Document ID: EPA-HQ-OPP-2009-0690-0001
Agency: epa
Document Type: Rule
Title: C10-C18-Alkyl dimethyl amine oxides; Exemption from the Requirement of a Tolerance
Posted Date: 2009-10-07T04:00Z

[Federal Register: October 7, 2009 (Volume 74, Number 193)]
[Rules and Regulations]               
[Page 51474-51481]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc09-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0690; FRL-8437-3]

 
C10-C18-Alkyl dimethyl amine oxides; 
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 C10-C18-Alkyl 
dimethyl amine oxides (ADAO) when used as the inert ingredient in 
pesticide formulations applied to raw agricultural commodities pre- and 
post-harvest. Exponent on behalf of Stepan Company and Rhodia submitted 
petitions 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 ADAOs.

DATES: This regulation is effective October 7, 2009. Objections and 
requests for hearings must be received on or before December 7, 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-2009-0690. All documents in the 
dockets 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: Lisa Austin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7894; e-mail address: austin.lisa@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I 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 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 to the guidelines at http://www.epa.gov/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. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. 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-2009-0690 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 on or before December 7, 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 your copies, identified by docket ID 
number

[[Page 51475]]

EPA-HQ-OPP-2009-0690, 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 and Statutory Findings

     EPA received two petitions requesting that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of ADAOs. These two petitions are grouped 
together because they fall under the same general chemical description 
criteria.
    In the Federal Register of February 1, 2006 (71 FR 5322) (FRL-7756-
5), EPA issued a notice pursuant to section 408 (d)(3)of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5E7003) by Stepan Company, 951 Bankhead Hwy., Winder, GA 
30680. The petition requested that 40 CFR 180.920 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of ADAOs (CAS Reg. Nos. 1643-20-5, 2571-88-2, 2605-79-0, 3332-
27-2, 61788-90-7, 68955-55-5, 70592-80-2, 7128-91-8, 85408-48-6, and 
85408-49-7). Also, in the Federal Register of December 3, 2008 (73 FR 
73644) (FRL-8390-4), EPA issued a notice pursuant to section 408 (d)(3) 
of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 5E7003) by Stepan Company, 951 Bankhead Hwy., 
Winder, GA 30680. This petition is an addendum to PP 5E7003 
and included the submission of new data only. Both notices included a 
summary of the petition prepared by the petitioner. There were no 
comments received in response to the notices of filing.
    Also, in the Federal Register of April 13, 2009 (74 FR 16869) (FRL-
8396-6), EPA issued a notice pursuant to section 408 (d)(3)of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8E7316) by Rhodia Inc. c/o SciReg, Inc., 12733 Director's 
Loop, Woodbridge, VA 22192. The petition requested that 40 CFR 180.920 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of ADAOs. The notice included a summary of the 
petition prepared by the petitioner. There were no substantial comments 
received in response to the notice of filing.
    Based upon review of the data supporting the petitions 
(5E7003 and 8E7316), EPA has modified the exemptions 
requested by limiting ADAOs to a maximum of 15% by weight in pesticide 
formulations. In addition, the risk assessment supports the expansion 
of the exemptions from a requirement of tolerance to include use in 
pesticide formulations intended for post- harvest as well as pre-
harvest application under 40 CFR 180.910. Further details can be found 
at http://www.regulations.gov in document Decision Document for 
Petition Numbers 5E7003 and 8E7316 (C10-16); 
C10-C18-Alkyldimethylamine oxides CAS Reg. No. 
1643-20-5, 2571-88-2, 2605-79-0, 3332-27-2, 61788-90-7, 68955-55-5, 
70592-80-2, 7128-91-8, 85408-48-6, 85408-49-7) in docket ID numbers 
EPA-HQ-OPP-2005-0310 and EPA-HQ-OPP-2008-0858.

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 ploymers 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 residues of ADAOs is 
limited to no more than 15% by weight in pesticide formulations when 
used as an inert ingredient in pesticide formulations for pre- and 
post-harvest uses. 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.
    The available toxicology database includes an acute, subchronic 
(rat and rabbit), 21 and 90 day dermal toxicity (rabbit), developmental 
(rat and rabbit), reproduction and fertility effects study, an OPPTS 
Harmonized Guideline 870.3650 combined repeated dose toxicity studies 
with the reproduction/developmental toxicity screening tests, chronic 
dermal toxicity (mouse), chronic/carcinogenicity (rat), mutagenicity, 
and metabolism studies.

[[Page 51476]]

    ADAOs have moderate acute toxicity via the oral routes and low 
toxicity via the dermal and inhalation routes. It is moderately 
irritating to the skin and severely irritating to the eye. It is not a 
skin sensitizer.
    Subchronic studies were available in the rat and rabbit. Following 
subchronic exposure to rats via the diet, a decrease in body weight was 
observed in females only while cataracts were observed in males only. 
In the rabbit, subchronic exposure via the diet resulted in decreased 
alkaline phosphatase levels and increased liver/body weight ratio.
    A 21/28 day study and 91-day dermal toxicity studies were available 
in rabbits. Systemic toxicity was not observed at the limit dose in the 
21/28 day study and was not observed at the highest dose (2.5 
milligrams/kilogram/day (mg/kg bw/day)) tested in the 91-day study.
    Three developmental studies were available for review (2-rat, 1-
rabbit). In one developmental toxicity study in the rat (Sprague-
Dawley), maternal (decreased body weight gain) and offspring (skeletal 
variation-bifid centrum) toxicity were manifested at 100 mg/kg/day. The 
NOAEL in this study was 25 mg/kg/day. In a second developmental 
toxicity study in the rat (CD), maternal and offspring toxicity 
occurred at the same dose (200 mg/kg/day), the highest dose tested. 
Effects similar to the previous study were observed. Maternal toxicity 
was manifested as decreased body weight, food intake and water 
consumption and offspring toxicity was manifested as a slight reduction 
in fetal ossification. The NOAEL in this study was 100 mg/kg/day. In 
the rabbit, maternal and offspring toxicity were not observed at doses 
up to 160 mg/kg/day (highest dose tested, HDT). In a reproduction and 
fertility effects study in the rat, neither maternal nor offspring 
systemic toxicity was not observed at doses up to 40 mg/kg bw/day 
(HDT). No treatment-related effects were observed on reproductive 
parameters.
    In an OPPTS Harmonized Test Guideline 870.3650 study designed to 
evaluate developmental, reproduction and neurological parameters, 
maternal toxicity in the rat [HanRcc:WIST(SPF)] was manifested as 
hyperkeratosis, parakeratosis, squamous cell hyperplasia, submucosal 
inflammation and submucosal edema in the forestomach at 100 mg/kg/day 
(mid dose tested, MDT). Mortality and decreased body weight were 
observed in the offspring at 250 mg/kg/day (HDT). Reproductive toxicity 
(decreased gestation index) was also manifested at 250 mg/kg/day. 
Reduced total locomotor activity was observed in females at 250 mg/kg/
day. However, this effect was considered a result of systemic toxicity 
rather than a result of neurological toxicity since it was transient, 
occurred at the high dose in one gender only, it was not observed at 
the lower doses, neuropathologic lesions were not observed and signs of 
neurotoxicity were not observed in other studies. Changes in absolute 
and relative thymus weights and atrophy were observed in males at the 
250 mg/kg/d (HDT). These were determined to be non-specific changes not 
indicative of immunotoxicity. In addition, no blood parameters were 
affected. Furthermore, these compounds do not belong to a class of 
chemicals that would be expected to be immunotoxic.
    Several mutagenicity studies (Ames, chromosome aberration, 
micronucleus assay, cell transformation, and cell dominant lethal 
assay) were available for review. The results for these studies were 
negative.
    There were two chronic studies available, a chronic dermal toxicity 
study in the mouse, and a chronic/carcinogenicity study in the rat. In 
the dermal toxicity study in the mouse, systemic toxicity and evidence 
of increased tumors were not observed at the HDT (5.6 mg/kg/day). In 
the chronic carcinogenicity study in the rat, systemic toxicity was 
manifested as decreased body weight and cataracts at 107 mg/kg/day 
(HDT). Evidence of increased tumors was not observed. Based on the lack 
of evidence of carcinogenicity in these studies and the negative 
response for mutagenicity ADAOs are not expected to be carcinogenic.
    Metabolism studies demonstrated that C12 ADAO was 
absorbed in rats and extensively and rapidly excreted. The distribution 
of C12 ADMO was similar between males and females. Among all 
the tissues analyzed, the largest amount and the highest concentration 
of radioactivity were found in the liver. The fractions of dosed 
radioactivity appearing in the liver, kidney, and blood reached maxima 
within 1 hour after the oral dose. The excretion of radioactivity was 
rapid with approximately 70% and greater excreted within 24 hours. The 
major excretory pathway was urine followed by expired CO2 
with much less found in feces and bile.
    Specific information on the studies received and the nature of the 
adverse effects caused by ADAOs, 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 the document Decision Document for Petition 
Numbers 5E7003 and 8E7316 (C10-16); C10-
C18-Alkyldimethylamine oxides CAS Reg. No. 1643-20-5, 2571-
88-2, 2605-79-0, 3332-27-2, 61788-90-7, 68955-55-5, 70592-80-2, 7128-
91-8, 85408-48-6, 85408-49-7) at pp 7-18 in docket ID numbers EPA-HQ-
OPP-2005-0310 and EPA-HQ-OPP-2008-0858.

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.
    A summary of the toxicological endpoints for ADAOs used for human 
health risk assessment is shown in Table 1 of this unit.

[[Page 51477]]

     Table 1.--Summary of Toxicological Doses and Endpoints for ADAOs 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                               No appropriate endpoints were identified for acute dietary risk
 (all populations)...................                                  assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 42.3 mg inert/   Chronic RfD = .42 mg/kg/ Chronic toxicity/
                                        kg/day                   day                      oncogenicity study-
                                       UFA = 10x..............  cPAD = .42 mg/kg/day...   rat (CAS Reg. No.
                                       UFH = 10x..............                            70592-80-2)
                                       FQPA SF = 1x...........                           .......................
                                                                                         LOAEL = 87.4 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight and
                                                                                          ophthalmological
                                                                                          opacities/cataracts
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short- and             NOAEL= 42.3 mg/kg/day    Residential/             Chronic toxicity/
 Intermediate Term Dermal and          UFA = 10x..............   Occupational LOC for     oncogenicity study-
 Inhalation                            UFH = 10x..............   MOE = 100.               rat (CAS Reg. No.
                                       FQPA SF = 1x (10%                                  70592-80-2)
                                        Dermal absorption;                               .......................
                                        100% inhalation and                              LOAEL = 87.4 mg/kg/day
                                        oral toxicity assumed                             based on decreased
                                        equivalent).                                      body weight and
                                                                                          ophthalmological
                                                                                          opacities/cataracts
----------------------------------------------------------------------------------------------------------------
Cancer                                   Classification: ADAOs are not expected to be carcinogenic based on the
(oral, dermal, inhalation)...........   lack of evidence of carcinogenicity in the chronic feeding study in rats
                                         or in the chronic dermal study in mice as well as the negative response
                                                                   for mutagenicity.
----------------------------------------------------------------------------------------------------------------
 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.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to the ADAOs, EPA considered exposure under the petitioned-for 
exemptions from the requirement of a tolerance. EPA assessed dietary 
exposures from ADAOs in food as follows:
     i. Acute exposure. No adverse effects attributable to a single 
exposure of ADAOs were seen in the toxicity databases. Therefore, acute 
dietary risk assessments for ADAOs 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 ADAOs. 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 levels 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 are 
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. In the case of ADAOs, EPA made a specific 
adjustment to the dietary exposure assessment to account for the use 
limitations of the amount of ADAOs that may be in formulations (to no 
more than 15% by weight in pesticide products) and assumed that the 
ADAOs are present at the maximum limitation rather than at equal 
quantities with 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

[[Page 51478]]

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. ADAOs are not expected to be carcinogenic since there 
was no evidence of carcinogenicity in the chronic feeding studies in 
mice and rats or in the chronic dermal study in mice as well as the 
negative response for mutagenicity. Since the Agency has not identified 
any concerns for carcinogenicity relating to ADAOs, a cancer dietary 
exposure assessment was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for ADAOs. Tolerance level residues and/or 100% CT 
were assumed for all food commodities.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for ADAOs, a conservative 
drinking water concentration value of 100 parts per billion (ppb) based 
on screening level modeling was used to assess the contribution to 
drinking water for chronic dietary risk assessments for ADAOs. 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). ADAOs 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 ADAOs as inert ingredients. The 
ADAO inerts are used in pesticide formulations that may be used around 
the home in pesticide formulations used on lawn, turf, or gardens. In 
addition, these inerts may be present in home cleaning products. The 
Agency selected representative scenarios, based on end-use product 
application methods and labeled application rates. The Agency conducted 
an assessment to represent worst-case residential exposure by assessing 
ADAOs in pesticide formulations (Outdoor Scenarios) and ADAOs in 
disinfectant-type uses (Indoor Scenarios). Based on information 
contained in the petition, ADAOs can be present in consumer cleaning 
products (maximum concentration 4%). Therefore, the Agency assessed the 
disinfectant-type products containing ADAOs using exposure scenarios 
used by OPP's Antimicrobials Division to represent worst-case 
residential handler exposure. The Agency conducted an assessment to 
represent worst-case residential exposure by assessing post application 
exposures and risks from ADAOs in pesticide formulations (Outdoor 
Scenarios) and ADAOs in disinfectant-type uses (Indoor 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.'' Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to ADAOs and any other substances and, this material does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has not 
assumed that ADAOs 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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on 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. Qualitative susceptibility 
was observed in the developmental toxicity studies in the rat. Skeletal 
variations were observed in rat fetuses at a dose (100 mg/kg/day) that 
caused maternal toxicity (decreased body weight gain). In a second 
developmental study in the rat, increased incidence of bifid centrum 
occurred in fetuses at a dose (100 mg/kg/day) that caused maternal 
toxicity (decreased body weight gain). However, the concern for 
qualitative fetal susceptibility is low because NOAELs are well 
established in these two studies and protective of fetuses. The NOAEL 
of 25 mg/kg/day established in the developmental study in the rat 
represents the lowest NOAEL in the database. However, the NOAEL of 42.3 
mg/kg/day was selected from the chronic/carcinogenicity study for use 
in risk assessment. This decision was based on the conclusion that the 
NOAEL of 25 mg/kg/day is an artifact of dose spread. The doses tested 
in the developmental study in the rat were 0, 25, 100, and 200 mg/kg/
day. The LOAEL for this study was 100 mg/kg/day. In a second rat 
developmental study and a 2-generation reproduction study, fetal and 
maternal effects were consistently seen at doses >100 mg/kg/day, the 
maternal and fetal NOAELs

[[Page 51479]]

were established at 100 mg/kg/day (developmental study) and >40 mg/kg/
day (2-generation reproduction study, highest dose tested). In a 
recently conducted combined developmental/reproduction screening study 
(OPPTS Harmonized Guideline 870.3650), the maternal and offspring 
NOAELs were 40 and 100 mg/kg/day, respectively, and effects were seen 
at doses >100 mg/kg/day further supporting the higher NOAEL. 
Additionally, in the chronic/carcinogenicity study, the NOAEL was 42.3 
mg/kg/day, effects (decreased body weight and cataracts) were observed 
at 87.4 mg/kg/day which is consistent with the dose at which other 
effects were seen. Given this weight-of-evidence, it was concluded that 
the NOAEL of 42.3 mg/kg/day most accurately reflected the true NOAEL. 
Therefore, the established Chronic Reference Dose (cRfD) (0.42 mg/kg/
day) is protective of any developmental effects observed at doses as 
low as 100 mg/kg/day in these studies. There are low concerns for 
residual uncertainties concerning prenatal and postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
     i. The toxicity database for the ADAOs inerts is considered 
adequate for assessing the risks to infants and children. The toxicity 
data available on the ADAOs is summarized in Unit IV.A.
     ii. Although qualitative susceptibility was observed in the 
developmental toxicity studies in the rat, the concern for qualitative 
fetal susceptibility is low for the reasons noted in Unit IV.D.2.
     iii. Evidence of neurotoxicity was noted in the combined 
developmental/reproduction screening test in rats. Total locomotor 
activity was reduced at the high dose (250 mg/kg/day) in females only. 
However, EPA concluded that the reduction in locomotor activity was due 
to excessive systemic toxicity at the high dose rather than due to 
neurological origin. This conclusion is based on the following: effects 
were seen only in one sex at the high dose, the effect was transient, 
neurotoxicity was not observed at the lower doses in this study, there 
were no neuropathological lesions in the study and clinical signs of 
neurotoxicity and neuropathology were not observed in any other studies 
in the database. Thus there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
     iv. The Agency noted changes in thymus weight and thymus atrophy 
were observed in males at the high dose (250 mg/kg/day) only. These 
were determined to be non-specific changes not indicative of 
immunotoxicity. In addition, no blood parameters were affected. 
Furthermore, these compounds do not belong to a class of chemicals that 
would be expected to be immunotoxic. Therefore, these identified 
effects do not raise a concern necessitating an additional uncertainty.
     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 ADAOs in drinking water. These assessments will 
not underestimate the exposure and risks posed by ADAOs.

E. Aggregate Risks and Determination of Safety

    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.
    1. Acute risk.There was no hazard attributable to a single exposure 
seen in the toxicity database for ADAOs. Therefore, the ADAOs are not 
expected to pose an acute risk.
    2. 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 and the use limitations of not more than 15% by 
weight in pesticide formulations, the chronic dietary exposure from 
food and water to ADAO is 14% of the cPAD for the U.S. population and 
45% of the cPAD for children 1 to 2 years old, the most highly exposed 
population subgroup.
    3. 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).
     ADAOs 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 ADAOs. Using the exposure 
assumptions described in this unit, EPA has concluded that the combined 
short-term aggregated food, water, and residential exposures result in 
aggregate MOEs of 250 for both adult males and females respectively. 
Adult residential exposure combines high end dermal and inhalation 
handler exposure from indoor hand wiping with a high end post 
application dermal exposure from contact with treated lawns. EPA has 
concluded the combined short-term aggregated food, water, and 
residential exposures result in an aggregate MOE of 200 for children. 
Children's residential exposure includes total exposures associated 
with contact with treated lawns (dermal and hand-to-mouth exposures). 
As the level of concern is for MOEs that are lower than 100, these MOEs 
are not of concern.
    4. 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).
    ADAOs 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 ADAOs. Using the 
exposure assumptions described in this unit, EPA has concluded that the 
combined intermediate-term aggregated food, water, and residential 
exposures result in aggregate MOEs of 840 for adult males and females. 
Adult residential exposure includes high end post application dermal 
exposure from contact with treated lawns. EPA has concluded the 
combined intermediate-term aggregated food, water, and residential 
exposures result in an aggregate MOE of 210 for children. Children's 
residential exposure includes total exposures associated with contact 
with treated lawns (dermal and hand-to-mouth exposures). As the level 
of concern is for MOEs that are lower than 100, this MOE is not of 
concern.

[[Page 51480]]

     5. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to ADAOs.
    6. 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 ADAOs.

V. Other Considerations

A. Endocrine Disruptors

    EPA is required under the Federal Food, Drug and Cosmetic Act 
(FFDCA), as amended by FQPA, to develop a screening program to 
determine whether certain substances (including all pesticide active 
and other ingredients) ``may have an effect in humans that is similar 
to an effect produced by a naturally occurring estrogen, or other such 
endocrine effects as the Administrator may designate.'' Following 
recommendations of its Endocrine Disruptor and Testing Advisory 
Committee (EDSTAC), EPA determined that there was a scientific basis 
for including, as part of the program, the androgen and thyroid hormone 
systems, in addition to the estrogen hormone system. EPA also adopted 
EDSTAC's recommendation that the Program include evaluations of 
potential effects in wildlife. For pesticide chemicals, EPA will use 
FIFRA and, to the extent that effects in wildlife may help determine 
whether a substance may have an effect in humans, FFDCA authority to 
require the wildlife evaluations. As the science develops and resources 
allow, screening of additional hormone systems may be added to the 
Endocrine Disruptor Screening Program (EDSP).
    When additional appropriate screening and/or testing protocols 
being considered under the Agency's EDSP have been developed, ADAOs may 
be subjected to further screening and/or testing to better characterize 
effects related to endocrine disruption.

B. Analytical Method(s)

    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.

C. International Tolerances

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

VI. Conclusions

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
residues of ADAOs. Accordingly, EPA finds that exempting ADAOs from the 
requirement of a tolerance when used as an inert ingredient in 
pesticide formulations applied to growing crops will be safe.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
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 exemption 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: September 25, 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.

* * * * *

[[Page 51481]]

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
C10-C18-Alkyl dimethyl amine      15% by weight in    Surfactant
 oxides (CAS Reg. Nos. 1643-20-    pesticide
 5, 2571-88-2, 2605-79-0, 3332-    formulation
 27-2, 61788-90-7, 68955-55-5,
 70592-80-2, 7128-91-8, 85408-48-
 6, and 85408-49-7)
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. E9-24055 Filed 10-06-09; 8:45 am]

BILLING CODE 6560-50-S