[Federal Register Volume 61, Number 188 (Thursday, September 26, 1996)]
[Rules and Regulations]
[Pages 50684-50685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24602]


      

[[Page 50683]]


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Part IX





Environmental Protection Agency





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40 CFR Part 180, et al.



Withdrawal of Pesticide Tolerance Revocations; Final Rule and Proposed 
Rule

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

[[Page 50684]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 185

[OPP-300438; FRL-5397-4]
RIN 2070-AC55


Withdrawal of Pesticide Tolerance Revocations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Rule.

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

SUMMARY: EPA is withdrawing final rules revoking 17 processed food 
tolerances. The Agency is withdrawing these revocations because they 
were based on two provisions of the Federal Food, Drug and Cosmetic Act 
that no longer are applicable to pesticide residues in food, 
specifically the Delaney clause and the ``ready-to-eat'' provision. 
Since the enactment of the Food Quality Protection Act, the basis for 
these revocations no longer exists as a matter of law. Accordingly, EPA 
is withdrawing these final rules.

EFFECTIVE DATE: This rule is effective September 26, 1996.

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, 110 Stat. 1489). 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)(A).

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.
    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 revocation actions. In 
the case of final revocations, many tolerances remain in effect because 
either EPA has delayed the effective date to allow for the filing of 
objections and hearing requests and to consider stay requests or EPA or 
a court has granted requests for stays of the effective date of 
revocation.

III. Today's Action

    EPA is today withdrawing a total of 17 revocations issued in 5 
separate actions. The tables in Unit IV of this notice list the 
specific tolerance revocations in those five actions that are being 
withdrawn. Revocations in those actions not listed in the table are not 
affected.
    1. Benomyl on tomato products and raisins.  This final revocation 
of section 409 tolerances (June 30, 1994, 59 FR 33685; July 14, 1993, 
58 FR 37862) was stayed by the D.C. Court of Appeals and the Agency 
reinstated the tolerances on September 12, 1994 (59 FR 46769). EPA is 
withdrawing the revocations of the tolerances on tomato products and 
raisins. Because EPA's reinstatement rule restablished the tomato 
products and raisin tolerances in full force, no amendment to the Code 
of Federal Regulations is ncessary inconjunction with the withdrawal of 
these revocations.
    2. Dichlorvos in bagged and packaged processed foods. This final 
revocation of the section 409 tolerance (November 10, 1993, 58 FR 
59663) was stayed by EPA on March 11, 1994 (59 FR 11556). EPA styled 
this revocation as a revision to the tolerance because the revocation 
had a delayed effective date. EPA is withdrawing that revision.
    3. Dicofol on dried tea. This final revocation of the section 409 
tolerance for dicofol (March 9, 1994, 59 FR 10993) was stayed by EPA on 
May 9, 1994 (59 FR 23799). EPA is withdrawing this revocation.
    4. March 1996 revocations. This group consists of final revocations 
of 26 section 409 tolerances for 7 pesticides (March 22, 1996, 61 FR 
11993)(FRL-5357-7). The revocations of 8 tolerances were stayed by EPA 
(May 20, 1996, 61 FR 22153). The remaining revocations became effective 
on May 21, 1996. EPA is today withdrawing the revocations of the 8 
tolerances for which stays were granted.
    5. July 1996 revocations. This group consists of final revocations 
of six section 409 tolerances and three section 408 tolerances for four 
pesticides (July 29, 1996, 61 FR 39527)(FRL-5388-2). These revocations 
are not yet effective. EPA is today withdrawing the revocations of five 
section 409 tolerances. The revocations of the remaining section 409 
tolerance and the section 408 tolerances will become effective on 
October 28, 1996.
    EPA is withdrawing 16 of the 17 revocations because they were based 
on the Delaney clause in section 409. Under the modified FFDCA, 
pesticide residues are no longer governed by

[[Page 50685]]

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 one revocation (imazalil/citrus oil) because it 
was based on EPA's conclusion that the tolerance in question is set on 
a not ready-to-eat food. EPA had reasoned that once the dilution 
associated with final processing of the ready-to-eat food 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 a ready-to-eat food have no basis 
in law and are therefore being withdrawn.
    In withdrawing these actions, 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 10 years, as required 
under the FQPA.

IV. Specific Revocations Being Withdrawn

    The specific actions EPA is withdrawing are presented in the two 
tables below.
    Table 1 lists section 409 tolerances for which final rules were 
issued on Delaney grounds.

      Table 1.--Revocations Which Were Based on the Delaney Clause      
------------------------------------------------------------------------
            Pesticide                  Commodity        40 CFR Citation 
------------------------------------------------------------------------
Acephate........................  food handling                  185.100
                                   establishments                       
Benomyl.........................  tomato products,               185.350
                                   raisins                              
Dichlorvos (DDVP)...............  bagged and packaged           185.1900
                                   processed foods                      
Dicofol.........................  dried tea                      185.410
Ethylene Oxide..................  ground spices                 185.2850
Iprodione.......................  dried ginseng,                185.3750
                                   raisins                              
Mancozeb........................  bran of oats                  185.6300
Propargite......................  dried figs, dried             185.5000
                                   tea                                  
Propylene oxide.................  cocoa, gums,                  185.5150
                                   processed nutmeats                   
                                   (except peanuts),                    
                                   processed spices                     
Triadimefon.....................  milled fractions of            185.800
                                   wheat                                
------------------------------------------------------------------------

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

    Table 2.--Revocation Which Was Based on Not Ready-To-Eat Grounds    
------------------------------------------------------------------------
            Pesticide                  Commodity        40 CFR Citation 
------------------------------------------------------------------------
Imazalil........................  citrus oil                    185.3650
------------------------------------------------------------------------

List of Subjects in Part 185

    Environmental protection, Food additives, Pesticides and pests

    Dated: September 19, 1996.

Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
    Accordingly, 40 CFR chapter I, part 185 is amended as follows:

PART 185--[AMENDED]

    The authority citation for part 185 continues to read as follows:

    Authority: 21 U.S.C. 346a and 371.


Sec. 185.410  [Amendment and Stay Withdrawn]

    2. The amendment removing Sec. 185.410, at 59 FR 10997, March 9, 
1994 and the subsequent stay of the effective date of that amendment, 
at 59 FR 23800, May 9, 1994 are withdrawn.


Sec. 185.1900  [Amendment and Stay Withdrawn]

    3. The revision of Sec. 185.1900 at 58 FR 59667, November 10, 1993 
and the subsquent stay of that revision at 59 FR 11556, March 11, 1994 
are withdrawn.


Sec. 185.2850  [Amendment and Stay Withdrawn]

    4. The amendment removing Sec. 185.2850 published at 61 FR 11993, 
March 22, 1996, and the subsequent stay at 61 FR 25153, May 20, 1996 
are withdrawn.


Secs. 185.5000, 185.5150 and 185.6300  [Amendment Withdrawn]

    5. The amendment to the text of Sec. 185.5000, and the amended text 
for Secs. 185.5150 and 185.6300, published at 61 FR 25153, May 20, 1996 
as a result of a partial stay of the removals published at 61 FR 11993, 
March 22, 1996 are confirmed as final.


Secs. 185.100, 185.800, 185.3650, 185.3750  [Amendment Withdrawn]

    6. The amendments removing Secs. 185.100, 185.800, 185.3650, and 
185.3750, at 61 FR 39542, July 29, 1996 are withdrawn.

[FR Doc. 96-24602 Filed 9-25-96; 8:45 am]
BILLING CODE 6560-50-F