In August, Food and Drug Administration (FDA) made three major Food Safety Modernization Act (FSMA) announcements as follows:
- FDA extended the compliance dates for certain provisions across four FSMA rules, which impact almond growers, huller/shellers, and handlers. Details of these extensions can be found here and here.
- FDA released five of 14 chapters of a Draft Guidance document, titled, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.”
- FDA released a Draft Guidance document titled, “Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities: Guidance for Industry.”
Guidance documents are often used by FDA to represent its current thinking on a topic or interpretation of a regulation, and to provide industry with useful information related to implementation and compliance. FDA is soliciting comments on these draft documents. The comment period will be open for 180 days from the date of publication, with comment periods ending on February 21, 2017, and February 22, 2017, respectively for the draft guidance documents listed above. Almond Board of California (ABC) will be working with industry and the Almond Alliance of California (AAC) to draft and submit comments.
According to FDA, certain compliance dates have been extended to address concerns about the practicality of compliance with certain provisions, to consider changes to the regulatory text, and to better align compliance dates across the FSMA rules.
Numerous trade associations and industry groups, including ABC and AAC, have voiced concerns over implementation as well as how FDA has determined which facilities fall under the Produce Safety Rule, and which fall under the Preventive Controls Rule. It is encouraging to see FDA take industry input into consideration and extend the compliance periods in order to allow guidance document development. It is also an important development that FDA is considering further refinement of the farm definition; this was a significant concern raised by the almond industry since the implications were that some companies would be subject to the Produce Safety Rule, while another company engaged in the same activity would be subject to the Preventive Controls rule, simply due to ownership issues.
A summary of key changes to compliance dates is shown below:
*1Companies must still comply with original compliance date for Food Safety Plan and Preventive Controls. The compliance date has been extended by two years only for provisions concerning required written customer assurances.
ABC is working with Hogan Lovells, our FSMA technical consultants, to better understand the compliance dates for different types of facilities in the almond industry, and will provide an update soon.
Please contact Tim Birmingham by email, or phone him at (209) 343-3222 if you have questions.
