Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6661

880TH—MEETING, FEBRUARY 9, 2005, REGULAR MEETING, 10 A.M.—Continued

Item No. Docket No. Company 

RP04–280–000 ....... Northern Natural Gas Company. 

RP04–94–000 ......... Northern Natural Gas Company. 

G–10 ............. OR05–2–000 ........... State of Alaska v. BP Pipelines (Alaska) Inc., ExxonMobil Pipeline Company, ConocoPhillips Transportation Alaska, Inc., Unocal Pipeline Company and Koch Alaska Pipeline Company. 

OR05–3–000 ........... Anadarko Petroleum Corporation v. TAPS Carriers. 

IS05–72–000 ........... ExxonMobil Pipeline Company. 

IS05–80–000 ........... ConocoPhillips Transportation Alaska, Inc. 

IS05–82–000 ........... BP Pipelines (Alaska) Inc. 

IS05–96–000 ........... Koch Alaska Pipeline Company. 

IS05–107–000 ......... Unocal Pipeline Company. 

G–11 ............. PR97–1–003 ........... Consumers Power Company. 

G–12 ............. TS04–53–002 .......... Destin Pipeline Company, L.L.C. 

TS05–2–001 ............ Energy West Development. 

TS04–280–001 ........ Jupiter Energy Corporation. 

TS04–258–000 ........ Nornew Energy Supply, Inc. 

TS04–7–003 ............ ONEOK, Inc., and OkTex Pipeline Company. 

TS04–7–002 ............ ONEOK, Inc., and OkTex Pipeline Company. 

G–13 ............. RP04–249–004 ....... AES Ocean Express LLC. 

ENERGY PROJECTS—HYDRO

H–1 ................ P–460–029 .............. City of Tacoma, Washington. 

H–2 ................ P–2816–032 ............ Vermont Electric Cooperative. 

H–3 ................ P–2493–016 ............ Puget Sound Energy, Inc. 

H–4 ................ P–1864–019 ............ Upper Peninsula Power Company. 

H–5 ................ P–2149–119 ............ Public Utility District No. 1 of Douglas County, Washington. 

ENERGY PROJECTS—CERTIFICATES

C–1 ................ RM05–1–000 ........... Regulations Governing the Conduct of Open Seasons for Alaska Natural Gas Transmission Projects. 

C–2 ................ CP04–373–000 ....... Texas Gas Transmission, LLC. 

C–3 ................ CP04–64–001 ......... Trunkline Gas Company, LLC. 

C–4 ................ CP04–396–000 ....... Transcontinental Gas Pipe Line Corporation. 

Magalie R. Salas, 

Secretary.

The Capitol Connection offers the 

opportunity for remote listening and 

viewing of the meeting. It is available 

for a fee, live over the Internet, via CBand Satellite. Persons interested in 

receiving the broadcast, or who need 

information on making arrangements 

should contact David Reininger or Julia 

Morelli at the Capitol Connection (703–

993–3100) as soon as possible or visit 

the Capitol Connection Web site at 

http://www.capitolconnection.gmu.edu

and click on ‘‘FERC’’.

[FR Doc. 05–2479 Filed 2–3–05; 4:26 pm] 

BILLING CODE 6717–01–P

DEPARTMENT OF ENERGY

Federal Energy Regulatory 

Commission 

Notice of Meeting, Notice of Vote, 

Explanation of Action Closing Meeting 

and List of Persons To Attend 

February 2, 2005. 

The following notice of meeting is 

published pursuant to Section 3(a) of 

the Government in the Sunshine Act 

(Pub. L. 94–409), 5 U.S.C. 552b:

AGENCY HOLDING MEETING: Federal 

Energy Regulatory Commission.

DATE AND TIME: February 9, 2005. 

(Within a relatively short time after the 

Commission’s open meeting on 

February 9, 2005.)

PLACE: Room 3M 4A/B, 888 First Street, 

NE., Washington, DC 20426.

STATUS: Closed.

MATTERS TO BE CONSIDERED: Non-public 

investigations and inquiries, 

enforcement related matters, and 

security of regulated facilities.

CONTACT PERSON FOR MORE INFORMATION:

Magalie R. Salas, Secretary, Telephone 

(202) 502–8400. 

Chairman Wood and Commissioners 

Brownell, Kelliher, and Kelly voted to 

hold a closed meeting on February 9, 

2005. The certification of the General 

Counsel explaining the action closing 

the meeting is available for public 

inspection in the Commission’s Public 

Reference Room at 888 First Street, 

NW., Washington, DC 20426. 

The Chairman and the 

Commissioners, their assistants, the 

Commission’s Secretary and her 

assistant, the General Counsel and 

members of her staff, and a stenographer 

are expected to attend the meeting. 

Other staff members from the 

Commission’s program offices who will 

advise the Commissioners in the matters 

discussed will also be present.

Magalie R. Salas, 

Secretary.

[FR Doc. 05–2480 Filed 2–3–05; 4:33 pm] 

BILLING CODE 6717–01–P

ENVIRONMENTAL PROTECTION 

AGENCY 

RIN: 2070–AD57

[OPP–2003–0132; FRL–7695–4] 

Human Testing; Proposed Plan and 

Description of Review Process

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces EPA’s 

plan to establish a comprehensive 

framework for making decisions about 

the extent to which it will consider or 

rely on certain types of research with 

human participants. Among other 

actions the plan provides for: Issuing 

proposed and final rules, and providing 

in this Notice a description of the 

Agency’s case-by-case process for 

evaluating human studies, which is to 

6662 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

remain in effect until superseded by 

rulemaking. This Notice invites public 

comments on the overall plan and 

particularly on the current case-by-case 

process.

DATES: Comments must be received on 

or before May 9, 2005.

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number OPP–2003–0132, by one of the 

following methods: 

• Agency website: http://

www.epa.gov/edocket/. EDOCKET, 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving comments. Follow 

the on-line instructions for submitting 

comments.

• E-mail: Comments may be sent by 

e-mail to opp-docket@epa.gov, 

Attention: Docket ID Number OPP–

2003–0132. 

• Mail: Public Information and 

Records Integrity Branch (PIRIB) 

(7502C), Office of Pesticide Programs 

(OPP), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001, Attention: 

Docket ID Number OPP–2003–0132. 

• Hand delivery: Public Information 

and Records Integrity Branch (PIRIB), 

Office of Pesticide Programs (OPP), 

Environmental Protection Agency, Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA, Attention: Docket ID 

Number OPP–2003–0132. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information.

Instructions: Direct your comments to 

docket ID number OPP–2003–0132. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http://

www.epa.gov/edocket/, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through EDOCKET, 

regulations.gov, or e-mail. The EPA 

EDOCKET and the regulations.gov 

websites are ‘‘anonymous access’’

systems, which means EPA will not 

know your identity or contact 

information unless you provide it in the 

body of your comment. If you send an 

e-mail comment directly to EPA without 

going through EDOCKET or 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the public docket and made 

available on the Internet. If you submit 

an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional information 

about EPA’s public docket visit 

EDOCKET on-line or see the Federal 

Register of May 31, 2002 (67 FR 38102) 

(FRL–7181–7).

Docket: All documents in the docket 

are listed in the EDOCKET index at 

http://www.epa.gov/edocket/. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This Docket Facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

William L. Jordan, Mailcode 7501C, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460; telephone number: 703–305–

1049; fax number: 703–308–4776; e-mail 

address: jordan.william@epa.gov.

SUPPLEMENTARY INFORMATION: This 

Notice is organized into five Units. Unit 

I. contains ‘‘General Information’’ about 

the applicability of this Notice, how to 

obtain additional information, how to 

submit comments in response to the 

request for comments, and certain other 

related matters. Unit II. provides 

background and historic information 

pertaining to human subject research. 

Unit III. describes the activities that EPA 

is planning to pursue to establish a 

framework within which it will address 

the broad range of issues related to the 

Agency’s consideration of or reliance on 

research with human participants. Unit 

IV. describes the current case-by-case 

process that EPA will continue to follow 

pending completion of the rulemaking 

efforts described in its plan. The last 

unit describes procedures followed in 

the development of this Notice and 

certain statutes and Executive Orders 

that the public may wish to consider in 

preparing comments. 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general. This action may, however, be 

of particular interest to those who 

conduct testing of substances regulated 

by EPA. Since other entities may also be 

interested, the Agency has not 

attempted to describe all the specific 

entities that may be affected by this 

action. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET, http:/

/www.epa.gov/edocket/, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/.

C. What Should I Consider as I Prepare 

My Comments for EPA?

1. Submitting CBI. Do not submit this 

information to EPA through EDOCKET, 

regulations.gov, or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD ROM that 

you mail to EPA, mark the outside of the 

disk or CD ROM as CBI and then 

identify electronically within the disk or 

CD ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2.

2. Tips for preparing your comments.

When submitting comments, remember 

to:

i. Identify the rulemaking by docket 

number and other identifying 

information (subject heading, Federal 

Register date, and page number).

ii. Follow directions. The agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number.

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes.

Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6663

iv. Describe any assumptions and 

provide any technical information and/

or data that you used.

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns, and suggest 

alternatives.

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified.

II. Introduction 

A. Background on Federal Standards for 

Conducting Human Research 

Over the years, scientific research 

with human subjects has provided 

much valuable information to help 

characterize and control risks to public 

health, but its use has also raised 

particular ethical concerns for the 

welfare of the human participants in 

such research as well as scientific issues 

related to the role of such research in 

assessing risks. Society has responded 

to these concerns by defining general 

standards for conducting human 

research. 

In the United States, the National 

Commission for the Protection of 

Human Subjects of Biomedical and 

Behavioral Research issued in 1979 The 

Belmont Report: Ethical Principles and 

Guidelines for the Protection of Human 

Subjects of Research. This document 

can be found on the web at http://

www.hhs.gov/ohrp/humansubjects/ 

guidance/belmont.htm. For many 

Federal agencies and departments in the 

United States, the principles of the 

Belmont Report are implemented 

through the Federal Policy for the 

Protection of Human Subjects (also 

known as the Common Rule). The 

Common Rule, which was promulgated 

by 15 Federal departments and agencies, 

including the EPA, on June 18, 1991 (56 

FR 28003), applies to all research 

involving human subjects conducted, 

supported or otherwise subject to 

regulation by any Federal department or 

agency that has adopted the Common 

Rule and has taken appropriate 

administrative action to make it 

applicable to such research. The 

Common Rule as promulgated by EPA 

(40 CFR part 26) has applied to human 

subjects research conducted or 

supported by EPA since it was put into 

place in 1991. 

More broadly, the international 

medical research community has 

developed and maintains ethical 

standards documented in the 

Declaration of Helsinki, first issued by 

the World Medical Association in 1964 

and revised several times since then. 

The latest version of the Declaration is 

available at: http://www.wma.net/e/

policy/b3.htm. These standards apply to 

research on matters relating to the 

diagnosis and treatment of human 

disease, and to research that adds to 

understanding of the causes of disease 

and the biological mechanisms that 

explain the relationships between 

human exposures to environmental 

agents and disease. 

In addition, many public and private 

research and academic institutions and 

private companies, both in the United 

States and in other countries, including 

non-federal U.S. and non-U.S. 

governmental organizations, have their 

own specific policies related to the 

protection of human participants in 

research. 

Much of the scientific information 

supporting EPA’s actions is generated 

by researchers who are not part of or 

supported by a Federal agency, 

including a significant portion of the 

research with human subjects submitted 

to the Agency or retrieved by the 

Agency from published sources. Such 

research, referred to here as ‘‘thirdparty’’ research, may be governed by 

specific institutional policies intended 

to protect research participants, may fall 

within the scope of the Declaration of 

Helsinki, or might actually be covered 

by the Common Rule if the particular 

testing institution holds an assurance 

approved for federalwide use by the 

Department of Health and Human 

Services’ (HHS) Office for Human 

Research Protections and the institution 

has voluntarily extended the 

applicability of the assurance to such 

research. In some instances, research is 

reported in such a manner that EPA 

cannot readily determine whether 

institutional policies are consistent with 

or as protective of human subjects as the 

Common Rule, or even the extent to 

which such policies or standards have 

been followed in the conduct of any 

particular study. Thus, even wellconducted third-party human studies 

may raise difficult questions for the 

Agency when it seeks to determine their 

acceptability for consideration. Unit IV. 

of this Notice contains a description of 

EPA’s case-by-case process for review of 

third-party human studies. 

B. Human Research Issues in EPA’s 

Pesticide Program 

Although data from human studies 

has contributed to assessments and 

decisions in most EPA programs, issues 

about consideration of and reliance on 

third-party human research studies have 

arisen most frequently, but not 

exclusively, with respect to pesticides. 

Under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), EPA is authorized to require 

pesticide companies to conduct studies 

with human subjects, for example, to 

measure potential exposure to pesticide 

users or to workers and others who reenter areas treated with pesticides, or to 

evaluate the effectiveness of pesticide 

products intended to repel insects and 

other pests from human skin. In 

addition, EPA sometimes encourages 

other research with human subjects, 

including tests of the potential for some 

pesticides--generally those designed for 

prolonged contact with human skin--to 

irritate or sensitize human skin, and 

tests of the metabolic fate of pesticides 

in the human body. These latter studies 

typically precede monitoring studies of 

agricultural workers and others to 

protect them from exposure to 

potentially dangerous levels of pesticide 

residues. 

In addition to these kinds of research 

which have been required or 

encouraged by EPA, other kinds of 

studies involving human subjects 

intentionally exposed to pesticides have 

occasionally been submitted to the 

agency voluntarily. Among these 

voluntarily submitted studies have been 

tests involving intentional dosing of 

human subjects to establish a No 

Observed Adverse Effect Level (NOAEL) 

or No Observed Effect Level (NOEL) for 

systemic toxicity of certain pesticides to 

humans. (Often the researchers reported 

observing no treatment-related 

responses in test participants.) For some 

two decades before passage of the Food 

Quality Protection Act (FQPA) in 1996, 

submission of such studies was rare. 

EPA considered and relied on human 

NOAEL/NOEL studies in a few 

regulatory decisions on pesticides made 

prior to 1996. After passage of FQPA, 

submission of these types of studies to 

EPA’s Office of Pesticide Programs 

increased; the Agency has received 

some 20 studies of this kind since 1996. 

In response to concerns about human 

testing expressed in a report of a nongovernmental advocacy organization, 

the Environmental Working Group, in 

July 1998, the Agency began a 

systematic review of its policy and 

practice. In a press statement on July 28, 

1998, EPA noted that it had not relied 

on any such studies in any final 

decisions made under FQPA. 

In further response to growing public 

concern over pesticide research with 

human subjects, EPA convened an 

advisory committee under the joint 

auspices of the EPA Science Advisory 

6664 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

Board (SAB) and the FIFRA Scientific 

Advisory Panel (SAP) to address issues 

of the scientific and ethical acceptability 

of such research. This advisory 

committee, known as the Data from 

Testing of Human Subjects 

Subcommittee (DTHSS), met in 

December 1998 and November 1999, 

and completed its report in September 

2000. Their report is available in the 

Docket cited above in this Notice, and 

on the web at: http://www.epa.gov/

science1/pdf/ec0017.pdf. 

The DTHSS advisory committee heard 

many comments at their two public 

meetings, and further comments have 

been submitted in response to their 

published report. No clear consensus 

emerged from the advisory committee 

process on the acceptability of NOAEL 

or NOEL studies of systemic toxicity of 

pesticides to human subjects, and 

significant differences of opinion 

remained on both their scientific merit 

and ethical acceptability. A vigorous 

public debate continued about the 

extent to which EPA should accept, 

consider, or rely on third-party 

intentional dosing human toxicity 

studies with pesticides. 

In December 2001, EPA asked the 

advice of the National Academy of 

Sciences (NAS) on the many difficult 

scientific and ethical issues raised in 

this debate, and also stated the Agency’s 

interim approach on third-party 

intentional dosing human subjects 

studies. The Agency’s press release on 

this subject is on the web at http://

yosemite.epa.gov/opa/admpress.nsf/ 

b1ab9f485b098972852562e7004dc686/ 

c232a45f5473 717085256b2200740ad4? 

OpenDocument. At that time the 

Agency committed that when it received 

the NAS report, ‘‘EPA will engage in an 

open and participatory process 

involving federal partners, interested 

parties and the public during its policy 

development and/or rulemaking 

regarding future acceptance, 

consideration or regulatory reliance on 

such human studies.’’ In addition, the 

press release also stated that while the 

Academy was considering these issues, 

EPA ‘‘will not consider or rely on any 

such human studies in its regulatory 

decision-making.’’

In early 2002, various parties from the 

pesticide industry filed a petition with 

the U. S. Court of Appeals for the 

District of Columbia for review of EPA’s 

December 2001 press release. These 

parties argued that the Agency’s interim 

approach constituted a ‘‘rule’’

promulgated in violation of the 

procedural requirements of the 

Administrative Procedure Act and the 

Federal Food, Drug, and Cosmetic Act. 

On June 3, 2003, the Court of Appeals 

concluded that:

For the reasons enumerated above, we 

vacate the directive articulated in EPA’s 

December 14, 2001 Press Release for a failure 

to engage in the requisite notice and 

comment rulemaking. The consequence is 

that the agency’s previous practice of 

considering third-party human studies on a 

case-by-case basis, applying statutory 

requirements, the Common Rule, and high 

ethical standards as a guide, is reinstated and 

remains in effect unless and until it is 

replaced by a lawfully promulgated 

regulation.

See Crop Life America v. Environmental 

Protection Agency, 329 F.3d 876, 884 - 

85 (D.C. Cir. 2003) (referred to as the 

Crop Life America case). 

In the meantime, under a contract 

with EPA, the NAS convened a 

committee to provide the requested 

advice. The committee met publicly in 

December 2002, and again in January 

and March 2003. The membership, 

meeting schedule, and other 

information about the work of this 

committee can be found on the NAS 

website at: http://www4.nas.edu/ 

webcr.nsf/5c50571a75df49 

4485256a95007a091e/ 

9303f725c15902f685256c44005d8931? 

OpenDocument&Highlight=0,EPA. The 

committee issued its final report, 

‘‘Intentional Human Dosing Studies for 

EPA Regulatory Purposes: Scientific and 

Ethical Issues,’’ in February 2004. That 

report is available at: http://

www.nap.edu/books/0309091721/html/. 

On May 7, 2003, EPA issued an 

advance notice of proposed rulemaking 

(ANPR) on Human Testing (68 FR 

24410) in which EPA announced its 

intention to undertake notice-andcomment rulemaking on the subject of 

its consideration of or reliance on 

research involving human participants. 

The ANPR also invited public comment 

on a broad range of issues related to this 

subject. EPA received over 600 

submissions in response to the ANPR. 

Approximately 15 were from pesticide 

companies, pesticide users, and 

associated trade associations and 

groups. These comments mostly favored 

the Agency’s use of data from 

scientifically sound, ethically 

appropriate studies conducted with 

human participants. Several of these 

groups urged EPA to apply the Common 

Rule to human research conducted for 

EPA by third parties. About 60 

submissions came from religious 

groups, farm-workers’ and children’s 

advocacy groups, and environmental 

and public health advocacy 

organizations. Most of these groups 

generally opposed EPA’s consideration 

of results from human testing, especially 

those involving intentional dosing of 

test participants with pesticides, on 

ethical grounds. Some of these 

commenters suggested, however, that, 

under certain strict conditions, EPA 

might appropriately consider data from 

human studies that complied with the 

Common Rule. Over 500 private citizens 

sent identical comments opposing the 

use of data from human studies with 

pesticides in EPA’s regulatory decisionmaking. A sizeable number of other 

private citizens expressed dismay in 

their comments at what they 

misunderstood to be an EPA proposal to 

test pesticides on human subjects. 

C. EPA’s Agency-wide Focus on Human 

Research Issues 

Human research issues affect all 

programs in EPA. In its Office of 

Research and Development, EPA 

conducts research with human subjects 

to provide critical information on 

environmental risks, exposures, and 

effects in humans. This is referred to as 

first-party research. In both its Office of 

Research and Development and its 

program offices (including the Office of 

Air and Radiation, the Office of Water, 

the Office of Solid Waste and 

Emergency Response, and the Office of 

Prevention, Pesticides and Toxic 

Substances), EPA also supports research 

with human subjects conducted by 

others. This is referred to as secondparty research. In all this work EPA has 

been and remains committed to full 

compliance with the Common Rule. 

This research has provided many 

important insights and has contributed 

to the protection of human health. The 

Agency will continue to conduct and 

support such research, and to consider 

and rely on its results in Agency 

assessments and decisions. 

EPA also remains committed to 

scientifically sound assessments of the 

hazards of environmental agents, taking 

into consideration all available, 

relevant, and appropriate scientific 

research. In at least some cases, some of 

the available, relevant, and appropriate 

scientific research is conducted with 

human subjects by third parties, without 

Federal government support. EPA 

programs have on occasion relied on 

such studies to more completely 

characterize and understand 

environmental risks to humans; the 

Agency will continue to do so when it 

is appropriate. 

EPA recognizes that its approach to 

the issues surrounding human research 

needs to be consistent across the 

Agency. EPA is interested in addressing 

the broad range of issues involving the 

consideration of and reliance on data 

from human subjects studies, 

particularly tests conducted by third 

Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6665

parties. After consideration of the Court 

of Appeals’ decision in the Crop Life 

America case, the public comments on 

the ANPR, and the report from the NAS, 

EPA has concluded that it should 

undertake a number of activities to 

address these issues fully. The Agency’s 

plan is described in Unit III. of this 

Notice. 

D. Legal Authority 

The actions described below are 

authorized under a variety of provisions 

of the different environmental statutes 

EPA administers. Section 25(a) of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) gives the 

Administrator authority to ‘‘prescribe 

regulations to carry out the purposes of 

[FIFRA].’’ Such a rule would implement 

EPA’s authority to require data in 

support of registration of pesticides (see, 

for example, FIFRA sections 3(c)(1)(F) 

and 3(c)(2)(B)) and to interpret the 

provision making it unlawful for any 

person ‘‘to use any pesticide in tests on 

human beings unless such human 

beings (i) are fully informed of the 

nature and purposes of the test and of 

any physical and mental health 

consequences which are reasonably 

foreseeable therefrom, and (ii) freely 

volunteer to participate in the test.’’

(FIFRA section 12(a)(2)(P)). In addition, 

section 408(e)(1)(C) of the Federal Food, 

Drug, and Cosmetic Act (FFDCA) 

authorizes the Administrator to issue a 

regulation establishing ‘‘general 

procedures and requirements to 

implement this section.’’

The Clean Air Act authorizes the 

Administrator to promulgate regulations 

necessary to carry out the Agency’s 

functions under that Act at 42 U.S.C. 

7601(a). The Clean Water Act contains 

a comparable provision at 33 U.S.C. 

1361. Section 42 U.S.C. 9615 in the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act authorizes the President to establish 

regulations to implement the statute; 

this authority has been delegated to EPA 

by Executive Order 12580. The 

Emergency Planning and Community 

Right-to-Know Act also contains a 

general rulemaking provision, 42 U.S.C. 

11048, authorizing the Administrator to 

promulgate rules necessary to carry out 

the Act. The Resource Conservation and 

Recovery Act specifically authorizes the 

Administrator to prescribe regulations 

necessary to carry out EPA’s functions 

under the Act, 42 U.S.C. 6912. The Safe 

Drinking Water Act contains similar 

language, authorizing the Administrator 

to prescribe such regulations ‘‘as are 

necessary and appropriate’’ to carry out 

EPA’s functions under the Act, 42 

U.S.C. 300j-9. In addition, EPA has 

broad authority under 5 U.S.C. 301 and 

42 U.S.C. 300v-1(b). 

III. EPA’s Proposed Plan for Addressing 

Issues Relating to Human Testing 

As a consequence of the public debate 

over whether it is appropriate to 

consider or rely on data from intentional 

dosing of humans, EPA recognizes that 

it is essential that the Agency state its 

positions on these issues so that the 

public can understand under what 

circumstances the Agency would take 

particular actions. The public debate 

has made clear that a number of aspects 

of EPA’s policy and procedures are 

affected and that changes should be 

considered. Thus, EPA has identified a 

number of activities including the 

issuance of a clarifying description of 

the current case-by-case approach, 

rulemakings, and administrative/

organizational changes that appear 

appropriate. EPA’s overall goals for 

these activities are: That human 

participants in any research required by, 

conducted for, or considered by EPA are 

treated ethically; and that all 

scientifically sound data relevant to 

EPA decision-making is considered and 

used appropriately in reaching 

decisions under our authorities. 

EPA has identified a variety of 

activities that, collectively, will 

establish a comprehensive framework to 

address the broad range of issues 

relating to the consideration of or 

reliance on data from human studies, 

particularly when conducted by third 

parties. EPA has drawn heavily on the 

recommendations contained in the NAS 

report in designing this framework. 

1. Publication of a clarifying 

description of the current case-by-case 

review of completed third-party human 

studies. Consistent with the Court’s 

opinion in the Crop Life America case, 

EPA will continue to evaluate thirdparty human studies on a case-by-case 

basis, applying statutory requirements, 

the Common Rule, and high ethical 

standards as a guide, until such time as 

this practice is replaced by a 

rulemaking. EPA is issuing a clarifying 

description of its current process in Unit 

IV. of this Notice. EPA intends to 

continue this process until such time as 

it is superseded by rulemaking. EPA, 

however, welcomes public comment on 

the description of its current process, 

and after reviewing comments, EPA may 

choose to publish additional 

clarification. 

2. Intent to publish a policy statement 

to third parties encouraging them to 

submit protocols for proposed human 

studies to EPA for review. EPA intends 

to develop and make public a policy 

statement that encourages, but does not 

require, ‘‘third-party’’ researchers, i.e., 

researchers who are not part of or 

supported by a Federal agency, who are 

planning to conduct studies involving 

human participants to support an EPA 

regulatory decision, to submit a 

proposed protocol to EPA prior to 

conducting the research. The policy 

statement would explain EPA’s intent to 

review and provide comments to the 

researcher concerning the ethical and 

scientific attributes of the proposal. 

3. Intent to publish guidance 

concerning compliance with the 

Common Rule for any future human 

studies specifically required by EPA. 

EPA intends to publish non-binding 

guidance reflecting its plans to extend 

the Common Rule to specifically cover 

third-party human subject studies that 

are intended to be submitted to the 

Agency either voluntarily or in response 

to an Agency-imposed requirement and 

setting forth its expectation that any 

such study intended to be submitted in 

the interim should endeavor to include 

protections such as those included in 

the Common Rule. 

Additionally, in the interim, the 

Agency intends to utilize existing 

authority, where appropriate, to require 

that test sponsors and testing facilities 

and personnel adhere to the Common 

Rule in conducting human studies if 

such studies are submitted to the 

Agency to satisfy specific data 

requirements, for example, studies with 

human participants that may be 

submitted to the Agency to satisfy data 

requirements under FIFRA section 

3(c)(2)(B) or pursuant to a TSCA section 

4 testing rule. 

4. Intent to conduct outreach to 

scientific journals encouraging 

improved reporting of the ethics of 

published human studies. Many 

biomedical journals have adopted 

voluntary, uniform requirements for 

submitted manuscripts. These 

requirements include reporting on the 

protection of human subjects, through 

indicating whether the procedures 

followed were in accordance with the 

ethical standards of the responsible 

institution and with the Declaration of 

Helsinki or other, comparable, ethics 

codes. EPA intends to conduct outreach 

to these journals to determine the extent 

of coverage and compliance, and to 

encourage the reporting of this ethics 

information in connection with 

publication of the results of research 

conducted with human participants. 

5. Intent to expand the functions of 

the EPA Human Subjects Research 

Review Official and to relocate the 

HSRRO office. Within EPA, the Human 

Subjects Research Review Official 

(HSRRO) has responsibility for assuring 

6666 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

that all human subjects research that is 

conducted or supported by EPA 

complies with the requirements of the 

Common Rule. The HSRRO’s specific 

responsibilities are described in EPA 

Order 1000.17 Change A1. See http://

www.epa.gov/oamrtpnc/forms/ 

1000_17a.pdf. These responsibilities, in 

effect, entail addressing the scientific 

and ethical issues raised by human 

studies. The HSRRO reviews and 

approves about 50 projects a year, of 

which only a few involve intentional 

dosing of human participants with 

environmental pollutants. Currently, the 

HSRRO is located within EPA’s Office 

of Research & Development, which is 

the Office within EPA that conducts or 

sponsors most of the research programs 

reviewed by the HSRRO. 

The NAS report included the 

recommendation that ‘‘[t]o ensure 

intentional dosing human studies 

conducted for EPA regulatory purposes 

meet the highest scientific and ethical 

standards, EPA should establish a 

Human Studies Review Board to 

address in an integrated way the 

scientific and ethical issues raised by 

such studies.’’ The NAS further 

recommended that the Human Studies 

Review Board ‘‘should report directly to 

the Office of the [EPA] Administrator.’’

Consistent with the NAS 

recommendation, EPA intends to 

expand the functions of the HSRRO and 

is looking at where to relocate those 

functions. In addition to the existing 

function of ensuring compliance with 

the Common Rule for human subjects 

research conducted or supported by 

EPA, the Agency intends that the 

HSRRO will have responsibility for 

overseeing implementation of the ethics 

screening of completed studies (see Unit 

IV.), overseeing the review of proposals 

to conduct new human studies, 

identifying emerging ethical issues for 

research not subject to the Common 

Rule, and developing additional 

policies, training, and best practices 

guidance. The Agency welcomes public 

comment on this part of its plan. 

6. Intent to pursue rulemaking. EPA 

intends to publish a proposed rule to 

make the provisions of the Common 

Rule, 40 CFR part 26, applicable to 

certain newly conducted third-party 

human studies and may propose to 

adopt some or all of the HHS regulations 

that provide additional protections for 

certain populations of vulnerable 

subjects. These HHS regulations are 

contained in HHS regulations at 45 CFR 

part 46, subpart B (Additional 

Protections for Pregnant Women, 

Human Fetuses and Neonates Involved 

in Research), subpart C (Additional 

Protections Pertaining to Biomedical 

and Behavioral Research Involving 

Prisoners as Subjects), and subpart D 

(Additional Protections for Children 

Involved as Subjects in Research), and 

apply to all research involving these 

respective vulnerable subject groups 

that is conducted or supported by HHS. 

This proposal may also require a 

sponsor or investigator to provide to 

EPA, for prior review and approval, the 

protocol for certain human studies. EPA 

will also consider whether to propose a 

rule applying to certain previously 

conducted human studies. In 

developing its proposals, EPA will 

consider both the report from the NAS 

and public comments on the ANPR and 

this Notice. 

IV. Description of EPA’s Current Caseby-Case Review Process for Third-Party 

Human Studies 

This unit describes the Agency’s 

process for reviewing and relying on 

completed, third-party studies that 

involve intentional dosing of human 

participants to identify or quantify a 

toxic endpoint. It is important to note 

that this is a case-by-case process. As 

such, it binds no one to a particular 

process or result--not the regulated 

community, not advocacy groups, not 

the public, and not EPA. Therefore, in 

any decision before EPA, any 

stakeholder may urge EPA to: (1) 

Conclude that this process is 

inapplicable; (2) consider factors other 

than those described here; or (3) make 

an exception to the process as 

described. EPA notes that it may 

determine, based on individual 

circumstances to act at variance from 

the review process as described. Thus, 

affected parties should not assume that 

EPA will follow a prescribed method of 

reviewing a particular human study in 

each and every instance. In any action 

involving consideration and review of a 

third-party, intentional dosing human 

study, EPA will explicitly state the basis 

upon which such a study has been 

evaluated. 

As mandated by the D.C. Circuit in 

the Crop Life America case, EPA has 

resumed consideration of third-party 

human studies on a case-by-case basis, 

applying statutory requirements, the 

Common Rule, and high ethical 

standards as a guide. In its 

consideration and review of human 

studies submitted to the Agency, EPA 

will continue to generally accept 

scientifically valid studies unless there 

is clear evidence that the conduct of 

those studies was fundamentally 

unethical (e.g., the studies were 

intended to seriously harm participants 

or failed to obtain informed consent), or 

was significantly deficient relative to 

the ethical standards prevailing at the 

time the study was conducted. The 

Agency notes that this approach is 

consistent with Recommendation 5-7 of 

the February 2004, NAS report. 

Primary responsibility for conducting 

case-by-case science and ethics reviews 

of third-party, intentional dosing human 

studies for toxic effects is vested in the 

EPA Office responsible for the relevant 

Agency action or risk assessment. To 

maintain high ethical standards the 

Agency screens all ‘‘priority’’ studies 

involving intentional dosing of human 

participants for toxic effects for existing 

ethics and scientific review information, 

and the responsible Office documents 

such reviews. A priority study is one 

which is expected to significantly affect 

the assessment, either by itself or as a 

substantial component of the weight of 

evidence, in determining: A regulatory 

standard, decision, or risk assessment 

value; determining an uncertainty factor 

or safety factor; or defining exposure or 

effects. The Agency also reviews as a 

‘‘priority’’ study any study which was 

not relied on but which, if considered, 

arguably would change the outcome of 

the Agency’s risk assessment or 

regulatory judgement or significantly 

affect the record underlying the 

Agency’s conclusions. In addition, an 

Office may selectively review the ethics 

of any non-priority study, as it deems 

appropriate. 

If a study raises potential ethical 

concerns or if there is uncertainty, the 

primary Office consults with the Human 

Subjects Research Review Official 

(HSRRO) and they jointly develop an 

evaluation plan for the study, which 

may include soliciting outside ethics 

advice. Senior Agency officials decide 

the appropriate action to take 

concerning ethically problematic 

studies on a case-by-case basis. 

Depending on the context, senior 

officials could include senior executives 

in the program office of concern, the 

Agency’s HSRRO, and/or the Agency 

Science Advisor. If appropriate, the 

senior Agency officials may seek 

independent advice from an external 

peer review group such as the Science 

Advisory Board or the FIFRA Scientific 

Advisory Panel. 

V. Statutory and Executive Order 

Reviews 

Since this Notice does not impose any 

requirements, and instead describes 

EPA’s current case-by-case approach for 

reviewing certain human studies, and 

seeks comments on EPA’s plans for 

amending that process and any 

suggestions for the Agency to consider 

in developing a subsequent notice of 

proposed rulemaking, the various other 

Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6667

1 In the Report and Order released November 4, 

2003, the Commission adopted rules for both 

unlicensed (Part 15) and licensed (Part 101) use of 

portions of these bands. Allocations and Service 

Rules for the 71–76 GHz, 81–86 GHz and 92–95 

GHz Bands, WT Docket No. 02–146, Report and 

Order, 69 FR 3257, January 23, 2004, 18 FCC Rcd 

23318 (2003) (Report and Order) (recon. pending). 

The instant Public Notice concerns licensed use of 

the bands, which involves all of the bands except 

for 100 megahertz of spectrum at 94.0–94.1 GHz. 

For convenience only, we refer to the licensed 

spectrum herein as ‘‘the bands,’’ ‘‘the Millimeter 

Wave 70/80/90 GHz Radio Service,’’ or ‘‘71–95 

GHz’’; such references do not include 94.0–94.1 

GHz. See note, infra.

2On February 23, 2004, The Wireless 

Communications Association International, Inc. 

filed a petition for reconsideration of certain aspects 

of the Report and Order relating to the 71–76 and 

81–86 GHz bands.

3 In the context of spectrum management, 

‘‘Federal Government’’ refers to use by the Federal 

Government and ‘‘non-Federal Government’’ refers 

to use by private entities and state and local 

governments. See Report and Order, 18 FCC Rcd at 

23319 n.3. See also 47 CFR 101.147(z) (sites may 

not operate until NTIA approval is received); 

101.511 (authorization will be granted upon proper 

application filing and link coordination in 

accordance with the Commission’s rules); 101.1523 

(sharing and coordination among non-Federal 

Government licensees and between non-Federal 

Government licensees and Federal Government 

services).

4The 71–76 GHz, 81–86 GHz and 92–95 GHz 

bands are allocated to both Federal Government and 

non-Federal Government users on a co-primary 

basis, except the 94.0–94.1 GHz portion, which is 

allocated for exclusive Federal Government use. See 

generally, Report and Order, 18 FCC Rcd at 23322–

31.

review requirements that apply when an 

agency imposes requirements do not 

apply to this action. 

As part of your comments on this 

Notice you may include any comments 

or information that you have regarding 

these requirements. In particular, any 

comments or information that would 

help the Agency to assess the potential 

impact of a rule on small entities 

pursuant to the Regulatory Flexibility 

Act (RFA) (5 U.S.C. 601 et seq.); to 

consider voluntary consensus standards 

pursuant to section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), Public Law 104–

113, section 12(d) (15 U.S.C. 272 note); 

or to consider environmental health or 

safety effects on children pursuant to 

Executive Order 13045, titled Protection 

of Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997). The Agency will 

consider such comments during the 

development of any subsequent notice 

of proposed rulemaking as it takes 

appropriate steps to address any 

applicable requirements.

List of Subjects 

Environmental protection, Protection 

of human research subjects.

Dated: February 2, 2005. 

Susan B. Hazen, 

Acting Assistant Administrator, Office of 

Prevention, Pesticides and Toxic Substances.

[FR Doc. 05–2371 Filed 2–3–05; 11:43 am] 

BILLING CODE 6560–50–S

FARM CREDIT ADMINISTRATION

Farm Credit Administration Board; 

Regular Meeting; Sunshine Act

AGENCY: Farm Credit Administration.

SUMMARY: Notice is hereby given, 

pursuant to the Government in the 

Sunshine Act (5 U.S.C. 552b(e)(3)), of 

the regular meeting of the Farm Credit 

Administration Board (Board).

DATE AND TIME: The regular meeting of 

the Board will be held at the offices of 

the Farm Credit Administration in 

McLean, Virginia, on February 10, 2005, 

from 9 a.m. until such time as the Board 

concludes its business.

FOR FURTHER INFORMATION CONTACT:

Jeanette C. Brinkley, Secretary to the 

Farm Credit Administration Board, 

(703) 883–4009, TTY (703) 883–4056.

ADDRESSES: Farm Credit 

Administration, 1501 Farm Credit Drive, 

McLean, Virginia 22102–5090.

SUPPLEMENTARY INFORMATION: This 

meeting of the Board will be open to the 

public (limited space available). In order 

to increase the accessibility to Board 

meetings, persons requiring assistance 

should make arrangements in advance. 

The matters to be considered at the 

meeting are: 

Open Session 

A. Approval of Minutes 

• January 13, 2005 (Open). 

B. New Business—Other 

• Spring Unified Agenda and 

Regulatory Performance Plan.

Dated: February 3, 2005. 

Jeanette C. Brinkley, 

Secretary, Farm Credit Administration Board.

[FR Doc. 05–2541 Filed 2–4–05; 2:26 pm] 

BILLING CODE 6705–01–P

FEDERAL COMMUNICATIONS 

COMMISSION 

[DA 05–311] 

Permanent Process For Registering 

Links In The 71–76 GHz, 81–86 GHz, 

And 92–95 GHz Bands

AGENCY: Federal Communications 

Commission.

ACTION: Notice.

SUMMARY: The Wireless 

Telecommunications Bureau (‘‘WTB’’ or 

‘‘Bureau’’) announces additional details 

of the link registration process for the 

71–76, 81–86, 92–94.0 and 94.1–95 GHz 

bands. This public notice also 

establishes February 8, 2005, as the date 

on which the Commission’s Universal 

Licensing System (ULS) will no longer 

process link registrations and the third 

party database system will become the 

sole source for registering links.

DATES: Effective February 8, 2005.

ADDRESSES: Federal Communications 

Commission, 445 12th Street, SW., 

Washington, DC 20554.

FOR FURTHER INFORMATION CONTACT:

Cheryl Black or Stephen Buenzow, 

Broadband Division, WTB, 717–338–

2687 or questions regarding the 

application filing and link registration 

procedure outlined in this public notice 

may be directed to the ULS Hotline at 

1–888–CallFCC Option #2.

SUPPLEMENTARY INFORMATION: The full 

text of this Public Notice is available for 

inspection and copying during normal 

business hours in the FCC Reference 

Center, Room CY–A–257, 445 12th 

Street, SW., Washington, DC 20554. The 

complete text may also be purchased 

from the Commission’s duplicating 

contractor, Best Copy and Printing, Inc., 

(BCPI), Portals II, 445 12th Street, SW., 

Room CY–B402, Washington, DC. The 

complete item is also available on the 

Commission’s Web site at http://

www.fcc.gov/wtb. 

Background 

On October 16, 2003, the Commission 

adopted a Report and Order 1

establishing service rules to promote 

non-Federal Government development 

and use of the ‘‘millimeter wave’’

spectrum in the 71–76 GHz, 81–86 GHz 

and 92–95 GHz bands 2 on a shared 

basis with Federal Government 

operations.3 The Commission adopted a 

flexible and innovative regulatory 

framework for the 71–95 GHz bands that 

would not require traditional frequency 

coordination among non-Federal 

Government users. Under this approach, 

the Commission issues an unlimited 

number of non-exclusive nationwide 

licenses to non-Federal Government 

entities for the 12.9 gigahertz of 

spectrum allocated for commercial use.4

These licenses serve as a prerequisite for 

registering individual point-to-point 

links, which in turn is required prior to 

operating a link. Furthermore, the 71–95 

GHz bands are allocated on a shared 

basis with Federal Government users. 

Therefore, a licensee may not operate on 

a link until the link has been 

coordinated with the National 

Telecommunications and Information