Document ID: EPA-HQ-OPP-2006-0230-0024
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: 2008-08-04T04:00Z

[Federal Register: August 4, 2008 (Volume 73, Number 150)]
[Rules and Regulations]               
[Page 45311-45316]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au08-7]                         

[[Page 45311]]

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Part III

Environmental Protection Agency

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40 CFR Part 180

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

Pesticide Inert Ingredients: Status of Revoked Tolerance Exemptions; 
Notice

[[Page 45312]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0230; FRL-8372-7]

 
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 
certain inert ingredient tolerance exemptions with insufficient data 
for reassessment as set forth in the Federal Register on August 9, 2006 
(71 FR 45415).

DATES: In the final rule published August 9, 2006 (71 FR 45421):
    1. The effective date is delayed from August 9, 2008, to August 9, 
2009, for the following amendments to Sec.  180.910: 2.a., c., i. 
through k., m. through o., s., t., w. through aa., and cc.
    2. The effective date is delayed from August 9, 2008, to August 9, 
2009, for the following amendments to Sec.  180.920: 3.a., b., e. 
through k., m. through p., s., y., z., bb., cc., ff., gg., ii., ll. 
through nn., and ss.
    3. The effective date is delayed from August 9, 2008, to August 9, 
2009, for the following amendments to Sec.  180.930: 4.b., c., d., f., 
l., n., o., s. through w., cc., and ee. through jj.
    4. The effective date is delayed from August 9, 2008, to August 9, 
2009, for the following amendments to Sec.  180.940: 5.a.i., ii., and 
5.c.i., ii., iv., vii., and viii.
    Objections and requests for hearings must be received on or before 
October 3, 2008, 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-2006-0230. 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: Karen Angulo, Registration Division 
(7505P), 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. 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.

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 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.
    EPA has received communications from pesticide registrants and 
inert ingredient manufacturers expressing interest in supporting 
certain inert ingredient tolerance exemptions that were revoked in the 
final rule of August 9, 2006. EPA developed voluntary guidance 
describing how interested parties could support these revoked tolerance 
exemptions, including consultations with the Agency about how they can 
demonstrate support, identifying test materials, and providing evidence 
that a laboratory has been hired to conduct the study. The voluntary 
guidance document, entitled ``Guidance for Supporting the Inert 
Ingredients Subject to the Revocation Notice of August 9, 2006'', is 
available on EPA's Web site at http://www.epa.gov/opprd001/inerts/.
    In the interest of keeping the stakeholders informed about 
activities that may affect these revoked tolerance exemptions, EPA 
published the support status of each of the revoked tolerance 
exemptions in the Federal Register of November 2, 2007, (72 FR 62232) 
(FRL-8155-4), and indicated whether the Agency had received a 
demonstration of intent to support (such as described in the guidance 
document). Be advised that the information provided in today's notice 
or the November 2, 2007 (72 FR 62232) notice on the revoked inert 
ingredients does not guarantee or in any way bind the Agency to 
reinstate tolerance exemptions or establish new tolerance exemptions. 
EPA cannot guarantee that the parties will, in fact, submit any data at 
all. Additionally, it is possible that the data submitted to support a 
tolerance exemption may not support a safety finding under FFDCA 
section 408(c)(2). In these cases, the tolerance exemption will not be 
reinstated nor will a new one be established. It is important to note 
that several parties have indicated that they may want to support only 
a portion of a tolerance exemption expression that includes a range of 
chemicals. At this time, EPA does not know exactly what range of 
chemicals within a tolerance exemption will eventually be supported by 
data. Until the data are submitted and reviewed, EPA will not know what 
portion, if any, of a current tolerance

[[Page 45313]]

exemption can be reinstated. If the results of the data permit, a 
supported exemption may be reinstated in whole, or a new tolerance 
exemption may be established if only a part of a revoked exemption is 
supported by the data. EPA recommends that registrants relying on the 
continued existence of a particular tolerance exemption contact the 
chemical's supplier to confirm their plans for supporting the 
exemption.

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

    EPA has received requests for an extension of the revocation date 
from pesticide registrants and inert ingredient manufacturers who have 
demonstrated their intent to support certain inert ingredient tolerance 
exemptions. For each of these supported tolerance exemptions, EPA has 
received data development plans and schedules with all data projected 
to be submitted by January 2009. EPA has determined that these parties 
have shown a good-faith effort to develop studies in a timely manner 
and have followed EPA's guidance (see guidance document) describing how 
interested parties can support the revoked tolerance exemptions. EPA 
recognizes that repeat-dose studies may take about a year to conduct, 
and this does not include any preliminary studies that often must be 
completed beforehand (e.g., range finding). EPA will then analyze the 
submitted data and develop risk assessments prior to making a safety 
finding and reinstatement determination. EPA, therefore, concludes that 
additional time is necessary for study generation and the development 
of EPA's risk assessments, and that the effective date of the 
revocation of the supported tolerance exemptions should be moved by one 
year to August 9, 2009.
    In addition, two other revoked tolerance exemptions received an 
acceptable demonstration of support and the effective date of the 
revocation is now August 9, 2009. In the Federal Register on August 9, 
2006 (71 FR 45415), the Agency revoked two inert ingredient tolerance 
exemptions with insufficient data under 40 CFR part 180. They were 
inadvertently removed from the CFR some time ago but are considered to 
be active tolerance exemptions subject to reassessment as required by 
the FFDCA section 408(q). The effective date of the revocation of the 
following two tolerance exemptions is now August 9, 2009: 1. Sec.  
180.910: ``[alpha]-Alkyl(C12-C15)-[omega]- 
hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, 
potassium, sodium, and zinc salts; the poly(oxyethylene) content 
averages 3 moles.'', and 2. Sec.  180.930: ``[alpha]-Alkyl 
(C12-C15)-[omega]-hydroxypoly(oxyethylene) 
sulfate and its ammonium, calcium, magnesium, potassium, sodium, and 
zinc salts; the poly(oxyethylene) content averages 3 moles.''
    It is important to note that this action does not move the 
effective date of those tolerance exemptions revoked in the Federal 
Register on August 9, 2006 (71 FR 45415) for which there has been no 
expression of an intent to support. Elsewhere in this issue of the 
Federal Register is a document providing the revocation date of each of 
the inert ingredient tolerance exemptions revoked because of 
insufficient data on August 9, 2006. Tolerance exemptions with no 
expression of an intent to support are revoked as of August 9, 2008. 
All commodities containing residues of these revoked inert ingredients 
on food are adulterated under FFDCA 408 if the residues are the result 
of applications of pesticide products made after August 9, 2008. At 
this time, EPA is no longer accepting or processing applications for 
registrations for food-use products containing a tolerance exemption 
that expires on August 9, 2008 unless accompanied by a petition for a 
new tolerance or exemption under the Pesticide Registration Improvement 
Renewal Act (PRIA 2), together with all necessary supporting data. 
Registrants who submitted a registration application for a food-use 
formulation containing an inert ingredient with an expiring tolerance 
exemption may submit a new application for registration with only those 
inert ingredients that are approved for the label's use sites. If the 
registration application is subject to PRIA 2, including registration 
applications submitted under PRIA 2 that include a petition for a new 
or amended food-use inert ingredient, the following Web site provides 
useful information: http://www.epa.gov/pesticides/fees/questions/
pria21day_wrksht.pdf. Currently approved food-use inert ingredient 
tolerance exemptions are found in 40 CFR part 180 (http://www.epa.gov/
opprd001/inerts/lists.html). Contact EPA's Inert Ingredient Assessment 
Branch at inertsbranch@epa.gov for information about how to establish a 
new inert ingredient.

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 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 9, 
2006 (71 FR 45415) for the convenience of the user. The structure 
mirrors the amendatory designations in the original document. The 
asterisks represent those amendatory designations that go into effect 
August 9, 2008. The amendatory designations shown are those with the 
effective date delayed until August 9, 2009.

Section 180.910

* * * * *
    a. [alpha]-Alkyl (C9-C18-[omega]-
hydroxypoly(oxyethylene) with poly(oxyethylene) content of 2-30 moles.
* * * * *
    c. [alpha]-Alkyl (C6-C14)-[omega]-
hydroxypoly(oxypropylene) block copolymer with polyoxyethylene; 
polyoxypropylene content is 1-3 moles; polyoxyethylene content is 4-12 
moles; average molecular weight (in amu) is approximately 635.
* * * * *
    i. Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the 
ethylene oxide content averages 3.5, 10, or 30 moles.

[[Page 45314]]

    j. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene), average 
molecular weight (in amu) of 600.
    k. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene) sulfate, sodium 
salt; the poly(oxyethylene) content is 3-4 moles.
* * * * *
    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.
    o. Polyglyceryl phthalate ester of coconut oil fatty acids.
* * * * *
    s. Sodium diisobutylnaphthalenesulfonate.
    t. Sodium dodecylphenoxybenzenedisulfonate.
* * * * *
    w. Sodium monoalkyl and dialkyl (C8-C16) 
phenoxybenzenedisulfonate mixtures containing not less than 70% of the 
monoalkylated product.
    x. Sodium mono- and dimethylnaphthalenesulfonates, molecular weight 
(in amu) 245-260.
    y. Sodium mono-, di-, and tributyl naphthalenesulfonates.
    z. Sodium mono-, di-, and triisopropyl naphthalenesulfonate.
    aa. Sodium N-oleoyl-N-methyltaurine.
* * * * *
    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 180.920

* * * * *
    a. [alpha]-Alkyl (C12-C18)-[omega]-
hydroxypoly(oxyethylene) copolymers with poly(oxypropylene); 
polyoxyethylene content averages 3-12 moles and polyoxypropylene 
content 2-9 moles.
    b. [alpha]-Alkyl (C10-C16)-[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 poly(oxyethylene) content averages 3-20 moles.
* * * * *
    e. [alpha]-Alkyl(C12-C18)-[omega]-hydroxypoly 
(oxyethylene/oxypropylene) hetero polymer in which the oxyethylene 
content averages 13-17 moles and the oxypropylene content averages 2-6 
moles.
    f. [alpha]-Alkyl (C10-C16)-[omega]-
hydroxypoly(oxyethylene)poly(oxypropylene) mixture of di- and 
monohydrogen phosphate esters and the corresponding ammonium, calcium, 
magnesium, monoethanolamine, potassium, sodium, and zinc salts of the 
phosphate esters; the combined poly(oxyethylene) poly(oxypropylene) 
content averages 3-20 moles.
    g. [alpha]-Alkyl (C12-C18)-[omega]-
hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the 
oxyethylene content is 8-12 moles and the oxypropylene content is 3-7 
moles.
    h. [alpha]-Alkyl (C12-C15)-[omega]-
hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the 
oxyethylene content is 8-13 moles and the oxypropylene content is 7-30 
moles.
    i. [alpha]-Alkyl (C21-C71)-[omega]-
hydroxypoly (oxyethylene) in which the poly(oxyethylene) content is 2 
to 91 moles and molecular weight range from 390 to 5,000.
    j. n-Alkyl(C8-C18)amine acetate.
    k. Amine salts of alkyl (C8-C24) 
benzenesulfonic acid (butylamine, dimethylaminopropylamine, mono- and 
diisopropylamine, mono- , di- , and triethanolamine).
* * * * *
    m. N,N-Bis[[alpha]-ethyl-[omega]-hydroxypoly(oxyethylene) 
alkylamine; the poly(oxyethylene) content averages 3 moles; the alkyl 
groups (C14-C18) are derived from tallow, or from 
soybean or cottonseed oil acids.
    n. N,N-Bis(2-hydroxyethyl)alkylamine, where the alkyl groups 
(C8-C18) are derived from coconut, cottonseed, 
soya, or tallow acids.
    o. N,N-Bis 2-([omega]-hydroxypolyoxyethylene) ethyl) alkylamine; 
the reaction product of 1 mole N,N-bis(2-hydroxyethyl)alkylamine and 3-
60 moles of ethylene oxide, where the alkyl group (C8-
C18) is derived from coconut, cottonseed, soya, or tallow 
acids.
    p. N,N-Bis-2-([omega]-hydroxypolyoxyethylene/polyoxypropylene) 
ethyl alkylamine; the reaction product of 1 mole of N,N-bis(2-
hydroxyethyl alkylamine) and 3-60 moles of ethylene oxide and propylene 
oxide, where the alkyl group (C8-C18) is derived 
from coconut, cottonseed, soya, or tallow acids.
* * * * *
    s. [alpha]-(Di-sec-butyl)phenylpoly(oxypropylene) block polymer 
with poly(oxyethylene); the poly(oxypropylene) content averages 4 
moles, the poly(oxyethylene) content averages 5 to 12 moles, the 
molecular.
* * * * *
    y. Linoleic diethanolamide (CAS Reg. No. 56863-02-6).
    z. Methyl bis(2-hydroxyethyl)alkyl ammonium chloride, where the 
carbon chain (C8-C18) is derived from coconut, 
cottonseed, soya, or tallow acids.
* * * * *
    bb. Methylnaphthalenesulfonic acid--formaldehyde condensate, sodium 
salt.
    cc. Methyl poly(oxyethylene) alkyl ammonium chloride, where the 
poly(oxyethylene) content is 3-15 moles and the alkyl group 
(C8-C18) is derived from coconut, cottonseed, 
soya, or tallow acids.
* * * * *
    ff. Naphthalenesulfonic acid-formaldehyde condensate, ammonium and 
sodium salts.
    gg. Partial sodium salt of N-lauryl-[alpha]-iminodipropionic acid.
* * * * *
    ii. Primary n-alkylamines, where the alkyl group (C8-
C18) is derived from coconut, cottonseed, soya, or tallow 
acids.
* * * * *
    ll. Sodium 1,4-dihexyl sulfosuccinate.
    mm. Sodium 1,4-diisobutyl sulfosuccinate.
    nn. Sodium 1,4-dipentyl sulfosuccinate.
* * * * *
    ss. N,N,N',N''-Tetrakis-(2-hydroxypropyl) ethylenediamine.
* * * * *

Section 180.930

* * * * *
    b. [alpha]-Alkyl (C12-C15)-[omega]-
hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the 
oxyethylene content is 8-13 moles and the oxypropylene content is 7-30 
moles.
    c. [alpha]-Alkyl (C8-C10) 
hydroxypoly(oxypropylene) block

[[Page 45315]]

polymer with polyoxyethylene; polyoxypropylene content averages 3 moles 
and polyoxyethylene content averages 5-12 moles.
    d. [alpha]-Alkyl (C6-C14)-[omega]-
hydroxypoly(oxypropylene) block copolymer with polyoxyethylene; 
polyoxypropylene content is 1-3 moles; polyoxyethylene content is 7-9 
moles; average molecular weight (in amu) approximately 635.
* * * * *
    f. Amine salts of alkyl (C8-C24) 
benzenesulfonic acid (butylamine; dimethylamino propylamine; mono- and 
diisopropyl- amine; and mono- , di-, and triethanolamine).
* * * * *
    l. Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the 
ethylene oxide content averages 3.5, 10, or 30 moles.
* * * * *
    n. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene), average 
molecular weight (in amu) of 600.
    o. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene), sulfate, sodium 
salt; the poly(oxyethylene) content is 3-4 moles.
* * * * *
    s. Naphthalenesulfonic acid and its sodium salt.
    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.
    w. Polyglyceryl phthalate esters of coconut oil fatty acids.
* * * * *
    cc. Sodium diisobutylnaphthalenesulfonate.
* * * * *
    ee. Sodium isopropylnaphthalenesulfonate.
    ff. Sodium monoalkyl and diakyl (C8-C13) 
phenoxybenzenedisulfonate mixtures containing not less than 70% of the 
monoalkylated product.
    gg. Sodium mono- and dimethylnaphthalenesulfonate, molecular weight 
(in amu) 245-260.
    hh. Sodium mono-, di-, and tributylnaphthalenesulfonates.
    ii. Sodium N-oleoyl-N-methyl taurine.
    jj. [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.
* * * * *

Paragraph (a) to Section 180.940

* * * * *
    i. [alpha]-Alkyl(C10-C14)-[omega]- 
hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight 
(in amu), 768 to 837.
    ii. [alpha]-Alkyl(C12-C18)-[omega] 
hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight 
(in amu), 950 to 1120.
* * * * *

Paragraph (c) to Section 180.940

* * * * *
    i. [alpha]-Alkyl(C10-C14)-[omega]-hydroxypoly 
(oxyethylene) poly (oxypropylene) average molecular weight (in amu), 
768 to 837.
    ii. [alpha]-Alkyl(C11-C15)-[omega]-
hydroxypoly (oxyethylene) with ethylene oxide content 9 to 13 moles.
* * * * *
    iv. [alpha]-Alkyl(C12-C18)-[omega]-
hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight 
(in amu), 950 to 1120.
* * * * *
    vii. Naphthalene sulfonic acid sodium salt, and its methyl, 
dimethyl and trimethyl derivatives.
    viii. Naphthalene sulfonic acid sodium salt, and its methyl, 
dimethyl and trimethyl derivatives alkylated at 3% by weight with 
C6-C9 linear olefins.
* * * * *

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).
    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. The factual basis for this certification is included in Unit 
II.B.8.
    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

[[Page 45316]]

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 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.

List of Subjects in 40 CFR Part 180

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

    Dated: July 23, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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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 45421), the 
effective date is delayed from August 9, 2008, to August 9, 2009, for 
the following amendments to Sec.  180.910: 2.a., c., i. through k., m. 
through o., s., t., w. through aa., and cc.

Sec.  180.920  [Amended]

0
3. In the final rule published August 9, 2006 (71 FR 45421), the 
effective date is delayed from August 9, 2008, to August 9, 2009, for 
the following amendments to Sec.  180.920: 3.a., b., e. through k., m. 
through p., s., y., z., bb., cc., ff., gg., ii., ll. through nn., and 
ss.

Sec.  180.930  [Amended]

0
4. In the final rule published August 9, 2006 (71 FR 45421), the 
effective date is delayed from August 9, 2008, to August 9, 2009, for 
the following amendments to Sec.  180.930: 4.b., c., d., f., l., n., 
o., s. through w., cc., and ee. through jj.

Sec.  180.940  [Amended]

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5. In the final rule published August 9, 2006 (71 FR 45421), the 
effective date is delayed from August 9, 2008, to August 9, 2009, for 
the following amendments in paragraph (a) to Sec.  180.940: 5.a.i. and 
ii.
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6. In the final rule published August 9, 2006 (71 FR 45421), the 
effective date is delayed from August 9, 2008, to August 9, 2009, for 
the following amendments in paragraph (c) to Sec.  180.940: 5.c.i., 
ii., iv., vii. and viii.

[FR Doc. E8-17458 Filed 8-1-08; 8:45 am]

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