Recalls
Currently, the FDA does NOT have the authority to call for a recall. The bill gives them the ability to do that.
Access to Records
In recent food safety outbreaks, the FDA has had a hard time getting access to company's records. The bill gives the FDA expanded access to records so they can see them (for example) while conducting inspections.
Traceability
Currently, there's no good way to know where foods or ingredients came from. The bill will set up a traceability system so we can do this. We don't yet have details on what this will look like (the government has no idea how they are going to do it). Farmers are exempt from this if they sell only directly to consumers and/or restaurants.
Funding the FDA
The FDA is cash- and resource-starved. This bill will provide them with funds by charging a $500/mo fee to all "food facilities." We need to make sure that the definition of "food facility" excludes small farms. While the bill excludes farms, once a farm begins to process foods, it may be considered a food facility.
This is what the FDA thinks is a farm:
"...a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term "farm" includes:
"(i) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and
"(ii) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership." [21 CFR § 1.227(3)]
If you manufacture or process food and sell it, then you are NOT a farm. Here is how they define that:
"Manufacturing/processing" is defined as "making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging." [21 CFR § 1.227(6)]
This definition could be problematic as it could put small farms who make jam to sell (for example) in the category of "food facility" and thus make them subject to $500 annual fees. There is a "guidance document" to further define farms, but that guidance document is not part of the law - it's just a suggestion. That document says:
"The term 'farm' also includes facilities that manufacture/process, pack, or hold food, provided that all food used in those activities is grown, raised, or consumed on that farm or another farm under the same ownership."
This means that you CAN make jam from your own fruit and still be considered a farm. But you cannot use food from other farms in processing - then you'll be subject to the $500/yr fees. While the guidance document is reassuring, it would be better if the contents of the document became part of the law so that the FDA would have to apply it.
Inspections
Food facilities are subject to an increased inspection schedule. Currently the FDA inspects a facility about once a decade. Under the bill, they will inspect facilities every 6 mos to 4 years, depending on that facility's risk. The bill was recently revised to allow them to inspect small businesses less than that, if they feel it would be safe to do so. Again, we want to make sure that farms do not fall under the definition of "food facility."
Growing Standards
This is a part of the bill that concerns me. Here is some text from the Farmer to Consumer Legal Defense Fund site about this:
The FSEA will also directly impact produce farmers by authorizing FDA to tell them how they can grow their crops. The bill would require the HHS Secretary to establish by regulation "science-based standards for the safe growing, harvesting, packing, sorting, transporting, and holding of raw agricultural commodities that-(1) are from a plant or a fungus; and (2) for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death to human or animals." [section 104(b), sec 419A(a)-p. 31]
Any issued regulation "may include standards addressing manure use, water quality, employee hygiene, sanitation and animal control, and temperature controls, as the Secretary determines to be reasonably necessary." [section 104(b), sec 419A(b)(3)-p. 32]
In issuing the regulation, the Secretary "shall take into consideration, consistent with ensuring enforceable public health protection, the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed-protection efforts, and organic production methods" [section 104(b), sec 419A(b)(7)-pp. 32-33]
Here's the Farmer to Consumer Legal Defense Fund's critique of this provision (which I tend to agree with):
Based on the FDA's track record with "good agricultural practices", the agency is unlikely to adequately address the differences between industrial operations and sustainable farms. The danger is that FDA will adopt regulations that treat small farms growing a diversity of crops organically (whether certified or not) the same as a facility growing thousands of acres of a single crop conventionally. The regulations could be expensive and burdensome, or simply not feasible, for small farms. Any produce that does not meet the established safety standards would be considered adulterated under the FSEA [section 104(a)-p. 30].
Quarantines
Another part of the bill that concerns farmers is the power to quarantine it gives the FDA:
"If the Secretary determines that there is credible evidence or information that an article of food presents a threat of serious adverse health consequences or death to humans or animals, the Secretary may quarantine any geographic area within the United States where the Secretary reasonably believes such food is located or from which such food originated. The authority to quarantine includes prohibiting or restricting the movement of food or of any vehicle being used or that has been used to transport or hold such food within the geographic area" [section 133(b)(1)-pp. 83-84].
Exemptions for Livestock Farms
This week, the bill was changed to exempt livestock and poultry operations, thanks to the lobbying of the pork industry. I can't say I'm thrilled about this because factory pork farms probably DO need to be regulated. But, at the same time, small livestock farmers are off the hook with the new changes to the bill too. Here is what the pork industry says of the recent changes to the bill:
The House Energy and Commerce Committee approved an amendment to the "Food Safety and Enhancement Act of 2009," H.R. 2749, that exempts livestock and poultry farms from a provision that expands the U.S. Food and Drug Administration's authority over food producers. It would allow FDA to conduct on-farm inspections, quarantine geographic areas over food-safety problems, create a tracing system for all food and require additional records to be kept. The provision will apply to the grain side of diversified livestock and grain operations. |
