# Presentation: 425292

## Metals Workshop

- Kevin Bromberg
- Assistant Chief Counsel for Environmental Policy
- Washington, D.C.
- February 20, 2002

- Office of Advocacy

**U.S. Small Business Administration**** **
- Championing America’s Entrepreneurs

**SBA**

## Key Questions

- What is the State of the Science of PBTs and Metals at EPA?
- What Peer Review Procedures Should EPA Now Conduct for the Lead/TRI Rule?

## SBA Office of Advocacy Letter

- April 2001 Letter to Administrator Whitman
- No Scientific Basis for TRI Lead Rule
- Urge EPA to Seek SAB Review of Scientific Controversy

## Slide 4

## PBT Science at EPA

- Metals and Organics Can Be Treated Alike
- PBT Rule - 1999 - Metals Can Be Treated Like Organics -  Because All Metals Can Be  Bioavailable Under Some Conditions
- Did Not Address Bioaccumulation

## 1998 OECD Report

- Use “Care” in Addressing Metals and		PBT Characterization Because Metals  Are Different in Several Ways
- Bioavailability
- Bioaccumulation

## 1999 PBT Rule

- Did Not Address Issue with “Care”
- Failed to Address Individual Metals with respect to Bioavailability
- Failed to Address Bioaccumulation

## Views of Leading US Gov’t Scientists

- NSF - “The criteria for organics ... do not provide a sound basis for discriminating benign and harmful [inorganic] substances”
- USGS - “The [BCF] approach ... should not be used for the risk assessment of metal compounds.”

## TRI/Lead PBT Rule

- 2001 Lead Rule Also Claims Same PBT Methodology Can be Applied to Metals and Organics
- No Literature Support for Proposition
- No Peer Review as Required by EPA Procedures

## Lead Rule Preamble

- EPA will seek SAB review _after_ promulgation.  “The external peer review will address how lead and other, as yet unclassified metals such as cadmium, should be evaluated using the PBT chemical framework, including which types of data (and which species) are most suitable for these determinations.”

## SAB Charge Timeline

- TRI Final Rule - January 2001 Announcing	Review
- SAB Charge Under Review - Spring/Summer/Fall
- Fisher Letter -  December - Announces Two Part SAB Review Addressing Metals/PBT
- February 20th Stakeholder Meeting

## 2001 IWG Report

- Report of Inorganics Working Group to		Environment Canada
- Approach for Synthetic Organics Not Applicable to Inorganics
- BCF/BAF Factors Should Generally Not Be Used for Inorganics

## IWG on Bioaccumulation

- “**Agreement was not achieved on the scientific relevance of B within Environment Canada’s regulatory framework, however, the IWG agreed that most published BCF (bioconcentration factor) and BAF (bioaccumulation factor) data for inorganics are, in practice, not useful for categorization.”**

## Peer Review at EPA

- TRI Lead Issue Never Received Peer Review	- SAB Peer Review Report - 		September 2001

## Peer Review Requirements

- December 2000 SAB Handbook
- Review of Supporting Materials for all “Major Scientific and Technical Products” Including TRI/Lead Rule
- Independent Review of Agency Science

## Documents Underlying Lead Rule

- Final Rule Preamble
- Response to Comments
- Bioaccumulation Analysis Document
- Other Documents
- EPA Does Not Need to Create New Documentation for this Rule

## Peer Review Procedures

- New SAB Procedures
- Diversity of Viewpoints and Expertise
- Public Comment on Expert List
- Full Disclosure of Background/ COI

## Peer Review Procedures

- Full Review - Not Consultation
- SAB Handbook - Independent Review for All Major Rules

## SAB Charge

- Is the PBT Methodology A Sound Method for Characterizing Inorganic Hazards?
- Can BCF and BAF Factors Be Used Appropriately for Metals?
- What Alternative Scheme Can Be Used?

## SAB Charge - Continued

- For Lead/TRI - Is it Appropriate to Apply the PBT Methodology to Lead?
- If Appropriate, Did EPA Properly Adopt a PBT Methodology for Distinguishing High and Low PBT Properties of Inorganic Substances (proper data selection etc.?)

## Next Steps

- Develop SAB Charge - Obtain Public Input
- Assemble SAB Panel
- Develop New Methodology
- Review Old Methodology and Materials

## Conclusion

- “EPA Will Not Reconsider Past Actions”
- But EPA Science is Not Infallible; Nor is Science Static
- If EPA Science Is Incorrect - Review of Past Actions Will Be Required