THE feed industry continued to sort through the many layers of the Food Safety Modernization Act (FSMA), submitting comments to the Food & Drug Administration on rules implementing foreign supplier and third-party certification provisions of FSMA as well as welcoming an extension of the most prominent one for animal feed and pet food.
The feed industry officially received word Jan. 31 that FDA would extend the comment period for the Current Good Manufacturing Practice & Hazard Analysis & Risk-Based Preventive Controls for Food for Animals rule, which the industry said is needed because assessing the rule will be a massive undertaking given its requirements — some of which are being implemented for the first time in some industry sectors.
A joint statement from the American Feed Industry Assn. (AFIA), National Grain & Feed Assn. (NGFA), National Renderers Assn. and Pet Food Institute welcomed the feed rule's extension from Feb. 26 to March 31, even though a court-mandated timeline limits the extension to just a few weeks.
With the extension, the comment period still will be open for only five months. In contrast, the human food proposed rule, which the animal food rule mirrors, was open for nine months.
FDA said it is unlikely to grant extensions for other FSMA proposed rules due to the strict timeline the agency is required to follow under that court order mandating FDA to issue all final regulations for foreign supplier verification and third-party auditors by June 30, 2015.
AFIA originally had requested that all three proposed rules have the same comment deadline as consistency in the rules is essential for the betterment of the feed industry. It intends to submit further comments on both proposed rules in comments on the animal feed preventive control proposed rule. AFIA explained that the foreign supplier and preventive control rules have crossover issues such as modified requirements for very small importers and very small foreign suppliers and the section on hazard analysis.
The FDA foreign supplier proposal would require importers to verify the safety of foreign foods and feed/feed ingredients imported and intended for use in the U.S., while the third-party certification provisions would establish criteria under which the agency would recognize and accredit third-party auditors who perform safety audits for such products.
Regarding FDA's Foreign Supplier Verification Programs proposed rule, AFIA stressed that one regulatory solution may not be appropriate for both human food and animal feed. AFIA was also keen to point out FDA's intent to align the foreign supplier verification rule with various provisions of the animal food preventive control rule, as required by international trade agreements.
In its comments on foreign supplier verification, NGFA urged FDA to exempt raw agricultural commodities — other than fruits and vegetables — intended for further processing and distribution, noting the complex and commingled nature of commodity systems by which grains, oilseeds and other commodities move through the supply chain.
NGFA also highlighted the importance of flexibility for importers, the role of audits, exclusion of food transshipped for export, limiting investigations of complaints to those related to safety and submission of electronic records to FDA.
Regarding the third-party accreditation rules, AFIA said although it supports development of an accreditation system that will increase the reliability of third-party food safety audits and certifications, the group expressed concern that the program will not garner the number of participants needed to make it a viable system due to the onerous notification and reporting requirements proposed by FDA.
"We are particularly concerned about the heavy requirements that would be placed on consultative audits, which are an important tool by which companies find out what they may be doing wrong and improve their food safety practices. Any requirements that discourage use of consultative audits or constrain the free exchange of information between the auditor and the audited facility would be highly counterproductive," AFIA commented.
AFIA urged FDA to use a narrow interpretation of the phrase "a serious risk to the public health," arguing that a broad interpretation could result in FDA being "flooded with notifications of minor conditions."
NGFA emphasized that Congress was "silent within FSMA on the use or recognition of third-party inspection ... for domestic facilities." As such, the group said it believes that FDA "needs to weigh the absence of express statutory language carefully when considering whether, and to what extent, to rely on third-party certification as a means to verify that food and feed from U.S. facilities also meet applicable safety standards."
NGFA added that it is incumbent upon FDA to engage in additional public rule-making to seek comments from stakeholders before proceeding in such a manner, particularly given the lack of express statutory language.
NGFA conveyed its strong belief that the decision of whether to voluntarily utilize third-party certification should be up to the individual company based on its assessment of the costs versus benefits of doing so.
NGFA's comments also identified issues with reporting audit results to FDA, audit criteria, third-party reporting of deficiencies and ensuring that third-party auditors are independent and free from conflicts of interest.