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Digging Into the FDA’s Proposed Rules for Produce

Food Safety News examines the potential impact of the U.S. Food and Drug Administration’s newly proposed produce rules, mandated by the Food Safety Modernization Act of 2011.

Part of the Food Safety Modernization Act, which has the goal of reducing the incidence of foodborne illness in the U.S., is an update to requirements for produce farmers that codifies accountability for food safety at the farm level. 

While the U.S. Food and Drug Administration already has inspection authority over farms, FSMA will widen the agency’s jurisdiction.  FDA’s proposed produce safety standards, released in January, provide a new regulatory scheme for farmers to comply with, but includes exemptions for certain types of farms. 

The rules attempt to reduce foodborne pathogens on produce by focusing on sources of contamination, including water sources, biological soil amendments, wild and domesticated animals, workers in the fields, equipment, buildings, and harvesting and packing.

The proposed rules begin by listing the farms that are partially exempted from FSMA regulation.  Those categories include: 

  • 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. 

© Food Safety News
  • http://twitter.com/MichaelBulger Michael Bulger

    As Renee Johnson of the Congressional Research Service says: “FSMA clarifies the types of facilities included as a “retail food establishment” and therefore generally not subject to the registration requirements. It requires the HHS Secretary to amend the definition of “retail food establishment” to include food sold directly to consumers by a roadside stand or farmers’ market, food sold through a community-supported agriculture (CSA) program, or sale and distribution of food at any other such direct sales platform as determined by the Secretary (§ 102(c)).”

    http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247548.htm#SEC102

    Based on this, CSAs would be a qualified end-user (in terms of exempting farms). CSAs would also be exempt from registering as a food facility.

    There seems to be some confusion about this, both at FDA and elsewhere. I intend to make a comment before the rules are finalized, and I don’t see any way that FDA would not clarify that CSAs are exempt. It’s spelled out very clearly by Congress.

  • Mike_Mychajlonka_PhD

    Thank you for this informative article. It seems to me that the statement: “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” contains many undefined terms. Foremost among these is the word “adequately.” How many decimal reductions of microbial load are to be deemed acceptable? Are we about to enter the world of “Pasteurized” produce? If so, will produce so processed be able to claim its “Pasteurized” status on the label? The term “Pasteurized” is itself a moving target. Is there to be a “safe haven” of what “Pasteurized” is going to mean for produce or do farmers have to figure this out for themselves?

  • Mike_Mychajlonka_PhD

    So far as I am aware, the smallest log reduction that currently carries the name of Pasteurization is the five-log reduction used for fruit juice. Let’s say you have a microbial load of 100,000 colony forming units/milliliter (1 x 10exp5 CFU/ml), notice that this number is basically five orders of magnitude of the number 10 or 10exp5. Now let’s say that you subjected materials to a process that killed all but one CFU of that hundred thousand. You would be left with 1 CFU/ml (1 x 10exp0). To calculate the reduction in microbial load, just subtract 100,000 CFU/ml – 1 = 99,999 CFU/ml (or 1 x 10exp5 CFU/ml – 1 x 10exp0 CFU/ml = 9.9999 x 10exp4). This rate of kill is usually expressed as a percentage 99,999/100,000 = 99.999%. Note that this percentage contains five significant figures. Answering your second question is more problematic. Producers of leafy greens subject their harvest to a vigorous washing step with water that may contain differing concentrations of sanitizers like chlorine, propylene glycol and phosphoric acid. Yet, FSN readers know that Taylor Farms recently was subject to an outbreak despite their excellent washing regimen. A farmer makes his livelihood selling quarts of strawberries (or whatever) to all comers. A food safety consultant trades in compliance issues, proprietary methods and ideas. Neither one is going to give away the farm. I have recently contacted the Leafy Greens Marketing Association regarding a novel method to Pasteurize leafy greens. Were you to sign a non-disclosure agreement, I would be happy to speak with you as well. Please contact me at mikem@foodsafetyanalysis.com.

  • http://twitter.com/MichaelBulger Michael Bulger

    I don’t think that will work. The law says that a CSA is a “retail food establishment”, and retail food establishments are not required to register as food facilities. So, the aggregation would have to be treated the same as aggregation at any other retail food establishment and not be covered by the rules.