Document ID: EPA-HQ-OPP-2008-0474-0009
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of Tolerance: Diethylene Glycol Mono Butyl Ether
Posted Date: 2011-06-29T04:00Z

[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Rules and Regulations]
[Pages 38026-38033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16188]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0474; FRL-8876-5]

Diethylene Glycol Mono Butyl 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 diethylene glycol mono butyl ether (CAS 
Reg. No. 112-34-5) when used as a pesticide inert ingredient as a 
solvent, stabilizer and/or antifreeze within pesticide formulations/
products without limitation under 40 CFR 180.920. Huntsman, Dow 
AgroSciences L.L.C., Nufarm Americas Inc., BASF, Stepan Company, 
Loveland Products Inc., and Rhodia Inc. submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an 
establishment of an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of diethylene glycol mono butyl ether.

DATES: This regulation is effective June 29, 2011. Objections and 
requests for hearings must be received on or before August 29, 2011, 
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-2008-0474. 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,

[[Page 38027]]

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: Lisa Austin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7894; e-mail address: Austin.Lisa@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:
     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 provides 
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 get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines 
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2008-0474 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
August 29, 2011. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2008-0474, 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. Petition for Exemption

    In the Federal Register of July 9, 2008 (73 FR 39291) (FRL-8371-2), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 8E7355) by Huntsman, 
10003 Woodloch Forest Drive, The Woodlands, TX 77380; Dow AgroSciences 
L.L.C., 9330 Zionsville Road, Indianapolis, Indiana 46268; Nufarm 
Americas Inc., 150 Harvester Drive Suite 220, Burr Ridge, Illinois 
60527; BASF, 26 Davis Drive, Research Triangle Park, NC 27709; Stepan 
Company, 22 W. Frontage Road, Northfield, IL 60093; Loveland Products 
Inc., PO Box 1286, Greeley, CO 80632; and Rhodia Inc., CN 1500, 
Cranbury, New Jersey 08512. The petition requested that 40 CFR 180.920 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of diethylene glycol mono butyl ether (CAS Reg. 
No. 112-34-5) when used as an inert ingredient solvent, stabilizer and/
or antifreeze without limitation in pesticide formulations applied to 
pre-harvest crops. That notice referenced a summary of the petition 
prepared by Huntsman, Dow AgroSciences L.L.C., Nufarm Americas Inc., 
BASF, Stepan Company, Loveland Products Inc., and Rhodia Inc., which is 
available in the docket, http://www.regulations.gov. The Agency 
received one comment in response to the notice of filing.

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(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for 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

[[Page 38028]]

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 establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors 
specified in FFDCA section 408(c)(2)(B), 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 diethylene glycol mono butyl 
ether including exposure resulting from the exemption established by 
this action. EPA's assessment of exposures and risks associated with 
diethylene glycol mono butyl ether follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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. Specific information on the studies received and the nature 
of the adverse effects caused by diethylene glycol mono butyl ether as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are 
discussed in this unit.
    Diethylene glycol mono butyl ether (DEGBE) has low acute toxicity 
via the oral and dermal routes. It is a slightly irritating to the skin 
and moderately irritating to the eyes. It is a skin not a sensitizer.
    Oral subchronic studies with DEGBE were available in the rat. In a 
study in F344 rats, toxicity was mainly manifested as an increase in 
creatinine levels at >51 mg/kg/day. Confidence in this study is low 
because of the high unexplained mortality. Also, in other studies in 
rats, toxicity was observed at doses >210 mg/kg/day. These effects 
included increased absolute relative liver weight; and hepatic 
cytochrome P450's and UGT levels; decreased total protein, cholesterol, 
and aspartate aminotransferase, very slight hepatocyte hypertrophy and 
increased individual hepatocyte degeneration in females only, decreased 
RBC count; hemoglobin (Hgb); and hematocrit (Hct) and increased 
absolute and relative kidney weights with an equivocal increase in 
minor histopathologic changes typical of early spontaneous nephropathy. 
In a well conducted 90-day toxicity study in rats via drinking water, 
rats were exposed to DEGBE at 0, 50, 250, or 1000 mg/kg/day. The NOAEL 
in this study was 250 mg/kg/day based on kidney, liver and blood 
effects seen at the LOAEL of 1000 mg/kg/day. In this study, no adverse 
treatment-related effects were observed on functional observational 
battery (FOB) parameters. Liver toxicity (including liver enzymes), 
kidney toxicity and blood parameters were affected at the limit dose of 
1000 mg/kg/day.
    There was one developmental toxicity study in Wistar rats conducted 
via the oral route of exposure. In this study, there were no maternal 
or developmental effects at doses up to 633 mg/kg/day. In a 
developmental toxicity study in mice via gavage, DEGBE did not produce 
any malformations at doses up to 2050 mg/kg/day. The maternal and 
developmental NOAEL in mice was 500 mg/kg/day. A developmental study in 
rabbits via the dermal route of exposure was available for review. In 
this study, maternal and developmental toxicity was not observed at 
doses up to 1000 mg/kg/day.
    There were 2 oral reproduction toxicity studies in rats available 
for review. In both studies rats were exposed to DEGBE via gavage at 
doses of 0, 250, 500 or 1000 mg/kg/day. In one study fetal 
susceptibility was not observed. Maternal (mortality) and offspring 
(reduced mean pup weight) toxicity occurred at the same dose (1000 mg/
kg/day). The maternal and developmental NOAELs in this study were 500 
mg/kg/day. In a second study quantitative fetal susceptibility was 
observed. Parental toxicity was not observed at doses up to 1,000 mg/
kg/day. Offspring toxicity (decreased bodyweight) was observed at 1000 
mg/kg/day. The offspring NOAEL was 500 mg/kg/day. Reproductive toxicity 
was not observed in either study. A reproductive toxicity study in rats 
with exposure via the dermal route was also available for review. 
Parental, offspring and reproduction toxicity was not observed at doses 
up to 2000 mg/kg/day.
    Dermal toxicity studies with DEGBE were available in the rat and 
rabbit. In a 13-week dermal toxicity study in the Sprague-Dawley (SD) 
rat, systemic toxicity was not observed at doses up to 2,000 mg/kg/day. 
In a separate 13-week dermal toxicity study in SD rats, the NOAEL was 
580 mg/kg/day based on renal tubular epithelium degeneration seen at 
the LOAEL of 1900 mg/kg/day. In a neurotoxicity study via the dermal 
route of exposure, degeneration of the renal tubular epithelium was 
observed at 2000 mg/kg/day. The NOAEL was 600 mg/kg/day. No effects on 
FOB parameters, motor activity or neuropathology were observed at doses 
up to 2000 mg/kg/day following dermal treatment. No local or systemic 
effects were observed in the New Zealand white rabbit.
    Several inhalation toxicity studies with DEGBE were available for 
review in rats. Perivascular and peribronchial infiltrate were observed 
in Wistar male and female rats and decreased spleen weights in males at 
doses > 100 mg/m3. In addition, liver toxicity, kidney toxicity and 
blood effects were identified as the target organs in inhalation 
studies.
    Immunotoxicity studies for DEGBE were not available for review. 
However, DEGBE belongs to the glycol ethers class of chemicals. 
Immunotoxicity studies were available for ethylene glycol mono butyl 
ether, also a glycol ether differing in only one ethyl group from 
DEGBE. These data were used to assess the immunotoxic potential of 
DEGBE. Signs of potential immunotoxicity were not observed in any of 
the available studies with the surrogate chemical. Nor was there 
evidence of immunotoxicity potential in any of the studies submitted 
for DEGBE. Therefore, DEGBE is not expected to be immunotoxic.
    Mutagenicity studies (Ames test, mammalian gene mutation, mouse 
lymphoma, chromosome aberration and unscheduled DNA synthesis) with 
DEGBE were available for review. All

[[Page 38029]]

the tests were negative with the exception of the mouse lymphoma assay 
in which cells were weakly positive in the absence of S-9, while it was 
negative in the presence of S-9.
    Chronic and carcinogenicity studies were not available on DEGBE. 
However, DEGBE belongs to the glycol ether class of chemicals which 
include structurally similar chemicals ethylene glycol and diethylene 
glycol. Therefore, carcinogenicity data available on these chemicals 
were used to assess DEGBE's potential to cause cancer. Based on the 
lack of evidence of carcinogenicity potential for ethylene glycol and 
diethylene glycol and the lack of mutagenic concerns for DEGBE, it is 
not expected to be carcinogenic to humans.
    Metabolism studies demonstrated that DEGBE was absorbed rapidly, 
metabolized and primarily eliminated via the urine. The major 
metabolite was identified as 2-(2-butoxyethoxy) acetic acid.
    Specific information on the studies received and the nature of the 
adverse effects caused by the diethylene glycol mono butyl ether, as 
well as, the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies can be 
found at http://www.regulations.gov in the document 042203, Diethylene 
glycol mono butyl ether; Human Health Risk Assessment and Ecological 
Effects Assessment to Support Proposed Exemption from the Requirement 
of a Tolerance When Used as Inert Ingredients in Pesticide Formulations 
at pp. 6-21 and pp. 19-22 in EPA-HQ-OPP-2008-0474.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 diethylene glycol mono 
butyl ether used for human risk assessment is shown in Table 1 of this 
unit.
    No acute endpoint of concern for general population was identified 
in the available data base.
    The 90 day oral toxicity study in rats via drinking water was 
selected to establish the chronic reference dose (cRfD). The NOAEL in 
this study was 250 mg/kg/day and the LOAEL was 1000 mg/kg/day based on 
kidney, liver, and blood effects. Although 51 mg/kg/day was the lowest 
LOAEL in the database, confidence in this study was low due to the 
observed unexplained mortality. A lower NOAEL (94 mg/kg/day) was also 
observed in a 30 day oral toxicity study in the rat. The LOAEL (210 mg/
kg/day) was based on decreased water consumption, growth retardation, 
and abnormalities in various organs. However, there is more confidence 
in the 90 day oral toxicity study in rats because it is a more recent 
study, was well conducted, tested more animals, provided more detailed 
information, provided data on all parameters measured in the 30-day 
study, has a well established NOAEL (250 mg/kg/day) and none of the 
aforementioned effects were observed. Therefore, the point of departure 
of 250 mg/kg/day was selected to establish the cRfD.
    The point of departure selected for the dermal exposure scenario is 
from the 13 week neurotoxicity screening battery in rats. The NOAEL in 
this study was 600 mg/kg/day and the LOAEL was 2,000 mg/kg/day based on 
mild degeneration of renal tubular epithelium in males. This endpoint 
and dose for dermal exposure assessment was further supported by a 90-
day dermal toxicity study in rats with a NOAEL of 580 mg/kg/day based 
renal tubular degeneration seen at the LOAEL of 1900 mg/kg/day. For the 
inhalation scenarios, 94 mg/m3 (~27 mg/kg/day) from an inhalation 
toxicity study in Wistar rats was selected for the point of departure. 
Although, 39 mg/m3 (~11 mg/kg/day) from an inhalation toxicity study in 
F344 rats represents the lowest NOAEL in the database for this scenario 
it was not selected because the observed liver changes were minor and 
occurred at the high dose (117 mg/m3). In addition, the selected study 
was more recent and one would expect changes to occur in the liver 
since animals in this study were treated for a longer duration. 
However, liver toxicity was not observed in the selected study. 
Therefore, 94 mg/m3 (~27 mg/kg/day) was selected for the point of 
departure for all inhalation scenarios.

  Table 1--Summary of Toxicological Doses and Endpoints for Diethylene Glycol Mono Butyl Ether for Use in Human
                                                 Risk Assessment
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                                       Point of departure and      RfD, PAD, LOC for risk        Study and
         Exposure/scenario           uncertainty/safety factors          assessment        toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years  An acute endpoint was not identified in the database.
 of age).
                                   -----------------------------------------------------------------------------
Chronic dietary (All populations).  NOAEL= 250 mg/kg/day          Chronic RfD = 2.5 mg/kg/ 90 Day Oral Toxicity
                                    UFA = 10x                      day                      Study LOAEL = 1000
                                    UFH = 10x                     cPAD = 2.5 mg/kg/day      mg/kg/day based on
                                    FQPA SF = 1x                                            kidney, liver, and
                                                                                            blood effects.
Incidental oral short-term (1 to    NOAEL= 250 mg/kg/day          LOC for MOE = 00         90 Day Oral Toxicity
 30 days).                          UFA = 10x                                               Study LOAEL = 1000
                                    UFH = 10x                                               mg/kg/day based on
                                    FQPA SF = 1x                                            kidney, liver, and
                                                                                            blood effects.

[[Page 38030]]

 
Incidental oral intermediate-term   NOAEL= 250 mg/kg/day          LOC for MOE = 100        90 Day Oral Toxicity
 (1 to 6 months).                   UFA = 10x                                               Study LOAEL = 1000
                                    UFH = 10x                                               mg/kg/day based on
                                    FQPA SF = 1x                                            kidney, liver, and
                                                                                            blood effects.
Dermal short-term (1 to 30 days)..  NOAEL = 600 mg/kg/day         LOC for MOE = 100        13 week Neurotoxicity
                                    (UFA = 10x                                              Screening Battery
                                    UFH = 10x                                               LOAEL = 2000 mg/kg/
                                    FQPA SF = 1x                                            day based on [mild
                                                                                            degeneration of
                                                                                            renal tubular
                                                                                            epithelium in males.
Dermal intermediate-term (1 to 6    NOAEL = 600 mg/kg/day         LOC for MOE = 100        13 week Neurotoxicity
 months).                           UFA = 10x                                               Screening Battery
                                    UFH = 10x                                               LOAEL = 2000 mg/kg/
                                    FQPA SF = 1x                                            day based on mild
                                                                                            degeneration of
                                                                                            renal tubular
                                                                                            epithelium in males.
Inhalation short-term (1 to 30      NOAEL= 27 mg/kg/day           LOC for MOE = 100        5 week Subchronic
 days).                              (inhalation absorption rate                            Inhalation Toxicity
                                     = 100%)                                                Study LOAEL was not
                                    UFA = 10x                                               established.
                                    UFH = 10x
                                    FQPA SF = 1x
Inhalation (1 to 6 months)........  NOAEL= 27 mg/kg/day           LOC for MOE = 100        5 week Subchronic
                                     (inhalation absorption rate                            Inhalation Toxicity
                                     = 100%)                                                Study LOAEL was not
                                    UFA = 10x                                               established.
                                    UFH = 10x
                                    FQPA SF = 1x
                                   -----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).  Not likely to be carcinogenic based on lack of evidence of carcinogenicity
                                     in structurally similar chemicals, ethylene glycol and diethylene glycol
                                     and the lack of mutagenicity.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to diethylene glycol mono butyl ether, EPA considered exposure 
under the proposed exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from diethylene glycol mono butyl ether in 
food as follows:
    No acute endpoint of concern was identified in the database. 
Therefore, acute dietary risk assessment was not conducted.
    i. Chronic exposure. In conducting the chronic dietary exposure 
assessments, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, no residue data were submitted for the diethylene 
glycol mono butyl 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 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 led 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 
concentration of active ingredient in agricultural products is 
generally at least 50 percent of the product and often can be much 
higher. Further, pesticide products rarely have a single inert 
ingredient; rather there is generally a combination of different inert 
ingredients used which additionally reduces the concentration of any 
single inert ingredient in the pesticide product in relation to that of 
the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at the highest tolerance level. In 
other words, EPA assumed 100 percent of all foods are treated with the 
inert ingredient at the rate and manner necessary to produce the 
highest residue legally possible for an active ingredient.

[[Page 38031]]

In summary, EPA chose a very conservative method for estimating what 
level of inert residue could be on food, then used this methodology to 
choose the highest possible residue that could be found on food and 
assumed that all food contained this residue. No consideration was 
given to potential degradation between harvest and consumption even 
though monitoring data shows that tolerance level residues are 
typically one to two orders of magnitude higher than actual residues in 
food when distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    ii. Cancer. For the reasons discussed above, the Agency has not 
identified any concerns for carcinogenicity relating to diethylene 
glycol mono butyl ether. Accordingly, a dietary exposure assessment to 
evaluate cancer risk was not performed.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for diethylene glycol 
mono butyl 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 the chronic dietary risk assessments 
for parent compound. 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., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    DEGBE may be used in inert ingredients in products that are 
registered for specific uses that may result in residential exposure. A 
screening level residential exposure and risk assessment was completed 
for products containing DEGBE as inert ingredients. The DEGBE inerts 
may be present in consumer personal (care) products and cosmetics (at 
concentrations up to 30%) (http://hpd.nlm.nih.gov/index.htm). The 
Agency conducted exposure assessments based on end-use product 
application methods and labeled application rates. The Agency conducted 
an assessment to represent worst-case residential exposure by assessing 
DEGBE in pesticide formulations used in crack and crevice applications. 
The Agency conducted an assessment to represent worst-case residential 
exposure by assessing post application exposures and risks from DEGBE 
in pesticide formulations.
    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 diethylene glycol mono butyl ether to share a 
common mechanism of toxicity with any other substances, and diethylene 
glycol mono butyl ether does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that diethylene glycol mono butyl 
ether does 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 Web site 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. Fetal susceptibility was not 
observed in either of the developmental toxicity studies with rats or 
rabbits. There were no toxic effects observed in parents or offspring 
in either study at the highest doses tested, 633 and 1000 mg/kg/day, 
respectively. No developmental effects were observed in mice at doses 
up to 2050 mg/kg/day. In a reproduction toxicity study in the rat, 
quantitative fetal susceptibility was observed. Parental toxicity was 
not observed at doses up to 1,000 mg/kg/day. However, offspring 
toxicity (decreased bodyweight) occurred at 1000 mg/kg/day. There was a 
well established NOAEL in this study protecting fetuses. Therefore, the 
concern for increased fetal susceptibility is low and there are no 
residual concerns.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for diethylene glycol mono butyl ether is 
adequate. The following acceptable studies are available:

Developmental toxicity in rodents (3 oral)
Developmental toxicity in rabbits (1 dermal)
Reproduction toxicity study in rats (2 oral, 1 dermal)

    ii. Signs of neurotoxicity were not observed in the neurotoxicity 
screening battery administered via the dermal route. Nor were signs of 
neurotoxicity observed in a 90 day oral toxicity (drinking water) in 
rats. In addition, signs of neurotoxicity were not observed in any of 
the other submitted studies. Therefore, EPA concluded that the 
developmental neurotoxicity study is not required.
    iii. Immunotoxicity studies for DEGBE were not available for 
review. However, DEGBE belongs to the glycol ethers class of chemicals. 
Immunotoxicity studies were available for ethylene glycol monobutyl 
ether, also a glycol ether differing only in one ethyl group. This data 
was used to assess the immunotoxic potential of DEGBE. Signs of 
potential immunotoxicity were not observed in any of the available 
studies with DEGBE and the surrogate chemical. Therefore, DEGBE is not 
expected to be immunotoxic.
    iv. Evidence of increased susceptibility was observed in a 
reproduction toxicity study in the rat. However, the concern for this 
increased susceptibility was low because there was a well established 
NOAEL of 500 mg/kg/d in this study. Also, the established cRfD (250 mg/
kg/day) is protective of the fetal effects.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed using 
very conservative assumptions. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to DEGBE in drinking

[[Page 38032]]

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 DEGBE.

E. Aggregate Risks and Determination of Safety

    Determination of safety section. EPA determines whether acute and 
chronic dietary pesticide exposures are safe by comparing aggregate 
exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For 
linear cancer risks, EPA calculates the lifetime probability of 
acquiring cancer 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 
appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. No adverse effects attributable to a single exposure 
of DEGBE were seen in the toxicity databases. Therefore, DEGBE is not 
expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
DEGBE from food and water will utilize 0.08% for the U.S. population 
and 0.25% of the cPAD for children 1-2 yrs old, the population group 
receiving the greatest exposure.
    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).
    DEGBE is currently used as an inert ingredient in pesticide 
products that are 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 DEGBE.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 102 for both 
adult males and females respectively. Adult residential exposure 
combines high end dermal and inhalation handler exposure from liquids/
trigger sprayer/home garden use with a high end post application dermal 
exposure from contact with treated lawns. As the level of concern is 
for MOEs that are lower than 100, this MOE is not of concern. EPA has 
concluded that the combined short-term aggregated food, water, and 
residential exposures result in an aggregate MOE of 163 for children. 
Children's residential exposure includes total exposures associated 
with contact with treated lawns (dermal and hand-to-mouth exposures). 
Because EPA's level of concern for DEGBE is a MOE of 100 or below, 
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).
    DEGBE is currently used as an inert ingredient in pesticide 
products that are 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 DEGBE.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 550 for adult males and females. Adult residential 
exposure combines high end dermal and inhalation handler exposure from 
liquids/trigger sprayer/home garden use with a high end post 
application dermal exposure from contact with treated lawns. EPA has 
concluded the combined intermediate-term aggregated food, water, and 
residential exposures result in an aggregate MOE of 230 for children. 
Children's residential exposure includes total exposures associated 
with contact with treated lawns (dermal and hand-to-mouth exposures). 
Because EPA's level of concern for DEGBE is a MOE of 100 or below, 
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 DEGBE.
    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 DEGBE residues.

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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established an MRL for diethylene glycol mono 
butyl ether.

C. Response to Comments

    The comment was received from a private citizen who opposed the 
authorization to sell any pesticide that leaves a residue on food. The 
Agency understands the commenter's concerns and recognizes that some 
individuals believe that no residue of pesticides should be allowed. 
However, under the existing legal framework provided by section 408 of 
the Federal Food, Drug and Cosmetic Act (FFDCA) EPA is authorized to 
establish pesticide tolerances or exemptions where persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by the statute.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180. 920 for diethylene glycol mono butyl 
ether when used as an inert ingredient (pesticide inert ingredient as a 
solvent, stabilizer and/or antifreeze within pesticide formulations/
products without limitation) in pesticide formulations applied to pre-
harvest crops.

VII. Statutory and Executive Order Reviews

    This final rule establishes 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

[[Page 38033]]

has been exempted from review under Executive Order 12866, this final 
rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it 
require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 20, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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.

    2. In Sec.  180. 920, the table is amended by adding alphabetically 
the following inert ingredients to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

------------------------------------------------------------------------
       Inert ingredients              Limits                Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Diethylene glycol mono butyl    Without            Pesticide inert
 ether (CAS Reg. No. 112-34-5).  limitation.        ingredient as a
                                                    solvent, stabilizer
                                                    and/or antifreeze
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2011-16188 Filed 6-28-11; 8:45 am]
BILLING CODE 6560-50-P