![handle is hein.journals/bothnl36 and id is 1 raw text is: The 2017 Update to the Coordinated Framework
for the Regulation of Biotechnology
By LUCIAN C. CHEN
IN THE WANING DAYS of the Obama administra-
tion, the White House issued the 2017 Update
to the Coordinated Framework for the Regulation
of Biotechnology,' the 30-year-old rubric that eval-
uates the safety of biotechnology products. Three
different agencies perform this evaluation: the Envi-
ronmental Protection Agency (EPA), the Food and
Drug Administration (FDA), and the United States
Department of Agriculture (USDA). The Update,
which issued on January 4, 2017, is intended to clar-
ify the current roles and responsibilities of these
three agencies in regulating biotech products.
Back in July of 2015, the Executive Office of the
President (EOP) directed these primary agencies
to update the Coordinated Framework, which first
issued in 1986, and was updated in 1992. The admin-
istration asked for three tasks to be accomplished:
1. Clarify the current roles and responsibili-
ties of the EPA, FDA, and USDA in the
regulatory process;
2. Develop a long-term strategy to ensure that
the federal regulatory system is equipped to
assess efficiently the risks, if any, of the
future products of biotechnology; and
3. Commission an expert analysis of the fu-
ture landscape of biotechnology products.
In September of 2016, a proposed Update to the
Coordinated Framework was published for public
comment, as well as the National Strategy for Mod-
ernizing the Regulatory System for Biotechnology
Products, which identifies future steps that should
be taken to ensure the regulatory system addresses
novel types of products appropriately.2 These docu-
ments were to demonstrate that these federal agen-
Lucian C. Chen is the Editor-in-Chief of Biotechnology Law
Report.
cies had a sustained commitment to ensuring the
safety of future biotechnology products, increasing
public confidence in the regulatory system, and pre-
venting unnecessary barriers to future innovation
and competitiveness.
The Coordinated Framework clarifies and speci-
fies the role of the three agencies:
The EPA is responsible for protecting human
health and the environment. Under the Federal
Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA regulates pesticides. Under sec-
tion 408 of the Federal Food, Drug, and Cos-
metic Act (FD&C Act), EPA establishes the
amount of pesticide chemical residues that
may be present in food. Under the Toxic Sub-
stances Control Act (TSCA) and regulations
implementing that statute, EPA currently regu-
lates biotechnology products that are new organ-
isms not specifically excluded by the statute
(generally those regulated by other statutes).3
FDA regulates a wide variety of products, in-
cluding human and animal foods (including dietary
supplements), cosmetics, human and veterinary
drugs, human biological products, and medical de-
vices. FDA regulates the safety of human and animal
IMODERNIZING THE REGULATORY SYSTEM FOR BIOTECHNOL-
OGY PRODUCTS: FINAL VERSION OF THE 2017 UPDATE TO
THE COORDINATED FRAMEWORK FOR THE REGULATION OF
BIOTECHNOLOGY (2017), https://obamawhitehouse.archives
.gov/sites/default/files/microsites/ostp/2017_coordinated_
frameworkupdate.pdf [hereinafter 2017 Coordinated Frame
work Update].
2NATIONAL STRATEGY FOR MODERNIZING THE REGULA-
TORY SYSTEM FOR BIOTECHNOLOGY PRODUCTS (Sept.
2016), https://obamawhitehouse.archives.gov/sites/default/
files/microsites/ostp/biotechnationalstrategy_final.pdf
32017 Coordinated Framework Update, supra note 1, at 10.
1
36 Biotechnology Law Report 1
Number 1, 2017
© Mary Ann Liebert, Inc.
DOI: 10.1089/bir.2017.29003.lcc
Prologue](ViewImageLocal?handle=hein.journals/bothnl36&div=1&collection=&method=preview&ext=.png&size=3)
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