
[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Rules and Regulations]               
[Page 37584-37591]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy09-15]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0098; FRL-8425-5]

 
Sodium Salts of N-alkyl (C8-C18)-beta-
iminodipropionic acid; 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 salts of N-alkyl (C8-
C18)-beta-iminodipropionic acid where the C8-
C18 is linear and may be saturated and/or unsaturated, 
herein referred to in this document as SSNAs when used as an inert 
ingredient for pre-harvest uses under 40 CFR 180.920 at a maximum of 
30% by weight in pesticide formulations. The Joint Inerts Task Force 
(JITF), Cluster Support Team Number 14, 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 SSNAs.

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-2009-0098. 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.

[[Page 37585]]


SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the Federal 
Register listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's e-CFR cite at 
http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.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-2009-0098 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-2009-0098, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background

    In the Federal Register of April 15, 2009 (74 FR 17487) (FRL-8409-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9E7525) by The Joint Inerts Task Force, Cluster Support Team 14 (CST 
14), c/o CropLife America, 1156 15th St., NW., Suite 400, Washington, 
DC, 20005. The petition requested that 40 CFR 180.920 be amended by 
establishing exemptions from the requirement of a tolerance for 
residues of the inert ingredient Sodium salts of N-alkyl 
(C8-C18)-beta-iminodipropionic acid where the 
C8-C18 is linear and may be saturated and/or 
unsaturated. That notice referenced a summary of the petition prepared 
by The Joint Inerts Task Force (JITF), Cluster Support Team Number 14 
(CST 14), 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.
     Based upon review of the data supporting the petition, EPA has 
modified the exemption requested to by limiting SSNAs to a maximum of 
30% by weight in pesticide formulations. This limitation is based on 
the Agency's risk assessment which can be found at http://
www.regulations.gov in document ``Sodium Salts of N-Alkyl 
(C8-C18)-[beta]-iminodipropionic Acid (SSNAs - 
JITF CST 14 Inert Ingredients). Human Health Risk Assessment to Support 
Proposed Exemption from the Requirement of a Tolerance When Used as 
Inert Ingredients in Pesticide Formulations'' in docket ID number EPA-
HQ-OPP-2009-0098.
    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

[[Page 37586]]

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 sodium 
salts of N-alkyl (C8-C18)-beta-iminodipropionic 
acid where the C8-C18 is linear and may be 
saturated and/or unsaturated provided that the concentration of the 
SSNA inerts is limited to no more than 30% by weight in pesticide 
formulations. EPA's assessment of exposures and risks associated with 
establishing tolerances follows.

 A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The available toxicity data indicate that the SSNAs have low acute 
oral and dermal toxicity, are potentially corrosive to the skin, and 
are also mild to moderate eye irritants. In the OPPTS Harmonized 
Guideline 870.3650 study with sodium coco [beta]-iminodipropionate in 
rats, decreased food consumption and body weight gain in males and 
females at 160 and 600 miligrams/kilograms body weight day (mg/kg bw/
day) were observed. Mean liver and kidney weights were increased at the 
high dose, while testis and epididymides were unaffected. Hypertrophy 
was found in the livers of males and/or females at the mid- and high-
doses as well as renal histopathology in males, acanthosis of the non-
glandular stomach in males and females, and inflammation of the 
glandular and non-glandular stomach in females. In the absence of any 
evidence of hepatic toxicity, liver hypertrophy was considered an 
adaptive effect and non-adverse.
    No reproduction or developmental effects were noted in the database 
and there was no evidence of neurotoxicity.
    In general, 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 studies, such as inflammation of the 
glandular stomach, can be attributed to the corrosive and irritating 
nature of these surfactants.
    There are no published metabolism studies for this series of 
surfactants. The SSNA mammalian metabolism pathway is based on analogy 
to well-described pathways for tertiary amines and fatty acids. Overall 
it is anticipated that the various metabolites are not systemically 
toxic and would be rapidly conjugated and excreted.
    The SSNA surfactants (mono and di-sodium propionates) may be 
conjugated and excreted directly. Alternatively, the tertiary amine 
dipropionate may be oxidized in the liver by monoamine oxidases to 
generate the intact tertiary amine dipropionate N-oxide which may 
either be conjugated and excreted or metabolically cleaved to a 
dipropionate oxime type metabolite that is conjugated and excreted. The 
linear fatty acid is metabolized via successive beta-oxidation cycles 
to release acetic acid and eventually carbon dioxide and water.
    There are no chronic toxicity studies available for this series of 
nonionic surfactants. The Agency used a qualitative structure activity 
relationship (SAR) database, DEREK Version 11, to determine if there 
were structural alerts suggestive of carcinogenicity. No structural 
alerts were identified.
    Specific information on the studies received and the nature of the 
adverse effects caused by the SSNAs, as well as, the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document ``Sodium Salts of N-Alkyl 
(C8-C18)-[beta]-iminodipropionic Acid (SSNAs - 
JITF CST 14 Inert Ingredients). Human Health Risk Assessment to Support 
Proposed Exemption from the Requirement of a Tolerance When Used as 
Inert Ingredients in Pesticide Formulations'' pages 8-13 and 46-49 in 
docket ID number EPA-HQ-OPP-2009-0098.

B. Toxicological Endpoints

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

[[Page 37587]]

human health risk assessment is shown in the Table 1 below:

  Table 1.--Summary of Toxicological Doses and Endpoints for the SSNAs 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                               An effect attributable to a single exposure was not identified.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 43 mg/kg/day      Chronic RfD =0.43 mg/kg/ Combined Repeated Dose
                                       UFA = 10x..............   day                      Toxicity Study with
                                       UFH = 10x..............  cPAD = 0.43 mg/kg/day..   the Reproduction
                                       FQPASF = 1x............                            Developmental Toxicity
                                                                                          Screening Test-Rat
                                                                                          OPPTS Harmonized
                                                                                          Guideline 870.3650
                                                                                          (CAS Reg. No. 3655-00-
                                                                                          3)
                                                                                         Parental LOAEL= 160 mg/
                                                                                          kg/day based on
                                                                                          decreased body weight
                                                                                          gain in males and
                                                                                          females during the pre-
                                                                                          mating period, and an
                                                                                          increased incidence of
                                                                                          microscopic lesions in
                                                                                          the kidneys of males
                                                                                          and acanthosis of the
                                                                                          glandular and non-
                                                                                          glandular stomachs of
                                                                                          females.
                                                                                         Reproductive/
                                                                                          Developmental LOAEL
                                                                                          was not observed.
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Dermal and            NOAEL= 43 mg/kg/day      Residential LOC for MOE  Combined Repeated Dose
 Inhalation (Short- and Intermediate-  UFA = 10x..............   = 100                    Toxicity Study with
 , and Long- Term)                     UFH = 10x..............                            the Reproduction/
                                       FQPA SF =1x............                            Developmental Toxicity
                                       5 PCT dermal and 100                               screening Test- Rat
                                        PCT inhalation                                    OPPTS Harmonized
                                        absorption assumed.                               Guideline 870.3650
                                                                                          (Cas Reg. No. 3655-00-
                                                                                          3).
                                                                                         Parental LOAEL = 160 mg/
                                                                                          kg/day based on
                                                                                          decreased body weight
                                                                                          gain in males and
                                                                                          females during the pre-
                                                                                          mating period and an
                                                                                          increased incidence of
                                                                                          microscopic lesions in
                                                                                          the kidneys of males
                                                                                          and acanthosis of the
                                                                                          glandular and non-
                                                                                          glandular stomachs of
                                                                                          females.
                                                                                         Reproductive/
                                                                                          Developmental LOAEL
                                                                                          was not observed.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)         Classification: No animal toxicity data available for an assessment.
                                          Based on SAR analysis, the SSNAs are not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose
  (a=acute, c=chronic). FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern. N/A = not applicable.

C. Exposure Assessment.

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to the SSNAs, EPA considered exposure under the petitioned-for 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from SSNAs in food as follows:
     i. Acute exposure. No adverse effects attributable to a single 
exposure of the SSNAs was seen in the toxicity databases; therefore, an 
acute exposure assessment for the SSNAs is not necessary.
     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 SSNAs. 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

[[Page 37588]]

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. In the case of the SSNAs, EPA made a specific 
adjustment to the dietary exposure assessment to account for the use 
limitations of the amount of SSNAs that may be in formulations (no more 
than 30% by weight in pesticide formulations) and assumed that the 
SSNAs are present at the maximum limitation rather than at equal 
quantities with the active ingredient. This remains a very conservative 
assumption because surfactants are generally used at levels far below 
this percentage.
    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 structure activity 
relationship (SAR) database, DEREK11, to determine if there were 
structural alerts suggestive of carcinogenicity. No structural alerts 
for carcinogenicity were identified. SSNAs are not expected to be 
carcinogenic. Therefore a cancer dietary exposure assessment is not 
necessary to assess cancer risk.
     iv. Anticipated residue and percent crop treated (PCT) 
information. EPA did not use anticipated residue and/or PCT information 
in the dietary assessment for SSNAs. Tolerance level residues and/or 
100% 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 SSNAs in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of SSNAs. 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 SSNAs. Modeling runs on four surrogate inert ingredients 
using a range of physical chemical properties that would bracket those 
of the SSNAs 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 
``Sodium Salts of N-Alkyl (C8-C18)-[beta]-
iminodipropionic Acid (SSNAs - JITF CST 14 Inert Ingredients). Human 
Health Risk Assessment to Support Proposed Exemption from the 
Requirement of a Tolerance When Used as Inert Ingredients in Pesticide 
Formulations'' pages 13-14 and 51-53 in docket ID number EPA-HQ-OPP-
2009-0098.
    For the purpose of the screening level dietary risk assessment to 
support this request for an exemption from the requirement of a 
tolerance for the SSNAs, a conservative drinking water concentration 
value of 100 ppb based on screening level modeling was used to assess 
the contribution to drinking water for the chronic dietary risk 
assessments for 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). SSNAs 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 the SSNAs as inert ingredients. In 
this assessment, representative scenarios, based on end-use product 
application methods and labeled application rates, were selected. For 
each of the use scenarios, the Agency assessed residential handler 
(applicator) inhalation and dermal exposure for indoor and outdoor 
scenarios with high exposure potential (i.e., exposure scenarios with 
high end unit exposure values) to serve as a screening assessment for 
all potential residential pesticides containing SSNAs. Similarly, 
residential post application dermal and oral exposure assessments were 
also performed utilizing high end indoor and outdoor exposure 
scenarios. Further details of this residential exposure and risk 
analysis can be found at http://www.regulations.gov in the memorandum 
entitled ``JITF Inert Ingredients. Residential and Occupational 
Exposure Assessment

[[Page 37589]]

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 SSNAs to share a common mechanism of toxicity 
with any other substances, and SSNAs do not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that SSNAs do not have a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The toxicology database is 
adequate to assess risk for the SSNAs when used as inert ingredients in 
pesticide formulations. The toxicity data available on the SSNAs 
consists of one OPPTS Harmonized Guideline 870.3650 combined repeated 
dose toxicity study with the reproduction/development toxicity 
screening test (rat) for the representative surfactant, sodium coco 
beta-iminodipropionate (CAS Reg. No. 3655-00-3). There was no evidence 
of increased sensitivity in young animals because no developmental or 
reproductive toxicity was observed in the OPPTS Harmonized Guideline 
870.3650. No treatment related effects were observed on litter sizes or 
on the early development of pups.
    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 SSNAs 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 
870.3650 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats following in utero and 
post-natal exposure.
     iii. 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 based on 
the minor nature of effects which were seen only at the mid- and high-
doses as well as the highly conservative nature of the exposure 
assessment. The conservative point of departure selected along with the 
standard uncertainty factor of 100X to account for inter- and intra-
species variability is considered health protective.
     iv. There are no neurotoxicity studies available for this series 
of nonionic surfactants. However a Functional Observation Battery (FOB) 
to evaluate neurotoxicity was performed in the Combined Repeated Dose/ 
Developmental Screening study and only a minor decrease in temperature 
was observed in males at the mid and high doses. The effect was likely 
due to normal biological variation and; therefore, was not considered 
treatment-related. Thus, there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
     v. There are no residual uncertainties identified in the exposure 
databases. The food and drinking water assessment is not likely to 
underestimate exposure to any subpopulation, including those comprised 
of infants and children. The food exposure assessments are considered 
to be highly conservative as they are based on the use of the highest 
tolerance level from the surrogate pesticides for every food and 100 
PCT is assumed for all crops. EPA also made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to SSNAs 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 SSNAs.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk.There was no hazard attributable to a single exposure 
seen in the toxicity database for SSNAs. Therefore, the SSNAs are not 
expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account exposure estimates from chronic dietary consumption of food and 
drinking water using the exposure assumptions discussed in this unit 
for chronic exposure and the use limitations of not more than 30% by 
weight in pesticide formulations, the chronic dietary exposure from 
food and water to SSNAs is 27% of the cPAD for the U.S. population and 
87% 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).
     SSNAs are used as inert ingredients in pesticide products that are 
currently registered for uses that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to SSNAs. 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 160 for both adult males and females

[[Page 37590]]

respectively. EPA has concluded the combined short-term aggregated 
food, water, and residential exposures result in an aggregate MOE of 
100 for children. 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).
    SSNAs are currently registered for uses that could result in 
intermediate -term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to SSNAs. 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 430 and 450, for adult males and 
females, respectively. EPA has concluded the combined intermediate-term 
aggregated food, water, and residential exposures result in an 
aggregate MOE of 110 for children. As the level of concern is for MOEs 
that are lower than 100, this MOE is not of concern.
     5. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to SSNAs.
    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 SSNAs.

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 
SSNAs 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 salts of N-alkyl (C8-
C18)-beta-iminodipropionic acid where the C8-
C18 is linear and may be saturated and/or unsaturated when 
used as an inert ingredient for pre-harvest uses under 40 CFR 180.920 
at a maximum of 30% by weight in pesticide formulations.

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. 180.920, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

[[Page 37591]]



----------------------------------------------------------------------------------------------------------------
            Inert Ingredients                           Limits                               Uses
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
sodium salts of N-alkyl (C8-C18)-beta-      Concentration in formulated end-   Surfactants, related adjuvants of
 iminodipropionic acid where the C8-C18    use products not to exceed 30% by                         surfactants
 is linear and may be saturated and/or      weight in pesticide formulations
 unsaturated (CAS Reg. Nos. 3655-00-3,
 61791-56-8, 14960-06-6, 26256-79-1,
 90170-43-7, 91696-17-2, 97862-48-1)
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                                                  * * * * * * *
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[FR Doc. E9-18064 Filed 7-28-09; 8:45 am]

BILLING CODE 6560-50-S
