FDA Answers Farmers' Questions: Answers to Questions about the Original FSMA Produce Safety Proposed Rule from Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine
The What You Need to Know about the Produce Safety Rule
In January 2013, the Food and Drug Administration (FDA) released for public comment its proposed rule to establish science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. The rule is one of five proposed rules that would lay the cornerstone for the prevention-based, modern food safety system mandated by the FDA Food Safety Modernization Act. Comments on the proposed rule are due by November 15, 2013. Submit comments on the proposed rule on regulations.gov.
Michael R. Taylor, deputy commissioner for foods and veterinary medicine at FDA, answers questions about why we need the produce safety rule and what it means for farmers.
Q. What is the most important thing you want farmers to know?
A. We want them to know that we are committed to developing, with their input, a final rule that prevents illnesses but that also is practical and adaptable to a wide diversity of growing conditions and practices.
The proposed rule would prevent an estimated 1.75 million cases of foodborne illness each year. This is important to all of us, because we are all consumers. Congress passed the Food Safety Modernization Act, which mandates that FDA write a rule on produce safety, in response to illness outbreaks and contamination incidents that have disrupted markets and reduced consumer confidence in produce.
The proposed rule is practical because it targets recognized, reasonably foreseeable hazards and potential pathways of contamination, such as are reflected in current good agricultural practices (GAPs).
And finally, the proposed rule is adaptable to the wide diversity of growing conditions and practices in the produce sector. For example, for certain requirements related to water and biological soil amendments, the proposed rule would permit farms to use alternative methods, as long as they achieve the same level of public health protection as FDA’s proposed rule, do not increase the risk of adulteration, and are based on adequate science. In addition, states and foreign governments would be able to seek variances from FDA’s proposed rule.
Q. How did you decide what farms and what produce should be covered under the proposed rule?
A. In keeping with the mandate Congress gave us, our proposed rules are risk-based and would not apply to many small farms and certain types of produce. This way we can protect consumers while ensuring that the rule is not unnecessarily burdensome.
First, there is a FSMA-mandated qualified exemption for farms with food sales of less than $500,000, if half or more of the value of those sales comes from sales directly to consumers in any location, or to restaurants or retail outlets (such as grocery stores) that are within the same state or no more than 275 miles from the farm. Farms eligible for this exemption would only be required to let consumers know the name and address of the farm where the produce was grown, and, as provided by Congress, could have their exemption withdrawn under certain circumstances, for example if there is an outbreak of foodborne illness that is directly linked to the farm. We estimate that approximately 76,000 farms would be eligible for the qualified exemption. The proposed rule also would not apply to certain produce that constitute the lowest risk in terms of contributing to foodborne illness. This includes produce that is rarely consumed raw, such as potatoes, and produce that will receive a commercial “kill step,” such as tomatoes and green beans going to a canning operation. About 40,000 additional farms are exempt because they only grow produce that meet these criteria. In addition, the proposed rule would not apply to produce grown for on-farm or personal consumption.
Finally, FDA proposed not to cover farms with food sales of $25,000 or less, regardless of who their buyers are. We estimate that there are about 34,000 additional farms that are not covered by the rule because they are under this threshold.
Altogether, these limitations mean that, of about 190,000 U.S. produce farms, about 150,000 -- or 79% -- are not covered by FDA's proposed rule, and about 50 percent of domestic produce acres are not covered. Importantly, even with these limitations, the proposed rule covers the great majority -- about 90% -- of the acres planted in crops that are potentially vulnerable to harmful contamination.
Q. But why didn’t you only focus on those produce commodities that had been associated with foodborne illness outbreaks?
In enacting FSMA, Congress told us to take a preventive approach to ensuring food safety. For produce, Congress said specifically that our rules should require those steps that are “reasonably necessary to prevent the introduction of known or reasonably foreseeable” hazards. Illness outbreaks are of course one way to identify hazards that need to be prevented, but many outbreaks are never detected and many detected outbreaks are never linked to a specific food. Past outbreaks are also poor predictors of the future. In fact, almost every year we have an outbreak associated with a produce item with no past history of reported outbreaks. For example, papayas had had not been associated with outbreaks before 2011. We also know from experience that the failure to observe basic practices like use of appropriately clean water, employee hygiene, and careful use of raw manure has the potential to introduce contamination that can make people sick. We have limited the scope of our proposed rule to commodities for which we believe the potential for illness is real, and, in keeping with our mandate from Congress, we have proposed steps that we think are reasonably necessary to prevent the introduction of reasonably foreseeable hazards. We look forward to comments from farmers that can help us get it right when we issue a final rule.
Q. Even if I’m not covered by these new requirements, my buyers are going to expect me to meet them anyway. Is that fair?
A. FDA recognizes that many buyers, for their own market-driven reasons, already require produce farms to observe good agricultural practices and other food safety specifications. FDA anticipates that by establishing a science-based federal standard, FDA’s rule could be a reference point for such requirements, and could reduce the number of separate standards to which a farm would be held by its buyers. Buyers, like FDA and farmers themselves, know that no one is exempt from the need to produce safe food, which is why FDA is committed to working with the farm community, USDA, state agriculture departments, and extension to support the food safety efforts of all farms, regardless of scale or type of operation or whether they are covered by FDA’s proposed rules.
Q. How did you decide what requirements to include in the rule?
A. We focused on reducing the risk associated with five recognized pathways of contamination. And within those pathways, we made sure that only those requirements that made a difference for food safety were included. The five pathways are:
- Soil amendments (for example, raw manure and composted manure)
- Health and hygiene
- Equipment/building sanitation
But as I said, we made sure that the requirements in each area make sense for food safety. So when it comes to water standards and testing, the proposed requirements would apply only to water that is intended or likely to contact the harvestable portion of the crop or food-contact surfaces. In the same way, the proposed waiting periods between application and harvest for certain types of soil amendments would apply only when the soil amendments are likely to contact the harvestable portion of the crop. Our proposed animal intrusion standards do not require fencing or other exclusion measures but only awareness of significant animal activity and removal of any visibly contaminated produce.
Q. Would I be required to have a written plan like processing plants do? That could get expensive.
A. No, FDA did not propose to require farms to develop individual food safety plans, or do product testing, except for those farms that grow sprouts. In addition, the proposed requirements for record keeping are minimized— and records would not have to be submitted to FDA, but would be required to be available when FDA asks for them.
Q. You mentioned that alternatives and variances would be permitted for certain practices. How would that work?
A. We are interested in providing flexibility in the requirements when possible. So for certain requirements for water and biological soil amendments, if you can come up with an alternative that is scientifically established to provide the same amount of protection as FDA’s proposed rule, you would be permitted to use your alternative practice. For example, if irrigation water applied directly to the harvestable portion of the crop does not meet the proposed microbial quality standard for generic E. coli, the water could still be used if it can be demonstrated that under local climate and growing conditions there would be adequate die-off of pathogens before harvest. This does not mean farmers would have to have these alternatives approved by FDA. Rather, farmers would be responsible for having the data to back up the alternative they want to use. FDA is working with USDA, the produce industry, and university researchers to help develop data to support alternative approaches.
In addition, a state or foreign country could request a variance from some or all of the provisions of the proposed rule when necessary in light of local growing conditions, as long as the procedures to be followed under the variance would achieve the same level of public health protection and not increase the risk of adulteration.
Q. Can FDA clarify how the produce and preventive controls rules would apply to farms that are involved in value-added and other processing?
A. We recognize that there are many challenging issues associated with these operations. They raise questions about how the preventive controls and produce rules interact and how exemptions apply, for instance. We will be coming out with additional materials to explain the proposed requirements. At the same time, we see the need for more dialogue on many of these challenging issues, and a major reason for extending the comment period until November 15 was to allow more time for input. We are committed to coming up with final rules that work for food safety and are practical for farms, including those that do some processing.
Q. What if farms have a hard time complying with the final requirements? Is extra time allowed?
A. Remember that this is a proposed rule, and it will take some time until a final rule is issued. FDA will need time to review all the comments and decide what to include in the final rule. We are also proposing staggered compliance dates to provide enough time for farms to meet the requirements.
Very small farms, with sales over $25,000 and up to $250,000, would have 4 years following the effective date of the final rule to comply, plus 2 more years (6 total) to comply with certain water requirements.
Small farms, with sales over $250,000 and up to $500,000, would have 3 years following the effective date of the final rule to comply, plus 2 more years (5 total) to comply with certain water requirements.
Other farms, with sales greater than $500,000, would have 2 years following the effective date of the final rule to comply, plus 2 more years (4 total) to comply with certain water requirements.
Q. What if I need help? I’ve never had to meet these requirements.
A. We have been planning for extensive technical assistance and outreach for several years now. We have been working with USDA, state agriculture departments, the Produce Safety Alliance, the Sprouts Safety Alliance and the American Farm Bureau, as well as others, to make sure there are resources out there for you.
We are planning to use a number of approaches, including clear guidance, training and technical assistance, and investment in research needed to support alternative means of complying with certain proposed standards for water and soil amendments.
Q. How will you know farms are doing what is required? Is FDA coming on our farms?
FDA’s on-farm inspections will be limited in number and targeted based on risk. This is due partly to limited resources and partly to the fact that FSMA envisions FDA working closely with State agencies to oversee compliance with the FSMA produce rule. We agree that is the best approach. We are thus working closely with the National Association of State Departments of Agriculture to devise collaborative strategies for overseeing implementation through outreach, education and technical assistance, as well as inspections.
We also expect that third-party audits will play a role in verifying that farms are meeting the final requirements.
Q. Any final messages?
The development of the FSMA produce safety rule remains very much a work in progress. We need your help in making sure the final rule is as good as it possibly can be in terms of making a practical difference for food safety and being adaptable and workable across the great diversity of the produce sector. We hope that many farms and their representatives will attend stakeholder outreach meetings that FDA and our partners hold and that you will comment on the proposed rule by the November 15 deadline.