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April 2008 Meeting Miuntes

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Workgroup Meeting Minutes
April 8, 2008

Introduction/Welcome

Ted Smith, US EPA Great Lakes National Program Office 

US EPA OPPT Updates on the Security and Prosperity Partnership Project

Presenter: Ellie Clark, US EPA Office of Pollution Prevention & Toxics 

Q&A:

1.      (Steve Risotto, HSIA):  What is the end product of the TSCA §5(b)(4) “Risk List” and how is the list used?

Response: 
(Ellie Clark, US EPA):  The list gives EPA authority regarding risk management, such as the authority to assign an unreasonable risk finding to a chemical.  In such a case, industry would need to rebut the finding in order to keep producing that chemical.  These are issues that need to be worked out.  This list is the approach EPA wants to take for chemicals of higher concern because this approach requires full agency rulemaking, but first the EPA needs to determine the chemical is an unreasonable risk.  In that case, industry could rebut the decision by showing that risk management reduces concerns.  EPA is still working this out and will publish advance notice of rulemaking to allow for stakeholder input.

2.      (Dale Phenicie, CGLI):  Slide 3 states MPV’s will build off of Canadian categorization efforts.  Please expand on this.

Response: 
(Ellie Clark, US EPA):  EPA has looked at the Canadian Domestic Substances List (DSL) Categorization, and the Canadians did an excellent job of looking at worldwide data sources to come to conclusions with respect to environmental and health hazards.  This presents a lot of useful data that EPA does not have for MPV’s because the MPV’s have not been subject to the HPV challenge.  There is no base set of information for hazard analysis for MPV’s like there are for HPV’s.  The Canadians have compiled a great deal of data about some of the chemicals the EPA expects will be MPV’s. More information may be needed, but the DSL Categorization data provides a good starting point.  The Canadian program has a different basis for conclusions than the EPA has, and some of the regulations and trigger factors differ, so there may be some data gaps.  As such, the data from the Canadian program will not be directly used, but instead will be applied under the U.S. TSCA authority.

3.      (Lin Kaatz Chary, NW Indiana Toxics Action):  This program appears to be a very conservative approach.  There are some chemicals for which a lot data already exists, but are still far from being acted on.  How will endocrine-disrupting chemicals (EDCs) fit into this framework when there is already quite a bit of information that is known about them and when there are areas in Europe that are already taking action on these chemicals?  It seems that under the described process it will be several more years before we begin to see conclusions, and during that time exposure will continue.  Please comment.

Response: 
(Ellie Clark, US EPA):  There are two sides to making a risk determination.  EPA needs to look at the hazard information and the exposure scenario.  Some chemicals look scary, such as DCAC, which is highly corrosive.  However, because DCAC is highly corrosive, it is not used in consumer or children’s products, and in the occupational setting, it is used under fairly strict controls. Therefore, EPA does not feel there is additional action needed for DCAC unless we receive contrary information about the exposure scenario.  We need to look at each individual situation.  There may be chemicals that have a fairly high hazard profile, but exposure data may still be needed.  There has to be an exposure concern for the assessed chemicals because that is how TSCA is applied.  For HBCD, there are concerns, but there is no indication yet that consumers and children are directly exposed to this chemical.  In addition, EPA has no information about HBCD on environmental release and exposure.  By publishing information we have, EPA is hoping to receive additional information to assist in the assessment process under TSCA.  There are limitations under TSCA to make a determination about chemicals.  The program described was developed under the available statutory abilities.

Comment:
(Lin Kaatz Chary):  I feel that we are at a dead end because there is a huge amount of data available.  I am not clear about what the ultimate criteria are for taking a regulatory action under TSCA.  For example, in some cases we see what the exposures are, that the exposures are multiple, and there are a lot of laboratory data about how these chemicals affect animals.  It appears that this is a very conservative process that takes many years, while nearly reinventing the wheel.

Response: 
(Ellie Clark, US EPA):  All of these processes (gathering and assessing data) take a long time.  All agencies, including those in Canada, the EU, and the U.S., have to assemble data packages and analyze them before determinations can be made.  EPA is publishing obtained data on the web and indicating data gaps in order to obtain more data.  EPA is very clear on the kind of information needed in order to make informed decisions about a particular chemical.  We have to assess one chemical or category at a time.      

4.      (Fe de Leon, Canadian Environmental Law Association):  To what extent is this program linked to the Voluntary Children’s Health Program (VCHP) under OPPT?

Response: 
(Ellie Clark, US EPA):  Two other chemicals assessed in the pilot program, monoglyme and diglyme, both had high health concerns related to developmental issues, but there is not enough information about these chemicals.  In contrast to HBCD, EPA did not find other sources of information about these two chemicals. EPA has recommended that these two chemicals be considered for the VCHP program and has spelled out the type of exposure data needed for these chemicals. EPA is trying to link the programs.

5.      (Ted Smith, US EPA):  Please further explain the challenge programs.  Are these voluntary challenges put out to industries?

Response: 
(Ellie Clark, US EPA):  The HPV Challenge Program has been in existence for quite a while.  Many years ago, in concert with the ACC and Environmental Defense, the EPA developed a voluntary challenge program for industry for HPV chemicals.  The challenge involved getting industry to voluntarily commit to submitting SIDS data sets and hazard information for each HPV chemical so that the EPA could analyze the chemicals, do a risk assessment, and determine what kind of action was needed.  Exposure information was obtained from the Inventory Update Rule reporting.  EPA is considering doing a similar type of challenge for inorganic HPV chemicals because it could be similarly structured. EPA is also looking at using available information for MPV chemicals, and if there is not enough data, then a challenge program may be useful for some of those chemicals as well.

Comment: 
(Ted Smith, US EPA):  When referring to “challenge program,” you are referring to producing data and not voluntary actions designed to reduce chemicals in commerce?

Response: 
(Ellie Clark, US EPA):  In the future, EPA could potentially develop those kinds of programs focusing on reduction of use in commerce.  We have to focus first on gathering the data in order to make a determination.

6.      (Ted Smith, US EPA):  Has the stakeholder engagement process been developed?

Response: 
(Ellie Clark, US EPA):  This is in the works.

7.      (Michael Murray, National Wildlife Federation):  Is TSCA Section 6 being considered for chemicals that are deemed to be problematic?

Response: 
(Ellie Clark, US EPA):  Yes.  If a chemical met the requirements of the Section 6 TSCA rule, EPA would consider this action.  There are other tools that are quicker and would generate other information, but this could still be an option. EPA would try any tool under TSCA.

8.      (Sue Brauer, US EPA Region 5):  Does the data-gathering process preclude you from gathering information about pesticides?  If a chemical has multiple uses, and is an active ingredient in a pesticide, could you collect information on it?

Response: 
(Ellie Clark, US EPA):  Chemicals subject to TSCA are primarily industrial chemicals.  If a chemical is a pesticide, it is excluded from TSCA.  If a chemical is used both in industry and as a pesticide, the program under TSCA would look at that chemical with regards to its use in industry only.

Comment: 
(Sue Brauer, US EPA Region 5):  What about pesticide inerts?  Would these fall under TSCA?

Response: 
(Ellie Clark, US EPA):  The program does not look at pesticide inerts.  If a chemical had an industrial use separate from its use as a pesticide ingredient, then the industrial use of that chemical may be assessed.  TSCA covers industrial chemicals not covered under other agencies. 

9.      (Erin Newman, US EPA Region 5):  Is the list of options for action listed on Slide 8 a hierarchy of actions?

Response: 
(Ellie Clark, US EPA):  The list is a hierarchy to a certain extent based on the basic requirements and amount of effort per action.  The TSCA tools have different levels of proof in order to use them, and so it depends on how much information and concern there are about a particular chemical whether or not certain TSCA tools are used.  The first choice is to ask for additional information from producers.  If no additional information is obtained, we would look at other sources for information.  The last option listed on Slide 8, creation of TSCA §5(b)(4) “Risk List,” has not yet been used by this program and requires a very high level of concern in order to be used as a tool.  The list on Slide 8 is somewhat of a hierarchy, but it is not intended to be a step-by-step process.

Canada’s Chemicals Management Plan (CMP)

Presenter:  Suzanne Easton, Environment Canada (EC) 

Q&A:

1.      (Lin Kaatz Chary, NW Indiana Toxics Action):  How are you addressing chemicals introduced into commerce after 1986?

Response:
(Suzanne Easton, EC):  We recognize some of our information is outdated. Substances not on the DSL that were introduced after 1986 were identified as “new substances” that are included in a new tracking program that requires assessment before the chemical is introduced into the Canadian market.  Due to the fact that DSL information pertains to substances in Canadian commerce prior to 1986, it is difficult to identify whether these substances are still in commerce today.  Environment Canada is in the process of identifying substances that are no longer in commerce through the use of mandatory information gathering surveys.

2.      (Ellie Clark, US EPA):  How has the response been for the voluntary versus mandatory request for information from industrial manufacturers as part of the batch data surveys?

Response:
(Suzanne Easton, EC):  There has been a lot of interest in the challenge.  Within the first year, EC dealt with over 3,700 responses.  A lot of information has been provided from various stakeholders respecting both the mandatory and voluntary surveys.  Exact response rates were not on hand at the meeting.

3.      (Dale Phenicie, CGLI):  What happens next, now that the comment period is closed for the Batch 1 chemicals?

Response:
(Suzanne Easton, EC):  Comments received will be reviewed, and a Government of Canada response will be provided.  The response will be published with the final screening level assessment explaining how the comments were considered.  This will be accompanied by a risk management approach document, if necessary, outlining proposed actions to address identified concerns.  Then there will be a 60-day public comment period regarding the proposed risk management actions.  Development of risk management actions will then commence if necessary.

4.      (Fe de Leon, Canadian Environmental Law Association):  Please expand on which chemicals and potential sectors within the Great Lakes will be reviewed as part of the sectoral approach for addressing CMP substances.  Also, with relation to surveys that have been conducted, would EC consider a survey question about whether a chemical of concern is relevant to the Great Lakes?

Response:
(Suzanne Easton, EC):  Workgroup co-chairs are not at the point yet where decisions have been made on which chemicals or sectors within the Great Lakes will be addressed as part of the GLBTS sectoral approach.  A great deal of feedback has been received on this issue, and co-chairs are still in the discussion process.  There is the potential that there may be synergies between the GLBTS sectoral approach and the CMP.  Stakeholders will be engaged during this process.

Response:
 (Edwina Lopes, EC):  Regarding whether a chemical is relevant to the Great Lakes, the question would be how to determine if a chemical is significant to the Great Lakes Basin.  We would have to look at how to define that so industry could respond.

5.      (Michael Murray, National Wildlife Federation):  Regarding Slide 7, how were the 500 high-priority chemicals narrowed down to 200 within the challenge?

Response:
(Suzanne Easton, EC):  The 500 included about 150 chemicals from the SNAcs (Significant New Use Activities) that were no longer in commerce and about 160 that were part of the Petroleum Sector, which will be addressed on a sectoral approach apart from the Challenge.

6.      (Michael Murray, National Wildlife Federation):  Is there any place within the process where toxicity information is requested from a producer or user of a chemical?

Response:
(Suzanne Easton, EC):  The Government of Canada is using mandatory information gathering provisions to obtain information from manufacturers, importers, and industrial users of high-priority substances.  Industry and interested stakeholders are also being invited to submit additional information that may be used to inform risk assessment and risk management. This information will feed into the preparation of the final screening level risk assessment reports, which will recommend one of three actions:  no further action, toxic with a potential need for control, or being placed on priority substances list for more in-depth assessment.

Screening Chemicals in Commerce to Identify Possible Persistent and Bioaccumulative Chemicals: New Results and Future Work

Presenter:  Philip Howard, Syracuse Research Corporation 

Q&A:

1.      (Lin Kaatz Chary, NW Indiana Toxics Action):  There appears to be a missing component of this study:  hazard classification.  We know a lot about plasticizers and other chemicals.  For example, we know that many of these chemicals are endocrine disruptors or affect development, but yet these chemicals are not characterized according to those issues.  Such effects help us understand how these chemicals operate in the human environment.  These issues should also be looked at when choosing how to deal with those chemicals.  We should try to replace existing chemicals with chemicals that are biodegradable and less hazardous.  Many programs focus on risk and not hazard, but if hazard is not addressed, related issues may remain undiscovered.  This study emphasizes that many decisions are based on uncertainty, since so little is known about chemicals.

Response:
(Phil Howard, Syracuse Research Corp.):  For many years organic chemists have been producing synthetic chemicals without considering the downside of the products.  However, EPA has developed a lot of tools such as the online PBT profiler that allows you to estimate the physical properties, ecotoxicity, and environmental fate of a chemical.  It is cost effective for a producer to look at all aspects of a chemical before money is spent on the development of a chemical that may have toxicity issues.

Comment:
(Lin Kaatz Chary, NW Indiana Toxics Action):  Often, organic chemists do not have training in toxicology so they do not understand the toxicological implications of what they are creating.

2.      (Allan Jones, Canadian Chlorine Chemistry Council):  Regarding the update of EC and EPA chemical inventories, it is important to distinguish between chemicals that are part of an inventory but that have never been commercialized.  There are many chemicals that are listed in inventories but have never been in commerce, and other substances that may have been in commerce in the past but are no longer in commerce.

Response:
(Ted Smith, US EPA):  This is an issue EPA needs to consider.  The purpose of the work Phil Howard has been doing is to identify substances that we think will be found in the environment.  Factors such as use and production are being considered when determining whether it is believed a chemical will be found in the environment.

Response:
(Phil Howard, Syracuse Research Corp.):  Of the 613 compounds identified in the study, all have IUR reporting quantities and are currently in commerce.

Response:
(Ellie Clark, US EPA):  EPA and EC are working on updating their inventories.  The agencies are aware that there may be chemicals on the inventories that have never been manufactured.

3.      (Suzanne Easton, EC):  In the study, what was the rationale for exclusion of some chemicals on the DSL?

Response:
(Phil Howard, Syracuse Research Corp.):  Of the 20,000+ chemicals on the DSL, there are only 10,000 to 11,000 that are discrete organic compounds.  The study looked primarily at organics because these are the chemicals that are persistent and tend to bioaccumulate.  Chemicals on the DSL that do not have such characteristics were not considered as part of this study.  In addition, we had to be able to draw a structure for the assessed chemicals.

4.      (Dale Phenicie, CGLI):  Please explain the correlation between screening for testing (monitoring) and screening for pollution prevention.  Why address pollution prevention at such an early stage before all monitoring data is collected?

Response:
(Phil Howard, Syracuse Research Corp.):  The main focus of the study was to identify compounds that could support a monitoring program.  It would take many more years to obtain all monitoring information.  Since most of these compounds are persistent, pollution prevention is likely to be relevant.  If it is determined that a chemical is not likely to be released to the environment, then pollution prevention may not be applicable.  It is risky to conclude that a chemical is not persistent or released to the environment because it was not found during monitoring.  Monitoring may have been completed in the wrong medium or location, resulting in incorrect data.  It is not a lot of work to look at alternatives to chemicals, so pollution prevention is a reasonable step forward.

Comment:
(Dale Phenicie, CGLI):  This approach could result in chemicals being indicted without actual proof that there is an issue.

Response:
(Ted Smith, US EPA):  How pollution prevention will be applied based on information collected under the GLBTS has not yet been established.  The June meeting will involve an in-depth discussion about pollution prevention strategies.  There is still a lot of coordination and input required before pollution prevention action can begin.

5.      (Gary Klecka, DOW Chemical):  Given the right set of tools, an analytical chemist can find any commercial substance in the environment.  Analytical capabilities far outweigh our ability to assess risk.  Although it is difficult, it is imperative that we complete chemical analysis in a risk context.  If substances are monitored at low enough levels, it is likely they will be found in the environment.  We need to determine the importance of the monitoring levels.

6.      (Ray Vaughan, NYS Attorney General’s Office):  This study reiterates the difficulty in obtaining analytical capability for some of the compounds.

Regarding the DSL and other substance lists, I would suggest that each list include the best applicable bioassay method for each substance, as provided by manufacturers or others.  Bioassays are good screening tools, especially for addressing risk, and there are many types.

Comment:
 (Ted Smith, US EPA):  US EPA has been working with the National Center for Computational Toxicology, which is developing the ToxCast Program, a rapid bioassay program.  As a result, substances which are found in the environment and may be of concern to us may be able to be evaluated for biological effects using rapid bioassay methods.

7.      (Paul de Leo, The Soap and Detergent Association):  This is a useful exercise for manufacturers and formulators because it identifies substances that are in the public eye.  This study will help manufacturers/formulators focus on the safety concerns related to the 613 identified substances, and will help determine if reformulation should be considered.  The study allows manufacturers/formulators the ability to take action before there becomes widespread media attention or public concern about these substances.

8.      (Michael Murray, National Wildlife Federation):  We need to keep in mind that chemical inventories may under-represent the number of chemicals in use, especially based on CAS information.  There is also a need for additional testing beyond toxicity for the identified chemicals of concern, particularly with regards to physical chemical properties.  Models are only as good as the underlying data they are based on.

Response:
 (Ellie Clark, US EPA):  I do not agree that chemicals in use are under-represented on inventory lists.  However, there are problems with CAS numbers in that some chemicals may be associated with more than one CAS number, which makes it difficult to determine how many chemicals are actually being used.

Response:
 (Phil Howard, Syracuse Research Corp.):  Additional testing is needed, and one approach may be to have the substances listed by the Interagency Testing Committee, which automatically calls for additional data.  But to get the Committee to list 613 compounds may be a political decision and could prove difficult.

9.      (Sue Brauer, US EPA Region 5):  Please clarify the use of CAS numbers by the regulatory program.  Is there an agency-assigned number under TSCA that is used instead of the CAS number?

Response:
 (Ellie Clark, US EPA):  CAS numbers are not as specific as believed; one chemical may have numerous CAS numbers associated with it.  Initially, CAS numbers were issued for a broad range of substances.  Since then, some of these broad substances have become associated with more specific CAS numbers.  These problems are often associated with chemicals that do not have a specific structure.

10.  (Paul Helm, Ontario Ministry of the Environment):  Regarding persistent chemicals, how would this process capture other pseudo-persistent chemicals that are continuously available in aquatic environments?

Response:
 (Ted Smith, US EPA):  The GLBTS Substance Workgroup is specifically looking at substances that may bioaccumulate in aquatic life.  This project does not necessarily address pseudo-persistent chemicals, but these chemicals may still be taken into consideration.  The Workgroup needs to consider pseudo-persistent substances as well.

11.  (Charles Staples, Assessment Technologies):  What is the source of the information in the study?  Is the chemical list and associated justification published or documented?

Response:
 (Phil Howard, Syracuse Research Corp.):  The list of 613 chemicals and other reports are not publicly available but can be obtained through Phil Howard. Contact Phil Howard via email for more information.

Fish and Gull Egg Archive Analysis Project

Presenter:  Elizabeth Murphy, US EPA Great Lakes Fish Monitoring Program 

Q&A:

1.      (Ray Vaughan, NYS Attorney General’s Office):  What is the nature of the fish tissue archive, and are you aware of the archive in Buffalo, NY? 

Response:
(Elizabeth Murphy, US EPA):  No, not aware of Buffalo archive.  We collect lake trout from one location in each of the five Great Lakes annually and alternate between two different collection sites.  Over a two-year period, we collect fish from ten different locations.  

Comment:
(Ray Vaughan, NYS Attorney General’s Office):  The Buffalo, NY, archive included Lake Ontario fish for PCB testing, but it is probably available for other purposes. 

Response:
(Elizabeth Murphy, US EPA):  We have been archiving our fish tissues since the start of the program in 1972, so our archive is pretty extensive. 

2.      (Frank Anscombe, US EPA GLNPO):  Will the number of analytical parameters be consistent with the 613 chemicals identified in Phil Howard’s study? 

Response:
(Elizabeth Murphy, US EPA):  We will not be looking at 613 chemicals; the chemicals we assess will be a targeted list.  We need to discuss the targeted chemicals with the lab we are working with to determine their analytical capabilities.  We want to use the work that has already been completed for screening and prioritization.  

Closing Comments 

Ted Smith, US EPA Great Lakes National Program Office:

Suzanne Easton, Environment Canada:

Attendees

1 Abel Todd American Chemistry Council
2 Anscombe Frank US EPA GLNPO
3 Bailey Bob Bailey Associates
4 Berman Howard Dutko Worldwide
5 Brauer Sue US EPA Region 5
6 Chary Lin Kaatz NW IN Toxics Action Project & Great Lakes United
7 Cain Alexis US EPA
8 Clark Ellie US EPA HQ
9 Cooke Marcus Cooke Companies International
10 De Ken Environment Canada
11 De Leo Paul The Soap and Detergent Assoc.
12 de Leon Fe Canadian Environmental Law Assoc.
13 Dibblee Seth US EPA Region 5
14 Easton Suzanne Environment Canada
15 Gage Paul Minnesota
16 Graham Diana Keller & Heckman
17 Helm Paul Ontario Ministry of the Environment
18 Hornshaw Tom IL EPA
19 Howard Phil Syracuse Research Corp
20 Jackson John Great Lakes United
21 Jones Allan Canadian Chlorine Chemistry Council
22 Klecka Gary DOW Chemical (MI)
23 Krauel Bob Environment Canada
24 Leibrand Amy Battelle
25 Lippert Charlie Mille Lacs Band of Ojibwe Indians
26 Lohse-Hanson Carri MN Pollution Control Agency
27 Lopes Edwina Environment Canada
28 McClellan Teresa Canadian Environmental Law Assoc
29 Menkedick John Battelle
30 Murray Michael National Wildlife Federation
31 Murphy Beth US EPA GLNPO
32 Newman Erin US EPA Region 5
33 Phenicie Dale CGLI
34 Pocalujka Lou Consumers Energy
35 Risotto Steve Halogenated Solvents Industry Alliance (HSIA)
36 Rossi Sandy Environment Canada
37 Sasnett Sam US EPA OPPT
38 Smith Ted US EPA GLNPO
39 Staples Charles Assessment Technologies, Inc.
40 Taylor-Morgan Joy MI DEQ Air Quality Division
41 Vaughan Ray NYS Attorney General’s Office
42 Waffle Alan Environment Canada
43 Wong Peter Ontario Ministry of the Environment

 

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