New FDA Rule: Ramifications for Georgia’s Small and Direct Market Growers
Increased costs & increased obstacles, the new FDA rule is not for Georgia Organics’ farmers.
TAKE ACTION AND CONTACT THE FDA. INSTRUCTIONS BELOW. DEADLINE TO COMMENT IS SEPT. 16!
A proposed Food and Drug Administration (FDA) rule has been called the most sweeping reform to food safety in 70 years, which is the No. 1 reason you should read this entire post and share it with anyone you know who’s farming.
Due to nationwide food-borne pathogen outbreaks and new CSI-like analytical tools, the FDA has been empowered by the Food Modernization Safety Act (FSMA) to launch an all-out war against on-farm microbes that contaminate produce and sicken consumers.
Sounds good right?
Well, maybe not. Farmers are mobilizing, regulators are scratching their heads, and an overwhelming fog of confusion and even mistrust has descended on agricultural producers of all sizes.
But let’s back up and start at the beginning.
Earlier this year, the Georgia Department of Agriculture held a listening session on the new rule at its offices in Atlanta with top researchers and executives from the Department, agricultural groups, the University of Georgia ag school, and the FDA. Michael Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, explained that the new rule is actually intended to help farms implement better safety controls and sell more of their product.
The FSMA, when implemented, is a shift in the way the U.S. tackles food safety: no longer will the focus be on industry recalls. Instead, it’s going to take place preventatively in the field and the packing shed.
Here’s an FDA video that explains what’s new about this new rule.
What is FSMA?
In response to numerous outbreaks of food-borne pathogens over the past decade, the Food Modernization Safety Act seeks to transform the current reactive model of food safety in the United States to one of prevention. Instead of a regulatory regimen based on item recalls after health risks are already present, the FDA is working to put a rule in place that would eliminate microbial contamination through “science-based standards for growing, harvesting, packing, and holding produce on domestic and foreign farms.”
The FDA is currently receiving public input on produce safety regulations created as part of its FSMA mandate, officially titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” The proposed rule would apply to farms that hold fruits and vegetables in “their raw or natural (unprocessed) state.” It would focus on control measures in “commonly identified routes of microbial contamination,” namely:
- Agricultural water—Agricultural water and agricultural water systems would be regularly tested, i.e. well water once per year, pond once per month, river per once week.
- Farm worker hygiene—In addition to practicing good hygiene, personnel who handle produce would be required to receive training on the principles of food hygiene and food safety, health and personal hygiene, and other applicable topics.
- Manure or other additions to the soil—Set rules would be established on the length, heat, and time of materials composting before they could be applied to fields. Currently, recommendations are 9 months between the application of raw materials and harvest, 45 days between composted materials and harvest, and 0 days between the application of heat-treated materials and harvest. (This provision could be amended with science-based data).
- Animals in growing areas—Farms would be required to monitor wild animal intrusion, to leave produce visibly contaminated with animal excreta unharvested, and to allow for adequate waiting periods between the grazing or working of domesticated animals and the harvest of produce in a growing area.
- Equipment, tools and buildings.
- Specific issues pertaining to sprouts—For example, testing seed before sprouting, testing spent sprout irrigation water, and monitoring the growing environment for Listeria.
Does FSMA apply to you?
At the moment, it appears as if the FMSA won’t apply to the majority of the farmers that Georgia Organics works with. Thanks to the Tester-Hagan Amendment to FSMA, most direct market farmers in the state would be exempt from the new rule, although they would still have to conform to state and local health and sanitation laws.
While this is not intended to be free promotion, it should be noted that Sen. Jon Tester is not only the lone active farmer in the Senate but is also Certified Organic, growing mostly grains on his Montana family farm.
Along with Sen. Kay Hagan of North Carolina, Sen. Tester is attempting to protect small and direct sales farmers through an amendment to the FSMA.
Additional exemptions outside of the Tester-Hagan Amendment would apply to “produce that constitutes the lowest risk with respect to biological hazards. Examples include produce that is rarely consumed raw, such as potatoes, or that is destined for further processing that includes a kills step (with certain documentation), such as green beans destined for a canning operation.” Grains would not fall under these rules, nor would produce for personal or on-farm consumption.
Farms with an average annual value of food sold during the previous three-year period of $25,000 or less would not be covered.
According to FDA language, the limitations of coverage of the FSMA rule run accordingly:
As required by Congress, farms would be partially exempt from the proposed rule if they meet two requirements. First, they must have food sales averages less than $500,000 during the last three years (adjusted for inflation). Second, their sales to qualified end-users must exceed their sales to others during the same period. A qualified end-sure is either a consumer (in any location) or a restaurant or retail food establishment located in the same state as the farm or not more than 275 miles away from the farm. However, FDA may withdraw this partial exemption if the farm is directly linked to an outbreak, or if FDA determines it is necessary to protect the public health and prevent or mitigate an outbreak based on conditions or conduct that create a potential for the farm’s produce to cause an outbreak.
If a farm qualifies for this partial exemption, certain labeling requirements would apply. That is, if a label is otherwise required on the produce that would otherwise be covered (tomatoes packaged in a clam shell for example) then the label must include the name and business address of the farm where the produce was grown. If a label is not required, then the name and business address of the farm where the produce was grown must be displayed at the point of purchase (such as on a poster, for example).
(While this is not intended to be free promotion, it should be noted that Sen. Tester is not only the lone active farmer in the Senate but is also certified organic, growing mostly grains on his north-central Montana family farm.
The FDA has created a handy flowchart for producers to understand the coverage and exemptions of the new rule:
|Does your farm grow, harvest, pack or hold produce? Sections 112.1 and 112.3(c)
|NO||You are NOT covered by this rule.|
|Is your produce rarely consumed raw? Section 112.2(a)(1)
|YES||This produce is NOT covered by this rule.|
|Is your produce for personal/on-farm consumption? Section 112.2(a)(2)
|YES||This produce is NOT covered by this rule.|
|Does your farm manufacture/process, pack, or hold produce that is not a *Raw Agricultural Commodity (RAC)? Section 112.2(a)(3)
|YES||Produce that is not a RAC
is NOT covered by this rule.
|Is your produce intended for commercial processing with a “kill step”? Section 112.2(b)(1)
|YES||This produce is NOT covered by this rule, EXCEPT as per
Sections 112.(b)(2) and (3)
|Does your farm on average (in the previous 3 years)
have < $25k annual food sales? Section 112.4(a)
|YES||You are NOT
covered by this rule.
|Does your farm on average (in the previous 3 years) as per Section 112.5:
“Qualified End-User” Section 112.3(c) means:
|YES||You are EXEMPT from this rule except as per
|You are COVERED by this rule.|
Two Realities: Money and Time
Current Federal budgetary restrictions place serious limitations on the effectiveness of recent legislation. With its scope and aggressiveness, FSMA may be more affected than most.
According to the Washington Post’s story on the bill’s passage in the House, the Congressional Budget Office estimates that the program will leave a $2.2 billion hole in the FDA budget.
President Obama’s budget has proposed a $295 million dollar increase to the FDA budget for FSMA. Of that increase, $43 million would be regular funding. The rest would come from food facility registration and inspection fees and food importer fees through proposed legislation.
“Can we afford all of the things we say we want?” Commissioner Black said at the Georgia Department of Agriculture listening session. “I don’t know if we can afford all of this.”
Commissioner Black’s concerns are legitimate: The burden of enforcement will fall to food safety regulators in each state. The FDA has no army of investigators on hand and no funding to hire them. The Georgia Department of Agriculture will have to take the lead on implementation in the state as the FDA suddenly reshapes part of itself into an agriculture-based preventative agency. But as Commissioner Black suggests, there’s no money on the state level either.
For those leery of the new law, these funding shortfalls are good news. There will be no FDA yearly audit or records on top of what already suffices for the state of Georgia. FDA representatives at the Listening Session admitted they’re unsure how compliance will be enforced. There’s not even a definable strategy to monitor FSMA exemptions.
Getting into the farming business is new territory for the FDA. More than anything, these initial difficulties mean that the effect of FSMA may take longer than originally attended.
Until then, farms would be well-served to implement a comprehensive Good Agricultural Practices (GAP) and recordkeeping program. According to Oscar Garrison, former head of the Georgia Department of Agriculture’s Food Safety Division, a good GAP system will likely cover farms under the FSMA proposed rule.
The FDA has proposed a three-tiered implementation period based on the size of agricultural operations and the commensurate risk. Farms would have to comply according to the following schedules after the effective date of the rule, which is 60 days after the final rule is published in the Federal register:
- Very small businesses, with an average value of food sold during the previous three years of no more than $250,000, would have four years after the effective date; six years for some water requirements.
- Small businesses, with an average value of food sold during the previous three years of no more than $500,000, would have three years after the effective date; five years for some water requirements.
- Other businesses to contained in the previous categories would have two years after the effective date; two years for some water requirements.
While the draft proposal looks good on the paper, it’s no reason for small, direct-market farmers to stand pat. The extent of the protections in the rule and their application is still being debated, and larger commodity groups aren’t pleased with a swath of farmers operating outside of the FDA’s sights.
“We want to make sure that the big producer and the small producer have a level playing field,” said Zippy Duvall, president of Georgia Farm Bureau.
In terms of enforcing regulation for imported food and maintaining food safety to protect sales and income across the industry, Duvall’s statement has substantial merit. If Listeria-contaminated lettuce is sold at the local farmers market and makes customers sick, it’s bad for the larger producers, too. However, according the FDA, almost 90% of produce grown and consumed by Americans would be covered by the regulation, consumed in a cooked state, or “sent to food processing plants that have processes designed to address biological hazards associated with produce.”
Small and direct-market farmers need to comment on the rules to maintain and possibly expand the exemptions. The Tester-Hagan Amendment realized that not all farms posed the same health risks or had the resources to comply effectively with FSMA. But the FDA could still be convinced otherwise, and a slight tweak of language might be detrimental to small farmer’s bottom line.
The FDA says it wants a practical rule. Farmers need to tell them what’s practical, and theTester Amendment is crucial for that.
Please tell the FDA how important the Tester-Hagan Amendment is for Georgia’s family farms, and that the FDA’s own exemptions for farms who sell to local markets are crucial for our local economies.
In order to comment on the new rule electronically or read other comments, follow the link: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0921-0028
Comments can also be sent by mail to
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
The last day to comment on the rules is now September 16. Georgia Organics will keep its members informed of updates and changes. We also recommend the checking in with the Georgia Fruit and Vegetable Growers Association, which is also providing extensive updates about FSMA for its members.