Document ID: EPA-HQ-OPP-2009-0138-0003
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: 2-Propanol, 1',1'-nitrilotris
Posted Date: 2010-07-23T04:00Z

[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Rules and Regulations]
[Pages 43076-43082]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18097]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0138; FRL-8825-6]

2-Propanol, 1,1',1''-nitrilotris-; 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 2-Propanol, 1,1',1''-nitrilotris- (TIPA) 
(CAS No. 122-20-3) when used as an inert ingredient for use as a 
neutralizer on growing crops and raw agricultural commodities pre- and 
post-harvest. Dow AgroSciences, LLC submitted a petition to EPA under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
establishment of an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of TIPA.

DATES: This regulation is effective July 23, 2010. Objections and 
requests for hearings must be received on or before September 21, 2010, 
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-2009-0138. 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: Lisa Austin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7894; e-mail address: austin.lisa@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I 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 cite at http://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines 
referenced in this document electronically, please go to http://www.epa.gov/oppts and select ``Test Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2009-0138 in the subject line on the first page of 
your submission. All

[[Page 43077]]

objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before September 21, 2010. 
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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2009-0138, 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. Petition for Exemption

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 8E7504) by Dow 
AgroSciences, LLC, 9330 Zionsville Rd, Indianapolis, IN, 46268. The 
petition requested that 40 CFR 180.910 be amended by establishing an 
exemption from the requirement of a tolerance for residues of TIPA (CAS 
No. 122-20-3) when used as an inert ingredient for use as a neutralizer 
in pesticide formulations applied to growing crops and raw agricultural 
commodities pre- and post-harvest. That notice referenced a summary of 
the petition prepared by Dow AgroSciences, LLC, the petitioner, which 
is available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.

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 section 408(c)(2)(B) 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 TIPA including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with TIPA 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 TIPA as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in this unit.
    TIPA has low acute toxicity via the oral and dermal routes. It is 
moderately irritating to the skin and severely irritating to the eye. 
It is not a skin sensitizer.
    A subchronic study was available in the dog. Following subchronic 
exposure to TIPA to dogs via the diet, no treatment related effects 
were noted up to the highest dose tested (288 milligrams/kilograms/day 
(mg/kg/day)).
    A developmental study was available for review (rat) on the 
surrogate chemical, diisopropanolamine (DIPA). In this study maternal 
and offspring toxicity were not observed at the highest dose tested 
(1,000 mg/kg/day).
    In a 1-generation reproduction toxicity study in rats with TIPA, no 
adverse clinical, histological, or reproductive effects were observed 
at the highest dose tested (M/F: 609/700 mg/kg/day).
    Three mutagenicity studies (Ames test, mammalian gene mutation, and 
chromosome aberration) with TIPA were available for review. The results 
for these studies were negative.

[[Page 43078]]

    TIPA is not expected to be carcinogenic since there were no 
triggers for carcinogenicity in the published study and a lack of 
systemic toxicity in the 1-generation reproduction study in rats as 
well as a negative response for mutagenicity. Also, TIPA is not listed 
as a carcinogen by ACGIH, IARC, NTP, or CA Prop 65.
    Metabolism studies demonstrated that TIPA was rapidly and 
extensively absorbed with a minimum of 83% oral absorption. Virtually 
the entire absorbed dose was rapidly excreted primarily as unchanged 
TIPA in the urine of treated rats.

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 TIPA used for human 
risk assessment is shown in the Table below. The 90-day toxicity study 
in the dog was selected for all exposure scenarios and durations for 
this risk assessment. The rationale for selecting this study is as 
follows. There was no toxicity observed at the highest dose (272 mg/kg/
day) tested in the 90-day dog study. Toxicity was not observed in the 
1-generation reproduction toxicity study in the rat at 609 mg/kg/day, 
the highest dose tested. In a 14-day toxicity study via drinking water, 
the NOAEL was 1,200 mg/kg/day. Although, the 30-day toxicity study via 
drinking water in the rat has a NOAEL of 140 mg/kg/day, there is no 
detail provided for microscopic findings in various organs. In 
addition, these findings were not reproduced in the 1-generation 
reproduction toxicity study in the rat. Therefore, less confidence was 
placed on the 30-day toxicity study in the rat. Finally, based on an 
EPA retrospective analysis, it was concluded that the 90-day toxicity 
and the 1-year toxicity studies in the dog are comparable. Therefore, 
based on the overall weight of evidence, the toxicity study in the dog 
provided a good basis for establishing the chronic reference dose 
(cRfD).

          Table--Summary of Toxicological Doses and Endpoints for TIPA for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                                    An acute endpoint was not identified in the database.
(Females 13-50 years of age).........
----------------------------------------------------------------------------------------------------------------
Acute dietary                                    An acute endpoint was not identified in the database.
(General population including infants
 and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL = 272 mg/kg/day    Chronic RfD = 2.72 mg/   90-Day Oral Toxicity-
(All populations)....................   UFA = 10x                kg/day                   Dog
                                       UFH = 10x..............  cPAD = 2.72 mg/kg/day..  LOAEL = was not
                                       FQPA SF = 1x...........                            established.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term             NOAEL = 272 mg/kg/day    LOC for MOE = 100        90-Day Oral Toxicity-
(1 to 30 days).......................   UFA = 10x                                         Dog
                                       UFH = 10x..............                           LOAEL = was not
                                       FQPA SF = 1x...........                            established.
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term      NOAEL = 272 mg/kg/day    LOC for MOE = 100        90 Day Oral Toxicity-
(1 to 6 months)......................   UFA = 10x                                         Dog
                                       UFH = 10x..............                           LOAEL = was not
                                       FQPA SF = 1x...........                            established.
----------------------------------------------------------------------------------------------------------------
Dermal short-term                      Dermal (or oral) study   LOC for MOE = 100        90-Day Oral Toxicity-
(1 to 30 days).......................  NOAEL = 272 mg/kg/day..                            Dog
                                       (dermal absorption rate                           LOAEL = was not
                                        = 100%.                                           established.
                                       UFA = 10x..............
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term               Dermal (or oral) study   LOC for MOE = 100        90-Day Oral Toxicity-
(1 to 6 months)......................  NOAEL = 272 mg/kg/day..                            Dog
                                       (dermal absorption rate                           LOAEL = was not
                                        = 100% when                                       established.
                                        appropriate).
                                       UFA = 10x..............
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------

[[Page 43079]]

 
Inhalation short-term                  Inhalation (or oral)     LOC for MOE = 100        90-Day Oral Toxicity-
(1 to 30 days).......................   study                                             Dog
                                        NOAEL = 272 mg/kg/day.                           LOAEL = was not
                                       (inhalation absorption                             established.
                                        rate = 100%).
                                       UFA = 10x..............
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Inhalation                             Inhalation (or oral)     LOC for MOE = 100        90-Day Oral Toxicity-
(1 to 6 months)......................   study                                             Dog
                                       NOAEL = 272 mg/kg/day                             LOAEL = was not
                                        (inhalation absorption                            established.
                                        rate = 100%.
                                       UFA = 10x..............
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Cancer                                   Not likely to be carcinogenic based on no evidence of increased liver
(Oral, dermal, inhalation)...........                foci in rats and negative genotoxicity studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to TIPA, EPA considered exposure under the proposed exemption 
from the requirement of a tolerance. EPA assessed dietary exposures 
from TIPA in food as follows:
    i. Acute exposure. No adverse effects attributable to a single 
exposure of TIPA were seen in the toxicity databases. Therefore, an 
acute dietary risk assessment for TIPA is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) [1994-1996 and 1998] Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, no residue data were submitted for TIPA. In the absence 
of specific residue data, EPA has developed an approach which uses 
surrogate information to derive upper bound exposure estimates for the 
subject inert ingredient. Upper bound exposure estimates are based on 
the highest tolerance for a given commodity from a list of high use 
insecticides, herbicides, and fungicides. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data is contained in the memorandum entitled ``Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,'' 
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation (if any) between the 
active and inert ingredient and that the concentration of inert 
ingredient in the scenarios leading to these highest levels of 
tolerances would be no higher than the concentration of the active 
ingredient.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentrations of active ingredient in agricultural products are 
generally at least 50 percent of the product and often can be much 
higher. Further, pesticide products rarely have a single inert 
ingredient; rather, there is generally a combination of different inert 
ingredients used which additionally reduces the concentration of any 
single inert ingredient in the pesticide product in relation to that of 
the active ingredient.
    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. TIPA is not expected to be carcinogenic since there 
were no triggers for carcinogenicity in the published study and a lack 
of systemic toxicity in the 1-generation

[[Page 43080]]

reproduction study in rats as well as a negative response for 
mutagenicity. Since the Agency has not identified any concerns for 
carcinogenicity relating to TIPA, a cancer dietary exposure assessment 
was not performed.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for TIPA, a conservative 
drinking water concentration value of 100 parts per billion based on 
screening level modeling was used to assess the contribution to 
drinking water for the chronic dietary risk assessments for parent 
compound. 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).
    TIPA may be used in inert ingredients in products that are 
registered for specific uses that may result in residential exposure. A 
screening level residential exposure and risk assessment was completed 
for products containing TIPA as inert ingredients. The TIPA inerts may 
be present in consumer personal (care) products and cosmetics (at 
concentrations up to 1%). The Agency selected representative scenarios, 
based on end-use product application methods and labeled application 
rates. The Agency conducted an assessment to represent worst-case 
residential exposure by assessing TIPA in pesticide formulations 
(outdoor scenarios) and TIPA in disinfectant-type uses (indoor 
scenarios). Further details of this residential exposure and risk 
analysis can be found at http://www.regulations.gov in the memorandum 
entitled: ``JITF Inert Ingredients. Residential and Occupational 
Exposure Assessment Algorithms and Assumptions Appendix for the Human 
Health Risk Assessments to Support Proposed Exemption from the 
Requirement of a Tolerance When Used as Inert Ingredients in Pesticide 
Formulations,'' (D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-
HQ-OPP-2008-0710.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found TIPA to share a common mechanism of toxicity with 
any other substances, and TIPA does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that TIPA does not have a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. Fetal susceptibility was not 
observed in either the developmental study with DIPA or the one 
generation reproduction study with TIPA in the rat. There were no toxic 
effects observed in parents nor offspring in either study at the 
highest doses tested, 1,000 and 700 mg/kg/day, respectively. A 
developmental toxicity study in rabbits is not available in the 
database. However, the concern for the lack of this study is low 
because no systemic toxicity was observed at the limit dose in the 
developmental and reproduction studies in rats (700 mg/kg/day). Also, 
other studies in the database such as the 90-day toxicity study in the 
dog and the 14-day toxicity study via drinking water in the rat do not 
show significant systemic toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for TIPA is adequate.
    ii. There is no indication that TIPA is a neurotoxic or immunotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that DIPA or TIPA result in increased 
susceptibility in in utero rats in the prenatal developmental studies 
or in young rats in the 1-generation reproduction study, respectively.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on the assumptions of 100% crop treated and tolerance-level residues. 
EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to TIPA in drinking 
water. EPA used similarly conservative assumptions to assess 
postapplication exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by TIPA.

E. Aggregate Risks and Determination of Safety

    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, 
TIPA is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
TIPA from food and water will utilize 22.9% of the cPAD for children 1 
to 2 years old, the population group receiving the greatest exposure. 
Based on the explanation in this unit, regarding residential use 
patterns, chronic residential exposure to residues of TIPA is not 
expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water

[[Page 43081]]

(considered to be a background exposure level).
    TIPA is currently used as an inert ingredient in pesticide products 
that are 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 TIPA.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 679 for both 
adult males and females. Adult residential exposure combines high end 
dermal and inhalation handler exposure from indoor hand wiping with a 
high end post application dermal exposure from contact with treated 
lawns. EPA has concluded the combined short-term aggregated food, 
water, and residential exposures result in an aggregate MOE of 337 for 
children. Children's residential exposure includes total exposures 
associated with contact with treated lawns (dermal and hand-to-mouth 
exposures). Because EPA's level of concern for TIPA is a MOE of 100 or 
below, 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).
    TIPA is currently used as an inert ingredient in pesticide products 
that are 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 TIPA.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 1,114 for adult males and females. Adult residential 
exposure includes high end post application dermal exposure from 
contact with treated lawns. EPA has concluded the combined 
intermediate-term aggregated food, water, and residential exposures 
result in an aggregate MOE of 387 for children. Children's residential 
exposure includes total exposures associated with contact with treated 
lawns (dermal and hand-to-mouth exposures). Because EPA's level of 
concern for TIPA is a MOE of 100 or below, these MOEs are not of 
concern.
    5. Aggregate cancer risk for U.S. population. TIPA is not expected 
to be carcinogenic since there were no triggers for carcinogenicity in 
the published study and a lack of systemic toxicity in the 1-generation 
reproduction study in rats as well as a negative response for 
mutagenicity.
    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 TIPA residues.

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 2-
Propanol, 1,1',1''-nitrilotris- nor have any CODEX Maximum Residue 
Levels (MRLs) been established for any food crops at this time.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for TIPA (CAS No. 122-20-3) when used 
as an inert ingredient (used as a neutralizer) in pesticide 
formulations applied to growing crops and raw agricultural commodities 
pre- and post-harvest without limitation.

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) (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

[[Page 43082]]

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 7, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In the table in Sec.  180.910, add alphabetically an entry for 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
------------------------------------------------------------------------
                              * * * * * * *
2-Propanol, 1,1',1''-nitrilotris- without limitation  neutralizer
  (CAS No. 122-20-3)
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-18097 Filed 7-22-10; 8:45 am]
BILLING CODE 6560-50-S