Alkyl Alcohol Alkoxylate Phosphate and Sulfate Derivatives; Exemption From the Requirement of a Tolerance, 37571-37578 [E9-18033]
Download as PDF
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
[FR Doc. E9–17945 Filed 7–28–09; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0131; FRL–8424–6]
Alkyl Alcohol Alkoxylate Phosphate
and Sulfate Derivatives; Exemption
From the Requirement of a Tolerance
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
exemptions from the requirement of a
tolerance for residues of alkyl alcohol
alkoxylate phosphate derivatives when
used as inert ingredients in growing
crops under 40 CFR 180.920 and for
residues of alkyl alcohol alkoxylate
sulfate derivatives when used as inert
ingredients in pesticide formulations
applied to growing crops, raw
agricultural commodities after harvest,
and animals under 40 CFR 180.910 and
40 CFR 180.930. The Joint Inerts Task
Force (JITF), Cluster Support Team
Number 2 (CST 2) 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
alcohol alkoxylate phosphate and
sulfate derivatives.
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).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0131. All documents in the
docket are listed in the docket index
available at https://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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
sroberts on DSKD5P82C1PROD with RULES
ADDRESSES:
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
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:
leifer.kerry @epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to 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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
To access the OPPTS Harmonized
Guidelines referenced in this document,
go directly to the guidelines at https://
PO 00000
Frm 00077
Fmt 4700
Sfmt 4700
37571
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–2009–0131 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–2009–0131, by one of the
following methods:
• Federal eRulemaking Portal: https://
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 9E7533) by JITF,
CST 2, c/o CropLife America, 1156 15th
St., NW., Suite 400, Washington, DC
20005, The petition requested that 40
CFR 180.910, 40 CFR 180.920, and 40
CFR 180.930 be amended by
establishing exemptions from the
E:\FR\FM\29JYR1.SGM
29JYR1
sroberts on DSKD5P82C1PROD with RULES
37572
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
requirement of a tolerance for residues
of various alkyl alcohol alkoxylate
phosphate and sulfate derivatives when
used as inert ingredients in pesticide
formulations applied to raw agricultural
commodities, growing crops, and
animals. The petition specifically
requested the establishment of an
exemption from the requirement of a
tolerance under 40 CFR 180.920 for
residues of a-alkyl (minimum C6 linear,
branched, saturated and/or
unsaturated)-w-hydroxypolyoxyethylene
polymer with or without
polyoxypropylene, mixture of di- and
monohydrogen phosphateesters and the
corresponding ammonium, calcium,
magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the
phosphate esters; minimum oxyethylene
content is 2 moles; minimum
oxypropylene content is 0 moles
(Chemical Abstract Service Registry
numbers (CAS Nos.) 9046–01–9, 39464–
66–9, 50643–20–4, 52019–36–0, 68071–
35–2, 68458–48–0, 68585–36–4, 68815–
11–2, 68908–64–5, 68511–37–5,68130–
47–2, 42612–52–2, 58318–92–6, 60267–
55–2, 68070–99–5, 68186–36–7, 68186–
37–8, 68610–65–1, 68071–17–0,
936100–29–7, 936100–30–0, 73038–25–
2, 78330–24–2, 154518–39–5, 317833–
96–8, 108818–88–8, 873662–29–4,
61837–79–4, 68311–02–4, 68425–73–0,
37280–82–3, 68649–29–6, 67711–84–6,
68891–13–4); and the establishment of
an exemption from the requirement of a
tolerance under 40 CFR 180.910 and 40
CFR 180.930 for residues of a-alkyl(C6C15)-w-hydroxypoly(oxyethylene)sulfate,
and its ammonium, calcium,
magnesium, potassium, sodium, and
zinc salts, poly(oxyethylene) content
averages 2–4 moles (CAS Nos. 9004–82–
4, 68585–34–2, 68891–38–3, 9004–84–6,
13150–00–0, 26183–44–8, 68611–55–2,
68511–39–7, 3088–31–1, 9004–82–4,
25446–78–0, 32612–48–9, 50602–06–7,
62755–21–9, 68424–50–0, 73665–22–2).
For ease of reading, the alkyl alcohol
alkoxylate phosphate and sulfate
derivatives are referred to throughout
this document as AAAPDs and AAASDs
respectively, and collectively as
AAAPSDs. That notice referenced a
summary of the petition prepared by
JITF, CST 2, the petitioner which is
available to the public in the docket,
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
This petition, which also included a
limitation of the concentration of alkyl
alcohol alkoxylate phosphate and
sulfate derivatives to not exceed 30% by
weight of the pesticide formulation, was
submitted in response to a final rule of
August 9, 2006 (71 FR 45415) (FRL–
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
8084–1) in which the Agency revoked,
under FFDCA section 408(e)(1) 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, by a document
published in the Federal Register issue
of August 4, 2008 (73 FR 45312) (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
PO 00000
Frm 00078
Fmt 4700
Sfmt 4700
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 chemical residues.
First, EPA determines the toxicity of
pesticide chemicals. Second, EPA
examines exposure to the pesticide
chemical through food, drinking water,
and through other exposures that occur
as a result of the pesticide chemical use
in residential settings.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), 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 AAAPSDs
when used as inert ingredients in
pesticide formulations applied to
growing crops, raw agricultural
commodities and 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.
The AAAPSDs are not acutely toxic
by the oral and dermal routes of
exposure under normal use conditions;
however, concentrated materials are
generally moderate to severe eye and
skin irritants and may be skin
sensitizers. Following subchronic
exposure to rats, gastrointestinal
irritation (increased incidences of
hyperplasia, submucosal edema, and
ulceration) was observed, but no
specific target organ toxicity or
neurotoxicity was seen. No
neurotoxicological effects were detected
in a functional observational battery or
a motor activity assessment. No
reproductive effects were noted in the
database. There was a qualitative
increase in susceptibility to pups seen
in a rat developmental/reproductive
toxicity screening study; however,
effects were seen only in one study and
were in the presence of maternal
toxicity. Further, a clear no-observedadverse-effect-level (NOAEL) was
E:\FR\FM\29JYR1.SGM
29JYR1
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
established for the developmental
effects and this NOAEL is significantly
higher than the toxicological points of
departure selected for risk assessment.
There are no carcinogenicity concerns
based on structure activity modeling.
Points of departure for chronic dietary,
incidental oral, inhalation, and dermal
exposure were selected from a 2–
generation reproduction and fertility
effects study in rats. The endpoint was
decreased absolute and relative liver
weights and increased incidence in the
number of animals with minimal
hepatocyte necrosis in males.
Sufficient data were provided on the
chemical identity of the AAAPSDs;
however, limited data are available on
the metabolism and environmental
degradation of these compounds. The
Agency relied collectively on
information provided on the
representative chemical structures, the
submitted physicochemical data,
structure activity relationship (SAR)
information, as well as information on
other surfactants and chemicals of
similar size and functionality to
determine the residues of concern for
the AAAPSDs. The Agency has
concluded that since metabolites and
environmental degradates are not likely
to be more toxic than the parent
compounds, a risk assessment based on
the parent compounds is not likely to
underestimate risk.
Specific information on the studies
received and the nature of the adverse
effects caused by the AAAPSDs as well
as the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document Alkyl
Alcohol Alkoxylate Phosphate and
Sulfate Derivatives (AAAPDs and
AAASDs—JITF CST 2 Inert Ingredients).
Human Health Risk Assessment to
Support Proposed Exemption from the
Requirement of a Tolerance When Used
as Inert Ingredients in Pesticide, pages
11–17 in docket ID number EPA–HQ–
OPP–2009–0131.
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
37573
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 https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for AAAPSDs used for human
risk assessment is shown in Table 1 of
this unit.
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR AAAPSDS FOR USE IN HUMAN RISK ASSESSMENT
Point of Departure and Uncertainty/
Safety Factors
Exposure/Scenario
Acute dietary
(all populations)
RfD, PAD, LOC for
Risk Assessment
Study and Toxicological Effects
No appropriate endpoint was identified for acute dietary assessment
NOAEL= 87 millgrams/kilograms/day (mg/kg/
day)
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.87
mg/kg/day
cPAD = 0.87 mg/kg/
day
Reproduction/fertility effects in male rats (Master Record Identification number (MRID)
47060903))
LOAEL = 223 mg/kg/day based on a dose-related decrease in absolute and relative liver
weight and an increased incidence in the
number
of
animals
with
‘‘minimal’’
hepatocyte necrosis in males in the highdose group compared to control group
Incidental oral shortterm
(1 to 30 days) and
intermediate-term
(1 to 6 months)
sroberts on DSKD5P82C1PROD with RULES
Chronic dietary
(all populations)
NOAEL= 87 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Reproduction/fertility effects in male rats (MRID
47060903)
LOAEL = 223 mg/kg/day based on a dose-related decrease in absolute and relative liver
weight and an increased incidence in the
number
of
animals
with
‘‘minimal’’
hepatocyte necrosis in males in the highdose group compared to control group
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
PO 00000
Frm 00079
Fmt 4700
Sfmt 4700
E:\FR\FM\29JYR1.SGM
29JYR1
37574
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR AAAPSDS FOR USE IN HUMAN RISK
ASSESSMENT—Continued
Point of Departure and Uncertainty/
Safety Factors
RfD, PAD, LOC for
Risk Assessment
Study and Toxicological Effects
Oral study NOAEL = 87 mg/kg/day (dermal absorption rate = 5% (inhalation absorption
rate = 100%)
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Reproduction/fertility effects in male rats (MRID
47060903)
LOAEL = 223 mg/kg/day based on a dose-related decrease in absolute and relative liver
weight and an increased incidence in the
number
of
animals
with
‘‘minimal’’
hepatocyte necrosis in males in the highdose group compared to control group.
Exposure/Scenario
Dermal and inhalation
(all durations)
Cancer
(oral, dermal, inhalation)
Classification: No animal toxicity data available for an assessment; based on SAR analysis, AAAPSDs 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). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin
of exposure. LOC = level of concern.
sroberts on DSKD5P82C1PROD with RULES
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to AAAPSDs, EPA considered
exposure under the petitioned-for
exemptions from the requirement of a
tolerance. EPA assessed dietary
exposures from AAAPSDs 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 AAAPSDs. 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 https://
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
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
tolerances would be no higher than the
concentration of the active ingredient.
The Agency believes the assumptions
used to estimate dietary exposures lead
to an extremely conservative assessment
of dietary risk due to a series of
compounded conservatisms. First,
assuming that the level of residue for an
inert ingredient is equal to the level of
residue for the active ingredient will
overstate exposure. The concentrations
of active ingredient in agricultural
products are generally at least 50% 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 comparison with
the active ingredient. In the case of
AAAPSDs, EPA made a specific
adjustment to the dietary exposure
assessment to account for the use
limitations of the amount of AAAPSDs
that may be in formulations (no more
than 30%) and assumed that the
AAAPSDs are 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%
and that none of the surfactants were
AAAPSDs.
Second, the conservatism of this
methodology is compounded by EPA’s
decision to assume that, for each
commodity, the active ingredient which
PO 00000
Frm 00080
Fmt 4700
Sfmt 4700
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
sum, EPA chose a very conservative
method for estimating what level of
inert residue could be on food, and 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.
ii. Cancer. The Agency used a
qualitative SAR database, DEREK11, to
determine if there were structural alerts
for potential carcinogenicity of a
E:\FR\FM\29JYR1.SGM
29JYR1
sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
representative AAAPSD. No structural
alerts for carcinogenicity were identified
and the AAAPSDs are not expected to
be carcinogenic. Therefore a
quantitative cancer exposure assessment
is not necessary to assess cancer risk.
iii. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue or PCT
information in the dietary assessment
for AAAPSDs. Tolerance level residues
or 100 PCT 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 AAAPSDs in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of AAAPSDs.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://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 AAAPSDs. Modeling runs on four
surrogate inert ingredients using a range
of physical chemical properties that
would bracket those of the AAAPSDs
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 https://
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,
pages 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
AAAPSDs, 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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
indoor pest control, termiticides, and
flea and tick control on pets). AAAPSDs
are used as inert ingredients in pesticide
products that are registered for specific
uses that could result in indoor
residential exposures and 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 AAAPSDs as inert
ingredients. In this assessment,
representative scenarios, based on enduse 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 use 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 AAAPSDs.
Similarly, residential postapplication
dermal and oral exposure assessments
were also performed utilizing high-end
exposure scenarios. Further details of
this residential exposure and risk
analysis can be found at https://
www.regulations.gov in document JITF
Inert Ingredients. Residential and
Occupational Exposure Assessment
Algorithms and Assumptions Appendix
for the Human Health Risk Assessments
to Support Proposed Exemption from
the Requirement of a Tolerance When
Used as Inert Ingredients in Pesticide
Formulations 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 AAAPSDs to share
a common mechanism of toxicity with
any other substances, and AAAPSDs do
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
AAAPSDs 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 https://
www.epa.gov/pesticides/cumulative.
PO 00000
Frm 00081
Fmt 4700
Sfmt 4700
37575
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 SF. In applying this provision,
EPA either retains the default value of
10X, or uses a different additional SF
when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity.
The toxicity database consists of OPPTS
Harmonized Guideline 870.3650
(combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test) studies in rats
conducted with representative AAAPDs,
as well as a 2–generation rat
reproduction toxicity (OPPTS
Harmonized Guideline 870.3800) study
and a rat developmental toxicity study
conducted with a representative
AAASD.
In an OPPTS Harmonized Guideline
870.3650 study conducted with a
representative AAAPD, no increased
susceptibility to the offspring of rats
following prenatal and postnatal
exposure was observed. In a second
OPPTS Harmonized Guideline 870.3650
study conducted with another
representative AAAPD, there was
evidence of increased qualitative
susceptibility as indicated by the
increased number of stillborn pups and
pups dying within lactation day (LD) 4/
5 and clinical observations (coldness to
the touch, discolored heads, and a lack
of nesting behavior) at 800 mg/kg/day
where lesions in the forestomach and
thymus atrophy was observed in the
parental animals. However, this
qualitative susceptibility seen in the
OPPTS Harmonized Guideline 870.3650
study does not indicate a heightened
risk for infants and children because a
clear NOAEL (200 mg/kg/day) was
established for developmental effects
and an additional margin of safety is
provided since the point of departure
selected from the 2–generation rat
reproduction study for chronic exposure
is 87 mg/kg/day.
In a rat developmental study with
AAASD, no maternal or developmental
toxicity was observed at the limit dose.
In the 2–generation reproduction study
with AAASD, the only significant
effects observed were liver effects
E:\FR\FM\29JYR1.SGM
29JYR1
sroberts on DSKD5P82C1PROD with RULES
37576
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
characterized by dose-related decrease
in absolute and relative liver weight and
an increased incidence in the number of
animals with ‘‘minimal’’ hepatocyte
necrosis in males. No treatment-related
effects were observed on reproduction
or in the offspring.
There are no residual uncertainties
identified in the exposure databases.
The food exposure assessments are
considered to be conservative. The food
and drinking water assessment is not
likely to underestimate exposure to any
subpopulation, including those
comprised of infants and children.
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 AAAPSDs
is considered adequate for assessing the
risks to infants and children (the
available studies are described in Unit
IV.D.2.).
ii. No susceptibility was demonstrated
in the offspring in the reproductive/
developmental screening test portion of
an OPPTS Harmonized Guideline
870.3650 study with one AAAPD
following prenatal and postnatal
exposure at 800 mg/kg/day.
iii. Although increased qualitative
susceptibility was demonstrated in the
offspring in a reproductive/
developmental screening test portion of
an OPPTS Harmonized Guideline
870.3650 study with another AAAPD,
the Agency did not identify any residual
uncertainties after establishing toxicity
endpoints and traditional UFs to be
used in the risk assessment of the
AAAPSDs.
iv. There is no indication that
AAAPSDs are neurotoxic chemicals and
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 AAAPSDs in
drinking water. EPA used similarly
conservative assumptions to assess
postapplication exposure of children as
well as incidental oral exposure of
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
toddlers. These assessments will not
underestimate the exposure and risks
posed by AAAPSDs.
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 AAAPSDs as inert
ingredients in pesticide product
formulations into its exposure
assessment. Specifically the petition
includes a use limitation of AAAPSDs at
not more than 30% by weight in
pesticide formulations.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. No adverse effects attributable to
a single exposure to the AAAPSDs were
seen in the toxicity databases, therefore,
AAAPSDs 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
AAAPSDs is 13% of the cPAD for the
U.S. population and 43% 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).
AAAPSDs 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
PO 00000
Frm 00082
Fmt 4700
Sfmt 4700
determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to AAAPSDs.
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 130 and 140, for
adult males and females respectively,
for a combined high-end dermal and
inhalation handler exposure with a
high-end postapplication dermal
exposure and an aggregate MOE of 110
for children for a combined turf dermal
exposure with hand-to-mouth exposure.
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).
AAAPSDs 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 AAAPSDs.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded the
combined intermediate-term food,
water, and residential exposures
aggregated result in aggregate MOEs of
270 and 280, for adult males and
females respectively, for a combined
high-end dermal and inhalation handler
exposure with a high-end
postapplication dermal exposure and an
MOE of 110 for children for a combined
high-end dermal exposure with hand-tomouth exposure.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
structural alerts for carcinogenicity,
AAAPSDs are not expected to pose a
cancer risk to humans.
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
AAAPSDs.
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.
E:\FR\FM\29JYR1.SGM
29JYR1
37577
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
B. International Residue Limits
The Agency is not aware of any
country requiring a tolerance for
AAAPSDs nor have any CODEX
Maximum Residue Levels been
established for any food crops at this
time.
VI. Conclusion
Therefore, exemptions from the
requirement of a tolerance are
established for residues of AAAPDs
when used as inert ingredients in
pesticide formulations applied to
growing crops only under 40 CFR
180.920 and residues of AAASDs when
used as inert ingredients in raw
agricultural commodities, growing
crops, and animals under 40 CFR
180.910, 40 CFR 180.920, and 40 CFR
180.930.
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
Inert ingredients
3. In § 180.920, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
sroberts on DSKD5P82C1PROD with RULES
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
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 20, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
Limits
*
*
*
*
*
a-Alkyl(C6–C15)-w-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2–4
moles (CAS Reg. Nos. 3088–31–1, 9004–82–4, 9004–84–6, 13150–00–0, 25446–
78–0, 26183–44–8, 32612–48–9, 50602–06–7, 62755–21–9, 68424–50–0, 68511–
39–7, 68585–34–2, 68611–55–2, 68891–38–3, 73665–22–2).
*
*
*
*
*
■
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
Not to exceed 30% of
pesticide formulation.
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
PO 00000
*
Frm 00083
*
*
Fmt 4700
*
Sfmt 4700
E:\FR\FM\29JYR1.SGM
29JYR1
*
*
Uses
Surfactants, related adjuvants of surfactants
37578
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
Inert ingredients
Limits
*
*
*
*
*
a-Alkyl (minimum C6 linear, branched, saturated and/or unsaturated)-whydroxypolyoxyethylene polymer with or without polyoxypropylene, mixture of di- and
monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters;
minimum oxyethylene content is 2 moles; minimum oxypropylene content is 0 moles
(CAS Reg. Nos. 9046–01–9, 37280–82–3, 39464–66–9, 42612–52–2, 50643–20–4,
52019–36–0, 58318–92–6, 60267–55–2, 61837–79–4, 67711–84–6, 68070–99–5,
68071–35–2, 68071–17–0, 68130–47–2, 68186–37–8, 68186–36–7, 68311–02–4,
68425–73–0, 68458–48–0, 68511–37–5, 68610–65–1, 68585–36–4, 68649–29–6,
68815–11–2, 68908–64–5, 68891–13–4, 73038–25–2, 78330–24–2, 108818–88–8,
154518–39–5, 317833–96–8, 873662–29–4, 936100–29–7, 936100–30–0).
*
*
*
*
*
4. In § 180.930, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
■
Not to exceed 30% of
pesticide formulation.
*
*
*
*
*
Limits
*
*
*
*
*
a-Alkyl(C6-C15)-w-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2–4
moles (CAS Reg. Nos. 3088–31–1, 9004–82–4, 9004–84–6, 13150–00–0, 25446–
78–0, 26183–44–8, 32612–48–9, 50602–06–7, 62755–21–9, 68424–50–0, 68511–
39–7, 68585–34–2, 68611–55–2, 68891–38–3, 73665–22–2).
*
*
*
*
*
BILLING CODE 6560–50–S
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
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
sroberts on DSKD5P82C1PROD with RULES
SUMMARY:
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
Not to exceed 30% of
pesticide formulation.
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).
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 https://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
https://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,
ADDRESSES:
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
Surfactants, related adjuvants of surfactants
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
Inert ingredients
[FR Doc. E9–18033 Filed 7–28–09; 8:45 am]
Uses
PO 00000
Frm 00084
Fmt 4700
Sfmt 4700
Uses
Surfactants, related adjuvants of surfactants
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:
leifer.kerry@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to 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
E:\FR\FM\29JYR1.SGM
29JYR1
Agencies
[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
[Pages 37571-37578]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18033]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0131; FRL-8424-6]
Alkyl Alcohol Alkoxylate Phosphate and Sulfate Derivatives;
Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of alkyl alcohol alkoxylate phosphate
derivatives when used as inert ingredients in growing crops under 40
CFR 180.920 and for residues of alkyl alcohol alkoxylate sulfate
derivatives when used as inert ingredients in pesticide formulations
applied to growing crops, raw agricultural commodities after harvest,
and animals under 40 CFR 180.910 and 40 CFR 180.930. The Joint Inerts
Task Force (JITF), Cluster Support Team Number 2 (CST 2) 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 alcohol alkoxylate phosphate and sulfate
derivatives.
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-2009-0131. All documents in the
docket are listed in the docket index available at https://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 https://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: leifer.kerry @epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to 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
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part180 through the Government Printing Office's e-CFR cite
at https://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at https://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-2009-0131 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-2009-0131, by one of the following methods:
Federal eRulemaking Portal: https://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
9E7533) by JITF, CST 2, c/o CropLife America, 1156 15\th\ St., NW.,
Suite 400, Washington, DC 20005, The petition requested that 40 CFR
180.910, 40 CFR 180.920, and 40 CFR 180.930 be amended by establishing
exemptions from the
[[Page 37572]]
requirement of a tolerance for residues of various alkyl alcohol
alkoxylate phosphate and sulfate derivatives when used as inert
ingredients in pesticide formulations applied to raw agricultural
commodities, growing crops, and animals. The petition specifically
requested the establishment of an exemption from the requirement of a
tolerance under 40 CFR 180.920 for residues of [alpha]-alkyl (minimum
C6 linear, branched, saturated and/or unsaturated)-[omega]-
hydroxypolyoxyethylene polymer with or without polyoxypropylene,
mixture of di- and monohydrogen phosphateesters and the corresponding
ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and
zinc salts of the phosphate esters; minimum oxyethylene content is 2
moles; minimum oxypropylene content is 0 moles (Chemical Abstract
Service Registry numbers (CAS Nos.) 9046-01-9, 39464-66-9, 50643-20-4,
52019-36-0, 68071-35-2, 68458-48-0, 68585-36-4, 68815-11-2, 68908-64-5,
68511-37-5,68130-47-2, 42612-52-2, 58318-92-6, 60267-55-2, 68070-99-5,
68186-36-7, 68186-37-8, 68610-65-1, 68071-17-0, 936100-29-7, 936100-30-
0, 73038-25-2, 78330-24-2, 154518-39-5, 317833-96-8, 108818-88-8,
873662-29-4, 61837-79-4, 68311-02-4, 68425-73-0, 37280-82-3, 68649-29-
6, 67711-84-6, 68891-13-4); and the establishment of an exemption from
the requirement of a tolerance under 40 CFR 180.910 and 40 CFR 180.930
for residues of [alpha]-alkyl(C6-C15)-[omega]-
hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium,
potassium, sodium, and zinc salts, poly(oxyethylene) content averages
2-4 moles (CAS Nos. 9004-82-4, 68585-34-2, 68891-38-3, 9004-84-6,
13150-00-0, 26183-44-8, 68611-55-2, 68511-39-7, 3088-31-1, 9004-82-4,
25446-78-0, 32612-48-9, 50602-06-7, 62755-21-9, 68424-50-0, 73665-22-
2). For ease of reading, the alkyl alcohol alkoxylate phosphate and
sulfate derivatives are referred to throughout this document as AAAPDs
and AAASDs respectively, and collectively as AAAPSDs. That notice
referenced a summary of the petition prepared by JITF, CST 2, the
petitioner which is available to the public in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
This petition, which also included a limitation of the
concentration of alkyl alcohol alkoxylate phosphate and sulfate
derivatives to not exceed 30% by weight of the pesticide formulation,
was submitted in response to a final rule of August 9, 2006 (71 FR
45415) (FRL-8084-1) in which the Agency revoked, under FFDCA section
408(e)(1) 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, by a document published in the Federal Register issue of August
4, 2008 (73 FR 45312) (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. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide chemical residues. First, EPA
determines the toxicity of pesticide chemicals. Second, EPA examines
exposure to the pesticide chemical through food, drinking water, and
through other exposures that occur as a result of the pesticide
chemical use in residential settings.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 AAAPSDs when used
as inert ingredients in pesticide formulations applied to growing
crops, raw agricultural commodities and 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.
The AAAPSDs are not acutely toxic by the oral and dermal routes of
exposure under normal use conditions; however, concentrated materials
are generally moderate to severe eye and skin irritants and may be skin
sensitizers. Following subchronic exposure to rats, gastrointestinal
irritation (increased incidences of hyperplasia, submucosal edema, and
ulceration) was observed, but no specific target organ toxicity or
neurotoxicity was seen. No neurotoxicological effects were detected in
a functional observational battery or a motor activity assessment. No
reproductive effects were noted in the database. There was a
qualitative increase in susceptibility to pups seen in a rat
developmental/reproductive toxicity screening study; however, effects
were seen only in one study and were in the presence of maternal
toxicity. Further, a clear no-observed-adverse-effect-level (NOAEL) was
[[Page 37573]]
established for the developmental effects and this NOAEL is
significantly higher than the toxicological points of departure
selected for risk assessment. There are no carcinogenicity concerns
based on structure activity modeling. Points of departure for chronic
dietary, incidental oral, inhalation, and dermal exposure were selected
from a 2-generation reproduction and fertility effects study in rats.
The endpoint was decreased absolute and relative liver weights and
increased incidence in the number of animals with minimal hepatocyte
necrosis in males.
Sufficient data were provided on the chemical identity of the
AAAPSDs; however, limited data are available on the metabolism and
environmental degradation of these compounds. The Agency relied
collectively on information provided on the representative chemical
structures, the submitted physicochemical data, structure activity
relationship (SAR) information, as well as information on other
surfactants and chemicals of similar size and functionality to
determine the residues of concern for the AAAPSDs. The Agency has
concluded that since metabolites and environmental degradates are not
likely to be more toxic than the parent compounds, a risk assessment
based on the parent compounds is not likely to underestimate risk.
Specific information on the studies received and the nature of the
adverse effects caused by the AAAPSDs as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at https://www.regulations.gov in document Alkyl Alcohol
Alkoxylate Phosphate and Sulfate Derivatives (AAAPDs and AAASDs--JITF
CST 2 Inert Ingredients). Human Health Risk Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide, pages 11-17 in docket ID number EPA-HQ-
OPP-2009-0131.
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for AAAPSDs used for human
risk assessment is shown in Table 1 of this unit.
Table 1.--Summary of Toxicological Doses and Endpoints for AAAPSDs for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of Departure and
Exposure/Scenario Uncertainty/ Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary No appropriate endpoint was identified for acute dietary assessment
(all populations)...................
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL= 87 millgrams/ Chronic RfD = 0.87 mg/ Reproduction/fertility
(all populations).................... kilograms/day (mg/kg/ kg/day effects in male rats
day) cPAD = 0.87 mg/kg/day.. (Master Record
UFA = 10x.............. Identification number
UFH = 10x.............. (MRID) 47060903))
FQPA SF = 1x........... LOAEL = 223 mg/kg/day
based on a dose-
related decrease in
absolute and relative
liver weight and an
increased incidence in
the number of animals
with ``minimal''
hepatocyte necrosis in
males in the high-dose
group compared to
control group
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term NOAEL= 87 mg/kg/day LOC for MOE = 100...... Reproduction/fertility
(1 to 30 days) and intermediate-term UFA = 10x.............. effects in male rats
(1 to 6 months). UFH = 10x.............. (MRID 47060903)
FQPA SF = 1x........... LOAEL = 223 mg/kg/day
based on a dose-
related decrease in
absolute and relative
liver weight and an
increased incidence in
the number of animals
with ``minimal''
hepatocyte necrosis in
males in the high-dose
group compared to
control group
----------------------------------------------------------------------------------------------------------------
[[Page 37574]]
Dermal and inhalation Oral study NOAEL = 87 LOC for MOE = 100 Reproduction/fertility
(all durations)...................... mg/kg/day (dermal effects in male rats
absorption rate = 5% (MRID 47060903)
(inhalation absorption LOAEL = 223 mg/kg/day
rate = 100%) based on a dose-
UFA = 10x.............. related decrease in
UFH = 10x.............. absolute and relative
FQPA SF = 1x........... liver weight and an
increased incidence in
the number of animals
with ``minimal''
hepatocyte necrosis in
males in the high-dose
group compared to
control group.
----------------------------------------------------------------------------------------------------------------
Cancer Classification: No animal toxicity data available for an assessment;
(oral, dermal, inhalation)........... based on SAR analysis, AAAPSDs 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). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a =
acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to AAAPSDs, EPA considered exposure under the petitioned-for
exemptions from the requirement of a tolerance. EPA assessed dietary
exposures from AAAPSDs 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 AAAPSDs. 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 https://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 are
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 comparison with the active
ingredient. In the case of AAAPSDs, EPA made a specific adjustment to
the dietary exposure assessment to account for the use limitations of
the amount of AAAPSDs that may be in formulations (no more than 30%)
and assumed that the AAAPSDs are 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%
and that none of the surfactants were AAAPSDs.
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 sum, EPA chose a
very conservative method for estimating what level of inert residue
could be on food, and 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.
ii. Cancer. The Agency used a qualitative SAR database, DEREK11, to
determine if there were structural alerts for potential carcinogenicity
of a
[[Page 37575]]
representative AAAPSD. No structural alerts for carcinogenicity were
identified and the AAAPSDs are not expected to be carcinogenic.
Therefore a quantitative cancer exposure assessment is not necessary to
assess cancer risk.
iii. Anticipated residue and percent crop treated (PCT)
information. EPA did not use anticipated residue or PCT information in
the dietary assessment for AAAPSDs. Tolerance level residues or 100 PCT
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 AAAPSDs in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of AAAPSDs. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
https://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 AAAPSDs. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of the AAAPSDs 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 https://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, pages 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 AAAPSDs, 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). AAAPSDs are used as
inert ingredients in pesticide products that are registered for
specific uses that could result in indoor residential exposures and 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 AAAPSDs 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 use 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 AAAPSDs. Similarly, residential
postapplication dermal and oral exposure assessments were also
performed utilizing high-end exposure scenarios. Further details of
this residential exposure and risk analysis can be found at https://www.regulations.gov in document JITF Inert Ingredients. Residential and
Occupational Exposure Assessment Algorithms and Assumptions Appendix
for the Human Health Risk Assessments to Support Proposed Exemption
from the Requirement of a Tolerance When Used as Inert Ingredients in
Pesticide Formulations 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 AAAPSDs to share a common mechanism of toxicity
with any other substances, and AAAPSDs do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that AAAPSDs 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 https://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 SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional SF when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The toxicity database
consists of OPPTS Harmonized Guideline 870.3650 (combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
test) studies in rats conducted with representative AAAPDs, as well as
a 2-generation rat reproduction toxicity (OPPTS Harmonized Guideline
870.3800) study and a rat developmental toxicity study conducted with a
representative AAASD.
In an OPPTS Harmonized Guideline 870.3650 study conducted with a
representative AAAPD, no increased susceptibility to the offspring of
rats following prenatal and postnatal exposure was observed. In a
second OPPTS Harmonized Guideline 870.3650 study conducted with another
representative AAAPD, there was evidence of increased qualitative
susceptibility as indicated by the increased number of stillborn pups
and pups dying within lactation day (LD) 4/5 and clinical observations
(coldness to the touch, discolored heads, and a lack of nesting
behavior) at 800 mg/kg/day where lesions in the forestomach and thymus
atrophy was observed in the parental animals. However, this qualitative
susceptibility seen in the OPPTS Harmonized Guideline 870.3650 study
does not indicate a heightened risk for infants and children because a
clear NOAEL (200 mg/kg/day) was established for developmental effects
and an additional margin of safety is provided since the point of
departure selected from the 2-generation rat reproduction study for
chronic exposure is 87 mg/kg/day.
In a rat developmental study with AAASD, no maternal or
developmental toxicity was observed at the limit dose. In the 2-
generation reproduction study with AAASD, the only significant effects
observed were liver effects
[[Page 37576]]
characterized by dose-related decrease in absolute and relative liver
weight and an increased incidence in the number of animals with
``minimal'' hepatocyte necrosis in males. No treatment-related effects
were observed on reproduction or in the offspring.
There are no residual uncertainties identified in the exposure
databases. The food exposure assessments are considered to be
conservative. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children.
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 AAAPSDs is considered adequate for
assessing the risks to infants and children (the available studies are
described in Unit IV.D.2.).
ii. No susceptibility was demonstrated in the offspring in the
reproductive/developmental screening test portion of an OPPTS
Harmonized Guideline 870.3650 study with one AAAPD following prenatal
and postnatal exposure at 800 mg/kg/day.
iii. Although increased qualitative susceptibility was demonstrated
in the offspring in a reproductive/developmental screening test portion
of an OPPTS Harmonized Guideline 870.3650 study with another AAAPD, the
Agency did not identify any residual uncertainties after establishing
toxicity endpoints and traditional UFs to be used in the risk
assessment of the AAAPSDs.
iv. There is no indication that AAAPSDs are neurotoxic chemicals
and 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 AAAPSDs 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 AAAPSDs.
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 AAAPSDs as
inert ingredients in pesticide product formulations into its exposure
assessment. Specifically the petition includes a use limitation of
AAAPSDs at not more than 30% by weight in pesticide formulations.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effects attributable to a single exposure to
the AAAPSDs were seen in the toxicity databases, therefore, AAAPSDs 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 AAAPSDs is 13% of the cPAD for the U.S. population
and 43% 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).
AAAPSDs 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 AAAPSDs.
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 130
and 140, for adult males and females respectively, for a combined high-
end dermal and inhalation handler exposure with a high-end
postapplication dermal exposure and an aggregate MOE of 110 for
children for a combined turf dermal exposure with hand-to-mouth
exposure.
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).
AAAPSDs 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 AAAPSDs.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded the combined
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of 270 and 280, for adult males and females
respectively, for a combined high-end dermal and inhalation handler
exposure with a high-end postapplication dermal exposure and an MOE of
110 for children for a combined high-end dermal exposure with hand-to-
mouth exposure.
5. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts for carcinogenicity, AAAPSDs are not expected to pose
a cancer risk to humans.
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 AAAPSDs.
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.
[[Page 37577]]
B. International Residue Limits
The Agency is not aware of any country requiring a tolerance for
AAAPSDs nor have any CODEX Maximum Residue Levels been established for
any food crops at this time.
VI. Conclusion
Therefore, exemptions from the requirement of a tolerance are
established for residues of AAAPDs when used as inert ingredients in
pesticide formulations applied to growing crops only under 40 CFR
180.920 and residues of AAASDs when used as inert ingredients in raw
agricultural commodities, growing crops, and animals under 40 CFR
180.910, 40 CFR 180.920, and 40 CFR 180.930.
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 20, 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. 180.910, the table is amended by adding alphabetically the
following inert ingredients to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
[alpha]-Alkyl(C6-C15)-[omega]- Not to exceed 30% Surfactants,
hydroxypoly(oxyethylene)sulfate of pesticide related adjuvants
, and its ammonium, calcium, formulation. of surfactants
magnesium, potassium, sodium,
and zinc salts,
poly(oxyethylene) content
averages 2-4 moles (CAS Reg.
Nos. 3088-31-1, 9004-82-4, 9004-
84-6, 13150-00-0, 25446-78-0,
26183-44-8, 32612-48-9, 50602-
06-7, 62755-21-9, 68424-50-0,
68511-39-7, 68585-34-2, 68611-
55-2, 68891-38-3, 73665-22-2).
* * * * *
------------------------------------------------------------------------
0
3. 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 37578]]
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
[alpha]-Alkyl (minimum C6 Not to exceed 30% Surfactants,
linear, branched, saturated and/ of pesticide related adjuvants
or unsaturated)-[omega]- formulation. of surfactants
hydroxypolyoxyethylene polymer
with or without
polyoxypropylene, mixture of di-
and monohydrogen phosphate
esters and the corresponding
ammonium, calcium, magnesium,
monoethanolamine, potassium,
sodium, and zinc salts of the
phosphate esters; minimum
oxyethylene content is 2 moles;
minimum oxypropylene content is
0 moles (CAS Reg. Nos. 9046-01-
9, 37280-82-3, 39464-66-9,
42612-52-2, 50643-20-4, 52019-
36-0, 58318-92-6, 60267-55-2,
61837-79-4, 67711-84-6, 68070-
99-5, 68071-35-2, 68071-17-0,
68130-47-2, 68186-37-8, 68186-
36-7, 68311-02-4, 68425-73-0,
68458-48-0, 68511-37-5, 68610-
65-1, 68585-36-4, 68649-29-6,
68815-11-2, 68908-64-5, 68891-
13-4, 73038-25-2, 78330-24-2,
108818-88-8, 154518-39-5,
317833-96-8, 873662-29-4,
936100-29-7, 936100-30-0).
* * * * *
------------------------------------------------------------------------
0
4. In Sec. 180.930, the table is amended by adding alphabetically the
following 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
------------------------------------------------------------------------
* * * * *
[alpha]-Alkyl(C6-C15)-[omega]- Not to exceed 30% Surfactants,
hydroxypoly(oxyethylene)sulfate of pesticide related adjuvants
, and its ammonium, calcium, formulation. of surfactants
magnesium, potassium, sodium,
and zinc salts,
poly(oxyethylene) content
averages 2-4 moles (CAS Reg.
Nos. 3088-31-1, 9004-82-4, 9004-
84-6, 13150-00-0, 25446-78-0,
26183-44-8, 32612-48-9, 50602-
06-7, 62755-21-9, 68424-50-0,
68511-39-7, 68585-34-2, 68611-
55-2, 68891-38-3, 73665-22-2).
* * * * *
------------------------------------------------------------------------
[FR Doc. E9-18033 Filed 7-28-09; 8:45 am]
BILLING CODE 6560-50-S