Document ID: EPA-HQ-OPP-2005-0251-0001
Agency: epa
Document Type: Proposed Rule
Title: Inert Ingredients; Proposal to Revoke 30 Pesticide Tolerance Exemptions for 28 Chemicals
Posted Date: 2005-11-16T05:00Z

[Federal Register: November 16, 2005 (Volume 70, Number 220)]
[Proposed Rules]               
[Page 69489-69493]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no05-25]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0251; FRL-7741-6]

 
Inert Ingredients; Proposal to Revoke 30 Pesticide Tolerance 
Exemptions for 28 Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke 30 exemptions from the requirement 
of a tolerance that are associated with 28 inert ingredients because 
these substances are no longer contained in active Federal Insecticide, 
Fungicide,

[[Page 69490]]

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). Upon the issuance of 
the final rule revoking the tolerance exemptions, the 30 tolerance 
exemptions will be counted as ``reassessed'' for purposes of FFDCA's 
section 408(q).

DATES: Comments must be received on or before January 17, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number OPP-2005-0251, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/. 

Follow the on-line instructions for submitting comments.
     Agency Website: http://www.epa.gov/edocket/. EDOCKET, 

EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving comments. Follow the on-line instructions for 
submitting comments.
     E-mail: Comments may be sent by e-mail to 
opp-docket@epa.gov, Attention: Docket ID number OPP-2005-0251.

     Mail: Public Information and Records Integrity Branch 
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001, Attention: Docket ID number OPP-2005-0251.
     Hand Delivery: Public Information and Records Integrity 
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental 
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St., 
Arlington, VA, Attention: Docket ID number OPP-2005-0251. Such 
deliveries are only accepted during the Docket's normal hours of 
operation, and special arrangements should be made for deliveries of 
boxed information.
    Instructions: Direct your comments to docket ID number OPP-2005-
0251. EPA's policy is that all comments received will be included in 
the public docket without change and may be made available online at 
http://www.epa.gov/edocket/, including any personal information 

provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through EDOCKET, 
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov 
websites are ``anonymous access'' systems, which means EPA will not 
know your identity or contact information unless you provide it in the 
body of your comment. If you send an e-mail comment directly to EPA 
without going through EDOCKET or regulations.gov, your e-mail address 
will be automatically captured and included as part of the comment that 
is placed in the public docket and made available on the Internet. If 
you submit an electronic comment, EPA recommends that you include your 
name and other contact information in the body of your comment and with 
any disk or CD ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit EDOCKET on-line or see the Federal Register of May 31, 
2002 (67 FR 38102) (FRL-7181-7).
    Docket: 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. 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/.

C. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of 
the information that you claim to be CBI. For CBI information in a disk 
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM 
as CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the rulemaking by docket ID number and other 
identifying information (subject heading, Federal Register date, and 
page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a

[[Page 69491]]

Code of Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background and Statutory Findings

    This proposed 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 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)).

III. What Action is the Agency Taking?

    EPA is proposing to revoke 30 exemptions from the requirement of a 
tolerance for 28 inert ingredients because those substances are no 
longer contained in currently registered pesticide products requiring 
reassessment under section 408(q) of FFDCA. It is EPA's general 
practice to revoke tolerances and tolerance exemptions for pesticide 
chemical residues (which includes both active and inert ingredients) 
for which there are no associated active registered uses under FIFRA, 
or for which there are no registered products to which the tolerance or 
tolerance exemption applies, or for tolerances or tolerance exemptions 
that have been superseded, unless a person commenting on the proposal 
indicates a need for the tolerance or exemption to cover residues in or 
on imported commodities or legally treated domestic commodities.
    Listed below are the 28 inert ingredients and their associated 30 
tolerance exemptions that are subject to this proposal. EPA is 
proposing that the revocation of these 30 tolerance exemptions will 
become effective on the date of the final rule's publication in the 
Federal Register. For counting purposes, and based on this proposed 
action, 30 exemptions would be counted as reassessments toward the 
August 2006 review deadline of FFDCA section 408(q), as amended by FQPA 
in 1996.
    1. Ammonium thiocyanate (40 CFR 180.920).
    2. Animal waste material (produced by the thermophilic digestion of 
cattle and poultry manure) (40 CFR 180.920).
    3. Butyl benzyl phthalate (40 CFR 180.1062).
    4. Condensation product of orthophenylphenol with 5 moles of 
ethylene oxide (40 CFR 180.920).
    5. Coumarone-indene resin, conforming to 21 CFR 172.215 (40 CFR 
180.910).
    6. Diacetone alcohol (40 CFR 180.920).
    7. Diacetyl tartaric acid esters of mono, and diglycerides of 
edible fatty acids (40 CFR 180.910 and 180.930).
    8. 2,2-Dichloro-N-(1,3-dioxolan-2-ylmethyl)-N-2-propenylacetamide 
(40 CFR 180.1077).
    9. Isoamyl acetate (40 CFR 180.920).
    10. Methyl ester of rosin, partially hydrogenated (as defined in 21 
CFR 172.615) (40 CFR 180.910).
    11. Methyl-1-alkylamido ethyl-2-alkyl-imidazolinium methyl sulfate 
(40 CFR 180.1133).
    12. 2-[Methyl [(perfluoroalkyl)alkyl(C2-C8)sulfonyl] 
amino]alkyl(C2-C8) acrylate--alkyl (C2-C8)methacrylates-N-
methylolacrylamide copolymer (40 CFR 180.930).
    13. Modified polyester resin derived from ethylene glycol, fumaric 
acid, and rosin (40 CFR 180.910).
    14. Montmorillonite-type clay treated with polytetrafluoroethylene 
(PTFE; CAS Reg. No. 9002-84-0) (40 CFR 180.910).
    15. Nitrile rubber modifed acrylonitrile methylacrylate (CAS Reg. 
No. 27012-62-0) conforming to 21 CFR 177.1480 (40 CFR 180.930).
    16. Paraformaldehyde (40 CFR 180.920 and 180.930).
    17. Pentaerythritol ester of modified resin (40 CFR 180.910).
    18. 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) (40 CFR 180.910).
    19. Phenolic resins (40 CFR 180.920).
    20. Sodium N-lauroyl-N-methyltaurine (40 CFR 180.910).
    21. Sodium N-palmitoyl-N-methyltaurine (40 CFR 180.910)
    22. Sodium oleyl sulfate (40 CFR 180.910).
    23. Sodium salt of partially or completely saponified dark wood 
rosin (as defined in 21 CFR 178.3870(a)(4)) (40 CFR 180.920).
    24. Tannin (40 CFR 180.920).
    25. Toluene (40 CFR 180.920).
    26. Trimethylolpropane (CAS Reg. No. 77-66-9) (40 CFR 180.920) 
(Note: This entry in 40 CFR 180.920 has an incorrect CAS number and it 
will be revoked. The other entry in 40 CFR 180.920 for this chemical 
has the correct CAS number, is currently being used in pesticide 
products, and is a candidate for reassessment.)
    27. Wood rosin acid, potassium salts, conforming to 21 CFR 178.3870 
(40 CFR 180.930).
    28. Woolwax alcohol (40 CFR 180.920).

A. What Can I Do if I Wish to Maintain an Exemption that the Agency is 
Proposing to Revoke?

    EPA's records show that the inert ingredients subject to this 
proposed rule are not contained in any currently registered pesticide 
products with uses that would require tolerances or tolerance 
exemptions under section 408 of FFDCA. Parties who believe that EPA's 
records are incorrect and that one or more of these ingredients are 
indeed contained in a currently registered pesticide product are 
encouraged to submit documentation to EPA in the form of the currently 
registered pesticide product's accepted Confidential Statement of 
Formula. Parties who know of a pending registration action for a 
product that contains an inert ingredient subject to this proposed rule 
may submit documentation to EPA in the form of a copy of the Agency's 
letter confirming the receipt of an application for registration or 
registration amendment for such product. In addition, parties who are 
currently in the process of developing a pesticide product containing 
an inert ingredient subject to this proposed rule may submit to EPA a 
letter asserting their intention to apply for a FIFRA section 3 
registration of said product within 2 years. This letter must include 
documentation of the inclusion of the inert ingredient in the proposed 
pesticide product, such as a description of the formulation's 
ingredients, and must confirm their intention to submit an application 
for registration or registration amendment within 2 years

[[Page 69492]]

from the publication date of this proposed rule.
    EPA is aware that inert ingredients are also contained in pesticide 
adjuvant products which are not subject to registration under FIFRA. 
The Agency does not keep records of currently used adjuvants or their 
ingredients, therefore, it has been unable to conclusively confirm the 
use of adjuvants containing one of these inert ingredients. Parties who 
know of currently used adjuvant products that contain an inert 
ingredient subject to this proposed rule are encouraged to submit 
documentation to EPA in the form of the adjuvant product's current 
label and/or documentation of the registration of the adjuvant product 
with a State adjuvant registration program.
    Also, inert ingredient tolerance exemptions will be retained if the 
tolerances or exemptions (which EPA refers to as ``import'' tolerances) 
are necessary to allow importation into the United States of food 
containing such residues. Through this proposed rule, the Agency is 
inviting individuals who need these import tolerance exemptions to 
identify those exemptions that are needed to cover imported 
commodities.
    EPA will retain an inert ingredient tolerance exemption if the 
documentation described above is submitted to EPA by the end of the 
comment period as specified under DATES in this document, and the 
Agency can verify the existence of a currently registered pesticide 
product, a registration action pending at EPA, an import tolerance, or 
a currently used adjuvant product that contains the ingredient in 
question.
    Parties interested in the retention of any of the tolerance 
exemptions subject to this proposed rule should be aware that because 
these ingredients are currently subject to reassessment under section 
408(q) of FFDCA, additional data may be needed to support retention of 
the exemption. Reassessment activities for such ingredients must be 
completed by August 2006. If the Agency is unable to determine that the 
exemptions for these ingredients meet the FFDCA standard for 
reassessment, the Agency will revoke the exemptions.

B. When Do These Actions Become Effective?

    EPA is proposing that revocation of these tolerance exemptions 
become effective on the day the final rule revoking these tolerance 
exemptions is published in the Federal Register. If you have comments 
regarding whether the effective date allows sufficient time for treated 
commodities to clear the channels of trade, please submit comments as 
described under Unit I.C. Similarly, if you have comments regarding 
these tolerance exemption revocations or the effective date of the 
revocations, please submit comments as described under Unit I.C. Any 
commodities treated with the pesticide products containing an inert 
ingredient subject to this proposed rule, and in the channels of trade 
following the tolerance revocations, shall be subject to FFDCA section 
408(i)(5), as established by 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 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 tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates that the 
pesticide was applied to such food.

VI. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke specific 
tolerance exemptions established under section 408(d) of the FFDCA. 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 
proposed rule has been exempted from review under Executive Order 12866 
due to its lack of significance, this proposed 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 proposed 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 tolerance in 
this proposed 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 proposed 
action 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 
proposed 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 
proposed 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

[[Page 69493]]

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 proposed 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 proposed rule.

List of Subjects in 40 CFR Part 180

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

    Dated: October 28, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, it is proposed that 40 CFR chapter I be 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.  180.910  [Amended]

    2. 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);
    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; and
    i. Sodium N-palmitoyl-N-methyltaurine; and
    j. Sodium oleyl sulfate.

Sec.  180.920  [Amended]

    3. 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. Tannin;
    j. Toluene;
    k. Trimethylolpropane (CAS Reg. No. 77-66-9) (180.920); and
    l. Woolwax alcohol.

Sec.  180.930  [Amended]

    4. 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.

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

    5. Sections 180.1062, 180.1077, and 180.1133 are removed.
[FR Doc. 05-22614 Filed 11-15-05; 8:45 am]

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