Docket Number: EPA-HQ-OPP-2010-0694 

www.regulations.gov 

Diethylene Glycol Monomethyl Ether (DGME) 

Summary Document 

Registration Review: Initial Docket 

December 2010 

Docket Number: EPA-HQ-OPP-2010-0694 

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TABLE OF CONTENTS 

 Page # 

I. Preliminary Work Plan (PWP) 5 

II. Fact Sheet 13 

________________________________________ 

Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents: 

1. Summary of Human Health Effects Data for the DGME Registration Review Decision 

Document. October 12, 2010. 

2. Diethylene Glycol Monomethyl Ether: Product Chemistry/Environmental Chemistry and 

Eco-Effects Scoping Document. October 27, 2010. 

Additional supporting documents for DGME may be found in the registration review docket

EPA-HQ-OPP-2010-0694 located on the internet at www.regulations.gov. 
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DGME Registration Review Team 

Human Health & Environmental Effects 

Nathan Mottl 

Najm Shamim 

Risk Management

Eliza Blair 

Lance Wormell 

Office of General Counsel

Philip Ross 
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I. Preliminary Work Plan – DGME 

Introduction:

The Food Quality Protection Act of 1996 mandated a registration review program. All pesticides 

sold or distributed in the United States generally must be registered by the Environmental 

Protection Agency (EPA), based on scientific data showing that they will not cause unreasonable 

risks to human health or the environment when used as directed on product labeling. The 

registration review program is intended to make sure that, as the ability to assess risk evolves and 

as policies and practices change, all registered pesticides continue to meet the statutory standard 

of no unreasonable adverse effects to human health or the environment. Changes in science, 

public policy, and pesticide use practices will occur over time. Through the registration review 

program, the Agency periodically reevaluates pesticides to make sure that as change occurs, 

products in the marketplace can be used safely. Information on this program is provided at: 

http://www.epa.gov/oppsrrd1/registration_review/. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the registration review of diethylene glycol monomethyl ether (DGME). 

The DGME case currently contains one product. The product is registered for use as an 

antimicrobial preservative and anti-icing agent for hydrocarbon fuels. DGME was first registered 

as a pesticide in June 2002. Because it was registered after November 1, 1984, no Reregistration 

Eligibility Decision (RED) has been issued for this chemical. 

Documents associated with the registration review of DGME can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2010-0694. Below is a summary of the issues 

relevant to the registration review of DGME. 

Anticipated Risk Assessment and Data Needs:

The Agency does not anticipate the need to conduct an ecological risk assessment, including an 

endangered species risk assessment, for uses of DGME. The Agency does not anticipate the 

need to conduct a human health risk assessment. The Agency does not anticipate needing 

additional physical chemistry, ecological or human health data for registration review. 
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Ecological Risk: 

• No ecological risk assessment has been performed for DGME. The Agency did not 

perform an ecological risk assessment for DGME when it was first registered in 2002 

because of the limited use pattern and low chances for exposure to the environment and 

because available and model-generated environmental fate data indicate that DGME 

biodegrades rapidly in the environment and is not expected to bioaccumulate in aquatic 

organisms. 

• The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for DGME. However, due to DGME’s limited use patterns (fuel 

preservative) and low probability of contact with species of concern, the Agency does not 

intend to conduct a full ecological risk assessment at this time. Additionally, due to the 

limited use patterns and low probability of contact, the Agency has sufficient information 

to make an Endangered Species Risk Assessment determination. The Agency has 

determined that the registered uses of DGME will have “No Effect” on endangered and 

threatened terrestrial or aquatic species, or any designated critical habitat, as listed by the 

United States Fish and Wildlife Service and the National Marine Fisheries Service. 

• Available and model-generated environmental fate data indicate that DGME is highly 

volatile and transfers to air and ground water easily, but biodegrades rapidly in the 

environment. Additionally, it is not expected to bioaccumulate in aquatic organisms. 

• Available and model-generated ecotoxicity data characterize technical-grade DGME as 

practically non-toxic to birds and aquatic organisms. 

• The Agency has reviewed the environmental fate and ecological database for the DGME 

case and anticipates that, due to the limited use pattern and low chances for exposure to 

the environment, no additional environmental fate and ecotoxicity data will be needed for 

registration review. 

• Please refer to “Diethylene Glycol Monomethyl Ether: Product Chemistry/Environmental 

Chemistry and Eco-Effects Scoping Document”, located in the docket, for a detailed 

discussion of these anticipated risk assessment and data needs. 

Human Health Risk:

• No human health risk assessment has been performed for DGME. The Agency did not 

perform a human health risk assessment for DGME when it was first registered in 2002 

due to DGME’s limited use patterns (hydrocarbon fuel preservative) and low probability 

of human exposure during use. 
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• The Agency has reviewed the human health exposure and toxicity database for the 

DGME case and anticipates that no additional exposure and toxicity data will be needed 

for registration review. 

• The Agency generally requires a 90-day inhalation toxicity study to assess inhalation 

toxicity endpoints, but, in the case of DGME, the study was not needed based on the 

label’s use and engineering controls (e.g. closed mixing/loading) which prevent 

inhalation exposure. At the time of registration in 2002, the Agency also indicated some 

concern based on the developmental effects and first believed that a 2-generation 

reproductive study may be needed. However, the 2-generation reproductive study will 

not be required since DGME is only used in closed delivery systems for non-food uses. 

New uses or new registrations could potentially trigger the need for these toxicity data 

considerations in the future. 

• For more information please refer to “Summary of Human Health Effects Data for the 

DGME Registration Review Decision Document”, located in the docket. 

Product Chemistry:

• The Agency has reviewed the product chemistry database for the DGME case and 

anticipates that no additional product chemistry data will be needed for registration 

review. 

• Please refer to “Diethylene Glycol Monomethyl Ether: Product Chemistry/Environmental 

Chemistry and Eco-Effects Scoping Document”, located in the docket, for a detailed 

discussion of these anticipated risk assessment. 
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Timeline:

EPA has created the following estimated timeline for the completion of the DGME registration 

review. 

Registration Review for DGME – Projected Registration Review Timeline

Activities Estimated Date 

Opening the Docket 

Open Docket and Public Comment Period 2010 – December 

Close Public Comment 2011 – February 

Case Development 

Final Work Plan 2011 – June 

Issue DCI 2012 – Jan - March 

Data Submission 2013 – Jan – March 

Open Public Comment Period for Draft Risk Assessments 2014 – Aug – Sept 

Close Public Comment Period 2014 – Nov – Dec 

Registration Review Decision 

Open Public Comment Period for Proposed Registration Review 

Decision 

 2015 – Jan – March 

Close Public Comment Period 2016 – June – Aug 

Registration Review Decision and Begin Post-Decision Follow-up 2016 

Total (years) 5.5 

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary work plan and rationale. The 

Agency will consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for the DGME case. 

Trade Irritants 

Through the registration review process, the Agency intends to solicit information on 

trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. 

Growers and other stakeholders are asked to comment on any trade irritant issues resulting from 

lack of Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in 

key export markets, providing as much specificity as possible regarding the nature of the 

concern. 

Water Quality 

DGME is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act, based on information provided at 
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http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for DGME, based 

on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES. More information on impaired water bodies and 

TMDLs can be found at http://www.epa.gov/owow/tmdl/. The Agency invites submission of 

water quality data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm), in order to ensure 

they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice 

EPA seeks to achieve environmental justice, the fair treatment and meaningful 

involvement of all people, regardless of race, color, national origin, or income, in the 

development, implementation, and enforcement of environmental laws, regulations, and policies. 

To help address potential environmental justice issues, the Agency seeks information on any 

groups or segments of the population who, as a result of their location, cultural practices, or other 

factors, may have atypical, unusually high exposure to DGME, compared to the general 

population. Please comment if you are aware of any sub-populations that may have atypical, 

unusually high exposure compared to the general population. 

Structure Activity Relationships 

EPA must rely upon information of appropriate quality and reliability for each decision 

made by the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a 

pesticide chemical traditionally begins with the applicant’s submission of a set of studies 

conducted with the specific pesticide chemical of interest. The use of the results of such testing 

(measured data) is a logical, scientifically rigorous process that identifies the physical, chemical, 

and environmental fate properties of the pesticide, as well as the dose and endpoints at which an 

adverse effect can occur in various animal species. 

Today, there is significant interest in alternative techniques, i.e., techniques other than 

data generation that could significantly inform the Agency’s decision-making process. Recently, 

OPP has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties. 

Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 
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develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

property is used to derive a model (an equation) to predict the value of that property. 

 Since SAR assessments and QSAR modeling are another set of tools that are available to 

Agency scientists, OPP has begun a process shift that envisions shifting from the current studyby-study approach to an approach in which the use of predicted data, generated using validated 

models, is considered along with information from open literature and studies specifically 

generated under Part 161 requirements. All relevant information would be considered as part of 

a weight-of-the-evidence evaluation. 

At this time, EPA believes that for certain endpoints, especially physical/chemical and 

fate properties, that SAR and QSAR might be effectively utilized to fulfill these data 

requirements for many antimicrobial pesticide chemicals. When considering biological 

properties, at this time, EPA believes that SAR and QSAR can be most effectively utilized in the 

evaluation of chemicals that exhibit lower toxicity for human health and/or ecotoxicity 

parameters. This is appropriate because the risk assessment for lower toxicity chemicals can be 

stream-lined, i.e., a screening-level assessment procedure rather than multiple tiers of 

assessments with progressively more data requirements. 

If stakeholders believe that submission of predicted data can fulfill one of the data needs 

for DGME, then the Agency invites submission of this information. The submitter would be 

expected to supply a rationale describing the utility of the information and provide 

documentation on the scientific validity of the information. The determination that the predicted 

data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission 

consultation with the Agency is encouraged. 

Endocrine Disruptor Screening Program 

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by 

a “naturally occurring estrogen, or other such endocrine effects as the Administrator may 

designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 
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Between October 2009 and February 2010, EPA issued test orders/data call-ins for the 

first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert 

ingredients. This list of chemicals was selected based on the potential for human exposure 

through pathways such as food and water, residential activity, and certain post-application 

agricultural scenarios. This list should not be construed as a list of known or likely endocrine 

disruptors. 

DGME is not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide 

chemicals. Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins for 

Registration Review cases, including those for which EPA has already opened a Registration 

Review docket for a pesticide active ingredient. 

For further information on the status of the EDSP, the policies and procedures, the list of 

67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/. 

Additional Information 

Stakeholders are also specifically asked to provide available information and data that 

will assist the Agency in refining the ecological and human health risk assessments. The Agency 

is interested in obtaining the following information regarding the use of DGME: 

1. Confirmation on the following label information: 

a. Sites of application 

b. Formulations 

c. Application methods and equipment 

d. Maximum application rates 

e. Frequency of application, application intervals and maximum number 

of applications 

f. Geographic limitations on use 

2. Use or potential use distribution 

3. Use history 

4. Usage/use information for non-agricultural uses (e.g., materials preservation) 

5. Typical application interval 

6. State or local use restrictions 

7. Ecological incidents (non-target plant damage and avian, fish, reptilian, 

amphibian and mammalian mortalities) not already reported to the Agency 

8. Monitoring data 

9. Structure Activity Relationships 
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Next Steps:

After the 60-day comment period closes, the Agency will review and respond to any comments 

received in a timely manner, and then issue a Final Work Plan (FWP) in June 2011 for DGME.
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II. FACT SHEET

 

Background Information:

• DGME PC code: 042204 

• Registration Review Case: 5010 

• CAS No: 111-77-3 

• Technical Registrant: ConocoPhillips Company 

• The first DGME-containing pesticide was registered for use in the U.S. in June 2002. 

• No Reregistration Eligibility Decision (RED) has been issued for DGME because it was 

registered after 1984. 

• There is currently one registered product containing DGME.

• No tolerances or tolerance exemptions currently exist for DGME. 

• Antimicrobials Division Chemical Review Manager: Eliza Blair, blair.eliza@epa.gov

• Antimicrobials Division Product Manager (PM): Marshall Swindell, 

swindell.marshall@epa.gov

Use & Usage Information:

• The one registered DGME-containing product is formulated as a soluble concentrate, and 

is registered for use as a preservative and anti-icing compound in jet fuel, diesel fuel, 

marine fuel and fuel oils. 

• The product label restricts application to a “closed delivery system” (open-pouring of the 

product is not allowed). 

• Personal Protective Equipment (PPE) is required on the label for handling of this product, 

including long pants, long-sleeved shirt, shoes and socks, and chemical-resistant gloves. 

Recent and Pending Regulatory Actions:

• There have been no recent or pending regulatory actions involving the chemical DGME 

since it was first registered in 2002. 

Ecological Risk Assessment Status: 

The Agency has not performed an ecological risk assessment for DGME. Please refer to

“Diethylene Glycol Monomethyl Ether: Product Chemistry/Environmental Chemistry and EcoEffects Scoping Document”, located in the docket, for further details. 

Summary of Risk: 

• Available and model-generated environmental fate data indicate that DGME is highly 

volatile and transfers to air and ground water easily, but biodegrades rapidly in the 
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environment. Additionally, it is not expected to bioaccumulate in aquatic organisms. Due 

to the limited use pattern and low chances for exposure to the environment, the Agency 

does not anticipate the need to require additional environmental fate or ecotoxicity data 

for DGME at this time. 

• Available and model-generated ecotoxicity data characterize technical-grade DGME as 

practically non-toxic to birds and aquatic organisms. 

Human Health Risk Assessment Status:

No human health risk assessment has been performed for DGME. The Agency does not 

anticipate conducting human dietary, residential, and occupational risk assessments due to 

DGME’s limited use patterns (hydrocarbon fuel preservative) and low probability of human 

exposure during use. Please refer to “Summary of Human Health Effects Data for the DGME 

Registration Review Decision Document”, located in the docket, for further details. 

Hazard Characterization: 

• The human health exposure database to support the registration review of DGME is 

considered complete based on data that were submitted in 2002 to support the initial 

registration of DGME as a pesticide active ingredient in a product used only in a closed 

delivery system. 

Dietary (Food and Water): 

• No dietary exposure is expected due to DGME’s limited use patterns (hydrocarbon fuel 

preservative) and closed delivery system application. 

Residential: 

• No residential exposure is expected due to DGME’s limited use patterns (hydrocarbon 

fuel preservative) and closed delivery system application. 

Aggregate: 

• In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to pesticide residues in food and drinking water, and 

non-occupational pesticide exposures. Dietary (food and drinking water) exposures of 

concern are not anticipated for DGME. An aggregate risk assessment for DGME is not 

needed since there is no dietary or residential exposure for the active ingredient. 

Therefore, an aggregate assessment is not needed. 
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Occupational: 

 

• The only potential for occupational exposure to DGME is at the point of loading. The 

label prohibits mixing or loading of DGME with any fuel unless it is done through closed 

delivery systems. These systems typically use automatic metering pumps using hoses and 

various connecting devices to facilitate transfer from drums, totes, holding tanks, etc. 

According to data from the supplier, the closed system process begins at “pickup” from 

the supplier. The additive, in bulk, is loaded into the railroad tank cars or tank trucks 

through closed piping or hose systems. The bulk is delivered at a gasoline terminal 

where it is transferred through closed mixing to a holding tank. When an order is made, 

additive is metered into the fuel of a tank truck at a rate of 0.1-0.15% by weight, as it is 

loaded. 

Cumulative: 

• EPA does not have, at this time, available data to determine whether DGME has a 

common mechanism of toxicity with other substances or how to include this pesticide in 

a cumulative risk assessment. For the purposes of this Registration Review, EPA has 

assumed that DGME does not have a common mechanism of toxicity with other 

substances.

Incidents:

Ecological:

• There have been no ecological incidents reported in any of the OPP databases associated 

with exposure to DGME as a fuel additive. 

Human Health: 

• There have been no human incidents reported in any of the OPP databases associated 

with exposure to DGME as a fuel additive. 

Tolerances and International Harmonization: 

• No tolerances or tolerance exemptions have been established for DGME. 

Data Call-In Status

• No data call-in has been issued for DGME. 
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Labels: 

 

• DGME product labels can be obtained from the Pesticide Product Label System (PPLS) 

website: http://oaspub.epa.gov/pestlabl/ppls.home

EPA Reg. 

Number 

Product Name Formulation 

Type 

% Active 

Ingredient

Registrant 

224-32 Phillips Fuel 

Additive 56 MB 

Petroleum 

Distillate 

99.7 Phillips 66 Company/ a 

Subsidiary of Phillips 

Petroleum Company