• Farms that grow “certain specified produce commodities that are rarely consumed raw.”  Examples of these crops include, but are not limited to:  asparagus, beets, black-eyed peas, kale, figs, lentils, okra, rhubarb, sweet potatoes, turnips and yams.  To clarify, if a producer grows kale, or any of the other listed crops, that producer is not regulated under the proposed rules.
• Farms that grow “produce that is used for personal or on-farm consumption, or that is not a raw agricultural commodity.”
• Farms that grow “produce that receives commercial processing that adequately reduces the presence of microorganisms (e.g. a “kill step”) as long as certain documentation is kept.”
• Farms “that have an average annual value of food sold during the previous three-year period of $25,000 or less.”

There are also a qualified exemption and modified requirements for farms that meet two requirements:

• The farm must have food sales averaging less than $500,000 per year during the last three years; and
• The farm’s sales to qualified end-users must exceed sales to others.  A qualified end-user is either:  a) the consumer of the food, or b) a restaurant or retail food establishment that is located in the same state as the farm or not more than 275 miles away.

The farms that sell most of their produce to qualified end-users, and do not exceed $500,000 in sales, must include a label on their produce with the complete business name and address.  Also, this exemption can be withdrawn during an investigation into a foodborne illness outbreak.  Qualified end-users are people who consume the produce and restaurants. Earlier this month, Food Safety News reported on some of the comments from stakeholders regarding the proposed rules. Recently, FSN spoke to Ariane Lotti, assistant policy director at the National Sustainable Agriculture Coalition, to get NSAC’s perspective on how the rules may impact farmers.  “Our approach to these rules is we want to ensure a safe food supply and thriving family farms,” Lotti said. “So what we’ve asked ourselves is, ‘How do you construct scale-appropriate regulations so that you can meet those two goals?’” Along with the proposed rules for growing, harvesting and packing produce, FDA released proposed rules on good manufacturing practices and preventive controls in processing facilities.  Farms are required to comply with the produce regulations if the farm is a mixed-type facility that conducts certain types of processing onsite.  Under the preventive controls regulations, processing facilities (including those found on farms) will have to implement HACCP-type procedures into their processing.  The proposed rules list activities that would fit the definition of manufacturing or processing, including washing, trimming of outer leaves, removing stems and husks, sifting, filtering, threshing, shelling, cooling, packaging, mixing, coating, stickering/labeling, drying, sorting/grading, cutting, coring, chopping or slicing, etc. Examples of “on farm” activities that would not be subject to the additional processing regulations include harvesting, packing food “grown, raised or consumed on that farm or another farm under the same ownership,” or holding.  When a farmer conducts any activity that would change the produce into a “processed food,” the off-farm regulations would likely apply. “We are in the process of analyzing the rules right now, but a number of things are clear,” Lotti said.  “One is that around some of the key issues for farmers in the proposed rules, there is a lack of clarity.  It’s unclear what could happen on farms that would trigger that processing definition and how those two rules would interact with a farmer on the ground.” The comment period for stakeholders ends on May 16, 2013.  If the proposed rules are finalized as written, here are some of the rules farmers will have to comply with on the farm: Agricultural Water Sources The proposed rules lay out a hierarchy of safe water irrigation sources, with water from a public source at the top of the list, and surface water such as ponds and streams that are susceptible to runoff at the bottom. Ground water from deep aquifers and water pumped from shallow wells are in between. The lower a water source is on that list, the more the farmer will be required to test the water for E. coli contamination.  The proposed rules set different thresholds for generic E. coli testing results depending on the intended use of the water. If a high level of E. coli is present in the water, it must be treated before applying it to crops.  If a farmer uses water that must be tested, the farmer must also keep good records of all testing.  “Farms, through these proposed rules, are being asked to ensure the quality of the water coming onto their farms, which is an enormous burden,” Lotti said. “We anticipate that it will be a significant cost, both in terms of the testing and infrastructure improvements, and also in terms of the farmer’s time.” The rules offer an alternative mechanism for farmers to be in compliance without having to follow the testing and record keeping standards.  To do so, farmers would have to provide scientific research that shows that the water controls or soil amendment controls in place are as protective to public health as what the rules would require.  “Record keeping certainly carries with it somewhat of a burden,” FDA Director of Produce Safety Samir Assar said in an interview with Food Safety News.  “We tried to minimize the record keeping burden as much as possible.” Biological Soil Amendments The proposed rules also discuss the application of manure and compost to crops as fertilizer, and the regulations relating to those practices.  Specifically targeting the use of animal waste as a soil amendment, the proposed rule discusses treated and untreated animal waste. Untreated animal waste must be applied in a way that prevents any contact with produce, and any application of untreated animal waste must be at least nine months before harvest.  “What we’re finding in our review of the biological soil amendments part of the rule, and what we’re finding in the scientific literature that we are reviewing is that the literature on manure and on the time it takes to kill pathogens on manure is varied and inconclusive,” Lotti said.  “It’s not clear from our analysis of the rules and the process that we are going through to analyze scientific literature how FDA came up with that interval.”  For treated manure or compost, restrictions on use are minimal if the farmer complies with certain time and temperature controls in the treatment process.  Farmers also have to be cognizant of cross-contamination while transporting or applying animal waste. The rules provide guidance for keeping tools and equipment clean after touching untreated manure.  Wild and Domesticated Animals Of all the new regulations proposed under the Act, those governing animals on the farm may be the most difficult for farmers to follow.  Grazing animals in the field, working animals, pets and wild animals are all discussed as potential sources of E. coli or Salmonella.  The proposed rules would require a farmer to follow certain requirements if there is a “reasonable probability that animals will contaminate covered produce.”  For working animals, such as draft horses, the rules do not prohibit their use, but they do suggest creating and using segregated “horse paths” that would presumably be next to the rows of produce.    The rules recommend monitoring for wild animals before and during the growing season, but do not require farmers to exclude wild animals.  The rules also make it clear that farmers should not disrupt animal habitat or remove endangered species from their farms.  If a farmer suspects a pet or a wild animal has gone into the field, they must wait a “suitable time period” based on relevant factors before harvesting the produce in the field.  The rules state the time period does not need to be nine months (the waiting period used when applying untreated manure), but does not specify what a “suitable time period” would be.  The rules do not require documentation of these events, but if an outbreak were to be traced back to a particular farm, FDA would likely ask for evidence of compliance in the form of documentation.  Harvesting, Packing and Holding The proposed rules offer guidance on handling of produce while harvesting, packing and holding it on the farm.  Food packing materials must be cleanable or single-use, and must be unlikely to support bacterial growth.  This regulation may require farmers to purchase new equipment if the containers used during harvest are not easily cleaned.  Farmers are prohibited from distributing produce that drops to the ground before harvest.  The rules state that “dropped produce” is more susceptible to bacterial growth.  This standard doesn’t apply if produce, such as tree nuts, is dropped to the ground as part of the harvesting practice.  It is unclear if a farmer will be prohibited from selling apples that have accidentally spilled on the ground.  Equipment, Buildings and Sanitation Some of the new FSMA regulations are a reaction to recent foodborne illness outbreaks.  One of the factors listed as a possible source of Listeria contamination in the Jensen Farms cantaloupe outbreak was a retrofitted potato cleaner used to clean cantaloupes.  The rules require all equipment to be easily accessible for cleaning. Also, any seams on surfaces where produce would come into contact with pathogens would need to be bonded or maintained to prevent bacterial growth.  Bathrooms and wash stations will also be required, and farmers will have to keep those areas clean. Bathrooms must be situated away from the produce to avoid contamination.  Compliance, Enforcement and Education The rules point out that FDA has authority to inspect farms and initiate enforcement actions when needed.  It also admits that FDA has limited resources for conducting inspections and enforcement.  In the face of this reality, FDA will conduct its inspections on a risk-based system using past outbreaks and other relevant information to determine which farms will be targeted.  “We are looking at all of the mechanisms that are out there that we can utilize or look at to better focus our inspection resources,” Assar said.  “That’s all being worked out right now.” FDA will also provide education and technical assistance to help facilitate the implementation of the new regulations.  “We are also concerned about the lack of training,” Lotti said.  “If they’re going to bring farmers and small businesses in compliance with the rules, while there are later compliance dates for small businesses, there’s this whole aspect of training that is almost absent from the rules.” “When we talk about training, we talk about building capacity at the farm level and at the processing facility level, so that farms and small businesses can follow good food safety practices and continue to grow and run their businesses and essentially respond to consumer demand for local and healthy and fresh food.”  Assar said that FDA will rely on three specific efforts to provide information and training to help farmers implement the new regulations, including the Produce Safety Alliance at Cornell University, a call center that would offer assistance and information and an updated version of FDA’s and USDA’s Good Agricultural Practices guidance.  “Cornell has had years and years of experience in developing produce safety curriculum and delivering safety curriculum,” Assar said.  We have set up this cooperative agreement to set up standardized curriculum across the board.” FDA may also consider funding non-profit organizations that intend to work with farmers to make it easier for them to transition into compliance, according to Assar. However, FSMA does not specifically authorize any funds for such programs.  “At this point we are evaluating our resources and looking for ways to implement the Food Safety Modernization Act to the fullest extent, achieving this vision of overall compliance,” Assar told Food Safety News. Impact on growing local food systems? Farms that process food from other separately owned farms could also be considered a mixed-type facility, which would mean that they’d need to comply with the preventive controls rules in addition to the produce rules. Food hubs, CSA programs and farmer cooperatives often use a centralized location to combine produce from multiple and separately-owned farms.  If you’re packing somebody else’s produce, then you may be a facility that is required to register,” Assar said.  “A farmer that aggregates someone else’s product or includes someone else’s product in their CSA box comes under the rules,” Lotti said.  “And that is going to be a big problem for local and regional food systems. It’s an area we will certainly be commenting on.” FDA does not see it as a barrier for the growth of local food systems, according to Assar. “We regard it as an opportunity to achieve overall accountability for enhancing the safety of fresh produce.” he said. 

Plaintiffs in this case claim that USDA’s action is arbitrary and capricious because it will not achieve its intended purpose. Among other reasons, they allege that testing is prohibitively expensive and that the industry is already doing all it can to control the problem….

In response, Defendants argue that their program has already begun to achieve its intended purpose of spurring industry to use preventative measures….

After reviewing the evidence and arguments presented by the Parties, the Court finds that the Defendants E. coli sampling program was not arbitrary and capricious. There is certainly a rational basis for the USDA to conduct some sort of testing in order to educate itself about this problem. Furthermore, the evidence indicates that the program has been at least partially successful in spurring industry to take greater preventative measures. Moreover, in light of the common cooking practices of most Americans, there is at least a rational basis for treating E. coli differently than other pathogens. Finally, the Court finds that the Defendants’ changing policy is a rational response to an emerging problem.

The Texas Food Industry Association case affirmed the new FSIS policy, making official the idea that the slaughterhouse was where the agency’s focus should be. “Inspection was changing,” Marcy said. “There was a need to both cook [the ground beef] and to look at ways to reduce O157:H7 in the supply going to the [meat] grinders.” “[The Jack in the Box] incident brought increased focus on reducing [E. coli] at the slaughter facilities, because that’s the only place you can reduce it under FSIS inspection,” Marcy added. More changes since Jack in the Box In 1994, the E. coli-as-an-adulterant determination only applied to ground beef. Since then, FSIS has added “trim” and non-intact beef to the list of E. coli-inspected meat products. Beef trimmings are used in ground beef, while non-intact beef is blade or needle-tenderized beef. “Just having it as an adulterant in ground beef wasn’t enough,” Marcy said. “Having it declared as an adulterant in trim was probably a bigger step.” In October 2012, an FSIS official stated the department may expand its testing for E. coli to include other beef products. As an example of how the system works, on January 15, FSIS announced a recall of ground beef due to possible E. coli contamination. A Wisconsin firm recalled more than 2,500 pounds of raw ground beef from Glenn’s Markets and Catering in Watertown, WI. That recall occurred five days after the Wisconsin Division of Public Health reported three illnesses from E. coli O157:H7. Another major shift in food handling has been the mandatory implementation of the HACCP (Hazard Analysis and Critical Control Points) system, a science-based risk-management system developed by NASA and Pillsbury to keep astronauts safe from illness in space. The principle of HACCP is to identify steps in food processing where contamination is likely to occur and take measures to address those risks. Beginning in the late 1990s, USDA-inspected plants were mandated to submit their HACCP plans to FSIS for approval. In 2012, FSIS added six other strains of E. coli to the list of those that are now considered adulterants in ground beef, beef trimmings and non-intact beef. Those strands include O26, O45, O103, O111, O121, and O145. “It was a good move,” Raymond said of the additional required testing. “We will see more outbreaks and more recalls and that’s a burden to the industry, but it is something that will have to happen one way or the other.”

1) A company can utilize expert scientific opinions to conclude that an ingredient is GRAS. The company does not have to provide information to either the FDA or consumers regarding that determination.

2) Alternatively, a manufacturer may issue a “GRAS notification” to FDA, providing the scientific support for the specific ingredient. FDA will respond by issuing a letter that either does not question the offered research or rejects the notification. An ingredient manufacturer who wishes to market its product to different food companies may choose this route in order to publicize the availability of the new ingredient. If the company requests that FDA cease its evaluation of a GRAS notification at any time, the agency will do so.

The statutory requirements are the same for options 1 and 2, but self-affirmation gives the company the option of simply relying on a trained scientific safety recognition before selling an ingredient. In 1997, FDA stopped using a process where FDA would make GRAS affirmations, and first gave food manufacturers the opportunity to use the “GRAS Notification” process. According to Tom Neltner, project director for Pew’s Food Additives Project, this development resulted in a noticeable increase the following year in ingredient information made available to FDA. “If you look at it, the numbers went way up in 1998,” Neltner said in an interview with Food Safety News. “That suggests that companies that used self affirmation without ever notifying FDA started notifying FDA. “The GRAS notifications bring in more information and allow FDA to see things they never would have been notified about before.” Neltner added that while the notification system led to companies more freely providing information to FDA, it also cut back on the public’s involvement in food regulation. A food additive petition includes a step where FDA must correspond with the public through a regulatory procedure called “notice and comment” rule making. “Obviously we also note that if you use a notification, while it may be administratively more streamlined, it does cut the public out of the loop,” Neltner said. “The notice and comment is taken away and [FDA’s] requirement to respond to comments is gone, so you don’t get the input of academics; you don’t get the input of competitors; you don’t get the input of the public on these issues. And that’s a drawback.” Even with the influx of notifications since 1998, FDA still may be unaware of ingredients due to the voluntary nature of the GRAS self-determination option that companies may utilize. In order for a food manufacturer to self-determine that an ingredient is GRAS, it must comply with the same standard that a food additive must meet, meaning that it must “be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food.” “You have to actually be qualified to understand the field,” Neltner said. “But you don’t have to have a scientific panel look at it. The law does not prohibit a company employee from making a determination of safety. The only thing the FDA insists on is that there be published studies.” Marianna Naum, in the Office of the Deputy Commissioner for Foods and Veterinary Medicine, said that the flexibility of GRAS self-determination helps the food industry. “The advantage of having that, as the manufacturer, you don’t have to wait on the agency to render a decision,” Naum said in an interview with Food Safety News. “It’s a more expedited process.” A company has no requirement to contact FDA when they make a GRAS self-determination. Does that mean FDA is unaware of a lot of the chemical ingredients being used in food today? “There aren’t a lot of ingredients that FDA is unaware of,” Naum said. “Since you’re talking about general recognition of safety, you have to be talking about familiarity with the ingredient in the scientific community. I do think it is important for us to keep in mind that these ingredients aren’t necessarily new ingredients. We are just finding a new use for it. I think it is a misconception of the GRAS program. These are mostly old ingredients used in new ways.” Referring to the self-determination system, Pew figures that there are a large number of new ingredients that have never been reviewed by FDA. “We estimated that there were 1000 chemicals that were self affirmed as GRAS and never reviewed by FDA,” Neltner said. “It could be as low as 500. It could be as much as 2000. But we think there are 1000 new chemicals that the FDA has never reviewed.” Once a company has made a self determination of GRAS, or it has notified FDA of its GRAS substance, the ingredient is free to enter the market. At that point, what would it take for FDA to come to a different conclusion? How many consumer complaints would it take for FDA to do their own research or even ban the substance? Naum said FDA doesn’t have a set system for reviewing GRAS ingredients. “If there is a substantiated reason [for further testing], yes we would,” Naum said. “There has to be some reason for us to do that. If a company makes a self determination of GRAS, it means there’s a scientific body behind them that supports that decision.” Naum added that FDA can review a particular ingredient at any point, and for any reason. “That can really vary on a case by case basis,” Naum said. “In a sense, it’s good that there’s no set criteria because it allows for flexibility for the agency. Right now that there is no set criteria for a minimum level of questioning gives the agency more flexibility. It can take one case. It can take 10 cases.” Neltner said a reassessment system might lead to more rigorous review of GRAS ingredients. “There is no systematic reassessment of chemicals,” Neltner said. “Pesticides have to get reviewed for safety by the EPA every 15 years. They just went through a massive review of over-the-counter drugs at FDA.” “Without a system it’s hard to set priorities. Without a system, you are relying on citizens petitions. So without a system to deal with it, it’s often very hard to change the status of a chemical.” Pew estimates that there are more than 10,000 ingredients allowed under FDA’s food additive and GRAS regulatory structure, with 49 percent of those being approved through the food additive petition process and 43 percent coming in as GRAS. Those numbers might be hard to comprehend for someone walking the aisles of his or her local grocery. Neltner says it’s not easy for FDA to work in that environment either. “These are very complicated issues, Neltner said. “The law hasn’t been revised in the last 50 years. … And [FDA] is an office that keeps getting more and more work on them.”  

1) The introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded

2) The adulteration or misbranding of any food in interstate commerce

3) The receipt in interstate commerce of any food that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

“Everyone was put on notice,” Hutt said. “If you’re not prepared to comply with the FDCA, you ought to get into some other business. This is such an important area. You can’t live without food, and therefore there are special rules.” Supreme Court decisions have backed that up and added language to the regulatory structure. In 1943, the Supreme Court upheld the unique criminal standard under the FDCA in U.S. v. Dotterweich, which says that even if a person within a corporation is not intentionally acting fraudulently, they can be held criminally culpable under the act for having a responsible relationship to the distribution of misbranded or adulterated food. The Supreme Court upheld that standard in 1975, during Hutt’s tenure at the FDA, in U.S. v. Park, wherein the president of Acme Markets, Inc. was personally found guilty of violating the FDCA after Acme food storage facilities were determined to be accessible to rodents, leading to the adulteration of food before it was sold in Acme stores. Writing for the Court, Justice Burger held the following:

Thus Dotterweich and the cases which have followed reveal that in providing sanctions which reach and touch the individuals who execute the corporate mission – and this is by no means necessarily confined to a single corporate agent or employee – the [FDCA] imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur. The requirements of foresight and vigilance imposed on responsible corporate agents are beyond question demanding, and perhaps onerous, but they are no more stringent than the public has a right to expect of those who voluntarily assume positions of authority in business enterprises whose services and products affect the health and well-being of the public that supports them.

Both Dotterweich and Park are still good law today. Hutt said these cases had a huge impact on the food industry. “The Park decision made it clear to everyone that the CEO couldn’t create the position of the Vice President of Going to Jail,” Hutt said. “There’s no way the CEO can get off the hook under the Dotterweich and Park decisions. Quality control people would stop me on the street and say that was the single most important Supreme Court decision in American history. It allowed the quality control people to say to the CEOs that this is your responsibility and you can be found liable.” If the FDA has the broad authority to prosecute executives under the FDCA, why are these widely-publicized cases coming and going without any criminal penalties being levied? The public does not have access to the answer to this question. After conducting criminal investigations, the FDA refers its cases to the Department of Justice (DOJ). The FDA may have already transferred these cases to the DOJ, but until either department releases information to the public, consumers will be out of the loop. “First, the [Peanut Incorporation of American] investigation should’ve been over long before now” Hutt said. “Second, the FDA should’ve released their information. For all we know, this could be sitting at the Department of Justice. I don’t know who to blame, the FDA, the DOJ, or nobody.” Almer is hopeful that the length of the investigation is due to the importance of the case. “My understanding of what is going on is this is definitely unique,” Almer said. “They want to cross all their t’s and dot their i’s. They want to get it right. “My guess is people will be surprised by what they find. It might be more far-reaching than people are expecting.” But waiting can be the hardest part for those with a personal interest in the outcome of any criminal investigation. “I wish somebody like 60 Minutes would just explain this story to people out there,” Almer said. “People just assume the guy went to jail. Nobody follows it after the big story breaks, and here it is four years later and we don’t know anything.”

The food facility registration requirement of FSMA mandates that food facilities renew and update their registration information, regardless of any prior registration.

According to Section 102 of the FSMA – which amended the registration provision of the Food, Drug, and Cosmetic Act – food facilities are required to provide the following information:

• Name and address of each facility where the registrant conducts business

• Email address for the contact person of the facility;

• Or for a foreign facility, the email address of the U.S. agent for the facility;

• An assurance that the FDA will be permitted to inspect the facility according to the Food and Drug Cosmetic Act inspection provisions; and

• When determined by the FDA, the general food category of any food manufactured, processed, packed or held at each facility.

For those who wish to get up-to-date information on the availability of facility registration, FDA suggests checking www.access.fda.gov or signing up for FSMA updates here. Updates will also be available on the agency’s system status page.

This latest delay continues the uncertainty concerning the status of FSMA’s implementation as regulations mandated by the act go through the lengthy review process at the Office of Information and Regulatory Affairs at the White House’s Office of Management.

As soon as the FDA allows food facilities to do so, registrants will have to register between Oct. 1 and Dec. 31 every other year.