Proposed revisions to four rules in the FDA Food Safety and Modernization Act (FSMA) are intended to make the original proposals more flexible and practical. The revisions are based on comments received from farmers and others directly affected by the original proposals, and the revisions are now open to public comment.
The original proposals related to produce safety elicited the most public comment, with more than 15,000 sent to the FDA. In response to those comments, the proposed revisions include more flexible criteria for determining the safety of agricultural water for certain uses and a tiered approach to water testing.
Also, the FDA has decided to conduct a risk assessment and extensive research on its originally proposed manure strategy. Because of that commitment to research and risk assessment, the FDA is deferring its decision on an appropriate time interval between application of raw manure and the harvesting a crop, as well as removing the nine-month interval originally proposed.
According to FDA spokesperson Douglas Karas, the FDA is “working with USDA and other stakeholders to conduct research on application intervals necessary to ensure the safety of covered produce when raw manure is applied to a growing area and covered produce is reasonably likely to contact the soil.”
Original proposals related to preventive controls for human food drew more than 8,000 comments, prompting several revisions. These include not requiring farms that pack or hold food from other farms to be subject to the preventive controls rule. The proposed rule on preventive controls for animal food prompted more than 2,000 comments. Among the proposed revisions is one affecting brewers. If brewers already comply with FDA human food safety requirements, they would not need to implement additional preventive controls or current Good Manufacturing Practice (cGMP) regulations when supplying a by-product (such as wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed cGMPs to prevent physical and chemical contamination when holding and distributing the by-product.
The FDA is proposing a more comprehensive evaluation of food and supplier risk as one revision to its foreign supplier verification programs; the original proposals prompted more than 300 comments, Karas says.
Comment is being accepted on all of the revisions, and a public meeting is planned for Thursday, Nov. 13, 2014, in College Park, Md. The final set of rules will be issued in 2015.