On January 4, 2013, the U.S. Food and Drug Administration (FDA) released a draft Produce Safety Rule as required under the Food Safety Modernization Act (FSMA) of 2011. This proposed regulation would establish mandatory practices that farmers must take to prevent microbial contamination of fresh produce. Below are highlights of requirements FDA would issue in the final regulation:
Worker Health and Hygiene – Farm and packing house workers who harvest or handle fresh produce, and their supervisors, must receive training on personnel hygiene and health conditions that can increase the risk for food contamination. Growers are required to show proof of training by keeping written records. Toilet facilities have to be readily accessible, kept reasonably clean, and supplied with toilet paper. Hand-washing stations must be close to toilet facilities and supplied with potable running water, hand soap, and clean single use towels.
Agricultural Water – Growers must be able to demonstrate that the water they use for irrigation, pesticide preparation, cooling and washing, etc. is safe for its intended use. Maximum average E. coli levels of 126 cells per 100 milliliters have been proposed for irrigation water that can contact the edible part of the crop. Water used for post harvest operations face more stringent standards; no detectable levels of E. coli are allowed.
Biological Soil Amendments – At least a 9 month interval (270 days) would be required between application of raw animal manure to produce fields and harvesting if there is a possibility that the manure may contact the produce. Composted animal manures can be applied from 0 to 45 days before harvest depending on whether or not it can contact the crop. Growers, or commercial compost suppliers, must provide proof through laboratory testing that the composting process was adequate to make it safe to use. No human waste is allowed on fields except in the case of sewage sludge biosolids that are treated according to already existing regulations.
Domesticated Animals – Working animals, such as mules and horses, are allowed in produce fields as long as the grower can demonstrate that they have taken adequate measures to prevent contamination. If animals are allowed to graze in areas intended for produce growing, the waiting period specified for application of raw manure (270 days) would apply.
Wild Animals – FDA recognizes that it is impossible to keep all wild animals away from produce fields. If the situation is out of control and there is a reasonable probability that wild animals can contaminate produce, growers would be required to monitor their fields for signs of animals and take some kind of preventative measure to keep them out or discourage them from entering.
Equipment, Tools, and Buildings – Equipment and tools need to be kept reasonably clean. Sanitation standards for packing buildings requires good water drainage, control of dripping condensation, a pest control program, and regular clean-up of trash. Partially-enclosed packing buildings are acceptable if the grower or packer takes precautions to prevent birds and other pests from becoming established in the buildings.
Here are some important points that need to be made about the proposed rule.
• The proposed rule covers only fresh produce that is sold commercially. It does not apply to produce used for personal consumption, such as home gardens.
• The focus of the new regulation is on fruits, vegetable, nuts, herbs, mushrooms, and sprouts that are typically eaten raw, not commodities that are generally cooked or further processed. For example, potatoes, egg plant, winter squash, beets, and beans for drying are exempt.
• Not all farms that grow fresh produce are required to comply with the rule.
• Farms with gross food sales under $25,000 are exempt
• Farms with gross food sales over $500,000 are generally required to comply.
• Those with total sales of between $25,000 and $500,000 may or may not receive exemptions, depending on what kind of marketing channels are used.
For instance, if a farmer sells than more than half of his/her strawberry crop directly to consumers, such as at a farmers market, farm stand, as a CSA, or if he/she delivers it directly to a grocery store or restaurant, they are exempt from the regulation. However, to receive this exemption, these kinds of direct sales must be to buyers in the same state as the farm, or if out of state, no farther than 275 miles from the farm.
• If a crop is mostly sold through wholesale outlets, such as through distributors, warehouses, or fresh-cut processors, the farm is not exempt and is covered under the rule.
• Exemptions can be cancelled if FDA determines that a farm may be a source of contaminated produce.
• And finally, keep in mind that growers of any size who sell at least some of their crop through wholesale marketing channels, even if technically not covered by the federal regulation, have been facing and will to continue to face standards at least as stringent as anything in the final FDA regulations.
Remember, this is a proposed rule. It is not a final regulation. This means that growers have an opportunity to comment on any part of the rule they do not understand or object to.
The draft ruling is available for viewing at http://www.fda.gov/Food/FoodSafety/FSMA/ucm304045.htm. The public will have the opportunity to submit comment on the draft rule until May 16, 2013. Before this date, FDA will be holding public meetings to explain the proposal and to provide additional opportunity for input.
There are two ways to send comments. You may submit comments through the internet at http://www.regulations.gov. Once you are on the site, follow the instructions for submitting comments.
For written comments, you may fax them to FDA at 301-827-6870 or mail them to:
Division of Dockets Management (HFA-305)
Food and Drug Administration,
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.
All written submissions received must include the Docket No. (FDA-2011-N-0921)
Look for updates on the rule making process and upcoming GAP training opportunities at the Penn State Farm Food Safety web site at http://extension.psu.edu/food-safety/farm, or contact Dr. Luke LaBorde at email@example.com or 814-863-2298.