Description
Innovation with respect to emerging technologies --such as nanotechnology, synthetic biology, and genetic engineering, among others --requires not only coordinated research and development but also appropriate and balanced oversight.
Office of Science and United States Administrator
Technology Policy Trade Representative Office of Information and
Regulatory Affairs
March 11,2011
MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES
FROM: John P. Holdren \1Ji----
Assistant to the and Technology
Director, Office of Science and Technology Policy
Cass R. Sunstein (l Y
Administrator, Office of Information and Regulatory Affairs
Office of Management 'and Budget
Islam A. Siddiqui
Chief Agricultural - :c:::J
United States Trade Representative
SUBJECT: Principles for Regulation and Oversight of Emerging
Technologies
Innovation with respect to emerging technologies -- such as nanotechnology, synthetic
biology, and genetic engineering, among others -- requires not only coordinated research
and development but also appropriate and balanced oversight. The White House
Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has
developed the following broad principles, consistent with Executive Order 13563, to
guide the development and implementation of policies for oversight of emerging
technologies at the agency level.
We share a fundamental desire for regulation.and oversight that ensure the fulfillment of
legitimate objectives such as the prqtectio,fi,q{safety, health, and the environment.
Regulation and oversight should avoid inhibiting innovation, stigmatizing
new technologies, or creating trade balTiers.
To advance these goals, the following principles, consistent with Executive Order 13563
and discussed and approved by the ETIPC, should be respected to the extent permitted by
law:
Scientific Integrity: Federal regulation and oversight of emerging technologies should be
based on the best available scientific evidence. Adequate information should be sought
and developed, and new knowledge should be taken into account when it becomes
1
[': .
available. To the extent feasible, purely scientific judgments should be separated from
judgments of policy.
Public Participation: To the extent feasible and subject to valid constraints (involving,
for example, national security and confidential business information), relevant
information should be developed with ample opportunities for stakeholder involvement
and public participation. Public participation is important for promoting accountability,
for improving decisions, for increasing trust, and for ensuring that officials have access to
widely dispersed information.
Communication: The Federal Government should actively communicate information to
the public regarding the potential benefits and risks associated with new technologies.
Benefits and costs: Federal regulation and oversight of emerging technologies should be
based on an awareness of the potential benefits and the potential costs of such regulation
and oversight, including recognition of the role of limited information and risk in
decision making.
Flexibility: To the extent practicable, Federal regulation and oversight should provide
sufficient flexibility to accommodate new evidence and learning and to take into account
the evolving nature of infOlmation related to emerging technologies and their
applications.
Risk Assessment and Risk Management: Risk assessment should be distinguished from
risk management. The Federal Government should strive to reach an appropriate level of
consistency in risk assessment and risk management across various agencies and offices
and across various technologies. Federally mandated risk management actions should be
appropriate to, and commensurate with, the degree of risk identified in an assessment.
Coordination: Federal agencies should seek to coordinate with one another, with state
authorities, and with stakeholders to address the breadth of issues, including health and
safety, economic, environmental, and ethical issues (where applicable) associated with
the commercialization of an emerging technology, in an effort to craft a coherent
approach. There should be a clear recognition of the statutory limitations of each Federal
and state agency and an effort to defer to appropriate entities when attempting to address
the breadth of issues.
International Cooperation: The Fec;:leral should encourage coordinated and
,. " " I . .,
collaborative research across the internatioruil community. It should clearly
communicate the regulatory approaches and understanding of the United States to other
nations. It should promote infOlmed choices and both sharing and development of
relevant data, particularly with respect to the benefits and costs of regulation and
oversight. The Federal Government should participate in the development of
international standards, consistent with U.S. law and guidance (e.g., the National
Technology Transfer and Advancement Act and OMB Circular A-119). When
appropriate, international approaches should be coordinated as far in advance as possible,
to help ensure that such approaches are consistent with these principles.
Regulation: The Federal Government adhere to Executive Order 13563 and,
consistent with that Executive Order, tliefOllowing'principles, to the extent permitted by
law, when regulating emerging ,.,
• Decisions should be based on the best reasonably obtainable scientific, technical,
economic, and other information, within the boundaries of the authorities and
mandates of each agency;
• Regulations should be developed with a firm commitment to fair notice and to
public participation;
• The benefits of regulation should justify the costs (to the extent permitted by law
and recognizing the relevance of uncertainty and the limits of quantification and
monetary equivalents);
• Where possible, regulatory approaches should promote innovation while also
advancing regulatory objectives, such as protection of health, the environment,
and safety;
• When no significant oversight issue based on a.sufficiently distinguishing
attribute of the technology can be agencies
should consider the option not to regulate';
• Where possible, regulatory approaches should be performance-based and provide
predictability and flexibility in the face of fresh evidence and evolving
infOlmation; and
• Regulatory approaches shall comply with established requirements and guidance
such as the following:
o Executive Order 13563 - Improving Regulation and Regulatory Review.
Federal Register, Vol. 76, No. 14, Friday, January 21, 2011, 3821-3823,
available athttp://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-
1385.pdf;
o Executive Order 12866 - Regulatory Planning and Review. Federal
Register Vol. 58, No. 190, Monday, October 4, 1993, 51735-51744,
available athttp://www.whitehouse.gov/omb/inforeg/e012866.pdf;
t :-:"Ci'
o Information Quality Act 515 of the Treasury and General
Government Appl;opriations Act for FY 2001, Pub. L. No. 106-554);
InfOlmation Quality Guidelines: OMB (2002) Guidelines for Ensuring
and Maximizing the Quality, Objectivity, Utility, and Integrity of
3
InfOlmation Disseminated by Federal Agencies (2002), 67 Fed. Reg. 8452
(Feb. 22, 2002), available at http://www.whitehouse.gov/omb/fedreg/reproducible2.pdf;
o National Technology Transfer and Advancement Act of 1995
("NTTAA"). Public Law 104-113, available at http://standards.gov/standards gov/nttaa.cfm;
o Office of Management and Budget (OMB) Circular A-119, Transmittal
Memorandum, Federal Participation in the Development and Use of
Voluntary Standards (02/1 0/1998), available at http://www.whitehouse.gov/omb/circulars/aI19/aI19.html;
o OMB Final Information Quality Bulletin for Peer Review (December 16,
2004), available at http://www.whitehouse.gov/omb/memorandalfy2005/m05-03.pdf;
o OMB Bulletin No. 07-02 (M-07-07), Issuance of OMB's "Final Bulletin
for Agency Good Guidance Practices" (January 18,2007), available at http://www.whitehouse.gov/omb/memorandalfy2007Im07-07 .pdf;
o OMB/OSTP Memorandum: M-07-24, Updated Principles for Risk
Analysis (September 19, 2007), available at http://www.whitehouse. gov I omb/memorandalfy2007 /m07 -24. pdf;
o The Trade Agreements Act of 1979, as amended (Pub.L. 96-39, 93 Stat.
144, enacted July 26, 1979, codified at 19 U.S.C. ch.13 (19 U.S.C. §
2501-2581); ,
.:
c' "
o "A Strategy for Innovation: Driving Towards Sustainable
Growth and Quality Jobs" (September 2009), available at: http://www.whitehouse. gov Iassetsl documents/SEPT 20 Innovation Whi
tepaper FINAL.pdf; and
o Office of Information and Regulatory Affairs, Disclosure and Information
As Regulatory Tools (June 18, 2010), available at http://www.whitehouse.gov/sites/default/files/omb/assets/inforeg/disclosur
e principles.pdf
" \"
doc_864259396.pdf
Innovation with respect to emerging technologies --such as nanotechnology, synthetic biology, and genetic engineering, among others --requires not only coordinated research and development but also appropriate and balanced oversight.
Office of Science and United States Administrator
Technology Policy Trade Representative Office of Information and
Regulatory Affairs
March 11,2011
MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES
FROM: John P. Holdren \1Ji----
Assistant to the and Technology
Director, Office of Science and Technology Policy
Cass R. Sunstein (l Y
Administrator, Office of Information and Regulatory Affairs
Office of Management 'and Budget
Islam A. Siddiqui
Chief Agricultural - :c:::J
United States Trade Representative
SUBJECT: Principles for Regulation and Oversight of Emerging
Technologies
Innovation with respect to emerging technologies -- such as nanotechnology, synthetic
biology, and genetic engineering, among others -- requires not only coordinated research
and development but also appropriate and balanced oversight. The White House
Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has
developed the following broad principles, consistent with Executive Order 13563, to
guide the development and implementation of policies for oversight of emerging
technologies at the agency level.
We share a fundamental desire for regulation.and oversight that ensure the fulfillment of
legitimate objectives such as the prqtectio,fi,q{safety, health, and the environment.
Regulation and oversight should avoid inhibiting innovation, stigmatizing
new technologies, or creating trade balTiers.
To advance these goals, the following principles, consistent with Executive Order 13563
and discussed and approved by the ETIPC, should be respected to the extent permitted by
law:
Scientific Integrity: Federal regulation and oversight of emerging technologies should be
based on the best available scientific evidence. Adequate information should be sought
and developed, and new knowledge should be taken into account when it becomes
1
[': .
available. To the extent feasible, purely scientific judgments should be separated from
judgments of policy.
Public Participation: To the extent feasible and subject to valid constraints (involving,
for example, national security and confidential business information), relevant
information should be developed with ample opportunities for stakeholder involvement
and public participation. Public participation is important for promoting accountability,
for improving decisions, for increasing trust, and for ensuring that officials have access to
widely dispersed information.
Communication: The Federal Government should actively communicate information to
the public regarding the potential benefits and risks associated with new technologies.
Benefits and costs: Federal regulation and oversight of emerging technologies should be
based on an awareness of the potential benefits and the potential costs of such regulation
and oversight, including recognition of the role of limited information and risk in
decision making.
Flexibility: To the extent practicable, Federal regulation and oversight should provide
sufficient flexibility to accommodate new evidence and learning and to take into account
the evolving nature of infOlmation related to emerging technologies and their
applications.
Risk Assessment and Risk Management: Risk assessment should be distinguished from
risk management. The Federal Government should strive to reach an appropriate level of
consistency in risk assessment and risk management across various agencies and offices
and across various technologies. Federally mandated risk management actions should be
appropriate to, and commensurate with, the degree of risk identified in an assessment.
Coordination: Federal agencies should seek to coordinate with one another, with state
authorities, and with stakeholders to address the breadth of issues, including health and
safety, economic, environmental, and ethical issues (where applicable) associated with
the commercialization of an emerging technology, in an effort to craft a coherent
approach. There should be a clear recognition of the statutory limitations of each Federal
and state agency and an effort to defer to appropriate entities when attempting to address
the breadth of issues.
International Cooperation: The Fec;:leral should encourage coordinated and
,. " " I . .,
collaborative research across the internatioruil community. It should clearly
communicate the regulatory approaches and understanding of the United States to other
nations. It should promote infOlmed choices and both sharing and development of
relevant data, particularly with respect to the benefits and costs of regulation and
oversight. The Federal Government should participate in the development of
international standards, consistent with U.S. law and guidance (e.g., the National
Technology Transfer and Advancement Act and OMB Circular A-119). When
appropriate, international approaches should be coordinated as far in advance as possible,
to help ensure that such approaches are consistent with these principles.
Regulation: The Federal Government adhere to Executive Order 13563 and,
consistent with that Executive Order, tliefOllowing'principles, to the extent permitted by
law, when regulating emerging ,.,
• Decisions should be based on the best reasonably obtainable scientific, technical,
economic, and other information, within the boundaries of the authorities and
mandates of each agency;
• Regulations should be developed with a firm commitment to fair notice and to
public participation;
• The benefits of regulation should justify the costs (to the extent permitted by law
and recognizing the relevance of uncertainty and the limits of quantification and
monetary equivalents);
• Where possible, regulatory approaches should promote innovation while also
advancing regulatory objectives, such as protection of health, the environment,
and safety;
• When no significant oversight issue based on a.sufficiently distinguishing
attribute of the technology can be agencies
should consider the option not to regulate';
• Where possible, regulatory approaches should be performance-based and provide
predictability and flexibility in the face of fresh evidence and evolving
infOlmation; and
• Regulatory approaches shall comply with established requirements and guidance
such as the following:
o Executive Order 13563 - Improving Regulation and Regulatory Review.
Federal Register, Vol. 76, No. 14, Friday, January 21, 2011, 3821-3823,
available athttp://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-
1385.pdf;
o Executive Order 12866 - Regulatory Planning and Review. Federal
Register Vol. 58, No. 190, Monday, October 4, 1993, 51735-51744,
available athttp://www.whitehouse.gov/omb/inforeg/e012866.pdf;
t :-:"Ci'
o Information Quality Act 515 of the Treasury and General
Government Appl;opriations Act for FY 2001, Pub. L. No. 106-554);
InfOlmation Quality Guidelines: OMB (2002) Guidelines for Ensuring
and Maximizing the Quality, Objectivity, Utility, and Integrity of
3
InfOlmation Disseminated by Federal Agencies (2002), 67 Fed. Reg. 8452
(Feb. 22, 2002), available at http://www.whitehouse.gov/omb/fedreg/reproducible2.pdf;
o National Technology Transfer and Advancement Act of 1995
("NTTAA"). Public Law 104-113, available at http://standards.gov/standards gov/nttaa.cfm;
o Office of Management and Budget (OMB) Circular A-119, Transmittal
Memorandum, Federal Participation in the Development and Use of
Voluntary Standards (02/1 0/1998), available at http://www.whitehouse.gov/omb/circulars/aI19/aI19.html;
o OMB Final Information Quality Bulletin for Peer Review (December 16,
2004), available at http://www.whitehouse.gov/omb/memorandalfy2005/m05-03.pdf;
o OMB Bulletin No. 07-02 (M-07-07), Issuance of OMB's "Final Bulletin
for Agency Good Guidance Practices" (January 18,2007), available at http://www.whitehouse.gov/omb/memorandalfy2007Im07-07 .pdf;
o OMB/OSTP Memorandum: M-07-24, Updated Principles for Risk
Analysis (September 19, 2007), available at http://www.whitehouse. gov I omb/memorandalfy2007 /m07 -24. pdf;
o The Trade Agreements Act of 1979, as amended (Pub.L. 96-39, 93 Stat.
144, enacted July 26, 1979, codified at 19 U.S.C. ch.13 (19 U.S.C. §
2501-2581); ,
.:
c' "
o "A Strategy for Innovation: Driving Towards Sustainable
Growth and Quality Jobs" (September 2009), available at: http://www.whitehouse. gov Iassetsl documents/SEPT 20 Innovation Whi
tepaper FINAL.pdf; and
o Office of Information and Regulatory Affairs, Disclosure and Information
As Regulatory Tools (June 18, 2010), available at http://www.whitehouse.gov/sites/default/files/omb/assets/inforeg/disclosur
e principles.pdf
" \"
doc_864259396.pdf