Presentations and Discussion with Regulators that are users of the Global Arrangements. ILAC MCC Meeting April 22, 2015

Transcription

1 Presentations and Discussion with Regulators that are users of the Global Arrangements ILAC MCC Meeting April 22,

2 Agenda Introduction NIST Standards Coordination Office Overview of ILAC MCC Agency presentations CPSC EPA FCC/NIST NRC Discussion 2

3 UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION Third Party Testing The CPSC Program for Acceptance of Testing Laboratories Specifying the ILAC Mutual Recognition Arrangement Scott Heh Program Manager April 22,

4 CPSC STAFF REQUESTS OF ILAC Communication. Request ILAC to: Establish a designated point of contact to address CPSC inquiries Include CPSC on mailings as part of WG 3 distribution list Encourage every ILAC full member AB to have a designated point of contact to handle CPSC inquiries specific to that AB Information Sharing. Request ILAC to: Include CPSC on notifications of any proposed ILAC policy or procedure changes related to requirements for ILAC-MRA signatories Provide mechanism for CPSC comments Provide notifications of General Assembly resolutions, newsletters, announcements of new and revised standards 4

5 SECTION CONSUMER PRODUCT SAFETY IMPROVEMENT ACT OF 2008 (CPSIA) The CPSIA amended The Consumer Product Safety Act (CPSA) Section 14 [15 U.S.C. 2063] for Product Certification and Labeling Requires certification of regulated products by the manufacturer (includes importers) or private labeler General use consumer products Children s products Certification based on product testing A test of each general use consumer product or a reasonable test program Children s Products - Third-party testing by a CPSCaccepted laboratory 5

6 PRODUCT CERTIFICATION Initial certification required before product enters stream of commerce Requirement for continued testing and recertification of children s product Event-triggered testing Material change in: manufacturing process sourcing of materials product design Periodic testing Frequency Sampling Plan Representative samples Sample size 6

7 WHY SPECIFY THE ILAC-MRA? Laboratory Accreditation Process Identification of required standards ISO/IEC requirement for testing laboratories ISO/IEC requirement for ABs Specified CPSC regulations and standards Existing accreditation system International in scope Global recognition Demonstrated competence, peer-reviewed Open membership 7

8 BENEFITS TO CPSC Designating the ILAC-MRA allows CPSC to leverage resources To acknowledge the expertise and experience of an international organization comprised of accreditation bodies from over 60 countries Provide a reasonable degree of transparency and control over the accreditation and CPSCacceptance process. 8

9 TESTING LABORATORY BASELINE REQUIREMENTS FOR CPSC ACCEPTANCE The laboratory must be accredited by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). The scope of accreditation must include the test methods required by CPSC laws and regulations. The laboratory must apply to the CPSC (on-line application process) for recognition and must agree to fulfill the requirements of the CPSC program 16 CFR part 1112, FR notice published March 12, Provides for the participation of domestic and foreign ABs and Testing Laboratories 9

10 16 CFR part 1112 Overview CPSC Rules for Acceptance of Accreditation and Rules to Maintain and Renew CPSC Acceptance Adverse Actions: Withdrawal and Suspension of Acceptance of Accreditation Appeals Process Governmental and Firewalled Laboratories- Additional submission requirements: protections against undue influence no favorable treatment by government entities 10

11 Rules/Bans/Standards that Require Testing by a CPSC-accepted Laboratory Over 65 rules, bans, standards that require third party testing. Product Specific Standards (e.g., crib safety standards, infant walkers, children s sleepwear) Rules that apply to all children s products (e.g., limits on lead content in paint and substrate, limits on phthalates) Rules on product categories (e.g., electrical toys 16 CFR part 1505, Toy Safety Standard ASTM F963) 11

12 USA 91 United Kingdom 13 Germany 19 China 178 Italy 13 India 28 Taiwan CPSC-accepted laboratories Located in 42 economies Accredited by 49 Full Member ILAC ABs As of 3/31/ % (353) of the CPSC-accepted laboratories are located in 7 economies As of 3/31/

13 Austria - 1 Bangladesh - 11 Belgium - 1 Brazil 1 Cambodia - 3 Canada 6 Czech Republic - 1 Denmark - 3 Egypt - 1 France 5 Greece - 1 Guatemala - 2 Hungary - 1 Indonesia - 7 Japan - 8 Malaysia - 4 Other Economies 122 Laboratories Mauritius 1 Mexico - 8 Pakistan - 5 Peru - 1 Philippines - 3 Portugal 2 Romania - 1 Singapore 6 Slovakia - 1 South Korea - 8 Spain - 4 Sri Lanka 3 Sweden - 1 Switzerland - 2 Thailand 4 Tunisia - 1 Turkey - 6 Vietnam

14 14

15 15

16 16

17 17

18 18

19 Resources Laboratory Accreditation Manufacturing/Testing-Certification/Lab- Accreditation/ list signup and Small Business Ombudsman Third Party Testing Manufacturing/Testing-Certification/ Desktop Reference Guide Business Education Manufacturing/Business-Education/ 19

20 Thank You Scott Heh Program Manager Office of Hazard Identification and Reduction U.S. Consumer Product Safety Commission

21 Testing and Certification of ENERGY STAR Products ILAC MCC Meeting Eamon Monahan April 22, 2015

22 22

23 ENERGY STAR TODAY Source: National CEE Household Survey

24 Source: Fairfield Research, July

25 25

26 Product Certification Process Laboratory: Accredited ENERGY STAR Partner Certification Body (CB) EPA ENERGY STAR Laboratory: CB Witnessed/ Supervised 26

27 International Standards 27

28 EPA Recognition EPA accepts and reviews applications for recognition on an ongoing basis All ABs, CBs, and Labs require EPA recognition 28

29 ENERGY STAR Recognized Bodies for Certification (April 2015) Laboratories by Location Type Total Accreditation Bodies 26 Certification Bodies 24 Laboratories (Accredited and W/SMTLs) 600 Country Accredited Laboratories SMTLs WMTLs Totals Australia Austria Brazil Canada China Denmark Germany Guatemala Hong Kong India Italy Japan Malaysia Mexico Netherlands New Zealand Singapore South Korea Spain Sweden Taiwan Turkey United Kingdom United States Totals

30 Accredited labs in selected categories (April 2015) Product Category Labs Computers 113 Imaging equipment 87 Televisions 84 Light bulbs 39 Refrigerators 28 Central air conditioners 14 Dishwashers 13 Commercial fryers 10 Boilers 7 Pool pumps 4 30

31 Verification Testing Verification testing ensures models meet ENERGY STAR requirements postqualification % of representative models certified by each CB are selected for testing, with input from EPA and possibly other third parties. Partner funds verification testing, which will be off-the-shelf third-party testing, or off-the-line first-party testing witnessed by a third party. 3 CB has units tested; shares results with EPA. 31

32 2014 Verification Testing 1,968 Products Tested 116 Appliances 427 Lighting and Fans 377 HVAC 513 Consumer Electronics/ Information Technology 138 Commercial Food Service 367 Home Building Supplies 30 Other 32

33 2014 Verification Testing 57 unique disqualifications and 121 total products disqualified Number of Unique Disqualifications Total Number of Products Disqualified Product Category Ceiling Fans 4 5 CFLs Commercial Griddles 1 3 Commercial Refrigerators and Freezers 3 3 Computers 7 8 Furnaces 2 2 Geothermal Heat Pumps 1 3 Integral LED Lamps 3 7 Luminaires Roof Products 2 2 Ventilating Fans 7 23 Water Coolers 1 1 Windows, Doors, and Skylights

34 Possible New Product Categories, Clothes dryers Commercial coffee makers Hand dryers Large network equipment Lab-grade refrigerators Medical imaging 1. Finalize the test procedure 2. Finalize the spec 3. EPA-administered training for CBs 4. Open up the application for labs and CBs 34

35 Thanks! Eamon Monahan

36 FCC Equipment Authorization Program Office of Engineering and Technology Laboratory Division 36

37 FCC Regulations Federal Communications Commission (FCC) regulates the private sector telecommunications industry, in the public interest First, the Commission establishes technical regulations for transmitters and other equipment to minimize their potential for causing interference to radio services. Second, the Commission administers an authorization program to ensure that equipment reaching the market complies with the technical requirements. 37

38 Test Firm Accrediting Body Recognition FCC recognizes test firm accrediting bodies that are compliant with or equivalent to ISO/IEC Conformity Assessment General requirements for accrediting bodies accrediting conformity assessment bodies. Test firm accrediting bodies recognized to assess CABs within their territory to ISO/IEC (2005) General requirements for the competence of testing and calibration laboratories and the FCC requirements and to designate CABs to FCC FCC recognizes designated tests firms to test equipment to FCC requirements 38

39 Certification Body Accrediting Bodies FCC recognizes certification body accrediting bodies that are compliant with or equivalent to ISO/IEC to assess Telecommunication Certification Bodies (TCBs) Certification Body accrediting bodies are recognized to assess CABs (known as TCBs) within their territory to ISO/IEC Guide 65 General requirements for bodies operating product certification systems (2004) or ISO/IEC Conformity assessment-requirements for bodies certifying products, processes and services (2012) will replace Guide 65 on September 15, 2015 TCBs are also required to be compliant with ISO/IEC FCC recognizes designated TCBs to approve equipment to FCC requirements 39

40 Testing Laboratories Test Firm Accreditation Body (TFAB) recognition FCC order codifies requirements for recognition of laboratory Accreditation bodies - 47 CFR Recognition requirements include: Successful completion of ISO/IEC 17011(2004) assessment peer review» Being an ILAC signatory and having successfully completed the peer review is acceptable to show the peer review requirement is met Experience with accrediting EMC Labs to ISO/IEC Having personnel/assessors with specific technical experience on FCC requirements Having procedures and policies in place for accrediting Labs for FCC equipment authorization processes 40

41 QUESTIONS AND ANSWERS 41

42 TELECOMMUNICATIONS MRAs ENSURING COMPETENCE OF CABS RAMONA SAAR NIST DESIGNATING AUTHORITY FOR THE UNITED STATES TELECOM MRA PROGRAM 42

43 POINT #1 The APEC TEL MRA text acknowledges of the use of accreditation, reliance on accreditation bodies, and accreditation MRAs 43

44 - Confidence building is promoted by the development within each economy of rigorous systems of accreditation for Conformity Assessment Bodies, using guides such as ISO/IEC guides or recommendations issued by international bodies. - Parties to this Arrangement may rely on mutual recognition arrangements between such accreditation systems to secure and simplify their participation in this Arrangement. - An exporting Party may appoint one or more accreditation bodies which have entered into a mutual recognition arrangement among other accreditation bodies, to accredit Conformity Assessment Bodies. 44

45 POINT #2 In the Telecom MRA texts, there is no mandatory use of accreditation bodies or AB participation in the AB MRAs. 45

46 The exporting Party may use one or more Designating Authorities or one or more accreditation bodies, or both Designating Authorities and accreditation bodies, to accredit and designate testing laboratories that are capable of performing conformity assessment to an importing Party s Technical Regulations. - The Designating Authority is given the option of assessing competence of the CABS directly or using AB(s) - Some U.S. MRA Partners do not use the ILAC Signatory AB in their country - In such cases, the telecom regulator may assess the CABS directly, for example 46

47 POINT #3 NIST MRA Program Office serving as the Designating Authority for Telecom MRAs, appoints qualified U.S. ABs to assess the competency of U.S. CABS to foreign telecom/emc requirements and utilizes the AB MRA signatory status as part of the Lab AB qualifications. 47

48 Qualifications for U.S. Lab ABs: - AB MRA Signatory Status accepted, with required invitation for NIST to observe peer evaluation every 4 years + periodic NIST witness assessment of EMC/Telecom Labs - Results in inclusion of AB on NIST List of acceptable ABs for telecom MRA designation Qualifications for U.S. CB ABs: - Direct ISO/IEC on-site assessment of AB every two years + Periodic NIST witness assessments of CBs - Results in formal NIST/NCVASE Recognition 48

49 Summary - While Telecom MRA Text and other legal texts (such as the EU Directives) support the idea of formal accreditation, it is usually not the only path offered for verifying competency prior to designation/notification - The telecom MRAs, in general, give the MRA partners leeway to determine how the competency of the CABS to be designated to the other economies will be evaluated - NIST, as the Designating Authority under multiple Telecom MRAs does rely on the AB MRA signatory status as one part of the evaluation of our domestic lab ABs that are then listed as the appointed ABs for evaluating the competency of U.S. labs to the MRA partner requirements. -Formal accreditation by a NIST listed lab AB or a NVCASE Recognized CB AB is required by NIST for U.S. CABS prior to designation. 49

50 Thank you. Direct Contact Information: Ramona J. Saar NIST Program Manager Also, to contact the MRA Program Office at NIST: 50

51 U.S. NRC s Recognition of the International Laboratory Accreditation Cooperation Mutual Recognition Agreement ILAC Marketing and Communication Meeting Yamir Diaz-Castillo Mechanical Vendor Inspection Branch Division of Construction Inspection & Operational Programs Office of New Reactors 51

52 Agenda NRC: Who We Are and What We Do Background NRC s Review & Acceptance NRC s Conditions Next Steps Questions 52

53 NRC: Who We Are & What We Do The U.S. Nuclear Regulatory Commission (NRC) was established as an independent agency by Congress in 1974 to ensure the safe use of radioactive materials for beneficial civilian purposes while protecting people and the environment. The NRC is headed by five Commissioners nominated by the President and confirmed by the Senate for staggered five-year terms. No more than three can be from the same political party. The Commission as a whole: Formulates policies and regulations governing nuclear reactor and materials safety; Issues orders to licensees; and Adjudicates legal matters brought before it. 53

54 NRC: Who We Are & What We Do The NRC employs nearly 3,900 people among its suburban Maryland headquarters and four regional offices in Pennsylvania, Georgia, Illinois, and Texas. NRC inspectors are also assigned to 65 nuclear power plant sites and three nuclear fuel facilities. 54

55 NRC: Who We Are & What We Do Our Mission To license and regulate the nation s civilian use of byproduct, source and special nuclear materials to ensure adequate protection of public health and safety, promote the common defense and security, and protect the environment. 55

56 NRC: Who We Are & What We Do 101 nuclear power plants supply about 20 percent of the electricity in the U.S. The NRC Regulates: Nuclear reactors - commercial power reactors, research and test reactors, new reactor designs Nuclear materials - radioactive materials for medical and academic use; Nuclear waste - transportation, storage and disposal of nuclear material and waste, decommissioning of nuclear facilities Nuclear security - physical security of nuclear facilities and materials from sabotage or attacks 56

57 NRC: Who We Are & What We Do What We Do: Create Regulations Issue Licenses Provide Oversight Enforce Regulations Evaluate Operations Provide Support Respond to Incidents What We Don t Do: Regulate nuclear weapons, military reactors or space vehicle reactors Advocate for nuclear power Own or operate nuclear power plants Regulate naturally occurring radon, X-rays, and material produced in particle accelerators 57

58 NRC: Who We Are & What We Do External Blog Facebook Account YouTube Channel Twitter Account Flickr Account 58

59 Background In a letter dated September 5, 2004, Arizona Public Service requested NRC to provide acceptance of the NVLAP (National Voluntary Laboratory Accreditation Program) accreditation of suppliers of commercial-grade calibration services in lieu of performing a commercial-grade survey. In a letter dated September 28, 2005, NRC approved this request in a Safety Evaluation Report based on the review of the NVLAP and American Association of Laboratory Accreditation (A2LA) programs recognized through the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). In a letter dated March 15, 2006, the Nuclear Procurement Issues Committee (NUPIC) requested NRC to clarify whether this alternative may be adopted by suppliers for qualifying subsuppliers. 59

60 Background In a letter dated June 6, 2006, the NRC stated that suppliers may use the alternative for the qualification of commercial-grade subsuppliers as long as the conclusions of the safety evaluation report with regards to the quality of the supplier s programs also apply to the sub-suppliers. On February 20, 2008, NRC met with representatives from NVLAP, A2LA, ACLASS, Laboratory Accreditation Bureau, and the International Accreditation Service to further discuss the commercial calibration and testing laboratory accreditation process through the ILAC MRA. 60

61 Background The NRC initially recognized the accreditation provided by the following 6 U.S. accrediting bodies as an alternative to the methods used to qualify commercial-grade calibration suppliers for U.S. licensees and vendors: NVLAP, A2LA, ACLASS, LAB, IAS, and Perry Johnson Bases for Initial NRC Approval: Accreditation is to ISO 17025, General Requirements for the Competence of Testing and Calibration Laboratories Alternative is described in the licensee and vendor s Quality Assurance Program Scope of accreditation covers the contracted services 61

62 Background Bases for Initial NRC Approval (cont.): Purchase documents: Impose additional technical and administrative requirements to satisfy necessary Quality Assurance program and technical requirements Require reporting as-found calibration data when calibrated items are found to be out of tolerance Require identification of the laboratory equipment and standards used 62

63 Background In a letter dated February 26, 2009, Equipos Nucleares, S.A. (ENSA) requested the NRC to evaluate acceptance of international accrediting bodies belonging to ILAC as third party accreditation for commercial-grade calibration services. In a letter dated April 29, 2014, the Nuclear Energy Institute (NEI) submitted for NRC s review and endorsement its guidance to expand the acceptability of third party accreditation to include both domestic and international calibration and testing laboratories accredited under ILAC. NEI is a private industry group that develops policy on key legislative and regulatory issues affecting the nuclear industry. 63

64 NRC s Review & Acceptance Initial domestic recognition of U.S. Accrediting Bodies: Several meetings with interested parties (NVLAP, A2LA, ACLASS) Comparison of NUPIC checklist with ANSI/ISO/IEC Observation of an accreditation assessment performed by NVLAP Continued recognition of U.S. Accrediting Bodies and Possible International Expansion: Observation of A2LA, LAB and Perry Johnson s evaluation by ILAC Observation of ACLASS and IAS s accreditation of a commercial calibration laboratory Observation of the Japan Accreditation Board s (JAB) evaluation by ILAC and observation of JAB s accreditation of commercial calibration and testing laboratories 64

65 Background In a letter dated August 28, 2014, NEI submitted Revision 1 to the guidelines in response to NRC s request for additional information. Purpose of the guidance is to describe an acceptable approach for using the ILAC accreditation in lieu of performing a commercialgrade survey as part of the commercial-grade dedication process. The guidance describes the activities performed by the U.S. nuclear industry to expand the NRC s recognition of the ILAC accreditation process to include both domestic and international calibration and testing laboratories. By letter dated February 9, 2015, the NRC issued its safety evaluation report on the guidelines developed by NEI. 65

66 NRC s Conditions Method for qualifying calibration and testing laboratory and accepting its calibration services is applied only to commercialgrade calibration services as defined by Title 10 of the Code of Federal Regulations, Part 21. When purchasing commercial-grade calibration and testing services from domestic and international calibration and testing laboratories accredited by an ILAC MRA signatory, licensees and suppliers of basic components may use the ILAC accreditation process in lieu of performing a commercial-grade survey as part of the commercial-grade dedication process provided each of the following conditions are met: 1. Method to use accreditation by an ILAC MRA is documented in the quality assurance program 66

67 NRC s Conditions 2. A documented review of the supplier s accreditation is performed and includes verification of the following: Calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA and encompasses ISO For procurement of calibration services, the published scope of accreditation covers the needed measurement parameters, ranges and uncertainties For procurement of testing services, the published scope of accreditation covers the needed testing services including test methodology and tolerances/uncertainty 3. The purchase documents require that: Service must be provided in accordance with the ISO program and scope of accreditation 67

68 NRC s Conditions As found calibration data must be reported in the certificate of calibration when items are found to be out-of-tolerance Equipment/standards used to perform the calibration must be identified in the certificate of calibration Customer must be notified of any condition that adversely impacts the laboratory s ability to maintain the scope of accreditation Any additional technical and quality requirements, as necessary, based upon a review of the procured scope of services 4. It is validated, at receipt inspection, that the laboratory s documentation certifies that: Service was performed in accordance with the ISO program and within the scope of accreditation Purchase order s requirements are met 68

69 Next Steps Regulatory Issue Summary to be issued to communicate and clarify NRC s technical position on the use of the ILAC accreditation process as part of the commercial-grade dedication process. Expected to be issued during the Fall of

70 Questions? Contact Information Yamir Diaz-Castillo Mail Stop T-7D24 Washington, DC Phone:

71 Discussion 71