[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
[Pages 37584-37591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18064]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0098; FRL-8425-5]
Sodium Salts of N-alkyl (C8-C18)-beta-
iminodipropionic acid; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of sodium salts of N-alkyl (C8-
C18)-beta-iminodipropionic acid where the C8-
C18 is linear and may be saturated and/or unsaturated,
herein referred to in this document as SSNAs when used as an inert
ingredient for pre-harvest uses under 40 CFR 180.920 at a maximum of
30% by weight in pesticide formulations. The Joint Inerts Task Force
(JITF), Cluster Support Team Number 14, submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of SSNAs.
DATES: This regulation is effective July 29, 2009. Objections and
requests for hearings must be received on or before September 28, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0098. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8811; e-mail address: [email protected].
[[Page 37585]]
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the Federal
Register listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's e-CFR cite at
http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0098 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before September 28, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0098, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background
In the Federal Register of April 15, 2009 (74 FR 17487) (FRL-8409-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E7525) by The Joint Inerts Task Force, Cluster Support Team 14 (CST
14), c/o CropLife America, 1156 15th St., NW., Suite 400, Washington,
DC, 20005. The petition requested that 40 CFR 180.920 be amended by
establishing exemptions from the requirement of a tolerance for
residues of the inert ingredient Sodium salts of N-alkyl
(C8-C18)-beta-iminodipropionic acid where the
C8-C18 is linear and may be saturated and/or
unsaturated. That notice referenced a summary of the petition prepared
by The Joint Inerts Task Force (JITF), Cluster Support Team Number 14
(CST 14), the petitioner, which is available to the public in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the exemption requested to by limiting SSNAs to a maximum of
30% by weight in pesticide formulations. This limitation is based on
the Agency's risk assessment which can be found at http://www.regulations.gov in document ``Sodium Salts of N-Alkyl
(C8-C18)-[beta]-iminodipropionic Acid (SSNAs -
JITF CST 14 Inert Ingredients). Human Health Risk Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide Formulations'' in docket ID number EPA-
HQ-OPP-2009-0098.
This petition was submitted in response to a final rule of August
9, 2006, (71 FR 45415) in which the Agency revoked, under section
408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA), the
existing exemptions from the requirement of a tolerance for residues of
certain inert ingredients because of insufficient data to make the
determination of safety required by FFDCA section 408(b)(2). The
expiration date for the tolerance exemptions subject to revocation was
August 9, 2008, which was later extended to August 9, 2009 (73 FR
45312) to allow for data to be submitted to support the establishment
of tolerance exemptions for these inert ingredients prior to the
effective date of the tolerance exemption revocation.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA
[[Page 37586]]
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) of FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
exemption from the requirement of a tolerance for residues of sodium
salts of N-alkyl (C8-C18)-beta-iminodipropionic
acid where the C8-C18 is linear and may be
saturated and/or unsaturated provided that the concentration of the
SSNA inerts is limited to no more than 30% by weight in pesticide
formulations. EPA's assessment of exposures and risks associated with
establishing tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
The available toxicity data indicate that the SSNAs have low acute
oral and dermal toxicity, are potentially corrosive to the skin, and
are also mild to moderate eye irritants. In the OPPTS Harmonized
Guideline 870.3650 study with sodium coco [beta]-iminodipropionate in
rats, decreased food consumption and body weight gain in males and
females at 160 and 600 miligrams/kilograms body weight day (mg/kg bw/
day) were observed. Mean liver and kidney weights were increased at the
high dose, while testis and epididymides were unaffected. Hypertrophy
was found in the livers of males and/or females at the mid- and high-
doses as well as renal histopathology in males, acanthosis of the non-
glandular stomach in males and females, and inflammation of the
glandular and non-glandular stomach in females. In the absence of any
evidence of hepatic toxicity, liver hypertrophy was considered an
adaptive effect and non-adverse.
No reproduction or developmental effects were noted in the database
and there was no evidence of neurotoxicity.
In general, surfactants are surface-active materials that can
damage the structural integrity of cellular membranes at high dose
levels. Thus, surfactants are often corrosive and irritating in
concentrated solutions. It is possible that some of the observed
toxicity seen in the repeated studies, such as inflammation of the
glandular stomach, can be attributed to the corrosive and irritating
nature of these surfactants.
There are no published metabolism studies for this series of
surfactants. The SSNA mammalian metabolism pathway is based on analogy
to well-described pathways for tertiary amines and fatty acids. Overall
it is anticipated that the various metabolites are not systemically
toxic and would be rapidly conjugated and excreted.
The SSNA surfactants (mono and di-sodium propionates) may be
conjugated and excreted directly. Alternatively, the tertiary amine
dipropionate may be oxidized in the liver by monoamine oxidases to
generate the intact tertiary amine dipropionate N-oxide which may
either be conjugated and excreted or metabolically cleaved to a
dipropionate oxime type metabolite that is conjugated and excreted. The
linear fatty acid is metabolized via successive beta-oxidation cycles
to release acetic acid and eventually carbon dioxide and water.
There are no chronic toxicity studies available for this series of
nonionic surfactants. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK Version 11, to determine if there
were structural alerts suggestive of carcinogenicity. No structural
alerts were identified.
Specific information on the studies received and the nature of the
adverse effects caused by the SSNAs, as well as, the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Sodium Salts of N-Alkyl
(C8-C18)-[beta]-iminodipropionic Acid (SSNAs -
JITF CST 14 Inert Ingredients). Human Health Risk Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide Formulations'' pages 8-13 and 46-49 in
docket ID number EPA-HQ-OPP-2009-0098.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for the SSNAs used for
[[Page 37587]]
human health risk assessment is shown in the Table 1 below:
Table 1.--Summary of Toxicological Doses and Endpoints for the SSNAs for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary An effect attributable to a single exposure was not identified.
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL= 43 mg/kg/day Chronic RfD =0.43 mg/kg/ Combined Repeated Dose
UFA = 10x.............. day Toxicity Study with
UFH = 10x.............. cPAD = 0.43 mg/kg/day.. the Reproduction
FQPASF = 1x............ Developmental Toxicity
Screening Test-Rat
OPPTS Harmonized
Guideline 870.3650
(CAS Reg. No. 3655-00-
3)
Parental LOAEL= 160 mg/
kg/day based on
decreased body weight
gain in males and
females during the pre-
mating period, and an
increased incidence of
microscopic lesions in
the kidneys of males
and acanthosis of the
glandular and non-
glandular stomachs of
females.
Reproductive/
Developmental LOAEL
was not observed.
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Dermal and NOAEL= 43 mg/kg/day Residential LOC for MOE Combined Repeated Dose
Inhalation (Short- and Intermediate- UFA = 10x.............. = 100 Toxicity Study with
, and Long- Term) UFH = 10x.............. the Reproduction/
FQPA SF =1x............ Developmental Toxicity
5 PCT dermal and 100 screening Test- Rat
PCT inhalation OPPTS Harmonized
absorption assumed. Guideline 870.3650
(Cas Reg. No. 3655-00-
3).
Parental LOAEL = 160 mg/
kg/day based on
decreased body weight
gain in males and
females during the pre-
mating period and an
increased incidence of
microscopic lesions in
the kidneys of males
and acanthosis of the
glandular and non-
glandular stomachs of
females.
Reproductive/
Developmental LOAEL
was not observed.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment.
Based on SAR analysis, the SSNAs are not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose
(a=acute, c=chronic). FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC =
level of concern. N/A = not applicable.
C. Exposure Assessment.
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to the SSNAs, EPA considered exposure under the petitioned-for
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from SSNAs in food as follows:
i. Acute exposure. No adverse effects attributable to a single
exposure of the SSNAs was seen in the toxicity databases; therefore, an
acute exposure assessment for the SSNAs is not necessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the United
States Department of Agriculture (USDA) (1994-1996 and 1998) Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, no residue data were submitted for SSNAs. In the
absence of specific residue data, EPA has developed an approach which
uses surrogate information to derive upper bound exposure estimates for
the subject inert ingredient. Upper bound exposure estimates are based
on the highest tolerance for a given commodity from a list of high-use
insecticides, herbicides, and fungicides. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled ``Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and
[[Page 37588]]
Risk Assessments for the Inerts.'' (D361707, S. Piper, 2/25/09) and can
be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2008-0738.
In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products is
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient. In the case of the SSNAs, EPA made a specific
adjustment to the dietary exposure assessment to account for the use
limitations of the amount of SSNAs that may be in formulations (no more
than 30% by weight in pesticide formulations) and assumed that the
SSNAs are present at the maximum limitation rather than at equal
quantities with the active ingredient. This remains a very conservative
assumption because surfactants are generally used at levels far below
this percentage.
Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100% of all foods are treated with the inert
ingredient at the rate and manner necessary to produce the highest
residue legally possible for an active ingredient. In summary, EPA
chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
iii. Cancer. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts suggestive of carcinogenicity. No structural alerts
for carcinogenicity were identified. SSNAs are not expected to be
carcinogenic. Therefore a cancer dietary exposure assessment is not
necessary to assess cancer risk.
iv. Anticipated residue and percent crop treated (PCT)
information. EPA did not use anticipated residue and/or PCT information
in the dietary assessment for SSNAs. Tolerance level residues and/or
100% were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for SSNAs in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of SSNAs. Further information regarding EPA drinking
water models used in the pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
A screening level drinking water analysis, based on the Pesticide
Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) was
performed to calculate the estimated drinking water concentrations
(EDWCs) of SSNAs. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of the SSNAs were conducted. Modeled acute drinking water values ranged
from 0.001 ppb to 41 ppb. Modeled chronic drinking water values ranged
from 0.0002 ppb to 19 ppb. Further details of this drinking water
analysis can be found at http://www.regulations.gov in the document
``Sodium Salts of N-Alkyl (C8-C18)-[beta]-
iminodipropionic Acid (SSNAs - JITF CST 14 Inert Ingredients). Human
Health Risk Assessment to Support Proposed Exemption from the
Requirement of a Tolerance When Used as Inert Ingredients in Pesticide
Formulations'' pages 13-14 and 51-53 in docket ID number EPA-HQ-OPP-
2009-0098.
For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for the SSNAs, a conservative drinking water concentration
value of 100 ppb based on screening level modeling was used to assess
the contribution to drinking water for the chronic dietary risk
assessments for parent compounds and for the metabolites of concern.
These values were directly entered into the dietary exposure model.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). SSNAs may be used as
inert ingredients in pesticide products that are registered for
specific uses that may result in both indoor and outdoor residential
exposures.
A screening level residential exposure and risk assessment was
completed for products containing the SSNAs as inert ingredients. In
this assessment, representative scenarios, based on end-use product
application methods and labeled application rates, were selected. For
each of the use scenarios, the Agency assessed residential handler
(applicator) inhalation and dermal exposure for indoor and outdoor
scenarios with high exposure potential (i.e., exposure scenarios with
high end unit exposure values) to serve as a screening assessment for
all potential residential pesticides containing SSNAs. Similarly,
residential post application dermal and oral exposure assessments were
also performed utilizing high end indoor and outdoor exposure
scenarios. Further details of this residential exposure and risk
analysis can be found at http://www.regulations.gov in the memorandum
entitled ``JITF Inert Ingredients. Residential and Occupational
Exposure Assessment
[[Page 37589]]
Algorithms and Assumptions Appendix for the Human Health Risk
Assessments to Support Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations''
(D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-HQ-OPP-2008-0710.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found SSNAs to share a common mechanism of toxicity
with any other substances, and SSNAs do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that SSNAs do not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The toxicology database is
adequate to assess risk for the SSNAs when used as inert ingredients in
pesticide formulations. The toxicity data available on the SSNAs
consists of one OPPTS Harmonized Guideline 870.3650 combined repeated
dose toxicity study with the reproduction/development toxicity
screening test (rat) for the representative surfactant, sodium coco
beta-iminodipropionate (CAS Reg. No. 3655-00-3). There was no evidence
of increased sensitivity in young animals because no developmental or
reproductive toxicity was observed in the OPPTS Harmonized Guideline
870.3650. No treatment related effects were observed on litter sizes or
on the early development of pups.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for SSNAs is considered adequate for
assessing the risks to infants and children (the available studies are
described in Unit 4.D.2.
ii. No quantitative or qualitative increased susceptibility was
demonstrated in the offspring in the OPPTS Harmonized Guideline
870.3650 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats following in utero and
post-natal exposure.
iii. While there is no chronic toxicity data, the Agency has
concluded that an additional uncertainty factor is not needed for the
use of a subchronic study for a chronic exposure assessment based on
the minor nature of effects which were seen only at the mid- and high-
doses as well as the highly conservative nature of the exposure
assessment. The conservative point of departure selected along with the
standard uncertainty factor of 100X to account for inter- and intra-
species variability is considered health protective.
iv. There are no neurotoxicity studies available for this series
of nonionic surfactants. However a Functional Observation Battery (FOB)
to evaluate neurotoxicity was performed in the Combined Repeated Dose/
Developmental Screening study and only a minor decrease in temperature
was observed in males at the mid and high doses. The effect was likely
due to normal biological variation and; therefore, was not considered
treatment-related. Thus, there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
v. There are no residual uncertainties identified in the exposure
databases. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children. The food exposure assessments are considered
to be highly conservative as they are based on the use of the highest
tolerance level from the surrogate pesticides for every food and 100
PCT is assumed for all crops. EPA also made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to SSNAs in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by SSNAs.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk.There was no hazard attributable to a single exposure
seen in the toxicity database for SSNAs. Therefore, the SSNAs are not
expected to pose an acute risk.
2. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
drinking water using the exposure assumptions discussed in this unit
for chronic exposure and the use limitations of not more than 30% by
weight in pesticide formulations, the chronic dietary exposure from
food and water to SSNAs is 27% of the cPAD for the U.S. population and
87% of the cPAD for children 1-2 yrs old, the most highly exposed
population subgroup.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
SSNAs are used as inert ingredients in pesticide products that are
currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to SSNAs. Using the exposure
assumptions described in this unit, EPA has concluded that the combined
short-term aggregated food, water, and residential exposures result in
aggregate MOEs of 160 for both adult males and females
[[Page 37590]]
respectively. EPA has concluded the combined short-term aggregated
food, water, and residential exposures result in an aggregate MOE of
100 for children. As the level of concern is for MOEs that are lower
than 100, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
SSNAs are currently registered for uses that could result in
intermediate -term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to SSNAs. Using the
exposure assumptions described in this unit, EPA has concluded that the
combined intermediate-term aggregated food, water, and residential
exposures result in aggregate MOEs of 430 and 450, for adult males and
females, respectively. EPA has concluded the combined intermediate-term
aggregated food, water, and residential exposures result in an
aggregate MOE of 110 for children. As the level of concern is for MOEs
that are lower than 100, this MOE is not of concern.
5. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to SSNAs.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to residues of SSNAs.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Residue Limits
The Agency is not aware of any country requiring a tolerance for
SSNAs nor have any CODEX Maximum Residue Levels been established for
any food crops at this time.
VI. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of sodium salts of N-alkyl (C8-
C18)-beta-iminodipropionic acid where the C8-
C18 is linear and may be saturated and/or unsaturated when
used as an inert ingredient for pre-harvest uses under 40 CFR 180.920
at a maximum of 30% by weight in pesticide formulations.
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 21, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.920, the table is amended by adding alphabetically the
following inert ingredients to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
[[Page 37591]]
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Inert Ingredients Limits Uses
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* * * * * * *
sodium salts of N-alkyl (C8-C18)-beta- Concentration in formulated end- Surfactants, related adjuvants of
iminodipropionic acid where the C8-C18 use products not to exceed 30% by surfactants
is linear and may be saturated and/or weight in pesticide formulations
unsaturated (CAS Reg. Nos. 3655-00-3,
61791-56-8, 14960-06-6, 26256-79-1,
90170-43-7, 91696-17-2, 97862-48-1)
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[FR Doc. E9-18064 Filed 7-28-09; 8:45 am]
BILLING CODE 6560-50-S