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From: Food Quality & Safety magazine, October/November 2012

FSMA Stuck in Limbo

by Ted Agres

As the White House Office of Management and Budget continues to review—but not release—proposed regulations to implement the Food Safety Modernization Act, Canada and China are beginning to revise their own food safety laws in order to improve their domestic and imported food supplies. Those efforts are still in the early stages, and it remains to be seen how U.S. food producers and exporters will be affected by them.

The Canadian government announced draft legislation that would consolidate four separate food statutes administered and enforced by the Canadian Food Inspection Agency, increasing the safety and competitiveness of Canadian food domestically and internationally. The proposed legislation, called the Safe Food for Canadians Act, was introduced in the Senate in June. It is likely to undergo substantial debate and refinement during the legislative process.

At present, the draft legislation is more descriptive than specific. In general, it would standardize inspections across food types, provide for tougher penalties, strengthen food traceability, and increase import and export controls. Like FSMA, the Safe Food for Canadians Act would hold importers accountable for the safety of imported products, authorize the government to register or license importers, and prohibit the importation of unsafe food commodities. “Holding importers accountable for the safety of imported products will also promote a level playing field between importers and domestic producers,” said a legislative overview posted on the CFIA website.

The proposed legislation would give the CFIA increased authority to develop regulations related to tracing and recalling food, with “appropriate tools to take action on potentially unsafe food commodities, when needed.” This includes a specific prohibition against selling foods that have been recalled. The act would also provide new prohibitions on food tampering, deceptive practices, and hoaxes, with increased fines and penalties to deter “willful or reckless threats to health and safety.”

In an acknowledgement to its neighbor to the south, the Canadian legislation notes that it “will align more closely with those of our trading partners, such as the Food Safety Modernization Act in the United States.” As such, the traceability and import control provisions should be of particular interest to U.S. food companies, according to David Acheson, MD, managing director of the food and import safety practice at Leavitt Partners and former FDA associate commissioner of foods.

For example, Dr. Acheson noted, it is unclear whether the Canadian government will accept current U.S. export certificates or will require more robust certification, as will be expected under FSMA. It is also unclear whether the U.S. government will be allowed to “certify” exports for Canada and, if so, what that process will involve. Also unknown is the extent of product traceability and whether that tracking will be in sync with U.S. requirements under FSMA.

“This proposal is in the early stages of development,” Dr. Acheson wrote in a recent blog post, “but for anyone who is doing business with Canadian firms, this is clearly a space to watch as the process unfolds.”

Canada and China are beginning to revise their own food safety laws in order to improve their domestic and imported food supplies. Those efforts are still in the early stages, and it remains to be seen how U.S. food producers and exporters will be affected by them.

China Plans for Food Safety

Also in June, China’s Ministry of Health announced a new five-year plan to upgrade food safety regulations in an effort to address the serious problems that continue to plague that nation’s food supply. The plan—the latest in a dozen such pronouncements—came as one of China’s largest dairy product manufacturers, the Inner Mongolia Yili Industrial Group, recalled all powdered infant milk formula it had produced from November 2011 to May 2012 because of excessive amounts of mercury. The recall was the latest in a series of mishaps and scandals that have eroded public confidence in the nation’s domestic food supply (see October/November 2011 issue of Food Quality).

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.”


Agres is based in Laurel, Md. Reach him at tedagres@yahoo.com.

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