On FDA GAPs revisions - the questions

The planned update and revisions to FDA's Good Agricultural Practices guidance bring to mind several questions as the industry prepares to engage again with the agency.

Here are the questions that FDA has asked in their notice of rule making:

FDA Question#1:. Should any future GAPs/GMPs Guide rank or prioritize among potential issues according to relative risk or importance? If yes, please offer suggestions of how that information could be presented in a way that does not detract from the broad scope of the current guidance.


TK: Tom Stenzel of United and Hank Giclas of Western Growers note that the response to this question will be important, for the agency may create interventions or guidance on the basis of industry responses. Whereas the current guidance may be considered "generic" in some respects, the agency may want more specifics:

Hank Giclas said this to me about the FDA update:

"I would anticipate - especially given the fact that FDA is looking at third party accreditation and looking at the breadth and scope of how GAPs are implemented ... and from a leadership perspective, they are calling for authority to issue mandatory GAPs, I would anticipate there will be a move to make the guidelines more specific in many areas."


Tom Stenzel said this about this question:

"Is there a way to rank the relative risk. That's a good question. That (risk question ) targets toward regulatory action or some kind of intervention takes place if there is consensus."



FDA Question #2 : How should the GAPs/GMPs Guide be organized to enhance its usefulness?


FDA Question #3: While the GAPs/GMPs Guide has been generally accepted and widely adopted, we know that there are entities in the fresh produce industry that are not aware of it. What measures can be taken,and by whom, to expand awareness by the fresh produce industry of the GAPs/GMPs guide?

Tom Stenzel says:

"To me that i is just a clear signal that if we can't say 100% of the industry is complying with basic GAPs, does it it call for mandatory regulation?. There are some hooks in their questions. So we will have to be careful and scientific in how we respond to those."


FDA Question #4: How should the GAPs/GMPs Guide be modified to motivate all operations to implement? Please include information on economic impact.


TK: A leading question...making them mandatory, perhaps?



FDA Question #5: Can the GAPs/GMPs Guide be applied equally to, and implemented by, domestic and foreign growers and packers? if not, should the GAPs/GMPs Guide be revised to incorporate additional options or special considerations (e.g., utilizing draft animals for agricultural tasks) for application and implementation?

TK: For example, can the Amish use horse-drawn wagons at harvest and be in compliance?


FDA Question: #6: Is there a need for additional guidance to assist an operator in determining which provisions of the current Good Manufacturing Practice regulations (e.g. post harvest water quality, disease control, cleanliness and supervision) could be implemented voluntarily for operations that currently are excluded under Sec. 110.19? If so, which ones?


TK: End of the exclusion for GMP compliance for whole produce packers?


FDA Question #7 Should the GAPs/GMPs Guide recommend that growers and other relevant operations develop a written food safety plan, written SOPs, and/or written SSOPs? If so, please describe the types of information or recommendations that you believe would be helpful.


FDA Question #8: Records can be divided into the following two broad groups: 1) records to facilitate traceback, and 2) non-tracebook or operational records. Does the GAPs/GMPs Guide provide sufficient recommendations regarding record keeping? If not, please describe what would be most helpful and why.


TK: Traceability rears its head again.


FDA Question #9 The recent produce safety initiatives concerning leafy greens and tomatoes highlighted the importance of performing environmental assessments before planting, throughout production and prior to harvest. Would it be useful to enhance coverage of thee concepts in the GAPs/GMPs guide?

TK: Can science based numbers be established for environmental assessments?
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FDA Question # 10. Several newer produce safety programs, such as the California Leafy Green Products Handler Marketing Agreement (Ref. 8), incorporate recommendations (or requirements) for microbial testing. Does the information on microbial testing in the GAPs/GMPs Guide provide sufficient information?

FDA Question # 11. Some comments submitted in connection with the 2007 public hearings expressed concerns that field management activities intended to minimize microbial hazards, such as removing vegetation to reduce animal harborage near the production field, could have a negative, albeit unintended, impact on the environment and water sheds, among other areas. What data support these concerns? Could/should the GAPs/GMPs Guide do more to identify, address, and possibly mitigate unintended environmental consequences of food safety measures?

FDA Question # 12. Are there existing regulatory requirements at the Federal, State, or local level that act as a disincentive (or as an incentive) for growers or other operators to implement agricultural or manufacturing practices that should be taken into consideration when updating this guidance to reduce the risk of microbial contamination of fresh produce? If yes, please identify and explain.