# Presentation: 529917

## [Federal Register: June 17, 2003 (Volume 68, Number 116)][Rules and Regulations][Page 36407-36423]

- ----------------------------------------------------------------------- DEPARTMENT OF LABORMine Safety and Health Administration30 CFR Parts 6, 7, 18, 19, 20, 22, 23, 27, 33, 35, and 36 RIN 1219-AA87 Testing and Evaluation by Independent Laboratories
- and Non-MSHA Product Safety Standards**AGENCY:** Mine Safety and Health Administration (MSHA), Department of Labor. **ACTION:** Final rule. -----------------------------------------------------------------------

**Notes:**
Good morning. I’m Bud Page of the Approval and Certification Center’s Electrical Safety Division. 
If you like this rule, Dave Chirdon and I worked very hard to promulgate this rule. If you don’t like the rule, Dave is solely responsible for its content.
The notice of the final rule for Part 6 was published in the Federal Register on June 17, 2003 and was effective 60 days later. 

## Three Parts to the Rule

- Independent Laboratories
- Non-MSHA Product Safety Standards
- Quality Assurance Requirements

**Notes:**
There are three major parts to this rule
* First, the rule permits MSHA to use, in its investigation of an application for approval or certification, any evaluations or testing performed by an independent laboratory wherever these tests or evaluations would be essentially the same as the tests or evaluations that MSHA would perform in its investigation of the product.
* The second, is the use of Non-MSHA standards to evaluate equipment and materials for use in underground gassy mines. This will be the topic of another workshop.
* The third major element of the rule is the updated QA requirements intended to assure MSHA and the mining community that a product has been constructed of the components and materials specified in the drawings and documentation on file at MSHA for that product. These QA requirements will be discussed in detail this afternoon.

## What is an Independent Laboratory?

*A laboratory that: *
*     **(1) has been recognized by a laboratory accrediting organization to test and evaluate products to a [related] ****product safety standard****, and *
*     **(2) is free from commercial, financial, and other pressures that may influence the results of the testing and evaluation process. *
- —30CFR §6.2

**Notes:**
I’ve been asked to explain what an independent laboratory is in the context of this part 6 rule. 
* Part 6 defines an independent laboratory as a laboratory that:
* (1) has been recognized by a laboratory accrediting organization to test and evaluate products to a product safety standard that is similar to MSHA’s product requirements, and 
* (2) the laboratory is free from commercial, financial, and other pressures that may influence the results of the testing and evaluation process.

## What is a product safety standard?

*A document, or group of documents, that specifies the requirements for the testing and evaluation of a product for use in explosive gas and dust atmospheres, and, when appropriate, includes documents addressing the flammability properties of products.*
- —30CFR §6.2

**Notes:**
Before I discuss MSHA’s requirements for an independent lab, I will explain what we mean by a product safety standard.
A product safety standard is defined in section 6.2 to be a document, or group of documents, that specifies the requirements for the testing and evaluation of a product for use in explosive gas and dust atmospheres and for the flammability testing of materials. 
MSHA’s product safety standards for mining products are the regulations codified in Title 30 of the Code of Federal Regulations (often referred to as 30CFR) Subchapter B and supplemental policies and procedures. 

## MSHA current product safety standards

- 30 CFR, Subchapter B— Parts:
- 15 - Explosives
- 18 - Electrical machines and accessories
- 19 - Cap lamps
- 20 - Flashlights
- 22 - Portable methane detectors
- 23 - Telephones and signaling devices
- 27 - Methane monitoring systems
- 28 - Fuses
- 33 - Dust collectors
- 35 - Flame-resistant hydraulic fluids
- 36 - Diesel-powered equipment

**Notes:**
This is a list of MSHA’s current product safety standards
Part 15 is the requirements for permissible explosives. The testing and evaluation of explosives for use in underground gassy mines are performed exclusively by NIOSH using facilities and methods that are so unique and costly that it was determined that no independent laboratory would likely have interest in performing these tests. Therefore, permissible explosives were not included in the Part 6 rulemaking. 
Electrical machines and accessories must be designed, constructed and tested according to Part 18 and are evaluated by the MSHA Approval and Certification Center’s Electrical Safety Division. The Electrical Safety Division is also responsible for investigations of: 
Cap lamps according to Part 19; 
Flashlights to Part 20; 
Portable methane detectors to Part 22; 
Telephones and signaling devices to part 23; 
Methane-monitoring systems to part 27; 
Mine-duty fuses to part 28. These type fuses are currently evaluated by an independent test lab and, therefore, also were not included in the part 6 rulemaking.
Dust collectors used on permissible rock drilling machines are evaluated and tested under part 33 by the Approval and Certification Center’s Mechanical and Engineering Safety Division; 
Flame-resistant hydraulic fluids must meet the requirements of Part 35 and are evaluated by A&CC’s Quality Assurance and Materials Testing Division as are some flammability test specified in part 18; and
Diesel-powered transportation equipment, also the responsibility of Mechanical and Engineering Division, is approved under Part 36. 

## MSHA current product safety standards

- 30 CFR Part 7 Subparts--
- B – Brattice cloth and ventilation tubing
- C – Battery assemblies
- D – Multiple-shot blasting units
- E – Diesel engines
- F – Diesel power packages
- J – Electric motors
- K – Electric cables and splice kits

**Notes:**
In addition, mining products such as brattice cloth and ventilation tubing; battery assemblies; multiple-shot blasting units; diesel engines and power packages; and explosion-proof electric motors, are currently approved under applicable subparts of Part 7. 

## Part 7 Product Safety Standards

- No subjective analysis
- Test by manufacturer or 3rd party
- MSHA controls:
- Witness initial tests
- Evaluation of test results
- QA post-approval product audits
- Independent lab not required
- Equivalent standards

**Notes:**
Part 7 differs from the other approval regulations. The specific products that are approved under Part 7 were determined not to require subjective analysis or testing in order for MSHA to approve them for use in mines. The test procedures, test equipment and the pass/fail criteria are very specific so that consistent and repeatable test results are obtained regardless of the person conducting the test or the location of the test.
Part 7 requires that these products be tested by their manufacturer, or by a third-party selected by the manufacturer--not by MSHA. 
Since MSHA does not perform the initial tests of these products, we control the approval in three basic ways:
First, we witness at least the first tests performed by each new applicant and third-party test lab to assure that they have the proper test equipment and facilities to conduct the tests and that the persons performing the tests understand the test procedures specified in the appropriate part 7 approval subpart;
Second, knowledgeable persons at the Approval and Certification Center review the test data and test results submitted by the manufacturer or third-party lab;
Third, and probably the most important, the quality assurance requirements specified in Part 7 include periodic post-approval audits of representative samples of the product. Under this program MSHA performs periodic testing of representative samples of the product usually at our test facility to assure the continued required performance of the  product. These QA programs will also be required under the part 6 rule and will be discussed this afternoon. 
Under the Part 6 rulemaking, MSHA determined that it was unnecessary that a third-party lab doing testing under part 7 be required to be independent of the manufacturer. Therefore, the part 6 requirements for an independent lab are not applicable to these products. 
However, under the equivalency section of part 6 (§6.20), MSHA intends to consider other product safety standards published by recognized national or international standards-writing organizations for similar type products as alternative product safety standards to Part 7.

## Summary - Product Safety Standards

- MSHA’s current product safety standards are codified in 30CFR
- Policies and procedures supplement each regulation
- Part 7 products do not require an independent lab
- After a non-MSHA product safety standard has been determined to be equivalent to MSHA’s, that standard (with deviations) also becomes an alternative MSHA product safety standard

**Notes:**
To summarize,
* MSHA’s current product safety standards are codified in 30CFR
* Policies and procedures supplement each regulation
* Part 7 products do not require testing by an independent lab
* As non-MSHA Product Safety Standards are evaluated and are determined to be equivalent to MSHA’s current Product Safety Standards under section 6.20, this determination will be published in the Federal Register along with any necessary deviations, clarifications and additions to the requirements of the non-MSHA standard. After the effective date of the Federal Register Notice, the specific product safety standard (or standards) including any and all deviations, clarifications and additions contained in the Federal register notice will also become an alternative MSHA product safety standard. Again, non-MSHA product safety standards will be the topic of a later Workshop.

## Any questions concerning MSHA’s product safety standards?

**Notes:**
Any there any questions concerning MSHA’s product safety standards?

## What is an Independent Laboratory?

*A laboratory that: *
*     **(1) has been ****recognized by a laboratory accrediting organization**** to test and evaluate products to a [related] product safety standard, and *
*     **(2) is free from commercial, financial, and other pressures that may influence the results of the testing and evaluation process. *
- —30CFR §6.2

**Notes:**
Let’s go back to the Part 6 definition of an independent laboratory 
An independent laboratory must be recognized by a laboratory accrediting organization to test and evaluate products to a product safety standard that is similar to MSHA’s product requirements. 

## Laboratory Accrediting Organizations

- OSHA’s NRTL Program
- IEC Ex Scheme
- A2LA
- NIST’s NVLAP
- ANSI’s ACP

**Notes:**
First, let me emphasis that MSHA does not--and will not--accredit laboratories under this Part 6 Rule. The basis for MSHA accepting test and evaluation data from an independent laboratory will be the technical content of the test report that the applicant submits with its application—not the laboratory’s accreditation. Test data that does not show that a particular component had been properly tested or does not meet the MSHA’s pass/fail criteria may not be acceptable or may require additional testing. Written technical justifications for compliance with specific requirements that are not sufficiently detailed or are not valid based on MSHA experience would also not be accepted by MSHA. 
This is a list of laboratory accrediting programs that MSHA has identified as having the ability, but not necessarily the capability, to determine if a laboratory has the proper test equipment and facilities, trained staff, written testing procedures and the calibration and quality control programs to evaluate products for use in an explosive gas or dust atmosphere or to perform flammability or diesel exhaust emissions tests. 
As Dave explained earlier, the original proposed Part 6 rule required that an independent laboratory be accredited by OSHA under its Nationally Recognized Test Laboratory (NRTL) Program in order to be acceptable to MSHA. Under the final Part 6 rule, MSHA will accept independent laboratories that have been accredited either by OSHA or by another national or international organization that assesses the technical capabilities of the laboratory and accredits that laboratory to perform evaluation and testing to standards that are similar to MSHA’s. I will further explain the NRTL Program in subsequent slides.
The International Electrotechnical Commission (IEC) is an international organization that prepares and publishes international standards for all electrical, electronic and related technologies. The IECEx Scheme was organized several years ago by several European and Australian laboratories that use the 60079 series of IEC standards. There are currently 18 certification bodies in the IEC Ex Scheme including UL in the US and CSA in Canada. In addition, Factory Mutual has applied and will likely be accepted by the end of this year. The scheme is currently very active in attempting to monopolize the “global” marketplace by seeking a mandatory acceptance of electrical equipment for use explosive atmospheres in all member countries (including the United States). The scheme’s final objective is worldwide acceptance of (quote) “one standard, one certificate and one approval mark.” That approval mark being that of any one of the laboratories participating in the scheme.
Other organizations that, to my knowledge, do not, as of yet, have programs designed specifically to determine if a laboratory has adequate technical capabilities to evaluate and test products to product safety standards that would be similar to MSHA’s requirements. These organizations include the American Association for Laboratory Accreditation (or A2LA), the US Department of Commerce’s National Institute for Standards and Technology (NIST) National Voluntary Laboratory Accreditation Program (NVLAP), and the American National Standards Institute (ANSI) Accredited Certification Programs.

## OSHA’s NRTL Program

- Requirements (29 CFR 1910.7)
- Independent
- Ownership
- Conflict of Interest Policy
- Technical Capability
- Proper test equipment and facilities
- Trained staff
- Written testing procedures
- Calibration and quality control programs

**Notes:**
I’ll briefly explain OSHA’s requirements for a NRTL. These requirements are similar to the IECEx Scheme since both organizations use the same basic ISO/IEC guides for accrediting a laboratory.
Essentially, OSHA has two criteria it uses to determine if a laboratory is independent. One requirement is that the lab may not own, or be owned, by a company to which it provides product testing or calibration services. 
The other requirement is that the laboratory have an enforced written policy that prohibits its employees from having, or appearing to have, a financial or other interest in a company to which it provides services. In the case of publicly-owned test labs, OSHA recommends that no one client own more than 2% of the laboratory’s stock.
* Most importantly for MSHA, OSHA determines whether the test lab has the technical capabilities to perform the evaluations and tests required by the particular product safety standard covered by OSHA. 
Both OSHA and IECEx perform, as part of their accreditation process, on-site audits of the test laboratory applying for accreditation. These audits are to be performed by persons knowledgeable in the particular product safety standards the laboratory has requested.  These technical capabilities include verification that the lab has the proper test equipment and facilities necessary to conduct tests required by the standards; the laboratory has a trained staff knowledgeable in the content of the standard that has the proper education and training; the lab is also required to have written testing procedures and calibration and quality control programs in place.

## OSHA’s NRTL Program

- Related Product Safety Standards
- UL 674 Electric Motors
- UL 783 Flashlights
- UL 913, FMRC 3610 Intrinsic Safety
- UL 1203 Explosion Proof
- _www.osha.gov/dts/otpca/nrtl/allstds_

**Notes:**
This is a list of test standards recognized under the NRTL Program that are considered similar to MSHA’s product safety standards. These standards include 
UL 674 Electric Motors, 
UL 783 Flashlights, 
UL 913 and FMRC 3611 for Intrinsic Safety, 
and UL 1203 for Explosion Proof equipment.
A complete list of standards are listed on the OSHA NRTL website and are updated as necessary. 
Remember—these non-MSHA product standards have not been, as yet, evaluated under section 6.20 to be “equivalent” to MSHA’s current product safety standards as codified in 30CFR. These listed standards are related to MSHA’s standards in that they apply to similar type electrical equipment and would require test procedures that would be similar to MSHA’s test procedures.

## OSHA’s NRTL Program

- MET Laboratories, Inc
- Underwriters Laboratories Inc
- FM Global Technologies LLC
- SGS U. S. Testing Company, Inc.
- Canadian Standards Association
- Intertek Testing Services NA, Inc
- _www.osha.gov/dts/otpca/nrtl/nrtllist_

**Notes:**
Here is a list of NRTL’s that have been accredited by OSHA to perform testing under one or more of the previous list of standards. These laboratories are:
MET Laboratories
Underwriters Laboratories 
FM Global Technologies 
U. S. Testing Company
The Canadian Standards Association 
And Intertek Testing Services
A current list of NRTLs are listed on the OSHA website at the address shown 

## Part 6 Approval Triangle

**APPLICANT**

-   **LAB **

- Test and evaluation procedures

- Test and evaluation data

- Product approval

**Notes:**
This is the Part 6 product approval triangle. 
Under this Part 6 program, the Applicant contracts with the independent laboratory to evaluate and test its product according to MSHA’s product safety standards. 
After the tests and evaluations are successfully completed, the Applicant would apply to MSHA for approval under the appropriate part in 30CFR.
MSHA will investigate the application and will contact the Applicant whenever additional information or clarification is necessary to continue the investigation. 
To facilitate this process, an independent laboratory may exchange test and evaluation procedures with MSHA. 

## Laboratory’s Responsibilities

- Provide the Applicant:
- Evidence of its independence
- Scope of its accreditation
- Assurance that it performed or witnessed all testing
- A complete and credible test report

**Notes:**
What are the laboratory’s responsibilities under this program?
* One, it must provide the applicant with evidence that it is independent. Laboratory’s that have been accredited by OSHA as an NRTL or are Certified Bodies under the IECEx Scheme have already been determined by those accrediting organization to be independent. So the report of the findings of the laboratory auditor’s report would be sufficient evidence of the laboratory’s independence. Also, a simple signed statement from the laboratory that it is free from commercial, financial, and other pressures that may influence the results of the testing and evaluation process would be sufficient evidence.
* Two, the laboratory must provide a statement of the scope of its accreditation to include the name and address of the laboratory accrediting organization, the covered product safety standards, the effective date of its accreditation, the expiration or renewal date for its accreditation, and any limits or special conditions specified in the lab auditor’s report. At the laboratory’s discretion, it may provide a copy of the lab auditor’s report directly to MSHA.
* Three, as required in section 6.10(c), the laboratory must assure the applicant and MSHA that all tests were performed or witnessed by the laboratory’s personnel. This could simply be a written statement from the laboratory that it did, in fact, performed or witnessed all the tests included in the test report. Where the laboratory did not perform the test at its own laboratory with its own personnel, the statement should identify those tests and explain the reason that the tests were not conducted at that laboratory.
* Last, but most important, is a complete and credible test report.

## Laboratory’s Responsibilities

- A test report that:
- Identifies the applicable requirements
- Provides a technical explanation of how the product complies with each requirement
- Contains valid test data
- Identifies and specifies the critical components and features of the product
- Lists all documents used in the evaluation

**Notes:**
So what should be included in the test report?
* 1) The report must identify the applicable requirements in MSHA’s product safety standard.
* 2) It must provide a complete technical explanation of how the product complies with each applicable requirement. Where a specific requirement does not apply to that product, there must be a technical explanation why the requirement does not apply.
* 3) The test report must include the “raw” test data that has been validated by the laboratory.
* 4) It must identify and specify the components and features of the product the laboratory considers critical in its evaluation of the safety of the product. And 
* 5) includes a list of all the drawings and specifications that were used to evaluate or test the product.
Each of these points will be discussed later in this workshop.

## Applicant’s Responsibilities

- Provide to MSHA:
- Evidence of the laboratory’s independence
- Scope of laboratory’s accreditation
- Test report including test data
- Drawings submitted to the laboratory
- Documentation required by 30CFR
- Representative samples of the product
- Components as necessary for test

**Notes:**
Now, I’ll briefly list the applicant’s responsibilities in this program. Each of these responsibilities will be discussed in detail later in this workshop.
The applicant must provide to MSHA:
Evidence of the laboratory’s independence.
* Scope and limits of the laboratory’s accreditation. This would include the name of the laboratory accreditation organization, the applicable product safety standards and the expiration or renewal date of the laboratory’s accreditation. MSHA will review the laboratory auditor’s report and contact the laboratory, if necessary, to discuss any outstanding issues that would affect MSHA’s evaluation of the test report. 
*Test report including test data. Submitting the test data is an important point. Because MSHA has extensive experience testing and evaluating equipment for use in explosive methane and coal dust atmospheres, we will make the determination if a product passes or fails a certain test based on the test data—not the laboratory’s conclusions of the results of the test.
If the laboratory’s test report or test results differ from what MSHA would expect from its own evaluations and tests  of the product, MSHA will contact the applicant. MSHA, with the concurrence of the applicant, will decide whether the product will be retested by MSHA or be retested by the independent laboratory with MSHA having the option to witness the testing.
* Drawings submitted to the laboratory. These are the drawings used by the laboratory to evaluate the product. Using these drawings and the laboratory’s test report and test data, MSHA can determine how the product was evaluated by the laboratory. If any of the drawings have been revised or changes have been made to the product, include both the current drawings and the drawings used in the laboratory’s evaluation of the product. Please provide a list of drawings and indicate which drawings were submitted to the laboratory.
* Documentation required by 30CFR. This documentation is specified in MSHA’s application procedures.
* Representative samples of the product. The product sample will be compared with the drawings submitted with the approval application. If parts of the product are encapsulated or otherwise inaccessible for inspection you must provide an additional unit that has exposed parts that can be inspected.
* Components as necessary for test. MSHA will notify the applicant of any components or assemblies that would be necessary for additional evaluation or testing of the product. 

## MSHA’s Responsibilities

- Provide to the _mining industry_:
- Products that will not cause a fire or explosion in an underground mine
- “So that each and every miner may return home safe and healthy after their work shift.”

**Notes:**
Finally, it is MSHA’s is responsibility to assure the American miner that the products he or she uses when working in an underground mine will not cause a fire or explosion so that each and every miner may return home safe and healthy after his or her work shift.

## You may be an Independent Lab if you-

- Have been accredited to test to a product safety standard that is similar to MSHA’s
- Are free from pressures that may influence the results of your testing and evaluation process
- Produce test reports that are complete and are technically credible

**Notes:**
So, in summary.
* You may be an Independent Lab if you have been accredited to test to a product safety standard that is similar to MSHA’s 
* You may be an Independent Lab if you are free from pressures that may influence the results of your testing and evaluation process
* You may be an Independent Lab if you produce test reports that are complete and are technically credible
Are there any questions?

## Questions regarding what is an Independent Laboratory?

**Notes:**
Are there any questions regarding what is an Independent Lab?

According to the schedule we will take a short break.