FDA should reconsider FSMA regulations - The Packer

FDA should reconsider FSMA regulations

04/26/2013 09:42:00 AM
Chris Schlect

Chris Schlect, Northwest Horticultural CouncilChris Schlect, Northwest Horticultural CouncilDanger and harm rushed forward this month: a deadly earthquake in China, a fertilizer plant blast in Texas, ricin-laced letters sent to politicians in Washington, D.C., and the Boston Marathon terrorist bombings.

And in the middle, Commissioner Margaret Hamburg of the U.S. Food and Drug Administration informed Congress that the agency would allow an additional 120 days for public comment on two proposed rules implementing the Food Safety Modernization Act.

Those who grow and/or pack fresh tree fruits should take a hard look at this regulatory activity springing from Washington, D.C., and take advantage of this newly extended opportunity to comment.

FDA’s two proposed rules, if made final, will add significant direct and indirect costs — and with no showing of an empirical risk to the public from the consumption of tree fruits that justifies such an expansive extension of federal power.

Unless the FDA changes its regulatory approach, I see major problems ahead.

For example, while the FSMA calls for the same rules to be applied to foreign grown imports, I am skeptical this will happen in practice.

Will FDA inspectors be in on plantations and orchards in Asia, Africa and South America? No, the FDA will probably rely on importer verifications and third-party audits.

And speaking of international trade, won’t other countries find it convenient to impose their own versions of on-site food safety inspections of American orchards whose fruit may eventually be shipped overseas?

With about 30% of our apples, pears and cherries making their way to foreign markets, we are sure to encounter new technical barriers to trade — ones not solely grounded on legitimate food safety concerns.

Moreover, the FDA does not have the money for its grand new scheme. It is already pleading for user fees, which, if granted, would add new costs that fruit growers and packers can ill afford.

In terms of the specifics of the proposed rules, I would point out just two of many problems: picking bags and irrigation water.

The FDA wants picking bags and other such harvest equipment in the orchard to be sanitized. With scores of harvesters, how does a family farmer do this in an inherently dirty and windblown out-of-doors environment?

As for irrigation water, what does required frequent microbiological testing accomplish during the growing season at the orchard level beyond spiking a grower’s costs?

The FDA should rethink its implementation of the FSMA. It should shift to a commodity-specific approach based on significant risk and demonstrated harm. This is how the European Food Safety Agency is approaching the issue.


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Ken Nye    
Lansing, Michigan  |  April, 30, 2013 at 01:14 PM

Chris, Your comments are spot on. We have plenty of concerns with the proposal from both the a cost standpoint and practicality. Michigan has about 4000 fruit and vegetable growers. Probably 2000 would be covered by the proposed rule. FDA has estimates annual compliance costs of $5000 to $30,000 per year based on size. So the potential cost of compliance will be more than $10 million, likely $20 to 30 million per year. Yet most major produce commodities grown in Michigan have not, and likely will not, be associated with food safety issues. Is it reasonable to cause an industry to spend millions of dollors on compliance when virtually no public good will result. At our in-state Listening Session last week, FDA did a nice job of explaining the basics of the proposal and responding to questions. I came away from that meeting feeling that the agency had listened to concerns expressed at the earlier sessions (I also attended the Chicago session back in March). The agency indicated that they wanted to hear from commodity sectors that believe they should be exempted (non covered). This was news to me, and FDA addmitted that. They also indicated that they wanted to know if growers should be required to be registered. Wow, that is a loaded question. We also had quite a bit of discussion about wildlife contaimination and about produce that could be utilized either fresh or processed, depending on the year and market considerations. As you noted in your opinion, we are also very concerned about the international consequences. A Canadian representative was at our listening seesion, and Canada is already smarting over our unfair livestock and meat product COOL requirements.

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