[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: morris.jeffrey@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov.
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
