Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov



## Diethylene Glycol Monomethyl Ether (DGME) Summary Document Registration Review: Initial Docket

December 2010Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

3 

### TABLE OF CONTENTS

Page #

I. Preliminary Work Plan (PWP) 5

II. Fact Sheet 13

______________________ __________________

Please Note

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency's current position based on the following documents:

1. Summary of Human Health Effects Data fo r 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

.Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

4 DGME Registration Review Team

Human Health & Environmental Effects

Nathan Mottl Najm Shamim

Risk Management

Eliza Blair

Lance Wormell

Office of General Counsel Philip RossDocket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

5 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 Un ited States generally must be registered by the Environmental Protection Agency (EPA), based on scientific data showing that they wi ll 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 su re that, as the ability to assess risk evolves and as policies and practices change, al l 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 pr actices will occur over time. Through the registration review program, the Agency periodically reevaluates pestic ides 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/oppsrr d1/registration_review/

.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The Agency will consid er 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 whatit knows about the pesticide and what additional risk analyses and data or information it belie ves 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 de velop and commit to a final work plan and schedule for the registration review of di ethylene glycol monom ethyl ether (DGME).

The DGME case currently contains one product. The product is registered for use as an antimicrobial preservative and anti-icing agent fo r hydrocarbon fuels. DGME was first registered as a pesticide in June 2002. Because it was re gistered after November 1, 1984, no Reregistration Eligibility Decision (RED) has b een issued for this chemical.

Documents associated with the registrati on review of DGME can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2010-0694. Belo w is a summary of the issues relevant to the regist ration review of DGME.

Anticipated Risk Assessment and Data Needs:

The Agency does not anticipate the need to condu ct 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 hu man health data for registration review.Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

6 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 envi ronmental 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 asse ssment that supports a complete endangered species determination for DGME. However, due to DGME’s limite d use patterns (fuel preservative) and low probability of contact with species of concer n, the Agency does not intend to conduct a full ecological risk assessm ent at this time. A dditionally, due to the limited use patterns and low probability of cont act, the Agency has sufficient information to make an Endangered Species Risk A ssessment 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 ha bitat, as listed by the

United States Fish and Wildlife Service a nd 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 bird s 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 a nd low chances for exposure to the environment, no additional environmental fa te 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 patt erns (hydrocarbon fuel pres ervative) and low probability of human exposure during use.Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

7 • The Agency has reviewed the human health exposure and toxicity database for the DGME case and anticipates that no additional ex posure 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 registra tion 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 ne ed 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 chemistr y 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.Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

8 Timeline:

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

review.

Registration Review for DGME – Proj ected 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 comme nt on EPA’s preliminary work plan and rationale. The Agency will consider all comments as well as an y 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, th e 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 comme nt 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 specifici ty as possible regarding the nature of the

concern.

Water Quality

DGME is not identified as a cause of impairme nt for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided atDocket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

9 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 (T MDL) have been developed for DGME, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?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 exte nt possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ), in order to ensure they can be used quantitatively or qual itatively in pesticide risk assessments.

Environmental Justice

EPA seeks to achieve environmental justi ce, 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 envir onmental justice issues, the Agency seeks information on any groups or segments of the population who, as a resu lt of their location, cultur al 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-populati ons 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 traditionall y begins with the applicant’s submission of a set of studies conducted with the specific pesticid e chemical of interest. The use of the results of such testing (measured data) is a logical, scie ntifically rigorous pr ocess that identifies the physical, chemical, and environmental fate properties of the pesticid e, as well as the dose and endpoints at which an adverse effect can occur in various animal species.

Today, there is significant interest in altern ative 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 (S AR) 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 p hysical, chemical, and bi ological properties. Thus, the chemical’s physical, chemical, and biol ogical properties are a f unction of (or directly related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. ToDocket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

10 develop a QSAR, a selected set of measured da ta on a single physical, chemical, or biological property is used to derive a model (an equatio n) to predict the valu e 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 w ould be considered as part of a weight-of-the-evide nce evaluation.

At this time, EPA believes that for certai n 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 c onsidering biological properties, at this time, EPA believes that SAR a nd QSAR can be most effectively utilized in the

evaluation of chemicals that exhibit lower t oxicity 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 assessmen t procedure rather than multiple tiers of assessments with progressively more data requirements.

If stakeholders believe that submission of pr edicted 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 th e utility of the information and provide

documentation on the scientific valid ity of the information. The de termination that the predicted data fulfills the data requiremen t would be at the sole discretio n of the Agency. Pre-submission consultation with the Agency is encouraged.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar 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 ap proach 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

11 Between October 2009 and February 2010, EPA issu ed 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 sele cted based on the potenti al for human exposure through pathways such as food and water, resi dential activity, and cer tain 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 acti ve 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 issu ing 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 pestic ide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, plea se 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 refini ng 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, applica tion 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-agricultura l 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 RelationshipsDocket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

12 Next Steps:

After the 60-day comment period closes, the Ag ency 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.Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

13 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 regi stered 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 regist ered 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 Ma nager (PM): Marshall Swindell, swindell.marshall@epa.gov

Use & Usage Information:

• The one registered DGME-contai ning product is formulated as a soluble concentrate, and is registered for use as a pr eservative and anti-icing compoun d in jet fuel, diesel fuel,

marine fuel and fuel oils.

• The product label restricts appl ication 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, shoe s and socks, and chemical-resistant gloves.

Recent and Pending Regulatory Actions:

• There have been no recent or pending regulat ory actions involving the chemical DGME since it was first registered in 2002.

Ecological Risk Assessment Status :

The Agency has not performed an ecological ri sk assessment for DGME. Please refer to “Diethylene Glycol Monomethyl Ether: Produc t Chemistry/Environmen tal 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 theDocket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

14 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 additi onal 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 bird s 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 occ upational 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 s upport 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 pestic ide active ingredient in a pr oduct 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 de livery system application.

Residential:

• No residential exposure is expected due to DGME’s limited use pa tterns (hydrocarbon fuel preservative) and closed delivery system application.

Aggregate:

• In examining aggregate exposure, EPA take s into account the available and reliable information concerning exposures to pesticid e residues in food and drinking water, and non-occupational pesticide exposures. Dietar y (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 reside ntial exposure for the active ingredient. Therefore, an aggregate assessment is not needed.Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

15 Occupational :

• The only potential for occupational exposure to DGME is at the point of loading. The label prohibits mixing or loading of DGME w ith any fuel unless it is done through closed delivery systems. These systems typically us e automatic metering pumps using hoses and various connecting devices to facilitate transf er from drums, totes, holding tanks, etc. According to data from the supplier, the clos ed 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 tr uck at a rate of 0.1-0.15% by weight, as it is

loaded.

Cumulative:

• EPA does not have, at this time, availabl e data to determine whether DGME has a common mechanism of toxicity with other substa nces or how to includ e this pesticide in a cumulative risk assessment. For the purpos es of this Registration Review, EPA has

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

substances.

Incidents:

Ecological:

• There have been no ecological incidents report ed 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 exempti ons have been established for DGME.

Data Call-In Status

• No data call-in has been issued for DGME.Docket Number: EPA-HQ-OPP-2010-0694 www.regulations.gov

16 Labels :

• DGME product labels can be obtained from th e 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