October 2014- By Steve Adler - Recently released revisions to the proposed federal Food Safety Modernization Act contain significant changes that address many concerns expressed by farmers and ranchers since the original proposal was released for comment last year.
Based on extensive comments from farmers and organizations including the California Farm Bureau Federation, the U.S. Food and Drug Administration proposed revisions to the act that it said aim to strengthen food safety by shifting the focus to preventing food safety problems rather than responding to problems after the fact.
Josh Rolph of the CFBF Federal Policy Division, who submitted 30 pages of comments on the proposed rules, said, "Knowing there will be a complete revision to the most controversial sections of the current proposed rules is a huge relief to growers."
Since FSMA was signed into law in January 2011, the FDA has proposed seven rules to implement it. The four updated proposed rules include those governing produce safety, preventive controls for human food, preventive controls for animal food, and a foreign supplier verification program. The provisions relating to produce safety and animal food have generated the most concern from farmers and ranchers.
The provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing a qualified exemption for certain farms.
One farmer who has been very involved in the process is San Joaquin County walnut grower Joe Ferrari, who carefully analyzed the original proposal and pointed out many of its pitfalls and areas of concern.
What caught his attention in the original proposal, Ferrari said, was that FDA wanted to define a farm that harvested the crop of another farm as a "facility." The concern was that if FDA could label a single activity as "not harvesting," then a farm that performed that activity would be acting outside of the definition of a farm, and would be regulated as a facility.
"This flawed logic encompassed both the scenario of a farming establishment that employs the use of field harvesting equipment as well as one that uses stationary harvesting equipment such as nut hullers and dehydrators," he said.
Ferrari expressed satisfaction that the updated FDA proposals change the definition of what comprises a farm.
"This was a major change for them, so this was a big deal. They actually had to listen to us and our commenting actually mattered," he said. "After reading the proposed changes to the rules, I am glad that the FDA has proposed to allow harvesting activities—even those performed on a farm under different ownership—to be considered 'harvesting' activities under the umbrella of the 'farm' definition. This helps to shield farmers from being treated as a facility."
Ferrari said the new proposal defines a huller as an operation that hulls, shells and dries nuts without additional manufacturing, which would place walnut hulling outside the scope of the FSMA preventive-controls rule.
"I am glad that we got it in writing," he said.
April Mackie, director of food safety and regulatory compliance for Ramco Enterprises Inc. in Salinas, has also followed FSMA closely because of her involvement in leafy greens and other vegetable crops.
"I think that FDA has done a great job working with producers as well as industry professionals in trying to capture the real issues and concerns," she said.
Mackie said more improvements could still be made to the FSMA rules, but credited FDA with doing "a very good job of addressing some of the key issues" that had concerned farmers.
"It appears that they have learned a little bit from the Leafy Greens Marketing Agreement and they now understand that science needs to be behind the rulings that they are putting out there," she said. "Science is always changing and situations come up, so that revisions to the FSMA rules will have to be made over time. Right now, I think they are very open to that. I hope that understanding continues."
The FDA also is proposing, based on comments received to date, a new definition of which farms would be subject to the produce safety rule. The proposed rule would not apply to farms with $25,000 or less in produce sales alone, rather than setting the threshold based on sales of all foods produced on the farm. The updated proposed rules also would simplify which entities are covered by the produce safety rule and which would be covered by the preventive controls rules.
In addition, the revisions address the use of spent grains, which are by-products of alcoholic beverage brewing and distilling that are commonly used as animal food. Concerns were raised that the proposed rules would require brewers and distillers to comply with the full rules for both human food and animal food if they made their wet spent grains available for animal feed.
The updated proposal would clarify that processors of food for human consumption that create by-products used as animal food, and are already complying with FDA human food safety requirements, would not need to comply with the full animal food rule.
The water quality testing provisions in the proposed produce safety rule have been revised to account for natural variations in water sources, and to adjust its approach to manure and compost used in crop production pending further research on this issue.
The FDA will accept comments on the proposed revisions of the four proposed rules until Dec. 15, while continuing to review comments already received on the sections of the proposed rules that are staying the same. The agency will consider both sets of comments before issuing final rules in 2015.
To view the revisions and make comment, visit http://1.usa.gov/1CHgQ99.
(Steve Adler is associate editor of Ag Alert. He may be contacted at sadler@cfbf.com.)
Reprinted with permission: California Farm Bureau Federation
