Document ID: EPA-HQ-OPP-2005-0251-0008
Agency: epa
Document Type: Rule
Title: Inert Ingredients; Revocation of 29 Pesticide Tolerance Exemptions for 27 Chemicals
Posted Date: 2006-03-22T22:53:47Z

[Federal Register: March 22, 2006 (Volume 71, Number 55)]
[Rules and Regulations]               
[Page 14411-14415]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr06-18]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0251; FRL-7760-6]

 
Inert Ingredients; Revocation of 29 Pesticide Tolerance 
Exemptions for 27 Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking 29 exemptions from the requirement of a 
tolerance that are associated with 27 inert ingredients because these 
substances are no longer contained in active Federal Insecticide, 
Fungicide,

[[Page 14412]]

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 29 tolerance 
exemptions are considered ``reassessed'' for purposes of FFDCA's 
section 408(q).

DATES: This regulation is effective March 22, 2006. Objections and 
requests for hearings must be received on or before May 22, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit V. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number EPA-HQ-OPP-2005-0251. 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: angulo.karen@epa.gov.

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 (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 November 16, 2005 (70 FR 69489; FRL-
7741-6), EPA issued a proposed rule to revoke 30 exemptions from the 
requirement of a tolerance that are associated with 28 inert 
ingredients because those substances are no longer contained in 
pesticide products. 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.
    In this final rule, EPA is revoking 29 exemptions from the 
requirement of a tolerance that are associated with 27 inert 
ingredients because these specific tolerance exemptions correspond to 
uses no longer current or registered under FIFRA in the United States. 
The tolerance exemptions revoked by this final rule are no longer 
necessary to cover residues of the relevant pesticide chemicals in or 
on domestically treated commodities or commodities treated outside but 
imported into 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. 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 three comments in response to the proposed 
revocation notice. One commentor provided sufficient evidence to the 
Agency that the inert ingredient tannin is currently used in a 
registered pesticide product, therefore, the exemption from the 
requirement of a tolerance for tannin will not be revoked as part of 
this action and tannin will undergo tolerance reassessment. Another 
commenter requested that an inert ingredient be retained but did not 
provide to the Agency any evidence as specified in the proposed rule in 
the Federal Register (November 16, 2005; EPA-HQ-OPP-2005-0251;) that 
the inert ingredient is currently used in a registered pesticide 
product, therefore, the inert is being revoked as part of this action.
    The third commentor requested that the tolerance exemptions for 
paraformaldehyde currently found in 180.920 and 180.930 be retained for 
some unspecified future use. The Agency's ``Guidance for the 
Reregistration of Pesticide Products Containing Formaldehyde and 
Paraformaldehyde as the Active Ingredient'' (5/31/88; EPA publication 
number 540/RS-88-080; page 7) states ``This standard covers products 
containing formaldehyde or paraformaldehyde currently classified as 
either active or inert ingredients. As inert ingredients, formaldehyde 
and paraformaldehyde are intentionally added to preserve the pesticidal 
activity of formulations by preventing deterioration caused by bacteria 
and

[[Page 14413]]

fungi. As preservatives in formulations, formaldehyde or 
paraformaldehyde perform a pesticidal function. Therefore, the Agency 
has determined that formaldehyde and paraformaldehyde should be 
characterized as active ingredients in all products in which they are 
used, including those in which they currently are only intentionally 
added as an inert ingredient. Thus, all products containing 
formaldehyde and paraformaldehyde as a preservative of the formulation 
will be considered to contain these chemicals as active ingredients.'' 
The Agency's determination that paraformaldehyde is considered to be an 
active ingredient may explain why there are no current inert ingredient 
uses. Therefore, the tolerance exemptions for paraformaldehyde are 
being revoked now.
    Therefore, for the reasons stated herein and in the proposed rule, 
EPA is revoking the 29 exemptions from the requirement of a tolerance 
that were identified in Federal Register Notice of November 16, 2005 
(EPA-HQ-OPP-2005-0251).

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 the date of publication of this 
final rule in the Federal Register.
    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 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 EPA-HQ-OPP-2005-0251 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 May 22, 
2006.
    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 V.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 EPA-HQ-OPP-2005-0251, 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. Please use an

[[Page 14414]]

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 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: March 7, 2006,
Lois Rossi,
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), 346a and 371.

Sec. Sec.  180.1062, 180.1077, and 180.1133  [Removed]

0
2. Sections 180.1062, 180.1077, and 180.1133 are removed.

Sec.  180.910  [Amended]

0
3. Section 180.910 is amended by removing from the table the entries 
for:
    a. Coumarone-indene resin, conforming to 21 CFR 172.215;
    b. Diacetyl tartaric acid esters of mono- and diglycerides of 
edible fatty acids;
    c. Methyl ester of rosin, partially hydrogenated (as defined in 21 
CFR 172.615);

[[Page 14415]]

    d. Modified polyester resin derived from ethylene glycol, fumaric 
acid, and rosin;
    e. Montmorillonite-type clay treated with polytetrafluoroethylene 
(PTFE; CAS Reg. No. 9002-84-0);
    f. Pentaerythritol ester of modified resin;
    g. Pentaerythritol stearates mixture (CAS Reg. No. 85116-93-4) 
which include pentaerythritol monostearate (CAS Reg. No. 78-23-9), 
pentaerythritol distearate (CAS Reg. No. 13081-97-5), pentaerythritol 
tristearate (CAS Reg. No. 28188-24-1) and pentaerythritol tetrastearate 
(CAS Reg. No. 115-83-3);
    h. Sodium N-lauroyl-N-methyltaurine;
    i. Sodium N-palmitoyl-N-methyltaurine; and
    j. Sodium oleyl sulfate.

Sec.  180.920  [Amended]

0
4. Section 180.920 is amended by removing from the table the entries 
for:
    a. Ammonium thiocyanate;
    b. Animal waste material (produced by the thermophilic digestion of 
cattle and poultry manure);
    c. Condensation product of orthophenylphenol with 5 moles of 
ethylene oxide;
    d. Diacetone alcohol;
    e. Isoamyl acetate;
    f. Paraformaldehyde;
    g. Phenolic resins;
    h. Sodium salt of partially or completely saponified dark wood 
rosin (as defined in 21 CFR 178.3870(a)(4));
    i. Toluene;
    j. Trimethylolpropane (CAS Reg. No. 77-66-9); and
    k. Woolwax alcohol.

Sec.  180.930  [Amended]

0
5. Section 180.930 is amended by removing from the table the entries 
for:
    a. Diacetyl tartaric acid esters of mono- and diglycerides of 
edible fatty acids;
    b. 2-[Methyl [(perfluoroalkyl)alkyl(C2-
C8)sulfonyl] amino]alkyl(C2-C8) 
acrylate--alkyl (C2-C8)methacrylates-N-
methylolacrylamide copolymer;
    c. Nitrile rubber modifed acrylonitrile methylacrylate (CAS Reg. 
No. 27012-62-0) conforming to 21 CFR 177.1480;
    d. Paraformaldehyde; and
    e. Wood rosin acid, potassium salts, conforming to 21 CFR 178.3870.

[FR Doc. 06-2631 Filed 3-21-06; 8:45 am]

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