2014-18357. Approach for Estimating Exposures and Incremental Health Effects From Lead Due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings; Notice of Availability and Request for Comment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is currently in the process of determining whether or not lead-based paint hazards are created by renovation, repair, and painting (RRP) activities in public and commercial buildings (P&CBs), as required under the Toxic Substances Control Act (TSCA). EPA is making the following documents available for public review and comment before they undergo external peer review: “Approach for Estimating Exposures and Incremental Health Effects from Lead Due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings” (the Approach); the detailed appendices for the Approach; and a supplementary report, entitled “Developing a Concentration-Response Function for Pb Exposure and Cardiovascular Disease-Related Mortality.” Together, these documents describe a methodology for estimating exposures and incremental health effects created by renovations of P&CBs. This methodology could be used to identify and evaluate hazards from RRP in P&CBs. Also available for public review and comment is a list of charge questions that will be directed to the external peer reviewers for the Approach.

DATES:

Comments must be submitted September 22, 2014.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2010-0173, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Stan Barone, Jr., Risk Assessment Division (7403M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including independent contractors and contracting companies involved in renovation, repair, and painting, as well as academics and members of the public interested in environmental and human health assessment and the assessment of chemical risks. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

B. What should I consider as I prepare my comments for EPA?

1. Submitting confidential business information (CBI). Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Background

EPA is currently in the process of determining whether or not lead-based paint hazards are created by RRP activities in P&CBs, as required under TSCA, Subtitle IV (15 U.S.C. 2681 et seq.). For those renovation activities in P&CBs that create lead-based paint hazards, TSCA directs EPA to address the hazards through regulation.

EPA recently published in the Federal Register of May 30, 2014 (Ref. 1) a document for public comment, entitled “Framework for Identifying and Evaluating Lead-Based Paint Hazards from Renovation, Repair, and Painting Activities in Public and Commercial Buildings” (Ref. 2). This Framework document described, in general terms, how EPA could identify and evaluate hazards in P&CBs.

The current document, entitled “Approach for Estimating Exposures and Incremental Health Effects from Lead Due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings” (Ref. 3) describes how EPA is modeling the potential overall magnitude and distribution of renovation-related health effects due to lead exposure from a renovation in a P&CB, taking into account background lead levels when no such renovation exposure occurs. Based on information developed through the Approach, renovation-related health effects will be estimated as the difference between total health effects (background plus renovation-related) and background. Exposures from renovation activities that disturb lead-based paint are connected to subsequent health effects in children and adults through modeling. Separate Monte-Carlo based models were constructed for the analysis of exterior renovations of P&CBs and interior renovations of P&CBs.

The Monte Carlo analysis is designed to capture potential population-level variability within each exposure scenario and, as such, approximates the potential distribution of effects to the part of the U.S. population who would fall within any scenario. However, the results presented in the Approach are not representative of an overall distribution of the entire U.S. population. All scenarios are not equally likely, and in fact some scenarios may be very unlikely to occur. In the future, EPA plans to estimate how many people may be reasonably expected to be exposed in different scenarios.

After further analysis, the full results of the Approach, along with information about how often any scenario is expected to actually occur, will be used to consider whether or not renovation activities in P&CBs create hazards and, if so, what mitigation measures may be appropriate. EPA plans to consider renovation-related dust loadings, blood lead, and health effect changes across exposure scenarios in order to evaluate whether a hazard occurs. A detailed discussion of the additional analyses and considerations that would inform EPA's process of making a hazard finding, or a finding of no hazard, are contained in the Approach. By itself, the Approach methodology cannot be used to determine whether hazards exist from P&CB renovations. EPA will need to conduct additional analyses and make certain science policy decisions in order to determine whether such hazards exist.

EPA's Office of Pollution Prevention and Toxics (OPPT) has identified the Approach as an influential product and according to EPA peer review guidance is conducting an external peer review of that document, supplemental files, appendices (Ref. 4), and attendant models used for exposure scenarios. The external peer reviewers will assess the accuracy and content of the Approach, ensuring that the Approach and initial results are scientifically sound. The external peer review will also address the supplemental documents, which include detailed appendices for the Approach and a supplementary report relating lead exposure to Cardiovascular Disease (CVD) mortality and proposing an approach to quantify adult health benefits from a reduction in lead (Pb) exposure for CVD mortality, entitled “Developing a Concentration-Response Function for Pb Exposure and Cardiovascular Disease-Related Mortality” (Ref. 5). The panel peer review meetings are expected to occur later in 2014, and the public will have an opportunity to review and comment on the materials given to the external peer reviewers.

III. Request for Comment

EPA is requesting public review and comment on all aspects of the Approach and its supplemental files, appendices, attendant models, peer review charge (Ref. 6), and particularly related to the following:

• The utility of the Approach for estimating exposures through summarizing building use configuration types and human-activity patterns to incorporate variability across the wide variety of P&CBs.
• The utility of the updated Leggett Model (original model described in Leggett 1993 (Ref. 7); updated model described in the appendices to the Approach (Ref. 4)) to estimate blood lead levels for both children and adults, and specifically the use of the various outputs derived from the Leggett Model (concurrent blood lead, lifetime blood lead, and bone lead) in concentration-response curves for children and adults.
• The utility of concentration-response functions for health endpoints in both children and adults for assessing risk to human health inside P&CBs as a result of P&CB renovations.

IV. References

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Lead; Framework for Identifying and Evaluating Lead-Based Paint Hazards From Renovation, Repair, and Painting Activities in Public and Commercial Buildings. Federal Register (79 FR 31072, May 30, 2014) (FRL-9910-44).

2. EPA. Framework for Identifying and Evaluating Lead-Based Paint Hazards From Renovation, Repair, and Painting Activities in Public and Commercial Buildings. May 2014. Document ID number EPA-HQ-OPPT-2010-0173-0196. Also available at http://www2.epa.gov/​sites/​production/​files/​2014-05/​documents/​lead_​pncb_​framework_​document.pdf.

3. EPA. Approach for Estimating Exposures and Incremental Health Effects from Lead Due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings. July 2014. Docket ID number EPA-HQ-OPPT-2010-0173.

4. EPA. Appendices to the Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings. July 2014. Docket ID number EPA-HQ-OPPT-2010-0173.

5. EPA. Developing a Concentration-Response Function for Pb Exposure and Cardiovascular Disease-Related Mortality. July 2014. Docket ID number EPA-HQ-OPPT-2010-0173.

6. EPA. Charge Questions for Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings. July 2014. Docket ID EPA-HQ-OPPT-2010-0173.

7. Leggett, R.W. An age-specific kinetic model of lead metabolism in humans. Environmental Health Perspectives. 101:598-616. 1993.

List of Subjects

Environmental protection, Business and industry, Commercial buildings, Lead, Peer revew, Renovation, Risk assessment.

Dated: July 28, 2014.

Wendy C. Hamnett,

Director, Office of Pollution Prevention and Toxics.