FSMA Is in Operation. Are You?

In years to come, 2011 will be heralded as the year in which was passed the first major piece of federal legislation addressing food safety since 1938. But, within the industry, it is likely that 2017 will be the year most remembered as the one in which FDA began its real enforcement of the “new” Food Safety Modernization Act (FSMA). It is the year in which inspections took a new turn, focused primarily on written food safety plans and environmental control “swab-a-thons” — but with a leniency and partnering tone focused on “educate before and while we regulate.”

In addition to a year of writing about these topics to educate the QA readers, 2017, for me, has been a year of food safety conferences. With a conference a month from March through July, I have been struck by the similarities of the session topics and speaker focus. While I would expect this to a certain extent, it is the repetition of phrases, objectives, and goals of both FDA and the industry that is particularly striking this year.

For example, while there always will be at least some “federalese” in a talk by a government official, when a phrase resounds from every podium at which an agency official speaks at every conference — as did FDA’s “educate before and while we regulate” — it becomes more than jargon. With such focus and repetition, how can it not be followed by the inspectors in the field? (Or, that is, by the “investigators,” the phrasing which was emphasized as the correct terminology by one official.)

And it was both FDA officials and industry representatives who began using the term “swab-a-thon” to illustrate the vast extent to which the new Preventive Controls (PC) inspections are including environmental sampling. FDA also is conducting modernized GMP (or “PC Lite”) inspections at some plants with less swabbing included, and this is particularly the case when it is the state conducting the inspection through the new agency partnerships.

Learn more about what to expect with the new PC (and PC Lite) inspections in “Educate Before and While We Regulate” (page 32) and about FDA’s environmental “swab-a-thons” in “Pathogen: Pet or Pest?” (page 36).

FSMA was signed into law six and a half years ago. In that time there has been a great deal of anticipation, expectation, trepidation, and a general air of “hurry up and wait,” as FDA developed, wrote, rewrote, and issued the rules and provisions by which the Congressional orders would be implemented. Although the industry is still awaiting a few key provisions (such as the laboratory component and designation of high-risk foods requiring extra recordkeeping and traceability) along with a number of guidance documents, FSMA is in operation.... Are you?

The author is Editor of QA magazine. She can be reached at llupo@gie.net.