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OSHA 1910.217AppC

OSHA recognition of validation organizations

Subpart O

50 Questions & Answers
10 Interpretations

Questions & Answers

Under 1910.217AppC, who is eligible to apply to be an OSHA-recognized third-party validation organization for the PSDI standard?

Any person or organization that considers itself capable of performing PSDI-related third-party validation may apply for OSHA recognition. See 1910.217AppC which states that any person or organization may apply, and that foreign-based applicants will be evaluated for reciprocity of treatment after consultation with relevant U.S. agencies.

Under 1910.217AppC, what choices must an applicant specify about the scope of validation activities in the application?

The applicant must state which of three scope options it seeks recognition for: Design Certification/Validation; Installation Certification/Validation and Annual Recertification/Revalidation; or all three (Design, Installation, and Annual Recertification). See 1910.217AppC (Section I.A.2.a).

Under 1910.217AppC, what facility and laboratory qualifications must the application demonstrate?

The application must demonstrate that the applicant and any validating laboratory meet the qualifications described in section II of the appendix and the program requirements in section III. See 1910.217AppC (I.A.2.b–c). The application should include evidence such as staffing qualifications, laboratory accreditation or capabilities, quality systems, and records showing ability to perform the specified PSDI tests.

Under 1910.217AppC, what must an applicant describe about test methods in its application?

The applicant must identify the specific test and analysis methods it (or its validating laboratory) will use to evaluate PSDI components and operations, and explain why those methods are appropriate. See 1910.217AppC (I.A.2.d). Include method references, acceptance criteria, and supporting validation data.

Under 1910.217AppC, where must an application be filed?

An application must be filed with the PSDI Certification/Validation Program, Office of Variance Determination, Occupational Safety and Health Administration, Room N3653, 200 Constitution Avenue, NW., Washington, DC 20210. See 1910.217AppC (I.A.3).

Under 1910.217AppC, may an applicant change or withdraw its application before final staff recommendation?

Yes. An applicant may revise its application any time before the final staff recommendation, and may withdraw the application without prejudice before the Assistant Secretary's final decision. See 1910.217AppC (I.A.4.a–b).

Under 1910.217AppC, how does OSHA handle applications after receipt and what inspection may occur?

OSHA accepts all applications, acknowledges receipt in writing, may request additional information, and may inspect the applicant's facilities and validating laboratory. OSHA will review supporting documentation and prepare a field inspection report. See 1910.217AppC (I.B.1).

Under 1910.217AppC, what basic requirements must be met for OSHA recognition?

OSHA recognition requires that the program meet the qualifications in section II, the program requirements in section III, and that it has identified appropriate test and analysis methods to meet the PSDI standard and Appendix A. See 1910.217AppC (I.B.2).

Under 1910.217AppC, what happens if OSHA staff determine an applicant appears to meet recognition requirements?

OSHA staff will submit a written recommendation to the Assistant Secretary recommending approval, with a supporting explanation (a preliminary approval). See 1910.217AppC (I.B.3).

Under 1910.217AppC, what happens if OSHA staff find an applicant does not meet requirements?

OSHA will notify the applicant in writing of preliminary disapproval, listing the specific appendix requirements not met and the reasons. The applicant may then revise the application or request that the original application proceed to the Assistant Secretary with a statement of reasons. See 1910.217AppC (I.B.4–5).

Under 1910.217AppC, how is the Assistant Secretary's preliminary decision processed and made public?

The Assistant Secretary (or designee) issues a preliminary decision based on the application file and staff recommendation; that preliminary decision is sent to the applicant and published in the Federal Register with at least a 60-calendar-day public comment period. See 1910.217AppC (I.B.6–7).

Under 1910.217AppC, can the public or applicant request a hearing after the preliminary decision is published?

Yes. If the preliminary decision is favorable any member of the public may request a hearing, and if it is unfavorable the applicant may request a hearing, provided the requester submits detailed reasons and evidence showing why a hearing is needed beyond written comments. See 1910.217AppC (I.B.7.a and I.B.7.b). Hearings, when granted, follow procedures in 29 CFR part 1905, subpart C; see 1905SubpartC.

Under 1910.217AppC, what are the possible final decision routes and how are hearings handled?

If no hearing is requested, the Assistant Secretary issues a final decision based on the record. If a hearing is requested, an administrative law judge holds a hearing under 29 CFR part 1905, subpart C, issues a decision, and the Assistant Secretary reviews that record and issues the final decision. Final decisions are published in the Federal Register. See 1910.217AppC and 1905SubpartC.

Under 1910.217AppC, what does the OSHA recognition letter include and how long is recognition valid?

The recognition is evidenced by an OSHA letter that specifies the scope of recognition, any conditions imposed (including Federal monitoring), and the dates of the recognition; recognition is valid for five years unless terminated or renewed earlier. See 1910.217AppC (I.C.1.a–b).

Under 1910.217AppC, what ongoing obligations does a recognized validation organization have during its recognition period?

A recognized validation organization must continue to satisfy all the requirements of the appendix and the conditions in its letter of recognition for the duration of the recognition period. See 1910.217AppC (I.C.1.c).

Under 1910.217AppC, how can a recognized validation organization change a test method after recognition?

A recognized organization may change a test method by notifying the Assistant Secretary, certifying that the new method is at least as effective as the prior method, and providing supporting data that justify the claim. See 1910.217AppC (I.C.2).

Under 1910.217AppC, when and how should a recognized organization file for renewal of recognition?

A renewal request must be filed with the address in I.A.3 not less than 180 calendar days and not more than one year before the recognition's expiration date. Once a renewal request is filed, the current recognition does not expire until a final decision on renewal is made. See 1910.217AppC (I.C.3).

Under 1910.217AppC, will OSHA always reinspect a recognized validation organization at renewal?

No. A reinspection is not required for renewal, although OSHA may perform one. The renewal request will be processed under the same procedures as initial applications, except a reinspection is not mandatory. See 1910.217AppC (I.C.3).

Under 1910.217AppC, how can a recognized validation organization expand its scope of recognition?

A recognized organization may apply for expansion to cover additional PSDI certification/validation categories by submitting an application processed under the same review and decision procedures; if the organization has been recognized for more than one year, meets expansion requirements, and has no evidence of noncompliance, expansion is normally granted. See 1910.217AppC (I.C.4).

Under 1910.217AppC, can a recognized validation organization voluntarily terminate recognition, and are there limits on terminating certain functions?

Yes, a recognized organization may voluntarily terminate its recognition (in whole or in part) by giving OSHA written notice indicating the termination date. However, it may not terminate installation certification and recertification validation functions earlier than one year after notice or until another recognized validation organization can perform those validations. See 1910.217AppC (I.C.5 and I.C.5 note).

Under 1910.217AppC, on what grounds can OSHA revoke recognition and what process is followed before revocation?

OSHA may revoke recognition if the program fails to continue satisfying appendix requirements or the letter of recognition, fails to perform required validation functions, or has misrepresented itself. Before proposing revocation OSHA will notify the organization of the basis, allow rebuttal or correction, and if deficiencies remain OSHA may revoke recognition effective in 60 days unless the organization requests a hearing. See 1910.217AppC (I.C.6). If a hearing is requested it follows 29 CFR part 1905, subpart C; see 1905SubpartC.

Under 1910.217AppC, what parties are involved in a revocation hearing?

If a revocation hearing is requested, the parties to the hearing are OSHA and the recognized validation organization. The hearing is held before an administrative law judge under 29 CFR part 1905, subpart C. See 1910.217AppC and 1905SubpartC.

Under 1910.217AppC, what documentation and certifications must accompany an initial application?

The application must identify scope, provide evidence that the organization and any validating laboratory meet qualifications in section II and program requirements in section III, identify test methods and reasons for their appropriateness, may include attachments or exhibits, and must include a certification that the information is accurate. See 1910.217AppC (I.A.2.b–f).

Under 1910.217AppC, how will OSHA handle public comments and what opportunity does the public have to review application materials?

OSHA publishes the Assistant Secretary's preliminary decision in the Federal Register and provides at least a 60-calendar-day comment period; during that time the application, supporting documents, staff recommendation, the applicant's statement of reasons, and comments received will be available for public inspection in the OSHA Docket Office. See 1910.217AppC (I.B.6–7).

Under 1910.217AppC, may an applicant request the Assistant Secretary to consider a previously disapproved application without revising it?

Yes. After a preliminary disapproval, an applicant may either submit a revised application for further review or request that the original application be submitted to the Assistant Secretary accompanied by a statement explaining why the application should be approved. See 1910.217AppC (I.B.5).

Under 1910.217AppC, what happens if an expansion request is made and the organization has been recognized for more than one year?

If the organization has been recognized for over one year, meets the expansion requirements, and there is no evidence it has failed to follow the appendix or its recognition letter, OSHA will normally grant the expansion; any objection from the public triggers a hearing only if evidence of noncompliance is supplied. See 1910.217AppC (I.C.4).

Under 1910.217AppC, what must a recognized third-party validation organization allow OSHA to do on-site?

The validation organization must allow OSHA to perform unscheduled reviews or on-site audits and must cooperate with those reviews and audits. This is required by the provisions of recognition in 1910.217AppC and reinforces OSHA's oversight role under 1910.217.

Under 1910.217AppC, what independence criteria must a validation organization meet?

The validation organization must be financially capable of conducting validation work, free of direct influence or control by manufacturers/suppliers/vendors/employers/employee organizations, and its employees must be protected from discharge due to pressure from those groups. These independence requirements are set out in 1910.217AppC (II.B.1) and are part of OSHA's criteria for recognized validation organizations under 1910.217.

Under 1910.217AppC, can a validation organization with ties to manufacturers still be considered independent?

Yes — a validation organization may still be considered independent if it has ties with at least two of the three groups (manufacturers, employers, or employee representatives), includes representatives of all three groups on its governing board for certification/validation activities, and has a binding funding commitment of three years or more. That exception and the conditions for it are described in 1910.217AppC.

Under 1910.217AppC, what competence and experience must a validation organization demonstrate?

The validation organization must demonstrate competence and experience in power press design, manufacture, or use, or in testing, quality control, or certification/validation of equipment comparable to power presses and their control systems. It must also show capability for selecting, reviewing, and validating appropriate standards and test methods used for PSDI certification. These requirements are stated in 1910.217AppC (II.A).

Under 1910.217AppC, do the validation organization and validating laboratory need legal authority to perform validation?

Yes. Both the third-party validation organization and its validating laboratory must have legal authority to perform certification/validation activities. This requirement appears in 1910.217AppC (II.A.1 and II.C.1).

Under 1910.217AppC, can a validating laboratory design, manufacture, sell, promote, or use the equipment it certifies?

No. The validating laboratory shall not engage in the design, manufacture, sale, promotion, or use of the certified equipment, because such activities would impair its impartiality. This prohibition is stated in 1910.217AppC (II.C.3).

Under 1910.217AppC, what facilities and equipment must a validating laboratory have available?

The validating laboratory must have all testing facilities and necessary test and inspection equipment relevant to validating PSDI safety systems, installations, and operations. OSHA requires these resources so the lab can perform complete validations as described in 1910.217AppC (II.D).

Under 1910.217AppC, what are the minimum qualifications for the Administrative Director of a validation organization?

The Administrative Director must have at least a Bachelor's degree and five years of professional experience, with at least one year in responsible charge of functions in power press design/manufacture/use or in testing, quality control, or certification/validation of comparable equipment or control systems. These minimum qualifications are specified in 1910.217AppC (II.E.1).

Under 1910.217AppC, what are the minimum qualifications for the Technical Director of a validating laboratory?

The Technical Director must hold a Bachelor's degree in a technical field and have five years of professional experience, including at least one year in responsible charge of testing, quality control, or certification/validation of equipment comparable to power presses or their control systems. These requirements are in 1910.217AppC (II.E.2).

Under 1910.217AppC, can the administrative and technical responsibilities be combined into one position?

Yes — if the validation organization and the validating laboratory are the same organization, the administrative and technical responsibilities may be combined into a single position provided that the combined position meets the minimum experience and education requirements described for both roles. This allowance is described in 1910.217AppC (II.E.3).

Under 1910.217AppC and 1910.217(h)(11)(iii), what must the validation organization own and how is it used on labels?

The validation organization or validating laboratory must own a registered certification/validation mark or logo, and that mark must be suitable for inclusion on the label required by 1910.217(h)(11)(iii). The general mark/logo ownership requirement is in 1910.217AppC (II.F).

Under 1910.217AppC, what must the validation organization's written test and certification/validation procedures be based on?

The written procedures must be based on pertinent OSHA standards and test methods, or on publicly available standards and test methods generally recognized in the field (such as national consensus standards or published standards of professional societies). This requirement is in 1910.217AppC (III.A.1).

Under 1910.217AppC, must the validation organization's written procedures and the standards they rely on be available to the public and OSHA?

Yes — the written procedures and the standards or test methods on which they are based must be reproducible and available to OSHA and to the public upon request. See 1910.217AppC (III.A.2).

Under 1910.217AppC, what information must be included in a test report for each PSDI safety system tested?

A test report must include the manufacturer's name and catalog/model numbers of subsystems or major components; identification and description of test methods or procedures used (which may be by reference); results of all tests performed; and all safety distance calculations. These required elements are listed in 1910.217AppC (III.B.2.a–d).

Under 1910.217AppC, who must sign test reports and where must copies be kept?

Each test report must be signed by a technical staff representative and the Technical Director, and a copy must be maintained on file at the validation organization and/or validating laboratory and be available to OSHA upon request. See 1910.217AppC (III.B.1 and III.B.3).

Under 1910.217AppC, what must a certification/validation report contain, who must sign it, and when must it be submitted to OSHA?

A certification/validation report must include manufacturer and catalog/model numbers of subsystems or major components; results of all tests used as the basis for the certification; all safety distance calculations; and a statement that the safety system conforms with all requirements of the PSDI standard and appendix A. The report must be signed by the Administrative Director and the Technical Director, a copy must be maintained on file and be available to the public upon request, and a copy must be submitted to OSHA within 30 days of completion. These requirements are in 1910.217AppC (III.C.1–4) and relate to the labeling and validation responsibilities in 1910.217.

Under 1910.217AppC, what publication or list must the validation organization provide to the public on request?

The validation organization must make available upon request a list of PSDI safety systems that have been certified/validated by the program. This publications requirement is in 1910.217AppC (III.D).

Under 1910.217AppC, what follow-up activities must a validation organization perform after certification/validation?

The organization must have a follow-up system for inspecting or testing manufacturers' production of design-certified/validated PSDI safety system components and subassemblies where appropriate, and it must notify the appropriate product manufacturers of any reports from employers of point-of-operation injuries occurring while a press is operated in PSDI mode. These follow-up duties are described in 1910.217AppC (III.E.1–2).

Under 1910.217AppC, what records must the validation organization keep and who can inspect them?

The validation organization must maintain records of each certification/validation, including manufacturer/employer certification documentation, test and working data, test reports, certification/validation reports, follow-up inspections or testing, reports of equipment failures, reports of accidents involving the equipment, and other pertinent information. These records must be available for inspection by OSHA and OSHA State Plan offices. See 1910.217AppC (III.F).

Under 1910.217AppC, what dispute resolution procedures and fees may a validation organization use?

The validation organization must have a reasonable written procedure for acknowledging and processing appeals or complaints from program participants and other interested parties; it may charge a complainant a reasonable fee for repeating tests needed to resolve a dispute. These requirements are found in 1910.217AppC (III.G).

Under 1910.217AppC, what staffing and administrative capabilities must a validation organization maintain?

The validation organization and validating laboratory must be adequately staffed with administrative and technical personnel qualified by training and/or experience to conduct PSDI validations, and must assign overall responsibility to an Administrative Director and technical responsibility to a Technical Director (or combine roles when allowed). These staffing and responsibility requirements are in 1910.217AppC (II.E and II.F) and support the administrative measures described in 1910.217.

Under 1910.217AppC, who bears the burden of proof in a revocation proceeding for recognition of a validation organization?

OSHA bears the burden of proof by a preponderance of the evidence to demonstrate that recognition should be revoked because the validation organization is not meeting recognition requirements, has not been performing required validation functions, or has misrepresented itself in applications. This procedural allocation is explicitly stated in 1910.217AppC.

Under 1910.217AppC, may a validation organization rely on the competence and experience of its employees to meet qualification requirements?

Yes — the validation organization may utilize the competence, experience, and capability of its employees to demonstrate that the organization as a whole meets the required competence and experience standards. This is permitted in 1910.217AppC (II.A.4).

Under 1910.217AppC, what capability related to standards and test methods must the validation organization show?

The organization must demonstrate capability for selecting, reviewing, and validating appropriate standards and test methods to be used for PSDI certification, and for reviewing judgments on the safety and conformance of PSDI safety systems with the standard and appendix A. This requirement appears in 1910.217AppC (II.A.3).