The Senate is considering a bill, S.510, that would make broad changes to food safety regulation in this country. Unfortunately, in the effort to address the problems in the industrialized food supply, the bill threatens to harm the small, local food producers who provide an alternative for consumers.
The growing trend toward healthy, fresh, locally sourced vegetables, fruit, dairy, and value-added products improves food safety by providing the opportunity for consumers to know their farmers and processors, to choose products on the basis of that relationship, and to readily trace any problems should they occur.
Although S. 510 includes some provisions for flexibility for small and diversified producers and processors, the bill’s new hazard analysis and risk-based preventive controls would affect these facilities and authorize FDA to dictate growing and harvesting practices for produce. These requirements will impose significant expenses and burdens on individuals and small businesses.
Below are answers to some of the frequently asked questions.
QUESTION: What would S.510 do to farmers?
S.510 authorizes FDA to issue standards for production and harvesting of fruits and vegetables. Given the agency’s track record, it is likely that the regulations will discriminate against small, organic, and diversified farms. While the bill directs FDA to consider the impact of its rulemaking on small-scale and diversified farms, there are few enforceable limits to protect small, sustainable farms from inappropriate and burdensome federal rules.
The only enforceable limit is that FDA's new regulations cannot contradict the regulations for certified organic producers. But many local food producers are not certified organic. And even certified organic can still be subject to additional regulations by FDA imposing impractical or unfair burdens, so long as the regulations don’t directly contradict the organic regulations.
The Tester-Hagan amendment would exempt farms that have gross sales under $500,000 and that sell more than half of their produce directly to consumers and other “qualified end users” such as local restaurants and local stores.
QUESTION: Are direct marketing farms exempt from the bill?
No, direct-marketing farmers are not exempt from the produce safety standards. Under the bill as currently written, all farmers raising produce are subject to the produce safety standards (section 105 of the bill), regardless of how they market their fruits and vegetables.
The Tester-Hagan amendment is needed to protect direct marketing produce farmers from being told how to grow and harvest their crops by FDA bureaucrats.
QUESTION: What does S.510 require of people who process food?
Under S.510, anyone who processes food for sale will have to comply with extensive new regulations over every step of its process. This includes people who make such things as jam, bread, and cheese for local markets. S. 510 would require that all facilities would have to comply with a “Hazard Analysis and Risk-Based Preventative Controls,” which would require:
• Hazard analysis: Identify and evaluate known or reasonable hazards and develop written analysis of the hazards.
• Preventive Controls: Identify and implement preventive controls, to provide assurances that hazards indentified will be significantly minimized and prevented.
• Monitor effectiveness of the preventive controls.
• Establish procedures that a facility will implement if the preventive controls are found to be ineffective through monitoring.
• Verify that:
• the preventive controls are adequate.
• Monitoring is in accordance with 103(d).
• The owner is making appropriate decisions about corrective actions under 103(e).
• The preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards, including the use of environmental and product testing programs.
• There is documented, periodic reanalysis of the plan to ensure that it is still relevant.
• Recordkeeping: Maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented, instances of nonconformance, the results of testing, instances of corrective actions, and the efficacy of preventive controls.
• Written plan and documentation: Prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection 103(b) and identifying the preventive controls adopted under subsection 103(c) to address those hazards.
All of this would be subject to FDA approval, inspections, and fees for re-inspection. The paperwork burdens would drive many small-scale processors out of business.
The Tester-Hagan amendment would exempt processors that have gross sales under $500,000 and that sell more than half of their products directly to consumers and other “qualified end users” such as local restaurants and local stores. The amendment also exempts “very small businesses”, to be defined by FDA.
QUESTION: I heard that S.510 doesn’t require anyone to register who isn’t already required to do so. Is that true?
Technically, S.510 does not change the law on registration. But, in practical terms, there are thousands of small-scale processors who are not even aware that they have to register who will now be subject to extensive new requirements.
In 2002, Congress required all food “facilities” to register with the FDA under the Public Health Security and Bioterrrorism Preparedness and Bioterrorism Response Act of 2002. The rationale for such a sweeping federal reach into the smallest of food facilities was national security and bioterrorism.
While S.510 does not add new registration requirements, the reality is that there are many small-scale facilities that have not registered and are probably unaware that they are required to do so. FDA estimates that there are 37,000 facilities that have not yet registered.
In addition, S. 510 superimposes a significant regulatory burden on all of those facilities, regardless of the need from a food safety perspective. It is one thing to require a small-scale processor to register with the FDA; it is entirely different to require that small-scale processor to comply with extensive regulations on every step of its business. Small-scale producer and facilities that sell direct to consumers are inherently transparent and accountable and do not require federal oversight. Such facilities are already sufficiently regulated by state and local authorities.
QUESTION: Are direct marketing food processors exempt from the bill?
It depends. Based on FDA’s guidance documents, food processors who market directly to individual consumers might be exempt from the requirements for HACCP-type programs. But the language is far from clear.
The bill’s provisions for facilities are dependent on the definition of “facility” under the 2002 Bioterrorism Act, which exempted “retail food establishments” from being categorized as facilities, but did not define the term. FDA’s definition of the term does not address the majority of our local food producers. The specific examples of “retail food establishments” are establishments such as grocery stores, convenience stores, and vending machine locations. Not only are farmers markets, farm stands, and CSA’s not listed, but they may not qualify because they typically sell food at a different physical location than where the food is held, packed, or processed. Consider the typical example of a small-scale processor who buys local ingredients and makes jams, breads, cheeses, etc. to sell at the farmers market. It may be that the farmers market itself qualifies as a "retail food establishment" -- but the commercial kitchen where the goods were prepared would not qualify, because the main purpose of that location is to process food, not sell to consumers. Different physical locations may mean different requirements under the FDA’s definitions.
In addition, the current definitions specifically limit the exemption to producers who sell directly to individual consumers. It excludes producers who sell directly to end users such as restaurants, local grocers, and schools. So many food producers who provide healthy, safe foods to these institutions would be subject to the extensive new regulations under S.510.
The Tester Hagan amendment would do two things: (1) it would clarify that people selling directly to individual consumers are exempt, even if the physical location of the sale is different from the physical location of the processing; and (2) it would add a new exemption for processors who gross less than $500,000 and who sell directly to both individual consumers and other end-users such as local restaurants and local stores.
QUESTION: Does S. 510 “help” small farmers and local food producers?
No. The bill does include provisions to try to reduce the burdens that will be imposed on small producers, such as providing for longer deadlines for compliance and directing FDA to consider various issues facing organic farms and small businesses. But none of these actually prevent FDA from imposing new, burdensome requirements. The provisions essentially tell FDA to be nice to local food producers, but do not create enforceable limits on the agency's power.
The Tester-Hagan amendment is a reasonable way to protect small-scale businesses from overly burdensome and unnecessary regulations, and thus protect consumers’ options to buy from local producers whom they trust.