[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Proposed Rules]
[Pages 3057-3060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1356]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185, and 186

[OPP-300551; FRL-5743-8]


Revocation of Tolerances and Exemptions From the Requirement of a 
Tolerance for Canceled Pesticide Active Ingredients

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to revoke the tolerances and exemptions 
from the requirement of a tolerance listed in this document. EPA is 
proposing to revoke these tolerances and exemptions because there are 
no active registrations for the pesticide chemicals covered by these 
tolerances and exemptions.

DATES: Written comments should be submitted to EPA by March 23, 1998.


[[Page 3058]]


ADDRESSES: By mail, submit written comments to the Public Information 
and Records Integrity Branch, Information Resources and Services 
Division (7506C), Office of Pesticide Programs, 401 M St., SW., 
Washington, DC 20460. In person, deliver comments to Rm. 1132, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under Unit V. of this document. No Confidential 
Business Information (CBI) should be submitted through e-mail.

FOR FURTHER INFORMATION CONTACT: By mail: Jeff Morris, Special Review 
and Reregistration Division (7508W), Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location, telephone 
number, and e-mail address: Special Review Branch, Crystal Station #1, 
3rd floor, 2800 Crystal Drive, Arlington, VA, Telephone: (703) 308-
8029; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Legal Authority

    The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et 
seq., as amended by the Food Quality Protection Act of 1996 (FQPA), 
Pub. L. 104-170, authorizes the establishment of tolerances (maximum 
residue levels), exemptions from the requirement of a tolerance, 
modifications in tolerances, and revocation of tolerances for residues 
of pesticide chemicals in or on raw agricultural commodities and 
processed foods pursuant to section 408, 21 U.S.C. 346(a), as amended. 
Without a tolerance or exemption, food containing pesticide residues is 
considered to be unsafe and therefore ``adulterated'' under section 
402(a) of the FFDCA, and hence may not legally be moved in interstate 
commerce (21 U.S.C. 331(a) and 342(a)). For a pesticide to be sold and 
distributed, the pesticide must not only have appropriate tolerances or 
exemptions under the FFDCA, but also must be registered under section 3 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 
U.S.C. 136a.
    Under FFDCA section 408(f), if EPA determines that additional data 
are needed to support continuation of a tolerance, EPA may require that 
those data be submitted by registrants under FIFRA section 3(c)(2)(B), 
by producers under the Toxic Substances Control Act (TSCA) section 4, 
or by other persons by order after opportunity for hearing. EPA intends 
to use Data Call-In (DCI) procedures for pesticide registrants, and 
FFDCA section 408(f)(1)(C) orders for non-registrants as its primary 
means of obtaining data. In general, EPA does not intend to use the 
procedures under TSCA section 4, because such procedures generally will 
not be applicable to pesticides.
    Section 408(f) of the FFDCA states that if EPA determines that 
additional data are needed to support the continuation of an existing 
tolerance or exemption, EPA shall issue a notice that: (1) Requests 
that any parties identify their interest in supporting the tolerance or 
exemption, (2) solicits the submission of data and information from 
interested parties, (3) describes the data and information needed to 
retain the tolerance or exemption, (4) outlines how EPA will respond to 
the submission of supporting data, and (5) provides time frames and 
deadlines for the submission of such data and information.

II. Regulatory Background

    It is EPA's general practice to propose revocation of tolerances 
for residues of pesticide active ingredients for which FIFRA 
registrations no longer exist. In accord with FFDCA section 408, 
however, EPA will not revoke any tolerance or exemption proposed for 
revocation if any person will commit to support its retention, and if 
retention of the tolerance will meet the tolerance standard established 
under FQPA. Generally, interested parties commit to support the 
retention of such tolerances in order to permit treated commodities to 
be legally imported into the United States, since raw or processed food 
or feed commodities containing pesticide residues not covered by a 
tolerance or exemption are considered to be adulterated.
    Tolerances and exemptions established for pesticide chemicals with 
FIFRA registrations cover residues in or on both domestic and imported 
commodities. To retain these tolerances and exemptions for import 
purposes only, EPA must make a finding that the tolerances and 
exemptions are safe. To make this safety finding, EPA needs data and 
information indicating that there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide residues 
covered by the tolerances and exemptions.
    EPA determines on a case-by-case basis the data required to 
determine that a tolerance or exemption is safe, and in general 
requires the same technical chemistry and toxicology data for 
tolerances without related U.S. registrations as are required to 
support U.S. food-use registrations and any resulting tolerances or 
exemptions. (See 40 CFR part 158 for EPA's data requirements to support 
domestic use of a pesticide and the establishment and maintenance of a 
tolerance. At a future date, EPA will issue its import tolerance 
policy.) In most cases, EPA also requires residue chemistry data (crop 
field trials) that are representative of growing conditions in 
exporting countries in the same manner that EPA requires representative 
residue chemistry data from different U.S. regions to support domestic 
use of a pesticide and any resulting tolerance(s) or exemption(s). Good 
Laboratory Practice (GLP) requirements for studies submitted in support 
of tolerances and exemptions for import purposes only are the same as 
for domestic purposes; i.e., the studies are required to either fully 
meet GLP standards, or have sufficient justification presented to show 
that deviations from GLP requirements do not significantly affect the 
results of the studies.
    Monitoring and enforcement of pesticide tolerances and exemptions 
are carried out by the U.S. Food and Drug Administration (FDA) and the 
U.S. Department of Agriculture (USDA). This includes monitoring for 
pesticide residues in or on commodities imported into the United 
States.

III. Proposed Actions

    This document proposes to revoke the tolerances and exemptions from 
the requirement of a tolerance listed at the regulatory text of this 
document. EPA is proposing these revocations because EPA has cancelled 
the registrations for the pesticide chemicals associated with the 
tolerances and exemptions, and it is EPA's general practice to propose 
revocation of those tolerances and exemptions for residues of pesticide 
chemicals for which there are no active registrations.

IV. Effective Date

    EPA proposes that these actions become effective 30 days following 
publication in the Federal Register of a final rule revoking the 
tolerances. EPA is proposing this effective date because EPA believes 
that all existing stocks of pesticide products labeled for the uses 
associated with the tolerances proposed for revocation were exhausted 
more than 1 year ago, giving ample time for any treated fresh produce 
to clear trade channels.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this proposal, and that are 
in the channels of trade following the tolerance revocations, shall be 
subject to FFDCA section 408(1)(5), as established by FQPA. Under this 
section, any

[[Page 3059]]

residue of these pesticides in or on such food shall not render the 
food adulterated so long as it is shown to the satisfaction of FDA 
that: (1) The residue is present as the result of an application or use 
of the pesticide at a time and in a manner that was lawful under FIFRA, 
and (2) the residue does not exceed the level that was authorized at 
the time of the application or use to be present on the food under a 
tolerance or exemption from a tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates that the 
pesticide was applied to such food.

V. Public Comment Procedures

    EPA invites interested persons to submit written comments, 
information, or data in response to this proposed rule. After 
consideration of comments, EPA will issue a final rule. Such rule will 
be subject to objections. Failure to file an objection within the 
appointed period will constitute waiver of the right to raise in future 
proceedings issues resolved in the final rule.
    Comments must be submitted by March 23, 1998. Comments must bear a 
notation indicating the docket number OPP-300551. Three copies of the 
comments should be submitted to either location listed under 
``ADDRESSES'' at the beginning of this proposal.
    This proposal provides 60 days for any interested person to request 
that a tolerance be retained. If EPA receives a comment to that effect, 
EPA will not revoke the tolerance, but will take steps to ensure the 
submission of supporting data and will issue an order in the Federal 
Register under FFDCA section 408(f). The order would specify the data 
needed, the time frames for its submission, and would require that 
within 90 days some person or persons notify EPA that they will submit 
the data. Thereafter, if the data are not submitted as required, EPA 
will take appropriate action under FIFRA or FFDCA.
    Information submitted as a comment concerning this proposal may be 
claimed confidential by marking any or all of that information as CBI. 
EPA will not disclose information so marked, except in accordance with 
procedures set forth in 40 CFR part 2. A second copy of such comments, 
with the CBI deleted, also must be submitted for inclusion in the 
public record. EPA may publicly disclose without prior notice 
information not marked confidential. A record has been established for 
this proposal under docket number OPP-300551 (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 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in room 1132 of the Public 
Information and Records Integrity Branch, Information Resources and 
Services 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:
    [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 proposal, 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 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 
proposal.

VI. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA 
must determine whether the regulatory action is ``significant'' and 
therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
E.O. 12866 defines a ``significant regulatory action'' as an action 
that is likely to result in a rule: (1) Having an annual effect on the 
economy of $100 million or more, or adversely and materially affecting 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or state, local, or tribal 
governments or communities; (2) creating serious inconsistency or 
otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlement, 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or (4) raising novel legal or policy issues arising 
out of legal mandates, the President's priorities, or principles set 
forth in this Executive Order.
    Pursuant to the terms of E.O. 12866, EPA has determined that this 
proposed rule is not a significant regulatory action and, since this 
action does not impose any information collection requirements subject 
to approval under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), 
it is not subject to review by OMB. In addition, this action does not 
impose any enforceable duty, or contain any ``unfunded mandates'' as 
described in Title II of the Unfunded Mandates Reform Act of 1995 (Pub. 
L. 104-4), or require prior consultation as specified by Executive 
Order 12875 (58 FR 58093, October 28, 1993), entitled Enhancing the 
Intergovernmental Partnership, or special considerations as required by 
Executive Order 12898 (59 FR 7629, February 16, 1994).

B. Regulatory Flexibility

    The Regulatory Flexibility Act (RFA) generally requires an agency 
to conduct a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements unless the agency certifies 
that the rule will not have a significant economic impact on a 
substantial number of small entities. Small entities include small 
businesses, small not-for-profit enterprises, and small governmental 
jurisdictions. EPA believes that revocation of a tolerance after use of 
the pesticide becomes illegal in this country will generally not have a 
significant impact on a substantial number of small entities.
    In the case of domestically grown food, the tolerances proposed for 
revocation by this proposal will have no economic impact. The 
associated pesticide registered uses have already been canceled. Since 
U.S. growers may no longer use these pesticides on such crops, revoking 
the tolerances should have no effect on food grown in the U.S. after 
cancellation of registered uses. As for food legally treated under 
FIFRA before the cancellation occurred, it will not be considered 
adulterated if the residue level complies with the tolerance in effect 
at the time of treatment.
    Revocation has a greater potential to affect foreign-grown food, 
since the uses of a pesticide prohibited in the U.S. may still be 
lawful in other countries. If foreign growers use a pesticide on crops 
for which there is no tolerance, the food they grow will be considered 
adulterated and subject to detention and regulatory action when offered 
for import or imported into the United States. However, while 
revocation may have an economic effect on foreign growers that export 
food to the U.S., the RFA is concerned only with the effect of U.S. 
regulations on domestic small entities.
    Revocation may also have an effect on domestic importers of 
foreign-grown

[[Page 3060]]

 food to the extent their suppliers use pesticides in ways that result 
in residues no longer allowed in the U.S. Theoretically, U.S. importers 
could face higher food prices and transactions costs. However, EPA 
believes that the effect on U.S. importers will be minimal. The 
revocation of a particular tolerance is unlikely to have a significant 
impact on the price of a commodity on the international market. 
Transaction costs may occur as a result of having to find alternative 
suppliers of food untreated with pesticides for which tolerances were 
revoked. Affected importers, however, would have the options of finding 
other suppliers in the same country or in other countries, or inducing 
the same supplier to switch to alternative pest controls. Given the 
existence of these options, EPA expects any price increases or 
transaction costs resulting from revocations will be minor. As to the 
pesticide uses involved in this action, EPA has reviewed its available 
data on imports and foreign pesticide usage and concludes that there is 
a reasonable international supply of food not treated with these 
pesticides, generally within the same countries from which the relevant 
commodities are currently imported.
    Moreover, whatever the effect on U.S. importers of foreign-grown 
food, EPA believes that it would be inappropriate and inconsistent with 
the purpose of the RFA to ameliorate that effect. To the extent any 
adverse effect occurs, it will be the result of foreign growers using 
pesticides in ways or on crops not allowed in the U.S. Domestic growers 
have no choice but to refrain from using pesticides in ways or on crops 
prohibited by U.S. law. U.S. growers and those who follow them in the 
chain of commerce distributors and consumers will bear the cost of 
complying with U.S. law. For EPA to somehow address the economic effect 
of the revocation on U.S. distributors of foreign-grown food would 
potentially give those distributors a competitive advantage over 
distributors of U.S.-grown food, and that advantage could potentially 
translate to a competitive advantage for foreign growers over domestic 
growers. The RFA was enacted in part to preserve competition in the 
marketplace, and it would be perverse to implement it in a way that 
creates competitive inequities, particularly between U.S. and foreign 
products. Finally, EPA notes that potential increased costs to 
importers would not be cognizable as grounds for not revoking the 
tolerances.
    Based on the above analysis, I certify that this action will not 
have a significant economic impact on a substantial number of small 
entities.

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 185

    Environmental protection, Food additives, Pesticide and pests.

40 CFR Part 186

    Environmental protection, Animal feeds, Pesticide and pests.

    Dated: January 12, 1998.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
    Therefore, it is proposed that 40 CFR parts 180, 185, and 186 be 
amended as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as 
follows:

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

    b. In Sec. 180.2, by revising paragraph (a) to read as follows:


Sec. 180.2   Pesticide chemicals considered safe.

    (a) As a general rule, pesticide chemicals other than benzaldehyde 
(when used as a bee repellant in the harvesting of honey), ferrous 
sulfate, lime, lime-sulfur, potassium sorbate, sodium carbonate, sodium 
chloride, sodium hypochlorite, sulfur, and when used as plant 
desiccants, sodium metasilicate (not to exceed 4 percent by weight in 
aqueous solution) and when used as postharvest fungicide, citric acid, 
fumaric acid, oil of lemon, and oil of orange are not for the purposes 
of section 408(a) of the Act generally recognized as safe.
 * * * * *


Secs. 180.115, 180.118, 180.144, 180.148, 180.158, 180.159, 180.162, 
180.171, 180.219, 180.239, 180.263, 180.277, 180.305, and 
180.306  [Removed]

    c. By removing Secs. 180.115, 180.118, 180.144, 180.148, 180.158, 
180.159, 180.162, 180.171, 180.219, 180.239, 180.263, 180.277, 180.305, 
and 180.306.


Sec. 180.319  [Amended]

    d. By removing from the table in Sec. 180.319, the entire entry for 
Isopropyl carbanilate (IPC).


Secs. 180.321, 180.325, 180.326, 180.347, 180.357, 180.374  [Removed]

    e. By removing Secs. 180.321, 180.325, 180.326, 180.347, 180.357, 
180.374.
    f. In Sec. 180.1001, by revising paragraph (b)(1), removing 
paragraphs (b)(6) and (b)(9) and redesignating paragraphs (b)(7), 
(b)(8), and (b)(10) as (b)(6), (b)(7), and (b)(8), respectively and 
removing from the table in paragraph (d) the entry for Fumaric acid to 
read as follows:


Sec. 180.1001   Exemptions from the requirement of a tolerance.

 * * * * *
    (b)  *    *    *
    (1) The following copper compounds: Bordeaux mixture, basic copper 
carbonate (malachite), copper hydroxide, copper-lime mixtures, copper 
oxychloride, copper octanoate, copper sulfate basic, copper sulfate 
pentahydrate, cupric oxide, cuprous oxide. These compounds are used 
primarily as fungicides.
 * * * * *


Secs. 180.1010, 180.1018, 180.1030, 180.1031, 180.1034, 180.1055, 
180.1059, 180.1061, 180.1067, 180.1079, 180.1081, and 180.1085   
[Removed]

    g. By removing Sec. 180.1010, 180.1018, 180.1030, 180.1031, 
180.1034, 180.1055, 180.1059, 180.1061, 180.1067, 180.1079, 180.1081, 
and 180.1085.

PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:

    Authority: 21 U.S.C. 348.

Secs. 185.1350, 185.1650, 185.3600, 185.4250, 185.4300, and 
185.4800  [Removed]

    b. By removing Secs. 185.1350, 185.1650, 185.3600, 185.4250, 
185.4300, and 185.4800.

PART 186--[AMENDED]

    3. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:

    Authority: 21 U.S.C. 348.

Secs. 186.450, 186.850, 186.1350, 186.1650, 186.2450, and 186.3000   
[Removed]

    b. By removing Secs. 186.450, 186.850, 186.1350, 186.1650, 
186.2450, and 186.3000.
[FR Doc. 98-1356 Filed 1-20-98; 8:45 am]
BILLING CODE 6560-50-F