Polyoxyethylene polyoxypropylene mono(di-sec-butylphenyl) ether; Exemption from the Requirement of a Tolerance, 38945-38952 [E9-18717]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 149 (Wednesday, August 5, 2009)]
[Rules and Regulations]
[Pages 38945-38952]
From the Federal Register Online via the Government Printing 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 https://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; e-mail address: leifer.kerry@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
https://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at https://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at https://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at https://www.epa.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: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background

    In the Federal Register of 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, https://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 https://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 https://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 https://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
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)             An effect attributable to a single exposure was not identified.
----------------------------------------------------------------------------------------------------------------

[[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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
 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 https://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 https://www.epa.gov/oppefed1/models/water/index.htm.
    A screening level drinking water analysis, based on the Pesticide 
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) was 
performed to calculate the estimated drinking water concentrations 
(EDWCs) of 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 https://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 https://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 https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA 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