Amendments to timelines and to guidance documents for the FSMA were released last week and include extensions to specific parts of the rule as it applies to certain groups, said the US Food and Drug Administration (FDA). The guidelines offer more information for feed facilities to meet good practice requirements.
“AFIA appreciates FDA issuing this direct final rule,” said Leah Wilkinson, vice president of legislative, regulatory and state affairs. “It extends some of the compliance dates for animal food in the requirements for customer assurance when preventive controls are applied later in the supply chain.”
However, the NGFA is also asking for additional guidance regarding draft hazard analysis and preventive controls guidance for feed, said David Fairfield, NGFA senior vice president of feed services.
“The first compliance date for those requirements [is] September 18, 2017,” he told us.
The updated timelines include changes for facilities that either pack or house raw, produce-based agricultural commodities or nut hulls and shells; buildings that would be considered 'secondary activities farms' except that they do not meet ownership requirements; and cotton ginning operations that provide ingredients for animal feed, said the FDA. Compliance dates for these groups now start January 26, 2018, except for cotton facilities which have until January 28, 2019.
The FDA also extended the dates by which facilities have to meet rules regarding specific customer assurances if there are controls downstream in a distribution process.
The timeline revisions pertaining to animal feed producers were expected, said Fairfield. “Hopefully, the extension for the customer assurances will provide time necessary for FDA to revisit these provisions and come up with feasible requirements to which affected facilities can comply,” he added.
“These requirements, as currently finalized, for many facilities would create a tremendous burden in terms of the quantity of written assurances that would be required to be established and maintained,” he said. “We are pleased that FDA extended the compliance dates for these provisions by two years, and that the agency will further evaluate the feasibility of the requirements.”
The FDA also released a draft of its guidance for current good manufacturing practices for feed. The document covers both domestic and foreign facilities that “manufacture, process, pack or hold animal food,” the agency said.
The document was designed to aid facilities in understanding what, if any, current good manufacturing practice requirements they need to use and how to comply with those rules, the agency said. “This guidance also provides additional information and recommendations for compliance with the CGMP requirements for animal food, as well as compliance with related requirements such as training and recordkeeping,” it added.
“The NGFA was pleased that FDA this week released its draft current good manufacturing practice (CGMP) guidance for animal food,” said Fairfield. “The compliance date for large animal food companies is less than one month away – September 19, 2016 – so the industry definitely needed this guidance.”
The guidance was one that the AFIA had also been interested in seeing, because of the looming deadlines, added Wilkinson.
“The NGFA and other trade industry associations continue to actively offer education and training opportunities [on FSMA compliance] to our industry,” he said. “The industry is engaged in many efforts to better understand how the requirements apply to their operation and what they need to do to comply.”