[Federal Register Volume 74, Number 115 (Wednesday, June 17, 2009)]
[Rules and Regulations]
[Pages 28616-28624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14113]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0738; FRL-8418-6]
Alkyl Amine Polyalkoxylates; 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 alkyl amine polyalkoxylates when used as
inert ingredients in pesticide formulations applied to growing crops
and animals. The Joint Inerts Task Force (JITF), Cluster Support Team
Number 4 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 alkyl amine polyalkoxylates.
DATES: This regulation is effective June 17, 2009. Objections and
requests for hearings must be received on or before August 17, 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-2008-0738. 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).
[[Page 28617]]
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.
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-2008-0738 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 August 17, 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-2008-0738, 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 December 3, 2008 (73 FR 73644) (FRL-
8386-9), 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
8E7382) by The Joint Inerts Task Force (JITF), Cluster Support Team
Number 4 (CST 4), c/o CropLife America, 1156 15th Street, NW., Suite
400, Washington, DC 20005, The petition requested that 40 CFR 180.920
and 40 CFR 180.930 be amended by establishing exemptions from the
requirement of a tolerance for residues of the inert ingredient N,N-
Bis-[alpha]-ethyl-[omega]-hydroxypoly(oxy-1,2-ethanediyl)
C8-C18 saturated and unsaturated alkylamines; the
poly(oxy-1,2-ethanediyl) content is 2-60 moles and N,N-Bis-[alpha]-
ethyl-[omega]-hydroxypoly(oxy-1,2-ethanediyl/oxy(methyl-1,2-ethanediyl)
C8-C18 saturated and unsaturated alkylamines; the
poly(oxy-1,2-ethanediyl/oxy(methyl-1,2-ethanediyl) content is 2-60
moles (these substances are referred to throughout this document as
alkyl amine polyalkoxylates). That notice referenced a summary of the
petition prepared by JITF, CST 4, 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.
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 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 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
[[Page 28618]]
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 alkyl
amine polyalkoxylates when used as inert ingredients in pesticide
formulations applied to growing crops or food-producing animals. 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.
Alkyl amine polyalkoxylates are not acutely toxic by the oral and
dermal routes of exposure, or via inhalation under normal use
conditions. Concentrated materials are generally corrosive, eye and
skin irritants and may be dermal sensitizers. There is no evidence that
alkyl amine polyalkoxylates are neurotoxic, mutagenic, or clastogenic.
Following subchronic exposure to rats, some gastrointestinal
irritation was observed, but no specific target organ toxicity or
neurotoxicity was seen. In subchronic studies in rats and/or dogs, the
most sensitive effects noted were increased mortality, clinical signs
(salivation, wheezing, emesis, and/or soft feces), cataracts, cellular
changes in the stomach, and liver effects characterized by enzyme
induction, and pigment accumulation in Kupffer cells and bile
canaliculi. There was no increased susceptibility to the offspring of
rats following in utero exposure in two prenatal developmental toxicity
studies. However, there is evidence of increased susceptibility in a
reproductive screening study in rats.
Specific information on the studies received and the nature of the
adverse effects caused by alkyl amine polyalkoxylates 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 Alkyl Amine Polyalkoxylates
(JITF CST 4 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 10-17 in docket ID
number EPA-HQ-OPP-2008-0738.
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 alkyl amine
polyalkoxylates used for human risk assessment is shown in the
following Table.
Table--Summary of Toxicological Doses and Endpoints for Alkyl Amine Polyalkoxylates for Use in Human Risk
Assessment
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Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
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Acute dietary (all populations) NOAEL = 72 milligrams/ Acute RfD = 0.72 mg/kg/ 90-Day Oral Toxicity
kilograms/day (mg/kg/ day Study in Rats LOAEL =
day) aPAD = 0.72 mg/kg/day.. 216 mg/kg/day based on
UFA = 10x.............. mortality (2 deaths
UFH = 10x.............. after 2 exposures;
FQPA SF = 1x........... gestation day (GD) 2),
with a total of 6/25
deaths during GD 6-15.
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Chronic dietary (all populations) NOAEL 15 mg/kg/day Chronic RfD = 0.15 mg/ 90-Day Oral (Gavage)
UFA = 10x.............. kg/day Toxicity Study in Rats
UFH = 10x.............. cPAD = 0.15 mg/kg/day.. LOAEL = 30 mg/kg/day
FQPA SF = 1x........... based on increased
mortality (2 deaths
(days 36, 78)),
salivation, and
posterior subcapsular
cataracts in males as
well as wheezing, and
macro- and microscopic
changes in the
nonglandular stomach
of both sexes.
----------------------------------------------------------------------------------------------------------------
[[Page 28619]]
Incidental oral short-term (1 to 30 NOAEL= 15 mg/kg/day LOC for MOE = 100 90-Day Oral (Gavage)
days) and intermediate-term (1 to 6 UFA = 10x.............. Toxicity Study in Rats
months) UFH = 10x.............. LOAEL = 30 mg/kg/day
FQPA SF = 1x........... based on increased
mortality (2 deaths
(days 36, 78)),
salivation, and
posterior subcapsular
cataracts in males as
well as wheezing, and
macro- and microscopic
changes in the
nonglandular stomach
of both sexes.
----------------------------------------------------------------------------------------------------------------
Dermal and Inhalation (all durations) Oral study NOAEL = 15 LOC for MOE = 100 90-Day Oral (Gavage)
mg/kg/day (dermal Toxicity Study in Rats
absorption rate = 5% LOAEL = 30 mg/kg/day
(inhalation absorption based on increased
rate = 100%) mortality (2 deaths
UFA = 10x.............. (days 36, 78)),
UFH = 10x.............. salivation, and
FQPA SF = 1x........... posterior subcapsular
cataracts in males as
well as wheezing, and
macro- and microscopic
changes in the
nonglandular stomach
of both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment;
Based on SAR analysis, alkyl amine polyalkoxylates are not expected to
be carcinogenic.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). RfD = reference dose.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to alkyl amine polyalkoxylates, EPA considered exposure under
the petitioned-for exemptions from the requirement of a tolerance. EPA
assessed dietary exposures from alkyl amine polyalkoxylates in food as
follows:
i. Acute and chronic exposure. In conducting the acute and chronic
dietary exposure assessments, 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 alkyl amine polyalkoxylates. 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
ingredients. 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 dietary
exposure and risk assessment can be found at http://www.regulations.gov
in Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic
Aggregate (Food and Drinking Water) Dietary Exposure and Risk
Assessments for the Inerts in docket ID number EPA-HQ-OPP-2008-0738.
In the 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 relative to that of
the active ingredient. In the case of alkyl amine polyalkoxylates, EPA
made a specific adjustment to the dietary exposure assessment to
account for the use limitations of the amount of alkyl amine
polyalkoxylates that may be in formulations (no more than 25 percent in
herbicides and no more than 10 percent in fungicides and insecticides)
and assumed the alkyl amine polyalkoxylates to be present at the
maximum limitations rather than at equal quantities with the active
ingredient. This remains a very conservative assumption because
surfactants are generally used at levels far below these percentages.
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 percent and that none of the
surfactants were alkyl amine polyalkoxylates.
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 sum, 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
[[Page 28620]]
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.
ii. Cancer. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts for potential carcinogenicity of both a
representative alkyl amine polyalkoxylate, as well as a possible
metabolite/degradate of alkyl amine polyalkoxylate that had been
extensively dealkylated, with the amine group intact. No structural
alerts for carcinogenicity were identified in either case. Alkyl amine
polyalkoxylates are not expected to be carcinogenic. Therefore a cancer
dietary exposure assessment is not necessary to assess cancer risk.
iii. Anticipated residue and percent crop treated (PCT)
information. EPA did not use anticipated residue and/or PCT information
in the dietary assessment for alkyl amine polyalkoxylates. Tolerance
level residues and/or 100 percent CT were assumed for all food
commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for alkyl amine polyalkoxylates in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of alkyl amine polyalkoxylates. Further
information regarding EPA drinking water models used in 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 alkyl amine polyalkoxylates. Modeling runs on four surrogate
inert ingredients using a range of physical chemical properties that
would bracket those of the alkyl amine polyalkoxylates 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 document Alkyl Amine
Polyalkoxylates (JITF CST 4 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 18 and 70-72 in docket ID number EPA-HQ-OPP-2008-0738.
For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for alkyl amine polyalkoxylates, a conservative drinking
water concentration value of 100 ppb based on screening level modeling
was used to assess the contribution to drinking water for both the
acute and chronic dietary risk assessments. 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). Alkyl amine
polyalkoxylates are not used as inert ingredients in pesticide products
that are registered for specific uses that could result in indoor
residential exposures but may have uses as inert ingredients in
pesticide products that may result in outdoor residential exposures.
A screening level residential exposure and risk assessment was
completed for products containing alkyl amine polyalkoxylates 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
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 alkyl
amine polyalkoxylates. Similarly, residential postapplication dermal
and oral exposure assessments were also performed utilizing high end
outdoor exposure scenarios. Further details of this residential
exposure and risk analysis can be found at http://www.regulations.gov
in document Alkyl Amine Polyalkoxylates (JITF CST 4 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 22-26 and 74-80 in docket ID number EPA-HQ-OPP-
2008-0738.
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 alkyl amine polyalkoxylates to share a common
mechanism of toxicity with any other substances, and alkyl amine
polyalkoxylates do not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that alkyl amine polyalkoxylates 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 toxicity database
consists of a rat developmental toxicity study on an alkyl amine
polyalkoxylate and a rat reproduction study on two different alkyl
amine polyalkoxylates which covers the range of carbon chain lengths
and polyalkoxylation within the group. No quantitative or qualitative
increased susceptibility was demonstrated in the fetuses in the
prenatal developmental toxicity study in rats following in utero
exposure. There was some evidence of increased susceptibility in the
rat reproductive toxicity study (where the offspring NOAEL of 300 ppm
(12-14
[[Page 28621]]
mg/kg/day) was lower than the parental NOAEL of 1,000 ppm (41-48.6 mg/
kg/day). There are no neurotoxicity studies available for the alkyl
amine polyalkoxylates; however, there is no indication of neurotoxicity
in the available toxicity studies.
Based on the evidence of increased susceptibility in the offspring
relative to the parents in the rat reproduction study a Degree of
Concern analysis was performed. The purpose of the Degree of Concern
analysis was (1) to determine the level of concern for the effects
observed when considered in the context of all available toxicity data;
and (2) identify any residual uncertainties after establishing toxicity
endpoints and traditional uncertainty factors to be used in the risk
assessment.
There was no increased susceptibility to the offspring of rats
following in utero exposure to alkyl amine polyalkoxylates in the
prenatal development toxicity study. However, there was evidence of
increased susceptibility in the reproduction toxicity studies in rats.
Offspring effects include litter loss, increased mean number of
unaccounted-for implantation sites and decreased mean number of pups
born, live litter size and postnatal survival from birth to LD 4 (F1)
at 1,000 ppm for one alkyl amine polyalkoxylate homologue (41-48.6 mg/
kg/day) and at 2,000 ppm (134-148 mg/kg/day) for a second homologue.
However, the rat reproduction study identified a NOAEL of 300 ppm for
both homologues (12-14 mg/kg/day and 23-26 mg/kg/day, respectively) for
offspring effects, and the selected point of departure for the dietary,
dermal and inhalation risk assessments is protective of these offspring
effects, thus 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 alkyl amine polyalkoxylates is
considered adequate for assessing the risks to infants and children
(the available studies are described in Unit IV.4.D.2. above).
ii. There is no indication that alkyl amine polyalkoxylates are
neurotoxic chemicals and thus there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that alkyl amine polyalkoxylates result
in increased susceptibility in in utero rats in prenatal developmental
studies. Increased susceptibility of young rats in the 2-generation
reproduction study was seen, however the selected point of departure
for the dietary, dermal and inhalation risk assessments is protective
of these offspring effects, thus there are no residual concerns.
iv. No chronic studies on alkyl amine polyalkoxylates are
available, however, there is no need to add additional UFs to account
for an incomplete toxicity database because the adverse effects
observed in the available toxicity studies do not seem to increase in
severity over time (4 weeks to 13 weeks). Based on the lack of
progression of severity of effects with time along with the
considerable similarities of effects across the species tested and the
observation that the vast majority of the effects observed are related
to local irritation and corrosive effects, EPA concludes that an
additional UF for extrapolation from subchronic toxicity study to a
chronic exposure scenario is not needed.
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
percent 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 alkyl amine polyalkoxylates 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 alkyl amine polyalkoxylates.
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.
In conducting this aggregate risk assessment, the Agency has
incorporated the petitioner's requested use limitations of alkyl amine
polyalkoxylates as inert ingredients in pesticide product formulations
into its exposure assessment. Specifically the petition includes a use
limitation of alkyl amine polyalkoxylates at not more than 10 percent
by weight in fungicide and insecticide formulations and at no more than
25 percent in herbicide formulations.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, and the use limitations of not more than 10 percent
by weight in fungicide and insecticide formulations and at no more than
25 percent in herbicide formulations, the acute dietary exposure from
food and water to alkyl amine polyalkoxylates at the 95th percentile
for food and drinking water is 16 percent of the aPAD for the U.S.
population and 44 percent of the aPAD for children 1 to 2 years old,
the population group receiving the greatest exposure.
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 10
percent by weight in fungicide and insecticide formulations and at no
more than 25 percent in herbicide formulations, the chronic dietary
exposure from food and water to alkyl amine polyalkoxylates is 27
percent of the cPAD for the U.S. population and 85 percent of the cPAD
for children 1 to 2 years 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).
Alkyl amine polyalkoxylates 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 alkyl amine
polyalkoxylates.
Using the exposure assumptions described in this unit for short-
term
[[Page 28622]]
exposures, EPA has concluded the combined short-term food, water, and
residential exposures aggregated result in aggregate MOEs of 156 and
172, for adult males and females respectively, for a combined high end
dermal and inhalation handler exposure with a high end post application
dermal exposure and an aggregate MOE of 90 for children for a combined
turf dermal exposure with hand-to-mouth exposure. While the MOE for
short-term aggregate exposure for children is slightly below 100, EPA
does not consider this MOE to represent a risk of concern for the
following reasons.
The hazard assessment for the alkyl amine polyalkoxylates
is conservative. The PODs used to calculate aggregate risks for alkyl
amine polyalkoxylates were based on the most toxic surrogate chemical.
The alkyl amine polyalkoxylates are actually a mixture of compounds, so
it is likely that the POD is a conservative assessment of toxicity.
The Agency traditionally considers a level of concern
(LOC) for these risk assessments to be for an MOE of 100 based on the
standard 10x inter- and 10x intraspecies extrapolation safety factors.
However, for alkyl amine polyalkoxylates, the primary toxic effect seen
is related to the surfactants' inherent function to disrupt cell
membranes resulting in irritating properties to tissues. Given that a
significant difference between species for this type of effect is not
expected, an LOC lower than an MOE of 100 may be appropriate for the
non-dietary risk assessments.
The dietary (food and water) portion of the aggregate risk
assessment is a driver in this aggregate assessment and is considered
to be highly conservative.
The highest tolerance level from the surrogate pesticides
for every food is used adjusted by the limitation in formulation for
alkyl amine polyalkoxylates specified in the exemption. Estimating
alkyl amine polyalkoxylates exposure based on the assumption that alkyl
amine polyalkoxylates will be present at the maximum permitted amount
in the pesticide products producing the highest possible residue in
food is very conservative. 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
contained between 1 and 2.25 percent surfactant, none of which was
alkyl amine polyalkoxylates.
100 percent crop treated is assumed for all crops (every
food eaten by a person each day has tolerance-level residues).
Many of these high tolerances are based on very short pre-
harvest intervals where there is little time for degradation.
No consideration was given to potential degradation between
harvest and consumption (use of tolerance level residues which are
typically one to two orders of magnitude higher than actual residues
found in monitoring data).
No consideration was given to potential reduction in
residues from washing or cooking.
The residential portion of the assessment is based on
high-end application rates and assumes a dermal absorption of 5 percent
which is a conservative, health protective value.
Finally, the aggregate assessment assumes that a child
would receive a high-end dietary exposure with high-end dermal and
hand-to-mouth exposures concurrently.
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).
Alkyl amine polyalkoxylates are used as inert ingredients in
pesticide products that 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 alkyl
amine polyalkoxylates.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures aggregated result in aggregate MOEs of 156
and 172, for adult males and females respectively, for a combined high
end dermal and inhalation handler exposure with a high end post
application dermal exposure and an MOE of 102 for children for a
combined high end dermal exposure with hand-to-mouth exposure.
5. 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 alkyl amine polyalkoxylates.
IV. 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
alkyl amine polyalkoxylates nor have any CODEX Maximum Residue Levels
been established for any food crops at this time.
V. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of alkyl amine polyalkoxylates when used as an
inert ingredient in pesticide formulations applied to growing crops or
to animals.
VI. 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
[[Page 28623]]
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).
VII. 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: June 2, 2009.
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 Sec. 180.920, the table is amended by adding alphabetically the
new inert ingredients to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed 25% Surfactants,
hydroxypoly(oxy-1,2-ethanediyl) in herbicide related adjuvants
C8-C18 saturated and formulations and of surfactants
unsaturated alkylamines; the 10% in
poly(oxy-1,2-ethanediyl) insecticide and
content is 2-60 moles (CAS Reg. fungicide
Nos. 10213-78-2, 25307-17-9, formulations
26635-92-7, 26635-93-8, 288259-
52-9, 58253-49-9, 61790-82-7,
61791-14-8, 61791-24-0, 61791-
26-2, 61791-31-9, 61791-44-4,
68155-33-9, 68155-39-5, 68155-
40-8,70955-14-5, 73246-96-5)
* * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed 25% Surfactants,
hydroxypoly(oxy-1,2-ethanediyl/ in herbicide related adjuvants
oxy(methyl-1,2-ethanediyl) C8- formulations and of surfactants
C18 saturated and unsaturated 10% in
alkylamines; the poly(oxy-1,2- insecticide and
ethanediyl/oxy(methyl-1,2- fungicide
ethanediyl) content is 2-60 formulations
moles (CAS Reg. Nos. 68213-26-
3, 68153-97-9, 75601-76-2)
* * * * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930, the table is amended by adding alphabetically new
entries of inert ingredients to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed 25% Surfactants,
hydroxypoly(oxy-1,2-ethanediyl) in herbicide related adjuvants
C8-C18 saturated and formulations and of surfactants
unsaturated alkylamines; the 10% in
poly(oxy-1,2-ethanediyl) insecticide and
content is 2-60 moles (CAS Reg. fungicide
Nos. 10213-78-2, 25307-17-9, formulations
26635-92-7, 26635-93-8, 288259-
52-9, 58253-49-9, 61790-82-7,
61791-14-8, 61791-24-0, 61791-
26-2, 61791-31-9, 61791-44-4,
68155-33-9, 68155-39-5, 68155-
40-8,70955-14-5, 73246-96-5)
* * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed 25% Surfactants,
hydroxypoly(oxy-1,2-ethanediyl/ in herbicide related adjuvants
oxy(methyl-1,2-ethanediyl) C8- formulations and of surfactants
C18 saturated and unsaturated 10% in
alkylamines; the poly(oxy-1,2- insecticide and
ethanediyl/oxy(methyl-1,2- fungicide
ethanediyl) content is 2-60 formulations
moles (CAS Reg. Nos. 68213-26-
3, 68153-97-9, 75601-76-2)
* * * * * * *
------------------------------------------------------------------------
[[Page 28624]]
[FR Doc. E9-14113 Filed 6-16-09; 8:45 am]
BILLING CODE 6560-50-S