Protections for Subjects in Human Research; Nursing Women
[Federal Register: June 23, 2006 (Volume 71, Number 121)]
[Rules and Regulations]
[Page 36171-36176]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn06-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 26
[EPA-HQ-OPP-2003-0132; FRL-8071-6]
RIN 2070-AD57
Protections for Subjects in Human Research; Nursing Women
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is taking direct final action to explicitly ban research
for pesticides involving intentional exposure of human subjects who are
nursing women, and therefore providing protection to any nursing
infants who may also be exposed. The direct final rule also prohibits
EPA reliance in actions under the pesticide laws on research involving
intentional exposure of nursing women.
DATES: This direct final rule is effective on August 22, 2006 without
further notice, unless EPA receives adverse comment on or before July
24, 2006. If EPA receives adverse comments to the direct final rule,
EPA will publish a timely withdrawal document in the Federal Register
informing the public that this direct final rule rule will not take effect.
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
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2003-0132. EPA's policy is that all comments received will be included
in the 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
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., 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. What Does this Direct Final Rule Do?
With this direct final rule, EPA clarifies the protections for
subjects of ``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'') by prohibiting new research
involving intentional exposure of nursing women, intended for
submission to EPA under the pesticide laws, thereby providing
protection to any nursing infants who may also be exposed. This direct
final rule also prohibits any EPA research involving intentional
exposure of human subjects who are nursing women to pesticides or any
other substances. (Research conducted by EPA is referred to as ``first-
party'' research, and ``second-party'' research refers to research
supported by EPA but performed by others. ``Third-party'' research
refers to any research that is not ``first-party'' or ``second-party''
research.) Finally, this rule prohibits EPA reliance, in actions under
the pesticide laws, on human research involving intentional exposure of
nursing women as subjects.
B. Legal Authority
This direct final rule is authorized under provisions of the
following statutes that EPA administers: Section 25(a) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136-
136y), which authorizes the Administrator to ``prescribe regulations to
carry out the purposes of [FIFRA],'' and section 408(e)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a). FFDCA
authorizes the Administrator to issue a regulation establishing
``general procedures and requirements to implement [Section 408].'' In
addition, the portions of this regulation supplementing EPA's
codification of the Common Rule regarding first- and second-party
research are authorized pursuant to 5 U.S.C. 301 and 42 U.S.C. 300v-1(b).
This direct final rule amends the recently promulgated
``Protections for Subjects in Human Research Rule'' (hereinafter
referred to as the ``January 2006 rule'') to extend critical
protections for human research subjects contained in that rule to
nursing women and their nursing children. The January 2006 rule
published in the Federal Register on February 6, 2006 (71 FR 6138)
(FRL-7759-8). EPA is publishing this direct final rule without prior
proposal because the Agency believes that these amendments are non-
controversial and does not expect to receive adverse comments.
Nevertheless, EPA is also publishing a separate document in the
``Proposed Rules'' section of this issue of the Federal Register that
serves as the proposal to extend these critical protections for
subjects of human
[[Page 36173]]
research to nursing women and their nursing children, in the event that
adverse comments are submitted to EPA on or before July 24, 2006.
This direct final rule is effective on August 22, 2006 without
further notice, unless EPA receives comments that are adverse to the
direct final rule on or before July 24, 2006. If EPA receives comments
that are adverse to this direct final rule, the Agency will publish a
timely withdrawal document in the Federal Register informing the public
that the direct final rule will not take effect on August 22, 2006. EPA
will then address all public comments received in a subsequent final
rule based on the proposed rule that is published in the ``Proposed
Rules'' section of this issue of the Federal Register. The Agency 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 by the date indicated in this unit and in the proposed rule.
C. 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.
D. 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. EPA's January 2006 Promulgation of Protections for Subjects of
Human Research
On January 26, 2006, EPA issued a final rule significantly
strengthening and expanding the protections for subjects of human
research. 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.
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
decisionmaking under the pesticide laws involving reliance on the
results of completed intentional dosing human research.
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. The
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 this action, 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
[[Page 36174]]
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 Direct Final Rule
FIFRA section 25(a)(2)(B) provides: ``[a]t least 30 days prior to
signing any regulation in final form for publication in the Federal
Register, the Administrator shall provide the Secretary of Agriculture
a copy of such regulation.'' This section also authorizes the Secretary
to waive the opportunity to review and comment on final regulations.
FIFRA section 25(d)(1) states that ``[t]he Administrator shall submit
to an advisory panel for comment [the]
final form of regulations issued
under section 25(a) within the same time periods as provided for the
comments of the Secretary of Agriculture . . .'' This subsection also
authorizes the FIFRA Scientific Advisory Panel (SAP) to waive the
opportunity for review. Both, the FIFRA SAP and the U.S. Department of
Agriculture (USDA) have waived the opportunity under FIFRA to review
the direct final rule.
In addition, FIFRA section 25(a)(3) states that ``[a]t such time as
the Administrator is required under paragraph (2) to provide the
Secretary of Agriculture with . . . a copy of the final form of
regulations, the Administrator shall also furnish a copy of such
regulations to the 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)(B), EPA is not required to furnish a copy
of the final regulations to the specified committees 30 days prior to
signature of the direct final 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 direct final rule is not a
``significant regulatory action'' under section 3(f) of the Executive
Order.
The amendments contained in this 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 rule.
Based on the relatively small economic impact of the January 2006
rule, EPA believes that this direct final rule will have a minimal--if
any--impact on industry, regardless of the size of the entity.
B. Paperwork Reduction Act
This 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 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 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 direct
final rule, 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.
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 this direct final 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 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 direct final
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 rule. EPA has determined that this 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 direct
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final 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 rule. EPA has determined that this 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 rule because this action is not
designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866. Furthermore, this 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 rule.
H. Executive Order 13211
This 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 rule does
not have any significant adverse effect on the supply, distribution, or
use of energy.
I. National Technology Transfer and Advancement Act
This rule does not impose any technical standards that would
require Agency consideration of 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 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.
VI. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report that includes a copy of the rule to
each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
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, 40 CFR chapter I is 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:
[[Page 36176]]
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. 06-5649 Filed 6-22-06; 8:45 am]
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