FSMA is a landmark law that will impact the food industry for years. The “Request for Comment” process is an important way for you to contribute to how FSMA will be implemented.
The previous post provided a primer on the underlying Food Fraud/ Economically Motivated Adulteration concepts in the current FSMA Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food [FDA-2011-N-0920]. This was released on January 16, 2013 and comments are due May 16, 2013. The Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption [FDA-2011-N-0921] document was simultaneously released and has comments due at the same time.
This post will provide instructions on how you can respond to the FDA request. We will also present the questions related to Food Fraud in the FSMA documents (over 1,200 pages combined).
The Federal Register. Agencies post formal documents, new rulemaking, or request for comments on the Federal Register. This is the “Daily Journal of the United States Government” and it is updated daily. This is the formal way the US government communicates with the public.
Regulations.gov. This is the system for interested parties to formally submit comments to the US government.
To submit a response, first search the Federal Register for a document. Then click on “Submit a Formal Comment”. You will be taken to the Regulations.gov site where you will be prompted to create an ID and then upload your comments.
Now that we have reviewed the process to find and respond to the request for comments we will review the content of the documents. FDA stated “Intentional Adulteration” (Food Defense attacks and Economically Motivated Adulteration) is intended to be directly addressed in a future regulatory guidance document but they do begin the discussion on the topic now.
Here is specific text from the first FDA document (specific request for comments are in bold):
- II.B.1.f. Animal food and intentional adulteration. (p. 54)
- “In addition, this rulemaking is not intended to address “hazards that may be intentionally introduced, including by acts of terrorism.” (§ 418(b)(2) of the FD&C Act). FDA plans to implement section 103 of FSMA regarding such hazards in a separate rulemaking in the future.”
- “FDA tentatively concludes that intentional hazards, which are not addressed in traditional HACCP or other food safety systems, likely will require different kinds of controls and would be best addressed in a separate rulemaking.”
- “However, we also recognize that some kinds of intentional adulterants could be viewed as reasonably likely to occur, e.g., in foods concerning which there is a widely recognized risk of economically motivated adulteration in certain circumstances. An example of this kind of hazard is the addition of melamine to certain food products apparently to enhance perceived quality and/or protein content.”
- “We request comment on whether to include potential hazards that may be intentionally introduced for economic reasons.”
- “We also request comment on when an economically motivated adulterant can be considered reasonably likely to occur.”
Here is specific text from the second FDA document (specific request for comments are in bold):
- IV.D, Framework of the Rule
- “However, we request comment on whether we should include standards related to preventing economically motivated intentional adulteration of produce in this rule.”
- “Is economically motivated adulteration of produce reasonably likely to occur and, if so,”
- “by what mechanisms may potential hazards be intentionally introduced in produce for economic reasons?”
- “If such adulteration is reasonably likely to occur, what standards should FDA consider for preventing such adulteration?”
- FDA made clear they consider a need of separate plans for Food Quality, Food Safety, and Food Defense (including Economically Motivated Adulteration). “To make clear that the written plan is related to food safety rather than to other plans a facility may have (such as quality control plans or food defense plans), we have designated the “written plan” to be a “food safety plan.”( FDA-2011-N-0920, VII.A.2, p.299)
- FDA provided further insight that “intentional hazards likely will require different kinds of controls and would be best addressed in a separate rulemaking.”( FDA-2011-N-0921, p. 60) • The original FSMA law text mentioned “Intentional Adulteration” and not “Economically Motivated Adulteration.” The Request for Comment made clear that FDA is addressing Economically Motivated Adulteration in FSMA. Previously the EMA term was used and defined not in a law or guidance document but only in a Federal Register notice.
- There will be a specific regulatory focus – though probably not defined in detail – of addressing “reasonably foreseeable hazards.” This will apply to Food Fraud.
- Food Fraud is entrenched in FSMA. Food Fraud Prevention is here to stay.
This is a very important opportunity to engage the US Government. It is an incredible opportunity to help shape the laws that will protect citizens and our economy. Whether you submit comments directly or you go through intermediaries such as trade associations, please make an effort to have your insights known. JWS.