FDA’s Proposed Produce Safety Regulations - Focus on Agricultural Water Standards
Posted: September 23, 2013
Last January, 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.
Not every type of crop or farm will be covered by the regulation. It only applies to commercially grown fruits, vegetables, mushrooms, and sprouts that are typically eaten raw, not commodities that require cooking or further processing. For example, potatoes, eggplant, winter squash, and beets are not covered. And, green beans or apples sold for processing at a cannery would not be subject to the regulation.
In general, farms with gross food sales under $25,000 are exempt. Farms with gross food sales over $500,000 are required to comply. Those with total sales 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 more than half of his/her apple crop directly to consumers, such as at a farmers market, farm stand, at 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.
The proposed standards include requirements for controlling potential food safety hazards in areas where contamination is most likely to occur including farm worker hygiene, the use of soil supplements containing animal manure, and sanitation conditions for buildings, equipment and tools. An important part of the standards is the set of requirements for managing the safety of agricultural water. That’s because water is known to be both a potential source of contamination and a means by which harmful microorganisms can spread over great distances.
Here are some questions and answers on FDA’s proposed requirements for the sanitary quality of water used on farms and orchards.
Q) What kind of water used on farms does FDA propose to regulate?
A) The standards would only be applicable to “agricultural water”, a term which FDA defines as water that is intended to, or is likely to, contact either the harvestable produce crop or surfaces that come into contact with harvested produce (food contact surfaces). FDA states that food safety risk levels and therefore standards will vary depending on how and when the water is applied. Total risk also depends on whether the water is obtained from ground water from wells; surface water from ponds, rivers, creeks, and canals; or municipal or water district supplies.
Below are some questions and answers that I hope will help you understand what FDA is intending to establish in their upcoming regulation.
Q) What are some examples of agricultural water?
A) Examples include water for pre-harvest activities or harvest and post-harvest activities.
Pre-harvest agricultural water includes water used for:
• irrigation in a manner that may contact the crop (for example, overhead sprays),
• preparing fungicides and pesticides applied close enough to harvest that the crop could be considered harvestable.
Harvesting and post-harvest agricultural water includes water used for:
• cleaning and sanitizing harvesting containers that contact the crop
• cleaning and sanitizing crop contact surfaces (for example, prep tables, utensils, conveyers, wash tanks, and packing containers).
• washing, cooling, and re-hydrating harvested produce
• making ice that is used for packing produce
Q) What general requirements would be in place for all users of agricultural water?
A) For all farms covered by the regulation,
• water must be safe and of adequate sanitary quality for its intended use,
• before each season begins, you must inspect the entire agricultural water system under your control (e.g. pipes, sprinklers, pumps, valves, storage tanks, reservoirs, meters, fittings) to identify conditions that could eventually lead to produce contamination,
• when doing your inspection, you must consider the following risk factors:
– the source of your agricultural water (for example, ground water from wells, surface water, or municipal water)
– the extent of your control over each agricultural water source
– the likelihood that food safety hazards could be introduced on your property (for example, locating a well in a flood zone or too close to a septic system)
– the degree to which the water source is affected by nearby properties (for example, run-off from an upstream dairy farm or sewage treatment facility).
If, during your evaluation, you believe the water is potentially unsafe for its intended use, you must discontinue using it or treat the water so that it is safe for its specific intended purpose.
Q) How does FDA propose that you determine the actual safety of the water you use?
A) FDA has established microbial standards for the safety of agricultural water based on the amount of generic E. coli bacteria present.
Q) Under what circumstances would it be necessary for you to test the microbial quality of your water?
A) Agricultural water testing would be required for:
• surface water applied pre-harvest for irrigation or used for agricultural chemical spraying in a manner that is intended to, or likely to, contact the harvestable crop,
• water used during harvesting or post-harvest to clean food contact surfaces,
• water used to prepare ice that contacts the harvested crop,
• water used for hand washing,
• water used to make treated agricultural teas (for example compost tea).
Q) If I am required to test my water, how often would I have to do it?
A) FDA states that you would not have to test water obtained from a State approved public municipal or district water system. You would only need your water authority to provide you with test results or certificates of compliance indicating it meets EPA drinking water standards.
However, for untreated surface water, FDA is proposing that you test your water on the following basis:
• If the untreated surface water is obtained from a source where a significant amount of runoff is likely to drain into the source (e.g. river, creek, or lake), then you must test at least every 7 days during the growing season.
• From any source where underground aquifer water is transferred to a surface water containment structure, constructed and maintained in a manner that minimizes runoff drainage into the containment, must be tested at least once each month during the growing season.
FDA has not proposed a testing schedule for water obtained from private wells.
Q) What are the maximum allowable levels of generic E. coli that FDA is proposing for agricultural water?
A) FDA has proposed two different standards for agricultural water, one for pre-harvest water activities and another for harvesting and post-harvest activities.
Pre-harvest agricultural water: E. coli levels for water that is intended to, or likely to, contact the harvestable crop must contain:
• no more than 235 cells per 100 milliliters of water for any single sample.
• no more than 126 cells per 100 milliliters of water averaged over 5 successive sample periods (rolling geometric mean)
Harvesting and post-harvest water: E. coli levels for harvesting and post-harvest water, including water used for hand washing and drinking, must contain:
• no detectable levels of E. coli in 100 ml of water.
Q) What would I be required to do if monitoring shows E. coli levels are above the FDA limits?
A) Again, this depends on whether the water is used for pre-harvest or harvesting and post-harvest activities.
Pre-harvest agricultural water: According to FDA, exceeding the standards would not necessarily mean that produce in contact with the water is unsafe to eat, but it would suggest that there is reason for concern about your water source or how it’s delivered. You should re-evaluate the safety of your water source by considering:
– the extent of your control over your agricultural water source,
– the degree of protection of your agricultural water source,
– the use of adjacent or nearby land,
– the likelihood of introduction of food safety hazards.
If your evaluation indicates that you have no control over these factors, you should stop using the water source or make changes to your farming practices using ways that could reduce risks such as:
• switch from direct irrigation methods (for example, overhead sprays) to indirect methods (e.g. drip or furrow irrigation),
• treat your irrigation water with a disinfectant (for example, chlorine, chlorine dioxide, or hydrogen peroxide) at levels that will reduce E. coli levels to below the limit. Then retest it to make sure you are below the limit.
Harvesting and pre-harvest agricultural water: FDA states that the quality of water used during harvest and post-harvest activities is critical for food safety. Therefore if E. coli is detected in water used for these purposes, you should immediately stop using this water or take one of the following actions:
• switch to another water source that you know if free from E. coli bacteria,
• treat your water with a disinfectant at levels that are adequate to eliminate E. coli bacteria.
Keep in mind that disinfectants used to reduce bacterial levels in water must be registered for this use by the Environmental Protection Agency (EPA). Chlorine levels in drinking water must be no higher than 4 parts per million (ppm)
Q) When does FDA propose to begin enforcing these rules?
A) There will be a phase-in period starting on the date the final rule will be issued and which is based on average yearly food sales. The amounts of time growers will have to comply for different farm sizes are:
• 6 years for very small businesses (total food sales less than $250,000 per year),
• 5 years for small businesses (total food sales less than $500,000 per year), and
• 4 years for all other businesses
You can read the entire draft ruling from the Penn State Farm Food Safety web site. Click on “FDA Draft Produce Rule Information.”
What do you think about the proposed standards for agricultural water? Are they too strict or too lenient? Is it reasonable to assume that Pennsylvania produce growers can meet these standards? Should the exemption qualification be based on total yearly farm food sales and marketing channels? Some say that small farms need protection from costly regulations that could shut them down and that local produce is safer. Others say that there is no evidence that local means safer and that microorganisms don’t know what size operation they are on or where the produce is going. Should FDA be concentrating its efforts on high risk commodities? For instance, contaminated cantaloupes have been linked to many cases of foodborne disease, while no problems have been reported with tree fruits. Others say, that absence of reported illnesses does not mean that contamination and sickness could not happen in the future.
If you wish to make your comments or concerns known to FDA, you can make sure your voice is heard in Washington. You can send your comments to FDA in two ways.
1) Through the internet at http://www.regulations.gov. Once you are on the site, type or paste the docket number, which is FDA-2011-N-0921, in the search box.
2) Through written comments faxed to FDA at 301-827-6870 or mailed 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)
The deadline for comments to FDA is November 15, 2013.
Look for updates on the rule making process and upcoming GAP training opportunities at the Penn State Farm Food Safety web site or contact Dr. Luke LaBorde at email@example.com or 814-863-2298.