Last Friday, the FDA posted the revisions the White House Office of Information and Regulatory Affairs (OIRA) made to two food safety rules drafted by the agency two years ago. The proposed rules were issued under the Food Safety and Modernization Act, which Congress passed in the wake of widespread food safety disasters.
As we’ve mentioned in this space before, OIRA is the regulatory review body within the White House that frequently holds onto agency rules for longer than the 120-day limit set by Executive Order 12866, often mangling and weakening the protections developed by agencies at the behest of regulated industries. For one of these rules, on the Foreign Supplier Verification Program (FSVP), OIRA didn’t loosen its grip for a year and eight months, giving it plenty of time to tinker around with the FDA’s proposal behind closed doors.
According to a memo accompanying each of the recent releases, the FDA was prepared to post the “redlined” documents showing OIRA’s revisions on August 15 of this year, and that is also the date the documents were supposedly “received” in the electronic rulemaking docket. So, why did they come out only last week? We may never know the answer, but we can finally see how the White House chopped and diced through the FSVP rule in ways that make it less protective of consumers and more appealing to food corporations.
The Importance of the FSVP Rule
This rule is intended to strengthen oversight of imported foods, which for the most part fall right through the cracks in our food safety system and land directly on our plates. Over 15 percent of the food we eat is imported, including over 50 percent of our fresh fruit, 20 percent of our fresh vegetables, and 61 percent of our honey. In 2011, 10.5 million unique food products were brought into the country, but the resource-strapped FDA was able to inspect just 2 percent of all imports and only 0.4 percent of foreign food facilities.
Much of this food is produced in developing countries with inadequate regulatory systems, where unsanitary practices are common. This year alone, we’ve seen a 162-person outbreak of Hepatitis A caused by pomegranate seeds from Turkey, an 84-person Salmonella outbreak caused by cucumbers from Mexico, and a 643-person Cyclospora outbreak linked to imported salad mix in two states and to imported cilantro in another.
The FSVP rule would make importers responsible for verifying that their foreign suppliers are providing the same level of public health protection that is required of domestic food producers. Importers must perform certain verification activities to ensure hazards are being adequately controlled. Beyond that, they must investigate and take corrective actions when problems arise. Companies that import foods without an adequate FSVP would face penalties.
Below is a summary of OIRA’s changes to the rule, compared to the FDA’s original draft.
Onsite Audits
Onsite audits are crucial for observing the conditions at the foreign facility and verifying that the supplier is actually following the food safety plans and procedures that it claims to. Other verification methods, like reviewing food safety records and sampling products, may be useful but they simply cannot replace the value of an actual visit.
Originally, the FDA was going to require the importer to conduct or obtain documentation of an onsite audit in all cases where the food is subject to a “designated food safety regulation,” which would include not only the FDA’s other proposed rules under the FSMA (on processed foods and produce), but also rules on dietary supplements, shell eggs, acidified foods, and bottled drinking water. In other words, most kinds of imported foods would have automatically required an onsite audit.
The seriousness of the hazard was significant only in deciding how frequent the follow-up audits would be. For “SAHCODHA” hazards—those posing a reasonable probability of “serious adverse health consequences or death to humans or animals”—follow-up audits would have to be done at least once a year. For less serious hazards, follow-up audits would have to be done at least every two years.
Once the White House was through with it, this clear, across-the-board requirement had been replaced by two new options that the FDA would select from in the final rule:
Option 1: Onsite audits would be required only for the most serious (SAHCODHA) hazards, while importers could choose any verification activity for less serious hazards.
Option 2: Theimporter would get to choose the appropriate verification activity for all kinds of hazards—onsite audits would never actually be required.
Even the stronger option here (Option 1) leaves much to be desired. It puts the importer in the catbird seat, since the importer gets to determine (at least in the first place) whether something is a SAHCODHA hazard or not, and thus whether the importer would have to do an onsite audit. As former FDA Associate Commissioner for Foods David Acheson keenly observed, it sets up a conflict of interest: “Why would an importer ever lean toward a SAHCODHA determination, especially in a close-call scenario?” Far fewer onsite audits will be conducted under these options than under the FDA’s original rule—which also would have been much simpler to administer and enforce.
Exemption for “Very Small” Importers and Foreign Suppliers
Originally, the FSVP requirements would have applied to importers of all sizes, and to food from foreign suppliers of all sizes. Foreign facilities with less than $500,000 in annual sales are generally exempt from the new food safety standards in other rules issued under the FSMA. But importers would still have been required to ensure that the food they supply is not “misbranded” or “adulterated” under the Food, Drug and Cosmetic Act by analyzing the hazards and verifying that they are being adequately controlled.
OIRA, however, introduced an exemption for “very small importers” and “importers of food from very small foreign suppliers” (with “very small” defined at the $500,000 cutoff). These importers would only have to comply with a minimal set of requirements, like obtaining written assurance of compliance from the supplier every two years instead of performing any of the usual hazard-analysis and verification activities.
In one fell swoop, OIRA exempted 39 percent of all importers from the rule’s major requirements, and ensured that food from a huge majority of foreign suppliers would continue to arrive in our country without any meaningful checks by importers: The FDA estimates that 59 percent (!) of foreign suppliers of processed foods and 93 percent (!!) of foreign suppliers of raw produce would qualify for “very small” status.
Exemption for Food from “Comparable” Countries
Originally, the FDA merely requested comment on whether an importer should be relieved of its obligation to do an onsite audit if the food was produced in a country whose food safety authority is officially recognized by the FDA as “comparable” to that of the United States. And if so, the FDA asked whether the importer should have to show an actual inspection report by that country’s food safety authority, or just a document stating that the supplier is in “good standing” with its own government.
The FDA intended for these questions to be informed by public comment before taking a position on the issue, but OIRA seized the opportunity to settle the question on its own. OIRA crafted an exemption to the standard FSVP requirements (including onsite audits) for foods from countries with comparable food safety systems, requiring only a showing that the supplier is in “good standing.”
At present, the only country deemed comparable is New Zealand, butthe FDA is currently finalizing a review of Canada’s system and is also reviewing the EU’s. More countries will scramble to be recognized as comparable if the FDA adopts this exemption, and the FDA will come under increasing pressure to grant them that recognition even if their regulatory systems are not truly comparable. Even if a country is comparable, it is still highly unlikely to inspect every facility within its borders each year—the FDA only inspected 11 percent of U.S. food facilities in 2011—whereas the FSVP requirements would require at least an annual verification of the supplier’s food safety practices. These regions may come to represent giant loopholes in our food safety net—exemptions that could eventually swallow the rule.
We are continuing to read through OIRA’s changes to the FDA’s other import-related rule (on accreditation of third party auditors), and we’ll keep you posted with any developments.
