[Federal Register Volume 59, Number 125 (Thursday, June 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15924]


[[Page Unknown]]

[Federal Register: June 30, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 185

[OPP-260054; FRL-4897-1]
RIN 2070-AB78

 

Mancozeb on Raisins; Removal of Food Additive Regulation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is removing the food additive regulation for mancozeb on 
raisins in 40 CFR 185.6300. Data show the food additive regulation is 
not needed because any residues of mancozeb on raisins are covered by 
the tolerance set for the corresponding raw commodity (grapes). This 
rule responds to a petition submitted by the Mancozeb Task Force, which 
requested that EPA revoke the food additive regulation for mancozeb on 
raisins.

EFFECTIVE DATE: This regulation is effective June 30, 1994. Written 
objections and/or request for a hearing may be submitted by August 1, 
1994.

ADDRESSES: Written objections and/or requests for a hearing, identified 
by the document control number [OPP-260054], may be submitted to the: 
Hearing Clerk (1900), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Copies of objections and/or hearing requests 
should also be submitted to the OPP docket for this action. Information 
supporting this regulaton is available through the Office of Pesticide 
Program's public docket. The docket is located in the 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. Comments or objections and/or hearing 
requests, identified by the document control number [OPP-260054], may 
be submitted to the Hearing Clerk. A copy of such comments should also 
be filed in the OPP docket for this action.

FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi, Office of 
Pesticide Programs (7508W), Environmental Protection Agency, 401 M St. 
SW., Washington, DC 20460. Office location and telephone number: 
Crystal Station #1, 2800 Crystal Drive, Arlington, VA, (703)-308-8010.

SUPPLEMENTARY INFORMATION:

I. Introduction

A. Statutory Background

    The Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301 et 
seq.) authorizes EPA to establish maximum permissible levels or 
``tolerances'' for pesticide residues in or on foods. The FFDCA has 
separate provisions for tolerances for raw agricultural commodities 
(RACs) and tolerances for processed foods. For pesticide residues in or 
on raw commodities, EPA establishes tolerances, or exemptions from the 
requirement of tolerances when appropriate, under section 408. 21 
U.S.C. 346a. In processed foods, food additive regulations setting 
maximum permissible levels of pesticide residues are established under 
section 409. 21 U.S.C. 348. Section 409 tolerances are required, 
however, only for certain pesticide residues in processed food. Under 
section 402(a)(2) of the FFDCA, no section 409 tolerance is required if 
any pesticide residue in a processed food is equal to or below the 
tolerance for that pesticide in or on the RAC from which it was 
derived. 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 tolerance is only necessary to prevent foods from being 
deemed adulterated when the concentration of the pesticide residue in a 
processed food is greater than the tolerance prescribed for the raw 
agricultural commodity, or if the processed food itself is treated or 
comes in contact with a pesticide.

B. Petitions to Revoke

    In 1989, the Natural Resources Defense Council, the State of 
California, Public Citizen, the AFL-CIO, and several individuals filed 
a petition requesting that EPA revoke several food additive regulations 
(including the food additive regulation for mancozeb on raisins) on the 
grounds that the regulations violated the Delaney clause in FFDCA 
section 409. In the Federal Register of July 14, 1993 (58 FR 37862), 
EPA revoked the food additive regulation for mancozeb on raisins; 
however, that revocation has been stayed. Published elsewhere in the 
rules and regulations section of this issue of the Federal Register is 
EPA's latest Order responding to the petition. That Order addresses 
food additive regulations other than mancozeb on raisins.
    On January 23, 1993, the Mancozeb Task Force, which includes E.I. 
du Pont de Nemours Company, Elf Atochem North America, Inc., and Rohm 
and Haas Co., filed a petition requesting revocation of the food 
additive regulations for raisins and the brans of barley, oats, rye, 
and wheat. The petition was based on the assertion that the food 
additive regulations were not needed since there was no concentration 
of residues in these processed commodities, and, consequently, the 
corresponding tolerances on the raw agricultural commodities are 
adequate to cover residues in both raw and processed foods.
    In the Federal Register of May 19, 1993 (58 FR 29318), EPA issued 
the receipt of that petition in a notice of availability and requested 
public comments on the petitioner's request and supporting materials. 
Contents of and comments received on that petition regarding the 
requested action on raisins are described in the next section. The 
Agency has not yet finished its review of the data submitted for the 
brans of barley, oats, rye, and wheat.

II. Revocation of the Food Additive Regulation for Mancozeb on 
Raisins

    The Mancozeb Task Force's petition requests revocation of the 
section 409 tolerance for mancozeb on raisins, on the basis of data 
showing that residues in grapes do not concentrate in raisins. The Task 
Force cited two studies reflecting six different use patterns. In all 
cases, mancozeb residues were lower in raisins than in the raw 
commodity, grapes. In addition to the petition, the Mancozeb Task Force 
filed comments in response to the May 19, 1993 Federal Register notice, 
where they reiterated their position and the significance of the 
supporting data. No other comments were filed in response to the May 
19, 1993 notice of availability.
    EPA agrees with the petitioner's assertion that the food additive 
regulation for mancozeb on raisins is not needed since the data show 
that levels of mancozeb on typically processed raisins are lower than 
those in the unprocessed grapes. The study used as a basis for setting 
the original food additive regulation was not reflective of the current 
typical processing practices which include washing of raisins as one of 
the processing steps. Subdivision O Residue Chemistry Guidelines 
require that the processing data submitted reflect typical processing 
practices (Refs. 1 and 2: U.S. EPA, Pesticide Assessment Guidelines, 
Subdivision O, Residue Chemistry, p. 21, October 1982 and Considine 
Considine, eds., Foods and Food Production Encyclopedia, p. 1640 
(1982)). Information currently available confirms that raisins are 
typically washed as a part of normal processing. In 1990, prior to the 
submission of their petition, the Mancozeb Task Force submitted a new 
processing study which did simulate commercial processing including 
washing of the raisins (Ref. 3: U.S. EPA, MRID 41483801). In an EPA 
review of those data, completed on August 11, 1992, EPA concluded that 
``residues of mancozeb concentrated up to 30x in raisin waste but did 
not concentrate in raisins, wet pomace, dry pomace, or juice'' (Ref. 4: 
U.S. EPA, Memorandum from Edward Zager, Health Effects Division, EPA to 
Lois Rossi, Reregistration Branch, EPA, ``Mancozeb Update to 
Reregistration Standard,'' p. 106 (August 11, 1992)). A copy of this 
EPA review is located in the OPP docket, the location of which is given 
under the ``Addresses'' section earlier in this document. EPA 
determined that ``the established food additive tolerance for mancozeb 
on raisins is not needed and should be revoked'' (Ref. 5: Same as Ref. 
4, p. 107).
    EPA's current policy mandates that we compare the residues in 
processed commodities to the residues in the raw agricultural 
commodities to determine whether concentration occurs. In this case, 
the residues in raisins, which have been washed during normal 
commercial processing are compared to the residues in unwashed grapes. 
Since the data show that levels of mancozeb on typically processed 
raisins are lower than those in the unprocessed grapes, EPA is granting 
the Mancozeb Task Force's petition as to the revocation of the section 
409 food additive regulation for mancozeb on raisins.

III. Procedural Matters

A. Filing of Objections and Requests for Hearings

    Any person adversely affected by this Order may file written 
objections to the Order, and may include with any such objection a 
written request for an evidentiary hearing on the objection. Such 
objections must be submitted to the Hearing Clerk at the address listed 
under ``ADDRESSES'' on or before August 1, 1994. Copies of such 
objections should be filed with the OPP docket for this action. 
Regulations applicable to objections and requests for hearings are set 
out at 40 CFR parts 178 and 179. Those regulations require, among other 
things, that objections specify with particularity the provisions of 
the Order objected to, the basis for the objections, and the relief 
sought. Additional requirements as to the form and manner of the 
submission of objections are set out at 40 CFR 178.25. The 
Administrator will respond as set forth in 40 CFR 178.30, 178.35 and/or 
178.37 to objections that are not accompanied by a request for 
evidentiary hearing.
    A person may include with any objection a written request for an 
evidentiary hearing on the objection. A hearing request must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on each such issue, and a summary of any 
evidence relied upon by the objector. A copy of any hearing requests 
filed with the Hearing Clerk should also be filed with the OPP docket 
for this action. Additional requirements as to the form and manner of 
submission of requests for an evidentiary hearing are set out at 40 CFR 
178.27. Under 40 CFR 178.32(c), the Administrator, where appropriate, 
will make rulings on any issues raised by an objection if such issues 
must be resolved prior to determining whether a request for an 
evidentiary hearing should be granted. The Administrator will respond 
to requests for evidentiary hearings as set forth in 40 CFR 178.30, 
178.32, 178.35, 178.37, and/or 179.20. Under 40 CFR 178.32(b), a 
request for an evidentiary hearing on an objection will be granted if 
the objection and request have been properly submitted and if the 
Administrator determines that the material submitted show: (1) There is 
a genuine and substantial issue of fact for resolution at a hearing; 
(2) there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor; and (3) resolution of one or 
more of the factual issues in the manner sought by the person 
requesting the hearing would be adequate to justify the action 
requested.
    Any person wishing to comment on any objections or requests may 
submit such comments to the Hearing Clerk on or before August 15, 1994. 
A copy of such comments should also be filed with the OPP docket for 
this action.

IV. Executive Order 12866

    Under Executive Order 12866 (58 FR 1735, October 4, 1993), EPA must 
determine whether the regulatory action is ``significant'' and 
therefore subject to all the requirements of the Executive Order (or 
review by the Office of Budget and Management). Section 3(f) defines 
``significant'' as those actions likely to (1) have an annual effect on 
the economy of $100 million or more, or adversely or materially affect 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments or communities; (2) create serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) materially alter the budgetary impacts of entitlements, grants, 
user fees, or loan programs; or (4) raise novel legal or policy issues 
arising out of legal mandates, the President's priorities, or the 
principles set forth in this Executive Order.
    The Agency has determined that this rule is not ``significant'' 
within the meaning of that term as defined in section 3(f) of Executive 
Order 12866. EPA is taking this action because it has determined that 
the subject food additive regulation is not needed; the Agency believes 
that mancozeb, when used according to the label instructions, will not 
result in residues on raisins that exceed the section 408 tolerance 
prescribed to cover mancozeb residues from the use on grapes. 
Therefore, the Agency expects no economic impact will result.

V. 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. As explained above, the Agency believes there 
will be no economic impact on small businesses, governments and 
organizations.

VI. Paperwork Reduction Act

    This order does not contain any information collection requirements 
subject to review by Office of Management and Budget under the 
Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.

List of Subjects in CFR Part 185

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Food additives, Pesticides and pests, Records 
and recordkeeping.

Dated: June 18, 1994.

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

    Therefore, 40 CFR part 185 is amended as follows:

PART 185--[AMENDED]

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

    Authority: 21 U.S.C. 346a and 348.

Sec. 185.6300   [Amended]

    2. By amending Sec. 185.6300 Zinc ion and maneb coordination 
product in the list at the end of the section by removing the entry for 
raisins.

[FR Doc. 94-15924 Filed 6-28-94; 11:46 am]
BILLING CODE 6560-50-F