Food safety has never been a more critical issue for the entire food industry. The increasingly common outbreaks of foodborne illnesses over the past decade have led to a growing concern surrounding the safety of our food. It is today’s reality that more stringent food safety regulations are here to stay. For the organic sector, the good news is that organic systems have always relied on effective preventive practices to maintain organic food’s high safety standards.

Organic producers and handlers have excellent management protocols in place, access to crucial and organic-
compliant tools for preventing foodborne illnesses and are at no disadvantage in terms of food safety. Organic producers, in fact, are ahead of the curve: The preventive control methods required under organic regulations are in line with the U.S. Food and Drug Administration (FDA)’s preventive approach in its new food safety regulations. Furthermore, organic growers and handlers are inspected at least once a year, and ingredients and products can be tracked from the farm to the grocery store shelf because of the traceability requirements included in organic regulations.

The Organic Trade Association (OTA), the membership-based business association for the organic industry in North America, was an early adopter of food safety reform. Recognizing the essential role food safety plays in organic food production and the unique requirements of organic regulations, OTA was fully engaged in the legislative process leading to congressional passage of the sweeping Food Safety Modernization Act (FSMA).

In 2009, OTA launched a Food Safety Task Force to track and analyze pending legislation for any impact on the organic sector. OTA lobbied the Senate Health, Education, Labor & Pensions Committee staff and several Senate offices to include language in the Produce Safety Rule prohibiting any new regulations from contradicting or duplicating the requirements of the U.S. Department of Agriculture’s National Organic Program (NOP). OTA’s efforts were successful, and the final version of FSMA signed into law on January 4, 2011, included language to this effect.

A New Focus for FDA on Prevention and Produce
FSMA amends the Federal Food, Drug, and Cosmetic Act concerning the safety of the food supply and is aimed at helping prevent food safety problems by shifting the focus to food contamination prevention rather than responding to outbreaks. This represents the most significant reform of food safety law in 70 years. In addition to giving FDA new enforcement authorities and new tools for managing imported foods, FSMA requires food facilities to identify potential food safety hazards and to develop and implement preventive control plans. It also requires FDA to create new federally mandated food safety regulations for fresh produce farms growing fruits and vegetables.

FSMA’s enactment marks the first time FDA will have real authority to regulate food production and handling on farms growing produce. For the organic sector, the language in FSMA specifically addressing organic growers is of critical importance and has become the major focus for organic stakeholders. Consistent with OTA’s work on FSMA legislation, FSMA requires the produce standard to avoid conflict with or duplication of NOP regulations, and to take into consideration conservation and environmental practice standards established by federal agencies. Also of significant importance, FSMA requires all regulations to be scale appropriate and science based.

Over the course of 2013, FDA released multiple proposed rules for public comment. The Produce Safety Rule establishes science-based standards for growing, harvesting, packing and holding fresh produce on farms. The Preventive Controls for Human Food Rule requires that food processors implement controls that prevent food contamination with human pathogens. Subsequently, FDA released proposed rules addressing preventive controls for animal food, the safety of imported foods and accreditation of third parties to conduct inspections on FDA’s behalf. This group of proposed rules reflects FDA’s preventive approach to food safety established by FSMA.

In 2013, following the release of these rules, OTA reconvened its Food Safety Task Force to prepare comments on behalf of organic stakeholders. OTA’s focus was to ensure that proposed food safety regulations reflect the law and fully take into account organic practices. Accordingly, the task force’s mandate was to analyze the proposed rules and ensure that they 1) do not duplicate or contradict organic methods and materials; 2) are science based; and 3) do not put an unnecessary burden on organic producers and handlers.

Widespread Concerns about the Produce Rule
FDA’s proposed Produce Safety Rule requires farms that grow, harvest, pack or hold fruits and vegetables to establish and follow science-based standards for the safe growing, harvesting, packing and holding of produce in its raw or natural (unprocessed) state. FDA proposes to set standards associated with identified routes of microbial contamination of produce, including agricultural water, biological soil amendments of animal origin, health and hygiene, animals in the growing area, equipment, tools, buildings and sprouts.
 

For the most part, the proposed Produce Safety Rule takes an integrated and common-sense approach focusing on common actions effective in achieving safe produce. While many organic stakeholders were pleased that the rule provides a fair amount of flexibility and in most cases does not duplicate or conflict with the organic standards, major concerns were immediately voiced about the proposed requirements for compost and manure, and the wait times between when compost or manure is applied and when produce is harvested (see “The Real Dirt on Manure and Compost”). Another concern centered on possible environmental and habitat destruction that might be needed to manage domesticated and wild animals in the growing area. Still another focused on the prescriptive and frequent testing requirements proposed for irrigation water. Although the proposed requirements for water were not in conflict with the organic standards, the implications to any farmer were drastic enough that organic and nonorganic growers alike weighed in with concern.

To get direct feedback from the farming sector, FDA held several public meetings and toured agricultural regions nationwide. These meetings and discussions elicited widespread concerns, and a common theme emerged: The proposed rules were flawed and would put many farmers out of business. FDA set out to learn more, with a genuine interest in getting it right.

During FDA’s tour of the Pacific Northwest, OTA focused our communications with FDA on the proposed requirements for the use of manure and compost as fertility inputs. We were able to show FDA how organic farms rely on crop rotations for pest, weed and disease controls, and the importance of manure and compost in farm fertility management. FDA saw firsthand the benefits to agriculture from composting, and learned how compost operations are currently regulated at the state level.

FDA Listens to the Organic Sector
On September 9, 2014, FDA released revised versions of four of the proposed rules in response to the direct outreach with stakeholders across the country and the thousands of the public comments received, followed by a 75-day period for public comment on the revisions. Of the proposed revisions, the most notable to the organic sector were changes made to the Produce Safety Rule relating to the use of compost and manure, water, domesticated and wild animals on the farm and “mixed-type” operations—farms that include on-site packing.

Biological Soil Amendments of Animal Origin (Manure and Compost)
The initial proposed regulations required a 9-month minimum application interval—the time between application of manure or compost and the harvesting of the crop—for untreated manure contacting or potentially contacting covered produce. NOP regulations require a 120- or 90-day application interval depending on whether the edible portion has direct or indirect contact with the soil. For manure treated by a composting process consistent with NOP composting standards, FDA proposed a 45-day minimum application interval. NOP does not require any interval in this case.

In comments to FDA on the initial proposed rule, OTA argued that a 9-month minimum application interval for untreated manure potentially conflicted with NOP standards requiring organic producers to rotate crops as part of their fertility and pest management practices, and was not supported by current science. Through a nationwide survey, OTA showed that a 9-month waiting time would adversely affect the efficacy of organic farms’ crop rotations and potentially put these operations out of compliance with organic standards. OTA also commissioned Will Brinton of Woods End Laboratory in Maine to conduct a comprehensive scientific literature review on pathogen persistence from manure and compost. The results of this review supported the current NOP preharvest intervals of 90 or 120 days following manure applications.

It is clear that FDA heard the concerns of organic producers and studied the science OTA included in the first round of comments. FDA’s revised proposed Produce Safety Rule defers a decision on the proposed 9-month minimum interval requirement for untreated manure. It commits FDA to conducting research into determining an appropriate science-based application interval. FDA expects this process will take at least 5 years. In the meantime, all organic operations covered under the Produce Safety Rule will continue to follow the established NOP organic regulations for application of raw manure, with 90- or 120-day application intervals.

For properly produced compost, FDA has aligned with NOP regulations to allow unrestricted use of compost and removed the 45-day minimum application interval (Table 1). FDA has also acknowledged the role in food safety that compost can serve and expressed a commitment to support composting education and infrastructure on produce farms.

The organic sector is particularly pleased with these revisions. FDA’s removal of restrictions on properly made compost corroborates its importance in sustainable agriculture.

Domesticated and Wild Animals
In the preamble of the initial proposed Produce Safety Rule, FDA asserted that, in general, carrying out the regulation would not require total exclusion of animals from outdoor growing areas, destruction of animal habitats near growing areas, clearing farm borders or any action violating environmental laws or regulations. OTA requested that these principles so clearly expressed in the preamble become part of the actual text of the final rule, because organic farmers are required to implement practices that maintain and improve the natural resources and biodiversity of their operations.

OTA’s concern was that organic farmers’ ability to satisfy these organic production requirements would be hampered by the language in the proposed rule. FDA responded directly in the proposed revisions by adding language explicitly stating that FDA does not authorize or require farms to take actions that would constitute the “taking” of a threatened or endangered species in violation of the Endangered Species Act. It states that “this regulation does not require farms to take measures to exclude animals from outdoor growing areas, or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages.”

Water
The initial proposed requirements prescribed frequent water testing (every 3 months and up to every 7 days for surface water) as well as treatment to ensure agricultural water (including irrigation water) meets proposed microbiological limits based on recreational water use rather than agricultural use. These proposed rules caused great concern among organic and conventional produce farmers alike, because the microbial standard, treatment requirements and testing frequencies were overly prescriptive, inflexible and insufficiently risk and science based.

FDA has since revised the water quality standard to reflect a more realistic, risk-based approach with less potential to impose economic hardship on organic farmers while still protecting public health. The revised rule outlines a tiered and more targeted approach to testing each source of untreated water. The revisions reduce how often the water is tested, with the frequency depending on the water source (i.e., surface or groundwater) and the results of prior tests. FDA requires that produce farmers establish a water profile through testing to determine the potential risk their specific irrigation water poses to food safety, and provides for known pathogen die-off rates in the field after the water has contacted produce. This pragmatic approach will continue to support the safest food supply in the world.

Mixed-Type Facilities
Under FDA’s initial proposed rules, farms handling or packing raw produce from other farms would automatically become subject to both the Produce Safety Rule and the Preventive Controls Rule, which was written for larger food processors and more complicated food processing. This outcome would disproportionally affect organic farmers, who often augment their offerings with other farms’ produce but engage in only simple postharvest handling of off-farm products such as washing, packing and holding.

OTA’s comments spelled out these concerns and suggested that farms only washing, packing or holding produce from other farms be subject just to the Produce Safety Rule. FDA’s proposed revisions align squarely with this view. This change supports a collaborative approach to local and regional agriculture and reduces unwarranted burdens for operations that pack and distribute produce from other farms.

Close, but Not Yet There!
With the release of FDA’s revised rules, OTA reconvened its Food Safety Task Force to analyze the proposed changes to shape OTA’s submission for the public comments. While FDA’s proposed changes clearly show that the agency listened to the feedback from OTA and other organic producers and handlers across the country, and responded to the unique requirements of the organic system, some concerns remain. These center on proposed regulations relating to manure use, mixed-type facilities and water.

Numerous public interest groups are worried that deferring the decision on a proper minimum application interval for raw manure does not adequately protect public health since nonorganic farmers will not be restricted from applying manure up to the day of harvest. They are suggesting an interim standard be established until FDA’s manure risk assessment is completed in 5 to 10 years. Regardless of FDA’s decision on setting an interim standard, organic producers will continue to be held to the 90- or 120-day waiting time established in the organic regulations.

Producers throughout the country continue to express concern about the proposed requirements for water. Many feel that science has not yet provided the “right” answer on the microbial water standard that should be used or the testing frequencies that should be prescribed by the rule. More research specifically targeted at the agricultural use of water is needed. Until science provides the answers, some are encouraging FDA to write a rule supporting a performance- and outcome-based approach based on risk assessment and to remove specific testing metrics from the regulation and add them to guidance.

Another consideration is that the regulatory burden will be inappropriate and excessive if food hubs shared by local and regional food distributors engaged simply in postharvest food handling activities are subject to the increased record-keeping and traceability requirements contained within the Preventive Controls Rule. However, organic producers and handlers of all scopes and scales are already required to maintain records fully tracking products moving through their operations. Thus, organic operations throughout the supply chain are already well positioned to embrace the additional oversight from FDA.

These concerns about the revisions warrant careful consideration by FDA. But regardless of how FDA ultimately decides on manure use, mixed-type facilities or other aspects of the proposed rules, certified organic producers already have a leg up in adjusting to the new production and handling rules. Organic operations’ record-keeping systems will be easily adapted to FDA traceability and supplier verification requirements, and the deferral of FDA’s decision on manure use will not affect the organic requirements that mandate organic farmers wait either 90 or 120 days to harvest their crops after the use of manure.

Going Forward
FDA acknowledges that adjustment to new regulations will be a burden on food producers. To ease some of that burden, the agency is proposing various exemptions from oversight based on the size of operation and whether sales are made directly to the consumer. The proposed rules also outline a phased-in approach requiring larger operations to come into compliance with the regulations first, with smaller operations allowed additional time to adjust (Figure 1).

What can organic producers and handlers do to prepare? The full implications of the sweeping new regulations will be revealed over time, but substantial portions of FSMA will be implemented within 3 years of the day the final rules are released. If you’re an organic or conventional producer, one of the best ways to prepare your operation for the new regulatory environment is to establish Good Agricultural Practices (GAPs). The Washington State Department of Agriculture has developed a fact sheet[1] comparing the organic production and record-keeping requirements with those of GAPs programs.

Growers can also look into the On-Farm Food Safety Project,[2] which offers technical assistance to use and teach best practices in food safety. If you’re a handler, initiate a Hazard Analysis and Critical Control Points program if you do not already have one in place. This includes close communications with foreign suppliers to ensure they also are operating under equivalent programs.
 

The organic foods industry has long-established, legally mandated safeguards that ensure food safety for consumers, including full food product traceability, accountability of food production methods and strict controls on potential sources of food contamination. Organic producers and handlers are familiar with planning, regulatory oversight, third-party certification and independent inspections. Certified organic growers follow strict guidelines for organic food production and, as with all food producers, they must comply with local, state and federal food safety and health standards.

Already adhering to a federally regulated and certified process, the organic food industry is uniquely positioned to respond to the new food safety requirements coming into effect in the next several years.

The organic sector looks forward to continued collaboration with FDA to help create and support food safety systems, helpful guidance and research that meet the needs of organic farmers, consumers and public health regulators.

Gwendolyn Wyard is OTA’s regulatory director of organic standards and food safety. She works on the development of policy strategy through regulatory engagement in the interest of OTA’s mission and its members. She serves on the Organic Material Review Institute Board of Directors in the OTA’s designated seat and as Technical Representative in North America for the Global Organic Textile Standard. She holds a degree in food science and a minor in chemistry. Gwendolyn completed her certificate as an independent farm and processing inspector through the International Organic Inspector’s Association in 1997 and has subcontracted for multiple certifiers, inspecting a diverse range of operations.

Nate Lewis is the OTA senior crops and livestock specialist. He provides staff support to OTA’s Farmer Advisory Council, on-the-ground outreach to OTA’s organic farmer membership community and analysis of policy issues that affect organic crop and livestock producers. Nate previously served as certification coordinator for Washington State Department of Agriculture (WSDA)’s organic certification program. Nate’s responsibilities at WSDA also included coordination of its periodic residue sampling program. Nate holds a bachelor of science from The Evergreen State College with a focus in agricultural science and organic chemistry.

References
1. agr.wa.gov/FP/Pubs/docs/FSCS/3010_Organic_GAP_Factsheet.pdf.
2. onfarmfoodsafety.org/.