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FDA seeks public comment on newest food safety rules

 

By JIM RUTLEDGE

D.C. Correspondent

 

COLLEGE PARK, Md. — The nation’s farm and food industry has less than a month to file new comments to the U.S. Food and Drug Administration’s (FDA) latest proposed rule changes to the agency’s Food Safety Modernization Act (FSMA), ahead of the FDA’s deadline of Dec. 15.

A panel of FDA officials addressed hundreds of private citizens and food companies and representatives in a daylong meeting Nov. 13, outlining the latest supplemental changes to four significant FSMA rules originally proposed in January 2013.

Two victims of E. coli food poisoning gave heart-wrenching accounts of how a lack of food safety standards killed one family member and nearly took the life of another’s husband and her two young children.

"There were moments of hope and of despair," the 22-year-old son of Linda Rivera, Richard Simpson, told the panel of his mother’s agonizing death years earlier. She had eaten a few spoonfuls of prepackaged cookie dough, later found to be contaminated with a dangerous strain of E. coli. "She fought very hard. We knew she didn’t want to give up."

Housewife Deborah Treen of Sammamish, Wash., described how her husband, Kent, became sick last year after eating contaminated sprouts served on a sandwich from a Jimmy John’s. The Centers for Disease Control and Prevention determined Evergreen Fresh Sprouts of Idaho was the supplier, and the likely source that sickened l8 other people in six days last May.

"We don’t know the source of the next outbreak," Treen told the panel. "(My family and I) urge strong food safety standards. Let’s not let another year go by." At the time of the outbreak last year, a spokesperson for Evergreen Fresh Sprouts denied it was responsible, saying its tests came back negative.

The latest proposed rule changes cover four specific rules: Preventive Controls for Human Food; Preventive Controls for Animal Food; Rules for Produce Safety; and Rules for Foreign Supplier Verification Programs. The panel urged the food-producing industry to study the rules closely, as the changes were made after considerable input from farmers and the industry.

In Preventive Controls for Human Food, the changes affect the definition of a farm as food facility, as several public speakers urged the FDA to carefully examine the definition further. Other changes were classifications for a "very small business," defining those as having less than $1 million in total annual sales. The previous rule proposed three options for businesses with annual sales ranging from $250,000-$1 million.

Another change pertained to exemptions for a qualified food-producing facility and established new guidelines the FDA will use to determine a company’s business practices. Other changes affect product testing, environmental monitoring and food supplier controls and the differences in compliance dates for various business classifications.

Changes to Preventive Controls for Animal Food cover revised manufacturing practice regulations, the definition of a "very small business," new language for product testing, animal food and feed supplier controls and business exemptions, and the FDA urges additional comment on the operational relationships between feed mills and its associated farms.

New Rules on Produce Safety cover water quality standards and more flexible testing; further study on a raw manure strategy plan for soil enhancement and crop harvesting and associated risks; a new "produce farm" definition; clarifying provisions on wild animal protections for animal habitats on or near farmlands; and new revised compliance dates.

Significant changes for the Foreign Supplier Verification Programs brought several public comments from officials of the Japanese Ministry of Agriculture Forestry, the French government and the European community. Questions were raised on food production inspections, testing and hazard analysis for imported food products and compliance dates.

More than two dozen comments raised questions on water quality standards and the uses and rules governing raw manure usage.

Raymond Yoder, an Amish farmer from Fredericksburg, Ohio, speaking on behalf of thousands of "plain" farmers, called for more scientific data in the use of raw manure and the agency’s description of when and how it is used and tested.

"I’m concerned about the plain people, the small growers, the produce growing on small farms in America," he said. Before the final rules are put in place, he added, there needs to be more education on the part of the farmer and the FDA.

Over the course of the past year, the FDA reported more than 109,764 public comments, the most, 69,878, pertaining to Preventive Controls for Human Food. Roberta Wagner, its deputy director of Regulatory Affairs for the Center of Food Safety and Applied Nutrition, urged more public comment. All of the proposed changes can be found at www.FDA.gov/FSMA

Wagner said the FDA is undergoing a massive upgrade of the agency’s operation and "we will be acting differently in the future" as it prepares to adopt the new regulations before the end of 2016. "We’re going to educate before we regulate."

There are two ways to submit comments, online and by USPS mail. Online, for Produce Safety, go to www.regula tions.gov/#!submitComment:D=FDA- 2011-N-0921-0973

For Preventive Controls For Human Food: www.regulations.gov/#!submit Comment:D=FDA-2011-N-0920-1553

For Preventive Controls for Animal Food: www.regulations.gov/#!submit Comment:D=FDA-2011-N-0922-0269

For Foreign Supplier Verification Program: www.regulations.gov/#!sub mitComment:D=FDA-2011-N-0143-0247

Written comments for any of these may be mailed to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

11/19/2014