SPECIAL NOTICE
B -- Economic Impact Analysis for NIOSH proposed addition of an inward/faceseal leakage approval requirement to Subpart I, 42 CFR Part 84
- Notice Date
- 6/14/2013
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Acquisition and Assistance Field Branch (Pittsburgh), Post Office Box 18070, Cochrans Mill Road, Pittsburgh, Pennsylvania, 15236-0070
- ZIP Code
- 15236-0070
- Solicitation Number
- 2013-61145
- Archive Date
- 7/2/2013
- Point of Contact
- Diane J Meeder, Phone: (412)386-4412
- E-Mail Address
-
DMeeder@cdc.gov
(DMeeder@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- NOTICE OF INTENT TO ISSUE A DELIVERY ORDER. The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), intends to negotiate and issue a delivery order to Eastern Research Group, Inc. 110 Hartwell Ace Ste. 1, Lexington, MA 02421 under GSA contract #GS-10F-0125P supported by a GSA Limited Source Justification. The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), has a requirement for "Complete Economic Impact Analysis for NIOSH proposed addition of an inward/faceseal leakage approval requirement to Subpart I, 42 CFR Part 84, for the half-mask respirators for which a product population "Fit Test" is not currently included as an approval requirement," under GSA contract #GS-10F-0125P supported by a GSA Limited Source Justification. The National Institute for Occupational Safety and Health (NIOSH) rulemaking activities to evaluate inward/faceseal leakage performance of NIOSH approved particulate filtering respirators began with the publication of a Notice of Proposed Rulemaking (NPRM) on October 30, 2009. NIOSH Docket 137 was opened simultaneously to solicit public comments to the NPRM. One major issue raised in the comments was the need for NIOSH to provide a detailed economic impact analysis concerning the proposed change in the regulation. NIOSH is currently working to revise the NPRM and intends to hold a public meeting during the last quarter of fiscal year 2013. ---DRAFT SOW--- The Agency requests that the contractor provide an economic analysis for NIOSH's proposed rule to add a new performance requirement as outlined below in section I. PROPOSED NPRM PROTOCOL. This rulemaking would establish inward/faceseal leakage minimum performance requirements and the NOSH certification testing for all half-mask particulate filtering respirators that have either (1) facepieces NOT designed to accept gas/vapor cartridges, or (2) facepieces which are NOT a component of a gas/vapor approved respirator configuration. This would include all filtering facepiece respirators (FFRs), widely used by healthcare workers. The current requirements in 42 CFR Part 84 Subpart K do not include a product population "fit test". The contractor will quantify the economic impact of updating 42 CFR Subpart K to require an inward/faceseal leakage test similar to an Occupational Safety and Health Administration (OSHA) quantitative fit test as a requirement for approval of the above described respirators. The newly proposed performance requirement is outlined below in a PROPOSED NPRM PROTOCOL. I. PROPOSED NPRM PROTOCOL The proposed procedures for implementing the added performance requirement would include the following elements: 1) The proposed test method requirement could include two alternative methods: • (PortaCount® PRO+ 8038 in N95 Companion TM mode) Condensation nuclei counter (CNC) and an electrostatic classifier with supplemental aerosol (salt or smoke), or • NIOSH corn oil chamber evaluation currently used for laboratory respirator protection level (LRPL) testing of other classes of respirators. 2) The number of test subjects per respirator model submitted for approval will be proposed as either 10 or 25 subjects per approval. The proposal would follow test procedures currently used by NIOSH for similar testing of other classes of respirators with human subjects. 3) The minimum acceptable performance criteria of achieving 10/10 with a fit factor of 100 or 10/10 with a fit factor of 50 or 19/25 with a fit factor of 100 or 19/25 with a fit factor of 50 should be considered as required for the issuance of an approval. 4) Continued authority to produce and sell currently approved products as NIOSH-approved, as well as those meeting the additional approval requirements. 5) Approval for any modification to currently-approved products would require the respirator meet all applicable requirements, including the additional inward/faceseal leakage testing using human subjects. Potential alternatives: Regulatory Flexibility Act requires a description of alternatives to the proposed rule which accomplish the stated objective of applicable statutes and which minimize any significant impact of the proposed rule on small entities • Not updating 42CFR Part 84 Subpart K to include a "fit test" requirement, work with OSHA to better enforce fit test requirements in the workplace. • Allow manufacturers to provide "fit test" data to NIOSH for approval applications rather than testing subjects at NIOSH, require a more statistically significant number of subjects, 40 or more. • Engage industry to support a national fit test campaign within the largest user group(s) (Healthcare Sector, perhaps) to identify a well-fitting respirator for each worker, with consideration given to models included in national stockpiles of FFRs. A model of collective industry efforts to support safety programs includes the Nuclear power industry's (December 1979, following the Three Mile Island accident) establishment of the Institute of Nuclear Power Operations (INPO) to promote the highest levels of safety and reliability - to promote excellence - in the operation of commercial nuclear power plants. Other potential models of functional health and safety programs that support respirator fit testing include: Bomb Techs training credentials and NASA Safety at Kennedy Space Center. • Develop a model for the "willingness to pay" criteria of the consumers, cancel the current NPRM, work with consumers and suppliers to develop new performance requirement(s); consider options potentially included in NIOSH Project BREATHE (Better Respirator Equipment using Advanced Technologies for Healthcare Employees. The following is a link to public information concerning the NIOSH Project BREATHE: http://www.cdc.gov/niosh/nas/ppt/QUADCharts12/TRB_INH_939ZUNK_FY12_QC.htm II. TASKS (1) Benefits, Cost and Economic Impact Analyses The contractor shall prepare an assessment which addresses the Regulatory Assessment Requirements including the estimates for costs, measures of benefits and economic impacts. The complete assessment shall meet the requirements of Executive Orders 12866 and 13563, the Regulatory Flexibility Act, the Small Business Regulatory Enforcement Act, and the Unfunded Mandatory Reform Act of 1995. Potential alternatives to the NPRM are given in the PROPOSED NPRM PROTOCOL (Section I, above). (2) Collect data to identify and quantify consumers of FFRs and the annual volume consumed - Develop current CONSUMER DEMAND function/curve: Address the Regulatory Flexibility Act - section 603(b)(3) which requires an estimate of the number of entities likely to be impacted. Provide a methodology for and an estimate of the number of consumers likely to be impacted by the NPRM in North America. Approval data reviewed by NIOSH throughout the informal rulemaking phase indicates that the vast majority of the respirator approvals impacted by the proposed rule are filtering facepiece respirators (FFRs -NIOSH certified as N, P or R). Provide an estimate of the number of FFRs purchased/owned annually by consumers. Quantify the average annual cost to the user to purchase these respirators. Identify the largest and smallest consumer group by North American Industry Classification System (NAICS) code, industry or occupation. Tell NIOSH who is consuming this class of respirators including: Identify and quantify the size of the regulated occupational consumer and the non-regulated market by NAICS including general industry or specific occupation descriptions and the number of FFRs consumed annually from 2008 to 2013. Include the statistical reliability of estimates. Develop the current DEMAND function/curve by quantity consumed and price for all consumers combined and for regulated occupational safety and health consumers Regulated Occupational Safety FFR Consumers Non-regulated FFR Consumers Government Stockpiles Studies by Frost and Sullivan's Chemicals, Materials and Food Practice (www.frost.com) may be used to assist the definition of consumers. The 2001 BLS Survey, Respirator Usage in Private Sector Firms may also be used: http://www.cdc.gov/niosh/docs/respsurv/pdfs/respsurv2001.pdf Use the Current CONSUMER DEMAND function and curve as the base analysis for the NPRM. Develop a COMPARITIVE CONSUMER DEMAND function and curve including the test requirement included in the proposed rule. NIOSH also requires the data and calculations to be interactive meaning the number of test subjects and the number of passing subjects can be varied, by NIOSH, to determine potential outcomes based on the NPRM. BASE DEMAND FUNCTION/CURVE COMPARITIVE DEMAND FUNCTION/CURVE What NIOSH would like to be able to do with the data: Current rule 42 CFR 84 Subpart K does not require a fit test for certification 10/10 subjects/respirators pass the fit test requirement with a fit factor of 100 Vary the number of test subjects from 10 to 100 with a 75% pass rate and a fit factor of 100, 50, 20 and compare results (3) Collect data to identify and quantify suppliers of FFRs and the annual market share - Develop current SUPPLY DEMAND function/curve: Classify the supplier as a Large-sized Business, Medium-sized Business or Small Business using measurable parameters to mathematically determine the size designation. According to the Regulatory Flexibility Act/Small Business Act, the size of a business can be estimated by number of employees employed during the preceding 12 months. Tell NIOSH who is supplying FFRs including: Quantify the number and size of North American NIOSH approved FFR Suppliers using the descriptors Small, Medium and Large. Quantify the market share for each market size. Identify the largest supplier and the smallest (include 3-5 small suppliers, if needed due to lack of variability). Indicate the statistical reliability of estimates. Develop the current SUPPLY function/curve by quantity sold and price for all suppliers combined. Identify significant increases or decreases in sales trends since 2008, including the impact of Pandemic Flu Preparedness and H1N1. Manufacturers in North America Global Manufacturers The list of manufacturers or suppliers that produce NIOSH certified FFRs may be obtained from the NIOSH Certified Equipment List (CEL): http://www.cdc.gov/niosh/npptl/topics/respirators/CEL/default.html Quantify the number of global suppliers of NIOSH approved FFRs, quantify the market share of FFRs sold in North America but manufactured outside of North America. Use measurable parameters to mathematically quantify the volume of product sold by the manufacturers. The data must be organized to facilitate sorting by the size of the business, total number of FFRs sold annually (since 2008) and number of unique product lines produced (FFRs only). Use the Current SUPPLY function and curve as the base analysis for the NPRM. Develop a COMPARITIVE SUPPLY function and curve including the test requirement included in the proposed rule. NIOSH also requires data and calculations to be interactive meaning the number of test subjects and the number of passing subjects can be varied, by NIOSH, to determine potential outcomes based on the NPRM. The COMPARITIVE SUPPLY function shall provide a methodology for and an estimate of the number of suppliers likely to be impacted by the NPRM in North America by indicating the supplier(s) with the potentially highest cost impact and the supplier(s) with the potentially lowest cost impact. BASE SUPPLY FUNCTION/CURVE COMPARITIVE SUPPLY FUNCTION/CURVE What NIOSH would like to be able to do with the data: Current rule 42 CFR 84 Subpart K does not require a fit test for certification 10/10 subjects/respirators pass the fit test requirement with a fit factor of 100 Vary the number of test subjects from 10 to 100 with a 75% pass rate and a fit factor of 100, 50, 20 (4) Develop an Analytical Model to Assess the Economic Impact of the Proposed Rule on the Consumers and Suppliers of the FFRs: Estimate the change in cost to the consumers and the change in cost to supplier (manufacturing) of the new performance requirement. Based on calculations of the DEMAND function and the SUPPLY Function (see 2 and 3, above), calculate an average annual cost of respirators per consumer or consumer group and an average cost to suppliers, defined as either small, medium or large businesses. What would the impact be to a given supplier if 10% of their current product failed the new performance test? 40% failed? 75% percent failed? What would the impact on the consumer populations be if 10%, 50%, 90% of all FFRs sold in North America, and globally, were no longer available? Determine the potential impact on international producers; estimate the demand to continue to develop new products at current rates. (5) Mathematically Estimate Benefit/Determine SENSITIVITY of HEALTH BENEFITS Given the potential change in production costs to suppliers and price paid by consumers due to implementation of the proposed rule, determine the benefit of the sale or purchase of FFRs meeting the proposed approval requirement. The FFRs approved under the new requirement could reduce the cost of fit testing since the newly certified respirators will have demonstrated the ability to fit subjects. Determine the significance of the benefit to the largest identified consumer group (see Task 2). What secondary benefits can be identified? For example, if nurses are identified as the largest consumer group, what are the primary health benefit(s) to the worker (nurses) during exposures to seasonal flu, potential pandemic flu, and tuberculosis, and the secondary health benefits to the patients and/or the employer? Other health benefits may include: • Reduce silica exposures and reduced prevalence of silicosis. OSHA has generated estimates and completed risk analysis in relation to the proposed rule for silica • Reduce hexavalent chromium exposures and the risk of lung cancer for metal workers, construction workers • Improved protection for nanotechnology workers (rapidly emerging industry with downstream workers in need of protection). http://www.cdc.gov/niosh/updates/upd-04-24-13.html http://www.cdc.gov/niosh/docs/2013-145/ Contact suppliers and seek information concerning estimates of new product development costs, modification of existing product (based on the NPRM) costs, including the costs associated with NIOSH certification, tooling, re-tooling, packaging, etc. The Department of Defense (DOD) has supported programs for respirator production with commercial suppliers; costs can be estimated based on DOD models, if needed. NIOSH requires a spreadsheet or computational model showing the risks to employees, the costs illness and the likely health benefits of an NIOSH rule which adds a requirement to measure inward/faceseal leakage of a NIOSH approved FFR. (6) Support for Economic Analysis Reports As directed by the NIOSH Program Manager, in consultation with the Contracting Officer's Representative (COR), the contractor may retain other consultants to provide changes or suggestions to documents prepared by NIOSH staff, or make such changes itself. These changes may be substantive or stylistic in nature and may reflect revisions to the analyses. (7) Support for the Small Business Advocacy Review (SBAR) Panel The contractor will provide technical and analytical support, as needed, to the Program (NIOSH/NPPTL) to respond to public comments relating to this analysis and to the SBAR Panel (Date TBD, potentially 2013 or 2014). The contractor may be asked to participate in public meeting(s) following the completion of the analysis and publishing of the revised NPRM. This task may include short turnaround research projects in response to emergent requests. This project is supported by a justification for GSA Limited Source Justification to Eastern Research Group, Inc under authority of FAR 13.106-1(b)(1) and FAR 8.405-6(a)(1)(i)(B). Responsible sources that believe they possess the expertise and capabilities identified above are hereby afforded the opportunity to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement and pricing information in the format they choose, not to exceed 10 pages. Please forward product and pricing information to Diane Meeder, Contracting Officer, CDC, Procurement and Grants, OAS, Branch-IV, PO Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA, 15236-0070; email Dmeeder@cdc.gov. All vendors must be registered in the System for Award Management (SAM) at www.sam.gov, prior to an award of a federal contract. This is not a Request for Proposals; however, the Government will review any/all product, capabilities, and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response will be used solely for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 15 days, in accordance with FAR 13.106-1(b)(1) and FAR 8.405-6(a)(1)(i)(B), a delivery order and/or negotiations will be conducted with Eastern Research Group, Inc. 110 Hartwell Ace Ste. 1, Lexington, MA 02421 as the only source.
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