White House Announces Plans To Revise the Coordinated Framework for the Regulation of Biotechnology

by BakerHostetler
Contact

The White House, through the Office of Science and Technology Policy (OSTP), announced a major initiative to overhaul the regulation of biotechnology products (OSTP Memo), which are products developed through genetic engineering (excluding human drugs and medical devices). This initiative, detailed in a memorandum to the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Department of Agriculture (USDA), aims to improve biotechnology regulation by reducing regulatory burdens and improving transparency, predictability, and coordination among regulatory agencies. The new regulatory approach will significantly impact the manner in which biotechnology products are approved, making this initiative an important one to follow.

The FDA, EPA, and USDA currently regulate biotechnology products in accordance with the Coordinated Framework for the Regulation of Biotechnology promulgated in 1986. Generally, FDA regulates the use of biotechnology products as food or food additives; EPA regulates the use of bioengineered products as pesticides or plant incorporated protectants; and USDA regulates (through the Animal and Plant Health Inspection Service) the release into the environment of genetically engineered plants, seeds, and other regulated articles. The OSTP updated the Coordinated Framework in 1992, setting forth a risk-based approach for the oversight of activities that introduce biotechnology products into the environment. This update affirmed that federal oversight should focus on the characteristics of the biotechnology product and the environment into which it is being introduced, rather than the process by which the product is created.

The recently announced initiative is the first major revision in over 20 years. The OSTP acknowledged that a revision is needed because the current system can cause biotechnology product developers to encounter “unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other [issues].” OSTP Memo at 2. These burdens have “limited the ability of small and mid-sized companies to navigate the regulatory process and of the public to understand easily how the safety of these products is assured,” resulting in reduced economic growth, innovation, and competitiveness.

To address these problems, the OSTP details five main developments that will take place over the next year. The first step in the process involves the creation of a new working group consisting of representatives from the Executive Office of the President, EPA, FDA, and USDA. Then, the working group will have one year to clarify the current roles and responsibilities of the regulatory agencies and develop a long-term strategy designed to efficiently assess risks of future biotechnology products while supporting innovation. In designing a regulatory program, the OSTP stresses that the working group must focus on “protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.” OSTP Memo at 4. In addition to the working group’s own study, the EPA, FDA, and USDA also will commission an external, independent analysis of the future landscape of biotechnology products to identify potential new risks and determine how to assess those risks and ascertain areas in which the risks (or lack thereof) relating to the products are well understood.

The remaining two developments are ministerial in nature, requiring the working group to come up with a budget to implement the provisions of the OSTP Memo and to produce an annual progress report detailing the actions taken to improve the regulatory framework. The progress report will be sent to the Executive Office of the President and made available to the public.

Given the breadth of this initiative, it will be important for biotechnology companies to review proposed regulatory revisions and provide the working group with comments. The OSTP Memo directs the working group to involve the public in the review process by seeking “input from the public” before updating the Coordinated Framework. OSTP Memo at 3. Public comments will likely help identify “the best available science” to be used in product evaluations, the “impediments to innovation,” ways to streamline the review and approval process, and which products are or are not regulated. OSTP Memo at 3-4. While there are no current opportunities for public participation, such opportunities will likely arise shortly given the working group’s one-year deadline.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© BakerHostetler | Attorney Advertising

Written by:

BakerHostetler
Contact
more
less

BakerHostetler on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.