Focused mitigation strategies under FSMA costlier, but not safer, AHPA asserts

By Hank Schultz contact

- Last updated on GMT

Focused mitigation strategies under FSMA costlier, but not safer, AHPA asserts

Related tags: Food safety, Ahpa

As part of its ongoing effort to influence the implementation of the Food Safety Modernization Act, the American Herbal Products Association has submitted 30 pages of comments on the way FSMA calls for mitigation strategies aimed at preventing intentional adulteration of foods and supplements.

In the comments, AHPA takes the position that broad mitigation strategies are a sufficiently effective method of preventing this sort of event, rather than the focused mitigation strategies called for in FDA’s proposed rule titled "Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.”

“Broad mitigation strategies include things like controlling the perimeter, locking all doors and only letting employees in,”​ Michael McGuffin, president and CEO of AHPA told NutraIngredients-USA.  “Most sophisticated manufacturers already do this. Most of us already have various security measures in place.  You put these measures into place and you do it once.

“Focused mitigation strategies are so much more detailed,” ​McGuffin said. “It starts to sound a lot like HACCP.  It’s asking the question, what could be a potential problem with a particular material or product.”

More cost without much added safety

This tight focus adds cost and complexity without adding much in the way of security, according to AHPA’s comments.  For example, the proposed rule calls for mitigation procedures to be established for every product that goes through what has been deemed as a vulnerable processing step. From AHPA’s point of view, that’s clear overkill.

“If ‘mixing’ is a vulnerable process activity then it does not matter whether the mixing occurs during production of boxed brownie mix or jarred tomato sauce or bottled vitamin C tablets. To  require documentation specific to each product type will simply increase the burdens imposed by the Rule without any countervailing benefits,” ​the comments state.

The comments also raise the issue of where intentional adulteration is most likely to occur. Terrorists could be expected to prefer a “soft” target, one that is not well controlled or guarded, to a “hard” one such as a well-monitored production facility open only to authorized personnel. The mitigation strategies called for in the rule would burden producers that are already the least likeliest targets in the distribution chain, the comments said. Meanwhile, the proposed rule has less to say about improving broad mitigation strategies along the other steps of the supply chain, something that AHPA advocates.

Based on opinion, not data

AHPA also takes issue with how FDA came to the conclusion that a focused mitigation strategy approach is the way to go.  This came about as a result of an intellectual risk assessment exercise that is not supported by data, the trade group asserts.  “The references cited by FDA contain no concrete experimental data demonstrating the assertions to be true, but rather consist of abstract, theoretical ‘vulnerability assessment’ exercises; FDA itself states that it is not practical to validate mitigation strategies,”​ AHPA’s comments state.

Only two tiers of companies

McGuffin said the proposed rule contains a peculiarity similar to other portions of FSMA, that being that it divides the industry into only two parts: small companies, defined as those with less than $10 million in annual revenue, and everybody else.  This would put the the same burden on brands that might be just breaking into profitability or that have held a mid-tier market position for some time as it would on the Campell’s Soups and Krogers of the world.  The risk of intentional adulteration is greatest at the biggest companies, the assumption being that terrorists would seek the broadest distribution of contaminant to have as big an impact on the food supply as possible. AHPA’s concern is that many of these mid-tier companies would not be able to afford the costly implementation of focused mitigation strategies.  Using a broad mitigation approach would keep those companies in business while still adequately protecting the public, McGuffin said.

“We are not in the least bit trying to minimize the concern. We don’t want to be so inattentive as to put products at risk of intentional adulteration. We are trying to balance the cost of doing business with an assessment of the real threat,”​ McGuffin said.

Related topics: Regulation, GMPs, QA & QC

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