Document ID: EPA-HQ-OPP-2009-0145-0003
Agency: epa
Document Type: Rule
Title: Alkyl Alcohol Alkoxylates; Exemption from the Requirement of a Tolerance
Posted Date: 2009-08-05T04:00Z

[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Rules and Regulations]               
[Page 38935-38945]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[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.

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

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,

[[Page 38936]]

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8811; e-mail 
address: leifer.kerry@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to 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 (703) 305-5805.

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

[[Page 38937]]

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

[[Page 38938]]

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.
----------------------------------------------------------------------------------------------------------------

[[Page 38939]]

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

[[Page 38940]]

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

[[Page 38941]]

(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

[[Page 38942]]

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,

[[Page 38943]]

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.

* * * * *

[[Page 38944]]

------------------------------------------------------------------------
        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
                                * * * * *
------------------------------------------------------------------------

[[Page 38945]]

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

BILLING CODE 6560-50-S