[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
[Pages 37578-37584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18076]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0046; FRL-8428-9]
N-alkyl (C8-C18) Primary Amines and Acetate
Salts; 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 N-alkyl (C8-C18)
primary amines and acetate salts where the alkyl group is linear and
may be saturated and/or unsaturated, herein referred to in this
document as NAPAAS, when used as inert ingredients for pre-harvest uses
under 40 CFR 180.920 at a maximum concentration in formulated end-use
products of 10% by weight in herbicide products, 4% by weight in
insecticide products, and 4% by weight in fungicide products. The Joint
Inerts Task Force (JITF), Cluster Support Team Number 25 (CST 25),
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 NAPAAS.
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-2009-0046. 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].
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
[[Page 37579]]
(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 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-2009-0046 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-2009-0046, 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 March 4, 2009 (74 FR 9397) (FRL-8401-8),
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 9E7519)
by The Joint Inerts Task Force (JITF), Cluster Support Team 25 (CST
25), c/o CropLife America, 1156 15th Street, N.W., 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 ingredients N-alkyl (C8-
C18) primary amines and acetate salts where the alkyl group
is linear and may be saturated and/or unsaturated (NAPAAS).
Concentration in formulated end-use products not to exceed 8% by weight
in herbicide products, 5% by weight in insecticide products, and 30% by
weight in fungicide products. That notice referenced a summary of the
petition prepared by JITF, CST 25, 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 by changing the use limitations in
pesticide products as follows: A maximum concentration in formulated
end-use products of 10% by weight in herbicide products, 4% by weight
in insecticide products, and 4% by weight in fungicide products. These
limitations are based on the Agency's risk assessment which can be
found at http://www.regulations.gov, in document N-alkyl
(C8-C18) Primary Amines and Acetate Salts (NAPAAS
- JITF CST 25 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-2009-0046.
This petition was submitted in response to a final rule of August
9, 2006 (71 FR 45415) (FRL-8084-1) in which the Agency revoked, under
section 408(e)(1) of the 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 45311) (FRL-8372-7) 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 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....''
[[Page 37580]]
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 NAPAAS
provided that the concentration of the NAPAAS inerts are limited in
formulated end-use product to no more than 10% by weight in herbicide
products, 4% by weight in insecticide products, and 4% by weight in
fungicide products. 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 mammalian toxicology database for NAPAAS consists of
one OPPTS Harmonized Guideline 870.3650 (combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
test in rats); acute oral, dermal, and eye toxicity data; and in vitro
mutagenicity data.
NAPAAS are not acutely toxic by the oral route of exposure but are
corrosive to the skin and are severe eye irritants. There is no clear
target organ identified for NAPAAS inert compounds. In the OPPTS
Harmonized Guideline 870.3650 study on the representative surfactant,
treatment-related microscopic lesions were observed in both sexes,
which included histomorphologic changes in the stomach (hyperplasia and
hyperkeratosis of the squamous mucosa of the forestomach), and
erosions, ulcers, inflammatory cell infiltrations, and/or edema in the
submucosa of the forestomach and glandular areas of the mucosa. The
accumulation of macrophages was most prevalent in the mesenteric lymph
nodes and small intestine where they were large with an abundant amount
of pale foamy cytoplasm. In the mesenteric lymph node and liver,
coalescence of the large macrophages occurred forming microgranulomas.
Thymic atrophy was observed in both sexes. Histologically, the thymus
was smaller due to a decrease in the amount of cortical lymphocytes,
which may be an indirect or secondary phenomenon, as thymic atrophy
often occurs in animals under stress. No evidence of potential
neurotoxicity was observed in the females, and the reduced motor
activity observed in the high-dose males was considered to be secondary
to the gastrointestinal irritation and general malaise and not a
neurotoxic effect.
There was no evidence of increased susceptibility to the offspring
following prenatal and postnatal (four days) exposure and reproductive
toxicity was not observed. There is no evidence of mutagenicity or
carcinogenicity.
Primary amines and primary amine acetates are biologically
equivalent and follow the same metabolic pathways of oxidation by
monoamine oxidases to generate the C8-C18 fatty
acid and ammonia. The fatty acid would be degraded by well-known
pathways ([beta]-oxidation) to successive releases of acetic acid,
which enters into intermediary metabolism or is metabolized ultimately
to carbon dioxide and water. The CST 25 NAPAAS primary amines and
primary amine acetate salt may also be conjugated, whether by
glucuronidation or sulfonation, and excreted directly.
There are no chronic toxicity studies available for this series of
surfactants. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK 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 NAPAAS, 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 N-alkyl (C8-C18)
Primary Amines and Acetate Salts (NAPAAS - JITF CST 25 Inert
Ingredients). Human Health Risk Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations at pp. 8-12 and pp. 19-22 in
docket ID number EPA-HQ-OPP-2009-0046.
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 NAPAAS used for
human health risk assessment is shown in Table 1. below:
[[Page 37581]]
Table 1.--Summary of Toxicological Doses and Endpoints for the NAPAAS for Use in Human Health Risk Assessment
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors\1\ assessment effects
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Acute dietary (all populations) No appropriate endpoint was identified for acute dietary assessment
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Chronic dietary (all populations) NOAEL= 5 mg/kg/day Chronic RfD = 0.05 mg/ OPPTS harmonized
UFA = 10x.............. kg/day guideline 870.3650
UFH = 10x.............. cPAD = 0.05 mg/kg/day.. reproduction/
FQPA SF = 1x........... developmental screen
in rats
LOAEL = 20 mg/kg/day,
based on microscopic
lesions in the
stomach, jejunum,
thymus, and lymph
nodes in both sexes
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Incidental oral short- (1-30 days) Oral NOAEL= 5 mg/kg/day Residential LOC for MOE OPPTS harmonized
and intermediate term (1-6 months) UFA = 10x.............. = 100 guideline 870.3650
UFH = 10x.............. reproduction/
FQPA SF = 1x 5% dermal developmental screen
and 100% inhalation in rats
absorption assumed. LOAEL = 20 mg/kg/day,
based on microscopic
lesions in the
stomach, jejunum,
thymus, and lymph
nodes in both sexes
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment.
Based on SAR analysis, the NAPAAS are not expected to be carcinogenic
----------------------------------------------------------------------------------------------------------------
\1\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 NAPAAS, EPA considered exposure under the petitioned-
for exemption from the requirement of a tolerance. EPA assessed dietary
exposures from NAPAAS in food as follows:
i. Acute exposure. No adverse effects attributable to a single
exposure of the NAPAAS inerts were seen in the toxicity databases;
therefore, an acute exposure assessment for the NAPAAS 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 the NAPAAS. In the
absence of specific residue data, EPA has developed an approach which
uses surrogate information to derive upper bound exposure estimates for
the subject inert ingredient. Upper bound exposure estimates are based
on the highest tolerance for a given commodity from a list of high-use
insecticides, herbicides, and fungicides. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled ``Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.''
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products is
generally at least 50% 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 NAPAAS, EPA made a specific adjustment to
the dietary exposure assessment to account for the use limitations of
the amount of NAPAAS that may be in formulations (4% by weight in
fungicide products) and assumed that the NAPAAS are present at the
maximum limitation rather than at equal quantities with the active
ingredient. The Agency does not expect that allowing a maximum of 10%
in the final formulation for herbicides only will have a significant
impact on the dietary exposure. Across the board it appears that
selecting the highest fungicide tolerance and correcting for its
limitation to 4% by weight as a maximum in the final formulation,
results in a higher residue input into the dietary risk assessment than
selecting the highest herbicide tolerance and correcting for 10% by
weight as a maximum in the final formulation. This remains a very
conservative assumption because surfactants are generally used at
levels far below this percentage. For example, EPA examined several of
the pesticide products associated with the tolerance/commodity
combination which are the driver of the risk assessment and found that
these products did not contain surfactants at levels greater than 2.25%
and that none of the surfactants were NAPAAS.
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
[[Page 37582]]
high number of inert ingredients, that a single inert ingredient or
class of ingredients would be present at the level of the active
ingredient in the highest tolerance for every commodity. Finally, a
third compounding conservatism is EPA's assumption that all foods
contain the inert ingredient at the highest tolerance level. In other
words, EPA assumed 100% of all foods are treated with the inert
ingredient at the rate and manner necessary to produce the highest
residue legally possible for an active ingredient. In summary, EPA
chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
iii. Cancer. The Agency used a qualitative SAR database, DEREK11,
to determine if there were structural alerts suggestive of
carcinogenicity. No structural alerts for carcinogenicity were
identified. The Agency has not identified any concerns for
carcinogenicity relating to the inerts NAPAAS. 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 NAPAAS. Tolerance level residues and/or 100%
crop treated 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 NAPAAS in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of NAPAAS. 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 NAPAAS. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of the NAPAAS were conducted. Modeled acute drinking water values
ranged from 0.001 parts per billion (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 N-alkyl (C8-
C18) Primary Amines and Acetate Salts (NAPAAS - JITF CST 25
Inert Ingredients). Human Health Risk Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations at pp. 13 and 25-27 in docket ID
number EPA-HQ-OPP-2009-0046.
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 NAPAAS, 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).
The Agency has reviewed the submitted petition as well as all
available data on the use of these inert ingredients in pesticide
formulations, and concludes that the NAPAAS inerts are not used in
formulations that would be applied in and around the home or in a way
that would result in residential exposures; therefore, a residential
exposure risk assessment is not necessary for the NAPAAS inerts.
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 NAPAAS to share a common mechanism of toxicity
with any other substances, and NAPAAS do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that NAPAAS 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. In the case of the NAPAAS,
there was no increased susceptibility to the offspring of rats
following prenatal and post-natal exposure in the OPPTS Harmonized
Guideline 870.3650 reproductive/developmental screening study.
Decreased pup body weight was observed at 40 and 80 mg/kg/day where
maternal/paternal toxicity was manifested as microscopic lesions in the
stomach, jejunum, thymus, and lymph nodes at 20, 40, and 80 mg/kg/day.
Since the rat reproduction/developmental study identified a clear NOAEL
of 20 mg/kg/day for offspring effects, and the selected point of
departure of 5 mg/kg/day (parental NOAEL for stomach/jejunum/thymus/
lymph node lesions) for the dietary risk assessment is protective of
the offspring effects, there are no residual concerns.
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 the NAPAAS inerts is considered
adequate for assessing the risks to infants and children. The toxicity
data available on
[[Page 37583]]
the NAPAAS consists of one OPPTS Harmonized Guideline 870.3650 combined
repeated dose toxicity study with the reproduction/development toxicity
screening test (rat); acute oral, dermal, and eye toxicity data; and in
vitro mutagenicity data. The Agency noted changes in thymus weight and
thymus atrophy. However, these were determined to be non-specific
changes not indicative of immunotoxicity. In addition, no blood
parameters were affected. Furthermore, these compounds do not belong to
a class of chemicals that would be expected to be immunotoxic.
Therefore, these identified effects do not raise a concern
necessitating an additional uncertainty.
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 prenatal and
postnatal exposure.
iii. Although the available mammalian toxicity database does not
include any chronic toxicity data, the effects observed in the parental
animals following gavage dosing are mainly portal-of-entry effects
(stomach irritation), and gavage dosing is not a relevant exposure
condition in humans. The effects observed would not be expected to
occur at a lower dose with increased duration of exposure under
relevant exposure conditions. Also, based on the very conservative
exposure assessment, the 10X interspecies and 10X intraspecies
uncertainty factor would be adequately protective, and no additional
uncertainty factor is needed for extrapolating from subchronic to
chronic exposure.
iv. No neurotoxicity was demonstrated in the OPPTS Harmonized
Guideline 870.3650 study. 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%
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 NAPAAS in drinking water. These assessments will
not underestimate the exposure and risks posed by NAPASS.
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. No residential
aggregate exposure assessment was conducted because no residential uses
for NAPAAS are anticipated. Therefore, the aggregate risk for these
inerts includes exposures through food and drinking water only.
1. Acute risk. There was no hazard attributable to a single
exposure seen in the toxicity database for NAPAAS. Therefore, the
NAPAAS 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 to no more than 4% in
fungicide and insecticide formulations and 10% in herbicide
formulations, the chronic dietary exposure from food and water to
NAPAAS is 36% of the cPAD for the U.S. population and 106% of the cPAD
for children 1-2 yrs old, the most highly exposed population subgroup.
While the Agency notes that the risk for children is slightly above a
cPAD of 100%, given the exceptionally conservative nature of the
exposure assessment detailed above, the Agency believes that actual
risks are significantly lower and are not of concern.
3. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to NAPAAS.
4. 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 NAPAAS.
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
NAPAAS 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 N-alkyl (C8-C18)
primary amines and acetate salts where the alkyl group is linear and
may be saturated and/or unsaturated when used as inert ingredients for
pre-harvest uses under 40 CFR 180.920 at a maximum concentration in
formulated end-use products of 10% by weight in herbicide products, 4%
by weight in insecticide products, and 4% by weight in fungicide
products.
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,
[[Page 37584]]
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 part 180 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 ingredient to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
N-alkyl (C8-C18) primary amines Concentration in Surfactants,
and their acetate salts where formulated end- related adjuvants
the alkyl group is linear and use products not of surfactants
may be saturated and/or to exceed 10% by
unsaturated (CAS Reg. Nos. weight in
61790-57-6, 61790-58-7, 61790- herbicide
59-8, 61790-60-1, 61788-46-3, products, 4% by
61790-33-8, 68155-38-4). weight in
insecticide
products, and 4%
by weight in
fungicide
products..
* * * * *
------------------------------------------------------------------------
[FR Doc. E9-18076 Filed 7-28-09; 8:45 am]
BILLING CODE 6560-50-S