Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79035 

conducts a pre-clearance consultation 

program to provide the general public 

and Federal agencies with an 

opportunity to comment on proposed 

and continuing collections of 

information in accordance with the 

Paperwork Reduction Act of 1995 [44 

U.S.C. 3506(c)(2)(A)]. This program 

helps to assure that requested data can 

be provided in the desired format, 

reporting burden (time and financial 

resources) is minimized, collection 

instruments are clearly understood, and 

the impact of collection requirements on 

respondents can be properly assessed. 

Currently, the Mine Safety and Health 

Administration (MSHA) is soliciting 

comments concerning the extension of 

the information collection for 30 CFR 

57.11053, Escape and Evacuation Plans. 

DATES: All comments must be received 

by midnight Eastern Standard Time on 

February 15, 2011. 

ADDRESSES: Comments must clearly be 

identified with the rule title and may be 

submitted to MSHA by any of the 

following methods: 

(1) Electronic mail: zzMSHAComments@dol.gov. 

(2) Facsimile: 202–693–9441. 

(3) Regular Mail: MSHA, Office of 

Standards, Regulations, and Variances, 

1100 Wilson Blvd., Room 2350, 

Arlington, VA 22209–3939. 

(4) Hand Delivery or Courier: MSHA, 

Office of Standards, Regulations, and 

Variances, 1100 Wilson Blvd., Room 

2350, Arlington, VA 22209–3939. Sign 

in at the receptionist’s desk on the 21st 

floor. 

FOR FURTHER INFORMATION CONTACT: 

Mario Distasio, Chief of the Economic 

Analysis Division, Office of Standards, 

Regulations, and Variances, MSHA, at 

distasio.mario@dol.gov (e-mail), 202– 

693–9445 (voicemail), 202–693–9441 

(facsimile). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 103(h) of the Federal Mine 

Safety and Health Act of 1977 (Mine 

Act), 30 U.S.C. 813, authorizes MSHA to 

collect information necessary to carry 

out its duty in protecting the safety and 

health of miners. 

Title 30 of the Code of Federal 

Regulations 30 CFR 57.11053 requires 

the development of an escape and 

evacuation plan specifically addressing 

the unique conditions of each 

underground metal and nonmetal mine. 

Section 57.11053 also requires that 

revisions be made as mining progresses. 

The following information is required 

with each escape and evacuation plan 

submission: 

(1) Mine maps or diagrams showing 

directions of principal air flow, location 

of escape routes, and locations of 

existing telephones, primary fans, 

primary fan controls, fire doors, 

ventilation doors, and refuge chambers; 

(2) Procedures to show how the 

miners will be notified of an emergency; 

(3) An escape plan for each working 

area in the mine including instructions 

showing how each working area should 

be evacuated; 

(4) A firefighting plan; 

(5) Surface procedures to be followed 

in an emergency, including the 

notification of proper authorities, 

preparing rescue equipment and other 

equipment which may be used in rescue 

and recovery operations; and 

(6) A statement of the availability of 

emergency communication and 

transportation facilities, emergency 

power, and ventilation, and location of 

rescue personnel and equipment. 

II. Desired Focus of Comments 

MSHA is particularly interested in 

comments that: 

• Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

• Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

• Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

• Minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submissions of responses. 

A copy of the Supporting Statement 

for the proposed extension of the 

information collection can be obtained 

by contacting the person listed in the 

FOR FURTHER INFORMATION CONTACT

section of this notice, or viewed on the 

Internet by selecting ‘‘Rules & Regs’’, and 

then selecting ‘‘FedReg.Docs’’. On the 

next screen, select ‘‘Paperwork 

Reduction Act Supporting Statement’’ to 

view documents supporting the Federal 

Register notice. 

III. Current Action 

This notice contains the request for an 

extension of the existing collection of 

information on 30 CFR 57.11053, Escape 

and Evacuation Plans. MSHA does not 

intend to publish the results from this 

information collection and is not 

seeking approval to either display or not 

display the expiration date for the OMB 

approval of this information collection. 

This information collection does not 

contain certification exceptions and 

does not employ statistical methods. 

Type of Review: Extension. 

Agency: Mine Safety and Health 

Administration. 

OMB Number: 1219–0046. 

Frequency: On Occasion. 

Affected Public: Business or other forprofit. 

Cost to Federal Government: $17,545. 

Total Burden Respondents: 234. 

Total Number of Responses: 468. 

Total Burden Hours: 3,978. 

Total Hour Burden Cost (operating/ 

maintaining): $248,513. 

Comments submitted in response to 

this notice will be summarized and 

included in the request for Office of 

Management and Budget approval of the 

information collection extension; 

Comments will also become a matter of 

public record. 

Dated: December 13, 2010. 

Patricia W. Silvey, 

Director, Office of Standards, Regulations, 

and Variances. 

[FR Doc. 2010–31691 Filed 12–16–10; 8:45 am] 

BILLING CODE 4510–43–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

[Docket No. OSHA–2008–0032] 

Nationally Recognized Testing 

Laboratories; Supplier’s Declaration of 

Conformity 

AGENCY: Occupational Safety and Health 

Administration, Labor. 

ACTION: Notice. 

SUMMARY: Based on its analysis of 

comments received in response to a 

Request for Information published in 

October 2008, the Occupational Safety 

and Health Administration will not 

initiate rulemaking to permit the use of 

a Supplier’s Declaration of Conformity 

as a means of ensuring the safety of 

products currently requiring approval 

by Nationally Recognized Testing 

Laboratories. 

FOR FURTHER INFORMATION CONTACT: 

Press inquiries: OSHA Office of 

Communications, Room N–3647, U.S. 

Department of Labor, 200 Constitution 

Avenue, NW., Washington, DC 20210; 

telephone: (202) 693–1999. General and 

technical information: MaryAnn 

Garrahan, Director, Office of Technical 


emcdonald on DSK2BSOYB1PROD with NOTICES
79036 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

1A third-party system is one of the three types 

of systems generally used for an attestation of 

conformity (i.e., attesting that certain requirements 

are met). The other types are first-party attestation, 

which is issued by the supplier (e.g., a 

manufacturer), and second-party attestation, which 

the user issues. 

Programs and Coordination Activities, 

NRTL Program, Occupational Safety and 

Health Administration, U.S. Department 

of Labor, 200 Constitution Avenue, 

NW., Room N–3655, Washington, DC 

20210; telephone: (202) 693–2110. 

OSHA’s Web page includes information 

about the NRTL Program (see http:// 

www.osha.gov, select ‘‘N’’ in the site 

index). 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

II. Background 

A. Requirement for a High Degree of 

Protection for Product Approval 

Standards 

B. Events Leading to the Second RFI on 

SDoC 

C. Overview of OSHA’s NRTL Program 

D. Overview of the EU’s SDoC System 

E. The EC’s Formal Proposal 

F. OSHA’s October 20, 2008, Request for 

Information on SDoC 

III. Summary of Findings 

A. Statistical Evidence Concerning 

Workplace Safety under an SDoC System 

B. Analysis of the Components of an SDoC 

System 

C. Proposed Alternatives 

D. Use of SDoC in the U.S. 

E. Post-Market Surveillance in NRTL v. 

SDoC Systems 

F. The Costs of Administering an SDoC 

System 

IV. Effects on Trade 

A. Background 

B. Analysis of the Trade-Barrier Issue 

V. Concluding Remarks 

I. Introduction 

In a Request for Information 

published in the Federal Register on 

October 20, 2008 (‘‘2008 RFI’’), the 

Occupational Safety and Health 

Administration (‘‘OSHA’’ or ‘‘Agency’’) 

requested comments on a proposal it 

received to permit use of a Supplier’s 

Declaration of Conformity (SDoC) as an 

alternative to OSHA’s current 

Nationally Recognized Testing 

Laboratories (NRTLs) product-approval 

process. (See 73 FR 62327.) OSHA 

received the proposal from the 

European Commission (EC), which 

advocated an SDoC system for specific 

electrical products. The European 

Union (EU) currently permits its 

Member States to use SDoC for these 

products. The EC’s proposal stems from 

its belief that SDoC assures the safety of 

such products, and that OSHA’s NRTL 

system constitutes a technical barrier to 

trade. 

After thorough analysis of the 

comments received, and due 

consideration of the concerns, issues, 

positions, and suggestions set forth in 

comments to the 2008 RFI, OSHA finds, 

based on the record, that an SDoC 

system would not provide the high 

degree of protection required by the 

Occupational Safety and Health Act of 

1970, 29 U.S.C. 651 et seq. (‘‘OSH Act’’ 

or ‘‘Act’’). By this determination, OSHA 

is not asserting or implying that the 

EU’s SDoC system is deficient for the 

safety purposes and goals it serves in 

the EU. The EU, like all governments, 

must choose an approach to safety 

approvals that comports with its 

political and legal authority and that 

satisfies its needs and priorities. 

However, as explained in this notice, 

OSHA finds that the evidence in the 

record does not support a conclusion 

that SDoC is appropriate for U.S. 

workplaces, given OSHA’s legal 

authority and responsibilities. 

NRTLs are independent (i.e., thirdparty) 1 laboratories that meet OSHA’s 

requirements for performing safety 

testing and certification of products 

used in the workplace. NRTLs test and 

certify (i.e., approve) these products to 

determine whether they conform to 

appropriate U.S. product-safety 

standards. The NRTL issues a certificate 

to declare the product conforms to the 

particular standard(s). In contrast, in an 

SDoC system, the manufacturer issues a 

declaration attesting that the product 

meets the standard or other 

requirements. This manufacturer’s 

declaration may be based on testing 

performed by the manufacturer, by a 

third-party, or by a user of the product. 

The EU’s SDoC system allows 

manufacturers to rely on, but does not 

require, third-party testing. 

Manufacturers are responsible for 

maintaining a written declaration of 

conformity or other allowable evidence 

of conformity, and a technical file 

demonstrating that the manufacturer 

tested the product to assure conformity 

with the requirements specified in the 

applicable EU directive. (See section 

II.D of this notice, for more 

information.) Under SDoC, regulatory 

authorities must also have a system to 

audit, and to bring enforcement action 

against, product manufacturers and, 

possibly, product distributors, including 

retailers. In some cases, as in the EU, 

such a system involves post-market 

surveillance, under which the authority 

checks the conformity of products after 

they are already sold in the market. 

Several U.S. Federal agencies allow 

SDoC for the specific products they 

regulate. 

The 2008 RFI is OSHA’s second RFI 

addressing SDoC. The Agency issued a 

similar RFI in 2005 (‘‘2005 RFI’’) in 

response to a proposal from an industry 

trade association for OSHA to use an 

SDoC system for information technology 

products. Much of the information 

submitted by the commenters in 

response to the 2005 RFI lacked the 

supporting data and details requested, 

or lacked adequate support or 

explanations for the data cited. OSHA 

found that the information provided by 

the commenters did not justify a 

decision to initiate rulemaking to adopt 

an SDoC system. Furthermore, OSHA 

believed that it lacked the legal 

authority and resources to adopt many 

of the enforcement measures required 

for an SDoC system, including product 

recalls, bans, and confiscation, among 

other measures. In view of these 

findings, which address only a few key 

areas of concern, OSHA decided to take 

no further action on the trade 

association’s proposal, and announced 

its decision in the Spring 2007 SemiAnnual Regulatory Agenda, published 

on April 30, 2007. (See 72 FR 22870– 

02.) For more information on this 

matter, see the discussion of the 2005 

RFI in the introduction to the 2008 RFI 

(73 FR 62328–29). 

OSHA seldom publishes a notice 

discussing the results of an RFI. It is 

issuing a notice in this case because of 

the unique and complex issues 

involved, and, as a result, to provide 

interested parties with details on 

OSHA’s reasoning on this decision. 

OSHA did not provide such rationale 

when it announced its decision on the 

2005 RFI. In this Federal Register 

notice, OSHA provides a summary of 

the 2008 RFI, a discussion of its analysis 

of the comments to the RFI and the 

trade issues involved, and its 

conclusion. The Background section 

begins with a discussion of the OSH 

Act’s standard-setting requirements, and 

then describes the events that led to the 

publication of the 2008 RFI. Next, the 

Background section provides an 

overview of both OSHA’s NRTL 

Program and the EU’s SDoC system, 

followed by the EU’s rationale for its 

proposal and a discussion of the 2008 

RFI. 

II. Background 

A. Requirement for a High Degree of 

Protection for Product-Approval 

Standards 

The primary purpose of the OSH Act 

is to assure, so far as possible, safe and 

healthful working conditions for every 

American working man and woman. 

(See 29 U.S.C. 651(b).) To fulfill this 

purpose, Congress gave the Secretary of 

Labor the authority to promulgate, 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79037 

2OSH standards contain requirements that are 

imposed on employers for ensuring safety and 

health in the workplace. They are different from a 

test standard, which we describe later in this notice, 

and which specify technical requirements that 

products must meet. 

3While OSHA uses the term ‘‘approval’’ to 

describe the type of testing and certification 

activities performed by NRTLs, the international 

community often uses the term ‘‘conformity 

assessment’’ to describe these activities. ISO Guide 

2 defines ‘‘conformity assessment’’ as ‘‘any activity 

concerned with determining directly or indirectly 

that requirements are fulfilled.’’ 

4OSHA does not regulate the ‘‘import and sale’’ 

of products, but its rules do affect whether 

employers may use specific products in the 

workplace, thus affecting, to some degree, whether 

those products may be sold or imported into the 

U.S. 

modify, and revoke mandatory 

occupational safety and health (OSH) 

standards.2 (See 29 U.S.C. 655.) The 

Act, and the case law developed under 

it, establish a number of requirements 

that OSHA must meet before exercising 

this authority. Some of these 

requirements are procedural. For 

example, OSHA must support its 

findings with substantial evidence in 

the record developed through the 

rulemaking proceedings, and explain 

the basis for accepting or rejecting major 

suggestions for modification of a 

proposed OSH standard. (See, e.g., 

‘‘Supplemental Statement of Reasons’’ 

for the final rule on Control of 

Hazardous Energy Sources, 58 FR 16612 

at 16621; see also 29 U.S.C. 655(b) and 

(f).) In addition, when OSHA decides to 

revise an OSH standard, it must provide 

a reasoned basis for the revision. 

(International Union, UAW v. OSHA, 37 

F.3d 665, 669–70 (DC Cir. 1994) 

(‘‘Lockout/Tagout II’’).) 

OSHA also is constrained by 

substantive rulemaking requirements. 

The OSH Act requires that safety 

standards, like the NRTL productapproval (or product-conformity) 

requirements, must provide ‘‘a high 

degree of worker protection.’’ (Lockout/ 

Tagout II, 37 F.3d at 669 (quoting 

‘‘Supplemental Statement of Reasons’’ 

for the final rule on Control of 

Hazardous Energy Sources, 58 FR 16612 

at 16615).) Thus, for OSHA to adopt an 

SDoC system, it must find, on the basis 

of substantial evidence, that the SDoC 

product-approval system provides a 

high degree of protection to workers 

who use equipment that would be 

covered by the standard. The ‘‘high 

degree of protection’’ requirement 

allows OSHA to ‘‘deviate only modestly 

from the stringency required by section 

6(b)(5) for health standards,’’ which 

must eliminate significant risk, or 

reduce that risk to the maximum extent 

feasible. (Lockout/Tagout II, 37 F.3d at 

669.) In this regard, OSHA is careful to 

ensure that modifications to its 

approach for product conformity 

maintain the required high degree of 

worker safety. (See 53 FR 12103.) 

OSHA considered two approaches to 

determine whether an SDoC system 

would provide a high degree of 

protection. One approach is to examine 

whether there are valid statistical data 

that show a direct correlation between 

a method of protection and low rates of 

illness or injury. Another approach is to 

examine qualitatively the operation, 

attributes, and elements of the system to 

determine whether it is likely to provide 

a high degree of protection. By way of 

illustration, consider the use of a 

warning alarm on equipment that 

operates near power lines to provide 

adequate warning of possible contact 

with a line. Having valid statistical data 

demonstrating that such an alarm 

measurably reduces these types of 

contacts and resulting injuries could 

provide a basis for concluding that 

requiring the alarm would provide a 

high degree of worker protection. OSHA 

then would consider proposing a 

requirement that employers working 

near power lines install such alarms on 

cranes or other equipment that could 

contact these lines. Alternatively, OSHA 

could examine the method’s operation 

and attributes. If the operation of the 

alarm under prescribed conditions 

showed that it consistently provides a 

timely warning, OSHA could conclude 

that requiring the alarm would 

contribute toward providing a high 

degree of worker protection, and could 

consider including it in a proposed 

rulemaking. However, if the elements of 

a method provided little or no assurance 

of safeguarding against a hazard, the 

method would not provide a high 

degree of worker protection. For 

example, if the alarm failed to operate 

in a predicable manner, and if safety 

testing provided inconsistent results, 

then OSHA would not have confidence 

that the alarm would contribute toward 

providing the required high degree of 

worker protection. 

As discussed later in this notice, 

commenters to the 2008 RFI did not 

submit to the record valid statistical 

data for determining the degree of 

protection afforded by an SDoC system. 

In this regard, OSHA found that the data 

submitted to the record did not 

demonstrate the low risk of injury 

claimed for an SDoC system by its 

proponents. In addition, OSHA 

analyzed the elements of the SDoC 

system to determine whether these 

elements would provide assurance of a 

high degree of worker safety; this 

analysis showed that the elements of the 

SDoC system did not provide such 

assurance. We discuss the results of this 

analysis in Section III (‘‘Summary of 

Findings’’) below. 

B. Events Leading to the Second RFI on 

SDoC 

On April 30, 2007, President Bush 

and his EU counterparts signed the 

Framework for Advancing Transatlantic 

Economic Integration Between the U.S. 

and the EU (‘‘Framework 

Understanding’’ or ‘‘Framework’’). 

(Exhibit OSHA–2008–0032–0002.) This 

trade-related understanding has a 

number of objectives, the foremost of 

which is ‘‘removing barriers to 

transatlantic commerce.’’ (See section II 

of the Framework.) The Framework’s 

Annex 1 lists a number of activities 

affecting different U.S. and EU agencies 

and sectors, including ‘‘initiating an 

exchange on conformity assessment 3

procedures for the safety of electrical 

equipment.’’ 

The Framework established a 

Transatlantic Economic Council (TEC) 

to monitor and advance progress toward 

meeting the goals of the Framework. As 

stated in the Framework, the TEC is ‘‘cochaired, on the U.S. side, by a U.S. 

Cabinet-level official in the Executive 

Office of the President and on the EU 

side by a Member of the European 

Commission, collaborating closely with 

the EU Presidency.’’ (See section IV of 

the Framework.) Through the TEC, in 

July 2007, the EC issued a brief 

statement proposing that OSHA adopt 

SDoC for ‘‘electrical and ICT 

equipment,’’ claiming that this action 

would ‘‘reduce unnecessary costs for 

transatlantic trade.’’ (Exhibit OSHA– 

2008–0032–0003.) 

Working in part through the TEC, 

OSHA and the EC arranged a meeting to 

exchange information on conformityassessment procedures for the safety of 

electrical equipment. The meeting was 

held on October 11, 2007. A summary 

of this meeting describes the key 

elements of each party’s respective 

NRTL and SDoC systems. (Exhibit 

OSHA–2008–0032–0004.) At a 

subsequent meeting on November 9, 

2007, the TEC issued a joint statement 

requesting OSHA to report, at the TEC’s 

next meeting, on ‘‘progress made to 

facilitate trade in electrical products 

with respect to conformity assessment 

procedures for the safety of such 

products.’’ (Exhibit OSHA–2008–0032– 

0009.) In March 2008, the EC issued 

another statement asking the ‘‘[U.S.] 

Government to allow the import and 

sale of any low-risk electrical and 

electronic product on the basis’’ of an 

SDoC.4 (Exhibit OSHA–2008–0032– 

0005.) 


emcdonald on DSK2BSOYB1PROD with NOTICES
79038 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

5While the EC distinguishes between electrical 

and electronic products, such products are 

electrical products for purposes of OSHA’s approval 

requirements. 

6That is, ‘‘accepted, or certified, or listed, or 

labeled, or otherwise determined to be safe’’ by an 

NRTL, as defined in 29 CFR 1910.399. 

7Except as noted, the information in this section 

comes from the summary of the October 11, 2007, 

information-exchange meeting between OSHA and 

EC representatives (Ex. OSHA–2008–0032–0004) 

and research by OSHA staff. 

At the second formal TEC meeting, 

held on May 13, 2008, the Secretary of 

Labor announced that OSHA would 

issue a second RFI on SDoC. (Exhibit 

OSHA–2008–0032–0009.) This second 

RFI would improve OSHA’s 

understanding of SDoC and other 

related topics and issues not fully 

explored in the 2005 RFI. In June 2008, 

at OSHA’s request, the EC submitted a 

formal rationale for its proposal that 

OSHA permit SDoC for electrical 

products.5 During these events, OSHA 

noted that it received no convincing 

information demonstrating that NRTL 

approval and program requirements are 

barriers to trade. Section IV (‘‘Effects on 

Trade’’) of this notice explains OSHA’s 

position on these trade issues. 

C. Overview of OSHA’s NRTL Program 

Since its inception, OSHA has 

required that electrical and other types 

of equipment be approved by qualified 

organizations as one means to ensure 

the safety of this equipment. Pursuant to 

the OSH Act, OSHA based this 

requirement on available consensus 

codes and standards. The requirements 

for NRTL approval of electrical 

equipment are detailed in 29 CFR 1910, 

subpart S. The provisions of this subpart 

require approval 6 of most electrical 

equipment used in the workplace. The 

purpose of the requirements is to ensure 

that the electrical products will, when 

used in the workplace, provide workers 

with a high degree of protection from 

the hazards associated with use of these 

products. 

Following its normal rulemaking 

process, OSHA published a rule on 

April 12, 1988 that established the 

NRTL Program. (See 53 FR 12102.) The 

rule implements the elements of 

OSHA’s product-approval approach, 

and requires that a testing laboratory 

must satisfy the following requirements 

to be recognized by OSHA as an NRTL: 

(1) Have the capability to perform the 

required testing; (2) have controls and 

services for assuring that tested 

equipment conforms to the appropriate 

test standards; (3) be independent from 

manufacturers, suppliers and vendors of 

tested products, and from other 

employers; and (4) have procedures for 

producing credible findings and reports, 

and for handling complaints. (See 29 

CFR 1910.7, 53 FR 12102.) 

OSHA found that each of these 

requirements was necessary to ensure 

that workers are safe when working 

with or exposed to electrical equipment. 

The capability requirement ensures that 

the NRTL has the requisite expertise to 

test specific products to the applicable 

standards. ‘‘Each NRTL’s capability 

must be demonstrated in relation to the 

specific product being tested, the testing 

standards, methods and procedures 

being used * * *, and the quality of 

engineering decision making needed to 

reach a workplace safety determination 

for the product.’’ (See 53 FR 12107.) 

NRTLs also must conduct continued 

oversight of certified products to ensure 

that the products continue to conform 

with the test standard as production 

proceeds. Specifically: 

This part of the definition of NRTL has 

three elements: The implementation of 

control procedures for identifying the listed 

or labeled equipment; production line 

inspection to assure [continued] conformance 

with the test standard; and * * * postmarketing field inspections to monitor and 

assure proper use of the mark or label. 

(Id.) Each of these three elements 

provides assurance that all units of the 

products approved by the NRTL 

continue to provide the same high 

degree of protection as the unit or 

prototype tested and certified initially 

by the NRTL. 

The independence requirement is a 

particularly important component of the 

NRTL Program. ‘‘Absent the direct 

involvement of OSHA in testing 

laboratory decision making, this 

independence requirement is necessary 

to assure the integrity of the testing 

activities.’’ (Id.) Thus, the independence 

requirement protects against self-dealing 

that may arise when an entity certifies 

a product it manufactures. 

Implementing adequate internal 

controls also is critical to the NRTL 

Program. Each NRTL must establish 

internal controls to ensure that it 

produces credible findings and reports 

to support its certification 

determinations, and each NRTL must 

have set procedures for handling 

complaints and disputes. These controls 

provide assurance that the NRTL’s 

testing and certification process is 

reliable. 

To satisfy the approval requirement 

when an employer uses a product in the 

workplace, the NRTLs generally must 

approve the product for the 

manufacturer before the manufacturer 

initially sells or ships the product. An 

NRTL performs two major functions in 

the product-approval process: Testing 

and certification. First, the NRTL tests a 

representative unit or prototype of the 

product to ensure it meets the 

requirements of the applicable product 

safety-test standard(s). For this purpose, 

the NRTL may rely on testing that it 

conducted, or it may accept testing 

performed by parties that the NRTL 

qualifies for that purpose. These parties 

typically include independent testing 

laboratories, but also may include the 

product’s manufacturer, which results 

in time and cost savings for a qualified 

manufacturer. Second, the NRTL 

authorizes the manufacturer to apply 

the NRTL’s mark on the product, 

indicating that the product meets the 

requirements of the appropriate test 

standard(s). To ensure that the product 

continues to comply with the applicable 

requirements, and that the manufacturer 

is conducting production-line tests on 

the product required by the test 

standard(s), the NRTL will conduct 

follow-up inspections on a regular basis 

at each of the product manufacturer’s 

factories or assembling facilities. NRTLs 

typically conduct these follow-up 

inspections two to four times per year 

at each facility. The NRTL may use a 

contractor under the NRTL’s control to 

conduct these inspections. 

OSHA’s NRTL Program recognition 

process involves a thorough analysis of 

an NRTL applicant’s policies and 

procedures, and a comprehensive onsite 

review of the applicant’s testing and 

certification facilities, to ensure that the 

applicant meets these requirements. 

OSHA’s staff also conduct annual onsite 

audits at each NRTL’s facilities to 

ensure that the NRTLs adequately 

perform their testing and certification 

activities, and maintain the quality of 

these operations. Thus, through the 

NRTL Program, OSHA ensures that a 

qualified, independent testing 

laboratory certifies the equipment before 

it reaches the market. 

In adopting the program’s 

requirements, OSHA found that 

implementation of these criteria and 

procedures would ‘‘assure no 

diminution of worker safety.’’ (53 FR 

12103.) Since implementation, OSHA 

received no evidence challenging this 

conclusion or the conclusion that the 

NRTL product-approval requirements 

provide the high degree of worker 

protection required by the OSH Act. 

D. Overview of the EU’s SDoC System 7

The Low Voltage Directive (‘‘LVD’’ or 

‘‘Directive’’) determines which products 

are covered by the EC’s SDoC system for 

electrical safety (Exhibit OSHA–2008– 

0032–0017); the EC implemented it in 

1973 to promote the free movement of 

goods across the EU. (The LVD does not 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79039 

apply to goods exported to countries 

outside the EU.) Directives are laws 

binding on the Member States enacted 

by the European Council and European 

Parliament. Generally, under the EU’s 

system, the EC proposes these laws. 

(More information on these institutions 

and their functions is available at 

http://europa.eu/index_en.htm.) The 

LVD covers all equipment between 50 

and 1,000 volts AC, and 75 and 1,500 

volts DC, except as specifically 

excluded in Annex II of the LVD. This 

annex lists, among other types of 

equipment, ‘‘electrical equipment for 

use in an explosive atmosphere, those 

for radiology and medical purposes, and 

those for goods and passenger lifts.’’ The 

lower and upper limits of the LVD were 

set to exclude electrical equipment of 

the telecommunication industry and 

electric-power industries, respectively. 

The EC’s proposal asserts that all 

products covered under the LVD in the 

EU are ‘‘low-risk’’ because electrocutions 

have become rare in the EU since 

implementation of the LVD; the EC 

concludes that the low rate of 

electrocutions demonstrates the 

effectiveness of the EC’s SDoC system. 

In general, the conformity-assessment 

approach used in the EU classifies 

products according to eight categories, 

with requirements ranging from the 

least stringent (Module A) to the most 

stringent (Module H). Module A, 

covering only the purportedly lowestrisk products, is the only category to 

which SDoC alone applies, i.e., without 

other and stronger regulatory controls. 

(See Exhibit OSHA–2008–0032–0015 for 

an illustration of the safety requirements 

for products covered by each module.) 

The Member States enforce the LVD 

through post-market surveillance. Each 

EU Member State must enact national 

laws to implement the LVD, and assign 

at least one agency (the ‘‘surveillance 

authority’’) to enforce these laws. In the 

United Kingdom, for example, 

approximately 250 local government 

agencies perform this function, whereas 

in other countries, one agency or one 

part of an agency may fill this role. The 

surveillance authority’s inspections are 

a critical activity. Among the EU 

countries, the type and number of 

inspections vary depending on the 

number of available inspectors, the level 

of funding, and the type and number of 

problems prevalent in the Member 

State. Some Member States base 

inspections primarily on complaints 

and accidents, while other Member 

States base inspections primarily on a 

random selection of products. (See 

Exhibit OSHA–2008–0032–014, p. 40.) 

Once an inspection identifies a potential 

deficiency, the surveillance authority 

may require the manufacturer, if known, 

to submit to the authority a report by an 

independent testing organization 

(referred to as a ‘‘notified body’’ in the 

EU) demonstrating that the product 

conforms to the applicable test standard. 

For products that do not conform, the 

manufacturer must perform a risk 

assessment and propose corrective 

actions. Ultimately, the surveillance 

authority makes a final decision on risk, 

which can vary substantially across 

countries. The authority then decides 

what remedial action to take, which 

may include a product recall, ban, 

quarantine, or confiscation; assessing 

financial penalties; and, in more serious 

cases, assessing criminal penalties. If 

the authority cannot locate the 

manufacturer or its authorized 

representative, the authority may hold 

the retailer (or other party that places 

the product in that Member State’s 

market) responsible, and impose the 

remedial action on that party. 

For products posing immediate safety 

risks and affecting more than one 

Member State, the EU has a rapid alert 

system (RAPEX). Another notification 

system, ICSMS, also serves this purpose, 

but not every EU Member State uses 

ICSMS. The goal of recently 

promulgated EU legislation is to 

harmonize the notification systems used 

by the Member States. 

Manufacturers must maintain 

technical files of products covered 

under the LVD for at least 10 years ‘‘after 

the last product has been 

manufactured.’’ Under the LVD, a 

technical file must contain evidence 

that the product complies with the 

applicable safety standards or other 

requirements, either through accredited 

tests, or through other evidence such as 

a manufacturer’s comprehensive safety 

analysis of the product’s design. Bodies 

called ‘‘European Standardisation 

Organisations’’ (ESOs) are responsible 

for developing and maintaining the 

technical safety specifications for the 

products (commonly referred to as the 

‘‘product safety test standard’’ or ‘‘test 

standard’’). In addition, marketsurveillance authorities accept products 

that conform to the ESO standards as 

being in compliance with the LVD. If 

challenged by a Member State’s 

surveillance authority, a manufacturer 

must prove that it complied with the 

LVD, either by demonstrating 

compliance with the ESO standard or by 

other means. If the manufacturer is 

unknown, the burden of demonstrating 

compliance passes to the importer, 

which can be liable for penalties and 

applicable fines. However, there is no 

requirement that manufacturers or 

importers register with any Member 

States, making it difficult in some cases 

to identify the responsible party. 

EU Member States cannot add safetyrelated requirements to the LVD. The 

LVD is binding on each Member State, 

which must codify it into national laws. 

If a Member State does not properly 

implement the LVD through legislation, 

it must nonetheless accept products 

declared by the manufacturers to 

comply with the Directive unless 

available evidence demonstrates that the 

products are noncompliant. Each 

Member State is responsible for 

imposing fines on manufacturers or 

importers for noncompliance with the 

LVD. 

E. The EC’s Formal Proposal 

In its statement of March 2008 

(Exhibit OSHA–2008–0032–0005), the 

EC called for OSHA to adopt an SDoC 

system, and supplemented this 

statement in its June 2008 rationale 

(Exhibit OSHA–2008–0032–0008), 

which formally requested that OSHA 

‘‘review its conformity assessment 

procedures in the area of electrical and 

electronic products.’’ According to the 

March 2008 statement, the EC advocated 

an SDoC system because it believes 

third-party conformity assessment of 

‘‘low-risk electrical and electronic 

products’’ in the U.S. ‘‘imposes 

unnecessary additional costs and 

market-entry barriers on exporters of 

these goods * * * .’’ The statement 

describes the types of products the EC 

considers to be outside the scope of its 

‘‘ ‘low-risk electrical and electronic 

product’ definition,’’ such as ‘‘electrical 

equipment for use in an explosive 

atmosphere, * * * for radiology and 

medical purposes, * * * [and] 

electricity meters, plugs, and socket 

outlets for domestic use * * * .’’ The 

statement noted that such products 

present a level of risk that makes SDoC 

an inappropriate means of conformity 

assessment under EU law, and that the 

EU requires the use of third-party 

approvals in such cases. 

In its June 2008 rationale, the EC 

noted that it has extensive experience 

with conformity-assessment regimes 

that do not require manufacturers to 

obtain third-party certification. The EC 

based its choice of an SDoC regime on 

its ‘‘assessment of the risk to consumers, 

workers and the general interest that 

non-compliant products would reach 

the market place that would pose 

danger.’’ The EC then concluded that the 

risks for these products ‘‘are at a level 

that they can be satisfactorily managed 

by obliging manufacturers to 

demonstrate compliance and to keep 

such proof at the disposal of public 


emcdonald on DSK2BSOYB1PROD with NOTICES
79040 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

8See discussion under section IV of this notice. 

9When multiple commenters raised a similar 

issue discussed in this notice, OSHA addresses the 

issue, but does not necessarily identify every 

commenter that raised the issue. 

10These statistics are taken from the Bureau of 

Labor Statistic’s database of Occupational Injuries 

and Illnesses and Fatal Injuries Profiles, which may 

be accessed at http://data.bls.gov:8080/GQT/servlet/ 

InitialPage (last viewed 7/20/10). 

authorities for inspection at all times.’’ 

According to the EC statement, such 

rules, along with product liability law, 

consumer protection legislation, and 

appropriate enforcement measures 

guarantee a high level of safety for 

European consumers. 

Also in the June 2008 rationale, the 

EC contends that OSHA’s third-party 

requirements cause an ‘‘imbalance in 

market access regimes governing 

transatlantic trade in electrical 

products,’’ and an ‘‘imbalance in market 

access for the certification industry as 

U.S. certifiers can without any barrier 

offer their services to U.S. industry to 

comply with EU rules, whereas EU 

certifiers require either recognition as an 

NRTL by OSHA or be accepted as a test 

house by NRTLs.’’ 8 According to the EC, 

these requirements increase the 

likelihood that countries importing 

products from the U.S. and the EU will 

establish different forms of testing and 

approval. The EC asserted that having 

OSHA adopt an SDoC system ‘‘is 

justified by the fact that European 

consumers and workers experience a 

high if not higher level of electrical 

safety as their counterparts in the U.S.’’ 

It attributes this effect in part to ‘‘the 

high level of safety of electrical and 

electronic devices.’’ Moreover, the EC 

contends that ‘‘[s]tatistics furthermore 

demonstrate that accidents can seldom 

be attributed to products, but are 

normally the result of ‘live’ wires and 

neglect. Where they can be attributed to 

products, there are no indications that 

in the EU there is a relationship 

between non-compliance and 

incidents.’’ Finally the EC claims that 

‘‘market mechanisms ensure that most 

electrical and electronic products and 

especially high technology products and 

high volume products follow rigid 

quality controls and have an excellent 

record of compliance.’’ 

F. OSHA’s October 20, 2008, Request for 

Information on SDoC 

In the 2008 RFI, OSHA posed 45 

questions to elicit information OSHA 

needed to decide whether to initiate 

rulemaking to allow an SDoC system for 

ensuring a high degree of safety for 

electrical products in the workplace. 

OSHA stressed the importance of 

‘‘specific detailed scientific, technical, 

statistical or similar data and studies, of 

a credible nature, supporting any claims 

made by commenters.’’ (73 FR 62327.) 

OSHA requested information and 

comments from all interested parties on 

the issues raised in the RFI, or any other 

issues the public deemed relevant for 

OSHA’s consideration. 

In addition, OSHA specifically noted 

that the EC’s proposal and rationale 

lacked sufficient evidence to support its 

contention that the safety risk of 

noncompliance was low under its LVD. 

Accordingly, in the 2008 RFI, OSHA 

requested evidence to support the EC’s 

assertion that European consumers and 

workers ‘‘experience a high if not higher 

level of electrical safety as their 

counterparts in the U.S.’’ without the 

safeguards required under the NRTL 

Program. (See 73 FR 62331 (quoting 

Exhibit OSHA–2008–0032–0008).) 

OSHA noted that it would need data in 

support of the EC’s assertions regarding 

the safety of its SDoC system to enable 

OSHA to determine whether adopting 

an SDoC system in the U.S. would 

provide U.S. workers with the high 

degree of worker protection required by 

the OSH Act. 

During the 90-day comment period, 

OSHA received 74 comments in 

response to the RFI. The relevant issues 

raised in these comments are discussed 

in Section III of this notice. 

III. Summary of Findings 

As noted earlier, two conceptual 

approaches applicable for evaluating the 

safety of a conformity-assessment 

system, such as SDoC, are: (1) An 

evaluation of statistics concerning the 

system’s safety record, and (2) an 

evaluation of the operations and 

elements of the system. In subsections A 

and B of this section, OSHA analyzes 

the evidence 9 submitted using each of 

these approaches. OSHA finds that the 

record does not support the conclusion 

that, under either approach, SDoC 

would provide a high level of worker 

protection against the hazards of 

electrical equipment in U.S. workplaces. 

The remainder of Section III addresses 

other arguments about SDoC raised in 

the record. Specifically, OSHA 

addresses alternative approaches 

recommended by commenters 

(subsection C), arguments relying on 

manufacturer-certification schemes used 

for other products in the U.S. 

(subsection D), arguments based on 

post-market surveillance required under 

each of the schemes (subsection E), and 

the costs of administering an SDoC 

system (subsection F). As discussed in 

detail below, OSHA decided that the 

record does not justify initiating a 

rulemaking to adopt SDoC for assuring 

the safety of electrical products used in 

the workplace. 

A. Statistical Evidence Concerning 

Workplace Safety Under an SDoC 

System 

No commenter submitted valid 

statistical data to the record, nor did 

OSHA find any such data, that 

demonstrate that SDoC presented the 

low risk claimed by its proponents. 

Indeed, commenters agreed that data do 

not exist, either in the U.S. or in Europe, 

to accurately differentiate between the 

safety of electrical equipment approved 

by a third party and products not 

approved by a third party. (See, e.g., 

Exhibits OSHA–2008–0032–0044.1 at 8, 

25; OSHA–2008–0032–0019; OSHA– 

2008–0032–0031.1; OSHA–2008–0032– 

0089.1; OSHA–2008–0032–0092.1.) 

Moreover, the limited EU and U.S. 

workplace statistics that are available, 

while not conclusive, raise concerns 

about the relative safety of an SDoC 

system. For the year 2005, the most 

recent available for both jurisdictions, 

U.S. Bureau of Labor Statistics show 

that 510 private-sector employees had 

injuries that caused them to be away 

from work for three or more days from 

‘‘contact with electric current of 

machine, tool, appliance, or light 

fixture.’’ 10 A total of 1,960 employees 

had injuries causing them to be away 

from work for three or more days for 

‘‘contact with electric current.’’ 

According to EC’s Directorate General 

for Employment, Social Affairs, and 

Equal Opportunities, a total of 1,584 

employees sustained injuries at work 

causing them to be away from work for 

more than three days from ‘‘electrical 

problem due to equipment failure,’’ and 

a total of 5,510 employees sustained the 

same degree of injuries from ‘‘direct 

contact with electricity, receipt of 

electrical charge in the body.’’ European 

Commission, Directorate-General for 

Employment, Social Affairs, and Equal 

Opportunities, Causes and 

Circumstances of Accidents at Work in 

the EU, at 172–73 (2009) (‘‘DG Report’’; 

available at http://ec.europa.eu/social/

main.jsp?catId=787&langId=en (last 

accessed 7/20/10) (hereafter EU 

Workplace Statistics Report). 

BLS statistics show that, in 2005, 

there were roughly 111 million privatesector employees in the U.S. See BLS 

Employment Situation, July 2005 & 

December 2005 (available at http://www.

bls.gov/schedule/archives/empsit_nr.

htm#2005, last accessed on 7/20/10). 

These statistics yield an incidence rate 

per 100,000 workers of 0.46 for 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79041 

11The EU report also gives a fatality number, but 

it is difficult to interpret because it is given for the 

period 2003–05. The number of member states 

reporting deaths for these classifications varied over 

this period, and, thus, these numbers are not 

comparable to the U.S. data. See EU Workplace 

Statistics at 118. 

12The EC submission does not directly state the 

total number of accidents in the IDB. However, 

Annex 5 of the EC submission states that the 1,721 

accidents attributed to ICT equipment constitute 

0.18% of the accidents in the IDB, indicating that 

the total number of accidents was 956,111 (i.e., 

0.0018 × 956,111 = 1,721). The EC argues that these 

data should be analyzed as a percentage of all 

injuries, rather than an absolute number. OSHA 

does not agree with this argument because a small 

percentage of injuries may mask the magnitude of 

the injuries, which is best expressed as an absolute 

number. OSHA is concerned about the risk posed 

by electrical equipment, not the comparison of 

electrical equipment injuries to other types of 

injuries in the EU. 

equipment-related electrical injuries 

(≥3 days lost), and 1.76 for all electrical 

injuries (≥3 days lost). The 

corresponding population of EU 

workers is more difficult to determine 

because the DG Report gives numbers 

ranging from 106 million to 183 million, 

EU Workplace Statistics Report at 117; 

however, using the most favorable 

number for the EU, this yields an 

incident rate per 100,000 workers of 

0.87 injuries (> 3 days) due to ‘‘electrical 

problem due to equipment failure,’’ and 

3.01 injuries (>3 days) due to direct 

contact with electricity. These data are 

summarized in Table 1 below. 

TABLE 1—U.S. PRIVATE-SECTOR AND EU ELECTRICAL INJURIES 2005 

Injuries Injuries/ 

100,000 wkrs 

U.S.—Contact with electric current of machine, tool, appliance, or light fixture, (private-sector injuries ≥ 3 days 

away from work) ................................................................................................................................................... 510 0.46 

U.S.—Contact with electric current, (private-sector injuries ≥ 3 days away from work) ........................................ 1,960 1.76 

EU—Electrical problem due to equipment failure, (injuries > 3 days lost) ............................................................. 1,584 0.87 

EU—Direct contact with electricity, receipt of electrical charge in the body, (injuries > 3 days lost) .................... 5,510 3.01 

There are obvious problems involved 

with directly comparing the above data. 

BLS based this data on a survey of 

employers required to record 

occupational injuries on logs 

maintained for this purpose; the EU 

statistics are a compilation of member 

country data which is collected, 

depending on the country, either from 

insurance claims or reports by 

employers adjusted to account for nonreported injuries. The EU records only 

data concerning injuries that result in 

more than three days lost; the published 

U.S. data include injuries resulting in 

three or more days lost. It is unclear 

whether the EU classification ‘‘electrical 

problem due to equipment failure’’ is 

equivalent to the U.S. category ‘‘Contact 

with electric current of machine, tool, 

appliance, or light fixture.’’ Regardless, 

the numbers do not directly measure 

injuries due to nonconforming electrical 

products. Nonetheless, the fact that the 

EU workplace electrical injury 11 rates 

for 2005 were nearly twice the rates for 

the U.S. suggests caution in considering 

whether to adopt the EU’s electricalproduct conformity scheme. 

Other injury data submitted to the 

record also gives OSHA pause. The EC 

submitted the statistics from the 

European Injury Database (IDB), which 

compiled accident and emergency data 

from ‘‘selected member state hospitals’’ 

in Austria, Denmark, France, and 

Sweden for 2002–05, and from the UK 

and Ireland for 2002. (Exhibit OSHA– 

2008–0032–0044.1, Annex 5.) The IDB 

data show substantial numbers of 

injuries related to the use of consumer 

electrical products which are subject to 

a SDoC system: 6,115 injuries involving 

all electrical products, and 1,721 

injuries involving ICT products. 

Although its methodology is not clear, 

the EC claims that, at most, 1,243 

injuries involved electrical product 

nonconformance, and 325 injuries 

involved nonconforming ICT 

equipment.1⁄2 These are substantial 

numbers, especially given the limited 

geographic and temporal scope of the 

data; accordingly, these numbers do not 

support moving to an SDoC system. 

The remaining statistical evidence 

provided by commenters was 

unconvincing. Although some 

proponents claimed that the data they 

submitted supported the safety of SDoC, 

they failed to submit source data or 

published studies to verify the statistics 

they cited. (See, e.g., Exhibits OSHA– 

2008–0032–0041.1 and OSHA–2008– 

0032–0051.) In addition, commenters 

often failed to explain adequately the 

methodology underlying the statistics 

they provided. (See, e.g., OSHA–2008– 

0032–0053.1.) Commenters also failed to 

address the limitations that OSHA 

described in Section IV of the 2008 RFI 

with respect to some items of 

information it previously received. For 

example, they failed to address 

adequately how SDoC controls the risks 

associated with non-compliant 

products. (See, e.g., OSHA–2008–0032– 

0089.1.) Consequently, as discussed 

below in further detail, OSHA found 

unconvincing the data submitted to the 

record supporting the safety of products 

under an SDoC system. 

An example of an unsupported claim 

in the record was a statement by the EC 

that the only electrical product to cause 

a fatal accident in the EU in the last 10 

years was a steam iron tested by a third 

party, but modified during production, 

(Exhibit OSHA–2008–0032–44.1 at 8, 

25). This comment did not explain what 

databases or records it searched to 

locate information about deaths from 

electrical products, nor is it clear that 

the EU surveyed all of the available 

sources of data. Published workplace 

statistics, noted above, show that EU 

workers had thousands of non-fatal 

accidents in 2005, and hundreds of fatal 

accidents between 2003 and 2005 

related to contact with electricity or 

other electrical problems. (See EU 

Workplace Statistics Report at 172–73) 

Further, the steam-iron incident 

highlights the fact that the EU’s SDoC 

system is not designed to prevent 

defective products from reaching the 

market because the surveillance 

authorities conduct few, if any, factory 

inspections to ensure that 

manufacturers continue to comply with 

the applicable safety requirements 

before products are sold or shipped. 

This point is discussed further in 

subsection II.B.1 below. 

The EC also pointed to RAPEX data as 

evidence of ‘‘pre-emptive’’ measures 

taken by EU Member States to remove 

noncompliant products from the market. 

(Exhibit OSHA–2008–0032–44.1 at 8–9.) 

The EU’s RAPEX is a system used by 

market-surveillance authorities to report 

sales bans, recalls, or orders to modify 

products they have issued. EU Member 

States use RAPEX for a number of ‘‘nonfood consumer products,’’ but do not 

typically use it for products having 

mainly industrial or commercial 

purposes. Member States also do not use 

RAPEX for notification of noncompliant 

products when ‘‘the effects do not or 


emcdonald on DSK2BSOYB1PROD with NOTICES
79042 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

cannot go beyond the territory of a 

Member State * * *.’’ (Exhibit OSHA– 

2008–0032–0017.) As a result, Member 

States may judge a number of actions 

that are of interest to OSHA to be 

outside the scope of RAPEX and, thus, 

not report them. Therefore, RAPEX 

results likely do not accurately capture 

the problems associated with some 

products, particularly products used in 

the workplace. Further, these 

notifications represent instances of 

noncompliant products reaching the 

market. As discussed in more detail 

below, this is a central feature of the 

EU’s SDoC system that raises critical 

concerns for OSHA: an SDoC system 

detects nonconforming products only 

after products reach the market. These 

RAPEX data do not demonstrate that the 

EU’s reactive SDoC system has the 

necessary elements to provide a high 

degree of worker protection for 

electrical safety in the U.S. workplace. 

Several commenters cited a graph 

showing the number of fatalities from 

electrical incidents in the U.S. and 

Germany as evidence that such 

incidents are decreasing more rapidly in 

the EU than in the U.S. (See, e.g., 

Exhibits OSHA–2008–0032–0044.1, 

Annex 4; OSHA–2008–0032–0045.1; 

OSHA–2008–0032–0054.1; OSHA– 

2008–0032–0060.1; OSHA–2008–0032– 

0087.1.) However, as OSHA noted in the 

2008 RFI, ‘‘[t]he source of the data does 

not appear to be readily available in the 

U.S., the actual numbers of 

electrocutions per year and a 

stratification by causes are not provided 

in the graph, no reason is given why 

more recent data were not obtained, and 

it is unclear whether the data are 

normalized for the two populations.’’ (73 

FR 62320.) No commenters responded 

to these issues. 

The Confederation of Danish Industry, 

while conceding that the question of 

whether SDoC is less safe than a thirdparty system is ‘‘difficult to answer,’’ 

provided information showing that 

accidents with electrical equipment and 

installations trended downward from 

1998 to 2007. (Exhibit OSHA–2008– 

0032–0089.1.) Similarly, a report from 

the Swedish National Electrical Safety 

Board provided statistics showing that 

the ‘‘number of products possessing a 

serious criticism risk has [been] reduced 

and the number of sales bans [also] have 

[been] reduced’’ from 1996 to 2006. 

(Exhibit OSHA–2008–0032–0092.1.) 

However, these statistics do not address 

directly the safety of these products in 

terms of fatalities and injuries, and, 

therefore, do not demonstrate that SDoC 

provides a sufficient level of worker 

protection to satisfy the requirements of 

the OSH Act. 

Finally, several commenters argued 

that ICT equipment presents a low risk 

of workplace injuries. (Exhibits OSHA– 

2008–0032–0019; OSHA–2008–0032– 

0031.1; OSHA–2008–0032–0041.1; 

OSHA–2008–0032–0057.1.) The 

submitted data, however, did not 

adequately support this position. For 

example, a joint ICT industry 

submission presented numerous 

statistics demonstrating a decline in 

fatalities, injuries, and illnesses in U.S. 

workplaces since 1972 (although illness 

data would appear to be irrelevant), and 

also showing a relatively low rate of 

incidents associated with ICT 

equipment in the U.S. (Exhibit OSHA– 

2008–0032–0019, p.3.) These data do 

not demonstrate the safety of an SDoC 

system because OSHA required NRTL 

approval of electrical products in U.S. 

workplaces for most of the time period 

involved; the data instead appear to 

support the effectiveness of the NRTL 

Program in preventing workplace 

fatalities and injuries. As another 

example, the Federation of French 

Electrical Electronic and 

Communication Industry stated that 

‘‘Certain product groups * * * are in 

many cases inherently safe,’’ (Exhibit 

OSHA–2008–0032–0041.1, p.7) but 

provided no technical or other 

information to justify its claim. 

Hewlett-Packard Company stated that 

‘‘the data currently under the product 

category ‘computer equipment’ available 

on the United States Consumer Product 

Safety Commission (CPSC) Web site 

indicates there has not been a single 

recall for desktop personal computers, 

workstations, or servers dating back to 

1990.’’ (Exhibit OSHA–2008–0032– 

0031.1) This statistic, however, covers 

only a narrow subset of ICT equipment, 

and excludes laptop computers and 

computer peripherals such as printers, 

scanners, monitors, and fax machines. A 

review of CPSC recalls for ICT 

equipment between 2003 and March of 

2009 shows a total of 60 product recalls, 

including laptop computers, scanners, 

monitors, printers, computer speakers, 

fax machines, and telephones. (See 

http://www.cpsc.gov/cpscpub/prerel/ 

prerel.html.) Included with these recalls 

were reports of electric shock and 

product overheating that resulted in 

property damage and personal burns. 

(Id.) Moreover, in March 2009 (shortly 

after the 2008 RFI comment period 

closed), there was a recall of a desktop 

personal computer for overheating as a 

result of short circuiting; the 

overheating melted internal components 

and the external casing. (Id.) 

In sum, the record contains no 

statistically sound evidence 

demonstrating that an SDoC system 

provides a high degree of protection for 

electrical safety in the workplace, and 

what evidence there is raises concerns 

that the SDoC system may be less 

protective than the NRTL system. 

B. Analysis of the Components of an 

SDoC System 

OSHA carefully reviewed the 

elements of the SDoC system. OSHA’s 

analysis concluded that, for electrical 

safety, the system does not provide the 

high level of worker protection required 

by the OSHA Act. This statement would 

apply to any similar SDoC system. As 

explained in more detail below, OSHA 

determined that SDoC’s protection is 

reactive, and, therefore, is less likely 

than the NRTL Program to find 

nonconforming products before the 

products reach the market. In addition, 

an SDoC system does not provide 

assurance that manufacturers are 

appropriately certifying products 

because it lacks an assessment of the 

manufacturers’ competence, 

independence, and production control. 

1. SDoC as a Reactive System 

A substantial problem with SDoC is 

that it appears to allow nonconforming 

products to reach the market. While 

OSHA designed the NRTL Program to 

detect product noncompliance before 

products reach the market, the SDoC 

system is reactive in that its principal 

means of protection, post-market 

surveillance, relies on authorities to 

verify the adequacy of testing only after 

products reach the market, or worse, 

after an incident that causes injury or 

death. In addition, such product 

verification is done for only for a 

limited number of products by 

surveillance authorities. As a result, 

post-market surveillance provides a 

lower degree of assurance that products, 

in general, are conforming and safe. 

Several studies noted in the 2008 RFI 

highlighted problems with ‘‘portable 

luminaires’’ (i.e., portable lamps) and 

extension cords in the European market. 

(Exhibits OSHA–2008–0032–0011; 

OSHA–2008–0032–0012.) The SDoC 

system in the EU allowed these 

products to reach the EU market. The 

Low Voltage Directive Administrative 

Cooperation (LVD AdCo), an 

‘‘independent Working Group run and 

chaired by the Member States’’ 

conducted the studies, with the 

Working Group described as ‘‘a forum 

for co-operation and exchange of 

information between national market 

surveillance authorities.’’ (Exhibit 

OSHA–2008–0032–0011.) In 2006, LVD 

AdCo organized its first cross-border 

market-surveillance project, a multicountry cooperative and coordinated 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79043 

effort involving surveillance authorities 

from 15 Member States. 

The first of these studies targeted 

portable luminaires in part because 

these products ‘‘are relatively cheap to 

purchase,’’ thus making this project 

feasible for ‘‘member states with small 

[market-surveillance] budgets.’’ (Id., 

p.6.) These products also had a large 

number of problem notifications as 

shown in a chart depicting past 

‘‘safeguard clauses and RAPEX 

notifications.’’ (Id.) The study results 

show that manufacturers were placing 

noncompliant products on the market. 

The study evaluated a total of 226 

luminaires for conformance to 

applicable administrative and technical 

requirements. (Id., p.4.) Of this total, 

38% originated in the EU, 23% 

originated from China, 10% originated 

from other countries outside of the EU, 

and 29% had no country of origin 

specified. (Id., p.15.) The study found 

that 72% (162) of the luminaires failed 

one or more of the technical 

requirements, nearly half (74) of which 

contained ‘‘serious’’ technical hazards, 

and 23% (53) of which had 

administrative nonconformities (missing 

‘‘CE’’ marks, missing or incorrect 

technical files, missing or incorrect 

declarations of conformity, and similar 

problems). (Id., p. 17.) According to the 

report of the study, the results obtained 

‘‘do not give a dependable estimate of 

the percentages [of] non-compliant 

luminaires on the market.’’ (Id., p. 18.) 

However, the report indicates that the 

results of the project are consistent with 

the experiences of several EU Member 

States. (Id., p. 19.) A summary of the 

report states: 

Many companies appear to neglect 

assuring conformity with the administrative 

requirements in the Directive. Declarations of 

conformity and technical files were often not 

available or did not fit the luminaires 

themselves. The LVD prescribes module A 

for conformity assessment, which amounts to 

self-certification by the manufacturer or 

importer into the EU. The choice for module 

A was made because of the relatively minor 

hazards associated with electrical products. 

However, the new and global approach is 

based on the assumption that the actors 

comply with the conformity assessment 

procedures before CE-marking the product in 

order to assure safe products on the markets. 

For fragmented markets like the one for 

luminaires, this assumption does not appear 

to be valid, if the results of this and previous 

national actions are indeed indicative. 

(Id., p. 19.) The report lacks any analysis 

of the underlying causes for the high 

rate of nonconformities found. 

The second study addressed 

extension cords. A press release 

provided a summary of the study’s 

results. (Exhibit OSHA–2008–0032– 

0012.) The press release indicated that 

20 EU Member States participated in the 

study and tested 210 extension-cord 

sets. The results of the study showed 

that only one in six extension-cord sets 

fully complied with the LVD and the 

General Product Safety Directive (GPSD) 

requirements. (The GPSD specifies 

requirements for general consumer 

products used in the EU.) Although the 

noncompliant samples included 

products that exhibited only 

administrative failures, the authorities 

considered approximately 58% of the 

extension-cord sets to be sufficiently 

unsafe to justify a sales ban or product 

recall. 

Both the luminaire and extensioncord studies show the difficulties that 

arise when moving to a system which 

depends so heavily on post-market 

surveillance for enforcement. When 

unscrupulous or incompetent 

manufacturers do not ensure that 

products meet the applicable safety 

standard, the first line of protection for 

workers does not occur until after the 

product reaches the market. In contrast, 

a third-party certification system is 

structured to find and correct such 

errors before manufacturers place the 

products on the market. In response to 

the discussion of these studies in the 

2008 RFI, several commenters reiterated 

that the luminaire and extension-cord 

studies were not representative of 

typical rates of noncompliance for 

electrical products on the European 

market because the studies did not 

select luminaires and extension cords 

randomly for evaluation. (See, e.g., 

Exhibits OSHA–2008–0032–0044.1; 

OSHA–2008–0032–0051; OSHA–2008– 

0032–0053.1; OSHA–2008–0032– 

0054.1; OSHA–2008–0032–0060.1; 

OSHA–2008–0032–0076.1.) Rather, the 

studies targeted luminaires and 

extension cords for evaluation because, 

in part, these products had high levels 

of noncompliance with SDoC 

requirements. (Id.) Whether these 

studies are broadly representative of 

SDoC noncompliance rates misses the 

point—which is that the data on 

luminaires and extension cords raise 

serious concerns for OSHA about the 

safety of the EU’s SDoC system. These 

studies make clear that SDoC allowed 

significant numbers of nonconforming 

products to reach the market. Although 

the EC alleges that no incidents 

occurred because of these defective 

products, the studies concluded that 

nearly half of the luminaires tested had 

‘‘serious’’ technical hazards, and 58% of 

the extension-cord sets tested were 

sufficiently unsafe to justify a sales ban 

or product recall. (Exhibits OSHA– 

2008–0032–0011, p. 17; OSHA–2008– 

0032–0012.) The EC also attempted to 

minimize the importance of these 

studies by noting that the studies 

addressed products that were 

inexpensive and involved low-level 

technology. (Exhibit OSHA–2008–0032– 

44.1.) This rationale seems to be a 

concession that manufacturers engaged 

in producing such items are less likely 

to ensure product conformity under an 

SDoC. OSHA cannot ignore the risks 

posed by these products when 

evaluating a conformity-assessment 

scheme. These data raise serious 

questions about whether an SDoC 

system would assure a high degree of 

protection for U.S. workers. We note 

that commenters presented no studies 

demonstrating that the rates of 

nonconforming products in the EU are 

low. 

OSHA also reviewed a document 

prepared by EC staff (Exhibit OSHA– 

2008–0032–0013) which provided 

details about the EU’s marketsurveillance system, and served as the 

basis for associated legislation that the 

EU was considering. This document 

covers a wide range of issues in a 

number of areas in which the EU’s 

system needs improvement. Under 

‘‘What are the Problems to Tackle,’’ the 

report states, ‘‘Experience with the 

implementation of [European] 

Community legislation in the area of 

free movement of goods has highlighted 

certain weaknesses and shown that the 

effectiveness of the system can still be 

improved.’’ (Exhibit OSHA–2008–0032– 

0013, p. 12.) The document states 

further: 

It is generally noted that the enforcement 

of EU product legislation is unsatisfactory 

and a considerable number of non-compliant 

(and potentially dangerous) products reach 

the market. The share of non-compliant 

products can only be estimated and the 

situation differs very much from sector to 

sector and from Member State to Member 

State. 

(Id., p. 19.) This statement partially 

corroborates the findings in the report 

on luminaires, which indicated that the 

high level of nonconformities results 

from difficulties Member States have 

enforcing the LVD. In this regard, the 

staff document notes, ‘‘Currently, market 

surveillance does not operate effectively 

throughout the [European] Community. 

***’’ (Id., p. 20.) The document 

continues, ‘‘In practice market 

surveillance authorities often 

experience difficulties in identifying the 

person who has actually manufactured 

and/or supplied the products * * *.’’ 

(Id., p. 23.) This EC document highlights 

the reliance of its SDoC system on postmarket surveillance, and underscores 


emcdonald on DSK2BSOYB1PROD with NOTICES
79044 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

13BVCPS is a testing laboratory accredited under 

the IECEE CB scheme that conducts technical folder 

reviews to determine CE compliance of Europeanbased retailers having Asian supply chains. The 

IECEE CB scheme provides for health and safety 

testing through the IECEE (IEC System for 

Conformity Testing and Certification of 

Electrotechnical Equipment and Components). 

14BVCPS recommended modifying the NRTL 

system rather than transitioning to an SDoC system. 

OSHA addresses this recommendation below. 

the risks to workers that would result 

without an adequate enforcement 

scheme. 

In its proposal, the EC suggested that 

reliance on product liability laws would 

provide some assurance that an SDoC 

system functioned properly. However, 

none of the commenters demonstrated 

that such laws would contribute 

significantly to ensuring that an SDoC 

would provide a high degree of worker 

protection for electrical safety in the 

workplace. As noted by one commenter, 

liability laws would not be an effective 

deterrent against foreign manufacturers, 

and any remedy ‘‘depends on the 

injured or damaged party(ies) having 

knowledge, resources, evidence, time, 

and desire to initiate and follow through 

with legal action * * *.’’ (See OSHA– 

2008–0032–0072.1.) As noted in the 

comment, any injuries would occur 

before invoking the laws, which would 

not provide a high degree of worker 

protection. 

2. Competence and Independence of 

Testing Organizations, and Production 

Control by Manufacturers 

Under the EU’s SDoC system, the 

parties performing product testing do 

not have to demonstrate, either initially 

or continually, competence in 

determining whether a tested product 

complies with the applicable standard. 

Without assurance of competence, 

OSHA questions the degree to which 

that testing will be performed 

appropriately. Similarly, a manufacturer 

performing product certification has a 

financial interest in the profitability of 

the product, which provides an 

incentive for self-dealing when a 

manufacturer self-certifies its products. 

Although OSHA recognizes that many 

manufacturers would test products 

appropriately, it is concerned that 

allowing SDoC would increase the 

probability that at least some 

manufacturers would test products 

poorly, which would cause unsafe 

products to enter the workplace. In 

addition, the EU’s SDoC system has no 

requirement for monitoring product 

design changes and for retesting 

products periodically to ensure 

continued safety. More importantly, no 

comparable requirement exists to 

perform multiple annual inspections at 

critical points of control (i.e., every 

factory making a certified product) to 

ensure that the products conform to the 

testing requirements. 

Underwriters Laboratories (UL), an 

NRTL and standards-developing 

organization, submitted data to illustrate 

some of these issues. UL stated that ‘‘in 

a sampling of more than 25,000 

investigations [of equipment installed in 

the field without third-party 

certification] carried out by UL, 63% of 

products reviewed had safety 

deficiencies.’’ (Exhibit OSHA–2008– 

0032–0072.1.) In addition, UL reported 

for eight industries the percentage of 

products that failed to comply with the 

applicable standard when UL tested the 

products initially: 31% for appliances, 

24% for components, 24% for insulating 

materials, 14% for fire protection 

equipment, 24% for industrial 

equipment, 16% for information 

technology equipment, 45% for lighting, 

39% for power distribution equipment, 

and 34% for wires and cables. (Id.) UL 

cites these statistics as the basis for its 

estimate that ‘‘at least 20% of the 

products submitted to [UL] on a global 

basis would likely have been placed on 

the market with non-conformances if UL 

had not reviewed them.’’ (Id.) Although 

UL did not explain the methodology it 

used to obtain these results, the data 

illustrate the risk to electrical safety that 

could result when products are not 

tested appropriately. 

The American Council of 

Independent Laboratories (ACIL) also 

submitted similar data. (Exhibit OSHA– 

2008–0032–0037.1.) ACIL is a national 

trade association representing 

‘‘independent scientific laboratory, 

testing, consulting, product certifying, 

and R&D firms; manufacturers’ 

laboratories; and consultants and 

suppliers to the industry.’’ (Id.) ACIL 

responded to OSHA’s concerns, 

expressed in the 2008 RFI, that ACIL 

did not explain the methodology behind 

the data it submitted in response to the 

2005 RFI. (Exhibit OSHA–2008–0032– 

0037.1.) In its comment for the 2008 

RFI, ACIL explained that it presented 

data indicating a high level of 

nonconformance among initial product 

submissions made by manufacturers to 

its member laboratories. (Id.) ACIL also 

explained that these data came from a 

survey of its member laboratories. (Id.) 

To clarify its earlier submission, ACIL 

presented, in response to the 2008 RFI, 

updated data from a recent survey in 

which six of its member laboratories 

participated. (Exhibit OSHA–2008– 

0032–0037.2.) In conclusion, the ACIL 

and UL data raise the question of 

whether manufacturers are qualified to 

determine whether products conform to 

the applicable product-safety test 

standards. 

The EC took issue with the 

implication that ACIL’s initial 

submission data demonstrate that an 

NRTL system provides a higher level of 

safety than an SDoC system: 

We have heard arguments from the NRTLs 

that argue that, since substantial percentages 

of products fail the safety tests they perform, 

an SDoC system is likely to lead to 

substantial percentages of non-compliance. 

This rationale is not substantiated. Our 

reading is that during product development, 

manufacturers have prototypes evaluated in 

order to see whether they would meet safety 

standards. Also under an SDoC system, 

manufacturers would do such testing and 

would correct designs, when they would not 

pass. Manufacturers that intend to comply 

with the legislation will only market 

products that have passed such tests. 

(Exhibit OSHA–2008–0032–0044.1, p. 

6.) The EC does not, however, cite any 

data to support its assumption that 

manufacturers would be just as likely as 

NRTLs to detect and correct defects 

before putting a product on the market. 

OSHA believes that such an assumption 

is less likely to be appropriate when, as 

a general rule, the manufacturer may be 

unqualified to perform testing, lacks 

independence, and has financial 

incentives that could override the need 

to identify defects. However, OSHA 

recognizes that some manufacturers 

would take the necessary actions to test 

products appropriately. 

The comment submitted by Bureau 

Veritas Consumer Products Services 

(BVCPS) further reinforce OSHA’s 

concerns regarding SDoC.13 (Exhibit 

OSHA–2008–0032–0038.1.) BVCPS 

asserted, ‘‘It is our experience based on 

testing over 5000 products per year in 

Asia with CE marking and FCC 

regulatory requirements that high levels 

of non compliance exceeding 50% 

exist.’’ (Id., p. 1.)1⁄4 Although this 

statement is anecdotal, and not 

necessarily statistically valid, it 

nevertheless suggests that the SDoC 

system allows significant numbers of 

nonconforming products to reach the 

market. These data raise serious 

concerns regarding whether an SDoC 

system would provide a high degree of 

worker protection required by the OSH 

Act. Whereas, the NRTL Program 

detects product noncompliance before 

products reach the market, the 

luminaire and extension cord studies 

exemplify the main drawback of an 

SDoC system—that it detects 

noncompliant products only after 

products reach the market, and, 

therefore, fails to provide workers with 

a high degree of protection. The data in 

the record submitted by the EC and 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79045 

15The Baltic Sea Network is a cooperative effort 

among market surveillance authorities in Denmark, 

Estonia, Finland, Germany, Latvia, Lithuania, 

Poland, and Sweden. The Network is co-financed 

by the EC. 

16 In this regard, OSHA notes that the EU also 

does not directly accept NCB certifications; 

however, at least one Member State designated the 

NCB as a notified body. Unlike NRTLs, EU notified 

bodies must reside in the country that authorizes 

them. 

others supporting an OSHA transition to 

SDoC fail to show that, despite these 

large numbers of noncompliant 

products on the market in the EU, the 

EU’s reactive SDoC system is as safe as 

OSHA’s proactive NRTL Program. 

OSHA also received a comment from 

CSA International, an NRTL and 

provider of certification and testing 

services, which raised further concerns 

about the safety of the SDoC system. 

(Exhibit OSHA–2008–0032–0049.1.) 

This comment quoted from the Fourth 

Report of the Baltic Sea Network 2008 15

(See http://www.hamburg.de/ 

contentblob/749300/data/ 

kooperationsbericht-vierter-2008.pdf): 

To date, market surveillance activities 

within the Baltic Sea Network have usually 

been carried out on the basis of the Low 

Voltage Directive and/or PPE Directive. The 

ratio of faulty products is at a constantly high 

level for all product groups. About one-third 

is without defects and formal faults and 

about two thirds of the examined products 

show more or less serious failures. 5–10% of 

the checked products exhibit failures that are 

so severe that a serious danger to consumers 

cannot be ruled out. In the case of electric 

equipment this means the possibility of an 

electric shock or household fire because of 

the defective electrical outfit. 

(Id., p. 2.) The report does not provide 

source data for these statistics or an 

explanation of the underlying 

methodology. Yet, these numbers serve 

as anecdotal evidence of serious safety 

concerns associated with the EU SDoC 

system. 

In sum, the record lacks credible 

evidence sufficiently demonstrating that 

SDoC would provide a high degree of 

worker protection. Before revising its 

regulations, OSHA must determine, on 

the basis of substantial evidence, that 

the revised regulations would provide 

U.S. workers with a high degree of 

protection for electrical safety. 

Therefore, OSHA concludes that the 

lack of sufficient evidence counsels 

against revising its regulations to 

implement an SDoC system for the 

approval of electrical products used in 

U.S. workplaces. 

C. Proposed Alternatives 

A number of commenters proposed 

that OSHA modify its NRTL Program 

instead of transitioning to an SDoC 

system. (See, e.g., Exhibits OSHA–2008– 

0032–0038.1; OSHA–2008–0032– 

0097.1.) These commenters suggested 

that OSHA retain its NRTL Program, but 

broaden it to recognize certifications 

issued by National Certification Bodies 

(NCBs) under the IECEE CB scheme. 

However, these commenters identified 

the incorrect scheme: the scheme that 

involves acceptance of such 

certifications is the IECEE Full 

Certification Scheme (FCS). While 

OSHA does not directly accept the 

certifications of NCBs, and currently has 

no plan to do so, it allows NRTLs to use 

testing reports from these bodies when 

issued under the IECEE CB Scheme.16

The ICT industry proposed a parallel 

NRTL–SDoC system that would allow 

manufacturers to use SDoC as an 

alternative to certifying products 

through the NRTL Program. OSHA will 

not initiate rulemaking to propose a 

parallel SDoC system for the same 

reason it is rejecting the EC proposal for 

a stand-alone SDoC system: the 

evidence in the record does not 

demonstrate that an SDoC system would 

provide a high degree of protection to 

U.S. workers. 

ITI (Ex. OSHA–2008–0032–0057.1) 

also submitted a comment proposing an 

alternative to the NRTL Program in 

which manufacturers would have 

products tested by an NRTL, or a thirdparty organization operating under the 

IECEE CB Scheme; the manufacturers 

then would certify the products through 

SDoC. This proposal would retain thirdparty testing, but eliminate the posttesting NRTL certification requirements. 

Importantly, this alternative would 

exclude: (1) Initial follow-up 

inspections of each manufacturing 

facility to verify that the products 

resulting from production runs conform, 

or will conform, to the applicable test 

standard’s requirements; and (2) 

subsequent follow-up inspections to 

ensure that the product currently 

manufactured at the facility and bearing 

the NRTL’s mark is identical to the 

product the NRTL tested and certified. 

As OSHA explained in the preamble to 

the 1988 rule establishing the NRTL 

Program, an NRTL’s continued oversight 

of products the NRTL certified serves 

important OSHA goals. (See 53 FR 

12107.) A similar suggestion was made 

by the Technology Association of 

America (Exhibit OSHA–2008–0032– 

0043.1) to allow the testing to be done 

by a third-party organization accredited 

under the International Laboratory 

Accreditation Cooperation (ILAC) 

Scheme. ITI and the other commenters 

are suggesting an alternative without the 

critical requirement for factory 

inspections. These commenters did not 

submit information to the record 

showing that this alternative, absent 

post-testing inspections of 

manufacturers’ facilities, would provide 

U.S. workers with a high degree of 

protection. Also, before relying on these 

schemes, OSHA must first determine 

that organizations accredited under 

these schemes are as effective in testing 

products as laboratories granted 

recognition under the NRTL Program. 

Phillips Electronics also suggested 

that OSHA ‘‘allow manufacturers to 

apply for OSHA recognition to conduct 

specific product testing, but continue to 

seek certification from a recognized 

NRTL.’’ (Ex. OSHA–2008–0032–67.1.) 

This suggestion would require OSHA to 

operate a recognition program for 

manufacturers, similar to the NRTL 

Program, that would ensure that 

manufacturers are qualified to perform 

the testing, and to verify that they do so 

consistently and appropriately. OSHA 

would need to undertake rulemaking to 

adopt such a program. OSHA believes 

that such a program would have to 

impose stringent requirements on 

manufacturers trying to gain 

accreditation to, in part, counter their 

self-interest in the product. However, 

OSHA is unsure at this time what these 

requirements would be or whether they 

would be effective. Further, OSHA 

would have to resolve technical issues, 

such as verifying the adequacy of initial 

product testing and identifying and 

testing product changes. Obtaining and 

maintaining adequate and trained staff 

for such a program would be difficult, 

especially if numerous manufacturers 

participated in the program. OSHA 

could fund the program by charging 

manufacturers fees for program-related 

activities performed by OSHA, similar 

to the fees OSHA currently charges 

NRTLs. These fees, however, may be 

larger for manufacturers than NRTL 

fees, depending on the extent of OSHA’s 

activities. 

Phillips’ suggestion has merit because 

it proposes to retain factory inspections 

by NRTLs. It is unclear, however, 

whether NRTLs would perform these 

inspections; NRTLs may be reluctant to 

do so because they would not be 

conducting initial testing of the 

products and, thus, have no assurance 

that the products meet test standards. If 

NRTLs do not perform inspections, 

OSHA would have to perform them to 

assure conformance with test standards, 

thereby adding to OSHA’s staffing and 

funding burden. 

OSHA believes that a manufacturers’ 

accreditation program would not be 

favored by SDoC proponents, and, as 

noted above, such a program would be 


emcdonald on DSK2BSOYB1PROD with NOTICES
79046 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

resource intensive for OSHA to 

administer. Further, it is unclear 

whether OSHA could implement the 

program in a way that preserves the 

high degree of worker protection 

currently afforded to workers by the 

NRTL program. In light of these 

concerns, OSHA will not undertake 

rulemaking to propose such a program. 

OSHA notes again that it currently 

permits NRTLs to accept testing 

conducted by non-NRTL testing 

laboratories, including laboratories 

operated by manufacturers, as part of 

the NRTL certification process. This 

testing can provide time and cost 

savings to manufacturers. (See 

Nationally Recognized Testing 

Laboratories; Clarification of the Types 

of Programs and Procedures, 60 FR 

12980 (March 9, 1995).) NRTL 

acceptance of such testing is voluntary 

because OSHA’s regulations do not 

require that NRTLs accept testing from 

any party. However, for an NRTL to 

accept these test data, OSHA must issue 

an approval for the NRTL to use one or 

more ‘‘supplemental programs,’’ which 

are another segment of the NRTL 

Program. OSHA recognizes most NRTLs 

for these supplemental programs. One of 

these programs allows NRTLs to accept 

testing conducted by a testing laboratory 

accredited under the IECEE CB Scheme, 

while another program allows an NRTL 

to use other parties to perform the posttesting inspections of manufacturers’ 

production facilities provided the NRTL 

retains responsibility for the 

inspections. An NRTL meeting the 

regulatory requirements for capability 

and independence may use these 

programs provided the NRTL preserves 

ultimate responsibility for approving the 

product and authorizing use of its NRTL 

mark. (Id.) 

D. Use of SDoC in the U.S. 

Several commenters suggested that, 

because several U.S. agencies use SDoC 

for automobiles and personal protective 

equipment (PPE), OSHA also should 

permit SDoC for electrical equipment 

used in the workplace. (See, e.g., 

Exhibits OSHA–2008–0032–0041.1; 

OSHA–2008–0032–0043.1; 44.1; OSHA– 

2008–0032–0057.1.) OSHA does not 

find this argument persuasive. 

As OSHA explained in the 2008 RFI, 

the authority of the National Highway 

Transportation Safety Administration 

(NHTSA), which regulates automobile 

safety, is different from OSHA’s 

authority to regulate the workplace. For 

example, the NHTSA’s inspection 

authority appears to have a broader 

geographical scope than OSHA’s 

authority. (Compare 29 U.S.C. 657(a)(1) 

with 49 U.S.C. 30166(c)(3).) In addition, 

the OSH Act at 29 U.S.C. 658(a) gives 

OSHA authority to cite employers for 

violations of the Act and its 

implementing regulations, and to 

impose related penalties; however, the 

National Traffic and Motor Vehicle 

Safety Act at 49 U.S.C. 30163(a) allows 

the Department of Justice to seek an 

injunction in U.S. District Court to 

enjoin the sale of defective or 

nonconforming motor vehicles and 

equipment. OSHA does not appear to 

have the authority to enjoin 

manufacturers from producing unsafe 

electrical products, and no commenter 

provided a legal argument contrary to 

this conclusion. Thus, significant 

statutory differences exist between 

OSHA’s authority to regulate electrical 

products in the workplace and NHTSA’s 

authority to regulate motor vehicles and 

equipment under an SDoC system. 

Congress would need to revise this 

authority significantly for OSHA to 

perform functions similar to the 

functions NHTSA performs. Currently, 

no justification exists for such a 

revision. 

Additionally, the automobile industry 

differs from the electrical products 

industry in important ways. For 

example, a small number of large, wellknown manufacturers dominate the 

automobile industry. The group remains 

fairly constant. In contrast, the electrical 

products industry consists of a large 

number of manufacturers that may vary 

in size and that operate, for some 

product types, in a highly fluctuating 

market. These manufacturers can be 

small and based abroad, making 

regulatory interventions difficult. In 

addition, automobiles are extremely 

expensive to recall compared to most 

low-voltage electrical products. Thus, 

the incentives for manufacturers are 

different in the two sectors: the risks of 

a product defect are much greater for a 

large, well-known manufacturer of 

expensive automobiles than they are for 

a small, relatively anonymous 

manufacturer of inexpensive electrical 

products. Third-party certification is 

more important for electrical products 

than for automobiles because the 

incentives to overlook or ignore testing 

requirements are higher for 

manufacturers of electrical products 

than for automobile manufacturers. 

With respect to PPE, visual inspection 

by the user or compliance official 

generally can confirm compliance. In 

contrast, a typical user or inspector of 

electrical equipment is not in a position 

to inspect and evaluate the safety of its 

electrical components. Furthermore, 

OSHA recently conducted rulemaking 

to clarify the standards for PPE in the 

workplace (see 74 FR 46350), and none 

of the commenters suggested that OSHA 

require third-party approval of PPE. 

Therefore, PPE and electrical products 

have different characteristics, and these 

differences support the need for thirdparty approval of electrical products. 

E. Post-Market Surveillance in NRTL v. 

SDoC Systems 

Several commenters suggested that 

post-market surveillance is equally 

important in an NRTL system as in an 

SDoC system. (See, e.g., Exhibits 

OSHA–2008–0032–0041.1; OSHA– 

2008–0032–0044.1; OSHA–2008–0032– 

0045.1; OSHA–2008–0032–0051; 

OSHA–2008–0032–0053.1; OSHA– 

2008–0032–0057.1.) For example, the 

EC argued: 

[I]n any market there are ‘‘willing’’ also [sic] 

‘‘non-willing’’ market players. Both the U.S. 

and the EU are faced with counterfeits and 

rogue market players that ignore rules that 

are in place. This implies that governments, 

independent of the conformity assessment 

rules they put into place, need to have an 

infrastructure to detect non-compliant 

products and to take effective action against 

market players that place non-compliant 

products on the market so as to enforce the 

rules. 

(Exhibit OSHA–2008–0032–0041.1, p. 

6.) OSHA agrees that counterfeit 

products are a potential problem under 

both SDoC and NRTL systems. This 

problem, however, is more difficult to 

address under an SDoC system than 

under the NRTL Program. Under an 

SDoC system, the burden of conducting 

market surveillance to detect counterfeit 

marks would fall on a government 

agency. In contrast, under the NRTL 

Program, each NRTL may conduct 

market surveillance to assure that 

manufacturers use only its mark on 

certified products, i.e., each NRTL is 

responsible for ensuring the integrity of 

its mark. 

OSHA believes that market 

surveillance is an important means that 

NRTLs can use to detect counterfeit 

products. Several NRTLs also 

collaborate with the U.S. Customs 

Service to monitor for counterfeit 

products imported into the U.S. 

Therefore, shifting to an SDoC system 

would impose market surveillance 

obligations on OSHA to monitor for 

counterfeit marks, which would require 

additional funding and staff resources; 

however, OSHA may obtain funding for 

such a program, in whole or part, by 

charging fees to manufacturers or 

exporters. 

OSHA raised the issue of authority in 

the 2008 RFI, stating it believes that 

implementation of SDoC may require 

revisions to its statutory authority. 

Revised statutory authority appears to 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79047 

17Some statements by SDoC proponents (e.g., 

asserting that the NRTL Program causes redundant 

testing, time burdens, and high costs (see, e.g., 

OSHA–2008–0032–0057.1)) are incorrect, not 

adequately demonstrated, or unfounded. On the 

contrary, the NRTL Program contains flexibilities 

that avoid or reduce duplication, delays, and costs. 

be necessary because OSHA lacks the 

authority to adopt many of the postmarket enforcement measures essential 

to ensuring electrical safety under an 

SDoC system, including product recalls, 

bans, and confiscation. Based on 

OSHA’s analysis of the record, no 

justification exists for revisions to 

OSHA’s current statutory authority. 

F. The Costs of Administering an SDoC 

System 

In the 2008 RFI, OSHA estimated that 

implementing an SDoC system in the 

U.S. could cost the Agency 

approximately $360 million annually. In 

contrast, the current budget associated 

with operating the NRTL Program is 

approximately $1 million per year. 

Based on this estimate, operating an 

effective SDoC program would require 

OSHA to incur substantial additional 

costs. OSHA’s current budget for all of 

its operations is about $558 million. 

Thus, based on OSHA’s estimate, 

adopting an SDoC system would 

increase OSHA’s entire current budget 

by more than half. 

OSHA asked four specific questions 

in the 2008 RFI regarding costs 

associated with administering an SDoC 

program. (See 73 FR 62337.) However, 

the cost information submitted to the 

record failed to rebut OSHA’s 

determination in the 2008 RFI that 

administering an SDoC system would be 

significantly more expensive than 

operating the NRTL Program. (See 

Exhibits OSHA–2008–0032–060.1, 

OSHA–2008–0032–062.1, OSHA–2008– 

0032–071, OSHA–2008–0032–092.1.) 

Extrapolating from data provided by one 

commenter (i.e., a cost of $10 million 

dollars for every 5 million inhabitants; 

OSHA–2008–0032–071), an SDoC 

system in the U.S. could cost at least 

$600 million for approximately 300 

million inhabitants. None of the 

respondents described the methodology 

used to determine the resources 

necessary to operate an SDoC system, 

including the number of inspectors 

required. The record only shows that 

most EU countries have fewer than ten 

inspectors devoted to enforcement of 

the LVD. 

The substantial additional cost 

associated with an SDoC system would 

be problematic for OSHA because 

Congress may not fund the system 

adequately, thereby reducing the level 

of post-market inspections required and 

jeopardizing worker protection. As 

noted in an EC staff document, 

inadequate budgets significantly reduce 

the level of market surveillance 

performed by some EU countries. 

(Exhibit OSHA–2008–0032–0013.) 

Jeopardizing worker protection because 

of inadequate funding would violate 

OSHA’s statutory mandate to provide 

workers with a high degree of 

protection. 

IV. Effects on Trade 

The EC based its request that OSHA 

move to a SDoC system on its claim that 

the NRTL Program is a barrier to trade, 

and many other commenters echoed this 

view. In this section, OSHA provides its 

analysis of this issue. 

The 2008 RFI contained three 

questions related to trade. Most 

commenters in favor of SDoC 

maintained that OSHA’s requirements 

are a trade barrier, and that OSHA 

should adopt SDoC to facilitate trade. 

(See, e.g., Exhibits OSHA–2008–0032– 

0041.1; OSHA–2008–0032–0044.1; 

OSHA–2008–0032–0045; OSHA–2008– 

0032–0051; OSHA–2008–0032–0057.1; 

OSHA–2008–0032–0060.1.) 

Interestingly, one SDoC proponent 

stated that SDoC does not have a trade 

advantage over third-party approvals 

because ‘‘most manufacturers rely on 

third party tests in any case.’’ (See 

OSHA–2008–0032–0053.1.) 

OSHA believes that its NRTL Program 

is not a barrier to trade because the 

third-party certification requirements 

apply to all covered products used in 

the workplace, regardless of the country 

in which the products originated. In 

addition, OSHA’s NRTL Program is 

equally accessible to both U.S. and 

foreign-based organizations. In this 

regard, several NRTLs currently have 

headquarters or facilities in foreign 

countries. In contrast to the NRTL 

system, when the EU requires thirdparty certification (e.g., for products 

excluded from the LVD), it does not 

permit foreign-based certification bodies 

to certify products for the EU market. 

Therefore, to comply with the EU’s 

third-party certification requirement, a 

U.S. certifier must register as an EUbased Notified Body for acceptance of 

any of its certifications in the EU, 

whether its certifications are for a U.S. 

manufacturer or a manufacturer from 

another country. This requirement 

contradicts the EC’s claim in its 

rationale (Exhibit OSHA–2008–0032– 

0008) that U.S. certifiers could ‘‘without 

any barrier offer their services to U.S. 

industry to comply with EU rules.’’ 

Although the EC contends that 

OSHA’s method of approval is an 

unnecessary obstacle to trade, OSHA 

never received information from the EC 

or any other source adequately 

explaining how the NRTL requirements 

constitute such an obstacle.17 Further, 

based on evidence submitted in the 

record, OSHA finds that implementing 

an SDoC system for electrical safety 

would increase the risk that unsafe 

products will enter the workplace and 

harm workers because such a system 

cannot control these risks effectively to 

provide the requisite level of worker 

protection. Therefore, OSHA concludes 

that the NRTL requirements are 

reasonably necessary to provide a high 

degree of worker protection required by 

the OSH Act. 

Another argument put forth by 

proponents of SDoC is that the NRTL 

Program forces other countries to 

develop similar programs, which 

proponents view as burdensome. OSHA 

rejects this argument because the 

Agency does not attempt to influence 

other countries in these decisions. Each 

country determines the methods it 

considers appropriate for its purposes. 

Countries are free to adopt SDoC when 

they find it is appropriate. In making 

this argument, proponents appear to be 

saying that these countries are more 

confident in a third-party system than in 

SDoC. Also unconvincing is the EC’s 

assertion that OSHA must adopt SDoC 

because the EU grants U.S. 

manufacturers access to the EU market 

without the need for third-party 

approval. However, this argument 

implies that, if a country adopts a trade 

measure for its purposes, then all 

countries must reciprocate, even if such 

action is inappropriate. 

V. Concluding Remarks 

OSHA requested information on the 

SDoC system to better understand and 

corroborate the statements the EC made 

when proposing that OSHA adopt an 

SDoC system. The record shows that the 

EU adopted SDoC to serve its safety and 

trade needs by harmonizing the 

different practices that existed among 

the Member States prior to joining the 

EU. As stated in the EC’s rationale, the 

EU based its decision to adopt the SDoC 

system on its ‘‘assessment of the risk to 

consumers, workers and the general 

interest that non-compliant products 

* * * [reaching] the market place * * * 

would pose danger.’’ (Exhibit OSHA– 

2008–0032–008, p. 1.) The EU then 

concluded that, for these products, the 

‘‘risks are at a level that they can be 

satisfactorily managed’’ by SDoC. (Id.) 

As the record shows, the EU failed to 

provide statistics or numerical analysis 

to support this assessment. 


emcdonald on DSK2BSOYB1PROD with NOTICES
79048 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

In conclusion, OSHA is not initiating 

rulemaking to permit the use of an SDoC 

as an alternative to OSHA’s current 

NRTL Program for approving electrical 

products for use in the workplace. By 

statute, OSHA must demonstrate, based 

on substantial evidence, that its safety 

regulations and standards will provide 

or maintain a high degree of protection 

for U.S. workers. The evidence in the 

record does not meet the burden 

required for OSHA to revise its 

standards to accommodate an SDoC 

system for electrical safety in the 

workplace. OSHA finds that such a 

revision would increase the risk that 

unsafe products will enter the 

workplace and harm workers because an 

SDoC system cannot control these risks 

effectively to provide the requisite level 

of worker protection. In addition, 

Congress would need to authorize and 

fund OSHA to regulate and enforce 

product-related activities of 

manufacturers, distributors, and 

retailers. The evidence in the record 

submitted in response to the 2008 RFI 

does not justify an expansion of, or 

funding for, OSHA’s regulatory and 

enforcement authority for the purpose of 

implementing an SDoC system. 

However, notwithstanding this decision, 

OSHA remains open to discuss concerns 

regarding the NRTL Program, as well as 

means that may be available to mitigate 

the concerns expressed by the EC and 

other pro-SDoC commenters, provided 

these means are within the limits of 

OSHA’s authority, funding, and staffing. 

VI. Authority and Signature 

David Michaels, PhD, MPH, Assistant 

Secretary of Labor for Occupational 

Safety and Health, 200 Constitution 

Avenue, NW., Washington, DC 20210, 

directed the preparation of this notice. 

This action is taken pursuant to sections 

4, 6, and 8 of the Occupational Safety 

and Health Act of 1970 (29 U.S.C. 657), 

Secretary of Labor’s Order No. 5–2007 

(72 FR 31159), and 29 CFR Part 1911. 

Signed at Washington, DC on December 13, 

2010. 

David Michaels, 

Assistant Secretary of Labor for Occupational 

Safety and Health. 

[FR Doc. 2010–31695 Filed 12–16–10; 8:45 am] 

BILLING CODE 4510–26–P 

NUCLEAR REGULATORY 

COMMISSION 

[NRC–2010–0150] 

Notice of Availability of the Models for 

Plant-Specific Adoption of Technical 

Specifications Task Force Traveler 

TSTF–514, Revision 3, ‘‘Revise BWR 

Operability Requirements and Actions 

for RCS Leakage Instrumentation’’ 

AGENCY: Nuclear Regulatory 

Commission (NRC). 

ACTION: Notice of availability. 

SUMMARY: As part of the consolidated 

line item improvement process (CLIIP), 

the NRC is announcing the availability 

of the model application (with model no 

significant hazards consideration 

determination) and model safety 

evaluation (SE) for the plant-specific 

adoption of Technical Specifications 

Task Force (TSTF) Traveler TSTF–514, 

Revision 3, ‘‘Revise BWR [boiling water 

reactor] Operability Requirements and 

Actions for RCS [reactor coolant system] 

Leakage Instrumentation.’’ TSTF–514, 

Revision 3, is available in the 

Agencywide Documents Access and 

Management System (ADAMS) under 

Accession Number ML103280389. The 

proposed changes revise the Standard 

Technical Specifications (STS) to define 

a new time limit for restoring inoperable 

RCS leakage detection instrumentation 

to operable status and establish alternate 

methods of monitoring RCS leakage 

when one or more required monitors are 

inoperable. Changes to the Technical 

Specifications (TS) Bases are included, 

which reflect the proposed changes and 

more accurately reflect the contents of 

the facility design bases related to the 

operability of the RCS leakage detection 

instrumentation. The CLIIP model SE 

will facilitate expedited approval of 

plant-specific adoption of TSTF–514, 

Revision 3. 

Documents: You can access publicly 

available documents related to this 

notice using the following methods: 

NRC’s Public Document Room (PDR): 

The public may examine and have 

copied for a fee publicly available 

documents at the NRC’s PDR, Room O1– 

F21, One White Flint North, 11555 

Rockville Pike, Rockville, Maryland 

20852. 

NRC’s Agencywide Documents Access 

and Management System (ADAMS): 

Publicly available documents created or 

received at the NRC are available 

electronically at the NRC’s Electronic 

Reading Room at http://www.nrc.gov/ 

reading-rm/adams.html. From this page, 

the public can gain entry into ADAMS, 

which provides text and image files of 

NRC’s public documents. If you do not 

have access to ADAMS or if there are 

problems in accessing the documents 

located in ADAMS, contact the NRC’s 

PDR reference staff at 1–800–397–4209, 

301–415–4737, or by e-mail at 

pdr.resource@nrc.gov. 

The model application (with model 

no significant hazards consideration 

determination) and model SE for the 

plant-specific adoption of TSTF–514, 

Revision 3, are available electronically 

under ADAMS Accession Number 

ML102300729. The NRC staff 

disposition of comments received on the 

Notice of Opportunity for Comment 

announced in the Federal Register on 

April 13, 2010 (75 FR 18907–18908), is 

available electronically under ADAMS 

Accession Number ML102300727. 

Federal rulemaking Web site: The 

public comments received and 

supporting materials related to this 

notice can be found at http:// 

www.regulations.gov by searching on 

Docket ID NRC–2010–0150. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Kristy Bucholtz, Reactor Systems 

Engineer, Technical Specifications 

Branch, Mail Stop: O7–C2A, Division of 

Inspection and Regional Support, Office 

of Nuclear Reactor Regulation, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001; telephone 

301–415–1295 or e-mail 

Kristy.Bucholtz@nrc.gov or Mrs. 

Michelle Honcharik, Senior Project 

Manager, Licensing Processes Branch, 

Mail Stop: O12–D1, Division of Policy 

and Rulemaking, Office of Nuclear 

Reactor Regulation, U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001; telephone 301–415– 

1774 or e-mail at 

Michelle.Honcharik@nrc.gov. 

SUPPLEMENTARY INFORMATION: TSTF– 

514, Revision 3, is applicable to BWR 

plants. Licensees opting to apply for this 

TS change are responsible for reviewing 

TSTF–514, Revision 3, and the NRC 

staff’s model SE, providing any 

necessary plant-specific information, 

and assessing the completeness and 

accuracy of their license amendment 

request (LAR). It is acceptable for 

licensees to use plant-specific system 

names, TS numbering and titles. The 

NRC will process each amendment 

application responding to this notice of 

availability according to applicable NRC 

rules and procedures. 

This CLIIP does not prevent licensees 

from requesting an alternate approach or 

proposing changes other than those 

proposed in TSTF–514, Revision 3. 

However, significant deviations from 

the approach recommended in this 

notice or the inclusion of additional 

changes to the license require additional 


emcdonald on DSK2BSOYB1PROD with NOTICES