Modernizing FDA rules and regulations to ease gin burdens

Dr. Stephen M. Ostroff, deputy commissioner, Office of Foods and Veterinary Medicine, Food and Drug Administration (FDA) addressed the National Cotton Ginners Association (NCGA) during the National Cotton Council’s (NCC) Annual Meeting held recently in Fort Worth, Texas, and a few attendees initially wondered why he was there.While the FDA does not regulate cotton fiber, it does regulate animal feed, and cottonseed is an important nutrient-dense supplemental feed source for many dairy cattle operations across the U.S. “Many of FDA’s regulations for overseeing human and animal food date back many decades and these rules hadn’t kept pace with the significant changes in the U.S. food supply over the years,” says Ostroff. “After a series of large human food-borne outbreaks in the 2000s, Congress decided it was finally time for a major overhaul of our approach to food safety.”Modernizing the FDA’s regulations was accomplished with the passage of the 2011 Food Safety Modernization Act (FSMA). It was the most comprehensive and sweeping overhaul that had occurred since the 1930s. “It required us to modernize what we did from the farm, all the way to the grocery store,” adds Ostroff. “After FSMA was signed by President Obama, we were charged with writing the regulations to implement the provisions of the new law, including the provisions related to animal feeds that contained cottonseed”

The FDA’s initial proposals for the regulations were finalized in 2016 after years of listening sessions, tens of thousands of comments from stakeholders both domestically and internationally, and several iterations of re-proposed regulations.

What is a farm?

One thing that would seem easy for most people involved in agriculture to explain, but gave FDA much consternation, was how to “define” a farm. “There are many ownership models and activities that occur on farms, so coming up with a consensus definition to use in the regulations proved more challenging than expected,” says Ostroff. “It’s like buying a car you thought was initially perfect, but once you started driving it, you found little things that weren’t as great as you thought.”The farm definition used in the FSMA rules had components that were based on ownership structure and physical location. “What happened as a result of [our] farm definition was we ended up regulating certain types of activities that were either similar or identical to each other simply based on their ownership structure or the location where they were being conducted.”

Ostroff and his colleagues at FDA soon discovered cotton gins fell into that category.

In the cotton industry, some gins are located on the cotton farm, while others may be miles from a farm. Gins that are off the farm can have different ownership models and relationships to the farms that supply cotton to the gin. As a result, on-farm cotton gins and off-farms cotton gins ended up being treated differently under the FSMA rules even though they were performing the same operation. “Those off-farm cotton gins ended up being subject to the ‘preventative controls for animal food rule’ while on-farm cotton gins ended up not being covered by that rule,” explains Ostroff. “It was purely based on that farm definition.”

It didn’t make any sense to the ginning industry or to those at the FDA. “It was also very difficult to explain,” adds Ostroff.

NCC and NCGA assistance

The NCC and the NCGA started discussions with the FDA about how to address the fact that ginning risks are the same no matter where the gin is located. Their functions and operational models are basically identical, and the FDA was committed to getting it right.

A result of those discussions led the FDA in 2016 to issue a rule extending the compliance date for the provisions that treated on-farm/off-farm operations differently. “It wasn’t just cotton gins either. Packing houses and hulling/shelling operations for tree nuts also fell into that category,” adds Ostroff.

Each of the commodities impacted by those provisions has a different compliance date extension. FDA officials thought they could rectify this problem before the New Year, but because they did not, an “enforcement discretion” was issued in early January. “Enforcement discretion simply means we will not enforce the provisions related to cotton gins that are covered by the preventative control for animal food rule for the foreseeable future until we can put in place a permanent solution,” says Ostroff.

FDA will take that extra time to revisit their definition of a farm. They will then have to re-propose the definition, seek comments from stakeholders and then finalize the definition – which will obviously take time. “We are committed to looking at a cotton gin from a risk-based activity perspective and not an ownership model or physical location perspective,” says Ostroff. “We recognize that cottonseed food safety risks are generally low, so we’ll make sure all gins are treated similarly under the revised definition.”

Ostroff understands that whenever new regulations are put in place, especially ones that are as significant as those related to FSMA, some problems are bound to arise. Solving those problems requires listening and flexibility, avoiding the one-size-fits-all approach, and paying attention to the concerns of people around the country. “We appreciate the FDA’s willingness to work with the ginning industry to resolve the FSMA issue and thank Dr. Ostroff and his staff for taking time to tour an Alabama cotton farm, gin and warehouse to see firsthand what’s involved in the production, harvesting, processing and storage of baled cotton and cottonseed,” says Harrison Ashley, vice president, Ginner Service, National Cotton Council.

Ostroff admits the visit he and his staff made to the Alabama operation in October, 2017 helped them more clearly understand the industry. “Based on what we saw and learned from that visit organized by the NCC, there is no reason for the FDA to differentiate cotton gins based simply on their location and ownership,” says Ostroff. “This is a great example of industry and government listening and working together to resolve a problem.”