Document ID: EPA-HQ-OPP-2011-0525-0003
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: alpha-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-omega-hydroxypoly(oxyethylene)
Posted Date: 2012-05-11T04:00Z

[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Rules and Regulations]
[Pages 27628-27631]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11064]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0525; FRL-9340-1]

[alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene); Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of [alpha]-[p-(1,1,3,3-
tetramethylbutyl)phenyl]-[omega]-hydroxypoly(oxyethylene) (CAS Reg. 
Nos. 9036-19-5, 9002-93-1) when used as an inert ingredient at levels 
not to exceed 7% in pesticide formulations applied to growing crops and 
raw agricultural commodities after harvest. The Joint Inerts Task 
Force, Cluster Support Team Number 5 submitted a petition to EPA under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
establishment of an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of [alpha]-[p-(1,1,3,3-tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene).

DATES: This regulation is effective May 11, 2012. Objections and 
requests for hearings must be received on or before July 10, 2012, 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-2011-0525. 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; email 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 get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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. 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-2011-0525 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
July 10, 2012. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0525, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online 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

    In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 1E7858) by Joint 
Inerts Task Force, Cluster Support Team 5, c/o CropLife America, 1156 
15th St. NW., Suite 400, Washington, DC 20005. The petition requested 
that 40 CFR 180.910 be amended by establishing an exemption from the 
requirement of a tolerance for residues of [alpha]-[p-(1,1,3,3-
tetramethylbutyl)phenyl]-[omega]-hydroxypoly(oxyethylene) (CAS Reg. 
Nos. 9036-19-5, 9002-93-1) when used as an inert ingredient at levels 
not to exceed 7% in pesticide formulations

[[Page 27629]]

applied to growing crops and raw agricultural commodities after 
harvest. That notice referenced a summary of the petition prepared by 
Joint Inerts Task Force, Cluster Support Team 5, the petitioner, which 
is available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Previously, in the Federal Register of May 17, 2010 (75 FR 27443) 
(FRL-8826-3), EPA established a time-limited tolerance exemption for 
[alpha]-[p-(1,1,3,3-tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) (herein referred to in this document as 
octylphenol ethoxylate) with an expiration date of May 17, 2012. The 2-
year time limitation was established for two purposes:
    1. To provide time for the development and submission of 
confirmatory toxicity data to address equivocal results in the 
available genotoxicity studies conducted on octylphenol ethoxylate (as 
described in Unit IV.C., of the May 17, 2010 final rule); and
    2. To provide additional time, should the initial testing not 
confirm EPA's conclusion regarding the lack of a cancer concern, for 
registrants to attain EPA approval of registration amendments for 
reformulation of their pesticide products to remove octylphenol 
ethoxylate and to replace existing products with reformulated products.
    In establishing the time-limited tolerance exemption for 
octylphenol ethoxylate, EPA stated that if the submitted data confirmed 
its conclusion regarding a lack of cancer concern, the Agency intended 
to remove the expiration date from the tolerance exemption prior to 
expiration of the exemption.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue * * *.''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for octylphenol ethoxylate 
including exposure resulting from the exemption established by this 
action.
    In the Federal Register of May 17, 2010, EPA issued a final rule 
establishing an exemption from the requirement of a tolerance for 
residues of octylphenol ethoxylate when used as an inert ingredient at 
levels not to exceed 7% in pesticide formulations applied to growing 
crops and raw agricultural commodities after harvest under 40 CFR 
180.910 with an expiration date of May 17, 2012. EPA has determined 
that establishing an exemption from the requirement of a tolerance for 
residues of octylphenol ethoxylate when used as an inert ingredient an 
inert ingredient at levels not to exceed 7% in pesticide formulations 
applied to growing crops and raw agricultural commodities after harvest 
will not significantly change the risk assessments the Agency relied on 
to support the May 17, 2010, tolerance action, as explained in this 
unit.
    As part of the Agency's conduct of the risk assessment in support 
of the May 17, 2010, tolerance action, it was determined that there 
were no acute, chronic, short- or intermediate term aggregate risks of 
concern. With regards to aggregate cancer risk, the assessment 
concluded that based on a weight of the evidence consideration of the 
available data, the Agency believed that cancer risks would be 
negligible. However, due to the equivocal findings in the mutagenicity 
data base, the Agency asked for confirmatory data. Specifically, EPA 
recommended that supporters of the octylphenol ethoxylate tolerance 
exemption perform the following studies for confirmatory purposes:
    A new Ames assay (OCSPP Harmonized Guideline 870.5100--Bacterial 
reverse mutation test) and a mouse lymphoma assay (OCSPP Harmonized 
Guideline 870.5300--in vitro Mammalian cell gene mutation test).
    A bone marrow assay (OCSPP Harmonized Guideline 870.5395--Mammalian 
erythrocyte micronucleus test).
    Since in vivo mutagenicity studies such as the bone marrow assay 
are generally regarded as more definitive than in vitro studies, and a 
negative result in the bone marrow test may outweigh whatever results 
are found in the Ames test and mouse lymphoma assay, supporters of the 
octylphenol ethoxylate tolerance exemption were given the option of 
conducting the mammalian erythrocyte micronucleus test in lieu of the 
two in vitro mutagenicity studies. If those data did not confirm EPA's 
cancer conclusion, then EPA would need 2-year cancer bioassays in the 
mouse and rat (OCSPP

[[Page 27630]]

Harmonized Guideline 870.4200--Carcinogenicity (mouse) and OCSPP 
Harmonized Guideline 870.4300--Combined Chronic Toxicity/
Carcinogenicity (rat)) to make a safety finding in support of the 
tolerance exemption.
    In response to the May 17, 2010, final rule, the Joint Inerts Task 
Force, Cluster Support Team Number 5 conducted an in vivo Mouse Bone 
Marrow Erythrocyte Micronucleus Test Following Oral Administration 
(OCSPP Harmonized Test Guideline 870.5395) of the representative test 
compound, poly(oxy-1,2-ethanediyl),[alpha]-[4-(1,1,3,3-
tetramethylbutyl)phenyl]-[omega]-hydroxy- (CAS Reg. No. 9002-93-1). 
These data were submitted to the Agency on November 12, 2010 (Master 
Record Identification Number 48293301).
    The data were evaluated by EPA and it was determined that the test 
substance did not induce numerical or structural chromosomal damage, 
providing further confirmation that octylphenol ethoxylate is not of 
concern for aggregate cancer risk. Further details of this evaluation 
can be found at http://www.regulations.gov in the document 
``Octylphenol Ethoxylates--(JITF CST 5 Inert Ingredients).--Review of 
Confirmatory Mutagencity Toxicity Data'' in docket ID number EPA-HQ-
OPP-2011-0525.
    Refer to the May 17, 2010, Federal Register document, available at 
http://www.regulations.gov, for a detailed discussion of the aggregate 
risk assessment and determination of safety.
    Therefore, based on this information and the findings in the final 
rule published in the Federal Register of May 17, 2010, EPA concludes 
that there is a reasonable certainty that no harm will result to the 
general population, or to infants and children from aggregate exposure 
to octylphenol ethoxylate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food 
and Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for octylphenol ethoxylate.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of [alpha]-[p-(1,1,3,3-
tetramethylbutyl)phenyl]-[omega]-hydroxypoly(oxyethylene) when used as 
an inert ingredient at levels not to exceed 7% in pesticide 
formulations applied to growing crops and raw agricultural commodities 
after harvest under 40 CFR 180.910.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) 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 FFDCA section 408(d), 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 Congress in the preemption provisions 
of FFDCA section 408(n)(4). 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) (Pub. L. 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).

VIII. 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.

[[Page 27631]]

    Dated: April 26, 2012.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

    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.

0
2. In Sec.  180.910, the table is amended by revising the entry for the 
inert ingredient which reads in part ``[alpha]-[p-(1,1,3,3-
tetramethylbutyl)phenyl]'' to read as follows:

Sec.  180.910  Inert ingredients used pre and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

 
------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
[alpha]-[p-(1,1,3,3-              Not to exceed 7%    Surfactants
 tetramethylbutyl)phenyl]-         of pesticide        related adjuvants
 [omega]-                          formulation.        of surfactants.
 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
 (CAS Reg. Nos. 9036-19-5, 9002-
 93-1).
 
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[FR Doc. 2012-11064 Filed 5-10-12; 8:45 am]
BILLING CODE 6560-50-P