[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Rules and Regulations]
[Page 38935-38945]
[DOCID:fr05au09-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0145; FRL-8430-1]

Alkyl Alcohol 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 [alpha]-alkyl-[omega]-hydroxypoly
(oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain
contains a minimum of six carbons when used as an inert ingredient in
pesticide formulations. The Joint Inerts Task Force (JITF), Cluster
Support Team Number 1, submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of [alpha]-alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers
where the alkyl chain contains a minimum of six carbons.

DATES: This regulation is effective August 5, 2009. Objections and
requests for hearings must be received on or before October 5, 2009,
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-2009-0145. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs,

Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
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 those
engaged in the following activities:
     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 to
provide 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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2009-0145 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before October 5, 2009.
    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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0145, 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<PHONE_NUMBER>.

II. Background

    In the Federal Register of April 15, 2009 (74 FR 17487) (FRL-8409-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP [9E7534])
filed by The Joint Inerts Task Force, Cluster Support Team 1 (CST 1),
c/o CropLife America, 1156 15th Street, NW., Suite 400, Washington, DC
20005. The petition requested that 40 CFR 180.910, 40 CFR 180.930, 40
CFR 180.940a, and 40 CFR 180.960 be amended by establishing an
exemption from the requirement of a tolerance for residues of a group
of substances known as [alpha]-alkyl-[omega]-hydroxypoly (oxypropylene)
and/or poly (oxyethylene) polymers where the alkyl chain contains a
minimum of 6 carbons, herein referred to in this document as AAA. AAAs
are used as inert ingredients in pesticide products. That notice
referenced a summary of the petition prepared by The Joint Inerts Task
Force (JITF), Cluster Support Team Number 1 (CST 1)], the petitioner,
which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
    This petition was submitted in response to a final rule of August
9, 2006, (71 FR 45415) in which the Agency revoked, under section
408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA), the
existing exemptions from the requirement of a tolerance for residues of
certain inert ingredients because of insufficient data to make the
determination of safety required by FFDCA section 408(b)(2). The
expiration date for the tolerance exemptions subject to revocation was
August 9, 2008, which was later extended to August 9, 2009 by a final
rule published in the Federal Register of August 4, 2008 (73 FR 45312)
to allow for data to be submitted to support the establishment of
tolerance exemptions for these inert ingredients prior to the effective
date of the tolerance exemption revocation.
    Depending on the degree of alkoxylation, each of the AAA substances
included in the petition can vary in number average molecular weight
from a range of approximately 260 to 4,000. In the case where the
minimum number average molecular weight of an AAA is 1,100 or more, the
petition's basis of support for the establishment of an exemption from
the requirement of a tolerance under 40 CFR 180.960 is the fact that
such high molecular weight AAAs would meet the criteria for a low-risk
polymer as defined in 40 CFR 723.250. For the remaining AAAs (i.e., the
ones with molecular weights between 260 and 1,100), the petition seeks
to establish tolerance exemptions for all AAAs under 40 CFR 180.910, 40
CFR 180.930, and 40 CFR 180.940(a). Therefore, in its consideration of
the petition the Agency has conducted an assessment specific to the
establishment of an exemption from the requirement of a tolerance for
the lower weight AAAs under 40 CFR 180.910, 40 CFR 180.930, and 40 CFR
180.940(a) as well as an assessment specific to the establishment of an
exemption from the requirement of a tolerance under 40 CFR 180.960 for
the ``high molecular weight'' AAAs.

 III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and

hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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 performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
exemption from the requirement of a tolerance for residue of AAAs when
used as an inert ingredient in pesticide formulations applied pre- and
post-harvest, applied to livestock, and used in antimicrobial
formulations, and as a low risk polymer as defined in 40 CFR 723.250.
EPA's assessment of exposures and risks associated with establishing
tolerances follows.

 A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
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.
    1. For lower weight AAAs under 40 CFR 180.910, 40 CFR 180.930, and
40 CFR 180.940a. The available toxicology database includes acute
studies, subchronic (rat and dog) studies, a mutagenicity study, three
OPPTS Harmonized Guideline 870.3650 combined repeated dose toxicity
studies with the reproduction/developmental toxicity screening tests,
an OPPTS Harmonized Guideline 870.3550 reproduction/developmental
toxicity screening test, an OPPTS harmonized Test Guideline 870.3800
reproduction and fertility effects study, and reproduction and
developmental effects studies.
    The AAAs are not acutely toxic by the oral and dermal routes of
exposure under normal use conditions. Concentrated materials are
generally moderate to severe eye and skin irritants and may be skin
sensitizers. There is no evidence of mutagenicity in the Ames assay
(bacterial strains).
    Following subchronic exposure to rats and dogs, decreases in body
weight and food consumption were observed, but no specific target organ
toxicity or neurotoxicity was seen. No effects were detected in a
functional observational battery (FOB) or motor activity assessment. In
a 90-day dermal toxicity study with AAA surfactant, no systemic
toxicity was observed at doses up to 125 mg/kg/day (the highest dose
tested). In an OPPTS Harmonized Guideline 870.3650 study with the AAA
surfactant CAS No. 9004-98-2, parental toxicity observed at 110 mg/kg/
day included decreased absolute and relative thymus weight, decreased
body weight gain and decreased food consumption in females, and
clinical signs in both sexes. These clinical signs are indicative of
local irritation effects rather than systemic effects and thus were not
used as a basis for evaluating the safety of the AAA surfactants. No
reproductive or developmental/offspring toxicity was observed. In the
second OPPTS Harmonized Guideline 870.3650 study with the AAA
surfactant CAS 103818-93-5, parental systemic toxicity was observed at
300 mg/kg/day (HDT), based on decreased body weight gain (in males) and
clinical signs (orange/red perioral staining and moderate salivation)
in both sexes. No reproductive or developmental/offspring toxicity was
observed. In the third OPPTS Harmonized Guideline 870.3650 study with
the AAA surfactant CAS RN 64366-70-7, parental systemic toxicity was
observed at 500 mg/kg/day (HDT), based on decreased body weight in
males. No reproductive or developmental/offspring toxicity was
observed.
    In an OPPTS Harmonized Test Guideline 870.3550 reproduction/
developmental toxicity screening test with the AAA surfactant CAS No.
84133-50-6, parental toxicity was observed at 470 mg/kg/day based on
clinical signs (ptosis and hypoactivity), decreased absolute body
weight, body weight gain, and food consumption. Reproductive toxicity
was observed, as evidenced by the microscopic changes in the testes and
epididymides (testicular atrophy, increased intraluminal exfoliated
spermatogenic cells in epididymides, and dilated seminiferous tubules).
Developmental/offspring toxicity was observed at 470 mg/kg/day (the
highest dose tested), based on decreased litter size and increased
postimplantation loss.
    In a reproduction and developmental effects study with the AAA
surfactant CAS 68951-67-7, the only significant effects observed in
female rats were decreased body weight and body weight gain during
premating at 400.8 mg/kg/day. At this maternally toxic dose, offspring
toxicity observed was decreased body weight on lactation day (LD) 21
(both sexes in F1A, F1B, F2A, and
F2B). No treatment-related effects were observed on
reproductive parameters.
    In an OPPTS Harmonized Test Guideline 870.3800 reproduction and
fertility effects study with AAA surfactant CAS 68951-67-7, clinical
signs observed at 250 mg/kg/day were increased incidences of
lachrymation, incidences of unkemptness, hunched posture,
chromodacryorrhea and periocular swelling in F0 and F1 females. These
effects may be attributed to local irritant effects. No treatment-
related effects were observed on reproduction or the offspring at 250
mg/kg/day (HDT).
    It is generally accepted that increased ethoxylation decreases
lipophilicity resulting in decreased absorption and decreased toxicity.
The lower molecular weight AAAs would be expected to be absorbed and
distributed more readily than higher molecular weight AAAs and

therefore to potentially be more toxic. The representative ethoxylated
compounds tested have the lowest weight percent ethoxylation and lowest
molecular weight of the series and are potentially the most
bioavailable of the series. Although metabolism data are not available,
the major metabolic pathway for AAA surfactants is expected to include
the hydrolysis of ether linkage to the corresponding alkyl alcohol and
polyalkoxylate (POE or POE/POP) group which subsequently undergoes
oxidative degradation and/or excretion.
    There is no evidence that the AAA surfactants are carcinogenic. The
Agency used a qualitative structure activity relationship (SAR)
database, DEREK Version 11, to determine if there were structural
alerts. No structural alerts were identified. In addition, there was
little concern about any of the postulated metabolites having greater
toxicity than the parent compounds.
    Specific information on the studies received and the nature of the
adverse effects caused by AAA, as well as, the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document Alkyl Alcohol Alkoxylates (AAA - JITF
CST 1 Inert Ingredient). Human Health Risk Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as an
Inert Ingredient in Pesticide Formulations at pp 13-20 and pp 61-75 in
docket ID number EPA-HQ-OPP-2009-0145.
    2.  For the high molecular weight AAAs under 40 CFR 180.960. In the
case of certain chemical substances that are defined as polymers, the
Agency has established a set of criteria to identify categories of
polymers expected to present minimal or no risk. 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).
The high molecular weight AAAs conform to the definition of a polymer
given in 40 CFR 723.250(b) and meet the following criteria that are
used to identify low-risk polymers.
    i. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    ii. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    iii. 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).
    iv. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    v. 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.
    vi. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymers also meet as required the following
exemption criteria specified in 40 CFR 723.250(e).
    The polymer's number average MW of 1,100 daltons is greater than
1,000 and less than 10,000 daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer does not contain any reactive
functional groups.
    Thus, the high molecular weight AAAs meet the criteria for a
polymer to be considered low risk under 40 CFR 723.250. Generally,
polymers of this size would be poorly absorbed by all routes of
exposure, including through the intact gastrointestinal tract or
through intact human skin, and therefore, no mammalian toxicity is
anticipated from dietary, inhalation, or dermal exposure to the high
molecular weight AAAs.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    1. For the lower weight AAAs under 40 CFR 180.910, 40 CFR 180.930,
and 40 CFR 180.940a. A summary of the toxicological endpoints for the
AAAs used for human heatlh risk assessment is shown in the following
Table.

    Table--Summary of Toxicological Doses and Endpoints for the AAAs for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                       Point of Departure and
          Exposure/Scenario              Uncertainty/Safety     RfD, PAD, LOC for Risk   Study and Toxicological
                                              Factors                 Assessment                 Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)           No appropriate endpoint was identified for acute dietary assessment.
----------------------------------------------------------------------------------------------------------------

Chronic dietary (all populations)     NOAEL= 168 mg/kg/day     Chronic RfD = 1.68 mg/   OPPTS harmonized Test
                                      UFA = 10x..............   kg/day                   Guideline 870.3550
                                      UFH = 10x..............  cPAD = 1.68 mg/kg/day..   reproduction/
                                      FQPA SF = 1x...........                            developmental toxicity
                                                                                screening test MRID
                                                                                47676801 (2009) LOAEL =
                                                                                470 mg/kg/day based on
                                                                                one maternal death (GD
                                                                                22), decreased body
                                                                                weight, body weight
                                                                                gain, and food
                                                                                consumption, increased
                                                                                clinical signs (ptosis
                                                                                and hypoactivity), and
                                                                                microscopic changes of
                                                                                the testes and
                                                                                epididymides
                                                                                (testicular atrophy,
                                                                                increased intraluminal
                                                                                exfoliated
                                                                                spermatogenic cells in
                                                                                epididymides, and
                                                                                dilated seminiferous
                                                                                tubules) in parental
                                                                                animals, decreased
                                                                                litter size, and
                                                                                increased
                                                                                postimplantation loss.
----------------------------------------------------------------------------------------------------------------
Incidental Oral and Inhalation (all   NOAEL= 168 mg/kg/day     Residential LOC for MOE  OPPTS harmonized Test
 durations)                           UFA = 10x..............   = 100                    Guideline 870.3550
                                      UFH = 10x..............                            reproduction/
                                      FQPA SF = 1x...........                            developmental toxicity
                                                                                screening test MRID
                                                                                47676801 (2009) LOAEL =
                                                                                470 mg/kg/day based on
                                                                                one maternal death (GD
                                                                                22), decreased body
                                                                                weight, body weight
                                                                                gain, and food
                                                                                consumption, increased
                                                                                clinical signs (ptosis
                                                                                and hypoactivity), and
                                                                                microscopic changes of
                                                                                the testes and
                                                                                epididymides
                                                                                (testicular atrophy,
                                                                                increased intraluminal
                                                                                exfoliated
                                                                                spermatogenic cells in
                                                                                epididymides, and
                                                                                dilated seminiferous
                                                                                tubules) in parental
                                                                                animals, decreased
                                                                                litter size, and
                                                                                increased
                                                                                postimplantation loss.
----------------------------------------------------------------------------------------------------------------
Dermal (all durations)                NOAEL= 168 mg/kg/day     Residential LOC for MOE  OPPTS harmonized Test
                                      UFA = 10x..............   = 100                    Guideline 870.3550
                                      UFH = 10x..............                            reproduction/
                                      FQPA SF = 1x...........                            developmental toxicity
                                                                                screening test MRID
                                                                                47676801 (2009) Oral
                                                                                LOAEL = 470 mg/kg/day
                                                                                based on one maternal
                                                                                death (GD 22),
                                                                                decreased body weight,
                                                                                body weight gain, and
                                                                                food consumption,
                                                                                increased clinical
                                                                                signs (ptosis and
                                                                                hypoactivity), and
                                                                                microscopic changes of
                                                                                the testes and
                                                                                epididymides
                                                                                (testicular atrophy,
                                                                                increased intraluminal
                                                                                exfoliated
                                                                                spermatogenic cells in
                                                                                epididymides, and
                                                                                dilated seminiferous
                                                                                tubules) in parental
                                                                                animals, decreased
                                                                                litter size, and
                                                                                increased
                                                                                postimplantation loss.
                                                                                The final dose used to
                                                                                quantify dermal risk
                                                                                must correct for 50%
                                                                                dermal absorption, and
                                                                                should be multiplied by
                                                                                3 to take into account
                                                                                the differences in rat
                                                                                and human skin
                                                                                penetration. The
                                                                                resulting dose = 1,000
                                                                                mg/kg/day
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Classification: Based on SAR analysis, AAA surfactrants are not expected
                                                                  to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose
  (a=acute, c=chronic). FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern. N/A = not applicable.

    2. For the high molecular weight AAAs under 40 CFR 180.960. Since
the high molecular weight AAAs conform to the criteria that identify a
low risk polymer, and are not likely to be absorbed significantly by
any route of exposure, there are no concerns for risks associated with
any potential exposure scenarios that are reasonably foreseeable. Thus,
due to their low potential hazard, it was determined that a
quantitative risk assessment using safety factors applied to a point of
departure protective of an identified hazard endpoint is not
appropriate for the high molecular weight AAAs, and an exposure
assessment is not necessary. For the same reason, an additional safety
factor to protect infants and children is not needed.

C. Exposure Assessment

     Sufficient data were provided on the chemical identity of the
AAAs; however, limited data are available on the metabolism and
environmental degradation of these compounds. The Agency relied
collectively on information provided on the representative chemical
structures, the submitted physicochemical data, structure-activity
relationship information, as well as information on other surfactants
and chemicals of similar size and functionality to determine the
residues of concern for these inert ingredients. The Agency has
concluded that a risk assessment based on toxicity data for the parent
compounds is not likely to underestimate risk.
    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to the lower weight AAAs, EPA considered exposure under the
petitioned-for exemptions from the requirement of a tolerance. EPA
assessed dietary exposures from the lower weight AAAs in food as
follows:
     i. Acute exposure. No adverse effects attributable to a single
exposure of the AAAs was seen in the toxicity databases. Therefore,
acute dietary risk assessments for the AAAs are not necessary.
     ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, no residue data were submitted for the AAAs. In the
absence of specific residue data, EPA has developed an approach which
uses surrogate

information to derive upper bound exposure estimates for the subject
inert ingredient. Upper bound exposure estimates are based on the
highest tolerance for a given commodity from a list of high-use
insecticides, herbicides, and fungicides. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.
(D361707, S. Piper, 2/25/09) and can be found at http://
www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products is
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100 percent of all foods are treated with the
inert ingredient at the rate and manner necessary to produce the
highest residue legally possible for an active ingredient. In summary,
EPA chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
    Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
    iii. Cancer. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts suggestive of carcinogenicity. No structural alerts
for carcinogenicity were identified. The AAAs are not expected to be
carcinogenic. Therefore, a cancer dietary exposure assessment is not
necessary to assess cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for the AAAs. Tolerance level residues and/or 100%
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for the AAAs in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of the AAAs. Further information regarding EPA drinking
water models used in the pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
    A screening level drinking water analysis, based on the Pesticide
Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) was
performed to calculate the estimated drinking water concentrations
(EDWCs) of the AAAs. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of the AAAs were conducted. Modeled acute drinking water values ranged
from 0.001 ppb to 41 ppb. Modeled chronic drinking water values ranged
from 0.0002 ppb to 19 ppb. Further details of this drinking water
analysis can be found at http://www.regulations.gov in the document
Alkyl Alcohol Alkoxylates (AAA - JITF CST 1 Inert Ingredient). Human
Health Risk Assessment to Support Proposed Exemption from the
Requirement of a Tolerance When Used as an Inert Ingredient in
Pesticide Formulations at pp 20-21 and 77-79 in docket ID number EPA-
HQ-OPP-2009-0145.
    For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for the AAAs, a conservative drinking water concentration
value of 100 ppb based on screening level modeling was used to assess
the contribution to drinking water for chronic dietary risk assessments
for the parent compound. These values were directly entered into the
dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). The AAAs may be used
in inert ingredients in pesticide products that are registered for
specific uses that may result in both indoor and outdoor residential
exposures. A screening level residential exposure and risk assessment
was completed for products containing the AAAs as inert ingredients. In
this assessment, representative scenarios, based on end-use product
application methods and labeled application rates, were selected. The
AAAs may be used as inert ingredients in pesticide formulations that
are used in and around the home. Additionally, these inerts may be used
in pesticide products applied to pets as aerosol sprays intended for
flea control on carpeted surfaces and bedding, or in shampoo products
applied to pets. Lastly, these inerts may be present in home cleaning
products or paint products. For each of the use scenarios, the Agency
assessed residential handler (applicator) inhalation and dermal
exposure for use scenarios with high exposure potential (i.e., exposure
scenarios with high-end unit exposure values) to serve as a screening
assessment for all potential residential pesticides containing the
AAAs. Similarly, the Agency conducted an assessment to represent worst-
case residential exposure by assessing post application exposures and
risks from AAAs in pesticide formulations

(outdoor scenarios), AAAs in disinfectant-type uses (indoor scenarios),
AAAs in shampoo pet treatments (pet product scenarios) and AAAs in
paint products (paint product scenarios). Further details of this
residential exposure and risk analysis can be found at http://
www.regulations.gov in the memorandum entitled JITF Inert Ingredients
Residential and Occupational Exposure Assessment Algorithms and
Assumptions Appendix for the Human Health Risk Assessments to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide Formulations (D364751, 5/7/09, Lloyd/
LaMay in docket ID number EPA-HQ-OPP-2008-0710.
    4. 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 AAAs to share a common mechanism of toxicity with
any other substances, and the AAAs do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that the AAAs do 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 website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. In the case of the lower
weight AAA surfactants, there was no evidence of increased
susceptibility to the offspring of rats following prenatal and
postnatal exposure in the reproductive/developmental screening studies
on several representative AAA surfactants. Decreased litter size and
increased postimplantation loss were observed in one OPPTS Harmonized
Guideline 870.3550 reproduction/developmental toxicity screening study
at 470 mg/kg/day where maternal/paternal toxicity was manifested as one
maternal death (GD 22), decreased body weight, body-weight gain and
food consumption and clinical signs (ptosis and hypoactivity) and
microscopic changes in the testes (atrophy) and epididymides (increased
intraluminal exfoliated spermatogenic cells) and dilated seminiferous
tubules at the same dose (470 mg/kg/day). The maternal and offspring
toxicity NOAEL was 168 mg/kg/day. The offspring toxicity in the OPPTS
Harmonized Test Guideline 870.3650 study was manifested in the presence
of more severe maternal toxicity (deaths), therefore, EPA concluded
that there is no evidence of increased susceptibility in this study. In
addition, there was no evidence of increased susceptibility in other
submitted studies.
    3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for the lower weight AAAs. (As discussed
earlier, given the low toxicological concerns with the high weight
AAAs, a safety factor analysis is unnecessary). That decision as to the
lower weight AAAs is based on the following findings:
    i. The toxicity database for the AAAs is considered adequate for
assessing the risks to infants and children. The toxicity database
consists of three OPPTS Harmonized Test Guideline 870.3650 combined
repeated dose toxicity studies with the reproduction/developmental
toxicity screening tests, an OPPTS Harmonized Test Guidelinge 870.3550
reproduction/developmental toxicity screening test study, an OPPTS
Harmonized Test Guideline 870.3800 reproduction and fertility effects
study, and reproduction and developmental effects studies. The Agency
noted changes in thymus weight. However, the thymus/lymph node effects
are considered secondary effects caused by an overall stress response
to the irritant properties of this chemical, and therefore, not an
immunological response. In addition, no blood parameters were affected
in the database. Furthermore, these compounds do not belong to a class
of chemicals that would be expected to be immunotoxic. Also, in an
OPPTS Harmonized Test Guideline 870.3550 study, testicular effects,
such as, testicular atrophy, microscopic changes in the testes,
epididymides and dilated seminiferous tubules were observed in male
rats at the highest dose tested (470 mg/kg/day). However, none of the
reproductive parameters (pregnancy rate) were affected in this study.
In addition, there were no effects observed on reproductive parameters
in the OPPTS Harmonized Test Guideline 870.3800 reproduction and
fertility effects study. Furthermore, there was no histological
findings in the testes in that study. Based on the weight of the
evidence for immunotoxoicity and reproductive toxicity, there is no
need to add additional uncertainty factors.
    ii. EPA concluded that there is no evidence of qualitative or
quantitative increased susceptivility in the available database.
Therefore, there is no concern for increased susceptibility to infants
and children.
    iii. There is no indication that the AAAs are neurotoxic chemicals
and thus there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity
    iv. Although the chronic point of departure was selected from a
subchronic study, longer-term studies are available that support the
NOAEL selected. No additional uncertainty factor is needed for
extrapolating from subchronic to chronic exposure.
    v. There are no residual uncertainties identified in the exposure
databases. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children. The food exposure assessments are considered
to be highly conservative as they are based on the use of the highest
tolerance level from the surrogate pesticides for every food and 100%
crop treated is assumed for all crops. EPA also made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to the AAAs in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by the
AAAs.

E. Aggregate Risks and Determination of Safety

    1. For the lower weight AAAs under 40 CFR 180.910, 40 CFR 180.930,
and 40 CFR 180.940a. EPA determines whether

acute and chronic pesticide exposures are safe by comparing aggregate
exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent
the highest safe exposures, taking into account all appropriate SFs.
EPA calculates the aPAD and cPAD by dividing the POD by all applicable
UFs. For linear cancer risks, EPA calculates the probability of
additional cancer cases given the estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the POD to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
    i. Acute risk. There was no hazard attributable to a single
exposure seen in the toxicity database for the AAAs. Therefore, the
AAAs are not expected to pose an acute risk.
    ii. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for chronic exposure the chronic dietary exposure from food and water
to the AAAs is 11% of the cPAD for the U.S. population and 37% of the
cPAD for children 1 to 2 years old, the most highly exposed population
subgroup.
    iii. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    AAAs are used as inert ingredients in pesticide products that are
currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to the AAAs. EPA has concluded that
the combined short-term aggregated food, water, and residential
exposures result in aggregate MOEs of 110 for both adult males and
females. Adult residential exposure combines high end indoor inhalation
handler exposure with a high-end post application to pet exposures. EPA
has concluded the combined short-term aggregated food, water, and
residential exposures result in an aggregate MOE of 110 for children.
Children's residential exposure includes total combined pet exposures.
As the level of concern is for MOEs that are lower than 100, these MOEs
are not of concern.
    iv. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
     The AAAs are used as inert ingredients in pesticide products that
are currently registered for uses that could result in intermediate-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
intermediate-term residential exposures to the AAAs. EPA has concluded
that the combined intermediate-term aggregated food, water, and
residential exposures result in aggregate MOEs of 230 for both adult
males and females, respectively. Adult residential exposure includes
high-end post application dermal exposure from contact with treated
pets. EPA has concluded that the combined intermediate-term aggregated
food, water, and residential exposures result in an aggregate MOE of
110 for children. Children's residential exposure includes total
combined pet exposure. As the level of concern is for MOEs that are
lower than 100, these MOEs are not of concern.
     v.  Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to the AAAs.
    vi. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to residues of the lower weight AAAs.
    2. For the high molecular weight AAAs under 40 CFR 180.960. Since
AAA conforms to the criteria that identify a low-risk polymer, there
are no concerns for risks associated with any potential exposure
scenarios that are reasonably foreseeable. Therefore, EPA concludes
that there is a reasonable certainty that no harm will result to the
general population or to infants and children from aggregate exposure
to residues of the high molecular weight AAAs.

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

    The Agency is not aware of any country requiring a tolerance for
the AAAs nor have any CODEX Maximum Residue Levels been established for
any food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of the lower molecular weight [alpha]-alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers
where the alkyl chain contains a minimum of 6 carbons when used as an
inert ingredient in pesticide formulations applied pre- and post-
harvest, applied to livestock, and used in antimicrobial formulations
under 40 CFR 180.910, 40 CFR 180.930, and 40 CFR 180.940(a). In
addition, an exemption from the requirement of a tolerance is
established for residues of the larger molecular weight compounds of
[alpha]-alkyl-[omega]-hydroxypoly (oxypropylene) and/or poly
(oxyethylene) polymers where the alkyl chain contains a minimum of 6
carbons under 40 CFR 180.960.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of
tolerances 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 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 exemptions 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) (Public Law 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: July 29, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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:

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

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
[alpha]-alkyl-[omega]-                                Surfactants,
 hydroxypoly (oxypropylene) and/                       related adjuvants
 or poly (oxyethylene) polymers                        of surfactants
 where the alkyl chain contains
 a minimum of six carbons (CAS
 Reg. Nos. 9002-92-0, 9004-95-9,
 9005-00-9, 26183-52-8, 34398-01-
 1, 52292-17-8, 66455-14-9,
 66455-15-0, 68002-97-1, 68131-
 39-5, 68131-40-8, 68154-96-1,
 68213-23-0, 68439-45-2, 68439-
 46-3, 68526-94-3, 68439-50-9,
 68439-49-6, 68551-12-2, 68951-
 67-7, 71243-46-4, 97043-91-9,
 9043-30-5, 60828-78-6, 61827-42-
 7, 24938-91-8, 68439-54-3,
 69011-36-5, 78330-20-8, 78330-
 21-9, 106232-83-1, 127036-24-2,
 160875-66-1, 9004-98-2, 68920-
 66-1, 61804-34-0, 61791-28-4,
 71060-57-6, 26468-86-0, 31726-
 34-8, 52609-19-5, 61791-20-6,
 68155-01-1, 69013-19-0, 69364-
 63-2, 70879-83-3, 78330-19-5,
 97953-22-5, 157627-86-6, 34398-
 05-5, 72905-87-4, 84133-50-6,
 61702-78-1, 27306-79-2, 169107-
 21-5, 61791-13-7, 39587-22-9,
 85422-93-1; 68154-98-3, 61725-
 89-1, 68002-96-0, 68154-97-2,
 68439-51-0, 68551-13-3, 68603-
 25-8, 68937-66-6, 68987-81-5,
 69227-21-0, 70750-27-5, 103818-
 93-5, 166736-08-9, 120313-48-6,
 68213-24-1, 68458-88-8, 68551-
 14-4, 69013-18-9, 69227-22-1,
 72854-13-8, 73049-34-0, 78330-
 23-1, 37311-02-7, 64366-70-7,
 37251-67-5, 9087-53-0, 196823-
 11-7, 57679-21-7, 111905-54-5,
 61827-84-7, 172588-43-1)
                              * * * * * * *
------------------------------------------------------------------------

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

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

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
 [alpha]-alkyl-[omega]-                               Surfactants,
 hydroxypoly (oxypropylene) and/                       related adjuvants
 or poly (oxyethylene) polymers                        of surfactants
 where the alkyl chain contains
 a minimum of six carbons (CAS
 Reg. Nos. 9002-92-0, 9004-95-9,
 9005-00-9, 26183-52-8, 34398-01-
 1, 52292-17-8, 66455-14-9,
 66455-15-0, 68002-97-1, 68131-
 39-5, 68131-40-8, 68154-96-1,
 68213-23-0, 68439-45-2, 68439-
 46-3, 68526-94-3, 68439-50-9,
 68439-49-6, 68551-12-2, 68951-
 67-7, 71243-46-4, 97043-91-9,
 9043-30-5, 60828-78-6, 61827-42-
 7, 24938-91-8, 68439-54-3,
 69011-36-5, 78330-20-8, 78330-
 21-9, 106232-83-1, 127036-24-2,
 160875-66-1, 9004-98-2, 68920-
 66-1, 61804-34-0, 61791-28-4,
 71060-57-6, 26468-86-0, 31726-
 34-8, 52609-19-5, 61791-20-6,
 68155-01-1, 69013-19-0, 69364-
 63-2, 70879-83-3, 78330-19-5,
 97953-22-5, 157627-86-6, 34398-
 05-5, 72905-87-4, 84133-50-6,
 61702-78-1, 27306-79-2, 169107-
 21-5, 61791-13-7, 39587-22-9,
 85422-93-1; 68154-98-3, 61725-
 89-1, 68002-96-0, 68154-97-2,
 68439-51-0, 68551-13-3, 68603-
 25-8, 68937-66-6, 68987-81-5,
 69227-21-0, 70750-27-5, 103818-
 93-5, 166736-08-9, 120313-48-6,
 68213-24-1, 68458-88-8, 68551-
 14-4, 69013-18-9, 69227-22-1,
 72854-13-8, 73049-34-0, 78330-
 23-1, 37311-02-7, 64366-70-7,
 37251-67-5, 9087-53-0, 196823-
 11-7, 57679-21-7, 111905-54-5,
 61827-84-7, 172588-43-1)
                              * * * * * * *
------------------------------------------------------------------------

0
4. Section Sec. 180.940 is amended by alphabetically adding the
following entry to the table in paragraph (a):

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
      Pesticide Chemical             CAS Reg. No.             Limits
------------------------------------------------------------------------
                              * * * * * * *
[alpha]-alkyl-[omega]-         9002-92-0, 9004-95-9,     ...............
 hydroxypoly (oxypropylene)     9005-00-9, 26183-52-8,
 and/or poly (oxyethylene)      34398-01-1, 52292-17-8,
 polymers where the alkyl       66455-14-9, 66455-15-0,
 chain contains a minimum of    68002-97-1, 68131-39-5,
 six carbons.                   68131-40-8, 68154-96-1,
                                68213-23-0, 68439-45-2,
                                68439-46-3, 68526-94-3,
                                68439-50-9, 68439-49-6,
                                68551-12-2, 68951-67-7,
                                71243-46-4, 97043-91-9,
                                9043-30-5, 60828-78-6,
                                61827-42-7, 24938-91-8,
                                68439-54-3, 69011-36-5,
                                78330-20-8, 78330-21-9,
                                106232-83-1, 127036-24-
                                2, 160875-66-1, 9004-98-
                                2, 68920-66-1, 61804-34-
                                0, 61791-28-4, 71060-57-
                                6, 26468-86-0, 31726-34-
                                8, 52609-19-5, 61791-20-
                                6, 68155-01-1, 69013-19-
                                0, 69364-63-2, 70879-83-
                                3, 78330-19-5, 97953-22-
                                5, 157627-86-6, 34398-
                                05-5, 72905-87-4, 84133-
                                50-6, 61702-78-1, 27306-
                                79-2, 169107-21-5,
                                61791-13-7, 39587-22-9,
                                85422-93-1; 68154-98-3,
                                61725-89-1, 68002-96-0,
                                68154-97-2, 68439-51-0,
                                68551-13-3, 68603-25-8,
                                68937-66-6, 68987-81-5,
                                69227-21-0, 70750-27-5,
                                103818-93-5, 166736-08-
                                9, 120313-48-6, 68213-
                                24-1, 68458-88-8, 68551-
                                14-4, 69013-18-9, 69227-
                                22-1, 72854-13-8, 73049-
                                34-0, 78330-23-1, 37311-
                                02-7, 64366-70-7, 37251-
                                67-5, 9087-53-0, 196823-
                                11-7, 57679-21-7,
                                111905-54-5, 61827-84-
                                7, 172588-43-1)
                              * * * * * * *
------------------------------------------------------------------------

0
5. In Sec. 180.960, the table is amended by adding alphabetically the
following polymers:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
           Polymer                              CAS No.
------------------------------------------------------------------------
                                * * * * *
[alpha]-alkyl-[omega]-         9002-92-0, 9004-95-9, 9005-00-9, 26183-52-
 hydroxypoly (oxypropylene)     8, 34398-01-1, 52292-17-8, 66455-14-9,
 and/or poly (oxyethylene)      66455-15-0, 68002-97-1, 68131-39-5,
 polymers where the alkyl       68131-40-8, 68154-96-1, 68213-23-0,
 chain contains a minimum of    68439-45-2, 68439-46-3, 68526-94-3,
 six carbons, minimum number    68439-50-9, 68439-49-6, 68551-12-2,
 average molecular weight (in   68951-67-7, 71243-46-4, 97043-91-9, 9043-
 amu) 1,100.                    30-5, 60828-78-6, 61827-42-7, 24938-91-
                                8, 68439-54-3, 69011-36-5, 78330-20-8,
                                78330-21-9, 106232-83-1, 127036-24-2,
                                160875-66-1, 9004-98-2, 68920-66-1,
                                61804-34-0, 61791-28-4, 71060-57-6,
                                26468-86-0, 31726-34-8, 52609-19-5,
                                61791-20-6, 68155-01-1, 69013-19-0,
                                69364-63-2, 70879-83-3, 78330-19-5,
                                97953-22-5, 157627-86-6, 34398-05-5,
                                72905-87-4, 84133-50-6, 61702-78-1,
                                27306-79-2, 169107-21-5, 61791-13-7,
                                39587-22-9, 85422-93-1; 68154-98-3,
                                61725-89-1, 68002-96-0, 68154-97-2,
                                68439-51-0, 68551-13-3, 68603-25-8,
                                68937-66-6, 68987-81-5, 69227-21-0,
                                70750-27-5, 103818-93-5, 166736-08-9,
                                120313-48-6, 68213-24-1, 68458-88-8,
                                68551-14-4, 69013-18-9, 69227-22-1,
                                72854-13-8, 73049-34-0, 78330-23-1,
                                37311-02-7, 64366-70-7, 37251-67-5, 9087-
                                53-0, 196823-11-7, 57679-21-7, 111905-54-
                                5, 61827-84-7, 172588-43-1
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-18706 Filed 8-4-09; 8:45 am]

BILLING CODE 6560-50-S


U.S. DEPARTMENT OF TRANSPORTATION

NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION

1200 NEW JERSEY AVENUE SE.

WASHINGTON DC, 20590	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF AIR AND RADIATION

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2000 TRAVERWOOD DRIVE

ANN ARBOR, MI  48105-2498

March 14, 2016

MEMORANDUM

SUBJECT:	Discussion with Great Dane Trailers on March 9, 2016

FROM:	Jessica Brakora, Engineer, Assessment and Standards Division

Office of Transportation and Air Quality

TO:	Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for
Medium- and Heavy-Duty Engines and Vehicles - Phase 2 - Dockets
NHTSA-2014-0132 and EPA-HQ-OAR-2014-0827

On March 9, 2016, EPA and DOT/NHTSA staff met with representatives from
Great Dane via phone and web conference.  The purpose of the meeting was
to discuss Great Dane’s views on the Phase 2 medium- and heavy-duty
rulemaking.

The following participants attended the meeting:

Great Dane representatives:

Charlie Fetz, Vice President of Research and Development

Christian Lee, Vice President of Systems Engineering

EPA and DOT/NHTSA representatives:

Jessica Brakora, EPA

Tad Wysor, EPA

Coralie Cooper, Volpe

Great Dane provided confidential business information (CBI) to the
agencies for this discussion.  EPA and NHTSA asked Great Dane about
specialty trailers and the types of work performing devices that are
used on specialty trailers so the agencies can better understand how
work performing devices may impact trailer aerodynamic device
installation.  Great Dane guided the agencies through its trailer data
for the past few years, including an estimate of the specialty trailers
sold, the expected use of those trailers, the CO2- and fuel
consumption-reducing technologies adopted, and number of trailers with
work-performing equipment installed.

Page   PAGE  2  of   NUMPAGES   2


[Federal Register: September 9, 2008 (Volume 73, Number 175)]
[Notices]
[Page 52405]
[DOCID:fr09se08-119]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1763-DR]

Iowa; Amendment No. 19 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-1763-DR), dated May 27, 2008, and related
determinations.

DATES: Effective Date: August 26, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Iowa is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
catastrophe declared a major disaster by the President in his
declaration of May 27, 2008.

    Howard, Humboldt, Jackson, and Poweshiek Counties for Individual
Assistance (already designated for Public Assistance).

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-20830 Filed 9-8-08; 8:45 am]

BILLING CODE 9110-10-P