Document ID: EPA-HQ-OPP-2011-0949-0003
Agency: epa
Document Type: Rule
Title: Exemptions from Requirements of Tolerances: Alkyl Amines Polyalkoxylates
Posted Date: 2012-10-10T04:00Z

[Federal Register Volume 77, Number 196 (Wednesday, October 10, 2012)]
[Rules and Regulations]
[Pages 61515-61518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24776]

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 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0949; FRL-9361-7]

Alkyl Amines Polyalkoxylates; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the exemption from the requirement of a 
tolerance for residues alkyl amines polyalkoxylates under 40 CFR 
180.920 and 40 CFR 180.930 to include the additional Chemical Abstract 
Service Registry Number (CAS Reg. No.) 1266162-49-5. BASF Corporation 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting an amendment to an existing requirement of a 
tolerance.

DATES: This regulation is effective October 10, 2012. Objections and 
requests for hearings must be received on or before December 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0949 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Elizabeth Fertich, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 347-8560; email address: 
fertich.elizabeth@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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.

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-2011-0949 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 
December 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 (excluding 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 the non-

[[Page 61516]]

CBI copy of your objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0949, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 1E7931) by BASF 
Corporation, 100 Campus Drive; Florham Park, NJ 07932. The petition 
requested that 40 CFR 180.920 and 180.930 be amended by modifying an 
exemption from the requirement of a tolerance for residues of N,N-Bis-
[alpha]-ethyl-[omega]-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated 
and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-
60 moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8, 
288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-
2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8,70955-14-
5, 73246-96-5); herein referred to as alkyl amines polyalkoxylates. 
Specifically, the petition requested that the exemption also include 
the alkyl amines polyalkoxylate described by CAS Reg. No. 1266162-49-5. 
That notice referenced a summary of the petition prepared by BASF 
Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    In this petition, BASF Corporation claims that the chemical 
represented by CAS Reg. No. 1266162-49-5 (poly(oxy-1,2-ethandiyl), 
[alpha],[alpha]'-[[(2-propylheptyl)imino]di-2,1-ethanediyl]bis[[omega]-
hydroxy-) is covered by the published tolerance exemption for alkyl 
amines polyalkoxylates and that no further data or review is required 
to amend the existing tolerance exemption to include the additional CAS 
Reg. No.

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 ingredient 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 alkyl amine polyalkoxylates 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with alkyl 
amine polyalkoxylates follows.
    The Agency agrees with the petitioner that CAS Reg. No. 1266162-49-
5 is an alkyl amine polyalkoxylate similar to the other alkyl amine 
polyalkoxylates present in the exemption for N,N-Bis-[alpha]-ethyl-
[omega]-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and 
unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-60 
moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8, 
288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-
2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8, 70955-
14-5, 73246-96-5). In 2009, in establishing the exemption for the alkyl 
amine polyalkoxylates, EPA assessed the safety of the alkyl amine 
polyalkoxylates generally using worst case exposure assumptions. (74 FR 
28616) (FRL-8418-6). EPA concluded that that assessment showed that 
exempting the alkyl amine polyalkoxylates from the requirement from a 
tolerance would be safe. Inclusion of chemical described by the CAS 
Reg. No. 1266162-49-5 in the risk assessment for the alkyl amine 
polyalkoxylates would in no way alter that prior risk assessment given 
the generic findings on toxicity and the worst case exposure 
assumptions used in that risk assessment. Accordingly, based on the 
findings in that earlier rule, EPA has determined that there is a 
reasonable certainty that no harm to any population subgroup, including 
infants and children, will result from aggregate exposure to alkyl 
amine polyalkoxylates, including the chemical described by the CAS Reg. 
No.

[[Page 61517]]

1266162-49-5, under reasonably foreseeable circumstances. Therefore, 
the amendment of an exemption from tolerance under 40 CFR 180.920 and 
180.930 for residues of alkyl amine polyalkoxylates to include the 
chemical described by the CAS Reg. No. 1266162-49-5 is safe under FFDCA 
section 408.

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 Nations 
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 an MRL for alkyl amine polyalkoxylates.

VI. Conclusions

    Therefore, the exemption from the requirement of a tolerance under 
40 CFR 180.920 and 180.930 for alkyl amine polyalkoxylates is amended 
to include CAS Reg. No. 1266162-49-5.

VII. Statutory and Executive Order Reviews

    This final rule establishes 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: September 28, 2012.
Lois Rossi,
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.  180.920, the table is amended by revising the following 
inert ingredient to read as follows:

Sec.  180.920  Inert ingredients use pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
          Inert ingredients                     Limits                                 Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]-        Not to exceed 25% in        Surfactants, related adjuvants of surfactants.
 hydroxypoly(oxy-1,2-ethanediyl) C8-   herbicide formulations
 C18 saturated and unsaturated         and 10% in insecticide
 alkylamines; the poly(oxy-1,2-        and fungicide
 ethanediyl) content is 2-60 moles     formulations.
 (CAS Reg. Nos. 10213-78-2, 25307-17-
 9, 26635-92-7, 26635-93-8, 288259-
 52-9, 58253-49-9, 61790-82-7, 61791-
 14-8, 61791-24-0, 61791-26-2, 61791-
 31-9, 61791-44-4, 68155-33-9, 68155-
 39-5, 68155-40-8,70955-14-5, 73246-
 96-5, 1266162-49-5).
 

[[Page 61518]]

 
                                                  * * * * * * *
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0
3. In Sec.  180.930, the table is amended by revising the following 
inert ingredient to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
          Inert ingredients                     Limits                                 Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]-        Not to exceed 25% in        Surfactants, related adjuvants of surfactants
 hydroxypoly(oxy-1,2-ethanediyl) C8-   herbicide formulations
 C18 saturated and unsaturated         and 10% in insecticide
 alkylamines; the poly(oxy-1,2-        and fungicide
 ethanediyl) content is 2-60 moles     formulations.
 (CAS Reg. Nos. 10213-78-2, 25307-17-
 9, 26635-92-7, 26635-93-8, 288259-
 52-9, 58253-49-9, 61790-82-7, 61791-
 14-8, 61791-24-0, 61791-26-2, 61791-
 31-9, 61791-44-4, 68155-33-9, 68155-
 39-5, 68155-40-8,70955-14-5, 73246-
 96-5, 1266162-49-5).
 
                                                  * * * * * * *
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[FR Doc. 2012-24776 Filed 10-9-12; 8:45 am]
BILLING CODE 6560-50-P