Document ID: EPA-HQ-OPP-2010-0275-0005
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Polymerized Fatty Acid Esters with Aminoalcohol Alkoxylates
Posted Date: 2011-02-16T05:00Z

[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Rules and Regulations]
[Pages 8895-8900]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3400]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2010-0275; FRL-8860-8]

Polymerized Fatty Acid Esters With Aminoalcohol Alkoxylates; 
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 polymerized fatty acid esters with 
aminoalcohol alkoxylates (PFAEAA) with a minimum number average 
molecular weight (in amu) 1,200, limited to the chemicals listed in 
Unit 11 of the SUPPLEMENTARY INFORMATION, when used as an inert 
ingredient (surfactant) under 40 CFR 180.910 (growing crops and raw 
agricultural commodities after harvest) and 40 CFR 180.930 (animal 
application). Croda Inc. 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 PFAEAA.

DATES: This regulation is effective February 16, 2011. Objections and 
requests for hearings must be received on or before April 18, 2011, 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-2010-0275. 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: Deirdre Sunderland, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone

[[Page 8896]]

number: (703) 603-0851; e-mail address: sunderland.deirdre@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://www.gpoaccess.gov/ecfr. To access the harmonized 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-2010-0275 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 
April 18, 2011. 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-2010-0275, 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. Petition for Exemption

    In the Federal Register of June 8, 2010 (75 FR 32463) (FRL-8827-5), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 0E7699) by Croda 
Inc., 315 Cherry Lane, New Castle, DE 19720. The petition requested 
that 40 CFR 180.910 and 180.930 be amended by establishing an exemption 
from the requirement of a tolerance for residues of polymerized fatty 
acid esters with aminoalcohol alkoxylates (PFAEAA); limited to the 
following chemicals: Dimethylaminoethanol, ethoxylated, reaction 
products with fatty acid dimers (CAS Reg. No. 1173188-38-9); 
dimethylaminoethanol, ethoxylated, propoxylated, reaction products with 
fatty acid dimers (CAS Reg. No. 1173188-42-5 diethylaminoethanol, 
ethoxylated, reaction product with fatty acid dimers (CAS Reg. No. 
1173188-72-1); diethylaminoethanol, ethoxylated, propoxylated, reaction 
products with fatty acid dimers (CAS Reg. No. 1173188-75-4); 
dimethylaminoethanol, ethoxylated, reaction products with fatty acid 
trimers (CAS Reg. No. 1173188-49-2); dimethylaminoethanol, ethoxylated, 
propoxylated, reaction products with fatty acid trimers (CAS Reg. No. 
1173188-67-4); diethylaminoethanol, ethoxylated, reaction products with 
fatty acid trimers (CAS Reg. No. 1173188-81-2); diethylaminoethanol, 
ethoxylated, propoxylated, reaction products with fatty acid trimers 
(CAS Reg. No. 1173188-83-4); hydroxyethylmorpholine, ethoxylated, 
reaction products with fatty acid dimers (CAS Reg. No. 1173189-00-8); 
hydroxyethylmorpholine, ethoxylated, propoxylated, reaction products 
with fatty acid dimers (CAS Reg. No. 1173189-06-4); 
hydroxyethylpiperidine, ethoxylated, reaction products with fatty acid 
dimers (CAS Reg. No. 1173189-20-2); hydroxyethylpiperidine, 
ethoxylated, propoxylated, reaction products with fatty acid dimers 
(CAS Reg. No. 1173189-22-4); hydroxyethylmorpholine, ethoxylated, 
reaction products with fatty acid trimers (CAS Reg. No. 1173189-09-7); 
hydroxyethylmorpholine, ethoxylated, propoxylated, reaction products 
with fatty acid trimers (CAS Reg. No. 1173189-17-7); 
hydroxyethylpiperidine, ethoxylated, reaction products with fatty acid 
trimers (CAS Reg. No. 1173189-25-7); hydroxyethylpiperidine, 
ethoxylated, propoxylated, reaction products with fatty acid trimers 
(CAS Reg. No. 1173189-28-0), when used as insert ingredients 
(surfactants) in pesticide formulations applied to growing crops or to 
raw agricultural commodities after harvest and formulations applied to 
animals. That notice referenced a summary of the petition prepared by 
Croda Inc., 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 the notice of filing ``dimethylaminoethanol, 
ethoxylated, propoxylated, reaction products with fatty acid trimers'' 
was presented with the incorrect CAS Reg. No. of 1173189-17-7. The 
Petitioner mistakenly listed the same CAS Reg. No. for two of the 
chemicals in the petition. The correct CAS Reg. No. for 
dimethylaminoethanol, ethoxylated, propoxylated, reaction products with 
fatty acid trimers is CAS Reg. No. 1173188-67-4. EPA has adopted the 
correct CAS Reg. No. in promulgating the tolerance 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

[[Page 8897]]

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 section 408(c)(2)(A) of FFDCA, 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 PFAEAA including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with PFAEAA follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The acute oral median lethal dose (LD50) for one 
of the chemicals, (diethylaminoethanol, ethoxylated, reaction products 
with fatty acid trimers (CAS Reg. No. 1173188-81-2)) which has been 
used to represent the group of petitioned chemicals, was determined to 
be > 2,000 milligrams/kilogram (mg/kg) (Harmonized Test Guideline 
870.1100). In a non-guideline study used for supplemental purposes, the 
chemical was shown to be non-irritating to both skin and eyes. A 
reverse mutation assay ``Ames Test'' with and without activation 
(Harmonized Test Guideline 870.5100) indicated that PFAEAA are non-
mutagenic.
    In addition, the Agency has established a set of criteria to 
identify categories of polymers expected to present minimal or no risk 
to human health or the environment (i.e. 40 CFR 180.960). The 
definition of a polymer is given in 40 CFR 723.250(b) and the exclusion 
criteria for identifying these low-risk polymers are described in 40 
CFR 723.250(d). PFAEAA conforms to the definition of a polymer given in 
40 CFR 723.250(b) and meets all of the following criteria, with the 
exception of the ``reactive functional group'' criterion (specified in 
40 CFR 723.250(e) in this Unit), that are used to identify low-risk 
polymers.
    1. The polymer is not a cationic polymer nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. The polymer does contain as an integral part of its composition 
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its 
composition, except as impurities, any element other than those listed 
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably 
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or 
reactants that are already included on the TSCA Chemical Substance 
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number 
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, in order to meet the low risk polymer criteria, the 
polymer also meets as required the exemption criteria specified in 40 
CFR 723.250(e) regarding minimum MW and reactive functional groups. The 
polymer's number average MW of 1,200 is greater than 1,000 and less 
than 10,000 daltons, as required by 40 CFR 723.250(e). Further, the 
polymer meets the 40 CFR 723.250(e) requirement that it contain less 
than 10% oligomeric material below MW 500 and less than 25% oligomeric 
material below MW 1,000. This subsection also states that the polymer 
may not contain any reactive functional groups. PFAEAA contain one 
tertiary amine which makes it ineligible for registration under 40 CFR 
180.960; however, the Agency believes that these reactive functional 
groups are not a safety concern for humans because information provided 
by the petitioner indicates that the polymer exists in a zwitterionic 
form in which the tertiary amine nitrogen is internally protonated and 
not available for further covalent bonding. Additionally, the structure 
of the polymer and its conformation appear to reduce the compound's 
basicity and nucleophilicity. This is further supported by a 
measurement of the isoelectric point (pI) of the polymer.
    Available toxicity studies are limited. However, due to their large 
size (minimum number average molecular weight 1,200 amu) and the 
general conformance to the 40 CFR 180.960, polymerized fatty acid 
esters with aminoalcohol alkoxylates are not expected to pass through 
an intact gastrointestinal tract nor are they anticipated to penetrate 
intact human skin. Inhalation exposure is not expected. Because of 
their inability to enter systemic circulation when used as inert 
ingredients in pesticide formulation PFAEAA are essentially nontoxic. 
Therefore, the Agency concluded that a standard battery of 
toxicological studies are not necessary.

[[Page 8898]]

B. Toxicological Points of Departure/Levels of Concern

    Due to its low potential hazard and lack of a hazard endpoint, the 
Agency has determined that a quantitative risk assessment using safety 
factors applied to a point of departure protective of an identified 
hazard endpoint is not appropriate.
    A reverse mutation assay ``Ames Test'' with and without activation 
(Harmonized Test Guideline 870.5100) indicated that a representative 
chemical, diethylaminoethanol, ethoxylated, reaction products with 
fatty acid trimers (CAS Reg. No. 1173188-81-2), is non-mutagenic and 
based on the available information on PFAEAAs; they are not anticipated 
to be carcinogenic.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses and drinking water. In 
evaluating dietary exposure to PFAEAA, EPA considered exposure under 
the proposed exemption from the requirement of a tolerance. The primary 
route of exposure to PFAEAA from its use as an inert ingredient in 
pesticide products would most likely be through consumption of food to 
which pesticide products containing it have been applied, and possibly 
through drinking water (from runoff). Due to their physical and 
chemical properties it is unlikely that PFAEAA will pass through an 
intact gastrointestinal tract or intact human skin and are therefore, 
unlikely to enter systemic circulation. Because no hazard was 
identified for PFAEAA, a dietary exposure assessment for PFAEAA was not 
conducted.
    2. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    The proposed exemption will allow for various types of residential 
exposure; however, due to the characteristics of these chemicals it is 
not expected that PFAEAA will be absorbed through the intact 
gastrointestinal tract or intact human skin nor is it expected to be 
available via inhalation. Therefore, there is no increased risk from 
exposure to residential products containing PFAEAA as an inert 
ingredient. For that reason the Agency believes a residential risk 
assessment is not necessary.
    3. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found PFAEAA to share a common mechanism of toxicity 
with any other substances, and PFAEAA does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that PFAEAA does not have 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Due to large size of the PFAEAA polymers it is unlikely that they 
will enter systemic circulation from either the gastrointestinal tract 
or intact human skin. As a result, they are unlikely to elicit a toxic 
response in infants and children when used as an inert ingredient in 
pesticide products. Available toxicity studies confirm this belief and 
indicate low toxicity; therefore, the Agency did not use a safety 
factor (SF) analysis for assessing risk. For similar reasons, the 
additional SF for the protection of infants and children is not 
necessary.

E. Aggregate Risks and Determination of Safety

    As indicated in Unit IV, these nonirritant (eye and skin) inert 
ingredients would be incapable of entering systemic circulation and 
therefore, unable to elicit a toxic response in adults and infants/
children. Taking into consideration all available information on 
PFAEAA, EPA has determined that there is a reasonable certainty that no 
harm to any population subgroup will result from aggregate exposure to 
PFAEAA under reasonable foreseeable circumstances. Therefore, the 
establishment of an exemption from tolerance under 40 CFR 180.910 and 
180.930 for residues of PFAEAA when used as an inert ingredient in 
pesticide formulations applied to growing crops or to raw agricultural 
commodities after harvest and formulations applied to animals are 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 U.N. 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 PFAEAA.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 and 40 CFR 180.930 for the petitioned-
for PFAEAA chemicals when used as an inert ingredient (surfactant) in 
pesticide formulations applied to growing crops or to raw agricultural 
commodities after harvest and formulations applied to animals.

VII. 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

[[Page 8899]]

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 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) (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.

    Dated: February 7, 2011.
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.  180.910, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

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

* * * * *

----------------------------------------------------------------------------------------------------------------
             Inert ingredients                             Limits                             Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Diethylaminoethanol, ethoxylated, reaction   .................................  Surfactant.
 product with fatty acid dimers, minimum
 number average molecular weight (in amu),
 1,200 (CAS Reg. No. 1173188-72-1).
Diethylaminoethanol, ethoxylated,            .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid dimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173188-75-4).
Diethylaminoethanol, ethoxylated, reaction   .................................  Surfactant.
 products with fatty acid trimers, minimum
 number average molecular weight (in amu),
 1,200 (CAS Reg. No. 1173188-81-2).
Diethylaminoethanol, ethoxylated,            .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid trimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173188-83-4).
 
                                                  * * * * * * *
Dimethylaminoethanol, ethoxylated, reaction  .................................  Surfactant.
 products with fatty acid dimers, minimum
 number average molecular weight (in amu),
 1,200 (CAS Reg. No. 1173188-38-9).
Dimethylaminoethanol, ethoxylated,           .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid dimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173188-42-5).
Dimethylaminoethanol, ethoxylated, reaction  .................................  Surfactant.
 products with fatty acid trimers, minimum
 number average molecular weight (in amu),
 1,200 (CAS Reg. No. 1173188-49-2).
Dimethylaminoethanol, ethoxylated,           .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid trimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173188-67-4).
 
                                                  * * * * * * *
Hydroxyethylmorpholine, ethoxylated,         .................................  Surfactant.
 reaction products with fatty acid dimers,
 minimum number average molecular weight
 (in amu), 1,200 (CAS Reg. No. 1173189-00-
 8).
Hydroxyethylmorpholine, ethoxylated,         .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid dimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173189-06-4).
Hydroxyethylpiperidine, ethoxylated,         .................................  Surfactant.
 reaction products with fatty acid dimers,
 minimum number average molecular weight
 (in amu), 1,200 (CAS Reg. No. 1173189-20-
 2).
Hydroxyethylpiperidine, ethoxylated,         .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid dimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173189-22-4.
Hydroxyethylmorpholine, ethoxylated,         .................................  Surfactant.
 reaction products with fatty acid trimers,
 minimum number average molecular weight
 (in amu), 1,200 (CAS Reg. No. 1173189-09-
 7).
Hydroxyethylmorpholine, ethoxylated,         .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid trimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173189-17-7).

[[Page 8900]]

 
Hydroxyethylpiperidine, ethoxylated,         .................................  Surfactant.
 reaction products with fatty acid trimers,
 minimum number average molecular weight
 (in amu), 1,200 (CAS Reg. No. 1173189-25-
 7).
Hydroxyethylpiperidine, ethoxylated,         .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid trimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173189-28-0).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. In Sec.  180.930, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

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

----------------------------------------------------------------------------------------------------------------
             Inert ingredients                             Limits                             Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Diethylaminoethanol, ethoxylated, reaction   .................................  Surfactant.
 product with fatty acid dimers, minimum
 number average molecular weight (in amu),
 1,200 (CAS Reg. No. 1173188-72-1).
Diethylaminoethanol, ethoxylated,            .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid dimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173188-75-4).
Diethylaminoethanol, ethoxylated, reaction   .................................  Surfactant.
 products with acid trimers, minimum number
 average molecular weight (in amu), 1,200
 (CAS Reg. No. 1173188-81-2).
Diethylaminoethanol, ethoxylated,            .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid trimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173188-83-4).
 
                                                  * * * * * * *
Dimethylaminoethanol, ethoxylated, reaction  .................................  Surfactant.
 products with fatty acid trimers, minimum
 number average molecular weight (in amu),
 1,200 (CAS Reg. No. 1173188-38-9).
Dimethylaminoethanol, ethoxylated,           .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid dimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173188-42-5).
Dimethylaminoethanol, ethoxylated, reaction  .................................  Surfactant.
 products with fatty acid trimers, minimum
 number average molecular weight (in amu),
 1,200 (CAS Reg. No. 1173188-49-2).
Dimethylaminoethanol, ethoxylated,           .................................  Surfactant.
 propoxylated reaction products with fatty
 acid trimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173188-67-4 ).
 
                                                  * * * * * * *
Hydroxyethylmorpholine, ethoxylated,         .................................  Surfactant.
 reaction products with fatty acid dimers,
 minimum number average molecular weight
 (in amu), 1,200 (CAS Reg. No. 1173189-00-
 8).
Hydroxyethylmorpholine, ethoxylated,         .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid dimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173189-06-4).
Hydroxyethylpiperidine, ethoxylated,         .................................  Surfactant.
 reaction products with fatty acid dimers,
 minimum number average molecular weight
 (in amu), 1,200 (CAS Reg. No. 1173189-20-
 2).
Hydroxyethylpiperidine, ethoxylated,         .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid dimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173189-22-4).
Hydroxyethylmorpholine, ethoxylated,         .................................  Surfactant.
 reaction products with fatty acid trimers,
 minimum number average molecular weight
 (in amu), 1,200 (CAS Reg. No. 1173189-09-
 7).
Hydroxyethylmorpholine, ethoxylated,         .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid trimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173188-67-4).
Hydroxyethylpiperidine, ethoxylated,         .................................  Surfactant.
 reaction products with fatty acid trimers,
 minimum number average molecular weight
 (in amu), 1,200 (CAS Reg. No. 1173189-25-
 7).
Hydroxyethylpiperidine, ethoxylated,         .................................  Surfactant.
 propoxylated, reaction products with fatty
 acid trimers, minimum number average
 molecular weight (in amu), 1,200 (CAS Reg.
 No. 1173189-28-0).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-3400 Filed 2-15-11; 8:45 am]
BILLING CODE 6560-50-P