The Food Safety Modernization Act, Round 2; Your comments are critical, again!

By Bill Duesing 

Both organic and conventional foods can be a source of food poisoning outbreaks. However, in an organic system, there’s a much higher level of microbial biodiversity, so there are more naturally beneficial microbes in the system and soil.

Studies show that when you introduce pathogens into an organic system, they often don’t survive very long because the biologically rich community of organisms that’s naturally there either competes effectively with them or uses them for lunch.

 -Charles Benbrook, a research professor at Washington State University’s Center for Sustaining Agriculture and Natural Resources in Pullman.

We all want our food to be "safe."  We expect those mixed greens we buy for our salads to be free of microbes that could make us sick.  That's the case whether we pick up a plastic package of conventional mesclun which comes from the other side of the country or our organic CSA share, freshly mixed from produce of several neighboring farms. *(See #2 below.)

In September, as part of its implementation of the Food SafetyModernization Act (FSMA), the Food and Drug Administration (FDA) issued the second versions of the two Rules which apply to fresh fruits and vegetables which are normally eaten raw.  The Produce Rule applies to farms.  The Preventative Controls Rule applies to facilities which process food.  In the rules there are many references to RACs.  Those are raw agricultural commodities. The extensive Table 1 in the appendix lists all the different things that are done to RACs and whether they are classified as harvest activities or processing activities.

FDA will accept comments from farmers, eaters, handlers and researchers on these new versions until December 15, 2014. Your comments are critically important.

The first versions of these rules were released last year.  They were basically about three things:

1. How to keep pathogenic organisms in irrigation water, manure or biological soil amendments from contacting crops we are about to eat raw.

2. How to apply those rules to the diversity of farms which the two salad greens sources above only begin to describe. *

3. Where to draw the line between farms and packing facilities. 

The FDA received many comments on the first versions of the rules.  CT NOFA's partner, the NationalSustainable Agriculture Coalition (NSAC) provided extensive resources to help people submit valuable comments and also worked with the FDA this year to improve the rules.

The good news is that the Food and Drug Administration (FDA) took the comments we made on the first versions of the rules seriously.  The FDA made a number of positive changes in the second versions.

Manure and Compost

The FDA backed off of last year's proposal for a nine-month interval between raw manure application and harvest.  They accepted the National Organic Program's (NOP) standards for  organic farms.  These require an interval of 90 days for crops that don't contact the ground and 120 days for crops that do.  The FDA will conduct research and risk assessment on the use of manure and then provide a new opportunity for comments in five to 10 years. 

In the meantime, there is no limit on raw manure use on conventional farms.  However, as most soil health experts advise, the Produce Rule encourages the use of composted manure.  As in the NOP's organic standards, there is no interval between applying properly-made compost and harvesting a crop, rather than last year's 45-day interval. 

** Two stars indicate the areas where FDA is looking for input.

** FDA would like to hear from us about resources needed to encourage the use of compost rather than raw manure.

Water testing

How do you know that water from a pond or stream is not contaminated? (Remember that these rules are just about biological contamination, specifically by the organisms that would make us sick.) 

Previously, to use surface water for irrigation a farmer had to test the water every seven days and stop using that water if it reached a certain level of colony-forming units of E.coli.  E.coli is found in human and animal manure and is considered a marker for a number of other pathogenic organisms.

In the new version, the testing requirements are less rigorous and require establishing a baseline throughout one season, with less frequent testing if the baseline is appropriate. There are also options for increasing the time between application of water that doesn't meet the standard and harvest to one or three days depending on test results.  For untreated well water, farmers can establish a baseline with four tests in one season.  If that meets the standard, then only one test per growing season is needed.

** The FDA would like to hear comments on whether or not these are workable approaches and what amount of time between irrigation and harvest is appropriate if water doesn't meet standards.

It is good to know that the more conservative watering solutions, drip and furrow irrigation, are exempt from these requirements because the water doesn't contact plant leaves.

Who has to comply with how many rules, when?

I found this flow chart from our partners at the National Sustainable Agriculture Coalition very useful for understanding what farms and businesses are affected by these Rules.  Remember that they apply to fruits and vegetables that are usually eaten raw.  If you grow or process just potatoes and winter squash, these rules don't apply. 

The sustainable and organic community pushed hard for an exemption for small farms which sell produce locally.  Farms which sell less than $25,000 of all produce would be exempt under the current regulations. 

** Originally it had been the gross sales of all food (including dairy, grain, eggs, etc.).   Now the Rule says gross sales of all produce. Perhaps it should include just covered produce, that which is normally eaten raw. Let the FDA know.

Farms selling between $25,000 and $250,000 of all produce are called "very small businesses" and have four years after finalization to comply with requirements. (The law was passed in 2011 and we won't know the scientific findings about using manure until between 2019 and 2024.)

Farms under $500,000 are considered "small businesses" and have three years to comply.

Under the current versions of the Rules, there are ambiguities that could mean a CSA farm which includes produce from other farms in its shares, or a farm-based food hub or cooperative packing house is treated as a produce facility as well as a farm and therefore subject to both Rules.

** It is important to let the FDA know about the importance of new distribution methods and facilities for a local food system.  Should an on-farm farmstand, a farmers market or CSA be considered a facility and subject to the Preventative Controls Rule?

** The FDA is also looking for comments on new and more flexible language regarding notification, withdrawal and reinstatement of a qualified exemption after a food-borne illness event.

** The Center for Sustainable Agriculture at the University of Vermont Extension produced a very helpful summary of the Revisions in the Rules, pointing out all the areas where the FDA is looking for comments.

We have until December 15th to provide comments on these rules.  The FDA is especially looking for thoughtful and knowledgeable comments from farmers, market managers, food hub enthusiasts, eaters and others who will be affected when these rules go into effect. 

The easiest way to provide comments is through the NSAC FSMA web site. It has clear explanations of all the issues and provides many resources and links to help us make comments through the regulations.gov web site or by mail.

Participate in this important conversation with the Food and Drug Administration about what is required to keep our food safe.  Now's the time to speak up and be heard!

When you are ready to comment, start here.