By Vern Grubinger
October 2013 Issue
For many years, foods that pose significant safety risks if not properly handled have been highly regulated, including dairy, meat and seafood. Fruits and vegetables don’t pose nearly as much risk, so growers haven’t had to deal with food safety regulations aimed at fresh produce. Some growers voluntarily complied with Good Agricultural Practices (GAP) in order to satisfy their markets, but for the most part, the industry was left to take common-sense precautions to keep produce safe.
With Congress passing the Food Safety Modernization Act (FSMA), that situation has changed. Once implemented, this federal law will require many growers to spend a lot of time and resources on risk prevention. Even growers exempted from the law are likely to be affected, because over time food buyers will want documentation of similar food safety practices from all the farms they deal with.
According to the Centers for Disease Control and Prevention (CDC), about 48 million Americans get sick and 3,000 die each year from foodborne diseases. However, little of this is due to fresh produce. For example, from 1996 to 2010, there were 131 produce-related outbreaks resulting in 14,350 illnesses and 34 deaths. Thus, fresh produce accounts for about 1 percent of all foodborne disease-related deaths. While this is tragic and growers agree that more can be done to reduce food safety risks on their farms, it should be recognized that millions of pounds of fresh produce are consumed every day with hardly any problems. That said, FSMA is now the law, and growers will have to deal with its requirements, aimed at making a small risk even smaller.
The law and the rules
The FSMA law provides the framework for new food safety regulations, called rules. These are written after a law is passed, and they provide the specifics of how it will work. FSMA put the U.S. Food and Drug Administration (FDA) in charge of regulating food safety on produce farms, rather than the U.S. Department of Agriculture (USDA), which has typically regulated farm practices.
There are a variety of rules associated with FSMA, but two in particular specify what will be required of growers: the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (produce safety rule); and Preventive Controls for Human Food (preventive controls rule).
The draft rules are long, complicated documents, but there are many summaries available online. A good place to start is the FDA’s website: http://www.fda.gov/Food/GuidanceRegulation/FSMA. For summaries of the different sections of the rule online, visit:
National Sustainable Agriculture Coalition: http://sustainableagriculture.net/fsma
University of New Hampshire Cooperative Extension: http://extension.unh.edu/Food-Safety-Modernization-Act-FSMA
New England Farmers Union: http://www.newenglandfarmersunion.org/food-safety-modernization-act
Don’t miss the deadline
The deadline to submit comments to the FDA on the draft FSMA rules has been extended twice, to November 15, 2013. After that the FDA will finalize the rules, though it will be a few years before they’re implemented. Take the time to learn how the rules will affect your farm, and then submit your comments online.
Below are some key concepts about the proposed rule, and I have listed some specific concerns and suggestions. These are my personal opinions, not those of any organization I work for. Take time to develop your own views on these issues.
Farm versus facility
The produce safety rule applies to farms that grow, harvest, pack or hold what is termed “covered” produce. The preventive controls rule applies to facilities that manufacture, process, pack or hold human food, and those that buy and resell products grown on other farms. These facilities must register with the federal government. If you only grow, wash and trim off outer leaves, and if you only sell products you grow, then you run a farm and the preventive controls rule does not apply to you. However, if you peel, chop, combine ingredients, or buy and resell products from another farm, you run a facility or a mixed farm facility and you may be subject to this rule.
Facilities have to keep a written food safety plan, including a hazard analysis, and they will be required to keep records of preventive controls, monitoring, corrective actions and verification. There is still some confusion about what activities make a farm into a facility. Further, the scale of production that triggers designation as a facility and associated requirements is not yet set; exemptions up to $25,000 or even $500,000 have been suggested.
Many farms buy and resell products from other farms. Quite a few farms lightly process vegetables or do on-farm value-added processing. Even a minimal amount of additional paperwork will deter farms from engaging in these activities, which have been encouraged as ways to strengthen local food systems. Only farms that conduct these activities with large volumes of produce – over $1 million of sales to wholesale markets – should be regulated as facilities. Buying fresh produce in clearly labeled containers from other farms that have their own food safety plan does not increase food safety risks enough to warrant the buying farm coming under the preventive controls rule.
Covered produce is generally eaten raw, such as leafy greens, melons, tomatoes, etc. The produce safety rule does not apply to produce that is usually cooked, such as asparagus, beets, potatoes, pumpkins and sweet corn. It also does not apply to produce grown for personal consumption or consumption on the farm.
Buyers are not likely to distinguish between covered and noncovered produce and will want to see evidence of food safety risk management on all farms they purchase from. Further, since most farms grow, harvest and pack a mixture of covered and noncovered produce, these categories complicate the rule without providing significant regulatory relief to most farms. The rule requires careful separation of covered and noncovered produce. It would be simpler for the marketplace and diversified farms if FSMA simply applied to fresh produce.
Cost to growers
The FDA developed estimates for the cost of FSMA implementation. For farms with total food sales between $25,000 and $250,000, the cost is approximately $5,000 per year; farms with sales between $250,000 and $500,000 could spend about $13,000 per year; and for farms with sales over $500,000, the cost is estimated at $30,000 per year.
These are large expenses for small and medium-sized farms, especially when you consider that food sales include all types of food, while the costs are incurred only for covered produce, which may be a fraction of a farm’s total food sales. For example, many farms in my area gross just over $500,000 in food sales, and their covered produce accounts for perhaps half of that. A $30,000 hit will take a large part of their net revenues.
These high costs, in combination with the management burden of compliance, are likely to drive many small and medium growers out of the fresh produce business. It will be simpler to not grow fruits or vegetables and just have a store that sells other farms’ products. Even though many farms that sell retail or directly to retailers will be exempt from FSMA, they are likely to have similar costs if their customers or insurance agents demand analogous food safety documentation. These costs will hinder the development of local food systems that provide economic development, food security and access to fresh food for communities across the nation.
To submit comments online:
Produce safety rule: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0921-0199
Preventive controls rule: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-0188
If submitting online, write your comments ahead of time and save them on your computer. There is a time limit when using the Federal Register system, and you don’t want to lose what you’ve written. If your comment is less than one page, you can copy and paste it into the comment box. If it is longer, write “see attached” in the box and upload a separate Word or PDF file with your comments. Be sure to click the “submit” button! You should then see a new screen with a confirmation number.
To submit comments by mail, send them to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Include the docket number in your comments; the produce safety rule is FDA-2011-N-0921, and the preventive controls rule is FDA-2011-N-0920. Mailed comments must arrive by the deadline, so send them a week ahead just to be sure.
The author is a vegetable and berry specialist with University of Vermont Extension based at the Brattleboro office.