Occupational Safety and Health Standards: Machinery and Machine Guarding, Mandatory requirements for OSHA recognition of third-party validation organizations for the PSDI standard

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This Appendix prescribes mandatory requirements and procedures for OSHA recognition of third-party validation organizations to validate employer and manufacturer certifications that their equipment and practices meet the requirements of the PSDI standard. The scope of the Appendix includes the three categories of certification/validation required by the PSDI standard: Design Certification/Validation, Installation Certification/Validation, and Annual Recertification/Revalidation.

If further detailing of these provisions will assist the validation organization or OSHA in this activity, this detailing will be done through appropriate OSHA Program Directives.

I. Procedure for OSHA Recognition of Validation Organizations

A. Applications

1. Eligibility. a. Any person or organization considering itself capable of conducting a PSDI-related third-party validation function may apply for OSHA recognition.

b. However, in determining eligibility for a foreign-based third-party validation organization, OSHA shall take into consideration whether there is reciprocity of treatment by the foreign government after consultation with relevant U.S. government agencies.

2. Content of application. a. The application shall identify the scope of the validation activity for which the applicant wishes to be recognized, based on one of the following alternatives:

(1) Design Certification/Validation, Installation Certification/Validation, and Annual Recertification/Revalidation;

(2) Design Certification/Validation only; or

(3) Installation/Certification/Validation and Annual Recertification/Revalidation.

b. The application shall provide information demonstrating that it and any validating laboratory utilized meet the qualifications set forth in section II of this Appendix.

c. The applicant shall provide information demonstrating that it and any validating laboratory utilized meet the program requirements set forth in section III of this Appendix.

d. The applicant shall identify the test methods it or the validating laboratory will use to test or judge the components and operations of the PSDI safety system required to be tested by the PSDI standard and Appendix A, and shall specify the reasons the test methods are appropriate.

e. The applicant may include whatever enclosures, attachments, or exhibits the applicant deems appropriate. The application need not be submitted on a Federal form.

f. The applicant shall certify that the information submitted is accurate.

3. Filing office location. The application shall be filed with: PSDI Certification/Validation Program, Office of Variance Determination, Occupational Safety and Health Administration, U.S. Department of Labor, Room N3653, 200 Constitution Avenue, NW., Washington, DC 20210.

4. Amendments and withdrawals. a. An application may be revised by an applicant at any time prior to the completion of the final staff recommendation.

b. An application may be withdrawn by an applicant, without prejudice, at any time prior to the final decision bY the Assistant Secretary in paragraph I.B.8.b.(4) of this Appendix.

B. Review and Decision Process

1. Acceptance and field inspection. All applications submitted will be accepted by OSHA, and their receipt acknowledged in writing. After receipt of an application, OSHA may request additional information if it believes information relevant to the requirements for recognition have been omitted. OSHA may inspect the facilities of the third-party validation organization and any validating laboratory, and while there shall review any additional documentation underlying the application. A report shall be made of each field inspection.

2. Requirements for recognition. The requirements for OSHA recognition of a third-party validation organization for the PSDI standard are that the program has fulfilled the requirements of section II of this Appendix for qualifications and of section III of this Appendix for program requirements, and the program has identified appropriate test and analysis methods to meet the requirements of the PSDI standard and Appendix A.

3. Preliminary approval. If, after review of the application, any additional information, and the inspection report, the applicant and any validating laboratory appear to have met the requirements for recognition, a written recommendation shall be submitted by the responsible OSHA personnel to the Assistant Secretary to approve the application with a supporting explanation.

4. Preliminary disapproval. If, after review of the application, additional information, and inspection report, the applicant does not appear to have met the requirements for recognition, the Director of the PSDI certification/validation program shall notify the applicant in writing, listing the specific requirements of this Appendix which the applicant has not met, and the reasons.

5. Revision of application. After receipt of a notification of preliminary disapproval the applicant may submit a revised application for further review by OSHA pursuant to subsection I.B. of this Appendix or any request that the original application be submitted to the Assistant Secretary with a statement of reasons supplied by the applicant as to why the application should be approved.

6. Preliminary decision by Assistant Secretary. a. The Assistant Secretary, or a special designee for this purpose, will make a preliminary decision whether the applicant has met the requirements for recognition based on the completed application file and the written staff recommendation, as well as the statement of reasons by the applicant if there is a recommendation of disapproval.

b. This preliminary decision will be sent to the applicant and subsequently published in the FEDERAL REGISTER.

7. Public review and comment period. a. The FEDERAL REGISTER notice of preliminary decision will provide a period of not less than 60 calendar days for the written comments on the applicant's fulfillment of the requirements for recognition. The application, supporting documents, staff recommendation, statement of applicant's reasons, and any comments received, will be available for public inspection in the OSHA Docket Office.

b. If the preliminary decision is in favor of recognition, a member of the public, or if the preliminary decision is against recognition, the applicant may request a public hearing by the close of the comment period, if it supplies detailed reasons and evidence challenging the basis of the Assistant Secretary's preliminary decision and justifying the need for a public hearing to bring out evidence which could not be effectively supplied through written submissions.

8. Final decision by Assistant Secretary - a. Without hearing. If there are no valid requests for a hearing, based on the application, supporting documents, staff recommendation, evidence and public comment, the Assistant Secretary shall issue the final decision (including reasons) of the Department of Labor on whether the applicant has demonstrated by a preponderance of the evidence that it meets the requirements for recognition.

b. After hearing. If there is a valid request for a hearing pursuant to paragraph I.B.7.b. of this Appendix, the following procedures will be used:

(1) The Assistant Secretary will issue a notice of hearing before an administrative law judge of the Department of Labor pursuant to the rules specified in 29 CFR Part 1905, Subpart C.

(2) After the hearing, pursuant to Subpart C, the administrative law judge shall issue a decision (including reasons) based on the application, the supporting documentation, the staff recommendation, the public comments and the evidence submitted during the hearing (the record), stating whether it has been demonstrated, based on a preponderance of evidence, that the applicant meets the requirements for recognition. If no exceptions are filed, this is the final decision of the Department of Labor.

(3) Upon issuance of the decision, any party to the hearing may file exceptions within 20 days pursuant to subpart C. If exceptions are filed, the administrative law judge shall forward the decision, exceptions and record to the assistant secretary for the final decision on the application.

(4) The Assistant Secretary shall review the record, the decision by the administrative law judge, and the exceptions. based on this, the assistant secretary shall issue the final decision (including reasons) of the department of labor stating whether the applicant has demonstrated by a preponderance of evidence that it meets the requirements for recognition.

b. Publication. a notification of the final decision shall be published in the FEDERAL REGISTER.

C. Terms and Conditions of Recognition, Renewal and Revocation

1. The following terms and conditions shall be part of every recognition:

a. The recognition of any validation organization will be evidenced by a letter of recognition from OSHA. the letter will provide the specific details of the scope of the OSHA recognition as well as any conditions imposed by OSHA, including any Federal monitoring requirements.

b. The recognition of each validation organization will be valid for five years, unless terminated before or renewed after the expiration of the period. The dates of the period of recognition will be stated in the recognition letter.

c. The recognized validation organization shall continue to satisfy all the requirements of this appendix and the letter of recognition during the period of recognition.

2. A recognized validation organization may change a test method of the PSDI safety system certification/validation program by notifying the Assistant Secretary of the change, certifying that the revised method will be at least as effective as the prior method, and providing the supporting data upon which its conclusions are based.

3. A recognized validation organization may renew its recognition by filing a renewal request at the address in paragraph I.A.3. of this Appendix, above, not less than 180 calendar days, nor more than one year, before the expiration date of its current recognition. When a recognized validation organization has filed such a renewal request, its current recognition will not expire until a final decision has been made on the request. The renewal request will be processed in accordance with subsection I.B. of this Appendix, above, except that a reinspection is not required but may be performed by OSHA. A hearing will be granted to an objecting member of the public if evidence of failure to meet the requirements of this Appendix is supplied to OSHA.

4. A recognized validation organization may apply to OSHA for an expansion of its current recognition to cover other categories of PSDI certification/validation in addition to those included in the current recognition. The application for expansion will be acted upon and processed by OSHA in accordance with subsection I.B. of this Appendix, subject to the possible reinspection exception. If the validation organization has been recognized for more than one year, meets the requirements for expansion of recognition, and there is no evidence that the recognized validation organization has not been following the requirements of this Appendix and the letter of recognition, an expansion will normally be granted. A hearing will be granted to an objecting member of the public only if evidence of failure to meet the requirements of this Appendix is supplied to OSHA.

5. A recognized validation organization may voluntarily terminate its recognition, either in its entirety or with respect to any area covered in its recognition, by giving written notice to OSHA at any time. The written notice shall indicate the termination date. A validation organization may not terminate its installation certification and recertification validation functions earlier than either one year from the date of the written notice, or the date on which another recognized validation organization is able to perform the validation of installation certification and recertification.

6. a. OSHA may revoke its recognition of a validation organization if its program either has failed to continue to satisfy the requirements of this Appendix or its letter of recognition, has not been performing the validation functions required by the PSDI standard and Appendix A, or has misrepresented itself in its applications. Before proposing to revoke recognition, the Agency will notify the recognized validation organization of the basis of the proposed revocation and will allow rebuttal or correction of the alleged deficiencies. If the deficiencies are not corrected, OSHA may revoke recognition, effective in 60 days, unless the validation organization requests a hearing within that time.

b. If a hearing is requested, it shall be held before an administrative law judge of the Department of Labor pursuant to the rules specified in 29 CFR Part 1905, Subpart C.

c. The parties shall be OSHA and the recognized validation organization. The decision shall be made pursuant to the procedures specified in paragraphs I.B.8.b.(2) through (4) of this Appendix except that the burden of proof shall be on OSHA to demonstrate by a preponderance of the evidence that the recognition should be revoked because the validation organization either is not meeting the requirements for recognition, has not been performing the validation functions required by the PSDI standard and Appendix A, or has misrepresented itself in its applications.

D. Provisions of OSHA Recognition

Each recognized third-party validation organization and its validating laboratories shall:

1. Allow OSHA to conduct unscheduled reviews or on-site audits of it or the validating laboratories on matters relevant to PSDI, and cooperate in the conduct of these reviews and audits;

2. Agree to terms and conditions established by OSHA in the grant of recognition on matters such as exchange of data, submission of accident reports, and assistance in studies for improving PSDI or the certification/validation process.

II. Qualifications

The third-party validation organization, the validating laboratory, and the employees of each shall meet the requirements set forth in this section of this Appendix.

A. Experience of Validation Organization

1. The third-party validation organization shall have legal authority to perform certification/validation activities.

2. The validation organization shall demonstrate competence and experience in either power press design, manufacture or use, or testing, quality control or certification/validation of equipment comparable to power presses and associated control systems.

3. The validation organization shall demonstrate a capability for selecting, reviewing, and/or validating appropriate standards and test methods to be used for validating the certification of PSDI safety systems, as well as for reviewing judgements on the safety of PSDI safety systems and their conformance with the requirements of this section.

4. The validating organization may utilize the competence, experience, and capability of its employees to demonstrate this competence, experience and capability.

B. Independence of Validation Organization

1. The validation organization shall demonstrate that:

a. It is financially capable to conduct the work;

b. It is free of direct influence or control by manufacturers, suppliers, vendors, representatives of employers and employees, and employer or employee organizations; and

c. Its employees are secure from discharge resulting from pressures from manufacturers, suppliers, vendors, employers or employee representatives.

2. A validation organization may be considered independent even if it has ties with manufacturers, employers or employee representatives if these ties are with at least two of these three groups; it has a board of directors (or equivalent leadership responsibilities for the certification/validation activities) which includes representatives of the three groups; and it has a binding commitment of funding for a period of three years or more.

C. Validating Laboratory

The validation organization's laboratory (which organizationally may be a part of the third-party validation organization):

1. Shall have legal authority to perform the validation of certification;

2. Shall be free of operational control and influence of manufacturers, suppliers, vendors, employers, or employee representatives that would impair its integrity of performance; and

3. Shall not engage in the design, manufacture, sale, promotion, or use of the certified equipment.

D. Facilities and Equipment

The validation organization's validating laboratory shall have available all testing facilities and necessary test and inspection equipment relevant to the validation of the certification of PSDI safety systems, installations and operations.

E. Personnel

The validation organization and the validating laboratory shall be adequately staffed by personnel who are qualified by technical training and/or experience to conduct the validation of the certification of PSDI safety systems.

1. The validation organization shall assign overall responsibility for the validation of PSDI certification to an Administrative Director. Minimum requirements for this position are a Bachelor's degree and five years professional experience, at least one of which shall have been in responsible charge of a function in the areas of power press design or manufacture or a broad range of power press use, or in the areas of testing, quality control, or certification/validation of equipment comparable to power presses or their associated control systems.

2. The validating laboratory, if a separate organization from the validation organization, shall assign technical responsibility for the validation of PSDI certification to a Technical Director. Minimum requirements for this position are a Bachelor's degree in a Technical field and five years of professional experience, at least one of which shall have been in responsible charge of a function in the area of testing, quality control or certification/validation of equipment comparable to power presses or their associated control systems.

3. If the validation organization and the validating laboratory are the same organization, the administrative and technical responsibilities may be combined In a single position, with minimum requirements as described in E.1. and 2. for the combined position.

4. The validation organization and validating laboratory shall have adequate administrative and technical staffs to conduct the validation of the certification of PSDI safety systems.

F. Certification/Validation Mark or Logo

1. The validation organization or the validating laboratory shall own a registered certification/validation mark or logo.

2. The mark or logo shall be suitable for incorporation into the label required by paragraph (h)(11)(iii) of this section.

III. Program Requirements

A. Test and Certification/Validation Procedures

1. The validation organization and/or validating laboratory shall have established written procedures for test and certification/validation of PSDI safety systems. The procedures shall be based on pertinent OSHA standards and test methods, or other publicly available standards and test methods generally recognized as appropriate in the field, such as national consensus standards or published standards of professional societies or trade associations.

2. The written procedures for test and certification/validation of PSDI systems, and the standards and test methods on which they are based, shall be reproducible and be available to OSHA and to the public upon request.

B. Test Reports

1. A test report shall be prepared for each PSDI safety system that is tested. The test report shall be signed by a technical staff representative and the Technical Director.

2. The test report shall include the following:

a. Name of manufacturer and catalog or model number of each subsystem or major component.

b. Identification and description of test methods or procedures used. (This may be through reference to published sources which describe the test methods or procedures used.)

c. Results of all tests performed.

d. All safety distance calculations.

3. A copy of the test report shall be maintained on file at the validation organization and/or validating laboratory, and shall be available to OSHA upon request.

C. Certification/Validation Reports

1. A certification/validation report shall for which the certification is validated. The certification/validation report shall be signed by the Administrative Director and the Technical Director.

2. The certification/validation report shall include the following:

a. Name of manufacturer and catalog or model number of each subsystem or major component.

b. Results of all tests which serve as the basis for the certification.

c. All safety distance calculations.

d. Statement that the safety system conforms with all requirements of the PSDI standard and Appendix A.

3. A copy of the certification/validation report shall be maintained on file at the validation organization and/or validating laboratory, and shall be available to the public upon request.

4. A copy of the certification/validation report shall be submitted to OSHA within 30 days of its completion.

D. Publications System

The validation organization shall make available upon request a list of PSDI safety systems which have been certified/validated by the program.

E. Follow-up Activities

1. The validation organization or validating laboratory shall have a follow-up system for inspecting or testing manufacturer's production of design certified/validated PSDI safety system components and subassemblies where deemed appropriate by the validation organization.

2. The validation organization shall notify the appropriate product manufacturer(s) of any reports from employers of point of operation injuries which occur while a press is operated in a PSDI mode.

F. Records

The validation organization or validating laboratory shall maintain a record of each certification/validation of a PSDI safety system, including manufacturer and/or employer certification documentation, test and working data, test report, certification/validation report, any follow-up inspections or testing, and reports of equipment failures, any reports of accidents involving the equipment, and any other pertinent information. These records shall be available for inspection by OSHA and OSHA State Plan offices.

G. Dispute Resolution Procedures

1. The validation organization shall have a reasonable written procedure for acknowledging and processing appeals or complaints from program participants (manufacturers, producers, suppliers, vendors and employers) as well as other interested parties (employees or their representatives, safety personnel, government agencies, etc.), concerning certification or validation.

2. The validation organization may charge any complainant the reasonable charge for repeating tests needed for the resolution of disputes.

[53 FR 8361, Mar. 14, 1988]

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