[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36349-36356]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15266]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0474; FRL-8877-1]


Diethylene Glycol MonoEthyl Ether (DEGEE); 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 MonoEthyl Ether 
(DEGEE) when used as an inert ingredient as a solvent, stabilizer and/
or antifreeze within pesticide formulations/products, for preharvest 
use on growing crops and raw agricultural commodities, without 
limitation. 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 establishment of an exemption from the requirement 
of a tolerance. This regulation eliminates the need to establish a 
maximum permissible level for residues of DEGEE on growing crops and 
raw agricultural commodities.

DATES: This regulation is effective June 22, 2011. Objections and 
requests for hearings must be received on or before August 22, 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, 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.

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 22, 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 DEGEE (CAS Reg. No. 111-90-0) when used as an 
inert ingredient, as a solvent, stabilizer and/or antifreeze

[[Page 36350]]

in pesticide formulations applied to growing crops and raw agricultural 
commodities pre-harvest without limitation. 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., the petitioners, which is available in the docket, http://www.regulations.gov. The Agency received one comment in response to the 
notice of filing.
    Currently, there is a tolerance exemption for DEGEE under 40 CFR 
180.920 when it is used as a deactivator for formulations used before 
the crops emerge from the soil and stabilizer. This document provides 
an assessment of the risk to human health and the environment for DEGEE 
when used as a pesticide inert ingredient as a solvent, stabilizer and/
or antifreeze within pesticide formulations/products without 
limitation.

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 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 DEGEE including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with DEGEE 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 DEGEE 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.
    The following toxicity data on DEGEE were summarized from these 
sources, the World Health Organization (WHO), National Toxicology 
Program (NTP), Hazardous Substances Data Base (HSDB) and BIBRA 
Toxicology Advisory and Consulting (1976, 2003, respectively). DEGEE 
has low acute toxicity via oral and dermal routes. It is moderately 
irritating to the skin and is mildly irritating to the eye. It is not a 
skin sensitizer.
    Several subchronic studies with DEGEE were available in rodents, 
ferrets and pigs. In rodents, toxicity was primarily manifested in the 
kidneys and liver. Increased kidney weights, tubular dilatation and 
centrilobular hepatocyte enlargement were seen at doses > 2,500 
milligrams/kilogram/day (mg/kg/day). In ferrets, effects in the kidney 
were also observed. The concentrating power of the kidney was decreased 
and water intake was decreased at > 2.0 milliliter (mL)/kg/day (2,240 
mg/kg/day). Kidney and liver effects were also observed in pigs. Kidney 
weights were increased, tubular hydropic degeneration and enlarged 
centrilobular and midzonal hepatocytes with pyknotic nuclei and fatty 
infiltration were observed at > 500 mg/kg/day.
    A subchronic inhalation study with DEGEE in the rat was also 
available. No effects were observed at doses up to 1.1 milligrams/liter 
(mg/L) (approximately 314 mg/kg/day).
    Several chronic carcinogenicity studies with DEGEE were available 
in rodents. However, these studies were conducted with a limited number 
of animals and doses and a complete histopathological examination was 
not performed. Due to these deficiencies, a definitive conclusion 
regarding carcinogenicity of DEGEE cannot be made on the basis of these 
studies. However, there were no obvious tumors detected in mice and 
rats.
    Developmental studies with DEGEE in rodents were available for 
review. Fetal susceptibility was not observed in these studies. 
Parental (mortality and reduced body weight) and offspring (reduced 
mean pup birth weight) toxicity were observed in mice at the high dose 
(2,500 mg/kg/day). In a developmental toxicity study in rats via the 
dermal route of exposure, maternal toxicity was manifested as decreased 
body weight at 6,615 mg/kg/day. Developmental toxicity was not observed 
at this dose. In an inhalation developmental toxicity study in rats, 
maternal and developmental toxicity were not observed up to 100 parts 
per million (ppm) (approximately 31 mg/kg/day).
    Two reproduction toxicity studies were available for review with 
DEGEE in rodents. One study in rats reported that increased urinary 
protein, bladder calculi, epithelial necrosis of the renal

[[Page 36351]]

tubules and cloudy swelling of hepatic tissue were observed in all 
animals at 920 mg/kg/day of DEGEE with less than 0.2% of ethylene 
glycol. The NOAEL in this study was 200 mg/kg/day. In another study in 
mice, offspring toxicity (decreased live pup weights, decreased 
absolute brain and liver weights) and parental toxicity (increase water 
intake and decreased body weight in males) occurred at 2,500 mg/kg/day. 
There were no effects on reproductive parameters in either study.
    Several mutagenicity studies (Ames test, micronucleus assay and 
unscheduled DNA synthesis) with DEGEE were available for review. One 
Ames test reported ambiguous results, another reported positive results 
at high doses. However, in vivo assays (micronucleus and unscheduled 
DNA synthesis) reported negative results. Therefore, based on the 
weight of evidence, DEGEE is not considered mutagenic.
    As noted, available long-term carcinogenicity studies were 
considered inadequate to fully assess DEGEE's potential to cause 
cancer; however, these studies in mice and rats do not report any 
tumors. DEGEE belongs to the glycol ether class of chemicals which 
include structurally similar chemicals ethylene glycol (EG) and 
diethylene glycol (DEG). EG and DEG have toxicities similar to DEGEE. 
Target organs of toxicity are the kidney and liver. There was no 
evidence of carcinogenicity in rats and mice when treated with EG 
(NTP). Bladder tumors were observed in rats treated with DEG at >1,500 
mg/kg/day, however, these tumors were secondary to irritation from 
bladder stones. The resulting classification for EG and DEG was that 
they are not expected to pose a carcinogenic risk in humans. Therefore, 
the carcinogenicity data on EG and DEG were used to assess the cancer 
potential of DEGEE. Based on the lack of evidence of carcinogenicity 
potential for EG and DEG, lack of tumors in mice and rats with DEGEE, 
and the fact that DEGEE is not mutagenic, DEGEE is not expected to be 
carcinogenic to humans. Also, the established chronic reference dose/
chronic population adjusted dose (cRfD/cPAD) (2.0 mg/kg/day) for DEGEE 
will be protective of effects leading to kidney damage and tumor 
formation seen at >1,500 mg/kg/day following DEG exposures.
    Immunotoxicity studies for DEGEE were not available for review. 
However, DEGEE belongs to the glycol ethers class of chemicals. 
Immunotoxicity studies were available for ethylene glycol mono butyl 
ether (DEGBE), also a glycol ether differing in only one ethyl and 
butyl group from DEGEE. These data were used to assess the immunotoxic 
potential of DEGEE. Signs of potential immunotoxicity were not observed 
in any of the available studies for the surrogate chemical. Nor was 
there evidence of immunotoxicity potential in any of the studies 
submitted for DEGEE. Therefore, DEGEE is not expected to be 
immunotoxic.
    Dermal absorption studies were available with DEGEE. In a study 
using human epidermal membranes, the absorption rate of DEGEE was 0.206 
mg/cm\2\/hr.
    The available metabolism data in an adult human revealed that 68% 
of the administered dose of DEGEE was excreted in the urine as (2-
ethoxy) acetic acid. In a metabolism study in the rabbit, oral or 
subcutaneous exposure to DEGEE resulted in the excretion of glucuronic 
acid in the urine; the major part of the dose was oxidized.

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 DEGEE used for human 
risk assessment is shown in the following table.

         Table--Summary of Toxicological Doses and Endpoints for DEGEE for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary general population                 An acute endpoint was not identified in the database.
 including Females 13-50 years of age.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 200 mg/kg/day..  Chronic RfD = 2.0 mg/kg/ Reproduction Toxicity
                                       UFA = 10x..............   day cPAD = 2.0 mg/kg/    Study with chronic/
                                       UFH = 10 x.............   day.                     carcinogenicity
                                       FQPA SF = 1x...........                            measurements--rat
                                                                                          LOAEL = 920 mg/kg bw/
                                                                                          day, based on
                                                                                          decreased growth,
                                                                                          epithelial necrosis of
                                                                                          renal tubules and
                                                                                          cloudy swelling of
                                                                                          hepatic tissue.

[[Page 36352]]

 
Incidental oral short-term (1 to 30    NOAEL= 200 mg/kg/day...  LOC for MOE = 100......  Reproduction Toxicity
 days).                                UFA = 10x..............                            Study with chronic/
                                       UFH = 10 x.............                            carcinogenicity
                                       FQPA SF = 1x...........                            measurements--rat
                                                                                          LOAEL = 920 mg/kg bw/
                                                                                          day, based on
                                                                                          decreased growth,
                                                                                          epithelial necrosis of
                                                                                          renal tubules and
                                                                                          cloudy swelling of
                                                                                          hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term (1   NOAEL= 200 mg/kg/day...  LOC for MOE = 100......  Reproduction Toxicity
 to 6 months).                         UFA = 10x..............                            Study with chronic/
                                       UFH = 10 x.............                            carcinogenicity
                                       FQPA SF = 1x...........                            measurements--rat
                                                                                          LOAEL = 920 mg/kg bw/
                                                                                          day, based on
                                                                                          decreased growth,
                                                                                          epithelial necrosis of
                                                                                          renal tubules and
                                                                                          cloudy swelling of
                                                                                          hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).....  NOAEL= 200 mg/kg/day     LOC for MOE = 100......  Reproduction Toxicity
                                        (dermal absorption                                Study with chronic/
                                        rate = 25%).                                      carcinogenicity
                                       UFA = 10x..............                            measurements--rat
                                       UFH = 10x..............                            LOAEL = 920 mg/kg bw/
                                       FQPA SF = 1x...........                            day, based on
                                                                                          decreased growth,
                                                                                          epithelial necrosis of
                                                                                          renal tubules and
                                                                                          cloudy swelling of
                                                                                          hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term (1 to 6       NOAEL= 200 mg/kg/day     LOC for MOE = 100......  Reproduction Toxicity
 months).                               (dermal absorption                                Study with chronic/
                                        rate = 25% when                                   carcinogenicity
                                        appropriate).                                     measurements--rat
                                       UFA = 10x..............                            LOAEL = 920 mg/kg bw/
                                       UFH = 10x..............                            day, based on
                                       FQPA SF = 1x...........                            decreased growth,
                                                                                          epithelial necrosis of
                                                                                          renal tubules and
                                                                                          cloudy swelling of
                                                                                          hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 days).  Inhalation (or oral)     LOC for MOE = 100......  Reproduction Toxicity
                                        study NOAEL= 200 mg/kg/                           Study with chronic/
                                        day (inhalation                                   carcinogenicity
                                        absorption rate =                                 measurements--rat
                                        100%).                                            LOAEL = 920 mg/kg bw/
                                       UFA = 10x..............                            day, based on
                                       UFH = 10x..............                            decreased growth,
                                       FQPA SF = 1x...........                            epithelial necrosis of
                                                                                          renal tubules and
                                                                                          cloudy swelling of
                                                                                          hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Inhalation (1 to 6 months)...........  Inhalation (or oral)     LOC for MOE = 100......  Reproduction Toxicity
                                        study NOAEL = 200 mg/                             Study with chronic/
                                        kg/day (inhalation                                carcinogenicity
                                        absorption rate =                                 measurements--rat
                                        100%).                                            LOAEL = 920 mg/kg bw/
                                       UFA = 10x..............                            day, based on
                                       UFH = 10x..............                            decreased growth,
                                       FQPA SF = 1x...........                            epithelial necrosis of
                                                                                          renal tubules and
                                                                                          cloudy swelling of
                                                                                          hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....    Based on the lack of tumors in a study with DEGEE and carcinogenicity
                                         data available for the structurally similar chemicals, EG and DEG, and
                                        that DEGEE is not mutagenic, DEGEE is not expected to be carcinogenic to
                                                                         humans.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). 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 DEGEE, EPA considered exposure under the proposed exemption 
from the requirement of a tolerance. EPA assessed dietary exposures 
from DEGEE in food as follows:
    i. Acute exposure. No adverse effects attributable to a single 
exposure of DEGEE were seen in the toxicity databases. Therefore, an 
acute dietary exposure assessment for DEGEE is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the U.S.

[[Page 36353]]

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 DEGEE. 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 levels of 
tolerances would be no higher than the concentration of the active 
ingredient.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentrations of active ingredient in agricultural products are 
generally at least 50 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. 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. As discussed above, the Agency has not identified any 
concerns for carcinogenicity relating to DEGEE, and, therefore, a 
dietary exposure assessment to assess cancer risk is unnecessary.
    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 DEGEE, a conservative 
drinking water concentration value of 100 parts per billion (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).
    DEGEE 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 DEGEE as inert ingredients. The Agency selected 
representative scenarios, based on end-use product application methods 
and labeled application rates. The Agency conducted an assessment to 
represent worst-case residential exposure by assessing DEGEE in 
pesticide formulations (Outdoor Scenarios) and DEGEE in disinfectant-
type uses (Indoor Scenarios). The Agency is not aware of any use of 
DEGEE in hard surface cleaning products. However, this scenario was 
used for this assessment considering wide use of DEGEE in other 
products. Therefore, the Agency assessed the disinfectant-type products 
containing DEGEE using exposure scenarios used by the Antimicrobials 
Division in EPA's Office of Pesticide Programs to represent worst-case 
residential handler exposure. Further details of this residential 
exposure and risk analysis can be found at http://www.regulations.gov 
in the memorandum entitled: ``JITF Inert Ingredients. Residential and 
Occupational Exposure Assessment Algorithms and Assumptions Appendix 
for the Human Health Risk Assessments to Support Proposed Exemption 
from the Requirement of a Tolerance When Used as Inert Ingredients in 
Pesticide Formulations,'' (D364751, 5/7/09, Lloyd/LaMay in docket ID 
number EPA-HQ-OPP-2008-0710.
    In addition to pesticidal uses for DEGEE, there are non-pesticidal 
uses for DEGEE. However, dermal and inhalation exposure are expected to 
be negligible; therefore, a quantitative exposure assessment was not 
conducted.
    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 DEGEE to share a common mechanism of toxicity 
with any other substances, and DEGEE does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that DEGEE 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

[[Page 36354]]

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 the developmental toxicity studies with DEGEE in the mouse. 
Developmental studies were available via the oral (mice), dermal (rats) 
and inhalation (rats) routes of exposure in rodents. Following oral 
exposure to DEGEE, maternal (mortality and reduced body weight) and 
offspring (reduced mean pup birth weight) toxicity were observed in 
mice at the high dose (2,500 mg/kg/day). Following dermal exposure to 
DEGEE, maternal toxicity was manifested as decreased body weight at 
6,615 mg/kg/day in rats. Developmental toxicity was not observed at 
this dose. Following inhalation exposure to DEGEE, maternal and 
developmental toxicity were not observed up to 100 ppm (approximately 
31 mg/kg/day) in rats. A developmental toxicity study in rabbits is not 
available in the database. However, the concern for the lack of this 
study is low because toxicity was observed near the limit dose in the 
developmental and reproduction studies in rodents (>920 mg/kg/day).
    Evidence of increased fetal susceptibility was observed in a 
reproduction toxicity study in the mice. Offspring toxicity was 
manifested as decreased adjusted live pup weight and absolute brain 
weights and increased liver weights in the absence of parental 
toxicity. There is no concern for this increased susceptibility in mice 
because these pup effects were observed at a dose 2.5 times above the 
limit dose of 1,000 mg/kg/day and a clear NOAEL was established in the 
study. It is unclear if there is fetal susceptibility in the 
reproduction toxicity study in rats. In this study, it was stated that 
increased urinary protein, bladder calculi, epithelial necrosis of the 
renal tubules and cloudy swelling of hepatic tissue were observed in 
all animals at 920 mg/kg/day (NOAEL 200 mg/kg/day). It is not clear 
whether all animals referred in the study include both the parental and 
F1 animals or not. However, in any case the concern for fetal 
susceptibility is low because the aforementioned effects occured near 
the limit dose and the cRfD (2.0 mg/kg/day) will be protective of these 
effects.
    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 DEGEE is adequate for FQPA assessment. 
The following acceptable studies are available: Developmental and 
reproduction toxicity studies in mice and rats, subchronic and 
mutagenicity studies. A 2-generation reproduction toxicity study where 
tumors were evaluated is available. Also, chronic/carcinogenicity 
studies are available on a surrogate chemical, ethylene glycol. A 
developmental toxicity study in rabbits is not available in the 
database. However, the concern for the lack of this study is low 
because toxicity was observed at or above the limit dose in the 
developmental and reproduction studies in rodents.
    ii. Signs of neurotoxicity were not observed in a reproduction 
toxicity study in rats. Decreased absolute brain weights were observed 
in the offspring at 2,500 mg/kg/day. However, a developmental 
neurotoxicity study is not required because decreased brain weights 
were observed above the limit dose (1,000 mg/kg/day), the effect 
occurred in the presence of maternal toxicity and the cRfD (2.0 mg/kg/
day) will be protective of this effect. Therefore, there is no need for 
a developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. There is evidence that DEGEE results in increased fetal 
susceptibility in the multi-generation reproduction study in the mouse. 
However, the concern for fetal susceptibility is low because the 
effects seen in the offspring (adjusted live pup weight and absolute 
brain weights and increased liver weights) occur at 2,500 mg/kg/day 
(2.5times the limit dose), the effects occur in the absence of maternal 
toxicity, a clear NOAEL (1,250 mg/kg/day) was established and the cRfD 
(2.0 mg/kg/day) will be protective of these effects.
    iv. Immunotoxicity studies for DEGEE were not available for review. 
However, DEGEE belongs to the glycol ethers class of chemicals. 
Immunotoxicity studies were available for ethylene glycol monobutyl 
ether, also a glycol ether. This data were used to assess the 
immunotoxic potential of DEGEE. Signs of potential immunotoxicity were 
not observed in any of the available studies for the surrogate 
chemical. Nor was there evidence of immunotoxicity potential in any of 
the studies submitted for DEGEE. Therefore, DEGEE is not expected to be 
immunotoxic.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated (CT) and tolerance-level residues. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to DEGEE in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
DEGEE.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
DEGEE 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 
DEGEE from food and water will utilize 0.10% of the cPAD for the 
general U.S. population and 0.31% of the cPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure. Based on the 
explanation in this unit, regarding residential use patterns, chronic 
residential exposure to residues of DEGEE is not expected.

[[Page 36355]]

    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).
    DEGEE 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 DEGEE.
    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 264 for both 
adult males and females, respectively. Adult residential exposure 
combines high end dermal and inhalation handler exposure from homeowner 
mixer/loader/applicators using a trigger sprayer 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 
228 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 DEGEE 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).
    DEGEE 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 DEGEE.
    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 777 for adult males and females. Adult residential 
exposure combines high end dermal and inhalation handler exposure from 
homeowner mixer/loader/applicators using a trigger sprayer 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 267 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 DEGEE is a MOE of 100 or 
below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. DEGEE is not expected 
to pose a carcinogenic risk in humans based on the discussion in Unit 
IV.A.
    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 DEGEE 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 a MRL for DEGEE.

C. Response to Comments

    The comment was received from private citizens 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 DEGEE (CAS Reg. No. 111-90-0) when 
used as an inert ingredient (as a solvent, stabilizer and/or antifreeze 
within pesticide formulations/products without limitation) in pesticide 
formulations applied to growing crops and raw agricultural commodities 
pre-harvest.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from 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,

[[Page 36356]]

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 10, 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.


0
2. In Sec.  180.920, the table is amended by adding alphabetically the 
following inert ingredient:


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

* * * * *

------------------------------------------------------------------------
       Inert ingredients              Limits                Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Diethylene Glycol MonoEthyl     Without            Solvent, stabilizer
 Ether (CAS Reg. No. 111-90-0).  limitation.        and/or antifreeze.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2011-15266 Filed 6-21-11; 8:45 am]
BILLING CODE 6560-50-P