FSMA Stuck in Limbo

According to the announcement, by the end of 2015, Chinese government agencies will put in place national standards for more than 5,000 food types, including dairy products, infant food, meat, alcohol, vegetable oil, seasoning, health products, and food additives. The government will also revise regulations for food pollutants and pathogenic bacteria, said Su Zhi, a senior official with China’s Ministry of Health. There are currently more than 2,000 national, 2,900 industrial, and 1,200 local standards in China related to food and additives—many of which are overlapping and contradictory.

“National food safety standards are mandatory and important to protect public health, protect food safety, achieve food security, strengthen regulations, while also maintaining food production and operation and promote the healthy development of the food industry,” a government announcement said. Food safety violators will also be subject to “harsh crackdowns” and severe penalties “in accordance with laws and regulations.”

U.S. food safety experts generally lauded this latest Chinese effort to improve food standards, but they also noted that previous pronouncements have failed because officials are neither held accountable for their implementation nor punished for achieving results that conflict with the reforms. And while the Chinese plan makes note of such modern concepts as risk assessment, international standards, and transparency, it emphasizes government regulation and enforcement over improvements in industry practices.

European Opposition to FSMA

Although it is uncertain when OMB will release FSMA regulations for public comment, what is becoming clear are objections to FSMA by the 27 member countries of the European Union. In July, Carlos Alvarez Antolinez, the EU’s minister-counselor for food safety, health, and consumer affairs, told an international conference on food safety that European authorities have significant issues with FSMA provisions relating to third-party audits, inspections, and foreign supplier verification procedures.

“Our concern is about duplication of controls,” Antolinez told a meeting of the Association for Food Protection in Providence, R.I. He noted that the FSMA would require U.S. audit and approval of individual European companies, a significant change from the EU’s “government-to-government” approach, which relies on national authorities to oversee companies under their jurisdiction.

“It’s a fundamental difference in philosophy,” Dr. Acheson said. “FSMA will require certificates from foreign manufacturers, especially of high-risk foods, that document that they conform to FDA standards. The European approach generally is to work with foreign governments to set that up. It is a fundamental difference and, knowing FDA, I don’t think they will buy into that. FSMA calls on FDA to build the confidence and build the systems to rely more on foreign governments, but it’s not there yet.”

Free the Regs

During most of this year, numerous consumer, health, and environmental organizations, along with U.S. lawmakers, have been calling on the White House to release the draft FSMA regulations. In August, the Center for Food Safety and the Center for Environmental Health filed a federal lawsuit seeking a court-imposed deadline on FDA to enact FSMA regulations. That, in turn, would force OMB to release the regulations so that the public comment period can begin.

Many observers, including Craig W. Henry, PhD, director of enterprise risk services-business risk at Deloitte & Touche LLP, believe the Obama administration will not release the regulations until after the November elections.

“The outcome of the elections may impact the budget that gets approved to finalize the rules and enforce the act,” Dr. Henry said. “I believe this is one of the few major pieces of food safety legislation that had strong bipartisan support during the past four years. It will be in everyone’s interest to make it happen, but it will still require significant funding.”