This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

44174 

Vol. 77, No. 145 

Friday, July 27, 2012 

DEFENSE NUCLEAR FACILITIES 

SAFETY BOARD 

10 CFR Part 1708 

Procedures for Safety Investigations 

AGENCY: Defense Nuclear Facilities 

Safety Board. 

ACTION: Proposed rule. 

SUMMARY: The Defense Nuclear 

Facilities Safety Board (Board) is 

responsible for making 

recommendations to the Secretary of 

Energy and the President regarding 

health and safety issues at the 

Department of Energy’s (DOE) defense 

nuclear facilities. In this notice, the 

Board proposes a rule establishing 

procedures for conducting preliminary 

and formal safety investigations of 

events or practices at DOE defense 

nuclear facilities that the Board 

determines have adversely affected, or 

may adversely affect, public health and 

safety. The Board’s experience in 

conducting formal safety investigations 

necessitates codifying the procedures 

set forth in the proposed rule. These 

procedures, among other benefits, will 

ensure a more efficient investigative 

process, protect confidential and 

privileged safety information, and 

promote uniformity of future safety 

investigations. 

DATES: To be considered, comments 

must be mailed, emailed, or delivered to 

the address listed below by 5 p.m. on or 

before August 27, 2012. 

ADDRESSES: Comments should be 

mailed or delivered to John G. 

Batherson, Associate General Counsel, 

Defense Nuclear Facilities Safety Board, 

625 Indiana Avenue NW., Suite 700, 

Washington, DC 20004. Send comments 

by facsimile to (202) 208–6518. Send 

comments by email to John G. Batherson 

at JohnB@dnfsb.gov. 

FOR FURTHER INFORMATION CONTACT: John 

G. Batherson, Associate General 

Counsel, (202) 694–7018. 

SUPPLEMENTARY INFORMATION: 

Background 

The Board is authorized to 

promulgate this proposed rule pursuant 

to its enabling legislation in the Atomic 

Energy Act of 1954, as amended, at 42 

U.S.C. 2286b(c), which states that the 

Board may prescribe regulations to carry 

out its responsibilities. The Board is 

vested with broad authority pursuant to 

42 U.S.C. 2286a(a)(2) to investigate 

events or practices which have 

adversely affected, or may adversely 

affect, public health and safety at DOE 

defense nuclear facilities. 

The proposed rule establishes a new 

Part 1708 to the Board’s regulations, 

setting forth procedures governing the 

specific conduct of safety investigations. 

The rule is intended to state clearly the 

Board’s policy and procedures for safety 

investigations convened pursuant to the 

Board’s enabling legislation. The Board 

has not previously proposed a rule 

specifically addressing procedures to be 

utilized in safety investigations. Rather, 

the Board has conducted preliminary 

safety inquiries and formal safety 

investigations pursuant to its statutory 

authority, when appropriate, following 

standard safety investigation policies, 

practices, and procedures. The proposed 

rule is intended to formalize those 

practices and procedures. The 

experience of Board investigators was 

utilized in drafting the proposed rule. 

The proposed rule will ensure a more 

efficient investigative process, and 

promote uniformity in the investigation 

of events or practices that have 

adversely affected, or may adversely 

affect, health and safety of the public 

and workers at DOE defense nuclear 

facilities. The proposed rule also serves 

the Board’s duty to protect confidential 

and privileged safety information. 

It is imperative that Board 

investigators be able to obtain 

information from witnesses as necessary 

to form an understanding of the 

underlying causes of events or practices 

that have adversely affected, or may 

adversely affect, public health and 

safety at DOE defense nuclear facilities. 

Frank, open communications are critical 

if Board investigators are to be effective. 

The Board must also be viewed as 

uncompromising in maintaining nondisclosure of privileged safety 

information. The Board must be able to 

assure complete confidentiality in order 

to encourage future witnesses to come 

forward without fear of reprisal from 

employers. 

As such, the Board requires the 

authority to offer witnesses enforceable 

assurances of confidentiality in order to 

encourage their full and frank 

testimony. Without such authority, 

witnesses may refrain from providing 

the Board with vital information 

affecting public health and safety, 

which will, in turn, frustrate the 

efficient operation of the Board’s 

oversight mission. To encourage candor 

and facilitate the free flow of 

information, the Board adopts in this 

proposed rule procedures establishing a 

safety privilege to protect confidential 

witness statements from disclosure to 

the maximum extent permitted under 

existing law. 

Matters of Regulatory Procedure 

Administrative Procedure Act 

This rulemaking complies with the 

Administrative Procedure Act and 

allows for a 30-day comment period. 

Interested persons are invited to submit 

written comments to the Board on this 

proposed rule, to be received on or 

before August 27, 2012. The Board will 

review all comments received and 

consider any modifications to this 

proposal that appear warranted in 

issuing its final rule. 

Regulatory Flexibility Act 

For purposes of the Regulatory 

Flexibility Act, the rule will not have a 

significant economic impact on a 

substantial number of small entities. 

The rule addresses only the procedures 

to be followed in safety investigations. 

Accordingly, the Board has determined 

that a Regulatory Flexibility Analysis is 

not required. 

Unfunded Mandates Reform Act 

For purposes of the Unfunded 

Mandates Reform Act of 1995, the 

proposed rule would not significantly or 

uniquely affect small governments and 

would not result in increased 

expenditures by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(as adjusted for inflation). 

Executive Order 12866 

In issuing this regulation, the Board 

has adhered to the regulatory 

philosophy and the applicable 

principles of regulation as set forth in 


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section 1 of Executive Order 12866, 

Regulatory Planning and Review. This 

rule has not been reviewed by the Office 

of Management and Budget under that 

Executive Order since it is not a 

significant regulatory action within the 

meaning of the Executive Order. 

Executive Order 12988 

The Board has reviewed this 

regulation in light of section 3 of 

Executive Order 12988, Civil Justice 

Reform, and certifies that it meets the 

applicable standards provided therein. 

Paperwork Reduction Act 

The Paperwork Reduction Act does 

not apply because this regulation does 

not contain information collection 

requirements that require approval by 

the Office of Management and Budget. 

The Board expects the collection of 

information that is called for by the 

regulation would involve fewer than 10 

persons each year. 

Congressional Review Act 

The Board has determined that this 

rulemaking does not involve a rule 

within the meaning of the Congressional 

Review Act. 

List of Subjects in 10 CFR Part 1708 

Administrative practice, Procedure, 

and Safety investigations. 

For the reasons set forth in the 

preamble, the Defense Nuclear Facilities 

Safety Board proposes to add Part 1708 

to 10 CFR chapter XVII to read as 

follows: 

PART 1708—PROCEDURES FOR 

SAFETY INVESTIGATIONS 

Sec. 

1708.100 Authority to conduct safety 

investigations. 

1708.101 Scope and purpose of safety 

investigations. 

1708.102 Types of safety investigations. 

1708.103 Request to conduct safety 

investigations. 

1708.104 Confidentiality of safety 

investigations and privileged safety 

information. 

1708.105 Promise of confidentiality. 

1708.106 Limitation on participation. 

1708.107 Powers of persons conducting 

formal safety investigations. 

1708.108 Cooperation: ready access to 

facilities, personnel, and information. 

1708.109 Rights of witnesses in safety 

investigations. 

1708.110 Multiple interests. 

1708.111 Sequestration of witnesses. 

1708.112 Appearance and practice before 

the Board. 

1708.113 Right to submit statements. 

1708.114 Official transcripts. 

1708.115 Final report of safety 

investigation. 

1708.116 Procedure after safety 

investigations. 

Authority: 42 U.S.C. 2286b(c); 42 U.S.C. 

2286a(a)(2); 44 U.S.C. 3101–3107, 3301– 

3303a, 3308–3314. 

§ 1708.100 Authority to conduct safety 

investigations. 

(a) The Defense Nuclear Facilities 

Safety Board (Board) is an independent 

federal agency in the executive branch 

of the United States Government. 

(b) The Board’s enabling legislation 

authorizes it to conduct safety 

investigations pursuant to the Atomic 

Energy Act of 1954, as amended (42 

U.S.C. 2286a(a)(2)). 

§ 1708.101 Scope and purpose of safety 

investigations. 

(a) The Board shall investigate any 

event or practice at a Department of 

Energy defense nuclear facility which 

the Board determines has adversely 

affected, or may adversely affect, public 

health and safety. 

(b) The purpose of any Board 

investigation shall be: 

(1) To determine whether the 

Secretary of Energy is adequately 

implementing standards (including all 

applicable Department of Energy orders, 

regulations, and requirements) at 

Department of Energy defense nuclear 

facilities; 

(2) To ascertain information 

concerning the circumstances of such 

event or practice and its implications for 

such standards; 

(3) To determine whether such event 

or practice is related to other events or 

practices at other Department of Energy 

defense nuclear facilities; and 

(4) To provide to the Secretary of 

Energy such recommendations for 

changes in such standards or the 

implementation of such standards 

(including Department of Energy orders, 

regulations, and requirements) and such 

recommendations relating to data or 

research needs as may be prudent or 

necessary. 

§ 1708.102 Types of safety investigations. 

(a) The Board may initiate a 

preliminary safety inquiry or order a 

formal safety investigation. 

(b) A preliminary safety inquiry 

means any inquiry conducted by the 

Board or its staff, other than a formal 

investigation. Where it appears from a 

preliminary safety inquiry that a formal 

safety investigation is appropriate, the 

Board’s staff will so recommend to the 

Board. 

(c) A formal safety investigation is 

instituted by an Order of Safety 

Investigation issued either after a 

recorded notational vote of Board 

Members or after convening a meeting 

in accordance with the Government in 

the Sunshine Act and voting in open or 

closed session, as the case may be. 

(d) Orders of Safety Investigations 

will outline the basis for the 

investigation, the matters to be 

investigated, the Investigating Officer(s) 

designated to conduct the investigation, 

and their authority. 

(e) The Office of the General Counsel 

shall have primary responsibility for 

conducting and leading a formal safety 

investigation. The Investigating 

Officer(s) shall report to the Board. 

(f) The Board, or an individual Board 

Member authorized by the Board, may 

hold such closed or open hearings and 

sit and act at such times and places, and 

require the attendance and testimony of 

such witnesses and the production of 

such evidence as the Board or an 

authorized member may find advisable, 

or exercise any other applicable 

authority as provided in the Board’s 

enabling legislation. 

(g) Subpoenas in formal safety 

investigations may be issued only by 

signature of the Chairman, or any 

Member of the Board designated by the 

Chairman, and shall be served by any 

person designated by the Chairman, or 

otherwise as provided by law. 

§ 1708.103 Request to conduct safety 

investigations. 

(a) Any person may request that the 

Board perform a preliminary safety 

inquiry or conduct a formal safety 

investigation concerning a matter within 

the Board’s jurisdiction. 

(b) Actions the Board may take 

regarding safety investigation requests 

are discretionary. 

(c) The Board will offer to protect the 

identity of a person requesting a safety 

investigation to the maximum extent 

permitted by law. 

(d) Board safety investigations are 

wholly administrative and investigatory 

in nature and do not involve a 

determination of criminal culpability, 

adjudication of rights and duties, or 

other quasi-judicial determinations. 

§ 1708.104 Confidentiality of safety 

investigations and privileged safety 

information. 

(a) Information obtained during the 

course of a preliminary safety inquiry or 

a formal safety investigation may be 

treated as confidential, safety privileged, 

and non-public by the Board and its 

staff, to the extent permissible under 

existing law. The information subject to 

this protection includes but is not 

limited to: Identity of witnesses; 

recordings; statements; testimony; 

transcripts; emails; all documents, 

whether or not obtained pursuant to 

Board subpoena; any conclusions based 


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44176 Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Proposed Rules 

on privileged safety information; any 

deliberations or recommendations as to 

policies to be pursued; and all other 

related investigative proceedings and 

activities. 

(b) The Board shall have the 

discretion to assert the safety privilege 

when safety information, determined by 

the Board as protected from release, is 

sought by any private or public 

governmental entity or by parties to 

litigation who attempt to compel its 

release. 

(c) Nothing in this section voids or 

otherwise displaces the Board’s legal 

obligations with respect to compliance 

with the Freedom of Information Act, 

the Government in the Sunshine Act, or 

any procedures or requirements 

contained in the Board’s regulations 

issued pursuant to those Acts. 

§ 1708.105 Promise of confidentiality. 

(a) The Investigating Officer(s) may 

give a promise of confidentiality to any 

individual who provides evidence for a 

safety inquiry or investigation, to 

encourage frank and open 

communication. 

(b) A promise of confidentiality must 

be explicit. 

(c) A promise of confidentiality must 

be documented in writing. 

(d) A promise of confidentiality may 

be given only as needed to ensure 

forthright cooperation of a witness and 

may not be given on a blanket basis to 

all witnesses. 

(e) A promise of confidentiality must 

inform the witness that it applies only 

to information given to the Investigating 

Officer(s) and not to the same 

information if given to others. 

§ 1708.106 Limitation on participation. 

(a) A safety investigation under this 

rule is not a judicial or adjudicatory 

proceeding. 

(b) No person or entity has standing 

to intervene or participate as a matter of 

right in any safety investigation under 

this regulation. 

§ 1708.107 Powers of persons conducting 

formal safety investigations. 

The Investigating Officer(s) appointed 

by the Board may take informal or 

formal statements, interview witnesses, 

take testimony, request production of 

documents, recommend issuance of 

subpoenas, recommend taking of 

testimony in a closed forum, 

recommend administration of oaths, and 

otherwise perform any lawful act 

authorized under the Board’s enabling 

legislation in connection with any safety 

investigation ordered by the Board. 

§ 1708.108 Cooperation: ready access to 

facilities, personnel, and information. 

(a) Section 2286c(a) of the Atomic 

Energy Act of 1954, as amended, 

requires the Department of Energy to 

fully cooperate with the Board and 

provide the Board with ready access to 

such facilities, personnel, and 

information as the Board considers 

necessary, including ready access in 

connection with a safety investigation. 

(b) Each contractor operating a 

Department of Energy defense nuclear 

facility under a contract awarded by the 

Secretary is also required, to the extent 

provided in such contract or otherwise 

with the contractor’s consent, to fully 

cooperate with the Board and provide 

the Board with ready access to such 

facilities, personnel, and information of 

the contractor as the Board considers 

necessary in connection with a safety 

investigation. 

(c) The Board may make a written 

request to persons or entities relevant to 

the safety investigation to preserve 

pertinent information, documents, and 

evidence, including electronically 

stored information, in order to preclude 

alteration or destruction of that 

information. 

§ 1708.109 Rights of witnesses in safety 

investigations. 

(a) Any person who is compelled to 

appear in person to provide testimony 

or produce documents in connection 

with a safety investigation is entitled to 

be accompanied, represented, and 

advised by an attorney. 

(b) If an executive branch agency 

employee witness is represented by 

counsel from that same agency, counsel 

shall identify who counsel represents to 

determine whether counsel represents 

multiple interests in the safety 

investigation. 

(c) Counsel for a witness may advise 

the witness with respect to any question 

asked where it is claimed that the 

testimony sought from the witness is 

outside the scope of the safety 

investigation, or that the witness is 

privileged to refuse to answer a question 

or to produce other evidence. For these 

permissible objections, the witness or 

counsel may object on the record to the 

question and may state briefly and 

precisely the ground therefore. If the 

witness refuses to answer a question, 

then counsel may briefly state on the 

record that counsel has advised the 

witness not to answer the question and 

the legal grounds for such refusal. The 

witness and his or her counsel shall not 

otherwise object to or refuse to answer 

any question, and they shall not 

otherwise interrupt any oral 

examination. 

(d) When it is claimed that the 

witness has a privilege to refuse to 

answer a question on the grounds of 

self-incrimination, the witness must 

assert the privilege personally. 

(e) Any objections made during the 

course of examination will be treated as 

continuing objections and preserved 

throughout the further course of 

testimony without the necessity for 

repeating them as to any similar line of 

inquiry. 

(f) Counsel for a witness may not 

interrupt the examination by making 

any unnecessary objections or 

statements on the record. 

(g) Following completion of the 

examination of a witness, such witness 

may make a statement on the record, 

and that person’s counsel may, on the 

record, question the witness to enable 

the witness to clarify any of the 

witness’s answers or to offer other 

evidence. 

(h) The Investigating Officer(s) shall 

take all measures necessary to regulate 

the course of an investigative 

proceeding to avoid delay and prevent 

or restrain obstructionist or 

contumacious conduct or contemptuous 

language. 

(i) The Investigating Officer(s) may 

report to the Board any instances where 

counsel for a witness, or other 

representative, has refused to comply 

with his or her directions, or has 

engaged in obstructionism or 

contumacy. The Board may thereupon 

take action as the circumstances may 

warrant. 

(j) Witnesses appearing voluntarily do 

not have a right to have counsel present 

during questioning, although the 

Investigating Officer, in consultation 

with the Office of the General Counsel, 

may permit a witness appearing on a 

voluntary basis to be accompanied by an 

attorney or non-attorney representative. 

§ 1708.110 Multiple interests. 

(a) If counsel representing a witness 

appears in connection with a safety 

investigation, counsel shall state on the 

record all other persons or entities 

counsel represents in that investigation. 

(b) When counsel does represent more 

than one person or entity in a safety 

investigation, counsel shall inform the 

Investigating Officer and each client of 

counsel’s possible conflict of interest in 

representing that client. 

(c) When an Investigating Officer, or 

the Board, as the case may be, in 

consultation with the Board’s General 

Counsel, has concrete evidence that the 

presence of an attorney representing 

multiple interests would obstruct or 

impede the safety investigation, the 

Investigating Officer(s) or the Board may 


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prohibit that attorney from being 

present during testimony. 

§ 1708.111 Sequestration of witnesses. 

(a) Witnesses shall be sequestered 

during interviews, or during the taking 

of testimony, unless otherwise 

permitted by the Investigating Officer(s), 

or by the Board, as the case may be. 

(b) No witness, or counsel 

accompanying any such witness, shall 

be permitted to be present during the 

examination of any other witness called 

in such proceeding, unless permitted by 

the Investigating Officer(s), or the Board, 

as the case may be. 

§ 1708.112 Appearance and practice 

before the Board. 

(a) Counsel appearing before the 

Board or the Investigating Officer(s) 

must conform to the standards of ethical 

conduct required of practitioners before 

the Courts of the United States. 

(b) The Board may suspend and deny, 

temporarily or permanently, the 

privilege of appearing or practicing 

before the Board in any way to a person 

who is found: 

(1) Not to possess the requisite 

qualifications to represent others; or 

(2) To have engaged in unethical or 

improper professional conduct; or 

(3) To have engaged in obstructionism 

or contumacy; or 

(4) To be otherwise not qualified. 

(c) Obstructionist or contumacious 

conduct in an investigation before the 

Board or the Investigating Officer(s) will 

be grounds for exclusion of any person 

from such safety investigation 

proceedings and for summary 

suspension for the duration of the 

course of the investigation. 

(d) A witness may retain replacement 

counsel if original counsel is suspended 

or excluded. 

§ 1708.113 Right to submit statements. 

At any time during the course of an 

investigation, any person may submit 

documents, statements of facts, or 

memoranda of law for the purpose of 

explanation or further development of 

the facts and circumstances relevant to 

the safety matter under investigation. 

§ 1708.114 Official transcripts. 

(a) Official transcripts of testimony of 

witnesses, whether or not compelled by 

subpoena to appear before a Board 

safety investigation, shall be recorded 

either by an official reporter, or by any 

other person or means designated by the 

Investigating Officer or the Board’s 

General Counsel. 

(b) Such witness, after completing the 

compelled testimony may file a request 

with the Board’s General Counsel to 

procure a copy of the official transcript 

of that witness’s testimony. The General 

Counsel shall rule on the request, and 

may deny for good cause. 

(c) Good cause for denying a witness’s 

request to procure a transcript may 

include, but shall not be limited to, the 

protection of a trade secret, nondisclosure of confidential or proprietary 

business information, security sensitive 

operational or vulnerability information, 

safety privileged information, or the 

integrity of Board investigations. 

(d) Whether or not a request is made, 

the witness and his or her attorney shall 

have the right to inspect the official 

transcript of the witness’s own 

testimony, in the presence of the 

Investigating Officer or his designee, for 

purposes of conducting errata review. 

(e) Transcripts of testimony are 

otherwise considered confidential and 

privileged safety information and in no 

case shall a copy or any reproduction of 

such transcript be released to any other 

person or entity, except as provided in 

paragraph (2) above or as required under 

the Freedom of Information Act or the 

Government in the Sunshine Act, or any 

procedures or requirements contained 

in Board regulations issued pursuant to 

those Acts. 

§ 1708.115 Final report of safety 

investigation. 

(a) The Board will complete a final 

report of the safety investigation fully 

setting forth the Board’s findings and 

conclusions. 

(b) The final report of the safety 

investigation is confidential and 

protected by the safety privilege, and is 

therefore not releasable. 

(c) The Board in its discretion may 

sanitize the final report of the safety 

investigation by redacting confidential 

and safety privileged information so that 

the report is put in a publically 

releasable format. 

(d) Nothing in this section voids or 

otherwise displaces the Board’s legal 

obligations with respect to compliance 

with the Freedom of Information Act, 

the Government in the Sunshine Act, or 

any procedures or requirements 

contained in the Board’s regulations 

issued pursuant to those Acts. 

§ 1708.116 Procedure after safety 

investigations. 

(a) If a formal safety investigation 

results in a finding that an event or 

practice has adversely affected, or may 

adversely affect, public health and 

safety, the Board may take any 

appropriate action authorized to it 

under its enabling statute, including, 

but not limited to, making a formal 

recommendation to the Secretary of 

Energy, convening a hearing, or 

establishing a reporting requirement. 

(b) If a safety investigation yields 

information relating to violations of 

Federal criminal law involving 

Government officers and employees, the 

Board shall expeditiously refer the 

matter to the Department of Justice for 

disposition. 

(c) If in the course of a safety 

investigation a safety issue or concern is 

found to be outside the Board’s 

jurisdiction, that safety issue or concern 

shall be referred to the appropriate 

entity with jurisdiction for disposition. 

(d) Statements made in connection 

with testimony provided to the Board in 

an investigation are subject to the 

provisions of 18 U.S.C. 1001. 

Dated: July 20, 2012. 

Jessie H. Roberson, 

Vice Chairman. 

[FR Doc. 2012–18180 Filed 7–26–12; 8:45 am] 

BILLING CODE 3670–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 514 

[Docket No. FDA–2012–N–0447] 

Antimicrobial Animal Drug Sales and 

Distribution Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Advance notice of proposed 

rulemaking. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

soliciting comments regarding potential 

changes to its regulations relating to 

records and reports for approved new 

animal drugs. FDA is considering 

revisions to this regulation to 

incorporate the requirements of section 

105 of the Animal Drug User Fee 

Amendments of 2008 (ADUFA 105). As 

part of that process, FDA is reviewing 

other reporting requirements applicable 

to antimicrobial new animal drug 

sponsors to determine whether 

additional information should be 

reported. Collecting data on 

antimicrobial drugs used in foodproducing animals will assist FDA in 

tracking antimicrobial use trends and 

examining how such trends may relate 

to antimicrobial resistance. 

DATES: Submit electronic or written 

comments by September 25, 2012. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

0447, by any of the following methods: 


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