The US Food and Drug Administration (FDA) said yesterday that it has finalized the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule, which it described as "the product of an unprecedented level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local and tribal regulatory counterparts, academia and other stakeholders."
In addition, FDA set compliance dates for some businesses, starting in September 2016.
FDA said that "the final rule has elements of both the original and supplemental proposals, in addition to new requirements that are the outgrowth of public input received during the comment period for both proposals. For example, flexibility has been built into key requirements, including control of the supply chain, and the definition of farms - which are exempt from these regulations - has significantly changed to reflect modern farming practices."
You can read the detailed DA posting here.
In a statement released after the FDA announcement, Hilary Thesmar, vice president of food safety programs at the Food Marketing Institute (FMI), "While the Preventive Controls rule embodies one of the basic pillars of FSMA, which is to thwart the contamination of food and to prevent foodborne illness from occurring, food retailers are well aware that prevention starts with strong good manufacturing practices followed by conducting a rigorous hazard analysis to identify and evaluate any known and reasonably foreseeable hazards.
“FMI appreciates FDA's acknowledgement that the ‘relatively rare occurrence of significant safety concerns associated with the manufacture of food contact substances,’ and finished products, together with FDA’s extensive premarket review of these substances, provides adequate assurances of safety."
And Tom Stenzel, president/CEO of the United Fresh Produce Association, released the following statement: “The extension and clarification of compliance dates released yesterday by FDA, combined with the draft guidance documents released yesterday and today, enable the fresh produce industry to better understand how to comply with the applicable rules. We appreciate that FDA heard and responded to our concerns and requests.
"FDA recognizes that packinghouses should have the same amount of time to prepare for regulatory compliance regardless of whether they are located on or off a farm. The extended compliance dates for packinghouses subject to the Preventive Controls Rule, beginning January 26, 2018, allows us time to continue to work with FDA and the Food Safety Preventive Controls Alliance to develop a modified curriculum for these unique types of operations that are critical parts of the fresh produce supply chain. With the first compliance deadline for the Preventive Controls Rule less than a month away, our members continue to ask questions about which rule(s) they are subject to. We are hopeful that the draft guidance pertaining to industry classification for farms and facilities released today will provide examples that help the fresh produce industry understand which rules apply to them."
In addition, FDA set compliance dates for some businesses, starting in September 2016.
FDA said that "the final rule has elements of both the original and supplemental proposals, in addition to new requirements that are the outgrowth of public input received during the comment period for both proposals. For example, flexibility has been built into key requirements, including control of the supply chain, and the definition of farms - which are exempt from these regulations - has significantly changed to reflect modern farming practices."
You can read the detailed DA posting here.
In a statement released after the FDA announcement, Hilary Thesmar, vice president of food safety programs at the Food Marketing Institute (FMI), "While the Preventive Controls rule embodies one of the basic pillars of FSMA, which is to thwart the contamination of food and to prevent foodborne illness from occurring, food retailers are well aware that prevention starts with strong good manufacturing practices followed by conducting a rigorous hazard analysis to identify and evaluate any known and reasonably foreseeable hazards.
“FMI appreciates FDA's acknowledgement that the ‘relatively rare occurrence of significant safety concerns associated with the manufacture of food contact substances,’ and finished products, together with FDA’s extensive premarket review of these substances, provides adequate assurances of safety."
And Tom Stenzel, president/CEO of the United Fresh Produce Association, released the following statement: “The extension and clarification of compliance dates released yesterday by FDA, combined with the draft guidance documents released yesterday and today, enable the fresh produce industry to better understand how to comply with the applicable rules. We appreciate that FDA heard and responded to our concerns and requests.
"FDA recognizes that packinghouses should have the same amount of time to prepare for regulatory compliance regardless of whether they are located on or off a farm. The extended compliance dates for packinghouses subject to the Preventive Controls Rule, beginning January 26, 2018, allows us time to continue to work with FDA and the Food Safety Preventive Controls Alliance to develop a modified curriculum for these unique types of operations that are critical parts of the fresh produce supply chain. With the first compliance deadline for the Preventive Controls Rule less than a month away, our members continue to ask questions about which rule(s) they are subject to. We are hopeful that the draft guidance pertaining to industry classification for farms and facilities released today will provide examples that help the fresh produce industry understand which rules apply to them."
- KC's View:
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It seems to me that the FSMA rules are at once both highly complex and fairly straightforward ... complex because the food system is amazingly complicated, and straightforward because people and companies have no choice but to comply with both the rules of conduct and rules of transparency.
The details of the continuing FSMA rollout are way too complicated to go into here, but companies need to be sure to be absolutely in compliance - or be branded as bad actors.
I want to repeat something I've said here at various times about the new FSMA rules...
I'm very careful about mixing church and state here on MNB ... which means talking about a sponsor within the context of editorial. But in this case, there is a direct connection, and I want to be both transparent and informative.
ReposiTrak, which has created automated information management technology that allows companies to do the things necessary to comply with evolving FSMA regulations, is a longtime MNB sponsor ... and we've been running a series of videos from ReposiTrak here that have interviewed CEOs such as Kevin Davis of Bristol Farms and Karen Caplan of Frieda's who have been proactive ands progressive in their approach to this issue.
I hope you'll check it out; it was my pleasure to produce these videos, a task I welcomed because this is a serious issue that requires an industry-wide focus.
