
[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Rules and Regulations]               
[Page 37591-37598]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy09-16]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0725; FRL-8426-8]

 
Sodium N-oleoyl-N-methyl taurine; 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 sodium N-oleoyl-N-methyl taurine (MOTS), 
(CAS Reg. No. 137-20-2), herein referred to in this document as MOTS, 
when used as an inert ingredient in pesticide formulations for pre-
harvest and post-harvest uses under 40 CFR 180.910, as well as for 
application to animals under 40 CFR 180.930. The Joint Inerts Task 
Force (JITF), Cluster Support Team (CST 24), 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 MOTS.

DATES: This regulation is effective July 29, 2009. Objections and 
requests for hearings must be received on or before September 28, 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-2008-0725. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (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. To 
access the OPPTS Harmonized Guidelines referenced in this document, go 
directly to the guideline 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. 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-2008-0725 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 September 28, 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-2008-0725, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.

[[Page 37592]]

     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 December 3, 2008 (73 FR 73644) (FRL-
8386-9), 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 
8E742) by The JITF, CST 24, c/o CropLife America, 1156 15th 
Street, N.W., Suite 400, Washington, DC 20005. The petition was 
subsequently redesignated as PP 8E7423. The petition requested that 40 
CFR 180.910 and 40 CFR 180.930 be amended by establishing exemptions 
from the requirement of a tolerance for residues of the inert 
ingredient MOTS. That notice referenced a summary of the petition 
prepared by the JITF, CST 24, 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 (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.

 III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients..

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
exemption from the requirement of a tolerance for residues of MOTS when 
used as an inert ingredient in pesticide formulations for pre-harvest 
and post-harvest uses, as well as for application to animals. 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 existing toxicology database for MOTS consists of one OPPTS 
Harmonized Guideline 870.3650 combined repeated dose toxicity study 
with the reproduction/developmental toxicity screening test in rats and 
several studies in the scientific literature on acute toxicity, 
mutagenicity and repeat dosing exposures.
    The toxicology database is adequate to support the use of MOTS as 
an inert ingredient in pesticide formulations. MOTS has low acute oral 
and dermal toxicity, is not a skin irritant or dermal sensitizer, but 
is a mild to moderate eye irritant. MOTS was not mutagenic in an Ames 
test.
    In OPPTS Harmonized Guideline 870.3650 study, there was no evidence 
of increased susceptibility. Parental toxicity was manifested as 
clinical signs, decreased body weight gain and microscopic stomach 
lesions at 300 miligrams/kilogram/day (mg/kg/day). However, these 
effects were considered to be due to the corrosive nature of the test 
material and were not considered appropriate for risk assessment. At 
higher doses of 1,000 mg/kg/day, the offspring effects include 
increased post-implantation loss, decreased viability and decreased 
body weight in male and female offspring, which occurred only in the 
presence of parental toxicity. There was no increased susceptibility to 
the offspring of rats to MOTS following in utero and post-natal 
exposure in the OPPTS Harmonized Guideline 870.3650 combined repeated 
dose toxicity study with the reproduction/developmental toxicity 
screening test. Thyroid effects were observed in the OPPTS Harmonized 
Guideline 870.3650 study only at the limit dose in male, but not 
female, rats. The increased thyroid follicular hypertrophy seen in the 
study is considered secondary to the enhanced liver cell metabolism 
also observed in males at the limit dose. Moreover, rats are known to 
be quantitatively more sensitive than humans in response to thyroid 
toxicity. Thus, regulating at a no

[[Page 37593]]

observed adverse effect level (NOAEL) of 300 mg/kg/day with effects 
seen at 1,000 mg/kg/day with a 100 fold uncertainty factor 
(UFA=10X; UFh=10X) provides an adequate margin of 
protection.
    The Agency notes that surfactants are surface-active materials that 
can damage the structural integrity of cellular membranes at high dose 
levels. Thus, surfactants are often corrosive and irritating in 
concentrated solutions. It is possible that some of the observed 
toxicity seen in the repeated dose studies, such as microscopic stomach 
lesions or decreased body weight gain, can be attributed to the 
corrosive and irritating nature of these surfactants.
    No metabolism studies were located in the literature. The 
registrant proposed a metabolic pathway based on analogy to accepted 
metabolic pathways for amide hydrolysis and fatty acid beta-oxidation. 
It has been proposed that the initial step involves hydrolysis of the 
amide linkage to generate oleic acid and sodium N-methyl taurine. The 
enzyme fatty acid amide hydrolase (FAAH) may be involved in hydrolysis, 
and is also a primary terminator of lipic oleoamides as well as for the 
N-acyl taurines. It is possible the anionic sulfonate, MOTS species, 
would be excreted in the urine or converted to a dianionic salt with 
glucuronic acid that is excreted. A secondary step would involve 
metabolism of the oleic acid by the fatty acid beta-oxidation pathway.
    There is no evidence that MOTS is 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. EPA has low concern that any of the postulated 
metabolites have greater toxicity than the parent compounds. Based on 
the negative response for mutagenicity, lack of any alerts in model 
predictions, and SAR analysis, the Agency concluded that MOTS is not 
likely to be carcinogenic.
    Specific information on the studies received and the nature of the 
adverse effects caused by MOTS, as well as the NOAEL and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies can be 
found at http://www.regulations.gov in document MOTS (JITF CST 24 Inert 
Ingredient). Human Health Risk Assessment to Support Proposed Exemption 
from the Requirement of a Tolerance When Used as Inert Ingredients in 
Pesticide, pages 8-12 and 47-52 in docket ID number EPA-HQ-OPP-2008-
0725.

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 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-term, intermediate-term, 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 MOTS used for human 
health risk assessment is shown in the following Table.

      Table--Summary of Toxicological Doses and Endpoints for MOTS 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)            An endpoint attributable to a single exposure was not seen in the
                                               database; therefore, a point of departure was not selected.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 300 mg/kg/day     Chronic RfD = 3 mg/kg/   OPPTS Harmonized
                                       UFA = 10x..............   day                      Guideline 870.3650
                                       UFH = 10x..............  cPAD = 3 mg/kg/day.....   Combined Repeated Dose
                                       FQPA SF = 1x...........                            Toxicity Study with
                                                                                          the Reproduction/
                                                                                          Developmental Toxicity
                                                                                          Screening Test in rats
                                                                                         LOAEL = 1,000 mg/kg/
                                                                                          day, based on thyroid
                                                                                          histophathy in males
                                                                                          and organ weight
                                                                                          increases (adrenals
                                                                                          and liver in both
                                                                                          sexes; testes in
                                                                                          males)
                                                                                         Note that irritant
                                                                                          effects seen in the
                                                                                          forestomach of rats at
                                                                                          300 mg/kg/day were
                                                                                          considered to be due
                                                                                          to the corrosive
                                                                                          nature of the test
                                                                                          material and were not
                                                                                          considered appropriate
                                                                                          for risk assessment.
----------------------------------------------------------------------------------------------------------------

[[Page 37594]]


Incidental Oral, Dermal and            NOAEL= 300 mg/kg/day     Residential/             OPPTS Harmonized
 Inhalation (Short-term and             Dermal absorption of     Occupational LOC for     Guideline 870.3650
 Intermediate-term)                     20% is considered        MOE = 100                Combined Repeated Dose
                                        upper end screening                               Toxicity Study with
                                        level; Inhalation                                 the Reproduction/
                                        exposure is assumed to                            Developmental Toxicity
                                        be equivalent to oral                             Screening Test in rats
                                        exposureUFA = 10x                                LOAEL = 1,000 mg/kg/
                                       UFH = 10x..............                            day, based on thyroid
                                       FQPA SF = 1x...........                            histophathy in males
                                                                                          and organ weight
                                                                                          increases (adrenals
                                                                                          and liver in both
                                                                                          sexes; testes in
                                                                                          males)
                                                                                         Note that irritant
                                                                                          effects seen in the
                                                                                          forestomach of rats at
                                                                                          300 mg/kg/day were
                                                                                          considered to be due
                                                                                          to the corrosive
                                                                                          nature of the test
                                                                                          material and were not
                                                                                          considered appropriate
                                                                                          for risk assessment.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)         Classification: No animal toxicity data available for an assessment.
                                             Based on SAR analysis, MOTS is not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
 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

    Very limited information is available for MOTS with respect to 
plant and animal metabolism or environmental degradation. The Agency 
relied collectively on information provided on the representative 
chemical structure, the submitted physicochemical EPI 
SuiteTM data, SAR information, as well as information on 
other surfactants and chemicals of similar size and functionality to 
determine the residues of concern for this inert ingredient. The Agency 
has concluded that the parent compound MOTS is the residue of concern. 
Likely degradation in the environment would result in sodium N-methyl 
taurine and oleic acid (or shorter chain fatty acids). These compounds 
would likely be present in food and water at much lower concentrations 
than the parent compound, and since they are likely are less toxic than 
the parent, MOTS, are not of concern for risk assessment purposes. The 
Agency notes that taurine, synthesized by the liver, is important in 
bile acid metabolism.
    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to MOTS, EPA considered exposure under the petitioned-for 
exemptions from the requirement of a tolerance. EPA assessed dietary 
exposures from MOTS in food as follows:
     i. Acute exposure. No adverse effects attributable to a single 
exposure of MOTS was seen in the toxicity databases; Therefore, an 
acute dietary exposure assessments for MOTS is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the United 
States 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 MOTS. In the absence 
of specific residue data, EPA has developed an approach which uses 
surrogate information to derive upper bound exposure estimates for the 
subject inert ingredient. Upper bound exposure estimates are based on 
the highest tolerance for a given commodity from a list of high-use 
insecticides, herbicides, and fungicides. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data is contained in the memorandum entitled Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts. 
(D361707, S. Piper, 2/25/09) and can be found at http://
www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation (if any) between the 
active and inert ingredient and that the concentration of inert 
ingredient in the scenarios leading to these highest of tolerances 
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentrations of active ingredient in agricultural products is 
generally at least 50 percent of the product and often can be much 
higher. Further, pesticide products rarely have a single inert 
ingredient; rather there is generally a combination of different inert 
ingredients used which additionally reduces the concentration of any 
single inert ingredient in the pesticide product in relation to that of 
the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at the highest tolerance level. In 
other words, EPA assumed 100% 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

[[Page 37595]]

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 SAR database, DEREK11, 
to determine if there were structural alerts suggestive of 
carcinogenicity. No structural alerts for carcinogenicity were 
identified. Based on the negative response for mutagenicity, the lack 
of any alerts in model predictions, and SAR analysis, the Agency 
concluded that MOTS is not likely to be carcinogenic. Since the Agency 
has not identified any concerns for carcinogenicity relating to MOTS, 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 MOTS. Tolerance level residues and/or 100 PCT 
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 MOTS in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of MOTS. 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 MOTS. Modeling runs on four surrogate inert ingredients 
using a range of physical chemical properties that would bracket those 
of MOTS 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 MOTS (JITF 
CST 24 Inert Ingredient). Human Health Risk Assessment to Support 
Proposed Exemption from the Requirement of a Tolerance When Used as 
Inert Ingredients in Pesticide Formulations, pages 13 and 54-56 in 
docket ID number EPA-HQ-OPP-2008-0725.
    For the purpose of the screening level dietary risk assessment to 
support this request for an exemption from the requirement of a 
tolerance for MOTS, 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 the parent compounds and for the metabolites of 
concern. 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). MOTS may be used as 
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 MOTS as inert ingredients. MOTS 
is used as a surfactant in pesticide formulations intended for use in 
agricultural settings as well as outdoor residential applications. 
Additionally, the petition indicates that this inert may also be used 
in household cleaners. 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 MOTS in pesticide formulations 
(outdoor scenarios) and MOTS in disinfectant-type uses (indoor 
scenarios). Based on information contained in the petition, MOTS can be 
present in consumer cleaning products. Therefore, the Agency assessed 
the disinfectant-type products containing MOTS using exposure scenarios 
used by OPP's Antimicrobials Division to represent worst-case 
residential handler exposure. Standard methodologies based on the 
Agency's Residential standard operating procedures (SOPs) were used to 
assess residential post application exposure to hard surface cleaners. 
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 MOTS to share a common mechanism of toxicity with 
any other substances, and MOTS does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that MOTS does not have a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's 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. The toxicology database for 
MOTS consists of one OPPTS Harmonized Guideline repeated dose toxicity 
study with the reproduction/developmental toxicity screening test in 
rats and several studies in the scientific literature on acute 
toxicity,

[[Page 37596]]

mutagenicity and repeat dosing exposures.
    In the case of MOTS, there was no increased susceptibility to the 
offspring of rats following prenatal and postnatal exposure in the 
OPPTS Harmonized Guideline combined repeated dose toxicity study with 
the reproduction/developmental toxicity screening test. The offspring 
effects (increased post-implantation loss, decreased viability and 
decreased body weight in male and female offspring) occurred at 1,000 
mg/kg/day in the presence of maternal toxicity, which was manifested as 
clinical signs, decreased body-weight gain, thyroid effects in male 
rats, and microscopic stomach lesions at doses of 300 mg/kg/day and 
1,000 mg/kg/day. In an OPPTS Harmonized Guideline study, a slight 
decrease in body temperature was observed in males at doses of 300 and 
1,000 mg/kg/day and in females at doses of 1,000 mg/kg/day. Since these 
decreases in body temperature were minimal, within biological 
variability, they were not considered to be toxicologically relevant. 
Therefore, the Agency concluded that there is no evidence of 
neurotoxicity in the database.
    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 MOTS is considered adequate for 
assessing the risks to infants and children (the available studies are 
described in Unit 4.D.2.
     ii. No quantitative or qualitative increased susceptibility was 
demonstrated in the offspring in the OPPTS Harmonized Guideline 
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats following in utero and 
post-natal exposure.
     iii. Although there is some evidence of thyroid toxicity in the 
OPPTS Harmonized Guideline study, this occurred in males at the highest 
dose tested (HDT) and males are known to be the more sensitive sex for 
thyroid effects. Rats are also known to be more senstitive to these 
effects than humans. Additionally, the increased thyroid follicular 
hypertrophy is considered secondary to the enhanced liver cell 
metabolism observed in males at the HDT. Regulating at a NOAEL of 300 
mg/kg/day with effects seen at 1,000 mg/kg/day with a 100 fold 
uncertainty factor (UFA= 10X; UFH= 10X) provides 
an adequate margin of protection.
    iv. There is no indication that MOTS is a neurotoxic chemical in 
the database and thus there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    v. While there is no chronic toxicity data, the Agency has 
concluded that an additional uncertainty factor is not needed for the 
use of a subchronic study for a chronic exposure assessment considering 
the lack of any alerts in model predictions, as well as, the highly 
conservative nature of the exposure assessment. The conservative point 
of departure selected along with the standard UF factor of 100X to 
account for inter- and intra-species variablitiy is considered health 
protective.
     vi. 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 
PCT is assumed for all crops. EPA also made conservative (protective) 
assumptions in the ground water and surface water modeling used to 
assess exposure to MOTS 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 
MOTS.

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-term, intermediate-term, 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 MOTS. Therefore, MOTS is 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, the chronic dietary exposure from food and water 
to MOTS is 6% of the cPAD for the U.S. population and 21% of the cPAD 
for children 1-2 yrs 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).
     MOTS is used as an inert ingredient 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 MOTS. 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 240, for both adult males and females, respectively. 
Adult residential exposure combines high end dermal and inhalation 
handler exposure with a high end post application dermal exposure. EPA 
has concluded that the combined short-term aggregated food, water, and 
residential exposures result in an aggregate MOE of 360 for children. 
Children's residential exposure combines outdoor and indoor 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).
    MOTS is 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 MOTS. 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 1,500 for both adult males and 
females, respectively. Adult residential exposure includes high end 
post application dermal exposure from contact with treated lawns. EPA 
has concluded that the combined intermediate-term aggregated food, 
water, and residential exposures result in an aggregate MOE of

[[Page 37597]]

410 for children. Children's residential exposure combines outdoor 
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.
     5. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to MOTS.
    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 MOTS.

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 
MOTS 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 sodium N-Oleoyl-N-methyl taurine, when used 
as inert ingredients applied to crops pre-harvest and post-harvest, or 
to animals under 40 CFR 180.910 and 40 CFR 180.930.

VII. Statutory and Executive Order Reviews

    This final rule establishes 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 tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (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 21, 2009.
G. Jeffrey Herndon,
Acting 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 to read as follows:


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

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Sodium N-oleoyl- N-methyl                             Surfactants,
 taurine (CAS Reg. No. 137-20-2)                       related adjuvants
                                                       of surfactants
                              * * * * * * *
------------------------------------------------------------------------

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


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

* * * * *

[[Page 37598]]



------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Sodium N-oleoyl-N-methyl taurine                      Surfactants,
 (CAS Reg. No. 137-20-2)                               related adjuvants
                                                       of surfactants
                              * * * * * * *
------------------------------------------------------------------------


[FR Doc. E9-17960 Filed 7-28-09; 8:45 am]

BILLING CODE 6560-50-S
