Maryann D’Alessandro, Ph.D.Director, National Personal Protective Technology Laboratorybpj5@cdc.govSeptember 17, 2013

Toward a National Framework for ConformAssessment of Non-respiratory PPT

Personal Protective Technology Conformity Assessment Public Meeting
Overview

Conformity assand market suprocesses 

Basis for draft framework scope

N
Multiple activities contributed to the draft 

framework scope

PCAWG activities

Benchmarking

National PPT

CA Programs

PPT CA 

Draft 

Framework 

Scope
Questions for discussion today

1. Who defines the basic health and safety 

requirements (BHSRs) for your industry?

2. How should the BHSRs be established?3. Who should address what PPE is needed to 

BHSRs?

4. Who determines the technical standards tha

demonstrate the BHSRs are met?

5. How are conformity assessment requiremen

linked to PPE types?
This is the process needed to further define 

conformity assessment framework
BHSRs should be established as a basis of 

national conformity assessment system 

• BHSRs define the 

protection results to be attained

• BHSRs can be used to 

guide standards development

• Example – PPE to protect 

against mechanical vibration
PPE should be identified to address BHS

• Voluntary consensus standards 

should reference applicable BHSRs

• Address priority areas of research 

interest based on risk and national interest in areas that address the BHSR gaps

• Decisions about the technical 

approaches for achieving the relevant BHSRs for a product are made by the supplier
 Conformity assessment activities 

should be based on ISO conformity assessment standards

 A federal authority is needed to 

provide oversight of nonrespiratory occupational PPT CA

 Conformity with the BHSRs is the 

responsibility of the supplier

Conformity assessment should provide useconfidence that product complies with the 
 Technical documentation

 Product testing Supplier’s Declaration of Conformity (SDoC Conformity marking Type-examination Third-party certification Quality system Post-market surveillance

The appropriate CA components should bdetermined based on BHSRs and associathazard
 Hazards – corresponding to 

the BHSRs – should be placed in tiered categories

 Conformity assessment 

requirements should be assigned to each category of hazard.

 Requirements should be 

consistent with international standards and practices to facilitate trade

Conformity assessment should be based orepresenting tiered, hazard based approach

Example: OSHA Occupat

Pyramid for Pandemic In

OSHA 3327-02N (20
Next steps to move the conformity assess

processes of the draft framework scope fo

 Determine approach to maintain the products 

standards database 

 Develop a systematic approach and strategy t

documenting and disseminating information aPPE use with an emphasis on PPE use for higand medium risk workplace hazards 

 Determine which hazards are medium to high  Conduct an impact assessment regarding the 

draft framework scope 
Market surveillance will provide informatio

use by collecting data from many sources

Routine surveillance Complaints about a pro

Media reports Authorities in other co
 A federal market surveillance authority should b

established

 Market surveillance should follow the ISO stand Market surveillance plans should be based on h

and risk

 Plans should be monitored, evaluated & adapte

needed.

 An online, publicly accessible database of all th

party market surveillance bodies should be esta

Market surveillance guidelines and author
1. Inspect manufacturing facilities

2. Conduct documentary checks 3. Randomly select sample products,

either onsite or from the open market

4. Make initial physical checks

of the products

5. Conduct laboratory tests6. Make assessments

Accredited third-party market surveillance bodies should:
 Provide PPT users and customers a vehicle for 

PPT failures or requesting PPT evaluation

 Expand an existing reporting system to include P

 CPSC’s Publicly Available Consumer Product Safety 

Database (SaferProducts.gov)

 FDA’s Manufacturer and User Facility Device Experie

Database (MAUDE), or 

 FDA’s MedWatch Program

 The market surveillance authority should alert th

when actions have been taken against products conforming

Adverse event reporting system
1. Official warnings and fines

2. Alerts to consumers3. Sales bans4. Product withdrawals5. Product recalls

The market surveillance authority should bauthorized to enforce corrective actions.
• Evaluate from both an effectiveness and a 

cost/benefit perspective

• Third party market surveillance authorities 

should be required to provide data on outindicators

The market surveillance authority should bindependently evaluated
Evidence for prioritizing surveillance projects includ

 Census of Fatal Occupational Injuries (CFOI) Survey of Occupational Injuries and Illnesses (S MHSA’s Mine Accident Injury and Illness databa National Electronic Injury Surveillance System —

Work Supplement (NEISS- WORK)

 OSHA’s Data Initiative (ODI)  Worker’s Compensation data

Surveillance data for market surveillance p
 Expand existing data collection program(s) to i

reports of unsafe PPT & PPT-related injuries aillnesses

 Develop registry of third-party conformity asses

and market surveillance bodies

 Explore expanding consumer alert system(s) to 

PPT

 Develop data reporting requirements for third-p

bodies to support monitoring & evaluation of thconformity assessment and market surveillancsystems

Next steps to move the surveillance and daactivities of the draft framework scope forw
Near-term activities

Begin cost-benefit study of proposedCA market surveillance programsReview docket comments received through December 1

1st Quarter FY 2014 2nd Quarter FY 2014 

Reconcile comments ansubmit framework for pPost updated frameworConduct 2nd public mee

Publish final report on CContinue implementing 

3rd Quarter FY 2014

Oct 2013 
Questions for discussion today

1. Who defines the basic health and safety 

requirements (BHSRs) for your industry?

2. How should the BHSRs be established?3. Who should address what PPE is needed to 

BHSRs?

4. Who determines the technical standards tha

demonstrate the BHSRs are met?

5. How are conformity assessment requiremen

linked to PPE types?
Quality Partnerships Enhance Wo

Safety & Health

Thank you

Visit Us at: http://www.cdc.gov/niosh/programs/ppt

http://www.cdc.gov/niosh/npptl

Maryann D’Alessandro 

412-386-4033

bpj5@cdc.gov

Disclaimer: The findings and conclusions in this presentation have not been formally dissemina

Institute for Occupational Safety and Health and should not be construed to represent any agency d