Will small producers be exempt from new safety regulations?

During a forum/live webcast presented today by the Institute of Food Technologists, a couple speakers -- sharing their perspectives on different aspects of the new Food Safety Modernization Act of 2010 -- alluded to how the law might affect small businesses. Though they were addressing how the law might impact human food producers, their insights probably apply to petfood manufacturers, too.

David Acheson, MD, formerly associate commissioner of foods with the Food and Drug Administration and now managing director of food and import safety practice for Leavitt Partners, spoke about traceability and mentioned that in developing regulations based on the new law, FDA is aware small businesses have specific needs and challenges. "One size does not fit all," he said. But with the law just a few days old and so much still undefined, he wasn't able to be more specific.

Another speaker, Tony Pavel of K&L Gates LLC, is an expert on HACCP (hazard analysis and critical control points) who discussed the law's requirement for all producers registered with FDA -- that would include most petfood producers -- to have written hazard analysis and risk-based preventive control plans. ("HACCP by any other name," he said.) He commented that most large and medium-size companies already have such plans ins place, often because their customers require them to.

But what about smaller companies? The exemptions under the law include "very small" businesses, but that term or category is yet to be defined by FDA. Pavel said he believes FDA understands the need for practicality -- including that most small businesses can't afford to hire consultants to help them put preventive control plans in place -- but again, none of that is defined or clear yet.

So our industry will need to stay tuned over the next nine months to a year.

Once IFT sends out the presentations from today's webcast, I'll share more highlights. Meanwhile, here are a few more interesting tidbits from Pavel regarding preventive control plans:

* All such plans and related records will likely be "fair game" for inspections under the expanded records access authority the new law gives FDA.

* Preventive control plans will have to include recall plans.

* Regarding the verification step of preventive control plans, the language in the law says products must be tested for contaminants; it does not specify final products. This is key, Pavel says: Depending on how FDA develops the regulations, this provision may or may not require holding delivery on final products while tests are under way.