[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
[Pages 37598-37605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17957]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0665; FRL-8421-7]
Sodium monoalkyl and dialkyl (C6-C16)
phenoxybenzenedisulfonates and related acids; Exemption from the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Sodium monoalkyl and dialkyl
(C6-C16) phenoxybenzenedisulfonates and related
acids, often known as the ``alkyldiphenyl oxide sulfnates'', herein
referred to in this document as ADPOS, when used as inert ingredients
at a maximum of 20% by weight in pesticide formulations for pre-harvest
and post-harvest use under 40 CFR 180.910, as well as for application
to animals under 40 CFR 180.930. Dow AgroSciences, LLC, 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 ADPOS.
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-2008-0665. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8811; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0665 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-2008-0665, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
[[Page 37599]]
II. Background
In the Federal Register of October 8, 2008 (73 FR 58962) (FRL-8383-
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
8E7372) by Dow AgroSciences, LLC, 9330 Zionsville Rd., Indianapolis, IN
46268. The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be
amended by establishing exemptions from the requirement of a tolerance
for residues of the inert ingredient ADPOS at a maximum of 20% by
weight in pesticide formulations. That notice referenced a summary of
the petition prepared by Dow AgroSciences, LLC, the petitioner, which
is available to the public in the docket, http://www.regulations.gov.
The Agency received only one comment in response to the notice of
filing. One comment was received from a private citizen who opposed the
authorization to sell any pesticide that leaves a residue on food. The
Agency understands the commenter's concerns and recognizes that some
individuals believe that no residue of pesticides should be allowed.
However, under the existing legal framework provided by section 408 of
the Federal Food, Drug and Cosmetic Act (FFDCA), EPA is authorized to
establish pesticide tolerances or exemptions where persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute.
This petition was submitted in response to a final rule of August
9, 2006, (71 FR 45415) (FRL-8084-1) in which the Agency revoked, under
section 408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
the existing exemptions from the requirement of a tolerance for
residues of certain inert ingredients because of insufficient data to
make the determination of safety required by FFDCA section 408(b)(2).
The expiration date for the tolerance exemptions subject to revocation
was August 9, 2008, which was later extended to August 9, 2009 (73 FR
45312) to allow for data to be submitted to support the establishment
of tolerance exemptions for these inert ingredients prior to the
effective date of the tolerance exemption revocation.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
exemption from the requirement of a tolerance for residues of ADPOS
when used as inert ingredients at a maximum of 20% by weight in
pesticide formulations for pre-harvest and post-harvest use, as well as
for application to 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 available mammalian toxicology database includes acute,
subchronic repeat dose oral, reproductive/developmental screening
tests, chronic rat and dog studies and mutagenicity data for four
representative compounds of the C6 to C16 ADPOS
group. The Agency concluded that the four surrogate chemicals (CAS Reg.
Nos. 147732-60-3, 39354-74-0, 119345-04-9 (alternate CAS Reg. No.
28519-02-0), and 70191-76-3) are representative of all the chemicals in
the ADPOS cluster. Additionally, the Agency concluded that the
currently available toxicity dataset is adequate to apply to the ADPOS
inerts and to characterize these surfactants. Further, the Agency noted
that there was sufficient bracketing of the range of molecular weights
expected from the inerts in this grouping.
The ADPOS inerts are not acutely toxic by the oral, dermal, and
inhalation routes of exposure, and are moderately irritating to the
skin and eyes. Respiratory irritation is possible with mists. The ADPOS
inerts, like all surfactants, are surface-active materials that can
damage the structural integrity of cellular membranes at high dose
levels. Thus, surfactants are often corrosive and irritating in
concentrated solutions, as indicated by the acute toxicity studies for
these inert materials. It is possible that some of the observed
toxicity seen in the repeated studies, such as diarrhea,
gastrointestinal tract effects or decreased body weight gain, can be
attributed to the corrosive and irritating nature of these surfactants.
The liver and possibly kidney appear to be the primary target organs.
Following subchronic exposures to ADPOS inerts, the most sensitive
effects include increased liver enzymes (alanine and aspartate
aminotransferase), increased prothrombin time and soft/decreased feces
in males and significant decreases in body weight gain in both sexes
after 47-54 days of dosing at doses between 28 and 92 mg/kg/day. In
comparison, in most of the other studies, no effects were observed in
the range of 100 to 500
[[Page 37600]]
mg/kg/day, even following chronic exposures. There is some evidence of
neurotoxicity in a 28-day rat study, including high-stepping gait,
ataxia and salivation; however, these effects are seen at the highest
dose tested (HDT). The Agency considered these effects to be the result
of a high dose rather than a neurotoxic condition. No quantitative or
qualitative increased susceptibility was demonstrated in the offspring
in the two reproductive/developmental toxicity studies in rats
following in utero and postnatal exposure. In one OPPTS Harmonized
Guideline 870.3650 study there were no developmental effects at the HDT
in the presence of maternal toxicity such as increased liver enzymes
and prothrombin time. In a second OPPTS Harmonized Guideline 870.3650
study with test substance (CAS Reg. No. 147732-60-3) the developmental
effects were manifested as statistically significantly decrease in body
weight and clinical signs at 1,000 mg/kg which was in the presence
severe maternal toxicity which manifested as mortality, clinical signs,
and decrease in body weight were observed.
There is no evidence that the ADPOS inerts are mutagenic, but
there is some evidence of potential clastogenicity for a C6
inert formulation. In vitro data for genotoxicity are available for the
range of alkyl chains of the lower (C6) and upper
(C16) compounds in this group. The Ames tests were negative
for the C6 and C16 inerts. The C16
analogue was negative in the CHO/HGPRT forward mutation assay. In
chromosomal aberration tests that evaluate clastogenicity,
C6 (CAS Reg. No. 147732-60-3) was clastogenic in human
lymphocytes in the absence of metabolic activation (S9), but was
negative in rat lymphocytes. The registrants attributed this positive
response to peroxide as an unwanted constituent, and no longer use
peroxide in the ADPOS process. C16 was negative in both
human and rat lymphocytes, although the human lymphocyte study was not
acceptable. In vivo, there was no evidence of a cytogenetic response in
rat bone marrow cells for C16 (CAS Reg. No. 70191-76-3) in
an unacceptable study that lacked positive controls, which limits the
confidence of this finding. Based on these studies and the overall
weight of the evidence, the Agency concluded that the ADPOS inerts are
not likely to be mutagenic. There is no evidence of carcinogenicity in
the chronic/carcinogenicity rat study at does up to 500 mg/kg/day. In
addition, no tumors were observed in the two year toxicity study in
dogs. Based on the negative response for carcinogenicity in the
carcinogenicity study in rats and two year dog study, negative response
for mutagenicity, lack of any alerts in model predictions, and SAR
analysis, the Agency concluded that the ADPOS inerts are not likely to
be carcinogenic.
Specific information on the studies received and the nature of the
adverse effects caused by ADPOS as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Alkyl Diphenyl Oxide Sulfonates (JITF
CST 18 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 9-15 in docket ID
number EPA-HQ-OPP-2008-0665.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for ADPOS used for human
health risk assessment is shown in the Table of this unit.
Table --Summary of Toxicological Doses and Endpoints for ADPOS for Use in Human Health Risk Assessment
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Point of Departure and
Exposure Scenerio Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assesment Effects
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Acute Dietary NOAEL=115 milligrams/ Acute RfD=1.15 mg/kg/ 28-day oral toxicity
(General Population, including kilograms/day (mg/kg/ day study- rats (CAS No.
Infants and Children). day) UFA=10x aPAD=1.15 mg/kg/day.... 70191-76-3)
UFH=10x................ LOAEL= 367 mg/kg/day,
FQPA SF=1x............. based on Post-dosing
salivation (day 1 post-
dose in 3/5 male and 2/
5 female rats; 2-28
all rats.)
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[[Page 37601]]
Chronic Dietary NOAEL=28 mg/kg/day Chronic RfD=0.28 mg/kg/ Reproductive/
(all populations).................... UFA=10x day developmental- rat(CAS
UFH=10x................ cPAD=0.28 mg/kg/day.... No. 70191-76-3)
FQPA SF=1x............. LOAEL= 92 mg/kg/day,
based on increasted
ALT and AST in
females, increased
prothrombin time and
soft/decrease feces in
males and significant
decreased feces in
males and significant
decreased in body
weight gain in both
sexes after 47-54 days
of dosing.
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Short-Term NOAEL=115 mg/kg/day Residential/ 28-day oral toxicity
(1-30 days Incidental Oral/Dermal/ UFA=10x Occupational LOC for study- rats(CAS No.
Inhalation). UFH=10x................ MOE=100 70191-76-3)
FQPA SF=1x............. LOAEL= 367 mg/kg/day,
based on ost-dosing
salvation (day 1 post-
dose in 3/5 male and 2/
5 female rats; days 2-
28 all rats).
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Intermediate and Long-Term (1-6 NOAEL=28 mg/kg/day Residential/ Reproductive/
months/>6months UFA=10x Occupational LOC for developmental- rat(CAS
Incidental Oral/Dermal/Inhalation.... UFH=10x................ MOE= 100 No. 70191-76-3)
FQPA SF=1x............. LOAEL= 92 mg/kg/day,
based on increasted
ALT and AST in
females, increased
prothrombin time and
soft/decreased feces
in males and
significant decreased
feces in males and
significant decreased
in body weight gain in
both sexes after 47-54
days of dosing.
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Cancer (oral, dermal, inhalation) Classification: no
edivence of
carcinogenicity in
available studies
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1The LOAEL of 367 mg/kg/day was used from MRID 46989217 and NOAEL of 115 mg/kg/day was used from MRID 46989216
due to artifact of dose selection. Point of Departure (POD) = A data point or an estimated point that is
derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk
associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level.
LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to
human (interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). PAD = population adjusted dose (a=acute, c=chronic). FQPA SF = FQPA Safety Factor. RfD =
reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to ADPOS, EPA considered exposure under the petitioned-for
exemptions from the requirement of a tolerance. EPA assessed dietary
exposures from ADPOS 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 ADPOS inert ingredients. 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 general
approach taken to assess inert ingredient risks in the absence of
residue data is contained in the memorandum entitled ``Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.''
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products is
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient. In the case of ADPOS, EPA made a specific
adjustment to the dietary exposure assessment to account for the use
limitations of the amount of ADPOS that
[[Page 37602]]
may be in formulations (no more than 20% by weight) and assumed that
the ADPOS are present at the maximum limitations rather than at equal
quantities with the active ingredient. This remains a very conservative
assumption because surfactants are generally used at levels far below
this percentage.
Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100 percent of all foods are treated with the
inert ingredient at the rate and manner necessary to produce the
highest residue legally possible for an active ingredient. In summary,
EPA chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
ii. Cancer. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts suggestive of carcinogenicity. No structural alerts
for carcinogenicity were identified. There is no evidence of
carcinogenicity in the chronic/carcinogenicity study in rats at doe up
to 500 mg/kg/day. In addition, no tumors were observed in the two year
toxicity study in dogs. Based on the negative response of the
carcinogenicity study in rats and two year dog study, negative response
for mutagenicity, lack of any alerts in model predictions, and SAR
analysis, the Agency concluded that the ADPOS inerts are not likely to
be carcinogenic. Since the Agency has not identified any concerns for
carcinogenicity relating to the ADPOS inerts, a cancer dietary exposure
assessment was not performed.
iii. Anticipated residue and percent crop treated (PCT)
information. EPA did not use anticipated residue and/or PCT information
in the dietary assessment for ADPOS. Tolerance level residues and/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 ADPOS in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of ADPOS. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
A screening level drinking water analysis, based on the Pesticide
Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) was
performed to calculate the estimated drinking water concentrations
(EDWCs) of ADPOS. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of the ADPOS were conducted. Modeled acute drinking water values ranged
from 0.001 parts per billion (ppb) to 41 ppb. Modeled chronic drinking
water values ranged from 0.0002 ppb to 19 ppb. Further details of this
drinking water analysis can be found at http://www.regulations.gov in
document ``Alkyl Diphenyl Oxide Sulfonates (JITF CST 18 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 16 and 71-73 in docket ID
number EPA-HQ-OPP-2008-0665.
For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for ADPOS, 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). ADPOS may be used in
inert ingredients in pesticide products that are registered for
specific uses that may result in both indoor and outdoor residential
exposures. A screening level residential exposure and risk assessment
was completed for products containing ADPOS as inert ingredients. In
this assessment, representative scenarios, based on end-use product
application methods and labeled application rates, were selected.The
ADPOS inerts are not added to any insecticidal products intended for
pet use and are not likely to be used in personal care products. The
Agency conducted an assessment to represent worst-case residential
exposure by assessing ADPOS in pesticide formulations (outdoor
scenarios) and ADPOS in disinfectant type uses (indoor scenarios).
Based on information contained in the petition, the ADPOS inerts can be
present in consumer cleaning products. Therefore, the Agency assessed
the disinfectant-type products containing ADPOS using several anti-
microbial scenarios to represent worst-case residential handler
exposure. Standard methodologies based on the Agency's Residential SOPs
were used to assess residential post application exposure to hard
surfance cleaners.
Further details of this residential exposure and risk analysis can
be found at http://www.regulations.gov in ``Alkyl Diphenyl Oxide
Sulfonates (JITF CST 18 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 20-28 and 94-110 in docket ID number EPA-HQ-OPP-2008-0665.
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 ADPOS to share a common mechanism of toxicity
with any other substances, and ADPOS do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that ADPOS
[[Page 37603]]
do not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The toxicity database
consists of two rat reproductive/developmental screening studies. There
was no increased susceptibility to the offspring of rats following in
utero or postnatal exposure in the two reproductive/developmental
toxicity screening tests, In one study, there were no adverse effects
to offspring, while decreased pup body weight and clinical signs were
noted in the presence of maternal/parental toxicity at the limit dose
of 1,000 mg/kg/day in a second study.
There are no neurotoxicity studies available for the ADPOS,
however, there is some evidence of neurotoxicity in a subchronic rat
study at 367 mg inert/kg/day (1,000 mg product/kg/day), including high-
stepping gait, ataxia and salivation. However, since the effects noted
occurred at doses significantly higher than the current points of
departure for risk assessment, additional neurotoxicity data is not
required.
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 ADPOS is considered adequate for
assessing the risks to infants and children (the available studies are
described in Unit iv.D.2.
ii. There is some evidence of neurotoxicity in a 28-day rat study,
including high-stepping gait, ataxia and salivation; however, these
effects are seen at the HDT. Since these effects occurred at dose
levels significantly higher than the current points of departure used
for regulation, the Agency determined that the points of departure
selected for this risk assessment are protective of any neurotoxicity
effects. Therefore, additional neurotoxicity data and other toxicity
data are not required.
iii. No quantitative or qualitative increased susceptibility was
demonstrated in the offspring in the two reproductive/developmental
toxicity studies in rats following in utero and postnatal exposure.
iv. The Agency has concluded that an additional UF for
extrapolation from subchronic toxicity study to a chronic exposure
scenario would not be needed since toxicity is not expected to increase
with a longer duration of exposure for the ADPOS inerts. This is
because for the most sensitive endpoint, prothrombin time (PT), the
clotting factor proteins evaluated by the PT test have short plasma
half-lives, ranging from 4 hours for factor VII to a maximum of 96
hours for fibrinogen. The clotting factors are being continually
synthesized by the liver and by 47 days of exposure would have reached
steady state and further exposure is not expected to result in any
further increase in prothrombin time. Therefore, the Agency concluded
that the 10X interspecies and 10X intraspecies UF would be adequately
protective.
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 ADPOS in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by ADPOS.
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 ADPOS as
inert ingredients in pesticide product formulations into its exposure
assessment. Specifically, the petition includes a use limitation of
ADPOS at not more than 20% 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. Using the exposure assumptions discussed in this unit
for acute exposure, and the use limitations of not more than 20% by
weight in pesticide formulations, the acute dietary exposure from food
and water to ADPOS at the 95th percentile for food and drinking water
is 20% of the aPAD for the U.S. population and 55% of the aPAD for
children 1-2 yrs old, the population group receiving the greatest
exposure.
2. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
drinking water using the exposure assumptions discussed in this unit
for chronic exposure, and the use limitations of not more than 20% by
weight in pesticide formulations, the chronic dietary exposure from
food and water to ADPOS is 28% of the cPAD for the U.S. population and
90% 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).
ADPOS inerts 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 ADPOS. Using the exposure
assumptions described in this
[[Page 37604]]
unit, EPA has concluded the combined short-term food, water, and
residential exposures aggregated result in aggregate MOEs of 490 and
530, for adult males and females respectively, for a combined high end
dermal and inhalation handler exposure with a high end post application
dermal exposure and an aggregate MOE of 380 for children for a combined
dermal exposure with hand-to-mouth exposure. As the level of concern is
for MOEs that are lower than 100, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
ADPOS inerts 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 ADPOS.
Using the exposure assumptions described in this unit, EPA has
concluded the combined intermediate-term food, water, and residential
exposures aggregated result in aggregate MOEs of 320 and 400, for adult
males and females respectively, and an aggregate MOE of 100 for
children. As the level of concern is for MOEs that are lower than 100,
these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to the ADPOS
inerts.
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 ADPOS.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Residue Limits
The Agency is not aware of any country requiring a tolerance for
ADPOS nor have any CODEX Maximum Residue Levels been established for
any food crops at this time.
VI. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of sodium monoalkyl and dialkyl
(C6-C16) phenoxybenzenedisulfonates and related
acids, when used as inert ingredients at a maximum of 20% by weight in
pesticide formulations applied to crops pre-harvest and post-harvest,
or to animals.
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 21, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.910, 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.
* * * * *
[[Page 37605]]
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
Sodium monoalkyl and dialkyl (C6- Not to exceed 20% Surfactants,
C16) phenoxy in pesticide related adjuvants
benzenedisulfonates and related formulations of surfactants
acids (CAS Reg. Nos. 147732-59-
0, 147732-60-3, 169662-22-0,
70191-75-2, 36445-71-3, 39354-
74-0, 70146-13-3, 119345-03-8,
149119-20-0, 149119-19-7,
119345-04-9, 28519-02-0, 25167-
32-2, 30260-73-2, 65143-89-7,
70191-76-3)
* * * * *
------------------------------------------------------------------------
0
3. 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
------------------------------------------------------------------------
* * * * *
Sodium monoalkyl and dialkyl (C6- Not to exceed 20% Surfactants,
C16) phenoxy in pesticide related adjuvants
benzenedisulfonates and related formulations of surfactants
acids (CAS Reg. Nos. 147732-59-
0, 147732-60-3, 169662-22-0,
70191-75-2, 36445-71-3, 39354-
74-0, 70146-13-3, 119345-03-8,
149119-20-0, 149119-19-7,
119345-04-9, 28519-02-0, 25167-
32-2, 30260-73-2, 65143-89-7,
70191-76-3)
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
[FR Doc. E9-17957 Filed 7-28-09; 8:45 am]
BILLING CODE 6560-50-S