In comments to the FSMA proposed rule for produce safety, a number of industry associations asked FDA to take into account food-safety programs that already exist under federal and state marketing agreements and orders.

For instance, the California Leafy Green Products Handler Marketing Agreement (LGMA) wants to ensure that FSMA does not add extra layers of inspections, audits, and documentation, which LGMA already requires of its members.

“[W]e are already verifying that members are in compliance with our standards. If our standards don’t already encompass or exceed what is in FSMA, then we will make sure they do,” said Scott Horsfall, chief executive officer of LGMA.

Horsfall further explained that his organization supports FSMA and is not asking for an exemption. Rather, LGMA is seeking more of a “partnership” with FDA.

The Almond Board of California seems to have taken a slightly different approach and has asked FDA to consider an exemption or variance for almonds.

In the Almond Board’s comments on the proposed rule for produce safety, the group notes that the California almond industry is subject to a federal marketing order issued and enforced by the U.S. Department of Agriculture (USDA). The marketing order requires a minimum 4-log reduction of Salmonella bacteria in almonds before they enter commerce.

As such, the Almond Board’s comments suggest that a rule for produce safety would be duplicative and unnecessary for almonds, which are essentially a low-risk food by virtue of the mandatory kill step requirement created and enforced by USDA.

The Scope of Marketing Agreements and Orders

Notably, marketing agreements and orders have some key differences. Membership to marketing agreements, whether at the state or federal level, is voluntary. But marketing orders set mandatory standards for all affected parties.

So, while membership with the LGMA is voluntary, once a member joins LGMA, compliance with their standards is mandatory. Notably, LGMA, in combination with Arizona Leafy Green Products Shipper Marketing Agreement, encompasses 90 percent of the leafy greens entering commercial markets.

In contrast, all almonds grown in California, which make up 99 percent of all commercial almonds in the U.S., are subject to the California almond marketing order.

What will be the Relationship between Marketing Agreements and FSMA?

At this point, FDA is not poised to create industry-specific variances and exemptions, at least not based on marketing orders and agreements.

“FDA does not intend to grant a blanket exemption to growers or signatories of marketing orders,” a spokesperson for the agency told Food Safety News. “Alternatives to certain requirements would be permitted when adequate and documented scientific data or information support such alternatives.”

Moreover, FDA officials are both aware of, and willing to work with, existing or new compliance programs. As the FDA spokesperson stated, “[I]t is worth noting that rigorous food safety programs under national or regional marketing agreements can be an important tool for fostering compliance with the produce safety rule.”

• First, the farm must have average annual gross revenue of less than $500,000. The average is calculated based on the previous three-year period.

• Second, the farm must sell the majority of its products to qualified end users. Qualified end users are consumers, restaurants, or grocery stores that are in the same state as the farm or that are within 275 miles of the farm.

Farms that qualify for an exemption under the Tester-Hagan Amendment must still give their customers notice of their business name and address at the point of sale. But they do not have to comply with the more stringent FSMA requirements such as record-keeping and plan development. How FDA implements the small farm exemption When FDA proposed the Produce Safety Rule, it created two categories of exemptions. In doing so, it exercised its discretion to create flexible standards, as well as incorporated the Tester-Hagan Amendment exemption. While the two-part test under the amendment is a statutory mandate, FDA also has a degree of flexibility in how it chooses to implement it. For instance, FDA can define “farm” in such a way that affects who qualifies for the exemption.  Exemptions in the Produce Safety Rule First of all, FSMA mandates that the produce rule applies to farms that grow, harvest, pack, or hold produce for consumption in the U.S. But the rule does not apply to produce for personal or on-farm consumption, so the rule is completely irrelevant for home gardens or hobby farms. Additionally, FDA used its discretion to establish exemptions for what it considers relatively low-risk produce. This includes two categories: 1) produce rarely consumed raw, such as squash, and 2) produce that receives commercial processing to kill microorganisms. The third type of exemption is sometimes referred to as the “outright exemption.” Here, FDA used its discretion to exempt very small farms. To qualify, a farm must have an average annual value of food sold during the previous three-year period of $25,000 or less, regardless of the type of produce sold. In other words, to qualify for a complete exemption from FSMA requirements, a farmer needs to either not sell produce at all, sell only low-risk or processed produce, or meet the $25,000 revenue cap. In addition to these complete exemptions, the produce rule also has a “qualified exemption.” This exemption directly implements the Tester-Hagan Amendment, and it includes the same two-part test as laid out above. What does ‘exemption’ mean?  “People tend to use the term ‘exemption’ really loosely,” says Ariane Lotti, assistant policy director of the National Sustainable Agriculture Coalition (NSAC). Lotti makes three points about the term “exemption.” First, under the qualified exemption, e.g., the Tester-Hagan Amendment, producers must give consumers their business address at the point of sale. This ensures that if a problem arises, the products can then be traced back to the farm, Lotti says. Second, a farm that is exempt from the Produce Safety Rule might not be exempt from the Preventive Controls Rule. The Preventive Controls Rule is another proposed FSMA rule that focuses on processors rather than producers. Lotti notes that the Produce and Preventive Controls Rules are interrelated, but many people believe FDA has not clarified when each rule will or will not apply. Groups such as NSAC want FDA to further define and clarify terms in the rules. Finally, Lotti emphasizes that an exemption under the Produce Safety Rule only means that the producer or farmer will have to meet much less onerous requirements than the requirements of the full rule. But, no farmer, no matter how small, is lawfully allowed to sell adulterated food. “It is an exemption from the majority of requirements of the produce rule,” she says. “It is not an exemption from having to provide safe food.”

“[R]egulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.”

The U.S. Department of Health and Human Services (HHS), FDA’s parent agency, has a consultation policy to implement EO 13175. This policy states: “Before any action is taken that will significantly affect Indian Tribes it is the HHS policy to the extent practicable and permitted by law, consultation with Indian Tribes will occur.” On April 4, 2013, the National Congress of American Indians (NCAI) sent a letter on behalf of their tribal government members to the FDA commissioner requesting compliance with EO 13175 and the HHS consultation policy. FDA did not initiate formal consultation in response to NCAI’s request; rather, it responded with a letter stating FDA would include NCAI’s comments in the rulemaking docket and directed NCAI to FDA’s website for updates and further information. Before FDA released notice of the October webinar, it responded to questions about whether the agency would engage in consultation by stating that it had held a series of public listening sessions and two webinars but would soon release notice of formal consultation. The public listening sessions were held between Aug. 12-22 in Oregon, Washington, Maine, New Hampshire and Massachusetts. The FDA states that its tribal liaison sent notifications of the sessions to NCAI, which then distributed the information to tribes. Because FDA does not require registration at all listening sessions, it could not confirm whether any tribal representatives were actually present. FDA’s two previous webinars with NCAI and other tribal representatives were held in May and the last week of August. Before these webinars were held, NCAI told FDA that they would not constitute official consultation. According to FDA, a goal of the previous webinars was to “provide interested Tribes and Tribal organizations additional opportunities to express their views, in addition to providing formal comment to the administrative dockets.” The Administrative Procedure Act (APA) requires formal comment to the administrative docket regardless of tribal status when the FDA proposes new regulations. The APA rulemaking procedures are separate from EO 13175, and FDA’s compliance with those procedures is not considered tribal consultation. When a listener at the August webinar asked FDA how it would meet the consultation requirements of EO 13175, agency officials responded that they had consulted with Mary Hitch from FDA’s Office of External Affairs and Stacy Ecoffey, HHS’s Principal Advisor for Tribal Affairs. EO 13175, the Presidential Memorandum reaffirming the order, and HHS’s consultation policy do not suggest that an agency may comply with the consultation requirements by consulting with its own staff. HHS’s consultation policy, for example, includes guidelines with mechanisms such as mailings, teleconference, face-to-face meetings, roundtables, annual budget and policy consultation sessions and regular or special consultation sessions. The guidelines are not prescriptive, and the department must use an approach suited for the particular event. An example of formal compliance with EO 13175 is USDA’s consultation plan after Congress passed the 2008 Farm Bill (the HHS policy does not apply to USDA). USDA created a consultation plan to work with Indian tribes on 70 regulations spanning seven agencies. It then gave 30-45 day’s notice of the entire schedule to all 566 tribal headquarters. The notice announced the location and purpose of the meetings, and it included a CD of the regulations for tribal review beforehand. Overall, USDA held seven regional meetings where regional groupings of tribes normally meet. It had two days of briefings on the regulations, followed by one-on-one consultations with tribal leaders and their staffs. It also had two webinar briefings, which were followed by regional meetings and more webinars. Finally, USDA recorded every meeting, and it made the transcripts available. In contrast, FDA will initiate formal consultation on the FSMA Produce Safety and Preventive Controls for Human Food rules by hosting a webinar scheduled a little more than a month before comments close and nine months since the agency first published the rules. FDA gave NCAI less than 30 day’s notice of the webinar, and it intends to cover the entire proposed rules, including the plan to create an EIS for the Produce Safety rule. FDA also plans to answer questions and receive feedback from tribal governments during this two-hour webinar. However, the agency has not indicated how it will consult with tribes lacking Internet access or the necessary technology to attend a webinar.