The Lowdown on Food Safety Audits
March 1, 2011 Last April, a working group of the United Fresh Produce Association’s Food Safety & Technology council completed development of the Audits Benchmarking Matrix to enable side-by-side comparisons of the third-party audit organizations and standards most commonly used by the U.S. produce industry. We talked with David Gombas, senior vice president, food safety and technology for United Fresh, about how the new food safety legislation will impact these audits, and the growers being audited. His responses follow.
Q: How will the new food safety legislation impact third-party audits?
Gombas: Up until now, the only inspections that FDA would accept for regulatory purposes was their own or inspections performed by government agencies (state or foreign) that they had officially recognized as equivalent. They have never recognized a private sector auditor’s audit as sufficient.
The Act only discusses third party audits in terms of imports. For domestic processing and other registered facilities, the Act clearly states, “The regulation…[shall] not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls, except in the case of negotiated enforcement resolutions that may require such a consultant or third party.”
Section 105 of the Act has a similar restriction for regulations affecting produce operations. However, FSMA (section 307) does direct FDA to develop criteria to accept accreditation bodies that evaluate third party auditors: “the Secretary shall establish a system for the recognition of accreditation bodies that accredit third-party auditors to certify that eligible entities meet the applicable requirements of this section.” If FDA is not successful in developing those criteria within two years, the Act allows that FDA “may directly accredit third-party auditors.”
This accreditation process is important because of Section 303 of the Act, Authority to Require Import Certifications for Food, which authorizes FDA to require shipment- or facility-specific certification that the import meets the requirements of the Act. One of the ways that the Act authorizes facilities to provide that certification is by third-party auditors (“such other persons or entities accredited …to provide such certification or assurance”).
Two interesting details about these accredited third-party auditors doing foreign audits under this provision:
• “If, at any time during an audit, an accredited third-party auditor or audit agent of such auditor discovers a condition that could cause or contribute to a serious risk to the public health, such auditor shall immediately notify the Secretary of ‘(i) the identification of the eligible entity subject to the audit; and ‘(ii) such condition.” If an auditor finds a serious food safety problem, they are required to tell FDA. Up until now, third party auditors were under no obligation to notify FDA or any public health agency of food safety problems they saw in the course of an audit.
• “The Secretary shall withdraw accreditation from an accredited third-party auditor (i) if food certified under section 801(q) or from a facility certified under paragraph (2)(B) by such third-party auditor is linked to an outbreak of foodborne illness that has a reasonable probability of causing serious adverse health consequences or death in humans or animals; (ii) following an evaluation and finding by the Secretary that the third-party auditor no longer meets the requirements for accreditation; or (iii) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements set forth in this section.” Now the third party auditor shares the risk of a facility shipping adulterated food to the U.S., and can lose their accreditation if the facility decides not to allow FDA to re-inspect them.
If FDA finds these third-party certifications to be effective for imports, it is likely they would develop a similar system for domestic inspections. But that would be years away.
Q: How will exempt growers be impacted by audits?
Gombas: Farms that are exempt from produce regulations under the Act will not be subject to federal regulatory inspections. However, the Act does protect state and local agencies’ right to inspect farms according to their own regulations (“Nothing in this subsection preempts state, local, county, or other non-federal law regarding the safe production, harvesting, holding, transportation, and sale of fresh fruits and vegetables. Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law.”).
This could complicate issues for growers and for buyers. If States find a need to write new regulations for exempt growers, we could be looking at dozens or hundreds of similar but potentially conflicting requirements. This would not be a problem for produce that is grown and consumed in the same jurisdiction, but could become a problem for produce that is grown in one jurisdiction and shipped to another jurisdiction where it is no longer compliant (we’ve seen this problem emerge with imports from and exports to countries with differing regulations for use and residues of crop protection chemicals, i.e., MRLs). The Association for Food and Drug Officials (AFDO) tried to head this off with their Model Code for Produce Safety, published in 2009; we will see if this well-written document is successfully used.
As to requirements for private sector audits, I would expect that exempt operations will see either no change or an increase in audit requirements from buyers. Those buyers (foodservice, retail, etc.) that already recognize that food safety risks are equally likely to occur on “exempt” as “non-exempt” operations are already requiring food safety audits of both operations, and that is not likely to change. However, if consumers’ enthusiasm for “locally grown” produce continues, buyers will need to consider carefully whether to risk buying from an exempt operation when non-exempt, federally inspected operations are available. At the minimum, I see those buyers increasing their requirements for third-party food safety audits.
Q: What types of issues do you see arising as a result of some growers being required to have audits and others being exempt?
Gombas: Regarding the issue above, when State and local regulatory agencies begin developing their own regulations for exempt operation, the same provision of the Act allows for those regulations to spill over to non-exempt operations.
Q: What are four things in this bill that you think growers need to know?
Gombas: First, arguably the most public part of the Act was “mandatory recall”. FSMA immediately granted FDA mandatory recall authority if a company refuses to voluntarily recall a product for which “there is a reasonable probability” that the food is adulterated or contains an undeclared food allergen and consumption of the food will cause “serious adverse health consequences or death”, but companies must be given the opportunity to voluntarily recall first. Procedures will be established for informal hearings on mandatory recall orders, and only the FDA Commissioner has direct authority to issue a mandatory recall order, but failure to comply with a recall order would trigger a civil money penalty, and would constitute a prohibited act for which criminal penalties are provided under existing law. Also effective immediately, during an active investigation of a foodborne illness outbreak, FDA is authorized to direct that a farm identify potential immediate recipients of the food that is the subject of the investigation (see the fourth bullet, below).
• Second, federal regulations for the safe production of raw fruits and vegetables are coming, and will be proposed within the next 12 months. The Act (section 105) requires FDA to establish science-based minimum standards for the safe production and harvesting of produce, requires that those standards be based on known safety risks, which may include a history of foodborne illness outbreaks, and requires FDA to prioritize regulations for fruits and vegetables that have been associated with foodborne disease outbreaks. The wording of this section of the law is intended to direct FDA attention to specific commodities based on risk. This was a major goal of United Fresh efforts in Congress, and now FDA must be held to this Congressional intent rather than applying broad-brush one-size-fits-all regulations. In addition, any produce regulations are directed to provide sufficient flexibility and be appropriate to the scale and diversity of the production and harvesting of such commodities. The Act is otherwise relatively silent on the details of the regulations, but does require the produce standards to address growing, harvesting, sorting, packing and storage operations, through the development of science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water. Implementation of the Act, which must occur for large operations within 12 months after the comment period closes, will be staggered for small (1 year) and very small (2 years) operations.
• Third, foreign growers will be held to the same federal food safety standards as domestic growers, and importers will be held responsible for providing proof.
• And fourth, in addition to publishing regulations for fresh produce food safety, the Act requires FDA to issue a notice of proposed rulemaking, within 2 years, to establish additional recordkeeping requirements for product tracing, specifically applicable only to foods as defined by FDA as “high-risk”. In determining whether a food is high-risk for purposes of product tracing, FDA is directed to evaluate the history of outbreaks attributed to the food, likelihood of contamination, and steps taken during manufacturing to reduce the likelihood of contamination. The Act puts several restrictions on what FDA can require in such a regulation, but raw agricultural commodities will be among the foods considered by FDA.
Q: Is there anything you’d like to add?
Gombas: The Act was largely written to instruct FDA how to do a better job, and most of the provisions of the Act will have to be translated into regulations before they impact growers. But failure to comply with the regulations, when finally implemented, will be illegal. So the details of those regulations will be critical to the industry, and staffs of all regional, commodity, and national produce trade associations, like United Fresh, will be keeping a close eye on those regulations as FDA releases them, and will hold FDA accountable for standards that are risk-based, science-based, and appropriate for all commodities, domestic and imported, included in the regulations. However, the advocacy of the trade associations will only be as good as the input they get from their members. Growers need to remember that “rules are made by those who show up,” and they are all encouraged to stay informed and get involved with their trade associations. There is still time for their issues, concerns, and ideas to be heard.