[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Rules and Regulations]
[Pages 55293-55296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18831]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0069; FRL-7737-3]


Inert Ingredients; Revocation of 34 Pesticide Tolerance 
Exemptions for 31 Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking 34 exemptions from the requirement of a 
tolerance that are associated with 31 inert ingredients because these 
substances are no longer contained in active Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) pesticide product registrations. 
These ingredients are subject to reassessment by August 2006 under 
section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA). The 34 
tolerance exemptions are considered ``reassessed'' for purposes of 
FFDCA's section 408(q).

DATES: This regulation is effective September 21, 2005. Objections and 
requests for hearings must be received on or before November 21, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0069. 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, 1801 S. 
Bell St., 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: Karen Angulo, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0404; 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 code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 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

[[Page 55294]]

(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. To 
determine whether you or your business may be affected by this action, 
you should carefully examine the applicability provisions in Unit II. 
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 Get Electronic Documents and Other Related Information?

    In addition to using EDOCKET at (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. What Action is the Agency Taking?

    In the Federal Register of June 1, 2005 (70 FR 31401) (FRL-7712-7), 
EPA issued a proposed rule to revoke 34 exemptions from the requirement 
of a tolerance that are associated with 31 inert ingredients because 
those substances are no longer contained in pesticide products 
registered in the United States. The proposed rule provided a 60-day 
comment period that invited public comment for consideration and for 
support of tolerance exemption retention under the FFDCA standards. An 
additional 30-day comment period was provided based on a request from 
certain industry representatives (70 FR 45625, August 8, 2005, (FRL-
7729-4)).
    In this final rule, EPA is revoking these same 34 tolerance 
exemptions. EPA has historically been concerned that retention of 
tolerances and tolerance exemptions that are not necessary to cover 
residues in or on legally treated foods may encourage misuse of 
pesticides within the United States. Thus, it is EPA's policy to issue 
a final rule revoking those tolerances and tolerance exemptions for 
residues of pesticide chemicals for which there are no active 
registrations or uses under FIFRA, unless any person commenting on the 
proposal demonstrates a need for the tolerance to cover residues in or 
on imported commodities or domestic commodities legally treated.
    Generally, EPA will proceed with the revocation of these tolerances 
and tolerance exemptions on the grounds discussed in Unit II. if one of 
the following conditions applies:
    1. Prior to EPA's issuance of a section 408(f) order requesting 
additional data or issuance of a section 408(d) or (e) order revoking 
the tolerances or tolerance exemptions on other grounds, commenters 
retract the comment identifying a need for the tolerance to be 
retained.
    2. EPA independently verifies that the tolerance or tolerance 
exemption is no longer needed.
    3. The tolerance or tolerance exemption is not supported by data 
that demonstrate that the tolerance or tolerance exemption meets the 
requirements under FQPA.
    The Agency received several comments in response to the proposed 
revocation notice. The Fluoride Action Network Pesticide Project (FAN) 
supported EPA's proposal to revoke the exemption from the requirement 
of a tolerance for sodium fluoride.
    Two commenters requested clarification on EPA's policy concerning 
tolerance exemptions for inert ingredients that are reactive 
intermediates or reagents. The Agency confirms that the three reactive 
inert ingredients being revoked in this final rule (i.e., ethyl 
methacrylate, methyl methacrylate, and phosphorus oxychloride) do not 
require an exemption from the requirement of a tolerance because they 
are consumed during the manufacture of the final product. EPA intends 
to provide additional clarification and guidance in the future for 
reactive/reagent chemicals used in the manufacture of pesticide 
products.
    In addition, two commenters suggested several areas where 
additional guidance and policy clarifications would be helpful, 
including inert ingredients in non-food use pesticide products, 
impurities in technical grade active ingredients and inert ingredients, 
and consistency in the nomenclature for inerts. Although not directly 
relevant to the proposal to revoke the 34 tolerance exemptions, the 
Agency appreciates these suggestions and agrees that clear guidance 
would be helpful. The Agency intends to provide guidance for topics 
such as these in the future.
    Therefore, for the reasons stated herein and in the proposed rule, 
EPA is revoking the 34 exemptions from the requirement of a tolerance 
that were identified in the Federal Register of June 1, 2005 (70 FR 
31401).

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

    This final rule is issued pursuant to section 408(d) of FFDCA (21 
U.S.C. 346a(d)). Section 408 of FFDCA authorizes the establishment of 
tolerances, 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. Without a tolerance or tolerance exemption, food 
containing pesticide residues is considered to be unsafe and therefore 
``adulterated'' under section 402(a) of the FFDCA. If food containing 
pesticide residues is found to be adulterated, the food may not be 
distributed in interstate commerce (21 U.S.C. 331(a) and 342 (a)).
    EPA's general practice is to revoke tolerances and tolerance 
exemptions for residues of pesticide chemicals on crops for which FIFRA 
registrations no longer exist and on which the pesticide may therefore 
no longer be used in the United States. EPA has historically been 
concerned that retention of tolerances and 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 and tolerance exemptions 
even when corresponding domestic uses are canceled if the tolerances, 
which EPA refers to as ``import tolerances,'' 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, the Agency believes it is appropriate to 
revoke tolerances and tolerance exemptions for unregistered pesticide 
chemicals in order to prevent potential misuse.

IV. When Do These Actions Become Effective?

    These actions become effective on September 21, 2005. Any 
commodities listed in the regulatory text of this document that are 
treated with the pesticide chemicals subject to this final rule, and 
that are in the channels of trade following the tolerance exemption 
revocations, shall be subject to FFDCA section 408(1)(5), as 
established by the FQPA. Under this section, any residues of these 
pesticide chemicals in or on such food shall not render the food 
adulterated so long as it is shown to the satisfaction of the Food and 
Drug Administration that: (1) The residue is present as the result of 
an application or use of the pesticide chemical 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 an exemption from tolerance. Evidence to 
show that food was lawfully treated may include

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records that verify the dates that the pesticide chemical was applied 
to such food.

V. 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the 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 the FFDCA, as was provided in the old FFDCA sections 408 and 409 of 
the 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-2005-0069 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 November 
21, 2005.
    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 issue(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 (1900L), 
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 Suite 350, 1099 14th St., NW., 
Washington, DC 20005. 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) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit XI.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-2005-0069, 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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VI. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions 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 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). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. The Agency hereby certifies that this rule will not 
have 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

[[Page 55296]]

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 section 408(n)(4) of the 
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.

VII. 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: September 14, 2005.

Meredith F. Laws,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I 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), 346(a) and 371.


Sec.  180.1045 and Sec.  180.1066  [Removed]

0
2. Sections 180.1045 and 180.1066 are removed.


Sec.  180.910  [Amended]

0
3. Section 180.910 is amended by removing from the table the entries 
for Ethylene methylphenyglycidate; Phosphorus oxychloride; Sulfurous 
acid; and 1,1,1-Trichloroethane.


Sec.  180.920  [Amended]

0
4. Section 180.920 is amended by removing from the table the entries 
for:
    a. Acetonitrile;
    b. Almond, bitter;
    c. Aluminum 2-ethylhexanoate;
    d. 1,3-Butylene glycol dimethyacrylate;
    e. Calcium and sodium salts of certain sulfonated petroleum 
fractions (mahogany soaps); calcium salt molecular weight (in amu) 790-
1,020, sodium salt molecular weight (in amu) 400-500;
    f. Copper salts of neodecanoic acid and 2-ethylhexanoic acid;
    g. Diallyl phthalate;
    h. Dipropylene glycol dibenzoate;
    i. Ethyl methacrylate;
    j. Furfural byproduct (a granular steam-acid sterilized, 
lignocellulosic residuum in the extraction of furfural from corn cobs, 
sugarcane bagasse, cottonseed hulls, oat hulls, and rice hulls);
    k. Isopropylbenzene;
    l. Methyl isoamyl ketone;
    m. Methyl methacrylate;
    n. X-(p-Nonylphenyl)-v-hydroxy-poly(oxyethylene) sulfosuccinate 
isopropylamine and N-hydroxyethyl isopropylamine salts of: The 
poly(oxyethylene) content averages r moles;
    o. Propylene dichloride;
    p. Sodium fluoride;
    q. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinamate;
    r. (2,2'(2,5-Thiophenediyl)bis(5-tert-butylbenzoxazole)) (CAS Reg. 
No. 7128-64-5); and
    s. Tri-tert-butylphenol polyglycol ether (molecular weight (in amu) 
746).


Sec.  180.930  [Amended]

0
5. Section 180.930 is amended by removing from the table the entries 
for:
    a. Acetylated lanolin alcohol;
    b. Calcium and sodium salts of certain sulfonated petroleum 
fractions (mahogany soaps); calcium salt molecular weight (in amu) 790-
1020, sodium salt molecular weight (in amu) 400-500;
    c. Cumene (isopropylbenzene);
    d. Dibutyltin dilaurate (CAS Reg. No. 77-58-7);
    e. 4,4'-Isopropylidenediphenol alkyl (C12-
C15) phosphites (CAS Reg. No. 92908-32-2);
    f. Polyethylene esters of fatty acids, conforming to 21 CFR 
172.854;
    g. 1,1,1-Trichloroethane;
    h. Triethylene glycol diacetate (CAS Reg. No. 111-21-7); and
    i. Tri-tert-butylphenol polyglycol ether (molecular weight (in amu) 
746).

[FR Doc. 05-18831 Filed 9-20-05; 8:45 am]
BILLING CODE 6560-50-S