[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17960]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Sodium N-oleoyl-N-methyl taurine; Exemption from the Requirement
of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 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)
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: firstname.lastname@example.org.
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
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.
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.
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
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
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
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
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
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
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-
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
Screening Test in rats
LOAEL = 1,000 mg/kg/
day, based on thyroid
histophathy in males
and organ weight
and liver in both
sexes; testes in
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
for risk assessment.
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
and liver in both
sexes; testes in
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
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 =
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: July 21, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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
* * * * * * *
3. In Sec. 180.930, the table is amended by adding alphabetically
the following inert ingredients to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
Inert Ingredients Limits Uses
* * * * * * *
Sodium N-oleoyl-N-methyl taurine Surfactants,
(CAS Reg. No. 137-20-2) related adjuvants
* * * * * * *
[FR Doc. E9-17960 Filed 7-28-09; 8:45 am]
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