
[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Rules and Regulations]
[Pages 6335-6342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2408]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0098; FRL-8861-9]


Sodium and Potassium 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 and potassium salts of N-alkyl 
(C8-C18)-beta-iminodipropionic acid where the 
C8-C18 is linear and may be saturated and/or 
unsaturated, (CAS Reg. Nos. 110676-19-2, 3655-00-3, 61791-56-8, 14960-
06-6, 26256-79-1, 90170-43-7, 91696-17-2, and 97862-48-1), herein 
referred to in this document as SSNAs, when used as inert ingredients 
for pre- and post-harvest uses and for application to animals 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 the establishment of 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 February 4, 2011. Objections and 
requests for hearings must be received on or before April 5, 2011, 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: Karen Samek, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8825; e-mail address: samek.karen@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

B. How can i get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines 
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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 objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 5, 2011. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, 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 online 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. Petition for Exemption

    In the Federal Register of March 19, 2010 (75 FR 132771) (FRL-8813-
2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 9E7631) by The 
Joint Inerts Task Force, Cluster Support Team 14 (CST 14), c/o CropLife 
America, 1156 15th Street, NW., Suite 400, Washington, DC 20005. The 
petition requested that 40 CFR 180.910 and 40

[[Page 6336]]

CFR 180.930 be amended by establishing exemptions from the requirement 
of a tolerance for residues of the SSNAs (CAS Reg. Nos. 110676-19-2, 
3655-00-3, 61791-56-8, 14960-06-6, 26256-79-1, 90170-43-7, 91696-17-2, 
and 97862-48-1) when used as inert ingredients as a surfactant in 
pesticide formulations applied to crops pre- and post-harvest, as well 
as to animals at a maximum of 30% by weight in pesticide formulations. 
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 in the docket,  http://www.regulations.gov. Two comments were received in response to the 
Notice of Filing. One of the comments was received from a private 
citizen who opposed the authorization to sell any pesticide that leaves 
a residue on food. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that no residue of pesticides 
should be allowed. However, under the existing legal framework provided 
by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) EPA 
is authorized to establish pesticide tolerances or exemptions where 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by that statute. A 
second comment was received regarding endocrine effects from soybeans. 
Since the subject of this tolerance exemption request is not soybeans, 
this comment is not relevant to this action.
    EPA previously published a final rule to establish a tolerance 
exemption for sodium salts of SSNA (CAS Reg. Nos. 3655-00-3, 61791-56-
8, 14960-06-6, 26256-79-1, 90170-43-7, 91696-17-2, and 97862-48-1) 
under 40 CFR 180.920 in the Federal Register of July 29, 2009 (74 FR 
37584) (FRL-8425-5). That final rule established a tolerance exemption 
for sodium salts of SSNA when used as inert ingredients in pesticide 
formulations applied to growing crops only.

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(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for 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 establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors 
specified in FFDCA section 408(c)(2)(B), 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 SSNAs including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with the SSNAs follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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.
    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 pages 46-
49 in docket ID number EPA-HQ-OPP-2009-0098. In this human health risk 
assessment an exemption from the requirement of a tolerance was 
assessed for an exemption under 40 CFR 180.920 for pre-harvest use of 
sodium salts of SSNA where the C8-C18 is linear 
and may be saturated and/or unsaturated provided that the concentration 
of the SSNA inert is limited to no more than 30% by weight in pesticide 
formulations. It was noted in the document that this risk assessment 
also supports the use of the SSNA inert ingredients in pesticide 
formulations intended for use post-harvest as well. Because it is 
likely that the sodium or potassium salts of SSNA readily disassociate 
in the body to the salt and the active moiety and that the toxicity of 
the chemical is associated with the active moiety, the Agency concludes 
that its risk assessment is sufficient to support both the sodium and 
potassium salts of SSNA. The Agency also concludes that the risk 
assessment supports the application of these chemicals to animals under 
40 CFR 180.930 with the limitation of no more than 30% in pesticide 
formulations.
    The available toxicity data indicate that the SSNAs have low acute 
oral and dermal toxicity, are potentially

[[Page 6337]]

corrosive to the skin, but 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 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.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 
human health risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for the SSNAs for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/ scenario           and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary....................         An effect attributable to a single exposure was not identified.
                                  ------------------------------------------------------------------------------
Chronic dietary..................  NOAEL= 43 mg/kg/day   Chronic RfD = 0.43   Combined Repeated Dose Toxicity
(All populations)................   UFA = 10x.            mg/kg/day.           Study with the Reproduction/
                                   UFH = 10x...........  cPAD = 0.43 mg/kg/    Developmental Toxicity Screening
                                   FQPA SF = 1x........   day.                 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 + non-glandular
                                                                               stomachs of females.
                                                                              Reporductive/Developmental LOAEL
                                                                               was not observed.
Incidental Oral, Dermal and        NOAEL= 43 mg/kg/day.  LOC for MOE = 100..  Combined Repeated Dose Toxicity
 Inhalation (Short-, and           UFA = 10x...........                        Study with the Reproduction/
 Intermediate-, and Long-Term).    UFH = 10x...........                        Developmental Toxicity screening
                                   FQPA SF = 1x........                        Test-Rat OPPTS Harmonized
                                   5% dermal and 100%                          Guideline 870.3650 (Cas Reg. No.
                                    inhalation                                 3655-00-3).
                                    absorption assumed.                       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 + 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.
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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).

[[Page 6338]]

 
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 proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from the SSNAs in food as follows:
    i. Acute exposure. No adverse effects attributable to a single 
exposure of the SSNAs were 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 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 are 
generally at least 50 percent of the product and often can be much 
higher. Further, pesticide products rarely have a single inert 
ingredient; rather there is generally a combination of different inert 
ingredients used which additionally reduces the concentration of any 
single inert ingredient in the pesticide product in relation to that of 
the active ingredient. In the case of the SSNAs, EPA made a specific 
adjustment to this 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 percent of all foods are treated with the 
inert ingredient at the rate and manner necessary to produce the 
highest residue legally possible for an active ingredient. In summary, 
EPA chose a very conservative method for estimating what level of inert 
residue could be on food, then used this methodology to choose the 
highest possible residue that could be found on food and assumed that 
all food contained this residue. No consideration was given to 
potential degradation between harvest and consumption even though 
monitoring data shows that tolerance level residues are typically one 
to two orders of magnitude higher than actual residues in food when 
distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    iii. Cancer. The Agency used a qualitative structure activity 
relationship (SAR) database, DEREK11, to determine if there were 
structural alerts suggestive of carcinogenicity. No structural alerts 
for carcinogenicity were identified. 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% CT 
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for 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 
pages 51-53 in docket ID number EPA-HQ-OPP-2009-0098.

[[Page 6339]]

    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., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables). 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 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 the SSNAs to share a common mechanism of toxicity 
with any other substances, and the 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 the 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 Web site at http://www.epa.gov/pesticides/cumulative 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 combined repeated dose toxicity study. 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 IV.D.2.). The Agency has determined that the OPPTS 
Harmonized Guideline 870.3650, Combined Repeated Dose Toxicity Study 
with the Reproduction/Developmental Toxicity Screening Test in rats is 
adequate to assess the toxicity of this chemical because the study 
provides information on systemic toxicity, neurotoxicity and 
immunotoxicity following repeated exposure, as well as assessing 
possible developmental and reproductive effects. The study measures 
various toxicological parameters such as hematology, clinical 
biochemistry, gross pathology and histopathology. In this study, no 
treatment related adverse effects were observed in any of the observed 
or measured parameters at dose levels below the high dose level of 600 
mg/kg/day except for decreased body weight gain during the pre-mating 
period, and increased incidence of microscopic renal lesions in males 
and congestion and inflammation of the glandular and non-glandular 
stomachs of females at the mid level dose level of 160 mg/kg/day. 
Stomach epithelial cell congestion/inflammation is an effect 
attributable to local irritation rather than systemic activity. 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. The observed toxicity seen in the repeated dose 
studies are attributable to the corrosive and irritating nature of 
these surfactants. The Agency has considerable toxicity information on 
surfactants which indicates that their effects do not progressively 
increase in severity over time. In addition, use of the full 10X 
interspecies factor will actually provide an additional margin of 
safety because it is not expected that humans' response to local 
irritation/corrosiveness effects would be markedly different from 
animals. The database on the SSNAs indicates that the target organ 
toxicity is occurring at relatively high doses. Based on the above 
considerations, the Agency concluded that there is no need for 
additional data and an additional FQPA safety factor is not necessary.
    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. There are no neurotoxicity studies available for this series 
of nonionic

[[Page 6340]]

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.
    iv. There are no residual uncertainties identified in the exposure 
databases. The food and drinking water assessment is not likely to 
underestimate exposure to any subpopulation, including those comprised 
of infants and children. The food exposure assessments are considered 
to be highly conservative, as they are based on the use of the highest 
tolerance level from the surrogate pesticides for every food and 100% 
crop treated is assumed for all crops. EPA also made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to 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 the 
SSNAs.

E. Aggregate Risks and Determination of Safety

    Determination of safety section. EPA determines whether acute and 
chronic dietary pesticide exposures are safe by comparing aggregate 
exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For 
linear cancer risks, EPA calculates the lifetime probability of 
acquiring cancer 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 
appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. 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 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 not establishing a numerical tolerance for residues of 
the SSNAs in or on any food commodities. EPA is establishing a 
limitation on the amount of the SSNAs that may be used in pesticide 
formulations. That limitation will be enforced through the pesticide 
registration process under the Federal Insecticide, Fungicide, and 
Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register 
any pesticide for sale or distribution that contains greater than 30% 
of the SSNAs by weight in food use pesticide formulations.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The codex has not established a MRL for the SSNAs.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180. 910 and 40 CFR 180.930 for sodium and 
potassium salts of N-alkyl (C8-C18)-beta-
iminodipropionic acid where the C8-C18 is linear 
and may be saturated and/or unsaturated (CAS Reg. Nos. 110676-19-2, 
3655-00-3, 61791-56-8, 14960-06-6, 26256-79-1, 90170-43-7, 91696-17-2, 
and 97862-48-1) when used as inert ingredients in pesticide 
formulations for pre-harvest and post-harvest uses, as well as, for 
application to animals at a maximum of 30% by weight in pesticide 
formulations.

[[Page 6341]]

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the 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) (Pub. L. 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: January 24, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.910, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


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

* * * * *

------------------------------------------------------------------------
        Inert ingredients                Limits               Uses
------------------------------------------------------------------------
Sodium and potassium salts of N-   Concentration in    Surfactants,
 alkyl (C8-C18)-beta-               formulated end-     related
 iminodipropionic acid where the    use products not    adjuvants of
 C8-C18 is linear and may be        to exceed 30% by    surfactants.
 saturated and/or unsaturated       weight in
 (CAS Reg. Nos. 110676-19-2, 3655-  pesticide
 00-3, 61791-56-8, 14960-06-6,      formulations.
 26256-79-1, 90170-43-7, 91696-17-
 2, 97862-48-1).
------------------------------------------------------------------------

* * * * *


0
3. In Sec.  180.930, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


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

* * * * *

------------------------------------------------------------------------
        Inert ingredients                Limits               Uses
------------------------------------------------------------------------
Sodium and potassium salts of N-   Concentration in    Surfactants,
 alkyl (C8-C18)-beta-               formulated end-     related
 iminodipropionic acid where the    use products not    adjuvants of
 C8-C18 is linear and may be        to exceed 30% by    surfactants.
 saturated and/or unsaturated       weight in
 (CAS Reg. Nos. 110676-19-2, 3655-  pesticide
 00-3, 61791-56-8, 14960-06-6,      formulations.
 26256-79-1, 90170-43-7, 91696-17-
 2, 97862-48-1).
------------------------------------------------------------------------


[[Page 6342]]

* * * * *
[FR Doc. 2011-2408 Filed 2-3-11; 8:45 am]
BILLING CODE 6560-50-P


