Organic Regulations and the U.S. Food Safety System

Organic regulations include several rules that promote safety, such as prohibiting the use of chemical contaminants, eliminating the use of antibiotics that can lead to antimicrobial resistance, and the regulation of the preparation of compost and use of manure. However, the organic standard in the U.S. is not legally regarded as a food safety standard; it’s a marketing standard. Those in the organic processing business are well aware that in addition to meeting the strict standards of the National Organic Program (NOP), all organic products must meet the food safety rules and regulations applicable to each class of product in the United States, as well as food safety requirements for export.

The U.S. has a multi-faceted food safety system. Today, some products are regulated by the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS), while others fall under the stricter regulations of the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). A few other federal departments also have a piece of the action, as do state and even local governments. And, proposed national marketing agreements like that for “Leafy Green Vegetables Handled in the United States” (Marketing Agreement # 970), if implemented, will impose food safety practices on a “voluntary” basis. Voluntary is in quotes because marketing agreements such as this are proposed by groups within a commodity.  Retailers then fall in line with the terms of the marketing agreement, so if you want to sell to them you have to “volunteer” to be in compliance.  In the case of the leafy greens agreement organic practices would meet some strong challenges in the current proposal.

Improving Food Safety

Recalls and the practices they reflected to consumers and government authorities have caused considerable pressure to create new authorities to enable FDA to require preventive measures and to strengthen its enforcement capacity, and a review of the FSIS authorities is also under way. Congress is moving swiftly to strengthen the regulation of food safety practices. The Obama administration has taken steps to name a Food Safety Working Group, ordering new tracking and testing protocols even while new legislation is being discussed.

Third-party certification for food safety has been the subject of testimony and study in the conventional food industry and among members of Congress seeking food safety reforms. Because organic agriculture and processing is already subjected to third-party certification through the NOP, organic growers and processors are accustomed to meeting certification standards and this experience should help pre- pare organic businesses for new food safety procedures in proposed legislation.

While the legislation is still being considered, there are voluntary preparatory and preventive steps that all companies can consider, and even undertake. One of these preventive steps is incorporating solid sanitation procedures–and fortunately organic processing has many cleaning materials that are accepted for organic practices.  Sanitation and facility planning has always been important in organic production–both on-farm and in the processing facility.  Organic producers have known for a long time that it’s easier to keep pests–insects, animals and microbes–out of the product (while still recognizing they should remain in their natural environment) from the beginning through proper sanitation rather than taking later steps to eradicate pests. This is especially important considering chemical or pharmaceutical intervention to kill pests is not permitted by the organic rules. Organic farmers who raise animals know that keeping animals and their living environments clean aids animal health. Sanitation is the first step to safer food and is a step that is achievable for organic production. In fact, many organic processing facilities have been built specifically to avoid vector harborage and unsanitary nooks and crannies that cannot be cleaned easily.

The legislative proposals also entail putting in place other “preventive” measures. One such protocol is Hazard Analysis and Critical Control Points (HACCP), a systematic approach to the identification, evaluation and control of food safety hazards. Any organic processor of meat and poultry is already covered by so-called “mandatory” HACCP and Pathogen Reduction (HACCP-PR). However, with a few exceptions, FDA-regulated companies are not currently required to have HACCP in place.

Understanding HACCP

HACCP was actually developed by a cooperative effort between industry and the National Air and Space Administration (NASA) to ensure that astronauts would not get foodborne illness while flying in space.  For over 40 years it has been voluntarily placed into effect in many food plants, and has lowered the incidence of food safety problems in those plants.  But it has not reached enough food production facilities, and some companies buying ingredients have apparently not required supplier companies to adopt HACCP practices.  Clearly, neither conventional nor organic companies were demanding a stringent “preventive process” to be in use at Peanut Corporation of America, the company involved in the Salmonella debacle.

Over a period of three years, mandatory HACCP in the meat and poultry industries was successfully introduced into more than 6,000 plants that had not been previously operating with HACCP. And, while there is always room for improvement, HACCP-PR led to considerably enhanced food safety in meat and poultry in the early years following implementation. However, although CDC indicates that “significant declines in the incidence of certain foodborne pathogens occurred since 1996, these declines all occurred before 2004.  Comparing 2007 with 2004 to 2006, the estimated incidence of infections caused by Campylobacter, Listeria, Salmonella, Shigella, STEC O157, Vibrio, and Yersinia did not decline significantly, and the incidence of Cryptosporidium infections increased.”  Thus improvement has plateaued during the early ’00s, making it easy to understand the need for increased food safety efforts across the entire food sector.

Throughout the rest of the food processing industry, there are a variety of methods for HACCP implementation, but all are based on the same principles–with the variation around testing protocols, operations methods, and, of course, the advice of the lawyers and food scientists who consult on compliance in food safety.

HACCP is based on seven principles, including:

Principle 1: Conduct a Hazard Analysis.  Pay special attention to the hazards that are likely to occur, such as metals, glass, pathogens, toxins and mycotoxins, zoonotic diseases, parasites, spoilage, and so forth.  In addition, even though organic facilities may have strict regulations on use of chemicals, it’s important to check for chemical, pesticide and drug residues.  In organic operations, the area to pay the most attention to would be the surroundings, including the water used and potential overspray from conventional operatio
ns. A hazard analysis for pa
thogens might also look at pathways for unexpected hazards, such as those tracked in on employee shoes or boots not cleaned before entering the food plant.

Principle 2: Determine Critical Control Points (CCPs).  Using insight gained through the analysis, facilities can identify points where they can control or reduce hazards. One example is to establish the point where a product actually is baked or cooked to a temperature needed to kill a pathogen.  The point where that temperature ought to be reached, and its point of measurement, is a CCP.

Principle 3: Establish Critical Limits.  A critical limit is a maximum and/or minimum value or physical parameter to which the CCP must be controlled in order to prevent, eliminate or reduce the hazard. An example would be the limits of both the time and temperature at which the product would have to be processed and held in order to kill a pathogen, or chilled to prevent pathogen growth.

Principle 4: Establish Effective Monitoring Procedures.  This can include planned observations or other assessment measurements such as temperature recording and monitoring equipment, or a record of “test and hold” procedures and results if pathogens are likely to occur as hazards.  Track the data from these assessments and create an accurate record for verification in the future.  To continue the example above, one might have a thermometer measure and record the temperature during the process at set time intervals or as a continuous process.

Principle 5: Establish Corrective Actions.  Action is necessary when critical limits are exceeded or monitoring procedures fail. Prior noted records will show these deviations. Pre-planned corrective actions can be used to prevent products that may be hazardous from reaching consumers. These actions could include “test and hold” procedures or recall procedures.

Principle 6: Establish Verification Procedures.  This step goes beyond verification of the HACCP plan itself and includes looking at whether the HACCP plan is actually functioning in harmony with the facility or whether it is just “placed on top” of normal operations. Can the managers ensure through planned oversight that the overall HACCP plan is working? Has an analysis been done of how often an established CCP was not met? Did the company follow up with training to improve performance, and create a better plan, or did it fail to implement its plan effectively?

Principle 7: Establish Record-Keeping and Documentation Procedures. These records can be critical for guiding facility operations, or for legal compliance if the HACCP plan is mandated by law.

Food Safety Legislation

As noted, a food safety reform bill aimed at changing the authorities of the FDA recently passed the U.S. House of Representatives. While no bill has yet passed in the U.S. Senate, the House-passed bill has caused much consternation in the organic community since it appears to require additional procedures beyond those required by an organic system plan, such as additional or duplicative registrations, large fees assessed per facility, and different and potentially conflicting requirements for tracing of products when organic products must already be traceable backward and forward. A discussion known as a “colloquy” was held on the House floor during debate of the bill; this discussion was meant to clarify the House intention for organic farms and processors. A portion of that colloquy follows.

Representative Sam Farr, D-CA: “As a member of the Organic Caucus, I have concerns about the interplay between this bill and the National Organic Program. Is it the Chairman’s understanding that this bill would not establish any requirements for organically produced or processed products which are in conflict with the requirements established by the Organic Foods Production Act of 1990 and the USDA’s National Organic Program regulations? And would this bill necessarily require small farms to participate in an expensive and un-workable electronic traceability system that FDA will set up? . . .I would be remiss if I didn’t mention my concerns with the fee structure in the measure.”

Representative John Dingell, D-MI: “…We worked very hard to make sure that the bill would avoid these effects. We would be extremely concerned if this bill created a conflict between food safety measures and other farming practices aimed at protecting and sustaining the environment. The bill therefore has a number of provisions designed to prevent conflicts between organic regulations and proposed food safety legislation. For example, it requires FDA to take into consideration the impacts of any produce food safety standards on small-scale and diversified farms, on wildlife habitat, conservation practices, watershed-protection efforts and organic production methods. The bill also requires FDA to work in coordination with USDA and the administrators of the National Organic Program to ensure that safety standards are compatible with organic standards. Additionally, it prohibits FDA from setting any standards unless those standards are necessary to minimize the risk of serious adverse health consequences or death.

“Let me speak to your question about the traceability system in the bill. The traceability provisions in the bill are a critically important part because they will allow FDA to quickly track down the sources of foodborne outbreaks. Before FDA can establish any traceability requirements, the bill requires FDA to go through an extensive information gathering process, with public meetings and a pilot project. As part of that process, it requires FDA to consider the costs and benefits and the feasibility for different sectors of the food industry of any traceability technologies under consideration.  And for any regulation that would have an impact on farms, FDA must coordinate with USDA, and must take into account the nature of the impact of the regulation on farms.  Additionally, FDA will be prohibited from requiring farms selling food directly to consumers, restaurants, or grocery stores to participate in this system…”

The Impact of Legislation on Organic Farming

The required communication between the FDA and USDA outlined in this colloquy helps demonstrate that the House leadership has heard the concerns of the organic community. Although it appears improbable that final legislation will impose strict requirements on small farmers directly marketing to consumers, it seems certain that the bill will impose strong food safety procedures on the rest of the food industry after FDA and USDA consider risks, costs, and benefits of additional food safety steps.

We don’t know what the new law will require–the Senate may not accept all that the House has passed, and FDA may decide to implement preventive measures in a very specific regulatory framework.  Ultimately, the principles cited above are just a description of the HACCP points that have been used for many years, but may not be used by FDA.  The current House-passed version is a very complex bill, and will bring major changes to food processing in the U.S., and around the world in food plants that wish to export to the U.S. This discussion has only covered some of the potential operational challenges that may lie ahead.

No matter what happens, understanding prevention will help regardless of what is required by law in the future. And in those principles, organic practitioners should have heard a strong echo of some of the principles already followed in order to produce certified organic products. A number of the requirements being proposed in the legislation for every food processor are already being accomplished by organic processors.  For instance, because all organic production establishments are registered with USDA, an effort is under way to keep certified organic organizations from having to register twice.  Organic
farmers and processors already have a traceability system–one backward and one forward.  And, the concerns of organic farmers and processors are being presented to lawmakers.

Organic companies have an advantage over conventional processors who have never been subject to third-party certification, and who will be starting from scratch.  Organic practitioners also know that as a systems plan is put in place there can be new developments in procedures that have to be evaluated and inserted into the process–an insight gained when one operates from a perspective of continuous improvement.  While we cannot know now what version of the legislation will actually become law, as the food safety debate continues it is wise for organic processors to prepare and learn more about these additional voluntary processes, recognizing that some version of them may soon be required by U.S. law.

“Food Safety Legislation: Special Concerns and Opportunities For Organic Managing” originally appeared in the November-December 2009 issue of Organic Processing Magazine.  Reprinted with permission of the author and publishers. © 2009 by The Target Group