[Federal Register Volume 69, Number 79 (Friday, April 23, 2004)]
[Rules and Regulations]
[Pages 21959-21962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9136]



[[Page 21959]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0416;FRL-7353-5]


Revocation of Tolerance Exemptions for Certain Biopesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document revokes exemptions from the requirement of a 
tolerance, as expressed in 40 CFR part 180, for residues of the 
following pesticide active ingredients because of non-payment of 
maintenance fees and because there are no active FIFRA product 
registrations applicable to these exemptions: Dihydroazadirachtin; 
Kontrol HV; Metarhizium anisopliae strain ESF1 in attractant stations; 
polyhedral occlusion bodies of Autographa californica NPV; Pseudomonas 
fluorescens EG-1053; Pseudomonas fluorescens NCIB 12089; and Puccinia 
canaliculata (ATCC 40199). In addition, this document revokes the 
tolerance exemption for Bacillus thuringiensis CryIA(b) delta-endotoxin 
and the genetic material necessary for its production in corn because 
that tolerance exemption has been replaced by a tolerance exemption 
that applies to all plants. The regulatory actions in this document 
contribute toward the Agency's 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 by August 2006 to reassess tolerances in existence on 
August 2, 1996. For counting purposes, the revocations in this document 
count as nine (9) FQPA tolerance/exemption reassessments.

DATES: This regulation is effective July 22, 2004. Objections and 
requests for hearings must be received on or before June 22, 2004.

ADDRESSES: To submit a written objection or hearing request following 
the detailed instructions as provided in Unit IV. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2003-0416. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis 
Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Mandula, Biopesticides and 
Pollution Prevention Division (MC 7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460-0001; telephone number: (703) 308-7378; 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 entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532).
    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 unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B . How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at  http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR Beta Site Two at  http://www.gpoaccess.gov/ecfr/.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of November 26, 2003 (68 FR 66390) (FRL-
7332-4), EPA issued a proposed rule to revoke exemptions from the 
requirement of a tolerance, as expressed in 40 CFR part 180, for 
residues of the following pesticide active ingredients because of non-
payment of maintenance fees and because there are no active FIFRA 
product registrations applicable to these exemptions: 
Dihydroazadirachtin; Kontrol HV; Metarhizium anisopliae strain ESF1 in 
attractant stations; polyhedral occlusion bodies of Autographa 
californica NPV; Pseudomonas fluorescens EG-1053; Pseudomonas 
fluorescens NCIB 12089; and Puccinia canaliculata (ATCC 40199). In 
addition, the November 26, 2003 FR notice proposed to revoke the 
tolerance exemption for Bacillus thuringiensis CryIA(b) delta-endotoxin 
and the genetic material necessary for its production in corn because 
that tolerance exemption has been replaced by a tolerance exemption 
that applies to all plants. Also, the November 26, 2003 proposal 
provided a 60-day comment period which invited public comment for 
consideration and for support of tolerance retention under FFDCA 
standards.
    This final rule revokes all FFDCA tolerance exemptions for residues 
of: Polyhedral occlusion bodies of Autographa californica NPV in 40 CFR 
180.1125; Dihydroazadirachtin in 40 CFR 180.1169; Kontrol H.V. in 40 
CFR 180.1063; Metarhizium anisopliae strain ESF1 in attractant stations 
in 40 CFR 180.1116; Pseudomonas fluorescens EG-1053 in 40 CFR 180.1088; 
Pseudomonas fluorescens NCIB 12089 in 40 CFR 180.1129; and Puccinia 
canaliculata (ATCC 40199) in 40 CFR 180.1123. The tolerance exemptions 
revoked by this final rule are no longer necessary to cover residues of 
the relevant pesticides in or on domestically treated commodities or 
commodities treated outside but imported into the United States.
    This final rule also revokes the tolerance exemption in 40 CFR 
180.1152 for Bacillus thuringiensis CryIA(b) delta-endotoxin and the 
genetic material necessary for its production in corn because that 
tolerance exemption has been replaced by a tolerance exemption in 40 
CFR 180.1173 that applies to all plants.

B. What is the Agency's Authority for Taking this Action?

    Under section 408(e) of the FFDCA, it is EPA's general practice to 
propose

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revocation of tolerances/tolerance exemptions for residues of pesticide 
active ingredients on crop uses for which FIFRA registrations no longer 
exist. EPA has historically been concerned that retention of 
tolerances/tolerance exemptions that are not necessary to cover 
residues in or on legally treated foods may encourage misuse of 
pesticides within the United States. Nonetheless, EPA will establish 
and maintain tolerances/tolerance exemptions even when corresponding 
domestic uses are canceled if the tolerances/tolerance exemptions are 
necessary to allow importation into the United States of food 
containing such pesticide residues. However, where there are no 
imported commodities that require these import tolerances/tolerance 
exemptions, the Agency believes it is appropriate to revoke tolerances/
tolerance exemptions for unregistered pesticides in order to prevent 
potential misuse. Thus, it is EPA's policy to issue a final rule 
revoking tolerances/tolerance exemptions for residues of pesticide 
chemicals for which there are no active registrations under FIFRA, 
unless any person commenting on the proposal demonstrates a need for 
the tolerance/tolerance exemption to cover residues in or on imported 
commodities or domestic commodities legally treated.
    In response to the proposed revocations of tolerance exemptions 
published in the Federal Register of November 26, 2003 (68 FR 66390), 
EPA did not receive any comments regarding a need to retain any of the 
tolerance exemptions proposed for revocation. Therefore, the Agency is 
revoking the tolerance exemptions as proposed in the November 26, 2003 
FR notice.

C. When Do These Actions Become Effective?

    These actions become effective 90 days following publication of 
this final rule in the Federal Register. EPA has delayed the 
effectiveness of these revocations for 90 days following publication of 
this final rule to ensure that all affected parties receive notice of 
EPA's actions. Consequently, the effective date is July 22, 2004. For 
this final rule, tolerance exemptions are being revoked for products 
and uses that have been canceled for more than two years. No other 
registered pesticide products exist for these uses. The Agency believes 
that sufficient time has passed for stocks to have been exhausted and 
for treated commodities to have cleared channels of trade.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this final rule, and that 
are in the channels of trade following the tolerance revocations, shall 
be subject to section 408(1)(5) of FFDCA, as established by the FQPA. 
Under this section, any 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.

D. What is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006 to reassess the tolerances 
in existence on August 2, 1996. As of March 15, 2003, EPA has 
reassessed over 6,630 tolerances. The tolerance exemptions being 
revoked in this final rule contribute nine (9) tolerance reassessments 
towards the total due in August 2006.

III. Are There Any International Trade Issues Raised by this Final 
Action?

    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. When possible, EPA seeks 
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a 
tolerance that is different from a Codex MRL; however, section 
408(b)(4) of FFDCA requires that EPA explain in a Federal Register 
document the reasons for departing from the Codex level. EPA's effort 
to harmonize with Codex MRLs is summarized in the tolerance 
reassessment section of individual REDs. The U.S. EPA has developed 
guidance concerning submissions for import tolerance support (65 FR 
35069, June 1, 2000) (FRL-6559-3). This guidance will be made available 
to interested persons. Electronic copies are available on the internet 
at http://www.epa.gov/. On the Home Page select ``Laws and 
Regulations,'' then select ``Regulations and Proposed Rules'' and then 
look up the entry for this document under ``Federal Register--
Environmental Documents.'' You can also go directly to the Federal 
Register listings at http://www.epa.gov/fedrgstr/.

IV. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA 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) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. 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 ID number OPP-0416 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 June 22, 2004.
    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

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confidential may be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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 Objection 
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-
0001.
    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 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IV.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-0416, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. 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).

V. Statutory and Executive Order Reviews

    This final rule revokes tolerance exemptions established under 
section 408 of FFDCA. The Office of Management and Budget (OMB) has 
exempted this type of action (i.e., a tolerance exemption revocation 
for which extraordinary circumstances do not exist) from review under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993). 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 as required by 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 other 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). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.), the Agency previously assessed whether revocations of 
tolerances 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, and 
available information concerning the pesticides listed in this rule, I 
certify that this action will not have a significant economic impact on 
a substantial number of small entities. Specifically, as per the 1997 
notice, 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 canceled pesticides. Furthermore, the 
Agency knows of no extraordinary circumstances that exist as to the 
present revocations that would change EPA's previous analysis. 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

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provisions of section 408(n)(4) of FFDCA. 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 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.

VI. Congressional Review Act

    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 to 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 this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: April 8, 2004.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


Sec.  180.1063  [Removed]

0
2. Section 180.1063 is removed.


Sec.  180.1088  [Removed]

0
3. Section 180.1088 is removed.


Sec.  180.1116  [Removed]

0
4. Section 180.1116 is removed.


Sec.  180.1123  [Removed]

0
5. Section 180.1123 is removed.


Sec.  180.1125  [Removed]

0
6. Section 180.1125 is removed.


Sec.  180.1129  [Removed]

0
7. Section 180.1129 is removed.


Sec.  180.1152  [Removed]

0
8. Section 180.1152 is removed.


Sec.  180.1169  [Removed]

0
9. Section 180.1169 is removed.

[FR Doc. 04-9136 Filed 4-22-04; 8:45 am]
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