Food Safety Modernization Act means changes for producers, processors

HARRISBURG, Pa. -- Proposed new Food and Drug Administration regulations developed under the 2011 Food Safety Modernization Act, or FSMA, will affect how Pennsylvania farmers, processors and retailers operate.

But the devil is in the still-to-be-finalized details, and implementing the most sweeping changes to the nation's food-safety laws in more than 70 years will require collaboration, communication and education.

That was a common theme heard during testimony at a joint informational hearing before the state House and Senate Agriculture and Rural Affairs committees, April 11 at the Capitol. The hearing was held as part of the Penn State Agricultural Council's spring delegate meeting.

About 48 million people -- one in six Americans -- get sick, 128,000 are hospitalized and 3,000 die annually due to foodborne diseases, according to the Centers for Disease Control and Prevention. Food-safety experts believe these illnesses are largely preventable, and the new law for the first time gives the FDA the authority to require comprehensive, prevention-based controls across the food supply chain.

As part of its legislative mandate, the FDA in January published proposed rules for produce safety and for preventive controls in food manufacturing, which are the subject of a public comment period that ends May 16.

"Both (of these draft rules) have in common a new approach toward preventing foodborne illnesses," said Luke LaBorde, associate professor of food science in Penn State's College of Agricultural Sciences.

"Instead of solely relying on periodic visits from a state or federal inspector, food businesses are charged to take a preventative, instead of a reactive, approach," he told the legislators. "This means that growers and processors will be responsible for understanding potential risks in their operations and developing science-based measures to control those risks before a problem actually occurs."

LaBorde emphasized that a highly trained workforce is the best defense against food-safety and sanitation lapses, and the economic consequences that might result. "Education and training for all segments of the food industry is therefore of critical importance" in realizing the public-health goals of law, he said.

LaBorde testified that Penn State is well positioned to offer this type of training. He noted that the College of Agricultural Sciences and Penn State Extension have active and successful food-safety programs already in place that have trained thousands of produce growers, food processors and food-service workers.

As an example, he cited Penn State's leadership in developing research-based food-safety standards for the mushroom industry, known as mushroom good agricultural practices or MGAPs.

"Today, approximately 90 percent of the fresh mushrooms consumed in the United States have been grown on a farm that passed an MGAP third-party inspection," he said. "Mushroom growers therefore are more prepared than other produce groups to comply with the FDA produce-safety regulation."

According to LaBorde, the proposed preventive controls rule will necessitate more research and outreach related to a concept known as hazard analysis and critical control points -- often called HACCP (pronounced HASS-ip) -- which is another area in which Penn State offers science-based training and practical solutions.

"We anticipate that finalization of the preventive controls rule will greatly increase the demand for HACCP courses, in addition to requests for research studies to validate the effectiveness of process control measures as required under the proposed FDA regulations," he said.

LaBorde and Lydia Johnson, director of the Bureau of Food Safety in the Pennsylvania Department of Agriculture, both testified that a new collaboration between the department and Penn State would play a key role in helping producers comply with the new regulations.

With budget constraints posing a potential obstacle to developing new programs, the collaboration will leverage expertise from both organizations to establish three agricultural resource centers to focus on issues surrounding food safety, animal care and plant health.

The Food Safety Resource Center, said LaBorde, will help proactively identify emerging food-safety issues and develop strategies to address them before they reach crisis levels; enhance coordination in responding to foodborne disease outbreaks and product recalls; guide food-safety policy issues to account for the unique characteristics of the state's food system; and assist the food industry in applying food-safety regulations and best practices.

Johnson pointed out that the state, under interagency agreements with the FDA, will help enforce the new regulations but also must educate food producers to help them comply. She said the new center will aid state personnel in that effort.

"(FMSA) is a significant document, and once it moves forward, we are tasked with having our staff become very well versed very quickly," she said. "(The center) gives us an opportunity for our regulators -- the people who will be part of these inspections -- to be trained and receive education. We want to be a bridge between FDA and our stakeholders."

Others testifying at the hearing were Ross Pifer, director of Penn State's Agricultural Law Resource and Reference Center, who explained how the new law's three titles changed the FDA's authority to regulate food safety; Lee Showalter, food-safety manager for Rice Fruit Co., who discussed how some of the proposed new regulations would affect operations in the apple industry; and Hilary Thesmar, vice president for food-safety programs with the Food Marketing Institute, who testified about FSMA's impacts on food wholesalers and retailers.

More information about FSMA and the proposed FDA produce safety and preventive control rules is available on the FDA website.

The Penn State Agricultural Council is comprised of organizations, groups and businesses that represent a strategic agricultural or related interest in Pennsylvania. The council was formed in 1961 as the primary forum for interaction between the College of Agricultural Sciences and its industry clientele. It allows members to stay informed and to provide feedback on college programs, activities and opportunities.

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Last Updated April 24, 2013