It's not just people in the petfood industry who are getting antsy about when the US Food and Drug Administration will finally issue pending regulations in accordance with the Food Safety Modernization Act (FSMA). The human food industry has definitely noticed the delay, and now two organizations are trying to force FDA's hand.
According to an article by Jason R. Klinowski and John T. Shapiro on www.foodsafetymagazine.com, the Center for Food Safety and the Center for Environmental Health have filed a formal complaint in a US federal court against FDA (specifically, Margaret Hamburg, MD, FDA's commissioner) and the Office of Management and Budget (via its acting director, Jeffrey Zients) charging that FDA has missed seven deadlines, and counting, in implementing FSMA's major food safety regulations.
The "and counting" part of the complaint refers to the fact that at least nine more FSMA deadlines will come due in early 2013, and considering "FDA's lack of progress to date, the Centers have serious concerns regarding the likelihood that these future deadlines will be met," the complaint reads.
Klinowski and Shapiro, attorneys with Freeborn & Peters LLP in Chicago, write that the complaint was filed August 29, on the heels of FDA's second annual report on Food Facilities, Food Imports and FDA Foreign Offices, another requirement of FSMA. The report extolled progress made to date in implementing the food safety act, the attorneys say, but noticeably absent was any mention of even the status of several important regulations due this year.
The list of overdue regulations includes some that our industry is waiting on:
- Hazard analysis and risk-based preventive controls (section 103);
- Current good manufacturing practices and hazard analysis and risk-benefit preventive controls for food for animals (section 103);
- Produce safety regulations (section 105);
- Protection against intentional adulteration of food (section 106); and
- Foreign supplier verification program (Section 301).
The attorneys note that the report also lacked any mention of how FDA would obtain the resources needed to implement these regulations if issued. In terms of the lawsuit, FDA has yet to respond; and, as Klinowski and Shapiro point out, the complaint includes no mention of a key step in the development of these rules: the publishing of proposed regulations for public comment and FDA's subsequent consideration and addressing of any comments received.
So, it's debatable whether the lawsuit will have its intended effect, or any at all. What we do know was expressed expertly by Will Henry, director of technology R&D for Extru-Tech Inc., during a webinar on Building Effective Food Safety Systems for Petfoods: While no one in our industry really wants new regulations, we do want and need to know specifically -- and soon -- what the new regulations will entail so we can properly plan and prepare.