[Federal Register Volume 61, Number 188 (Thursday, September 26, 1996)]
[Proposed Rules]
[Pages 50686-50688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24603]



  Federal Register / Vol. 61, No. 188 / Thursday, September 26, 1996 / 
Proposed Rules  

[[Page 50686]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 186

[OPP-300439; FRL-5397-5]
RIN 2070-AC55


Withdrawal of Proposed Revocations of Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of proposed revocations.

-----------------------------------------------------------------------

SUMMARY: EPA is withdrawing the proposed revocations of a number of 
pesticide tolerances established under the Federal Food, Drug and 
Cosmetic Act (FFDCA). The enactment of the Food Quality Protection Act 
removed the legal basis for these revocations. Accordingly, EPA is 
withdrawing these proposed rules. EPA is also withdrawing the various 
proposed decisions to retain certain tolerances because the obligation 
to make decisions on these tolerances has been removed.

FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi-Glosson, 
Special Review Branch, (7508W), Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460; telephone number: (703) 308-8028; e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. 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). 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 and the U.S. 
Department of Agriculture.
    The FFDCA's provisions governing pesticides were significantly 
amended on August 3, 1996 by the enactment of the Food Quality 
Protection Act of 1996 (FQPA) (Pub. L. 104-170). The FQPA amendments 
were effective immediately.
    Among other things, the FQPA amends the FFDCA to bring all EPA 
pesticide tolerance-setting activities under a single section of the 
statute -- section 408 -- and added a new safety standard and new 
procedures in that section. Previously, regulatory authority over 
pesticides in the FFDCA had been divided between sections 408 and 409. 
The division of pesticides between sections 408 and 409 had been the 
subject of some controversy because of the differing safety standards 
in the two sections. Of particular significance was the inclusion in 
section 409, but not section 408, of the Delaney anti-cancer clause. 
The FQPA converted all existing section 409 tolerances for pesticide 
residues in processed food into section 408 tolerances. 21 U.S.C. 
346a(j).
    The FQPA also amended the so-called ``flow-through'' provision in 
section 402(a)(2) that governed whether tolerances for pesticide 
residues in raw agricultural commodities apply to pesticide residues in 
processed foods. Before being amended, the FFDCA had specified that a 
pesticide residue in a processed food would not render that food 
adulterated if, among other things, the level of the residue in the 
processed food ``when ready to eat'' is below the tolerance level for 
the pesticide in the precursor raw agricultural commodity. The FQPA 
maintained this flow-through concept that raw agricultural commodity 
tolerances would apply to pesticides in processed food but modified 
existing law by dropping the requirement that the level of residue in 
the processed food be evaluated at the ready-to-eat stage. 21 U.S.C. 
346a(a)(2)(C).

II. Regulatory Background

    In response to the decision in Les v. Reilly, 968 F.2d 985 (9th 
Cir.), cert. denied, 113 S.Ct. 1361 (1993), in which the U.S. Court of 
Appeals, Ninth Circuit held there was no de minimis exception to the 
Delaney clause, EPA began to initiate revocation actions against those 
existing section 409 tolerances which were inconsistent with the 
Delaney clause. EPA also began identifying those section 408 tolerances 
which would have to be revoked under EPA's coordination policy. Under 
the coordination policy, EPA will not permit use of a pesticide on a 
raw agricultural commodity if tolerances needed to prevent the 
adulteration of processed food can not be approved. Application of this 
policy was triggered by the revocation of various section 409 
tolerances on Delaney clause grounds.
    Further, on February 9, 1995, EPA entered into a court-approved 
consent decree in which EPA agreed to a timetable for deciding whether 
to revoke an extensive list of section 408 and 409 tolerances. Under 
the consent decree, EPA has taken a number of proposed and final 
revocation actions.

III. Today's Action

    EPA is today withdrawing certain proposed revocations included in 
two separate proposals:
    1. September 21, 1995 Proposed Revocations (60 FR 49141)(FRL-4977-
3). Proposed revocation of 36 section 409 tolerances (feed additives) 
for 16 pesticides (Appendix I, Group C). EPA is withdrawing the 
proposed revocations of 11 of these tolerances. EPA is not withdrawing 
the remaining 25 proposed revocations in the September 21, 1995 notice 
and, in the future, EPA will complete action on these proposals.
    EPA is withdrawing 2 of the 11 proposed revocations because they 
were based on the Delaney clause in section 409. Under the modified 
FFDCA, pesticide residues are no longer governed by section 409 or its 
Delaney clause and all of the section 409 tolerances which were still 
in effect on August 3, 1996 were converted to section 408 tolerances. A 
section 408 processed food tolerance cannot be revoked on the basis of 
the Delaney clause in section 409 and thus all pending revocations 
premised solely on the Delaney clause are being withdrawn as lacking 
any legal basis.
    EPA is withdrawing 9 proposed revocations because they were based 
on EPA's conclusion that the tolerances in question are set on not 
ready-to-eat foods. EPA had reasoned that once the dilution associated 
with final processing of ready-to-eat foods is taken into account the 
ready-to-eat food is unlikely to contain residues above the tolerance 
for the precursor raw commodity and hence no section 409 tolerance is 
necessary to prevent the processed food from being deemed adulterated. 
Because the FQPA removed the ready-to-eat factor from the flow-through 
provision governing the applicability of raw agricultural commodity 
tolerances to processed foods, revocations relying on the dilution 
which occurs in processing to a ready-to-eat food have no basis in law 
and are therefore being withdrawn.
    In the future, EPA will complete action on the remaining 25 
proposed revocations, which were based on determinations that the 
pesticide does not concentrate in the processed feed or that the 
processed feed is no longer a significant animal feed for which a 
tolerance is necessary. These determinations are not affected by the 
enactment of the FQPA.
    2. March 1, 1996 Proposed Revocations (61 FR 8173)(FRL-5351-6). 
Proposed revocation of 9 section 408 tolerances under the coordination

[[Page 50687]]

policy, and the proposed decision to retain 32 section 408 tolerances.
    EPA proposed to revoke 9 section 408 tolerances on the ground that 
the associated pesticide use needed a section 409 tolerance as well as 
a section 408 tolerance to prevent the adulteration of processed food 
and such section 409 tolerance is barred by the Delaney clause. Because 
the FQPA has moved authority for regulation of all pesticide residues 
into section 408, the Delaney clause in section 409 no longer bars the 
establishment of needed processed food tolerances. Thus there is no 
longer any basis for EPA to apply its coordination policy to this 
situation and the proposed revocations are withdrawn.
    In the same notice, EPA proposed to retain 32 section 408 
tolerances. EPA had issued a proposal to retain these tolerances 
because the consent decree mentioned in Unit II of this document 
required EPA to announce its decision regarding such tolerances and EPA 
believed revocation was not warranted. As provided by its own terms, 
the consent decree has now been superseded by the FQPA and EPA and all 
parties to the litigation have filed a joint motion seeking dismissal 
of the case and termination of the consent decree. Accordingly, EPA is 
withdrawing its proposed decisions to retain section 408 tolerances 
because there is no obligation on the Agency to make a decision 
regarding those specific tolerances.
    In withdrawing these proposed revocations, EPA would like to make 
clear two points. First, because these revocations concerned legal 
requirements no longer applying to pesticides, EPA will not assert a 
preclusive effect as to any factual findings regarding such 
requirements. Second, today's action should not be interpreted to mean 
that EPA has made a ``safety finding'' as to the pesticide tolerances 
in question under the FFDCA, as amended by the FQPA. EPA will 
systematically review the safety of all the tolerances within the next 
ten years, as required under the FQPA.

IV. Specific Proposals Being Withdrawn

    The specific actions EPA is withdrawing are presented in three 
tables.
    Table 1 lists section 409 tolerances for which a proposed 
revocation was issued on Delaney grounds.

    Table 1.--Proposed Revocations That Were Based on Delaney Grounds   
------------------------------------------------------------------------
                                                                40 CFR  
             Pesticide                      Commodity          citation 
------------------------------------------------------------------------
Simazine...........................  Sugarcane molasses         186.5350
Tetrachlorvinphos..................  Feed of beef, dairy         186.950
                                      cattle, and horses                
------------------------------------------------------------------------

    Table 2 lists section 409 tolerances for which a proposed 
revocation was issued on not ready- to-eat grounds.

   Table 2.--Proposed Revocations That Were Based on Not Ready-To-Eat   
                                 Grounds                                
------------------------------------------------------------------------
                                                                40 CFR  
             Pesticide                      Commodity          citation 
------------------------------------------------------------------------
Acephate...........................  Cottonseed hulls            186.100
Benomyl............................  Dried citrus pulp,          186.350
                                      rice hulls                        
Diflubenzuron......................  Soybean hulls              186.2000
Imazalil...........................  Dried citrus pulp          186.3650
Iprodione..........................  Rice bran, rice hulls      186.3750
Mancozeb...........................  Milled wheat fractions     186.6300
Thiodicarb.........................  Soybean hulls              186.5650
------------------------------------------------------------------------

    Table 3 lists section 408 tolerances for which EPA made a proposed 
determination to either retain or revoke based upon its coordination 
policy.

                     Table 3.--Proposed Revocations and Decisions on Section 408 Tolerances                     
----------------------------------------------------------------------------------------------------------------
               Pesticide                         Commodity           40 CFR Citation        Proposed Action     
----------------------------------------------------------------------------------------------------------------
Acephate...............................  Cottonseed                           180.108  Retain                   
Alachlor...............................  Sunflower seed                       180.249  Retain                   
Benomyl................................  Citrus                               180.294  Retain                   
                                         Rice                                 180.294  Retain                   
Captan.................................  Grapes,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 (direct                 180.151  Retain                   
                                          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                   

[[Page 50688]]

                                                                                                                
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                   
----------------------------------------------------------------------------------------------------------------

List of Subjects

40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, reporting and 
recordkeeping requirements.

40 CFR Part 186

    Environmental protection, Animal feeds, Pesticide and pests.
    Accordingly, for the reasons set out in the preamble above, EPA is 
withdrawing the following:
    1. The proposed rule published at 61 FR 8174, March 1, 1996 
proposing changes to part 180 is withdrawn.
    2. The amendments proposing to remove Secs. 186.100, 186.350, 
186.950, 186.2000, 186.3650, 186.3750 and 186.5350, 186.5650, and 
186.6300, published at 60 FR 49141, September 21, 1995 are withdrawn.

    Dated: September 19, 1996.

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

[FR Doc. 96-24603 Filed 9-25-96; 8:45 am]
BILLING CODE 6560-50-F