On Nov. 30, by a vote of 73-25, the Senate passed S. 510, the Food Safety Modernization Act. (At least 60 votes were required since Tom Coburn objected to the $1.4 billion cost.) Senate passage followed some mid-November drama stirred up by the Tester amendment to exempt small producers and the Feinstein amendment on bisphenol-A. The vote occurred close to one year after the Senate Committee on Health, Education, Labor and Pensions (HELP, chaired by Sen. Harkin) cleared the bill for consideration by the full Senate.
S. 510 was less rigorous than the House-passed Food Safety Enhancement Act (HR 2749) of 2009. Thus, there were two avenues to get this bill to the President for signature. One was to conference the differences in the bills, but many on Capitol Hill felt a conference would be tricky, given the little time left in this Congressional session, as well as the differences in the two bills. The second route was for the House to pass the Senate bill, which some thought was a likely scenario.
Shortly after S. 510 passed, it was realized that Section 107, authorizing the FDA to assess fees for recalls or failed inspections, would be considered a revenue-raising measure, and thus technically taxes under the Constitution—which must originate in the House. Therefore, the House procedurally would be unable to consider the Senate-passed bill. At that juncture, there was no solution or clear path forward. The House would need to pass the Senate bill as its own, and send it back to the Senate; or the Senate would need to pass a new bill without this fee authorization provision.
The final solution—which may be successful—was to attach the bill to the Continuing Resolution for the federal budget, which narrowly passed the House on Dec. 8 by a vote of 212-206. This very close vote included zero Republicans—who overwhelmingly favored a short-term measure to push the unfinished budget into next year, when they take majority. Now that the food safety bill is attached to the House-passed CR, it has a decent chance of becoming law because the Congress must take some action on the budget (the current CR expires on Dec. 18). The Senate will act on this in the next few days, but there is clear and strong opposition to this CR package (yet strong bi-partisan support for food safety legislation). Nonetheless, even if the Senate passes a different budget, it is likely that the final version will include S. 510.
Meanwhile, we continue to see some anti-S. 510 rhetoric and alarmist articles in our industry press. For example, on Dec. 9, NaturalNews published an article titled, “S 510 Food Safety bill is still alive and may unleash a new army of FDA agents.” These and other articles show a “healthy” skepticism about how this food "safety" bill will be implemented and enforced.
But I want to debunk an incorrect and spreading myth that S. 510 will trigger the start of "surprise" inspections by the U.S. Food and Drug Administration (FDA). FDA inspections have always been without prior notice, and thus "surprise." Based on the Federal Food, Drug, and Cosmetic Act, the FDA has the authority to inspect all food and supplement manufacturing and distribution facilities annually (and also based on consumer complaints and for follow-up to a failed inspection). Virtually all of these FDA inspectors show up unannounced for surprise visits.
My view is that the dietary supplement industry should be vocal that the real subject of S. 510 and the real safety problem in the United States are conventional foods (especially imports) and foodborne illness. Almost one-fifth of the nation’s food supply, and up to ¾ of our seafood are imported. And yet the FDA inspects less than 1 percent of all that food. This legislation will mandate that FDA do more inspections of food processing plants—emphasizing the foods that are highest risk, which now include peanut butter as well as eggs, etc.
Finally, the horror stories that led to S. 510 do not involve supplements or herbs, but contaminated spinach from 1 small producer that destroyed an entire crop for 1 year, and a pistachio producer that delayed a crop recall for days when requested by the FDA. This history will (if S. 510 passes) bring greater authority and resources—notably recall powers-- for the FDA to potentially use vs. supplements, some provisions of which are the remnants of Sen. McCain’s withdrawn Supplement Safety Act back in March. . . . but that is a story for another day.
(My next article will cover specific implications for the supplement industry, if S. 510 passes.)