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FSMA

Science + Law = New Breed of Business Challenge

Business challenges wax and wane – sometimes stiffer, sometimes less tough. They come in many forms and from different sources. After all, they’re part of, well, business.

For coffee, though, there’s a new breed of challenge that’s upping the ante. It’s a hybrid of sorts, kind of a cross between food safety and product liability.

Like most consumables, coffee comes from an agricultural product that must be processed into a safe and wholesome product. The process involves import/export, transportation, cooking, packaging and delivery. Problems can arise in one or more of these areas, and each step attracts government oversight and action in the interest of protecting public safety and health.

Recently, however, steady advances in scientific methods are fueling new legal and regulatory attention and action, giving rise to the new breed of business challenge. Science and law are becoming flip sides of the same regulatory coin, creating new potential liabilities and more complex compliance demands.

This conflation of law and science is putting serious pressures on coffee companies. They are getting sued under California’s Proposition 65 for a previously undetectable substance, acrylamide, which is naturally formed in the cooking process. They are struggling to comply with unfolding new federal regulations under the Food Safety Modernization Act (FSMA) to prevent foodborne illness, taking them into the weeds of food science and technology. And, with advancing techniques, scientists continue to “chase zero” to find minute molecular structures that happen to spell out still new chemical compounds in many foods.

Law & Science Symposium
It’s a mounting issue that will only get bigger over time. How can industry members prepare? By gaining at least a working knowledge of the science and the law, and how these two otherwise disparate disciplines overlap to challenge business. An MBA alone will no longer go the distance without at least some a little Ph.D. and Esq. blended in.

NCA works hard to keep its members and the entire U.S. coffee industry up to speed and ahead of the curve. That’s why we’re prefacing the 2013 NCA Convention with a special Symposium to help bridge the gap. Coffee at the Crossroads of Science and Law will bring together prominent industry scientists and attorneys to help attendees understand the essentials of science and law for navigating the new challenges.

Coffee at the Crossroads of Science and Law will cover challenges arising from California’s Proposition 65 and its application to acrylamide as well as other heat-formed toxicants already uncovered and still others yet to be detected and regulated. The symposium will also detail the complex new requirements of the Food Safety and Modernization Act, such as recently released draft regulations on hazard assessment and preventive controls that many say go beyond the original statutory mandate. The symposium will also cover how and to what extent health claims run afoul of legal and regulatory dictates.

Coffee at the Crossroads of Science and Law will be held on Thursday, March 21, 2013 at the Palace Hotel in San Francisco. The 2013 NCA Convention carries on from March 21 to 23 also at the Palace. Registration is now open.

Knowledge as Guide
The challenges posed by science-based legal and regulatory action will only increase over time. Scientists will inevitably uncover more heat-formed toxicants and other chemical traces in foods, and public policy will undoubtedly keep pace with laws and regulations to uphold food safety and integrity. For coffee companies and other food manufacturers finding their way around the crisscrossing maze of compliance, knowledge will be their most sure-footed guide.

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Federal Food Agency Tests Waters on FSMA Food Safety Plans

The wheels of government often grind slowly, but can still deliver a hefty pinch. After a yearlong delay, the Food and Drug Administration (FDA) has issued draft regulations that put significant new responsibilities on manufacturers for ensuring food safety.

Last week, the FDA issued a “proposed rule” to implement the Food Safety Modernization Act (FSMA) provision for “preventive controls,” essentially a series of backstops against potential contamination. Generally speaking, the 680-page document is the regulatory equivalent of an operating manual, spelling out proposed regulations implementing the statutory provision.

FSMA, which became law in January 2012, introduced a requirement that manufacturers of food for consumption in the U.S. develop a formal safety plan to prevent foodborne illness. However, just what compliance would entail is left up to the FDA to craft in accompanying regulations. The law provided for an automatic trigger of the preventive controls provision on July 3, 2012, but without the rules in place, the FDA had adopted temporary “discretionary enforcement” of the provision.

The newly issued proposed rule is now open to a 120-day public comment period. Following receipt and analysis of comments, the FDA will issue a final rule. Thereafter, the Agency says, it would make the preventive controls provision effective after one year. Small business are expected to be given additional time.

NCA will study the proposed rule carefully and consider filing formal comments if appropriate to advocate for the best interests of the U.S. coffee industry. NCA has already filed comments with the FDA on prior FSMA rulemaking proposals.

Preventive Controls
The FSMA preventive controls provision will require domestic or foreign manufacturers of food for sale in the United States to develop a formal plan to prevent foodborne illness. The provision also requires food makers to conduct analyses of reasonably foreseeable hazards, including acts of terrorism, and deploy preventive controls to minimize those risks. The proposed rule also requires food makers to put plans in place for correcting any problems that may spring up.

Preventive controls are one of many new provisions deployed by FSMA to improve U.S. food safety. FSMA itself signaled a fundamental shift in the nation’s approach to creating a safer food supply. Rather than the prior approach of remediation of problems after they arise, FSMA adopts an approach focused on prevention. The statute also emphasizes accountability for domestic and foreign food producers throughout the supply chain.

The first major revamp of federal food safety laws since the 1930s, FSMA grants new powers to the FDA and imposes added responsibilities for food safety throughout the supply chain. Passed by Congress in late 2010, the statute also calls for more frequent inspections of domestic and foreign facilities, re-registration by food companies, presumptive liability that companies that pack, receive or hold foods “knew or should have known” of problem conditions, a reduced threshold for administrative detention of food, and protections for whistleblowers.

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