Dioxin Briefing for the EPA Senior Management
May 10th, 2000

Presenters:
William H. Farland, Ph D
Director
National Center for Environmental Assessment
Office of Research and Development
US Environmental Protection Agency
and
Dwain L. Winters
Director, Dioxin Policy Project
Office of Pollution Prevention and Toxics
Office of Prevention, Pesticides and Toxic Substances
US Environmental Protection Agency

Current Status of Plan For Public release

1. Agency/interagency dialogue
* Science and communications coordination during next 4 weeks (NSTC/CENR)
* Review and revise food related Q & As (Food Safety Council)
* Near term/long term policy responses

2. Congressional Contact
* Provide background briefings for house and senate staff close to release
* Respond to specific requests

3. Press Response
* No press conference
* Note to correspondents
* Public statement available if needed
* Designated agency spokespersons

4. Public/Shareholder Notification and Access - after release in June
* FR Notice
* NCEA Dioxin web site
* Informal heads-up contact to stakeholders
* Stakeholder briefing

Key Findings of the Reassessment

1. Environmental Levels have declined since the 1970s
* Current regulatory efforts have addressed most of the known large industrial sources (75% reduction between "87 and ‘95)
* There remain unaddressed and uncharacterized sources

2. Air deposition onto plants consumed by domestic meat and dairy animals is the principle route for contamination of commercial food supply.

3. General Population Exposure is from animal fats in the commercial food supply (~1 pg/kg/day)
* Local sources make little contribution to most people's exposure
* Environmental levels in meat/dairy production areas major contributors
* Reservoir sources are a significant component of current exposure and may dominate future exposure
* Special populations may be more exposed but prevalence is not well substantiated.

4. Complex mixtures of dioxins are likely carcinogens.
* 2,3,7,8-TCDD is a human carcinogen and other dioxin-like compounds are likely human carcinogens
* Cancer risks to the general population are now in the 10(3) to 10 (2) range from background (dietary) exposure

5. Dioxins produce a variety of noncancer effects in animals and humans
* Developmental toxicity, immunotoxicity, endocrine effects, chloracne, others
* Some of these effects have been observed in animals and humans within 10 times background exposure
* It is likely that part of the general population is at or near exposure levels where adverse effects can be anticipated.

Two Stages of Review Will be Open to the Public Before the Reassessment is Completed

Stage 1: Independent Peer Review Panel (with input from outside writing group)

** Risk Characterization
** TEF Chapter
** FR notice
** Web posting
** Comment period

Stage 2: Science Advisory Board

** Risk Characterization
** TEF Chapter
** Dose Response Chapter
** FR Notice
** Web posting
** Comment period

The Goal of the EPA Dioxin Strategy Development Process is to Bring Together

1. The science of the reassessment
2. The Infrastructure and success of EPA’s Existing Programs
3. The Promise of EPA’s Dioxin Exposure Initiative (DEI)
4. Federal Partners with Interest in Dioxin Exposure

To Generate a Cross Media Strategy and Plan That Will Effectively and Efficiently Address Dioxin Risk

OPTION A (Recommended Option): Expand Current Programs with a Primary Goal of Reducing Human Exposure

1. Establish general population exposure reduction goal (0.1pg/kg/day)
2. Commit to control remaining unaddressed large sources
o Work with states to control back yard burning
o Work with PCP manufacturers, pole treaters and utilities to manage disposal of out of service utility poles
3. Initiate risk management for any newly identified large sources>500g
4. Establish emission reduction priorities for smaller sources based upon potential for exposure reduction o Accelerate DEI to complete qualitative linking of exposure to sources
o Establish regulatory agenda once information is available
5. Identify and pursue opportunities for exposure pathway intervention o Accelerate DEI to identify opportunities for pathway intervention o Work with FDA, USDA, and private sector to implement pathway interventions
6. Intensively track implementation of existing source standards for air and water
· Waste combustion MACT STD
· Pulp and paper effluent guidelines
· PCBs Identify and resolve any problem areas 2000 source inventory

7. Special populations · National effort to identify and characterize special populations
8. Issue Agency guidance on incremental exposure
9. Review/revise water quality criteria
10. Review/revise remedial action clean-up levels
11. Characterize poorly-characterized sources and reservoirs
Ø Ceramics manufacturers
Ø Electric arc furnaces Ø Foundries Ø Land-fill fires Ø Wood stoves Ø Forest
fires Ø Agricultural burning Ø Structural and automobile fires Ø Urban air
transects Ø Ambient air network Ø Air modeling Ø Particle size
distribution Ø Soil survey Ø Water survey Ø Sediment surveys

12. Environmental trends monitoring
Ø Meat and dairy resurvey
Ø Fish market basket survey
Ø Ambient air network

13. Strengthen cross-media and interagency coordination

14. International involvement
Ø NARAP
Ø Pops Treaty
Ø Bi-National agreement

B. Fully Implement Current Programs and Monitor Change in Environmental Levels

1. Aggressively implement existing programs to achieve maximum reductions in environmental release

2. Establish internal targets for exposure reduction

3. Expand DEI to carefully monitor improvements in environmental levels and human exposure over the next couple of years. Also pursue source characterization and attribution

4. Once EPA has a clearer sense of the exposure reduction resulting from current program, the Agency will decide what additional actions are needed

What can EPA DO NOW

D. Commit now to major DEI expansion ($3M/yr for 5yr)
1. Linking exposure to sources
2. Source testing and identification
3. Base line and trends monitoring

Discussion Points for AA/RA Meeting on Dioxin Reassessment

A. Are there any program-specific issues/actions that the current release schedule would significantly impact?

The week of June 12 is a critical window for releasing the document if ORD is to hold the peer review scheduled for the end of July. The Panel is selected and committed for that date. We have two technical review processes in place to do a substantive review of the document before the June release: internally through the Office Directors Work Group, and interagency through OSTP. These reviews are intended to catch “Show Stoppers”, and time has been provided for ORD or do some redrafting before the 12th of June. A much more detailed review will take place in parallel with the peer review. A process is also in place through the Food Safety Council to address policy and communications issues relating to the safety of the food supply, nutritional guidelines and breast-feeding. Assuming for a moment that each of these efforts is successful in preparing us for a June release, are there any programmatic issues that need to be considered before we release this document to the public (i.e., pending regs., law suits, hearings)?

B. Is the general focus and direction proposed by the ODs for the EPA Dioxin Strategy the appropriate course to pursue?

EPA is publicly committed to publishing for public comment an Agency-wide dioxin strategy when the Dioxin Reassessment goes final. The Office Directors Dioxin Working Group has developed three strategic options as alternative approaches to this strategy. Most of the AAs and RAs have been briefed on the content of these options. The OD workgroup is recommending an option based on setting exposure reduction as our primary goal (option A) rather than emission reductions. The ODs are seeking feedback from senior management before proceeding to develop a detailed strategy document.

· Is there enough general support for option A to direct the Office Directors Workgroup to develop this option in detail? Yes, no, don’t know yet

· Should development work continue on options B and C or can they be rejected?

· Are there any suggested fine tunings, additions or deletions that can be given to the OD workgroup for the supported options?

· Are there any other options that should be considered?

C. What programmatic commitments, if any, should the Agency make at the June release of the peer review draft?

There will be great pressure upon EPA from many stakeholders to take dramatic action when the draft reassessment is released. There will also be equally strong pressures from other interests, given the “extraordinary” findings of the reassessment, that these conclusions should have the benefit of peer review before EPA uses then as a basis of policy. The OD workgroup has identified several actions, which could be taken now that, bridge the gap between these two points of view. All of the options presented could be considered appropriate actions under the most foreseeable peer review response and each would give us a meaningful head start in future strategy implementation.

· Should EPA adopt any or all of the candidate actions identified by the ODs?

· Are there any additional actions that should be considered?

D. What additional communications issues/preparations should be considered?

Risk communication associated with our first release of the draft reassessment will be difficult, no matter how much preparation goes into the effort. We currently have a general framework in place, which includes a press strategy, designated Agency spokesperson, FR notice, Web site update, background papers, interagency coordination, and a plan for congressional briefings. A number of the specific materials are still under development such as the press statement and the interagency statements on the safety of the food supply, dietary guidelines and breast feeding. With much of the attention and energy for communication planning focused on food safety and progress in emission reductions through our technology-based standards, it is easy to overlook issues that are more specific to individual programs and regions.

· What program-specific issues do we anticipate to emerge with release of the reassessment?

· What region-specific issues do we anticipate to emerge with the release of the reassessment?

· What precautions need to be taken in crafting our broad message to make sure we don’t exacerbate program and region-specific problems?