White House OSTP requests comments on changes to Coordinated Framework

[Antony Evans]

Hello,

Earlier this year the White House asked EPA, USDA and FDA to review the Coordinated Framework on Biotechnology. Yesterday the White House Office of Science and Technology opened comments from the public on their process to make changes. This is the first review of the Coordinated Framework since 1992 so it may be a while till it's reviewed again, it's therefore very important for the DIY Bio community to engage with the process. You can bet big companies and anti-GMO activists are heavily involved in this process and most of them would like less DIY Bio. This comment process is one way for our voices to be heard. Link to submit comments is below.

They have specifically requested comments on the following five questions, but you can submit any kind of comment you want. The more thought out and supported by data the better. Case studies for examples where DIY Bio has been helped or hindered by regulation will be particularly helpful. OSTP seeks answers to these questions:

1. What additional clarification could be provided regarding which biotechnology product areas are within the statutory authority and responsibility of each agency?

2. What additional clarification could be provided regarding the roles that each agency plays for different biotechnology product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment?

3. How can Federal agencies improve their communication to consumers, industry, and other stakeholders regarding the authorities, practices, and bases for decision-making used to ensure the safety of the products of biotechnology?

4. Are there relevant data and information, including case studies, that can inform the update to the CF or the development of the long-term strategy regarding how to improve the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?

5. Are there specific issues that should be addressed in the update of the CF or in the long-term strategy in order to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?

Link to submit comments: http://www.regulations.gov/#!submitComment;D=FDA-2015-N-3403-0001

Regards,

Antony

[Antony Evans]

PS here are suggestion for how to write a good comment:

Overview 

A comment can express simple support or dissent for a regulatory action. However, a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making. These tips are meant to help the public submit comments that have an impact and help agency policy makers improve federal regulations. 

Summary 

 Read and understand the regulatory document you are commenting on 

 Feel free to reach out to the agency with questions 

 Be concise but support your claims 

 Base your justification on sound reasoning, scientific evidence, and/or how you will be impacted 

 Address trade-offs and opposing views in your comment 

 There is no minimum or maximum length for an effective comment 

 The comment process is not a vote – one well supported comment is often more influential than a thousand form letters 

Detailed Recommendations 

1. Comment periods close at 11:59 eastern time on the date comments are due - begin work well before the deadline. 

2. Attempt to fully understand each issue; if you have questions or do not understand a part of the regulatory document, you may ask for help from the agency contact listed in the document. Note: Although the agency contact can answer your questions about the document’s meaning, official comments must be submitted through the comment form. 

3. Clearly identify the issues within the regulatory action on which you are commenting. If you are commenting on a particular word, phrase or sentence, provide the page number, column, and paragraph citation from the federal register document. a. If you choose to comment on the comments of others, identify such comments using their comment ID’s before you respond to them. 

4. If a rule raises many issues, do not feel obligated to comment on every one – select those issues that concern and affect you the most and/or you understand the best. 

5. Agencies often ask specific questions or raise issues in rulemaking proposals on subjects where they are actively looking for more information. While the agency will still accept comments on any part of the proposed regulation, please keep these questions and issues in mind while formulating your comment. 

6. Although agencies receive and appreciate all comments, constructive comments (either positive or negative) are the most likely to have an influence. 

7. If you disagree with a proposed action, suggest an alternative (including not regulating at all) and include an explanation and/or analysis of how the alternative might meet the same objective or be more effective. 

8. The comment process is not a vote. The government is attempting to formulate the best policy, so when crafting a comment it is important that you adequately explain the reasoning behind your position. 

9. Identify credentials and experience that may distinguish your comments from others. If you are commenting in an area in which you have relevant personal or professional experience (i.e., scientist, attorney, fisherman, businessman, etc.) say so. 

10. Agency reviewers look for sound science and reasoning in the comments they receive. When possible, support your comment with substantive data, facts, and/or expert opinions. You may also provide personal experience in your comment, as may be appropriate. By supporting your arguments well you are more likely to influence the agency decision making. 

11. Consider including examples of how the proposed rule would impact you negatively or positively. 

12. Comments on the economic effects of rules that include quantitative and qualitative data are especially helpful. 

13. Include the pros and cons and trade-offs of your position and explain them. Your position could consider other points of view, and respond to them with facts and sound reasoning. 

14. If you are uploading more than one attachment to the comment web form, it is recommend that you use the following file titles: Attachment1_ Attachment2_ Attachment3_ This standardized file naming convention will help agency reviewers distinguish your submitted attachments and aid in the comment review process.  

15. Keep a copy of your comment in a separate file – this practice helps ensure that you will not lose your comment if you have a problem submitting it using the Regulations.gov web form.

Form Letters 

Organizations often encourage their members to submit form letters designed to address issues common to their membership. Organizations including industry associations, labor unions, and conservation groups sometimes use form letters to voice their opposition or support of a proposed rulemaking. Many in the public mistakenly believe that their submitted form letter constitutes a “vote” regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters.