National Editor Tom Karst
National Editor Tom Karst

It goes without saying there is heavy interest in the new proposed food safety rules from the FDA.

The Packer's coverage of the price tag of the produce safety regulation has had several passionate reader comments, revealing that this rulemaking process will be considered by a matter of life and death in both business and personal terms.

Here are a couple of comments on that story:

Chuck from Florida writes:

Americans are to pay $460 million, foreign farms pay$171 million. Over 60% of the fresh
fruits and veg consumed in the US are from foreign farms according to the USDA perhaps
I don't know how to do math but this doesn't calculate! Are American farms to help pay
foriegn farms portion of food safety? Americans speak up!

Chris from North Carolina adds:

680 pages... I can't afford for this farm to buy the paper to print it out, much less comply with this rule. Who is going to pay to fence my 20 acres?


Meanwhile, others feel the article's focus on costs shouldn't be the focus:

From Mexico, this comment:

Regarding the article's (and the commentator's) focus: $

Is that what this is really about?

"The proposed rule imposes new standards on growers for worker training and hygiene, agricultural water purity, biological soil amendments, equipment, tools and buildings".

Is that a necessary and valid goal? Of course! Serious (including fatal) Diseases have been spread by contaminated (improperly grown and handled) Produce.

Is that goal implemented in law effectively and efficiently?

That's the real question. (After reading the law and observing it's implementation we can comment further).


Another reader from Nevada said:

And what is the cost of a human life?


Just how reasonable are these proposed food safety regulations? Is there an objective, dispassionate way to measure the cost and benefit of the rules when human lives hang in the balance?

The sheer audacious volume of new regulation that will be coming industry's way in the next two years will be mind-boggling. I can't help agree with Chris Schlect of the Northwest Hort Council that more than 120 days will be needed to evaluate and comment on the proposed rules.

While we wait for more substantive input from industry associations, I've put together some links from the FDA. The agency has populated its website with all kinds of resources related to the newly published produce safety rule and the preventive controls rules.

Here is a brief listing of the links readers may find useful.

Overview: FDA strengthens food safety foundation


“Preventing problems before they cause harm is not only common sense, it is the key to food safety in the 21st century,” says FDA Commissioner Margaret A.
Hamburg, M.D. “We cannot afford to wait until people become ill to realize there is a problem.”  

Summary page: The New Food Safety Modernization Act

Key link: Get FSMA updates by email


Food Safety Modernization Act: Frequently Asked Questions

Key Question:

PT.3.4 When will FDA begin developing recordkeeping requirements for high-risk foods, as directed by FSMA?
Once the product tracing pilots are completed, and other data are gathered, the Agency will begin the development of a proposed rule.

PT.3.5 Will FDA expand requirements for recordkeeping requirements to foods that are not designated as high risk?
No. FSMA specifies that additional recordkeeping requirements developed under section 204 must apply only to high risk foods. FDA will be seeking input from stakeholders in considering whether to develop voluntary guidance for foods beyond those designated as high risk to enhance product tracing in the supply chain.

PT.3.6 Will FDA recommend certain product tracing technologies either for the pilot or for future regulations and potential guidance?
FDA does not plan to recommend specific software or systems at any of these stages. Rather, FDA will focus on the elements of a product tracing system that enable rapid and effective tracing of food products. Under section 204, FDA is not permitted to prescribe specific technologies to maintain records in the context of the additional recordkeeping requirements for high-risk foods.


Summary: Produce Safety Standards

Produce Safety Standards: Entire proposed rule

Can you believe? 547 pages

Produce Safety Standards: Analysis of economic impact

Key takeaway: 388 pages!


Summary page: Preventive control standards

Also note:

Along with the proposed rule, FDA is announcing the availability of, and requesting comment on, a draft qualitative risk assessment, Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF: 660KB), designed to provide a science-based risk analysis of those on-farm activity/food combinations that would be considered not reasonably likely to introduce hazards that are reasonably likely to cause serious adverse health consequences. Interested persons may submit written comments regarding the draft risk assessment by visiting 

Entire proposed rule: Preventive control standards

Comment: Roughly 700 pages long

Preventive control standards: Analysis of economic impact

Peer review of qualitative risk assessment for food facilities

Lest we forget: still more rules to come

    Foreign Supplier Verification for Importers: This program will require importers to verify that foreign suppliers are following procedures that provide the same level of health protection as that required of domestic food producers. About 15 percent of the food consumed in the U.S. is imported, including about 49 percent of fresh fruit and 21 percent of vegetables.
    Accredited Third Party Certification: The accreditation of third-party auditors would help ensure that food producers in other countries comply with U.S. food safety laws.
    Preventive Controls for Animal Food: This is the implementation of preventive controls at animal food facilities that are similar to those proposed for human food.