![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Protections for Subjects in Human Research; Nursing Women
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
? 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]
BILLING CODE 6560-50-S