Polymerized Fatty Acid Esters With Aminoalcohol Alkoxylates; Exemption From the Requirement of a Tolerance, 8895-8900 [2011-3400]
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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Rules and Regulations
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TABLE FIVE
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over all other lights
and obstructions.
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Approved: February 9, 2011.
M. Robb Hyde,
Commander, JAGC, U.S. Navy, Deputy
Assistant Judge Advocate, General (Admiralty
and Maritime Law).
Dated: February 9, 2011.
D.J. Werner,
Lieutenant Commander, Office of the Judge
Advocate General, U.S. Navy, Federal
Register Liaison Officer.
[FR Doc. 2011–3530 Filed 2–15–11; 8:45 am]
BILLING CODE 3810–FF–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0275; FRL–8860–8]
Forward masthead
light not in forward
quarter of ship.
Annex I, sec. 3(a)
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Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of polymerized
SUMMARY:
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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).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
PO 00000
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ADDRESSES:
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14.9
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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.
Percentage
horizontal
separation
attained
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DATES:
Polymerized Fatty Acid Esters With
Aminoalcohol Alkoxylates; Exemption
From the Requirement of a Tolerance
After masthead
light less than 1⁄2
ship’s length aft of
forward masthead
light. Annex I, sec.
3(a)
OPP–2010–0275. All documents in the
docket are listed in the docket index
available at https://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
https://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
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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Rules and Regulations
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 https://
www.gpoaccess.gov/ecfr. To access the
harmonized test guidelines referenced
in this document electronically, please
go to https://www.epa.gov/ocspp and
select ‘‘Test Methods and Guidelines.’’
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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).
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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: https://
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);
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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, https://
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
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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.
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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
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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.
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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 nonmutagenic and based on the available
information on PFAEAAs; they are not
anticipated to be carcinogenic.
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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 nonoccupational, 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
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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 https://
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.
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.
E. Aggregate Risks and Determination of
Safety
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.
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.
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
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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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
■
§ 180.910 Inert ingredients used pre-natal
and post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
*
Limits
*
*
*
*
*
Diethylaminoethanol, ethoxylated, reaction product with fatty acid dimers, minimum number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–72–1).
Diethylaminoethanol, ethoxylated, 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 products with fatty acid trimers, minimum number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–81–2).
Diethylaminoethanol, ethoxylated, propoxylated, reaction products with fatty acid trimers, minimum number
average molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–83–4).
*
...........................
*
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
*
*
*
*
*
Dimethylaminoethanol, ethoxylated, reaction products with fatty acid dimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–38–9).
Dimethylaminoethanol, ethoxylated, 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 products with fatty acid trimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–49–2).
Dimethylaminoethanol, ethoxylated, propoxylated, reaction products with fatty acid trimers, minimum number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–67–4).
erowe on DSK5CLS3C1PROD with RULES
Inert ingredients
*
...........................
*
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
*
*
*
*
*
Hydroxyethylmorpholine, ethoxylated, reaction products with fatty acid dimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–00–8).
Hydroxyethylmorpholine, ethoxylated, propoxylated, reaction products with fatty acid dimers, minimum
number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–06–4).
Hydroxyethylpiperidine, ethoxylated, reaction products with fatty acid dimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–20–2).
Hydroxyethylpiperidine, ethoxylated, propoxylated, reaction products with fatty acid dimers, minimum number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–22–4.
Hydroxyethylmorpholine, ethoxylated, reaction products with fatty acid trimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–09–7).
Hydroxyethylmorpholine, ethoxylated, propoxylated, reaction products with fatty acid trimers, minimum
number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–17–7).
*
...........................
*
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Rules and Regulations
Inert ingredients
Limits
Hydroxyethylpiperidine, ethoxylated, reaction products with fatty acid trimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–25–7).
Hydroxyethylpiperidine, ethoxylated, propoxylated, reaction products with fatty acid trimers, minimum number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–28–0).
...........................
Surfactant.
...........................
Surfactant.
*
*
*
3. In § 180.930, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
■
*
*
*
Uses
*
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
Inert ingredients
Limits
*
*
*
*
*
Diethylaminoethanol, ethoxylated, reaction product with fatty acid dimers, minimum number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–72–1).
Diethylaminoethanol, ethoxylated, 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 products with acid trimers, minimum number average molecular
weight (in amu), 1,200 (CAS Reg. No. 1173188–81–2).
Diethylaminoethanol, ethoxylated, propoxylated, reaction products with fatty acid trimers, minimum number
average molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–83–4).
*
...........................
*
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
*
*
*
*
*
Dimethylaminoethanol, ethoxylated, reaction products with fatty acid trimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–38–9).
Dimethylaminoethanol, ethoxylated, 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 products with fatty acid trimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–49–2).
Dimethylaminoethanol, ethoxylated, propoxylated reaction products with fatty acid trimers, minimum number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–67–4 ).
*
...........................
*
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
*
*
*
*
*
Hydroxyethylmorpholine, ethoxylated, reaction products with fatty acid dimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–00–8).
Hydroxyethylmorpholine, ethoxylated, propoxylated, reaction products with fatty acid dimers, minimum
number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–06–4).
Hydroxyethylpiperidine, ethoxylated, reaction products with fatty acid dimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–20–2).
Hydroxyethylpiperidine, ethoxylated, propoxylated, reaction products with fatty acid dimers, minimum number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–22–4).
Hydroxyethylmorpholine, ethoxylated, reaction products with fatty acid trimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–09–7).
Hydroxyethylmorpholine, ethoxylated, propoxylated, reaction products with fatty acid trimers, minimum
number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173188–67–4).
Hydroxyethylpiperidine, ethoxylated, reaction products with fatty acid trimers, minimum number average
molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–25–7).
Hydroxyethylpiperidine, ethoxylated, propoxylated, reaction products with fatty acid trimers, minimum number average molecular weight (in amu), 1,200 (CAS Reg. No. 1173189–28–0).
*
...........................
*
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
...........................
Surfactant.
*
*
*
[FR Doc. 2011–3400 Filed 2–15–11; 8:45 am]
BILLING CODE 6560–50–P
*
*
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
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44 CFR Part 65
[Docket ID FEMA–2011–0002]
Changes in Flood Elevation
Determinations
Federal Emergency
Management Agency, DHS.
AGENCY:
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ACTION:
Uses
*
Final rule.
Modified Base (1% annualchance) Flood Elevations (BFEs) are
finalized for the communities listed
below. These modified BFEs will be
used to calculate flood insurance
premium rates for new buildings and
their contents.
SUMMARY:
The effective dates for these
modified BFEs are indicated on the
following table and revise the Flood
Insurance Rate Maps (FIRMs) in effect
DATES:
E:\FR\FM\16FER1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to https://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: https://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, https://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 https://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).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
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BILLING CODE 6560-50-P
