Guide to Submitting Written Comments to FDA

A number of people have asked me about submitting comments to the FDA regarding the genetically engineered salmon. I have finally submitted my own public comments on the matter, and I documented the steps so you can follow along. Keep in mind that the FDA will accept comments on this topic until November 22, 2010.

But first let’s talk about the nature of the comments. What is the current state of the FDA approval process? Can my comments actually mean anything? What should I say?

What to Say?
First, I will not tell you what you should say. You will need to have your own opinion, and put that into writing. But I can tell you my understanding of the situation with the FDA.

As mentioned in my previous post, the FDA has already declared that the AquAdvantage Salmon are safe for human consumption. I think this will lead to a decision allowing AquaBounty to sell the genetically modified AquAdvantage Salmon eggs to farms, to be hatched and to eventually become food products.

The part that may still be up in the air is the labeling requirement for the food products made from the genetically modified salmon. The FDA has stated that the salmon eggs must be identified by labels that indicate the genetically engineered nature of the eggs. However, they apparently have not yet decided on whether they will require any specific labeling for the food products that are sold to the public.

Know What We’re Dealing With
I know that some people with whom I’ve been talking have some real concerns about the AquAdvantage Salmon. That’s understandable, as this may be the first genetically modified animal to enter our food supply. As I mentioned above, the FDA has determined that the fish is generally safe to eat, so I think it will enter our food supply. A number of people share my view that in this case, the genetically modified salmon should be labeled so the public can make a conscious decision on whether to consume this product.

Do we have a right to know that a fish is genetically modified just because we want to know?
Apparently the answer to this question is NO.
In the FDA’s Applicable Principles of Labeling Foods in their document Background Document: Public Hearing on the Labeling of Food Made from the AquAdvantage Salmon, principle 5 states

FDA cannot require additional labeling about production methods unless it is necessary to ensure that the labeling is not false or misleading. Another way of stating this point is that FDA cannot require labeling based solely on differences in the production process if the resulting products are not materially different due solely to the production process.

So this is telling us that we don’t have a right to know that a food product is genetically modified, just for the sake of knowing that it’s genetically modified. We only have a right to know if is in some way “materially different” than the non-genetically modified version of the product. Material differences could be differences in appearance, taste, or chemical composition.

My Soapbox
So even though this would be the first genetically engineered animal to enter our food supply, we don’t have the right to know.

And even though a long list of chemical substances were measured, compared to control samples, and evaluated, some of us are concerned about the substances that we don’t know about yet, and therefore could not test for. We would be in favor of a careful, controlled, limited introduction of the first genetically engineered animal to enter our food supply, and careful monitoring to detect unexpected effects. But we seem to be beyond any possibility of this.

And even though the FDA’s decisions on the safety of AquAdvantage Salmon are based on a sample size of only 6 or 7 fish, and the data was gathered and analyzed by or on behalf of the company that stands to profit by the mass commercialization of this product, the FDA seems to be confident enough in the absolute accuracy and reliability of the data to declare it safe for mass public consumption.

This is the situation that we have to live with for now. Our policies and laws are made by career bureaucrats and politicians whose loyalties are determined by money and power. But that’s another subject that I can write about at another time.

So it seems that our last hope is to promote mandatory product labeling, with hope that the public can be aware of what they are eating and make an informed decision on whether to consume the product.

Some Approaches
After reading the FDA’s Briefing Packet on AquAdvantage Salmon, I thought it would be a plausible argument that the AquAdvantage Salmon are materially different than their Atlantic Salmon progenitor, based on higher measured levels of the growth hormone insulin-like growth factor 1 (IGF-1). Therefore, I used this approach in the public comment letter that I submitted to the FDA.

Perhaps a similar case could be made with the FDA’s labeling principle 4, in which “the law requires that the label include a name that accurately describes the basic nature of the food.”

Regardless of your position, this is our opportunity for public comments. The FDA is asking for our comments on this issue. I refer you to several of their web pages on this issue, as well as quote some of the more significant entries. For example, in The Importance of Public Comment to the FDA they state

“People don’t always understand that FDA’s decisions in response to comments aren’t just based on the number of comments, or ‘majority rules,’” says Edwin V. Dutra Jr., director of the FDA’s Regulations Policy and Management Staff. “When a consumer sends in a comment based on sound grounds, that comment can definitely make a difference in the agency’s decision-making.”

So I encourage you to let them know what you’re thinking. But notice the “sound grounds” part of that statement. This refers to the legal labeling principles described in the previously mentioned Background Document: Public Hearing on the Labeling of Food Made from the AquAdvantage Salmon. In a nutshell, this is saying that if you submit a comment stating “The AquAdvantage Salmon food products should be labeled as genetically modified because consumers have a right to know” then your comment will probably be discarded, because it does not address the labeling principles.

Down to Business
OK, so let’s assume you have your comments written out and ready to submit. How do you actually submit them to the FDA?

First let’s cover the physical document.
Here are the basic requirements of the document:

  • Include the agency name
    AGENCY: Food and Drug Administration, HHS.
  • Include the docket number
    Docket No. FDA-2010-N-0385
  • State your sound arguments in a respectful, courteous manner.
  • Include your name and address, as the FDA says they will not accept anonymous comments.

The government document upload site give you two choices for uploading a document:

  1. You can type (or copy & paste) your document into a web form and submit directly from a web page.
  2. You can create a document off-line and upload it complete.

I chose the second option. So that I can have absolute control over the format of the document, I created and uploaded a PDF file. My instructions allow either method.

Here’s the process for submitting your comments to the FDA

  1. In your web browser, go to the Federal Government’s regulations.gov website
  2. Initial Form for Document Submission

  3. Fill out the search form to find the document that you want to comment on:
    1. Select Document Type: Agency Documents
    2. Check Open for Comment/Submission
    3. Enter Keyword or ID: FDA-2010-N-0385
    4. Click Search
    5. Wait for the results page to completely load

    Results of Document Search

  4. Verify the Title: Public Hearings: Food Labeling; Labeling of Food Made From AquAdvantage Salmon
  5. To the right, under Actions Click Submit a Comment
  6. See the Submit a Comment page
    Filled Comment Submission Form

    1. Enter your information
    2. Type or copy & paste your comments and/or select your file to attach.
      1. If attaching a file, click Attach
      2. Optionally Preview your comment, then close the preview window
    3. When everything is correct, click on Submit. This is the Point of No Return!
  7. Finally you will see a status page. Look for “Success” and make note of your comment tracking number.
  8. Results of Comment Submission

© 2010, John Edward Burt. All rights reserved.

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One Response to Guide to Submitting Written Comments to FDA

  1. Pingback: Homegrown Co-op » Blog Archive » Guide to Submitting Written Comments to FDA

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