Manufacturing Today - November/December 2016 - 14

14

SPACE TECH EXPO

and USDA identified areas where additional work is needed, including the
key commitments listed above.
The White House states that these
ongoing and future activities, along
with the commitment from the agencies to report annually on implementation progress, provide direction
for the federal regulatory system for
biotechnology products to keep pace
with all of the advances in science and
technology.

S U S TA I N A B I L I T Y

M A N U FA C T U R I N G

C ANADA MANUFACTURING

SERVICE

> EPA and FDA intend to clarify
their respective approaches for
oversight of products developed
using genome editing techniques,
including, for example, pesticidal
products at EPA and genetically
engineered animals at FDA;
> EPA, FDA and USDA will continue
to examine their regulatory structures with the goal of clarifying
how the federal government will
regulate genetically engineered
insects in an integrated and coordinated fashion to cover the full
range of potential products;
> EPA, FDA and USDA commit to
reporting annually, for at least the
next five years, on specific steps
that they are taking to implement
the National Strategy, as well as
any additional actions being taken to improve the transparency,
predictability, and efficiency of
biotechnology regulation and the
coordination among the regulatory agencies;
> EPA, FDA and USDA will continue
to provide leadership in international fora to promote scientific
competency, understanding of the

L E A N

AH
S R EXPO 2016

P RO F I TA B I L I T Y

COLUMN BY | LYNN L. BERGESON

manufacturing-today.com NOVEMBER/DECEMBER 2016

U.S. regulatory approach, and regulatory compatibility worldwide
for biotechnology products; and
> EPA, FDA, and USDA commissioned a study by the National
Academies of Science, Engineering and Medicine (NAS) entitled
"Future Biotechnology Products
and Opportunities to Enhance
Capabilities of the Biotechnology
Regulatory System." The forthcoming report will be used by EPA,
FDA and USDA to inform ongoing
and future agency activities.

Continued Engagement
The White House acknowledges that
while the proposed update to the
Coordinated Framework and the
national strategy represent major
steps forward in modernizing the
regulatory system for biotechnology
products, there is more work to be
done. While prefacing its overview
with the statement that the current
federal regulatory system effectively
protects health and the environment,
advances in science and technology
necessitate change.
In the National Strategy, EPA, FDA

in the national
strategy, the federal agencies demonstrated their commitment to ensuring
the safety of future
biotech products.
The update represents a useful first
step in a process that urgently needs
to continue into the next administration. The work to date nicely lays out a
blueprint for action that stakeholders
can only hope will be a priority for the
next administration.
The White House seeks continued
engagement from key stakeholders
regarding this. These including public and private organizations such as
companies, universities and research
institutes, trade associations, scientific societies, foundations, consumer
organizations, non-profits and individual citizens. mt
Lynn L. Bergeson is Managing Partner of Bergeson
& Campbell, P.C. (B&C®), a Washington, D.C. law firm
focusing on conventional, nanoscale, and biobased
industrial, agricultural, and specialty chemical product
regulation and approval matters, environmental health
and safety law, chemical product litigation, and associated business counseling and litigation issues. She is
President of The Acta Group, with offices in Washington,
D.C., Manchester, UK, and Beijing, China, and President
of B&C® Consortia Management, L.L.C. (BCCM), with
offices in Washington, D.C.


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Table of Contents for the Digital Edition of Manufacturing Today - November/December 2016

Table Of Contents
Manufacturing Today - November/December 2016 - Cover1
Manufacturing Today - November/December 2016 - Cover2
Manufacturing Today - November/December 2016 - 1
Manufacturing Today - November/December 2016 - Table Of Contents
Manufacturing Today - November/December 2016 - 3
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Manufacturing Today - November/December 2016 - Cover3
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