlighted the continued status of wet apple pomace as a
significant animal feed. Wet apple pomace is also considered a RTE
animal feed.
Dicofol currently has no FARs for apple pomace, wet or dried. Under
the new Residue Table II, no FAR is needed for dried apple pomace, but
one is needed for wet apple pomace. The average concentration factor in
the processing of wet apple pomace is 6.6 and the HAFT for dicofol on
apples is 2.32. Because multiplying the average concentration factor by
the HAFT exceeds the adjusted section 408 tolerance of 7 ppm for
dicofol on apples, EPA believes that it is likely that some wet apple
pomace will contain residues exceeding the adjusted tolerance level.
2. Dicofol on grapes. This use needs a section 409 for raisins.
The average concentration factor in the processing of raisins is 6.6
and the HAFT for dicofol on grapes is 3.02. Because multiplying the
average concentration factor by the HAFT exceeds the section 408
tolerance for dicofol on grapes (5 ppm), EPA believes that it is likely
that some raisins will contain residues exceeding the tolerance.
3. Dicofol on plums. The current section 408 tolerance for
dicofol on plums is 5 ppm (40 CFR 180.163). Evaluation of new residue
data indicates that the tolerance should be reduced to 1 ppm. This use
needs a section 409 FAR for prunes. The average concentration factor in
the processing of prunes is 3.1 and the HAFT for dicofol on plums is
0.79. Because multiplying the average concentration factor by the HAFT
exceeds the adjusted section 408 tolerance for dicofol on plums, EPA
believes that it is likely that some prunes will contain residues
exceeding the adjusted tolerance level.
4. Mancozeb on oats. The current section 408 tolerance for mancozeb
on oat grain is 5 ppm (40 CFR 180.176). Evaluation of new residue data
indicates that the tolerance should be reduced to 1 ppm. This use has a
section 409 FAR for oat bran and oat flour. EPA believes that the bran
FAR is needed under its concentration policy but the flour FAR is not.
EPA considers oat bran a significant human food item which is RTE. The
average concentration factor in the processing of oat bran is 2 and the
HAFT for mancozeb on oats is 0.98 ppm. Because multiplying the average
concentration factor by the HAFT exceeds the adjusted section 408
tolerance for mancozeb on oats, EPA believes that it is likely that
some oat bran will contain residues exceeding the recommended tolerance
level. After examining several processing studies involving mancozeb
residues on grains, EPA has determined that the average concentration
factor for the processing of flours is less than one.
In addition to a section 408 tolerance for oat grain, mancozeb has
a section 408 tolerance for oat straw. EPA believes that straw
production cannot be separated from grain production because oat grain
and straw are harvested simultaneously from the mature plant. Oats
would not be grown solely for straw considering its low value relative
to grain. Therefore, it is not practical to limit use of a pesticide to
oats grown for straw and the Agency is proposing to revoke the oat
straw tolerance for mancozeb.
5. Mancozeb on wheat. The current section 408 tolerance for
mancozeb on wheat grain is 5 ppm (40 CFR 180.176). Evaluation of new
residue data indicates that the tolerance should be reduced to 1 ppm.
This use has a section 409 FAR for wheat flour. EPA believes that the
flour FAR is not needed under its concentration policy. After examining
several processing studies involving mancozeb residues on grains, EPA
has determined that the average concentration factor for the processing
of flours is less than one. The section 409 FAR for wheat bran was
revoked on July 14, 1993 (58 FR 37682) because it violated the Delaney
clause. The bran FAR is needed to prevent the adulteration of wheat
bran. Multiplying the average concentration factor in the processing of
wheat bran (2) times the HAFT for mancozeb on wheat (0.97 ppm) yields a
result exceeding the adjusted tolerance level (1 ppm).
In addition to a section 408 tolerance for wheat grain, mancozeb
has a section 408 tolerance for wheat straw. Wheat production is
similar to oat production with respect to straw, and EPA is therefore
proposing to revoke the section 408 tolerance for mancozeb on wheat
straw.
6. Propargite on apples. The current section 408 tolerance for
propargite on
[[Page 8180]]
apples is 3 ppm (40 CFR 180.259). Evaluation of new residue data
indicates that the tolerance should be raised to 20 ppm.
This use currently has a section 409 FAR for dried apple pomace,
which covers residues in wet apple pomace. The FAR for dried apple
pomace is not needed; without the FAR for dried pomace, a FAR for wet
apple pomace is needed. The average concentration factor in the
processing of wet apple pomace is 5 and the HAFT for propargite on
apples is 13.4 ppm. Because multiplying the average concentration
factor by the HAFT exceeds the adjusted section 408 tolerance for
propargite on apples, EPA believes that it is likely that some wet
apple pomace will contain residues exceeding the tolerance.
7. Propargite on figs. This use has a section 409 FAR for dried
figs and EPA believes that this FAR is needed under its concentration
policy. The average concentration factor in the processing of dried
figs is 2.7 and the HAFT for propargite on figs is 1.8 ppm. Because
multiplying the average concentration factor by the HAFT exceeds the
section 408 tolerance for propargite on figs (3 ppm), EPA believes that
it is likely that some dried figs will contain residues exceeding the
tolerance.
8. Simazine on sugarcane. This use has a corresponding section 409
FAR for molasses as human food and animal feed and previously was
identified as needing FARs for syrup and bagasse. EPA considers
molasses to be a RTE food and feed item. The average concentration
factor in the processing of molasses is 10. A determination of the HAFT
has not been made since the concentration factor is so large that the
HAFT multiplied by that number is certain to appreciably exceed the
section 408 tolerance (.25 ppm).
EPA expects that in most cases the HAFT will not be lower than the
tolerance by a factor of two. This conclusion is based on EPA's
experience with setting 408 tolerances (i.e., how they are derived
based on the highest residue values) and with the relationships between
average residues in field trials and either tolerances or maximum field
trial residues, which are usually close to the tolerance. In most
cases, average residues across all field trials for a given crop are 2
to 6 times less than a tolerance or maximum field trial value. The
highest average field trial (HAFT) will be higher than the average
residue across all trials. Therefore, in this particular case the
Agency is confident that 10 times the HAFT will be appreciably higher
than the 408 tolerance. Examples of the relationships between average
residues and tolerances or maximum field trial residues will be placed
in the docket for this notice. EPA's conclusion regarding the level of
simazine residues in sugarcane molasses is confirmed by a processing
study in which sugarcane treated at the maximum application rate showed
total residues of 0.63 ppm in molasses, well above the 0.25 ppm
sugarcane tolerance. Therefore, EPA believes that it is likely that
some molasses will contain residues exceeding the tolerance. Sugarcane
syrup is not considered a significant human food and therefore no
section 409 FAR is needed. Bagasse is not considered a significant
animal feed.
9. Triadimefon on wheat. This use has a section 409 FAR for milled
fractions of wheat. EPA considers milled fractions of wheat to be RTE
human food (i.e. bran). The average concentration factor in the
processing of milled fractions of wheat is 3.7 and the HAFT for
triadimefon on wheat is 0.6 ppm. Because multiplying the average
concentration factor by the HAFT exceeds the section 408 tolerance for
triadimefon on wheat (1.0 ppm), EPA believes that it is likely that
some milled fractions will contain residues exceeding the tolerance.
In addition to a section 408 tolerance for wheat grain, triadimefon
also has section 408 tolerances for wheat green forage and straw. EPA
is proposing to revoke the section 408 tolerance for triadimefon on
wheat straw for the same reasons given for mancozeb. However, wheat
forage in some areas is grown solely for the purpose of producing
forage, and not grown to maturity to produce wheat grain. Some is grown
in mixed stands with other grassy crops such as ryegrass, making it
impractical to produce wheat grain from such fields. Based on these
agronomic practices, EPA believes that a pesticide label restriction
limiting the use of triadimefon to wheat grown for forage is practical.
Therefore, EPA is not proposing to revoke the section 408 tolerance for
triadimefon on wheat green forage even though the grain and straw
tolerances are proposed for revocation.
V. Delaney Clause Determinations For Needed Section 409 FARs
A. Induce cancer
For each of the pesticides listed in Unit IV.D., section 409 FARs
are either established or needed. In a number of published proposed
revocations, EPA has previously determined that the five pesticides
``induce cancer'' within the meaning of the Delaney clause (59 FR
10993; 59 FR 33941; 60 FR 3607). Full copies of each of these reviews
and other references in this document are available in the OPP Docket,
the location of which is given under `ADDRESSES'' above. Information on
dicofol is contained in OPP Docket OPP-300238, on mancozeb, propargite
and simazine in OPP Docket OPP-300335, and on triadimefon in OPP Docket
OPP-300360.
EPA is currently considering comments on the proposed revocations
of section 409 FARs for propargite, mancozeb, simazine and triadimefon.
B. DES Proviso
EPA may establish or maintain a section 409 FAR for a pesticide
that induces cancer if the DES proviso excepts the FAR from the Delaney
clause. Thus, when a pesticide needing a FAR is found to induce cancer,
EPA must determine if the FAR is nonetheless excepted from the Delaney
clause prohibition by the DES proviso.
The DES proviso applies to a FAR when no detectable residues are
expected in the animal commodities (meat, milk, poultry, eggs) as a
result of animal consumption of feeds containing residues permitted by
the FAR (60 FR 49142, September 21, 1995). If no detectable residues of
the chemical can be found in the animal commodities, the FAR can be
maintained or established.
The nine pesticide uses listed in Unit IV. D of this document have
or need section 409 FARs that are or would be inconsistent with the
Delaney clause. However, only three of these FARs are for animal feed
items and thus have been further analyzed to determine whether they are
allowed under the DES proviso.
1. Dicofol on wet apple pomace. EPA concludes that the DES proviso
would not except the dicofol FAR from the Delaney clause. A dicofol FAR
for wet apple pomace does not qualify because detectable residues in
animal commodities are expected as a result of feeding treated wet
apple pomace to animals. A memorandum explaining EPA's analysis is
included in the docket.
2. Propargite on wet apple pomace. EPA concludes that the DES
proviso does not except the propargite FAR from the Delaney clause. The
propargite FAR does not qualify because detectable residues in animal
commodities are expected as a result of feeding propargite treated wet
apple pomace to animals. A memorandum explaining EPA's analysis is
included in the docket.
3. Simazine on molasses. EPA has previously concluded that the DES
[[Page 8181]]
proviso does not except the simazine FAR from the Delaney clause. (60
FR 49142, September 21, 1995).
VI. Proposed Revocations
A. Section 408 Tolerances
EPA proposes that the nine section 408 tolerances listed in Table 3
of this unit be revoked. EPA no longer believes that these tolerances
meet the statutory standard under section 408 (``protect the public
health'') because use of a pesticide under these tolerances is likely
to result in residues in processed food exceeding such tolerance. Such
residues will render the processed food adulterated under the FFDCA
unless there is a section 409 FAR. Some of the nine section 408
tolerances have existing section 409 FARs that are inconsistent with
the Delaney clause and they will be or have been revoked. The others
need FARs but such FARs have not been, and under the Delaney clause
cannot be, established.
As EPA explained in its recent statement on the coordination
policy, (January 25, 1996, 61 FR 2378) it believes that, if the use of
a pesticide under a section 408 tolerance is likely to result in
residues in a processed food which Congress has, in the clearest terms,
deemed unacceptable, Congress' heightened concern regarding such
residues in processed food must be taken into account in determining
whether the section 408 tolerance complies with the statutory standard
for establishing or maintaining tolerances under section 408. Moreover,
EPA believes that where evaluation of available data indicate that
residues in processed food can exceed the section 408 tolerance,
Congress' heightened concern about such residues is determinative of
the finding under the section 408 standard, absent some extraordinary
impact upon the food supply. EPA believes that its revised
concentration policy (60 FR 31300, June 14, 1995) involves a reasonable
approach to determining the likelihood of residues in processed food
exceeding the associated section 408 tolerance. EPA expressly noted its
willingness to use all relevant and appropriate data in examining this
question. For example, EPA stated it would, where appropriate, consider
some type of average residue value, average concentration values, and
dilution factors for not RTE food.
Because EPA has concluded that the application of its concentration
policy to each of the nine section 408 tolerances in the following
Table 3 has shown that residues in processed food can exceed the
section 408 tolerance and because removal of these uses is unlikely to
have a significant, much less extraordinary, impact on the food supply,
EPA is proposing to revoke these section 408 tolerances because they
fail to meet the section 408 standard for establishing or maintaining
tolerances.
Table 3.--Section 408 Tolerances Proposed for Revocation
------------------------------------------------------------------------
Pesticide Raw Crop CFR Cite
------------------------------------------------------------------------
Dicofol.............................. Apples................. 180.163
Grapes................. 180.163
Plums.................. 180.163
Mancozeb............................. Oats................... 180.176
Wheat.................. 180.176
Propargite........................... Apples................. 180.259
Figs................... 180.259
Simazine............................. Sugarcane.............. 180.213
Triadimefon.......................... Wheat.................. 180.410
------------------------------------------------------------------------
B. Impacts
As noted in Unit IV.D. of this document, evaluation of the nine
pesticide uses listed in Table 3 of this document, under EPA's
concentration policy yields the conclusion that, in all likelihood,
residues in processed food can exceed the associated section 408
tolerance. For these pesticide uses, EPA also examined what the impact
on the food supply would be if these uses were disallowed. EPA has
concluded that removal of the uses would have little or no impact on
the price or availability of food to the consumer. In fact, removal of
most of these uses is not expected to have much effect on growers. For
four of the uses no impact is expected. For the other five, the impact
will be minor. Some individual apple, fig, and wheat growers may incur
significant impacts. See Unit IX. A. below for details.
VII. Consideration of Comments
Any interested person may submit comments on the proposed
revocations of tolerance or EPA's decisions not to revoke certain
tolerances on or before May 30, 1996 at the address given under
the``ADDRESSES'' section above. Before issuing final orders, EPA will
consider all relevant comments. After consideration of comments, EPA
will issue a final order. Such order will be subject to objections
pursuant to section 409(f) (21 U.S.C. 348(f)). Failure to file an
objection within the appointed period will constitute waiver of the
right to raise issues resolved in the order in future proceedings.
VIII. Public Docket
A record has been established for this rulemaking under docket
number [OPP-300415] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
IX. Regulatory Assessment Requirements
A. Executive Order 12866
EPA submitted this action to the Office of Management and Budget
(OMB) for review under Executive Order 12866 (58 FR 51735, October 4,
1993). Any comments or changes made during that review have been
documented in the public record.
EPA has evaluated the economic impacts of this particular action
for the nine proposed revocations. Below is a summary of the results of
the economic analysis by crop.
Apples. The most significant economic impacts of the 408 tolerances
currently proposed for revocation are expected on apples from the loss
of propargite and dicofol. Eight states produce more than 70% of the
apples grown in the United States; regionally, these include the
Northwest (CA, OR and WA), Michigan in the Midwest, and the New York/
Pennsylvania and North/South Carolina areas of the East.
[[Page 8182]]
In these areas, losses will be more acute for propargite which is
used on 29% of the overall acreage, but up to 50% of the acreage in New
York and Michigan. Dicofol, on the other hand, averages use on only 5%
of the overall acreage, with a range of 3% - 9% in the major producing
states.
The most likely chemical alternatives are projected to be
fenbutatin-oxide, formetanate hydrochloride, and oxythioquinox. These
alternatives are more toxic than propargite and dicofol to some
beneficial insects in some states, but would likely be used as
replacements in most cases. There are mixed results on efficacy of the
alternatives compared to propargite and dicofol for controlling mite
pests from field trials. Many trials suggest the alternatives have
equal or superior efficacy, while some others suggest that propargite
and dicofol are superior. The Agency assumed a three percent yield loss
due to substitution of the alternatives, resulting in a projected loss
of nearly $16 million annually to current users of propargite and
dicofol. This may overstate potential yield loss because the data on
the relative efficacy of these pesticides are mixed. This figure does
not include losses from higher toxicity of alternatives to beneficial
insects, or increased development of resistance to the remaining
alternatives. Alternatives are approximately the same or lower cost
than propargite and dicofol, so that there would be little increased
cost for alternatives.
Figs. Since there are no miticide alternatives to propargite,
annual loss to growers could be up to $100,000 in those years when mite
pressures are high.
Wheat. Triadimefon use on wheat is insignificant. Mancozeb is used
on less than 5% of the wheat acres, and numerous alternatives, some of
which may be more efficacious than mancozeb, are available.
Grapes. Impacts will be limited to the loss of dicofol, which is
expected to cause only marginal impacts. Dicofol was not used in
California in 1994, and is not recommended by grape specialists because
its non-selective mode of action kills beneficial insects. The
preferred alternative (propargite) offers superior mite control while
not harming beneficial insects.
The Delaney clause prohibits establishing or maintaining section
409 FARs for any pesticide meeting the ``induces cancer'' standard,
without regard to economic impacts. However, this proposed action to
revoke section 408 tolerances is due to the combined effect of the
Delaney clause and EPA's coordination policy. EPA believes that the
impacts due to these proposed revocations (and ultimately the
cancellation of the registered uses) are less burdensome than the
alternative of maintaining these tolerances and registrations. If the
uses and 408 tolerances remain in effect without needed 409 FARs
(prohibited by the Delaney clause), lawfully treated foods could
potentially be adulterated, and subject to seizure, and the need for
costly Federal monitoring and enforcement would increase. The
possibility of adulterated foods could create uncertainty among
pesticide users and food processors and erode consumer confidence in
the food supply.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 (Pub. L. 96-354; 94 Stat.
1164, 5 U.S.C. 601 et seq.) requires EPA to analyze regulatory options
to assess the economic impact on small businesses, small governments,
and small organizations.
Regulating pesticide residues in food is, by its nature,
indiscriminate with respect to the size of the business or farm that
was the source of the food. The existence or absence of a tolerance,
and the levels at which they are set must logically apply to all food
available to U.S. consumers. It is also not feasible to segregate and
track food from different farm sizes, once it is in channels of trade.
Therefore, there is no potential regulatory option that would treat
small farms differently from large farms with respect to pesticide
tolerances.
The Delaney clause leaves no option to retain the applicable
section 409 FARs. The section 408 tolerances could either be revoked,
as called for by the coordination policy, or maintained in the absence
of the needed 409 FARs. It is not feasible to quantify the economic
impacts of retaining the 408 tolerances, for the reasons discussed
above, and therefore a comparison of the impacts of these two options
cannot be made. The Agency's choice to revoke the 408 tolerances will
not disproportionately affect small farms over large farms, since the
loss of a pesticide is generally proportional to the crop acreage.
C. Unfunded Mandates Reform Act and Executive Order 12875
Under Title II of the Unfunded Mandates Reform Act of 1995 (Pub.L.
104-4), this action does not result in the expenditure of $100 million
or more by any State, local or tribal governments, or by anyone in the
private sector, and will not result in any ``unfunded mandates'' as
defined by Title II. The costs associated with this action are
described in Unit IX. A of this notice.
Under Executive Order 12875 (58 FR 58093, October 28, 1993), EPA
must consult with representatives of affected State, local, and tribal
governments before promulgating a discretionary regulation containing
an unfunded mandate. This action does not contain any mandates on
States, localities or tribes and is therefore not subject to the
requirements of Executive Order 12875.
D. Paperwork Reduction Act
This order does not contain any information collection requirements
and therefore is not subject to the Paperwork Reduction Act of 1980, 44
U.S.C. 3501 et seq.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 26, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, it is proposed that 40 CFR, chapter I, part 180 be
amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 2l U.S.C. 346a and 371.
Sec. 180.163 [Amended]
2. In Sec. 180.163, in the paragraph beginning with ``5 parts per
million...,'' remove the entries ``apples,'' ``grapes,'' and ``plums
(fresh prunes),''.
Sec. 180.176 [Amended]
3. In Sec. 180.176 by revising the paragraphs beginning with ``25
parts per million...'' and ``5 parts per million...'' to read
respectively as follows:
Sec. 180.176 Coordination product of zinc ion and maneb; tolerances
for residues.
* * * * *
25 parts per million in or on the straws of barley and rye.
* * * * *
5 parts per million in or on celery; corn fodder and forage; and
the grains of barley and rye.
* * * * *
Sec. 180.213 [Amended]
4. By removing from the table in Sec. 180.213 the entry for
``sugarcane''.
[[Page 8183]]
Sec. 180.259 [Amended]
5. By removing from the table in Sec. 180.259 the entries for
``apples'' and ``figs''.
Sec. 180.410 [Amended]
6. By removing from the table in Sec. 180.410 the entries for
``Wheat, grain'', and ``Wheat, straw''.
[FR Doc. 96-4836 Filed 2-29-96; 8:45 am]
BILLING CODE 6560-50-F
