[Federal Register Volume 66, Number 248 (Thursday, December 27, 2001)]
[Rules and Regulations]
[Pages 66769-66773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31802]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 153 and 180

[OPP-301026A; FRL-6813-6]
RIN 2070-AB78


Pesticide Chemicals Not Requiring a Tolerance or an Exemption 
from a Tolerance; Rhodamine B; Revocation of Unlimited Tolerance 
Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule creates a new subpart E in 40 CFR part 180. 
This subpart will be titled: Pesticide Chemicals Not Requiring a 
Tolerance or an Exemption from a Tolerance. It will contain a list of 
the pesticide chemicals (including, as appropriate, their limitations 
and use patterns) for which the Agency has determined that neither a 
tolerance nor an exemption from the requirement of a tolerance is 
needed under the Federal Food, Drug, and Cosmetic Act (FFDCA). The 
Agency is acting on its own initiative. This document also revokes the 
unlimited tolerance exemption for the inert ingredient Rhodamine B in 
40 CFR 180.1001 (c), and amends by time-limiting the unlimited 
tolerance exemption for Rhodamine B in 40 CFR 180.1001 (e). These 
regulatory actions are part of the tolerance reassessment requirements 
of the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as 
amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA 
is required to reassess 66% of the tolerances in existence on August 2, 
1996, by August 2002, or about 6,400 tolerances. The regulatory actions 
taken in this document, would be counted toward the August 2002 
deadline.

DATES: This final rule is effective on December 27, 2001.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle , Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 305-6304; fax number: (703) 305-0599; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes are provided to assist you and others in determining whether or 
not this action might apply to certain entities. If you have questions 
regarding the applicability of this action to a particular entity, 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR parts 153 and 180 are available at: http://www.access.gpo.gov/nara/cfr/cfrhtml_153/Title_40/40cfr153_00.html and 
http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.
    2. In person. The Agency has established an official record for 
this

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action under docket control number OPP-301026A. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

II. Background

    In the Federal Register of August 2, 2001 (66 FR 40170) (FRL-6598-
4), EPA issued a proposal pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a as amended by the FQPA (Public Law 104-170) to amend 40 CFR 
by creating a new subpart E, and to revoke two unlimited tolerance 
exemptions for the inert ingredient Rhodamine B (CAS Reg. No. 81-88-9). 
New subpart E will contain a list of the pesticide chemicals 
(including, as appropriate, their limitations and use patterns) for 
which the Agency has determined that neither a tolerance nor an 
exemption from the requirement of a tolerance is needed under the 
FFDCA. The only chemical included in subpart E at its creation is the 
inert ingredient Rhodamine B (CAS Reg. No. 81-88-9) when used as a dye 
for seed treatment. The revocations of the Rhodamine B tolerance 
exemptions were based on EPA's conclusion that the exemptions are for 
uses of Rhodamine B that are no longer extant other than the use 
included in subpart E. Three comments were received in response to the 
proposed rule.
    The comments from both the American Chemistry Council and from 
Gustafson supported the creation of the new subpart E. Gustafson has 
also suggested an additional chemical (an active ingredient) that it 
believes could be appropriately added to the new subpart. The Agency 
will consider this request, and, if appropriate, initiate such 
procedures as necessary to add this additional chemical to subpart E. A 
comment was also received from Boehringer Ingelheim Vetmedica, Inc. 
(BIVI) informing the Agency that currently there are two animal ear tag 
products containing Rhodamine B that are being manufactured and 
distributed. BIVI has agreed to remove the Rhodamine B from their 
products. To allow time for BIVI to reformulate and then for the ear 
tags containing Rhodamine B to clear the channels of trade, the Agency 
will time-limit the Rhodamine B tolerance exemption under 40 CFR 
180.1001 (e) to expire in 3 years.
    Based on the reasons set forth in the preamble to the proposed 
rule, and considering the comments received by the Agency in response 
to the proposed rule, EPA is creating a new subpart E, revoking one 
unlimited tolerance exemption, and revising one tolerance exemption by 
time-limiting the exemption to expire in three years.
    These regulatory actions are part of the tolerance reassessment 
requirements of section 408(q) of the FFDCA, as amended by the FQPA of 
1996. By law, EPA is required to reassess 66% of the tolerances in 
existence on August 2, 1996, by August 2002, or about 6,400 tolerances. 
The regulatory actions in this document, the revocation of two 
tolerance exemptions, would be counted toward the August 2002 deadline.

III. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301026A in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before February 
25, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

[[Page 66771]]

    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301026A, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; 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, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IV. Regulatory Assessment Requirements

    The Agency is acting on its own initiative under FFDCA section 
408(e) in revoking these tolerances and in establishing a new subpart E 
in 40 CFR part 180 that will contain a list of the pesticide chemicals 
(including, as appropriate, their limitations and use patterns) for 
which the Agency has determined that neither a tolerance nor an 
exemption from the requirement of a tolerance is needed under FFDCA. 
Under Executive Order 12866, entitled Regulatory Planning and Review 
(58 FR 51735, October 4, 1993), this action is not a ``significant 
regulatory action'' subject to review by the Office of Management and 
Budget (OMB). Because this rule has been exempted from review under 
Executive Order 12866 due to its lack of significance, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001).
    This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., or impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review 
or any Agency action under Executive Order 13045, entitled Protection 
of Children from Environmental Health Risks and Safety Risks (62 FR 
19885, April 23, 1997).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).
    This rule simply establishes a new subpart E in 40 CFR part 180 
that will contain a list of the pesticide chemicals (including, as 
appropriate, their limitations and use patterns) for which the Agency 
has determined that neither a tolerance nor an exemption from the 
requirement of a tolerance is needed under FFDCA, and only amends an 
existing unlimited tolerance exemption to make it time limited. The 
Agency has determined that this action will not result in significant 
adverse economic impacts. Pursuant to the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether 
revocations of tolerances or tolerance exemptions might significantly 
impact a substantial number of small entities and concluded that, as a 
general matter, these actions do not impose a significant economic 
impact on a substantial number of small entities. This analysis was 
published on December 17, 1997 (62 FR 66020), and was provided to the 
Chief Counsel for Advocacy of the Small Business Administration. Taking 
into account this analysis, the available information concerning the 
pesticide chemicals listed in this rule, the Agency knows of no 
extraordinary circumstances that exist as to the present revocation 
that would change EPA's previous analysis. Therefore, the Agency hereby 
certifies pursuant to the section 605(b) of the RFA that this rule will 
not have a significant negative economic impact on a substantial number 
of small entities.
    In addition, the Agency has determined that this action will not 
have a substantial direct effect on States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132, entitled Federalism (64 FR 43255, 
August 10, 1999). Executive Order 13132 requires EPA to develop an 
accountable process to ensure ``meaningful and timely input by State 
and local officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).
    For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal

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government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes, as 
specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

V. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 153 and 180

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


    Dated: December 14, 2001.
James Jones,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I be amended as follows:

PART 153--[AMENDED]

    1. In part 153:
    a. The authority citation for part 153 would continue to read as 
follows:

    Authority: 15 U.S.C. 136 et seq.

    b. Section 153.155 (c) is revised to read as follows.


Sec. 153.155  Seed treatment products.

* * * * *
    (c) EPA-approved dyes for seed treatment are listed in:
    (1) Section 180.1001(c) and (d) if an exemption from the 
requirement of a tolerance has been established.
    (2) Section 180.2010 if EPA has determined that residues of the dye 
will be present, if at all, at levels that are below the threshold of 
regulation.
    (3) Section 180.2020 if it has been determined that no tolerance or 
exemption from the requirement of a tolerance is needed as a result of 
a determination by EPA that the use is unlikely to result in residues 
in food/feed.

PART 180--[AMENDED]

    2. In part 180:

    a. The authority citation for part 180 would continue to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    b. In Sec. 180.1001 the table in paragraph (c) is amended by 
removing the entry for ``Rhodamine B'' and in paragraph (e) the table 
is amended by revising the entry to read as follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *
    (e) * * *

------------------------------------------------------------------------
       Inert ingredients                Limits                Uses
------------------------------------------------------------------------
*                  *                  *                  *
                  *                  *                  *
Rhodamine B                      Expires December 27,  Dye for use in
                                  2004.                 ear tags only
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------


    c. By adding new subpart E, consisting of Sec. 180.2000-180.2020, 
to read as follows:

Subpart E--Pesticide Chemicals Not Requiring a Tolerance or an 
Exemption from a Tolerance

Sec.
180.2000  Scope.
180.2003  Definitions.
180.2010  Threshold of regulation determinations. [Reserved]
180.2020  Non-food determinations.


Sec. 180.2000  Scope.

    This subpart sets forth the pesticide chemicals for use in 
agricultural or other food-related settings for which neither a 
tolerance nor an exemption is deemed to be needed by EPA.


Sec. 180.2003  Definitions.

    (a) Food uses are the uses of a pesticide chemical that are likely 
to yield residues in food or feed crops, meat, milk, poultry or eggs.
    (b) Non-food uses are those uses that are not likely to yield 
residues in food or feed crops, meat, milk, poultry or eggs.


Sec. 180.2010  Threshold of regulation determinations. [Reserved]


Sec. 180.2020  Non-food determinations.

    The following pesticide chemical uses do not need a tolerance or 
exemption from the requirement of a tolerance based on EPA's 
determination that they are not likely to result in residues in or on 
food.

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         Pesticide Chemical                 CAS Reg. No.                 Limits                    Uses
----------------------------------------------------------------------------------------------------------------
Rhodamine B                           81-88-9                  Not to exceed 2% by        Dye for seed treatment
                                                                weight of the formulated
                                                                product and 60 ppm on
                                                                the treated seed
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[FR Doc. 01-31802 Filed 12-26-01; 8:45 am]
BILLING CODE 6560-50-S