10:30 a.m.

Welcome and Introductions

Howard J. Cohen, Committee Chair

Maryann D’Alessandro, Associate Director for Science, NPPTL, NIOSH

Les Boord, Director, NPPTL, NIOSH

Discussion

12:00 p.m.

Lunch

1:00 p.m.

Context for the Study

1:00–1:45

Overview of Product Conformity Assessment and Examples of Various Approaches to Certification

Gordon Gillerman, NIST

Discussion

1:45–2:30

ASTM International—Certification Program

Tim Brooke, ASTM

Discussion

2:30–2:45

Break

2:45–3:30

Certification of Personal Flotation Devices

Samuel E. Wehr, Independent Consultant

Discussion

8:00 a.m.

Welcome and Opening Remarks

Howard J. Cohen, Committee Chair

8:10 a.m.

Overview and Terminology

Gordon Gillerman, National Institute of Standards and Technology

8:30 a.m.

Session 1: Current Certification Efforts in PPT: Firefighter Ensembles

Facilitator: Roger L. Barker

8:30–8:40

Overview of the Process

Roger L. Barker

8:40–8:50

Richard M. Duffy, International Association of Fire Fighters

8:50–9:00

Diane Haithcock, Underwriters Laboratories

9:00–9:10

Eric Beck, MSA, Inc.

9:10–9:30

Discussion with the Committee

certification process? What factors were considered in establishing the process as a third-party testing process?

• What is the typical time line? What is the typical fee structure? What is the duration of validity of the certification? What post-marketing surveillance activities are conducted? What production oversight procedures are in place? How are mislabeling or other false assertions of certification addressed?

• What are the incentives or barriers to assessing and asserting conformity?

• What are the challenges regarding innovation, interfaces among PPT components, etc.? What needs to be done to improve the conformity assessment process? What value is added by having a conformity assessment/certification process in place? Are data available on how certification of firefighter ensembles impacts firefighter safety and health?

9:30 a.m.

Session 2: Current Conformity Assessment Efforts: Other Products

Facilitator: Melissa A. McDiarmid

9:30–9:45

Body Armor Safety Initiative

Lance Miller, National Law Enforcement and Corrections Technology Center

9:45–10:00

EPA Noise Reduction Rating Program

Ken E. Feith, Environmental Protection Agency

10:00–10:15

Consumer Product Safety

J. Gibson Mullan, U.S. Consumer Product Safety Commission

10:15–10:30

CBRN Ensembles for Law Enforcement

Debra Stoe, National Institute of Justice

Questions:

• Overview of the certification/conformity assessment processes: Who sets standards? Who tests? Who accredits? Who provides the certification? What value is added by having a conformity assessment/certification process in place?

• What is the role of government in the process? How were decisions made regarding the role of government?

• What is the typical fee structure?

• What is the duration of validity of the certification? What production oversight procedures are in place? What post-marketing surveillance activities are conducted? How are mislabeling or other errors in assertions of conformity assessment addressed?

• What are the challenges regarding innovation? What are the incentives or barriers to assessing and asserting conformity? What needs to be done to improve the conformity assessment process? Are data available on how certification impacts worker or consumer safety?

11:00 a.m.

Session 3: Measuring the Impact of Certification on Worker Safety and Health

Facilitator: Barbara J. Burgel

11:00–11:15

Patricia A. Gleason, Safety Equipment Institute

11:15–11:30

Preston Anderson, Sperian Fall Protection, Inc.

11:30–11:45

Discussion with the Committee

• What value is added by having a certification/conformity assessment process in place?

11:45 a.m.

Lunch

12:30 p.m.

Session 4: Incentives and Barriers to Conformity Assessment and Certification

Facilitator: James S. Johnson

12:30–12:45

Ginny Fitzner, Directorate of Standards and Guidance, OSHA

Kevin Robinson, Nationally Recognized Testing Laboratories Program, OSHA

12:45–12:55

Louise Kuhny, Joint Commission (via phone)

12:55–1:05

Robin T. Scott, Sport Dimension, Inc.

1:05–1:15

Daniel K. Shipp, International Safety Equipment Association

1:15–1:45

Discussion with the Committee

• What are the relative costs of various certification mechanisms to the final product and what are the differences in manufacturing to meet different certification requirements globally?

• How does a manufacturer decide if it is worth investing in third-party testing or certification or if a new product is worth bringing to market if certification is required?

1:45 p.m.

Session 5: Risk-Based Approaches to Conformity Assessment

Facilitator: Anugrah Shaw

1:45–2:00

Gordon Gillerman, National Institute of Standards and Technology

2:00–2:15

Markham C. Luke, Center for Devices and Radiological Health, FDA

2:15–2:45

Discussion with the Committee

are devices (e.g., gowns) regulated that are sold without having gone through the FDA medical device clearance process?

2:45 p.m.

Session 6: Case Study: Healthcare Worker Gloves

Facilitator: Alexander Isakov

2:45–3:00

Terrell Cunningham, Food and Drug Administration

3:00–3:15

Michael S. Zedalis, Ansell Healthcare, LLC

3:15–3:30

David Hermann, Aspen Healthcare Metrics

3:30–3:45

Sharon Welbel, Cook County Health and Hospitals System

3:45–4:15

Discussion with the Committee

• What factors go into the decision to purchase? Would a third-party certification process make a difference in purchasing decisions?

4:15 p.m.

Public Comment—Registered Speakers

Moderator: Howard J. Cohen