Document ID: EPA-HQ-OPP-2009-0601-0002
Agency: epa
Document Type: Rule
Title: Inert Ingredients; Extension of Effective Date of Revocation of Certain Tolerance Exemptions with Insufficient Data for Reassessment
Posted Date: 2009-10-09T04:00Z

[Federal Register: October 9, 2009 (Volume 74, Number 195)]
[Rules and Regulations]               
[Page 52148-52151]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc09-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0601; FRL-8794-1]

 
Inert Ingredients; Extension of Effective Date of Revocation of 
Certain Tolerance Exemptions with Insufficient Data for Reassessment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: This document moves the effective date of the revocation of 
six inert ingredient tolerance exemptions as

[[Page 52149]]

set forth in the Federal Register on August 7, 2009 (74 FR 39543).

DATES: In the final rule published August 9, 2006 (71 FR 45415), and 
delayed on August 4, 2008 (73 FR 45312), and August 7, 2009 (74 FR 
39543):
    1. The effective date is delayed from October 9, 2009, to February 
9, 2010, for the following amendments to Sec. 180.910: 2.m., n., and 
cc.
     2. The effective date is delayed from October 9, 2009, to February 
9, 2010, for the following amendments to Sec. 180.930: 4.t., u., and v.
    Objections and requests for hearings must be received on or before 
December 8, 2009, and must be filed in accordance with the instructions 
provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY 
INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0601. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; e-mail address: leifer.kerry@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?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2009-0601 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 December 8, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2009-0601, by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

A. Background

    In a final rule published in the Federal Register on August 9, 2006 
(71 FR 45415) (FRL-8084-1), EPA revoked inert ingredient tolerance 
exemptions because insufficient data were available to the Agency to 
make the safety determination required by Federal Food, Drug, and 
Cosmetic Act (FFDCA) section 408(c)(2). In reassessing the safety of 
the tolerance exemptions, EPA considered the validity, completeness, 
and reliability of the data that are available to the Agency [FFDCA 
section 408 (b)(2)(D)] and the available information concerning the 
special susceptibility of infants and children (including developmental 
effects from in utero exposure) [FFDCA section 408(b)(2)(C)]. EPA 
concluded it had insufficient data to make the safety finding of FFDCA 
section 408(c)(2) and revoked the inert ingredient tolerance exemptions 
identified in the final rule under 40 CFR 180.910, 180.920, 180.930, 
and 180.940, with the revocations effective on August 9, 2008.
     In a direct final rule published in the Federal Register on August 
4, 2008 (73 FR 45312) (FRL-8372-7), EPA moved the effective date of the 
revocation of certain inert ingredient tolerance exemptions from August 
9, 2008, until August 9, 2009. This determination was made based on 
requests for an extension of the revocation date from pesticide 
registrants and inert ingredient manufacturers who had demonstrated 
their intent to support certain inert ingredient tolerance exemptions 
and who had provided data development plans and schedules for data 
submission to the Agency. In a subsequent direct

[[Page 52150]]

final rule published in the Federal Register on August 7, 2009 (74 FR 
39543) (FRL-8431-8), EPA moved the effective date of the revocation of 
six inert ingredient tolerance exemptions from August 9, 2009, until 
October 9, 2009. This action was based on the fact that EPA had 
received petitions for the establishment of tolerance exemptions which 
included the submission of data for these inert ingredients. Notices of 
filing of these petitions (PP 8E7466 and PP 8E7478) were published in 
the Federal Register on March 25, 2009 (74 FR 12856) (FRL-8399-4). The 
August 7, 2009, direct final rule was published to allow for the 
completion of the Agency's risk assessments needed to evaluate the 
petitions and to complete the safety determinations for the six 
tolerance exemptions.

B. Moving the Effective Date of the Revocation for Six Tolerance 
Exemptions

    Following the publication of the August 7, 2009, final rule 
delaying the effective date for the six revoked tolerance exemptions, 
EPA received significant additional toxicity, metabolism and 
environmental fate data from the petitioners in further support of 
pesticide tolerance petitions 8E7466 and 8E7478 which have been 
determined by the Agency to have a significant bearing on its safety 
evaluation under FFDCA section 408(c)(2) of the petition proposing that 
these exemptions be reestablished. Much of the data submitted were not 
previously available and thus could not have been submitted sooner. 
EPA, therefore, concludes that additional time is necessary to complete 
the safety determinations for these six tolerance exemptions and that 
the effective date of the revocation of these tolerance exemptions 
should be moved by four months to February 9, 2010.

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

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by FQPA, Public Law 104-170, authorizes the establishment of 
tolerances, exemptions from tolerance requirements, 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 exemption, food containing pesticide residues is 
considered to be unsafe and therefore ``adulterated'' under FFDCA 
section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in 
interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be 
sold and distributed, the pesticide must not only have appropriate 
tolerances under FFDCA, but also must be registered under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et 
seq.). Food-use pesticides not registered in the United States must 
have tolerances in order for commodities treated with those pesticides 
to be imported into the United States. Under FFDCA section 
408(e)(1)(B), 21 U.S.C. 346a(e)(1)(B), EPA may take action 
establishing, modifying, suspending, or revoking a tolerance exemption.

III. Delayed Effective Date for Certain Tolerance Exemptions

    The amendatory designations listed in this unit are reprinted from 
the final rule published in the Federal Register issue of August 7, 
2009 (74 FR 39543) for the convenience of the user. The structure 
mirrors the amendatory designations in the original document. The 
amendatory designations shown are those with the effective date delayed 
until February 9, 2010.

Section 180.910

    m. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene) mixture 
of dihydrogen phosphate and monohydrogen phosphate esters and the 
corresponding ammonium, calcium, magnesium, monoethanolamine, 
potassium, sodium, and zinc salts of the phosphate esters; the nonyl 
group is a propylene trimer isomer and the poly (oxyethylene) content 
averages 4-14 moles or 30 moles.
    n. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)sulfate, 
ammonium, calcium, magnesium, potassium, sodium, and zinc salts; the 
nonyl group is a propylene trimer isomer and the poly(oxyethylene) 
content averages 4 moles.
    cc. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of 
ethylene oxide: if a blend of products is used, the average range 
number of moles of ethylene oxide reacted to produce any product that 
is a component of the blend shall be in the range of 1-14 or 30-70.

Section 180.930

    t. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene) mixture 
of dihydrogen phosphate and monohydrogen phosphate esters and the 
corresponding ammonium, calcium, magnesium, monoethanolamine, 
potassium, sodium, and zinc salts of the phosphate esters; the nonyl 
group is a propylene trimer isomer and the poly(oxyethylene) content 
averages 4-14 moles.
     u. [alpha]-(p-Nonylphenyl)-[omega]-
hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, 
potassium, sodium, and zinc salts; the nonyl group is a propylene 
trimer isomer and the poly(oxyethylene) content averages 4 moles.
    v. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)sulfate, 
and its ammonium, calcium, magnesium, monoethanolamine, potassium, 
sodium, and zinc salts; the nonyl group is a propylene trimer isomer 
and the poly(oxyethylene) content averages 4-14 or 30-90 moles of 
ethylene oxide.

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by

[[Page 52151]]

Congress in the preemption provisions of section 408(n)(4) of FFDCA. As 
such, the Agency has determined that this action will not have a 
substantial direct effect on States or tribal governments, on the 
relationship between the national government and the States or tribal 
governments, or on the distribution of power and responsibilities among 
the various levels of government or between the Federal Government and 
Indian tribes. Thus, the Agency has determined that Executive Order 
13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 9, 2000) do not apply to this final 
rule. In addition, this final rule does not 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).
    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).

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: October 5, 2009.
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.  180.910  [Amended]

0
2. In the final rule published August 9, 2006 (71 FR 45415), and 
delayed on August 4, 2008 (73 FR 45312), and August 7, 2009 (74 FR 
39543) the effective date is delayed from October 9, 2009, to February 
9, 2010, for the following amendments to Sec. 180.910: 2.m., n., and 
cc.

Sec.  180.930  [Amended]

0
3. In the final rule published August 9, 2006 (71 FR 45415), and 
delayed on August 4, 2008 (73 FR 45312), and August 7, 2009 (74 FR 
39543) the effective date is delayed from October 9, 2009, to February 
9, 2010, for the following amendmentsto Sec. 180.930: 4.t., u., and v.

 [FR Doc. E9-24415 Filed 10-6-09; 4:15 pm]

BILLING CODE 6560-50-S