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[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Rules and Regulations]
[Pages 31471-31479]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13577]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0361; FRL-8870-7]

Ethylene Glycol; 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 ethylene glycol (CAS Reg. No. 107-21-1) 
when used as a pesticide inert ingredient as a solvent, stabilizer and/
or antifreeze within pesticide formulations/products without 
limitation. Huntsman, et. al, 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 ethylene glycol. Also, this regulation establishes an 
exemption from the requirement of a tolerance for residues of ethylene 
glycol (CAS Reg. No. 107-21-1) when used as an inert ingredient as an 
encapsulating agent for pesticides being applied post-harvest as 
residual, and crack and crevice sprays in and around food and nonfood 
areas of residential and nonresidential structures, including food 
handling establishments, with no limit. The Sumitomo Chemical Company 
submitted a petition to EPA under 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 ethylene glycol.

[[Page 31472]]

DATES: This regulation is effective June 1, 2011. Objections and 
requests for hearings must be received on or before August 1, 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 these actions under docket 
identification (ID) number EPA-HQ-OPP-2011-0361. 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-2011-0361 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 1, 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-2011-0361, 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

    EPA received two petitions requesting that 40 CFR 180.910 and 40 
CFR 180.920 be amended by establishing an exemption from the 
requirement of a tolerance for residues of ethylene glycol.
    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 ethylene glycol (CAS Reg. No. 107-21-1) 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.
    Also, in the Federal Register of August 4, 2004 (69 FR 47149) (FRL-
7367-7), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP 4E6828) 
by the Sumitomo Chemical Company, Ltd., 5-33 Kitahama, 4-chrome, chuo-
ku, Osaka 541-8550 Japan. The petition requested that 40 CFR 180.910 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of ethylene glycol (CAS Reg. No. 107-21-1) when 
used as an inert ingredient in encapsulating agents for pesticides 
being applied post-harvest as residual, and crack and crevice sprays in 
and around food and nonfood areas of residential and nonresidential 
structures, including food handling establishments, with no limit. That 
notice referenced a summary of the petition prepared by the Sumitomo 
Chemical Company, which is available

[[Page 31473]]

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 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 ethylene glycol including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with ethylene glycol 
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 ethylene glycol 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.
    Acute oral toxicity in rodents, as expressed as a lethal dose 
(LD)50, ranges from 1,500 milligram/kilogram (mg/kg) to 
8,800 mg/kg. In the guinea pig, the acute oral toxicity is about 6,600 
mg/kg and in the rabbit, 5,000 mg/kg. In the dog, the acute oral 
LD50 is greater than 8,000 mg/kg. It is minimally irritating 
to the eyes and skin of rabbits. Acute inhalation and dermal toxicity 
data were not identified. However, given the vapor pressure of 
undiluted ethylene glycol (0.092 millimeter (mm) mercury (Hg) @ 25 
[deg]C) acute inhalation concerns are not expected. According to the 
National Institute of Occupational Safety and Health (NIOSH) (1999), a 
``harmful contamination of the air will be reached rather slowly on 
evaporation of this substance at 20 [deg]C.''
    In subchronic and chronic testing, rats were more sensitive to the 
effects of ethylene glycol treatment than mice at comparable dose 
levels. Among rats, males appeared to be more sensitive than females. 
In subchronic toxicity testing in rats and mice, the kidney was 
adversely affected in all studies considered. Effects common to all 
studies include increased kidney weights, formation of lesions, and 
formation of oxalate crystals. In the rat, NOAELs range from 71 to 
4,000 mg/kg/day and in the mouse the NOAELs range from 1,000 to 3,230 
mg/kg/day. In chronic testing in rats, kidney effects similar to those 
seen in subchronic testing were observed. In addition, effects to the 
liver were seen (i.e., decreased liver weight; fatty changes). The 
lowest NOAEL (71 mg/kg/day) in the toxicity database occurred in a 
subchronic toxicity study in rats. The LOAEL in this study was 180 mg/
kg/day based on kidney effects. In chronic studies, the lowest NOAEL of 
150 mg/kg/day was observed in rats, the most sensitive species.
    Developmental toxicity testing was conducted in rats, mice, and 
rabbits. Overall, fetal toxicity was exhibited as increased fetal 
deaths, skeletal and external malformations, and reduced body weight. 
Maternal toxicity was manifested as decreased body weight gain, kidney 
effects (lesions, increased organ weight), and liver effects (decreased 
organ weight). The relative sensitivities of these species in terms of 
developmental toxicity during organogenesis are: Mice are the most 
sensitive and rabbits are the least sensitive. For maternal toxicity 
per se the sensitivity is: Rats are the most sensitive and rabbits are 
the least sensitive.
    In rabbits, statistically-significant fetal developmental toxicity 
was not observed; however, maternal toxicity was seen at 2,000 mg/kg/
day; it was manifested as renal toxicity (lesions, oxalate formation). 
In rats, fetal toxicity was seen at doses ranging from 1,000 mg/kg/day 
to 2,500 mg/kg/day. It manifested as decreased viability (2,250 mg/kg/
day); decreased body weight gain and decreased pup weight (1,000 to 
2,500 mg/kg/day); and skeletal effects and malformations (1,000 to 
2,500 mg/kg/day). The skeletal effects and malformations included: 
Poorly ossified and unossified vertebral centra; decrease in total 
ossification; hydrocephaly; and pup malformation. Maternal toxicity in 
rats was manifested as: Decreased body weight gain (1,250 to 2,500 mg/
kg/day); decreased liver weight (5,000 mg/kg/day); and kidney effects 
such as lesions and increased weight (1,250 to 2,500 mg/kg/day). In 
mice, fetal toxicity was seen at doses ranging from 500 to 1,500 mg/kg/
day. As with rats it manifested as decreased

[[Page 31474]]

fetal body weight and/or weight gain (750 to 1,500 mg/kg/day) and 
skeletal effects (500 to 1,500 mg/kg/day) which included: Pup 
malformations, fused ribs and arches, poor ossification in thoracic and 
lumbar centra, and increased occurrence of an extra 14th rib. The 
lowest developmental NOAEL in mice was 150 mg/kg/day. Maternal toxicity 
was demonstrated as decreased weight gain (1,500 mg/kg/day) and 
decreased liver weight (1,500 mg/kg/day).
    The reproductive toxicity of ethylene glycol was studied in rats 
and mice. In rats, no reproductive toxicity was noted. In mice, 
reproductive toxicity was seen at doses ranging from 897 to 2,826 mg/
kg/day. It manifested as: Decreased numbers of live implants and 
increased number of dead implants; sperm effects (abnormal sperm, 
decreased motility, decreased sperm count); testicular lesions; and 
decreased testes weight.
    Ethylene glycol is not known to be mutagenic. In a standard battery 
of in vitro genotoxicity assays conducted by the National Toxicology 
Program; Health and Human Services (NTP; HHS 1993), all results were 
negative. Ethylene glycol is not considered to be carcinogenic. In 
carcinogenicity testing conducted by the NTP in rats and mice, no 
evidence of carcinogenic potential was noted. Therefore, based on the 
lack of mutagenicity and lack of carcinogenicity in rodents, ethylene 
glycol is not expected to pose a carcinogenic risk in humans.
    Metabolism studies demonstrated that ethylene glycol was rapidly 
absorbed, metabolized and excreted. It is primarily metabolized via the 
liver and kidneys. Ethylene glycol and metabolites (glycolic acid and 
oxalic acid) are primarily excreted in the urine within 12-18 hours 
after administration.
    Specific information on the studies received and the nature of the 
adverse effects caused by the ethylene glycol, as well as, the NOAEL 
and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in the document ``800009, Ethylene Glycol; 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,'' pp. 7-24 in EPA-HQ-OPP-
2008-0474 and EPA-HQ-OPP-2004-0207.

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 (LOC) 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 the NOAEL and the LOAEL are identified. 
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)(acute = a and chronic = c) 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 ethylene glycol used 
for human risk assessment is shown in the Table of this unit.
    No acute endpoint of concern for general population was identified 
in the available data base. However, the endpoint of concern for 
females 13 plus age was identified in a developmental toxicity study in 
mice with a NOAEL of 150 mg/kg/day and LOAEL of 500 mg/kg/day based on 
an increased incidence of total malformations and bilateral extra 
rib14.
    The endpoint selected for the cRfD was based on a chronic toxicity 
study in rats. The NOAEL in this study was 150 mg/kg/day based on 
kidney lesions and mortality observed at 300 mg/kg/day. Although 71 mg/
kg/day is the lowest NOAEL in the database identified in a subchronic 
study in rats, the confidence in this subchronic study is low because 
subchronic and chronic studies support the NOAEL of 150 mg/kg/day and 
above. The NOAEL 150 mg/kg/day selected for the cRfD is protective of 
any developmental effects. Therefore, the Agency selected the point of 
departure of 150 mg/kg/day to establish the cRfD.
    The EPA Integrated Risk Information System (IRIS) established a 
oral cRfD based on the NOAEL of 200 mg/kg/day and uncertainty factor 
100. The currently chosen endpoint and the dose used for this risk 
assessment provide the most conservative assessment.

    Table--Summary of Toxicological Doses and Endpoints for Ethylene Glycol for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                Point of departure and
       Exposure/scenario           uncertainty/safety   RfD, PAD, LOC for risk   Study and toxicological effects
                                        factors                assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50    NOAEL = 150 mg/kg/day.  Acute RfD = 1.5 mg/kg/  Developmental toxicity study--
 years of age).                 UFA = 10x.............   day.                    mice.
                                UFH = 10x.............  aPAD = 1.5 mg/kg/day..  LOAEL = 500 mg/kg bw/day, based
                                FQPA SF = 1x..........                           on increased incidence of total
                                                                                 malformations and bilateral
                                                                                 extra rib 14.
Chronic dietary (All            NOAEL = 150 mg/kg/day.  Chronic RfD = 1.5 mg/   Chronic toxicity study.
 populations).                  UFA = 10x.............   kg/day.                LOAEL = 300 mg/kg/day based on
                                UFH = 10x.............  cPAD = 1.5 mg/kg/day..   kidney lesions and death in
                                FQPA SF = 1x..........                           males.
Incidental oral short-term (1   NOAEL = 150 mg/kg/day.  LOC for MOE = 100.....  Chronic toxicity study.
 to 30 days).                   UFA = 10x.............                          LOAEL = 300 mg/kg/day based on
                                UFH = 10x.............                           kidney lesions and death in
                                FQPA SF = 1x..........                           males.
Incidental oral intermediate-   NOAEL = 150 mg/kg/day.  LOC for MOE = 100.....  Chronic toxicity study.
 term (1 to 6 months).          UFA = 10x.............                          LOAEL = 300 mg/kg/day based on
                                UFH = 10x.............                           kidney lesions and death in
                                FQPA SF = 1x..........                           males.

[[Page 31475]]

 
Dermal short-term (1 to 30      NOAEL = 150 mg/kg/day   LOC for MOE = 100.....  Chronic toxicity study.
 days).                          (dermal absorption                             LOAEL = 300 mg/kg/day based on
                                 rate = 25%.                                     kidney lesions and death in
                                UFA = 10x.............                           males.
                                UFH = 10x.............
                                FQPA SF = 1x..........
Dermal intermediate-term (1 to  NOAEL = 150 mg/kg/day   LOC for MOE = 100.....  Chronic toxicity study.
 6 months).                      (dermal absorption                             LOAEL = 300 mg/kg/day based on
                                 rate = 25% when                                 kidney lesions and death in
                                 appropriate).                                   males.
                                UFA = 10x.............
                                UFH = 10x.............
                                FQPA SF = 1x..........
Inhalation short-term (1 to 30  NOAEL = 150 mg/kg/day   LOC for MOE = 100.....  Chronic toxicity study.
 days).                          (inhalation                                    LOAEL = 300 mg/kg/day based on
                                 absorption rate =                               kidney lesions and death in
                                 100%).                                          males.
                                UFA = 10x.............
                                UFH = 10x.............
                                FQPA SF = 1x..........
Inhalation (1 to 6 months)....  NOAEL = 150 mg/kg/day   LOC for MOE = 100.....  Chronic toxicity study.
                                 (inhalation                                    LOAEL = 300 mg/kg/day based on
                                 absorption rate =                               kidney lesions and death in
                                 100%).                                          males.
                                UFA = 10x.............
                                UFH = 10x.............
                                FQPA SF = 1x..........
                               ---------------------------------------------------------------------------------
Cancer (Oral, dermal,             Not expected to be carcinogenic based on the lack of mutagenicity and lack of
 inhalation).                                              carcinogenicity in rodents.
----------------------------------------------------------------------------------------------------------------
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.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ethylene glycol, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from ethylene glycol in food as follows:
    i. Acute and chronic exposure. In conducting the acute and chronic 
dietary exposure assessments, EPA used food consumption information 
from the United States Department of Agriculture (USDA) 1994-1996 and 
1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, no residue data were submitted 
for the ethylene glycol. 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 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 
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. 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

[[Page 31476]]

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. Ethylene glycol is not expected to be carcinogenic 
since it was negative for carcinogenicity in mice and rats in the 
available published studies and there was a negative response for 
mutagenicity. Since the Agency has not identified any concerns for 
carcinogenicity relating to ethylene glycol, a dietary exposure 
assessment to evaluate cancer risk was not performed.
    iii. Anticipated residue and percent crop treated (PCT) 
information. EPA did not use anticipated residue and/or PCT information 
in the dietary assessment for ethylene glycol. Tolerance level residues 
and/or 100 PCT were assumed for all food commodities.
    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 ethylene glycol, 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).
    Ethylene glycol 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 ethylene glycol as inert 
ingredients. The ethylene glycol inerts may be present in consumer 
personal (care) products and cosmetics (at concentrations up to 1%) 
(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 ethylene glycol 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 
ethylene glycol 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 ethylene glycol to share a common mechanism of 
toxicity with any other substances, and ethylene glycol does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
ethylene glycol 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 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. In the case of the ethylene 
glycol, some of the available studies suggest increased susceptibility 
to the offspring of rodents following pre-natal and post-natal 
exposure. However, the effects (described in this unit) occurred at 
doses that were > 500 mg/kg/day. The established cRfD of 1.5 mg/kg/day 
will be protective of these effects. 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 ethylene glycol is adequate. The 
following acceptable studies are available:
    Developmental toxicity studies in rodents (6);
    Multi-generation reproduction studies in rodents (4);
    Subchronic toxicity studies in multiple species;
    Inhalation and dermal toxicity studies;
    Chronic/carcinogenicity studies in rodents (5).
    ii. Signs of neurotoxicity (when observed) occurred at high doses 
and at doses above that which produced kidney toxicity. The established 
cRfD of 1.5 mg/kg/day (NOAEL = 150 mg/kg/day) is protective of kidney 
toxicity and is therefore protective of neurotoxic effects. Also, the 
International Programme on Chemical Safety Concise International 
Chemical Assessment Document 45 Ethylene Glycol: Human Health Aspects 
(IPCS CICAD 2002) concluded that ``data are limited, results of 
identified toxicity studies conducted (via oral, inhalation, or dermal 
routes) in rodents, rabbits, and monkeys do not indicate that 
neurological effects are critical end-points for ethylene glycol.'' 
IPCS (2002) also states that generally neurotoxicity effects occur at a 
dose higher than the dose producing kidney toxicity. Since the current 
cRfD is protective of kidney toxicity, the concern for neurotoxicity is 
low to none. Therefore, EPA concluded that the developmental 
neurotoxicity is not required.
    iii. Evidence of potential immunotoxicity was observed in a 
subchronic toxicity study in rats. Decreased relative thymus weights 
were observed at 4,000 mg/kg/day. Again, this effect occurred at a high 
dose and at a dose above that which produced kidney toxicity. The 
established cRfD of 1.5 mg/kg/day (NOAEL = 150 mg/kg/day) is protective 
of kidney toxicity and is approximately 2,600 times lower than the dose 
where decreased relative thymus weights were observed. Therefore, the 
cRfD will be protective of this immunotoxicity effects. The IPCS CICAD 
for ethylene glycol finds that although ``data are limited, results of

[[Page 31477]]

identified toxicity studies conducted (via oral, inhalation, or dermal 
routes) in rodents, rabbits, and monkeys do not indicate that 
immunological effects are critical end-points for ethylene glycol.'' 
(IPCS 2002).
    iv. Evidence of increased susceptibility was not observed in the 
developmental toxicity study in the rabbit. However, evidence of 
increased susceptibility was observed following prenatal exposure to 
ethylene glycol in mice. An increased incidence of total malformations 
and bilateral extra rib 14 were observed at 500 mg/kg/day. These 
effects occurred in the absence of maternal toxicity. In a 
developmental study in rats, there was evidence of qualitative fetal 
susceptibility. Maternal (tubular dilation and regeneration in the 
kidneys, increased gestational period, and decreased relative kidney 
weights) and developmental (decreased pup weight, increased cumulative 
mortality/litter, increased incidence of hydrocephaly, decreased 
relative kidney weights, decreased absolute brain weights, and 
increased incidences of hydrocephaly; defects in ribs, sternebrae, and 
vertebrae) were observed at the same dose (1,250 mg/kg/day). There was 
no evidence of increased fetal susceptibility in another developmental 
study in rats, maternal (pre-implantation loss) and developmental 
(poorly ossified and unossified vertebral centra) effects were observed 
at the same dose (1,000 mg/kg/day). However, there was a well 
established NOAEL in these two developmental toxicity studies in rats 
protecting fetuses. In addition, these fetal effects were generally 
seen at relatively high doses. In a reproduction study in mice, 
increased fetal susceptibility was observed but again it occurred above 
the limit dose. Developmental toxicity manifested as decrease number of 
live pups/litter, and mean live pup weight was observed in the absence 
of maternal toxicity at 1,640 mg/kg/day.
    In another reproduction study in mice, maternal (kidney lesions and 
oxalate crystals) and developmental toxicity (decrease in pup weight 
adjusted for litter size) were observed at 897 mg/kg/day.
    However, the concern for this increased susceptibility was low 
based on the following rationale:
    a. There is a well established NOAEL in these studies protecting 
fetuses/offspring from the aforementioned effects;
    b. Although increased susceptibility was observed, this occurred at 
doses close to the limit dose of 1,000 mg/kg/day;
    c. The effects seen in the developmental study were not reproduced 
in the reproduction studies; and
    d. The established chronic reference dose of 1.5 mg/kg/day will be 
protective of these effects. Therefore, based on the weight of evidence 
the concern for increased fetal susceptibility is low.
    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 water and surface water modeling used to 
assess exposure to ethylene glycol in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
ethylene glycol.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
aPAD and 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. Using the exposure assumptions described in this unit 
for acute exposure, EPA has concluded that acute exposure to ethylene 
glycol from food and water will utilize 26.5% of the aPAD for females 
13-49, the only population group identified as potentially facing an 
acute risk from exposure to ethylene glycol.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
ethylene glycol from food and water will utilize 12.8% of the cPAD for 
the general population and 41.6% 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).
    Ethylene glycol 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 ethylene glycol.
    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 200 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. EPA has 
concluded that the combined short-term aggregated food, water, and 
residential exposures result in an aggregate MOE of 170 for children. 
Children's residential exposure includes total exposures associated 
with contact with treated surfaces (dermal and hand-to-mouth 
exposures). Because EPA's LOC for ethylene glycol 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).
    Ethylene glycol 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 ethylene glycol.
    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 580 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. EPA has concluded that the combined short-
term aggregated food, water, and residential exposures result in an 
aggregate MOE of 200 for children. Children's residential exposure 
includes total exposures associated with contact with treated surfaces 
(dermal and hand-to-mouth exposures). Because EPA's LOC for ethylene 
glycol is a MOE of 100

[[Page 31478]]

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 ethylene 
glycol.
    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 ethylene glycol 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 ethylene glycol.

C. Response to Comments

    The two comments were received from private citizens who opposed 
the authorization to sell any pesticide that leaves a residue on food. 
The Agency understands the commentors' 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 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 180.910 for ethylene glycol (107-21-1) when 
used as an inert ingredient (in encapsulating agents for pesticides 
being applied post-harvest as residual, and crack and crevice sprays in 
and around food and nonfood areas of residential and nonresidential 
structures, including food handling establishments) and 40 CFR 180.920 
for ethylene glycol when used as an (inert ingredient as a solvent, 
stabilizer and/or antifreeze within pesticide formulations/products 
without limitation) 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 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: May 18, 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.  180.910, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:

[[Page 31479]]

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
           Inert ingredients                     Limits                                Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Ethylene glycol (CAS Reg. No. 107-21-   Without limitation.....  Encapsulating agent for pesticides being
 1).                                                              applied post-harvest as residual, and crack
                                                                  and crevice sprays in and around food and
                                                                  nonfood areas of residential and
                                                                  nonresidential structures, including food
                                                                  handling establishments.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. In Sec.  180.920, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:

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

* * * * *

----------------------------------------------------------------------------------------------------------------
           Inert ingredients                      Limits                               Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Ethylene glycol (CAS Reg. No. 107-21-1)  Without limitation.....  Pesticide inert ingredient as a solvent,
                                                                   stabilizer and/or antifreeze.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-13577 Filed 5-31-11; 8:45 am]
BILLING CODE 6560-50-P
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