The third major compliance date will soon arrive for the preventive-controls-for-animal-food rule under the FDA Food Safety Modernization Act. By Sept. 17, 2018, facilities that are small animal food businesses must comply with preventive controls (PC) requirements mandated by FSMA. Facilities that are large businesses were required to comply by September 2017. Large businesses are those with 500 or more full-time equivalent employees, and small businesses are those with fewer than 500 such employees.
The FDA noted on its website that the compliance dates for the Preventive Controls and Current Good Manufacturing Practice requirements were staggered for animal food companies. Facilities that are large and small businesses had to meet the CGMP requirements earlier; by September 2016, and September 2017, respectively. Very small animal food facilities will be required to meet the CGMPs on Sept. 17, 2018.
Since September 2016, some members of the food industry and grain trade associations such as the National Grain and Feed and American Feed Industry Association have expressed concern and uncertainty about many of the FSMA rules and enforcement measures. The FDA has since granted revisions/extensions on many of the issues in question, with the most recent one granted in August.
The FDA announced on Aug. 14, 2018 that they would extend its deadlines and inspection timeframes for when certain sized facilities should come into compliance with some FSMA rules and regulations.
In a recent press release, the AFIA praised the FDA announcement.
"By extending these deadlines, the FDA will have more time to release the final FSMA guidance documents and train its inspectors, while the regulated animal feed industry will have greater opportunity to perform the necessary retrofits to animal food safety plans and processes to ensure full compliance with federal regulations," said the AFIA.
"Throughout the rulemaking process, AFIA has asked the agency to take a staggered approach to implementation to allow the industry time to focus on current good manufacturing practice implementation and also to receive the necessary guidance to properly implement the hazard analysis and risk-based preventive controls requirements," said Leah Wilkinson, AFIA's vice president of public policy and education. "AFIA applauds the agency for continuing to offer this staggered approach and flexibility as the industry implements these broad, sweeping regulations."
AFIA also noted that the additional nine months provides small-sized facilities (those with sales totaling less than $2.5 million and certified to the FDA) the same opportunity that the FDA granted to large-sized facilities August 2017, to learn and implement the rules and regulations.
The NGFA said in an Aug. 14 newsletter that FDA's announcement means that although the compliance date for small businesses for the preventative control requirements remains the same, the agency will delay performing routine surveillance inspections to evaluate compliance until the fall of 2019. In addition, FDA will delay routine inspections for compliance with preventative control provisions that apply to very small businesses until the fall of 2020.
"Significantly, if FDA becomes aware of an animal food safety incident associated with a small business on or after the compliance date and needs to conduct a for-cause inspection to investigate the issue, the inspection will evaluate compliance with the PC requirements," said NGFA.
The NGFA gave the following examples of when FDA may conduct a for-cause PC inspection include if:
1) There is a history of violating samples (product or environmental)
2) The facility's food is subject to a recall
3) The facility has made a reportable food registry report involving a potential hazard
4) Significant observations were made during a previous inspection
5) The facility is subject to enforcement actions taken by FDA or state regulatory agencies.
TRAINING SESSIONS ONGOING
The Minnesota Grain and Feed Association and North Dakota Grain Dealers Association are two of many trade groups that have been holding training sessions since the FSMA rules were first published by the FDA. They will be co-sponsoring one final opportunity for affected firms to "get up to speed" with the requirements contained in the FSMA for the upcoming compliance date for the animal food safety rule.
Attendees will get an overview of the updated regulation as well as the requirements for compliance. The goal is for attendees to understand FSMA and know what they need to do bring their facility into compliance whether they operate a feed, food or grain facility. The day will conclude with a Q&A with all of the presenters in a panel format, so attendees' questions can be answered. The meeting is scheduled for Wednesday, Aug. 29 at the Courtyard by Marriott in Moorhead, Minn.
Here is a link to registration:
The NGFA has worked tirelessly offering training classes as well and has focused on FSMA regulations and compliance at many of their conferences. The next opportunity to attend a conference that will have "a strong focus on FSMA compliance" is their Feed and Pet Food Joint Conference, an annual collaboration between the NGFA and the Pet Food Institute designed specifically for feed and pet food sectors.
The conference will feature several industry leaders and education sessions that will provide the latest information to guide feed and pet food companies "through a complex regulatory environment as the U.S. Food and Drug Administration's (FDA) continues to implement the Food Safety Modernization Act." The ninth-annual Feed and Pet Food Joint Conference is scheduled for Sept. 17-19 in St. Louis, Missouri.
Here is a link to the conference information and registration:
If you are unable to attend any sessions mentioned above or other training sessions, the links below are from the FDA website and may answer your questions on all of the FSMA rules.
This link, titled "What to Expect With the Next Compliance Dates for the FSMA Preventive Controls for Animal Foods Rule," has a Q&A with Jenny Murphy, a consumer safety officer at FDA's Center for Veterinary Medicine and also, note on that the left side of the web page, you will find all the links to FSMA:
Here a link that will take you directly to Compliance Dates: https://www.fda.gov/…
Take the time to look these over to be sure that you are either exempt from some or all of the FSMA rules, or what you need to do to be compliant if you are required to comply. If you are still unsure, click on this link that informs you how to get answers to any questions by either submitting your question on line or in writing by mail: https://www.fda.gov/…
Mary Kennedy can be reached at firstname.lastname@example.org
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