[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]



     

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Part V





Environmental Protection Agency





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40 CFR Part 180



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Pesticide Tolerances, Proposed Revocations; Proposed Rule

  Federal Register / Vol. 61, No. 42 / Friday, March 1, 1996 / Proposed 
Rules  
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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: [email protected]. 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, nazmi@[email protected].
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   
------------------------------------------------------------------------
                                                                        
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         
------------------------------------------------------------------------


    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-D[email protected]


    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