[Federal Register Volume 74, Number 149 (Wednesday, August 5, 2009)]
[Rules and Regulations]
[Pages 38945-38952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18717]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0944; FRL-8429-4]
Polyoxyethylene polyoxypropylene mono(di-sec-butylphenyl) ether;
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 Polyoxyethylene polyoxypropylene
mono(di-sec-butylphenyl) ether when used as an inert ingredient in
herbicide formulations only, for pre-harvest uses and at no more than
30% by weight in herbicide formulations intended for application to
turf. The Joint Inerts Task Force (JITF), Cluster Support Team Number
20, 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 Polyoxyethylene polyoxypropylene
mono(di-sec-butylphenyl) ether.
DATES: This regulation is effective August 5, 2009. Objections and
requests for hearings must be received on or before October 5, 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-2008-0944. 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. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/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-2008-0944 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 October 5, 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-2008-0944, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background
In the Federal Register of March 25, 2009 (74 FR 12856) (FRL-8399-
4), 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
8E7494) by The Joint Inerts Task Force (JITF), Cluster Support Team 20
(CST 20), c/o CropLife America, 1156 15th Street, NW., Suite 400,
Washington, DC 20005. The petition requested that 40 CFR 180.920 be
amended by establishing exemptions from the requirement of a tolerance
for residues of the inert ingredient
[[Page 38946]]
Polyoxyethylene polyoxypropylene mono(di-sec-butylphenyl) ether, herein
referred to in this document as POE/POP mono(di-sec-butylphenyl) ether,
when used as an inert ingredient in herbicide formulations for pre-
harvest uses under 40 CFR 180.920. That notice referenced a summary of
the petition prepared by The JITF, CST 20, the petitioner, which is
available to the public in the docket, http://www.regulations.gov.
There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the exemption requested by limiting POE/POP mono(di-sec-
butylphenyl) to a maximum of 30% by weight in the herbicide
formulations intended for application to turf. This limitation is based
on the Agency's risk assessment which can be found at http://www.regulations.gov in document Polyoxyethylene Polyoxypropylene
Mono(di-sec-Butylphenyl) Ether (JITF CST 20 Inert Ingredients). Human
Health Risk Assessment to Support Proposed Exemption from the
Requirement of a Tolerance When Used as Inert Ingredients in Pesticide
Formulations in docket ID number EPA-HQ-OPP-2008-0944.
This petition was submitted in response to a final rule of August
9, 2006, (71 FR 45415) in which the Agency revoked, under section
408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA), the
existing exemptions from the requirement of a tolerance for residues of
certain inert ingredients because of insufficient data to make the
determination of safety required by FFDCA section 408(b)(2). The
expiration date for the tolerance exemptions subject to revocation was
August 9, 2008, which was later extended to August 9, 2009 by a final
rule published in the Federal Register of August 4, 2008 (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 residue of POE/POP
mono(di-sec-butylphenyl) ether when used as an inert ingredient in
herbicide formulations only, for pre-harvest uses, and provided that
uses in herbicide formulations intended for turf application are
limited to no more than 30% by weight in the final formulation. 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 consists of one
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats for the representative
POE/POP mono(di-sec-butylphenyl) ether, three subchronic oral toxicity
studies (rats and dogs), and acute data on representative POE/POP
mono(di-sec-butylphenyl) ether inerts.
The POE/POP mono(di-sec-butylphenyl) ether inert ingredients are
not acutely toxic by the oral, dermal and inhalation routes of exposure
and are slight to severe eye irritants and not a skin irritant.
The OPPTS Harmonized Guideline 870.3650 Combined Repeated Dose
Toxicity Study with rats demonstrated that the representative POE/POP
mono(di-sec-butylphenyl) ether had no effect on food consumption, body
weight gain, and FOB parameters in males and females at any of the
doses tested. Blood coagulation in male and female rats in the highest
dose group as measured by prothrombin time, was significantly reduced.
Microscopic effects observed included minimal or mild centrilobular
hepatocellular hypertrophy which was seen in the liver of 4 of 5 male
rats and 3 of 5 female rats in the 304 milligrams/kilogram/day (mg/kg/
day) dose group. In the affected livers, centrilobular areas were more
prominent due to enlarged (hypertrophied) hepatocytes with an increased
amount of dense granular eosinophilic cytoplasm. As hepatocellular
hypertrophy was not accompanied by inflammatory or degenerative
changes, this finding was considered to be adaptive in nature, in
response to metabolizing the test substance, and not adverse. An
increased incidence of thyroid follicular epithelial hypertrophy and
hyperplasia was observed in all male rats in the 304 mg/kg/day dose
group. This follicular change was characterized by increased size of
follicular epithelial cells (hypertrophy) and, in some areas, there
were increased amounts of small follicles and increased cells within
the follicles (hyperplasia). Thyroid
[[Page 38947]]
hormones were not measured in this study. It is possible that the
thyroid changes were due to an indirect effect by increased metabolism
of thyroid hormones by the liver. No treatment related effects were
observed on litter sizes or on the early development of pups.
In a 90-day oral toxicity study performed in rats (MRID 46610818),
Polyglycol 26-2 was administered to male and female rats at dose levels
of 0, 5, 15, 50, 150, and 500 mg/kg/day. The no-observed-effect-level
(NOAEL) was determined to be 50 mg/kg/day, and the lowest-observed-
effect-level (LOAEL) was determined to be 150 mg/kg/day based up
lesions in the liver and kidney of both sexes.
In a 90-day Oral Toxicity Study performed in Beagle dogs (MRID
46610819), Polyglycol 26-2 was administered orally at 0, 3, 10, 36, and
92 mg/kg/day. No evidence of adverse effects was observed at any of the
doses in this study.
A similar study in Beagle dogs was carried out for Polyglycol 26-3
(MRID 46610820). No adverse effects were noted at doses up to 100 mg/
kg/day (the higest dose tested). The study was classified as
Acceptable/non-guideline.
There are no published metabolism studies for this series of
surfactants. The mammalian metabolism pathway proposed in the petition
is based on the polyalkoxylate metabolism of alkyl alchohols documented
in publicly available literature. By analogy to the polyethoxylated
surfactants, the significant metabolic pathway could be hydrolytic or
oxidative removal of the polyalkoxylate chains to generate an isomeric
mixture of di-sec butyl phenol and the polypropoxylate polyethoxylate
alchohol that may be further oxidized.
The proposed polypropoxylates and polyethoxylates, alchohols and
carboxylic acids, should be rapidly excreted as conjugates. The liver,
lungs and gastrointestinal tract are the most important sites for
phenol metabolism with excretion proceeding rapidly through conjugation
to generate phenyl glucuronide and phenyl sulfate. The di-sec butyl
side chains may or may not be degraded but depending on their position
on the phenol, because of steric hindrance, may slow down conjugation
and conjugation of the phenolic polymeric component.
There are no chronic toxicity studies available for POE/POP
mono(di-sec-butylphenyl) ether. The Agency used a qualitative structure
activity relationship (SAR) database, DEREK Version 11, to determine if
there were structural alerts suggestive of carcinogenicity. No
structural alerts were identified.
Specific information on the studies received and the nature of the
adverse effects caused by POE/POP mono(di-sec-butylphenyl) ether, as
well as, the NOAEL and the LOAEL from the toxicity studies can be found
at http://www.regulations.gov in document Polyoxyethylene
Polyoxypropylene Mono(di-sec-Butylphenyl) Ether (JITF CST 20 Inert
Ingredients). Human Health Risk Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations at pp 9-14 and pp 42-47 in docket
ID number EPA-HQ-OPP-2008-0944.
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 POE/POP mono(di-sec-
butylphenyl) ether used for human health risk assessment is shown in
the following Table.
Table--Summary of Toxicological Doses and Endpoints for POE/POP mono(di-sec-butylphenyl) ether for Use in Human
Health Risk Assessment
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Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
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Acute dietary (all populations) An effect attributable to a single exposure was not identified.
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[[Page 38948]]
Chronic dietary (all populations) NOAEL= 82 mg/kg/day Chronic RfD = 0.82 mg/ Combined Repeated Dose
UFA = 10x.............. kg/day Toxicity Study with
UFH = 10x.............. cPAD = 0.82 mg/kg/day.. the Reproduction/
FQPA SF = 1x........... Developmental Toxicity
Screening Test-Rat
OPPTS Harmonized
Guideline 870.3650
Parental LOAEL = 304 mg/
kg bw/day based on
clinical signs in male
and female rats
(salivation),
increased incidence of
thyroid follicular
epithelial hypertrophy
and hyperplasia in
male rats, reduction
of prothrombin time in
male and female rats,
and reduction of
activated partial
thromboplastin time in
female rats.
Reproductive/
Developmental LOAEL
was not observed.
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Incidental Oral, Dermal, and NOAEL= 82 mg/kg/day Residential LOC for MOE Combined Repeated Dose
Inhalation (Short-, Intermediate-, UFA = 10x.............. = 100. Toxicity Study with
and Long-Term) UFH = 10x.............. the Reproduction/
FQPA SF = 1x........... Developmental Toxicity
50% dermal absorption; Screening Test-Rat
inhalation toxicity is OPPTS Harmonized
assumed to be Guideline 870.3650
equivalent to oral Parental LOAEL = 304 mg/
toxicity. kg bw/day based on
clinical signs in male
and female rats,
increased incidence of
thyroid follicular
epithelial hypertrophy
and hyperplasia in
male rats, reduction
of prothrombin time in
male and female rats,
and reduction of
activated partial
thromboplastin time in
female rats.
Reproductive/
Developmental LOAEL
was not observed.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment.
Based on SAR analysis, POE/POP mono(di-sec-butylphenyl) ether is not
expected to be carcinogenic.
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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. LOC = level of concern.
C. Exposure Assessment
Sufficient data were provided on the chemical identity of the POE/
POP mono(di-sec-butylphenyl) ether inert ingredients; 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 generic cluster
structures, the modeled physicochemical information, as well as the
structure-activity relationship information. Additionally, information
on other surfactants and chemicals of similar size and functionality
was considered to determine the residues of concern for these inert
ingredients.
The registrant selected Polyglycol 26-2 (CAS RN 69029-39-6), a
complex mixture of polyethoxylated/polypropoxylated, POE/POP, ethers of
a mixture of the three different isomeric di-sec-butyl phenols, for
toxicity testing. The Agency has concluded that the cluster grouping
was appropriate. Based on the chemical structure, it is likely that the
parent compound will degrade in the environment to 2,4-di-sec-butyl
phenol, and 2,6-di-sec-butyl phenol. The Agency considered the SAR
analysis, and information in the literature, and concluded that the
butyl-phenols are not likely to be more toxic than the parent
compounds. Considering the high residue approach to the dietary risk
assessment that basically assumes no degradation of the parent and 100%
CT, and the fact that the two degradates are not likely to be more
toxic than the parent, the parent compound risk assessment is
protective of any potential toxicity effects of the butylphenols.
Therefore, it is not necessary to assess the exposure to the
butylphenols separately.
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to POE/POP mono(di-sec-butylphenyl) ether, EPA considered
exposure under the petitioned-for exemptions from the requirement of a
tolerance. EPA assessed dietary exposures from POE/POP mono(di-sec-
butylphenyl) ether in food as follows:
i. Acute exposure. No adverse effects attributable to a single
exposure of POE/POP mono(di-sec-butylphenyl) ether was seen in the
toxicity databases. Therefore, acute dietary risk assessments for POE/
POP mono(di-sec-butylphenyl) ether is not necessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the U.S.
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 POE/POP mono(di-sec-
butylphenyl) ether. In the absence of specific residue data, EPA has
developed an approach which uses surrogate information to derive upper
bound exposure estimates for the subject inert ingredient. Upper bound
exposure estimates are based on the highest tolerance for a given
commodity from a list of high-use
[[Page 38949]]
insecticides, herbicides, and fungicides. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products is
generally at least 50% of the product and often can be much higher.
Further, pesticide products rarely have a single inert ingredient;
rather there is generally a combination of different inert ingredients
used which additionally reduces the concentration of any single inert
ingredient in the pesticide product in relation to that of the active
ingredient. In the case of POE/POP mono(di-sec-butylphenyl) ether, EPA
made a specific adjustment to the dietary exposure assessment to
account for the use of these inerts in herbicide formulations only. The
Agency identified the residue drivers (crop/tolerance combinations) in
this assessment that constitute the majority of the dietary risk, and
has replaced the residue value with the highest herbicide tolerances
for those commodities. The risk drivers for the dietary assessment for
which herbicide tolerances were used were the leafy vegetable (except
brassica) crop group, pome fruits, and grapes.
Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100% of all foods are treated with the inert
ingredient at the rate and manner necessary to produce the highest
residue legally possible for an active ingredient. In summary, EPA
chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
iii. Cancer. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts suggestive of carcinogenicity. No structural alerts
for carcinogenicity were identified. POE/POP mono(di-sec-butylphenyl)
ether are not expected to be carcinogenic. Therefore, a cancer dietary
exposure assessment is not necessary to assess cancer risk.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for POE/POP mono(di-sec-butylphenyl) ether.
Tolerance level residues and/or 100% CT were assumed for all food
commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for POE/POP mono(di-sec-butylphenyl) ether in drinking
water. These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of POE/POP mono(di-sec-
butylphenyl) ether. Further information regarding EPA drinking water
models used in the pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
A screening level drinking water analysis, based on the Pesticide
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) was
performed to calculate the estimated drinking water concentrations
(EDWCs) of POE/POP mono(di-sec-butylphenyl) ether. Modeling runs on
four surrogate inert ingredients using a range of physical chemical
properties that would bracket those of POE/POP mono(di-sec-butylphenyl)
ether were conducted. Modeled acute drinking water values ranged from
0.001 parts per billion (ppb) to 41 ppb. Modeled chronic drinking water
values ranged from 0.0002 ppb to 19 ppb. Further details of this
drinking water analysis can be found at http://www.regulations.gov in
the document Polyoxyethylene Polyoxypropylene Mono(di-sec-Butylphenyl)
Ether (JITF CST 20 Inert Ingredients). Human Health Risk Assessment to
Support Proposed Exemption from the Requirement of a Tolerance When
Used as Inert Ingredients in Pesticide Formulations at pp 15-16 and 50-
52 in docket ID number EPA-HQ-OPP-2008-0944.
For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for POE/POP mono(di-sec-butylphenyl) ether, a conservative
drinking water concentration value of 100 ppb based on screening level
modeling was used to assess the contribution to drinking water for
chronic dietary risk assessments for the parent compounds and for the
metabolites of concern. These values were directly entered into the
dietary exposure model.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). POE/POP mono(di-sec-
butylphenyl) ether may be used as inert ingredients in herbicide
products that are registered for specific uses that may result in
outdoor residential exposures. A screening level residential exposure
and risk assessment was completed for herbicide products containing
POE/POP mono(di-sec-butylphenyl) ether as inert ingredients. In this
assessment, representative scenarios, based on end-use product
application methods and labeled application rates, were selected. The
POE/POP mono(di-sec-butylphenyl)
[[Page 38950]]
may be used as inert ingredients in pesticide formulations (herbicides)
that are used around the home. The Agency did not identify any products
intended for use on pets or home cleaning products that contain the
POE/POP mono(di-sec-butylphenyl) ether inert ingredients. The Agency
conducted an assessment to represent worst-case residential exposures
to herbicides only by assessing POE/POP mono(di-sec-butylphenyl) ether
in herbicide formulations (Outdoor Scenarios). Further details of this
residential exposure and risk analysis can be found at http://www.regulations.gov in the memorandum entitled JITF Inert Ingredients.
Residential and Occupational Exposure Assessment Algorithms and
Assumptions Appendix for the Human Health Risk Assessments to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide Formulations (D364751, 5/7/09, Lloyd/
LaMay in docket ID number EPA-HQ-OPP-2008-0710.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found POE/POP mono(di-sec-butylphenyl) ether to share a
common mechanism of toxicity with any other substances, and the POE/POP
mono(di-sec-butylphenyl) ether do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that the POE/POP mono(di-
sec-butylphenyl) ether 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 available mammalian
toxicology database consists of one combined repeated dose toxicity
study with the reproduction/developmental toxicity screening test in
rats for alkyl phenolic glycol ether, three subchronic oral toxicity
studies (rats and dogs), and acute data on the representative inerts.
There was no evidence of increased susceptibility in the offspring
because no developmental or reproductive toxicity was observed in the
OPPTS Harmonized Guideline 870.3650 study. No treatment related effects
were observed on litter sizes or on the early development of pups.
3. Conclusion. EPA has determined that reliable data show that 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 POE/POP mono(di-sec-butylphenyl) ether
is considered adequate for assessing the risks to infants and children
(the available studies are described in Unit IV.D.2.).
ii. No developmental or reproductive toxicity was observed in the
OPPTS Harmonized Guideline 870.3650 combined repeated dose toxicity
study with the reproduction/developmental toxicity screening test in
rats following prenatal and postnatal exposure and there are no
concerns for sensitivity of the offspring.
iii. There was no evidence of neurotoxicity in the database. In
addition, there is no indication that POE/POP mono(di-sec-butylphenyl)
ether are neurotoxic chemicals and thus there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
iv. The primary target organ toxicity observed in the database is
thyroid toxicity, prothrombin time, and body weight effects. Thyroid
effects are manifested following short duration exposure and only
observed at 304 mg/kg/day (the higest dose tested). The Agency has
considerable knowledge and understanding of the mechanism of thyroid
toxicity. The Agency concluded that any dose that prevents pertuvation
of thyroid would be protective of chronic and cancer effects.
Therefore, the Agency concluded that regulating at a NOAEL of 82 mg/kg/
day with effects seen at 304 mg/kg/day with a hundredfold uncertainty
factor (UFA=10X; UFh=10X) provides an adequate
margin of protection and that an additional UF for extrapolation from
subchronic toxicity study to a chronic exposure scenario is not needed.
v. There are no residual uncertainties identified in the exposure
databases. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children. The food exposure assessments are considered
to be highly conservative as they are based on the use of the highest
tolerance level from the surrogate pesticides for every food and 100%
crop treated is assumed for all crops. EPA also made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to POE/POP mono(di-sec-butylphenyl) ether 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 POE/POP mono(di-sec-butylphenyl) ether.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the acute populations
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD represent the highest safe exposures, taking into account
all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the
POD by all applicable UFs. For linear cancer risks, EPA calculates the
probability of additional cancer cases given the estimated aggregate
exposure. Short-, intermediate-, and chronic-term risks are evaluated
by comparing the estimated aggregate food, water, and residential
exposure to the POD to ensure that the MOE called for by the product of
all applicable UFs is not exceeded.
1. Acute risk. There was no hazard attributable to a single
exposure seen in the toxicity database for POE/POP mono(di-sec-
butylphenyl) ether. Therefore, the POE/POP mono(di-sec-butylphenyl)
ether 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 (including limiting the uses of the POE/POP
mono(di-sec-butylphenyl)
[[Page 38951]]
ether inert ingredients in agricultural products to use in herbicide
formulations and using the maximum herbicide tolerances for key
commodities), the chronic dietary exposure from food and water to POE/
POP mono(di-sec-butylphenyl) ether is 14% of the cPAD for the U.S.
population and 36% of the cPAD for children 1 to 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).
POE/POP mono(di-sec-butylphenyl) ether 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 the POE/POP mono(di-sec-butylphenyl) ether. Using the exposure
assumptions described in this unit, EPA has concluded that the combined
short-term aggregated food, water, and residential exposures result in
aggregate MOEs of 110 for both adult males and females, respectively.
Adult residential exposure combines high end outdoor dermal and
inhalation handler exposure with a high end post application dermal
exposure from contact with treated lawns. EPA has concluded the
combined short-term aggregated food, water, and residential exposures
result in an aggregate MOE of 140 for children. Children's residential
exposure includes total exposures associated with contact with treated
lawns (dermal and hand-to-mouth exposures). 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).
POE/POP mono(di-sec-butylphenyl) ether 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 POE/POP mono(di-sec-butylphenyl) ether. Using the exposure
assumptions described in this unit, EPA has concluded that the combined
intermediate-term aggregated food, water, and residential exposures
result in aggregate MOEs of 470 and 490 for both adult males and
females, respectively. Adult residential exposure includes high end
post application dermal exposure from contact with treated lawns. EPA
has concluded that the combined intermediate-term aggregated food,
water, and residential exposures result in an aggregate MOE of 190 for
children. Children's residential exposure includes total exposures
associated with contact with treated lawns (dermal and hand-to-mouth
exposures). 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 POE/POP
mono(di-sec-butylphenyl) ether.
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 POE/POP mono(di-sec-butylphenyl) ether.
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
POE/POP mono(di-sec-butylphenyl) ether 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 Polyoxyethylene polyoxypropylene mono(di-
sec-butylphenyl) ether when used as an inert ingredient in herbicide
formulations only, for pre-harvest uses under 40 CFR 180.920 and used
at no more than 30% by weight in herbicide formulations intended for
application to turf.
VII. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance 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 exemption 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
[[Page 38952]]
(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 28, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.920, the table is amended by adding alphabetically the
following inert ingredients:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Polyoxyethylene polyoxypropylene Limited to Surfactants,
mono(di-sec-butylphenyl) ether herbicide related adjuvants
(CAS Reg. No. 69029-39-6) formulations of surfactants
only, and to no
more than 30% by
weight in
herbicide
formulations
intended for
application to
turf
* * * * * * *
------------------------------------------------------------------------
[FR Doc. E9-18717 Filed 8-4-09; 8:45 am]
BILLING CODE 6560-50-S