The U.S. Federal government has taken an important step to ensure public
confidence in the regulatory system for biotechnology products and to
improve the transparency, predictability, coordination, and, ultimately,
efficiency of that system.
In 1986, the White House Office of Science and Technology Policy (OSTP)
issued the Coordinated Framework for the Regulation of Biotechnology, which
outlined a comprehensive Federal regulatory policy for ensuring the safety
of biotechnology products. The Framework was updated in 1992. The oversight
system established by the Coordinated Framework led, in part, to decades of
development and commercialization of biotechnology products with
applications in medicine, agriculture, energy, biomanufacturing, and
environmental protection. It also contributed to the growth of a large and
competitive biotechnology sector in the United States and worldwide.
Advances in science and technology have dramatically altered the
biotechnology landscape since 1992. The complexity of the array of
regulations and guidance documents developed by the three primary Federal
agencies with jurisdiction over biotechnology products-the U.S.
Environmental Protection Agency (EPA), the U.S. Food and Drug Administration
(FDA), and the U.S. Department of Agriculture (USDA)-can make it difficult
for the public to understand how the safety of biotechnology products is
evaluated. Navigating the regulatory process for these products can be
challenging, especially for small companies.
For these reasons, last year the Administration initiated an effort to
modernize the regulatory system for biotechnology products by asking the
EPA, FDA, and USDA, to accomplish three tasks:
clarify the current roles and responsibilities of the EPA, FDA, and USDA in
the regulatory process;
develop a long-term strategy to ensure that the Federal regulatory system is
equipped to efficiently assess the risks, if any, of the future products of
commission an expert analysis of the future landscape of biotechnology
To accomplish these tasks, EPA, FDA, and USDA spent the last 14 months
performing a detailed analysis of the Federal system for regulation of
biotechnology products, including by reviewing more than 900 comments that
were submitted in response to a Request for Information that was posted last
fall, and interacting with members of the public at three public meetings
that were held in different regions of the country.
Clarifying current roles and responsibilities
Today's proposed Update to the Coordinated Framework represents the first
time in 30 years that the Federal government has produced a comprehensive
summary of the roles and responsibilities of the three principal regulatory
agencies with respect to the regulation of biotechnology products. The
proposed update offers the public a complete picture of a robust and
flexible regulatory structure that provides appropriate oversight for all
products of modern biotechnology. Within that regulatory structure the
Federal agencies maintain high standards that, based on the best available
science, protect health and the environment, while also establishing
transparent, coordinated, predictable and efficient regulatory practices.
In order to help product developers and the public understand what the
regulatory pathway for products might look like, this proposed Update to the
Coordinated Framework presents information about agency roles and
responsibilities in several forms, including:
graphics that illustrate agency-specific overviews of regulatory roles;
case studies that demonstrate how a product developer might navigate the
regulatory framework, and;
a comprehensive table that summarizes the current responsibilities and the
relevant coordination across EPA, FDA, and USDA for the regulatory oversight
of an array of biotechnology product areas.
This comprehensive set of information should also give the public the
confidence that products that are making it to market have been
appropriately reviewed for safety.
The Administration is seeking public comment on this proposed Update to the
Coordinated Framework, and will finalize it taking into account comments
received. Once the notice of request for public comment has posted in the
Federal Register, the public will have 40 days from the date of publication
to comment. To submit comments, follow the instructions in the notice.