Document ID: EPA-HQ-OPP-2003-0132-0665
Agency: epa
Document Type: Proposed Rule
Title: Protections for Subjects in Human Research; Nursing Women
Posted Date: 2006-06-23T18:12:12Z

[Federal Register: June 23, 2006 (Volume 71, Number 121)]
[Proposed Rules]               
[Page 36177-36180]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn06-19]                         

[[Page 36177]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

[EPA-HQ-OPP-2003-0132; FRL-8074-8]
RIN 2070-AD57

 
Protections for Subjects in Human Research; Nursing Women

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to amend EPA's final rule promulgated on 
January 26, 2006, concerning the protection of human subjects in 
research. The proposed amendments would explicitly ban research for 
pesticides involving intentional exposure of human subjects who are 
nursing women, and prohibit EPA reliance in actions under the pesticide 
laws on research involving intentional exposure of nursing women. EPA 
believes that these proposed amendments are non-controversial and does 
not expect to receive any adverse comments. Therefore, in addition to 
this Notice of Proposed Rulemaking, elsewhere in this issue of the 
Federal Register, EPA is promulgating these amendments as a direct 
final rule.

DATES: Written comments must be received on or before July 24, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2003-0132, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2003-0132. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available on-line 
at http://www.regulations.gov/, 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 regulations.gov. The 
regulations.gov website is an ``anonymous access'' system, which means 
EPA will not know your identity or contact information unless you 
provide it in the body of your comment. 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.
    Docket. EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2003-0132. All documents in the 
docket are listed in the index for the docket. Although listed in the 
docket index, some information is not publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not available through the electronic docket 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically at 
http://www.regulations.gov or, if only available in hard copy, at the 

Office of Pesticide Programs (OPP) Public Regulatory Docket, in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 
VA. The hours of operation for this Docket Facility are from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: William L. Jordan, Office of Pesticide 
Programs (7501P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-1049; 
fax number: (703) 308-4776; e-mail address: jordan.william@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you conduct human 
research on substances regulated by EPA. Potentially affected entities 
may include, but are not limited to, entities that conduct or sponsor 
research involving intentional exposure of human subjects that may be 
submitted to EPA under FIFRA or FFDCA. Although EPA has in the past 
received such third-party research from pesticide registrants, other 
entities could submit such information to EPA.
     Pesticide and other Agricultural Chemical Manufacturing 
(NAICS code 325320).
    This listing is not intended to be exhaustive, but rather provides 
a guide regarding entities likely to be affected by this action. Other 
types of entities not listed in this unit could also be affected. The 
North American Industrial Classification System (NAICS) codes have been 
provided to assist you and others in determining whether this action 
might apply to certain entities. To determine whether you or your 
business may be affected by this action, you should carefully examine 
the applicability provisions of 40 CFR part 26. 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?

    You may access an electronic copy of this Federal Register document 
and the associated electronic docket at http://www.regulations.gov, or 

you may access this Federal Register document electronically through 
the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr.
 A frequently updated electronic version of the 

Code of Federal Regulations (CFR) is available at http://www.gpoaccess.gov/ecfr
.

II. Context for the Proposed Rulemaking

    On January 26, 2006, EPA issued a final rule significantly 
strengthening and expanding the protections for subjects of human 
research (hereinafter referred to as the ``January 2006 rule''). The 
final rule appeared in the Federal Register on February 6, 2006 (71 FR 
6138) (FRL-7759-8). For ``third-party'' human research (i.e., research 
that is not conducted or supported by either EPA or by another federal 
department or agency under the Common Rule), that rule:
    1. Prohibited new research involving intentional exposure of 
pregnant women or children, intended for submission to EPA under the 
pesticide laws.

[[Page 36178]]

    2. Extended the provisions of the Federal Policy for the Protection 
of Human Subjects of Research (the ``Common Rule'') to other human 
research involving intentional exposure of non-pregnant adults, 
intended for submission to EPA under the pesticide laws.
    3. Required submission to EPA of protocols and related information 
about covered human research before it is initiated.
    4. Established an independent Human Studies Review Board to review 
both proposals for new research and reports of covered human research 
on which EPA proposes to rely under the pesticide laws.
 The January 2006 rule also contained other, similar requirements for 
first- and second-party research, as well as standards to guide EPA 
decision-making under the pesticide laws involving reliance on the 
results of completed intentional dosing human research.
    Elsewhere in this issue of the Federal Register, EPA is 
promulgating the proposed amendments as a direct final rule that 
extends the critical protections for human research subjects contained 
in the January 2006 final rule to nursing women and their nursing 
children. EPA is promulgating these amendments as a direct final rule 
without prior proposal because the Agency believes that these 
amendments to the January 2006 rule are non-controversial and does not 
expect to receive adverse comments. The Agency's reasons for these 
amendments are explained in the preamble to the direct final rule.
    If EPA does not receive adverse comments on the direct final rule, 
the Agency will not take further action on this proposed rule. If EPA 
receives comments adverse to the direct final rule, the Agency will 
withdraw the direct final rule and it will not take effect. EPA will 
then address all public comments in a subsequent final rule based on 
this proposed rule. EPA will not institute a second comment period on 
this action. Any parties interested in commenting must do so at this 
time, and must submit comments on or before July 24, 2006. EPA 
considers ``comments adverse to the direct final rule'' to be comments 
that explicitly state that the protections afforded research subjects 
under the Protections for Subjects in Human Research Rule should not be 
extended to nursing mothers and their nursing children.

III. Protections for Children Potentially Exposed Through Nursing Women 
Who Are Subjects in Human Research

    In the January 2006 rule, EPA provided additional protections for 
children, to prohibit their being intentionally exposed to test 
materials through human research. The Agency believed that it had 
achieved this goal by establishing a prohibition against the use of 
children as subjects in certain types of research involving intentional 
exposure of subjects. Since promulgation of the January 2006 rule, 
however, the Agency has been asked whether the final rule prohibits 
investigators from conducting, or EPA from relying on, research 
involving intentional exposure of nursing women, since use of nursing 
women as subjects of research could potentially result in exposure of 
nursing infants to the test material in nursing women's breast milk.
    The Agency notes that it has not conducted or supported intentional 
dosing studies targeted at nursing women and has no intention to do so 
in the future. Moreover, under the January 2006 rule, if, in accordance 
with 40 CFR 26.1125, a third-party researcher submitted to EPA a 
proposal to perform such research, EPA would not approve the proposal. 
The Agency has concluded that such research should never be performed 
because of the potential that it might result in exposure of nursing 
children. Accordingly, EPA is amending the January 2006 rule to clarify 
that the prohibitions in the January 2006 rule against conduct of new 
research involving intentional exposure of pregnant women and children, 
and the prohibition of the Agency's reliance on completed research 
involving intentional exposure of pregnant women or children, apply as 
well to research involving intentional exposure of nursing women. This 
proposed rule explicitly prohibits research involving intentional 
exposure of nursing women. EPA would consider a woman to be nursing if 
she is providing her breast milk to a child either during or after the 
research when the test material could be detected in her breast milk. 
(For purposes of applying the rule to research conducted after the 
effective date of these proposed amendments, an investigator could 
document compliance by obtaining a statement from a female subject that 
she is not providing and does not intend to provide her breast milk to 
a child during the research and for a period of time after the research 
ends during which the test material could reasonably be detected in her 
breast milk. The Agency does not intend, however, to prohibit research 
involving intentional exposure of a woman as a research subject simply 
because at some indefinite, future time the woman hopes to breast-feed 
a child.)
    In sum, the Agency believes that the kinds of explicit protections 
for children and pregnant women established by the January 2006 rule 
are equally appropriate for nursing women. Data indicate that some 
pesticides and other environmental substances pass into breast milk, 
but adequate data do not exist to characterize the fate of all 
substances that might be used in human research covered by the January 
2006 rule. Therefore, consistent with the intent of the January 2006 
rule to protect children from exposure to test materials through 
intentional dosing studies, EPA is reinforcing the protection for 
children by prohibiting the following:
    1. New research involving intentional exposure of nursing women 
conducted or supported by EPA.
    2. New research involving intentional exposure of nursing women 
conducted by third-party investigators who intend to submit the results 
to EPA under the pesticide laws.
    3. Reliance by EPA in its actions under the pesticide laws on 
research involving intentional exposure of nursing women.

(EPA notes that the absence of information about the nursing status of 
female subjects in a completed study does not justify application of 
the prohibition in Sec.  26.1703.)

IV. FIFRA Review Procedures for the Final Rule

    FIFRA section 25(a)(2)(A) provides: ``[a]t least 60 days prior to 
signing any proposed regulation for publication in the Federal 
Register, the Administrator shall provide the Secretary of Agriculture 
a copy of such regulation.'' Section 25(a)(2)(C) authorizes the 
Administrator and the Secretary to waive the opportunity to review and 
comment on final regulations. FIFRA section 25(d)(1) requires that the 
Administrator shall submit to the Scientific Advisory Panel for comment 
proposed rules issued under section 25(a) within the same time periods 
as provided for the comments of the Secretary of Agriculture. Section 
25(a) also authorizes the FIFRA Scientific Advisory Panel to waive the 
opportunity for review. Both, the FIFRA Scientific Advisory Panel (SAP) 
and the U.S. Department of Agriculture (USDA) have waived the 
opportunity under FIFRA to review the proposed rule.
    In addition, FIFRA section 25(a)(3) states that ``[a]t such time as 
the Administrator is required under paragraph (2) of this subsection to 
provide the Secretary of Agriculture with a copy of proposed 
regulations. . ., the Administrator shall also furnish a copy of such 
regulations to the

[[Page 36179]]

Committee on Agriculture in the House of Representatives, and the 
Committee on Agriculture, Nutrition, and Forestry in the United States 
Senate.'' Because USDA waived review under FIFRA section 25(a)(2)(C), 
EPA is not required to furnish a copy of the final regulations to the 
specified committees 60 days prior to signature of the proposed rule.

V. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that this proposed rule is not a 
``significant regulatory action'' under section 3(f) of the Executive 
Order.
    The amendments contained in this proposed rule are not expected to 
result in a significant increase, if any, to the estimated impacts of 
the January 2006 rule, which are presented in a document entitled 
Economic Analysis of the Human Studies Final Rule (Economic Analysis), 
a copy of which is available in the docket for this proposed rule.
    Based on the relatively small economic impact of the January 2006 
rule, EPA believes that this proposed rule will have a minimal-if any-
impact on industry, regardless of the size of the entity.

B. Paperwork Reduction Act

    This proposed rule contains no new information collection 
requirements. Therefore no further analysis, review or OMB approval is 
required under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq. The information collection requirements contained in the January 
2006 rule have been approved by OMB under OMB control number 2070-0169 
(identified under EPA ICR No. 2195.02). A copy of the approved 
information collection request document is available in the docket for 
this proposed rule.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency 
to prepare a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements under the Administrative 
Procedure Act or any other statute unless the agency certifies that the 
rule will not have a significant economic impact on a substantial 
number of small entities. Small entities include small businesses, 
small organizations, and small governmental jurisdictions.
    After considering the potential economic impacts of the January 
2006 rule on small entities, the Agency concluded pursuant to section 
605(b) of the RFA that the January 2006 rule did not have a significant 
adverse economic impact on a substantial number of small entities. EPA 
has determined that the potential additional impact from this 
amendment, if any, is minimal. For purposes of assessing the impacts of 
the January 2006 rule on small entities, small entity was defined in 
accordance with the RFA as: (1) A small business as defined by the 
Small Business Administration's (SBA) regulations at 13 CFR 121.201; 
(2) a small governmental jurisdiction that is a government of a city, 
county, town, school district, or special district with a population of 
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not 
dominant in its field.
    After considering the economic impacts of today's proposed rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. The Agency's 
determination is based on the economic analysis performed for the 
January 2006 rule, a copy of which is available in the docket for this 
action.

D. Unfunded Mandates Reform Act

    Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) 
(Public Law 104-4), EPA has determined that this action does not 
contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any 1 year. This proposed rule is 
expected to result in no more than a minor increase, if any, to the 
estimated impact of the January 2006 rule. The estimated total costs 
associated with the January 2006 rule are approximately $38,837 per 
year. Based on historical submissions, EPA has determined that State, 
local, and tribal governments rarely perform human research intended 
for submission to EPA under FIFRA or FFDCA. In addition, the proposed 
rule is not expected to significantly or uniquely affect small 
governments. Accordingly, this action is not subject to the 
requirements of sections 202 and 205 of UMRA.

E. Executive Order 13132

    Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 
1999), does not apply to this proposed rule. EPA has determined that 
this proposed rule does not have ``federalism implications'' because it 
will not have substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in the Executive Order. As indicated earlier, 
instances where a State performs human research intended for submission 
to EPA under FIFRA or FFDCA are rare. Therefore, this proposed rule may 
seldom affect a State government.

F. Executive Order 13175

    Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (59 FR 22951, November 6, 2000), does not 
apply to this proposed rule. EPA has determined that this proposed rule 
does not have ``tribal implications'' because it will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and the Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in the Executive Order. As 
indicated previously, instances where a tribal government performs 
human research intended for submission to EPA under FIFRA or FFDCA are 
extremely rare.

G. Executive Order 13045

    Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997) does not apply to this proposed rule because this action is not 
designated as an ``economically significant'' regulatory action as 
defined by Executive Order 12866. Furthermore, this proposed rule does 
not establish an environmental standard that is intended to have a 
negatively disproportionate effect on children. To the contrary, this 
action will provide added protections for children with regard to the 
research covered by the proposed rule.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, 
entitled Actions Concerning Regulations that Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) because 
this proposed rule does not have any significant adverse effect on the 
supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act

    This proposed rule does not impose any technical standards that 
would require Agency consideration of

[[Page 36180]]

voluntary consensus standards under section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 
note), because it does not require specific methods or standards to 
generate data. The NTTAA directs EPA to use voluntary consensus 
standards in its regulatory activities unless to do so would be 
inconsistent with applicable law or impractical. Voluntary consensus 
standards are technical standards (e.g., materials specifications, test 
methods, sampling procedures) that are developed or adopted by 
voluntary consensus standards bodies. NTTAA directs EPA to provide 
Congress, through OMB, with explanations when the Agency decides not to 
use available and applicable voluntary consensus standards.

J. Executive Order 12898

    This proposed rule does not have an adverse impact on the 
environmental and health conditions in low-income and minority 
communities. Therefore, under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994), the Agency is 
not required to consider environmental justice-related issues.

List of Subjects in 40 CFR Part 26

    Environmental protection, Human research subjects, Reporting and 
recordkeeping requirements.

    Dated: June 20, 2006.
 Stephen L. Johnson.
Administrator.

0
Therefore, it is proposed that 40 CFR chapter I be amended as follows:

PART 26--[AMENDED]

    1. The authority citation for part 26 continues to read as follows:

    Authority: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1); 21 U.S.C. 
346a(e)(1)(C); section 201 of Public Law No. 109-54; and 42 U.S.C. 
300v-1(b).

    2. By revising the heading of subpart B to read as follows:

Subpart B--Prohibition of Research Conducted or Supported by EPA 
Involving Intentional Exposure of Human Subjects who are Children 
or Pregnant or Nursing Women

    3. By revising Sec.  26.203 to read as follows:

Sec.  26.203  Prohibition of research conducted or supported by EPA 
involving intentional exposure of any human subject who is a pregnant 
woman (and therefore her fetus), a nursing woman, or child.

    Notwithstanding any other provision of this part, under no 
circumstances shall EPA conduct or support research involving 
intentional exposure of any human subject who is a pregnant woman (and 
therefore her fetus), a nursing woman, or a child.
    4. By revising the heading of subpart K to read as follows:

Subpart K--Basic Ethical Requirements for Third-Party Human 
Research for Pesticides Involving Intentional Exposure of Non-
pregnant, Non-nursing Adults

    5. By revising the heading of subpart L to read as follows:

Subpart L--Prohibition of Third-Party Research for Pesticides 
Involving Intentional Exposure of Human Subjects who are Children 
or Pregnant or Nursing Women

    6. By revising Sec.  26.1203 to read as follows:

Sec.  26.1203  Prohibition of research involving intentional exposure 
of any human subject who is a pregnant woman (and therefore her fetus), 
a nursing woman, or a child.

    Notwithstanding any other provision of this part, under no 
circumstances shall a person conduct or support research covered by 
Sec.  26.1201 that involves intentional exposure of any human subject 
who is a pregnant woman (and therefore her fetus), a nursing woman, or 
a child.
    7. By revising Sec.  26.1703 to read as follows:

Sec.  26.1703  Prohibition of reliance on research involving 
intentional exposure of human subjects who are pregnant women (and 
therefore their fetuses), nursing women, or children.

    Except as provided in Sec.  26.1706, in actions within the scope of 
Sec.  26.1701 EPA shall not rely on data from any research involving 
intentional exposure of any human subject who is a pregnant woman (and 
therefore her fetus), a nursing woman, or a child.
    8. By revising the heading of Sec.  26.1704 to read as follows:

Sec.  26.1704  Prohibition of reliance on unethical human research with 
non-pregnant, non-nursing adults conducted before April 7, 2006.

    9. By revising the heading of Sec.  26.1705 to read as follows:

Sec.  26.1705  Prohibition of reliance on unethical human research with 
non-pregnant, non-nursing adults conducted after April 7, 2006.

[FR Doc. 06-5648 Filed 6-22-06; 8:45 am]

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