Choose Site


Well Done


As part of its continuing implementation of the Food Safety Modernization Act (FSMA), on October 31, the FDA announced the availability of a draft guidance document titled “Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA” (Guidance).

The Guidance is meant to provide industry with more information on the content of the disclosure statements required by four of the seven foundational FSMA rules. Additionally, it identifies the types of documents that would and would not be appropriate vehicles for such disclosure statements.

The four relevant foundational FSMA rules are:

  1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Human PC Final Rule)[1]
  2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Animal PC Final Rule)[2]
  3. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Product Safety Final  Rule)[3]
  4. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (FSVP Final Rule)[4]

Contents and Documents for Disclosure Statements

The above-mentioned FSMA final rules contain provisions that require a disclosure statement to accompany a product in commerce whenever a manufacturer/processor identifies a hazard requiring a preventive control, but in lieu of controlling the identified hazard itself, the manufacturer/processor relies upon another entity in its distribution chain to address the hazard.[5],[6]

The Guidance discusses three types of hazards that would dictate a need for such disclosure statements: biological, physical, and chemical. The suggested statement(s) that should accompany these hazards are as follows:[7]  


Suggested Statement(s)


General terms that describe the hazard (e.g.,“microbial pathogens,” “microorganisms of public health significance”)


Specific terms that adequately communicate the key safety information regarding the chemical or physical hazard that needs to be controlled (e.g., “mycotoxins,” “aflatoxin,” “stones”)


The relevant FSMA final rules require that disclosure statements be made in “documents accompanying the food,” but the rules do not clearly define what types of documents would be appropriate as a vehicle for such disclosures. The Guidance attempts to resolve this point by suggesting a two-factor test to assess the appropriateness of a document:  

  1. Is the document specific to a shipment?
  2. Is the document one which a customer’s food safety manager is likely to have access to?

Examples of documents that would meet this test include labels, bills of lading, and shipment-specific certificates of analysis. Examples of documents that would not meet this test (and therefore are not recommended to be used as vehicles for disclosure statements) include contractual agreements, letters of guarantee, specifications, or terms and conditions.


On August 24, 2016, FDA affirmed that the compliance dates for the disclosure statement provisions remain staggered as specified in the four original final rules.

Next Steps

This Guidance is available for comment until May 1, 2017 [Docket No. FDA-2016-D-2841-0001]. Feel free to reach out to the authors of this post for assistance with comments.

An earlier version of this post incorrectly identified an extension of the compliance date for disclosure statements. We regret the error.





[5] 21 C.F.R. § 117.136(a)(2), (3), and (4) (Human PC Final Rule);  21 C.F.R. 507.36(a)(2), (3), and (4) (Animal PC Final Rule); 21 C.F.R. § 112.2(b) (Product Safety Final Rule);  21 C.F.R § 1.507(a)(2)(i), (a)(3)(i), and (a)(4)( I) (FSVP Final Rule).

[6] An analogous disclosure statement is found in the Product Safety Final Rule wherein “covered produce” (as set forth in 21 C.F.R. § 112.1 and 112.2) may be eligible for the commercial processing exemption articulated in 21 C.F.R. § 112.2(b)(2) if the farm that produces the produce discloses in documents accompanying the produce that the food is “not processed to adequately reduce the presence of microorganisms of public health significance.”

[7] The Guidance does not make these hazard-type distinctions for hazards identified under the Product Safety Final Rule. The Guidance goes on to indicate that a farm that discloses “not processed to adequately reduce the presence of microbial pathogens” or similar phrases would be in compliance with the requirements for the Produce Safety Final Rule disclosure statement.

[8] .