Document ID: EPA-HQ-OPP-2009-0601-0001
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: 2009-08-07T04:00Z

[Federal Register: August 7, 2009 (Volume 74, Number 151)]
[Rules and Regulations]               
[Page 39543-39545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au09-4]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0601; FRL-8431-8]

 
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 with insufficient data for 
reassessment as set forth in the Federal Register on August 4, 2008 (73 
FR 45312).

DATES: In the final rule published August 9, 2006 (71 FR 45415), and 
delayed on August 4, 2008 (73 FR 45312):
     1. The effective date is delayed from August 9, 2009, to October 
9, 2009, for the following amendments to Sec.  180.910: 2.m., n., and 
cc.
     2. The effective date is delayed from August 9, 2009, to October 
9, 2009, for the following amendments to Sec.  180.930: 4.t., u., and 
v.
     Objections and requests for hearings must be received on or before 
October 6, 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 index for the docket. 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. 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.

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 
Comestic 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

[[Page 39544]]

(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 subsequent 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.

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

     In the case of six of the revoked tolerance exemptions, EPA has 
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 
Agency has not yet fully completed the risk assessments needed to 
evaluate these petitions and to make a safety finding. 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 the these tolerance exemptions 
should be moved by two months to October 9, 2009.

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 4, 
2008 (73 FR 45312) 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 October 9, 2009.

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 ethyiene oxide.

IV. Statutory and Executive Order Reviews

     This rule changes the effective date of the revocation of certain 
tolerance exemptions under section 408(d) of FFDCA. The Office of 
Management and Budget (OMB) has exempted tolerance exemption 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 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).

[[Page 39545]]

     Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency hereby certifies that this action will not have a 
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 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 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 9, 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.

List of Subjects in 40 CFR Part 180

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

    Dated: August 4, 2009.
G. Jeffrey Herndon,
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), 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), the effective date is delayed 
from August 9, 2009, to October 9, 2009, 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), the effective date is delayed 
from August 9, 2009, to October 9, 2009, for the following amendments 
to Sec.  180.930: 4.t., u., and v.
[FR Doc. E9-19057 Filed 8-6-09; 8:45 am]

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