Agency seeks opinions on how to make rules 'scale appropriate'


Capital Press

FDA official Sharon Natanblut has flown across the U.S. several times in recent weeks to hear what growers have to say about new food safety rules.

"We want to develop good, responsible produce safety standards," Natanblut told growers at a listening session in Portland last week. "And to do that, we have to talk to people on the ground."

Natanblut said the agency wants rules that can be easily implemented, are not overly burdensome, yet enable the agency to limit food-borne illness. Also, when illness occurs, the agency wants the ability to trace problems to their source.

Agency officials typically don't travel the country holding listening sessions when writing new rules, Natanblut said. But, she said: "This is the hardest thing we've done."

She added: "This administration wants to get this right to begin with."

Natanblut and the three other FDA officials in Portland last week heard many of the same concerns that have been voiced elsewhere.

Small-scale producers said they are concerned new rules will run them out of business.

Large producers, conversely, are concerned that if an illness erupts from a small farm, it could result in a large-scale food-safety scare. They want all producers regulated.

Natanblut emphasized in her opening remarks that the agency in no way intends to run smaller growers out of business by piling on costly and unwieldy regulations.

The agency, she said, intends to craft rules that are flexible and "scale appropriate."

"No one size fits all," she said.

The question, she said, is what is "scale appropriate."

"Scale appropriate means something different to everyone," she said.

Natanblut also said the FDA intends to impose the same standards on imported food as on domestically produced food. But, she said, "It's very difficult."

"How do you police that?" asked FDA official Jim Gorny, who also was in Portland last week for the hearing.

The FDA plans to write its rules and make them available for public comment by early next year, Natanblut said.

The agency plans to make its rules consistent with rules being advanced in two sweeping congressional bills.

In a bill the House passed last summer, a $500 annual registration fee charged to all producers and importers would be used to pay for increased FDA inspections and enforcement activities.

The bill requires processors to develop hazard analysis and critical control point plans to identify hazards in food processing, and to develop responses if tainted food is shipped from a plant.

It requires the FDA to set safety standards for farmers and food processors and it calls for importers to meet the same standards.

In the Senate, the Food Safety Modernization Act also requires food processing facilities to develop HACCP plans and pay fees for inspections and recalls. The bill also calls for federal officials to improve traceability of raw agricultural commodities.

The full Senate has yet to vote on the bill.

Natanblut characterized the congressional bills as adding teeth to food safety laws and providing the FDA more tools.

The bills represent the first big overhaul of U.S. food safety laws in more than 70 years, she said.

Food safety comments

Comments on the Food and Drug Administration's new food safety rules can be sent by mail to The Division of Dockets Management; HFA-305; FDA; 5630 Fishers Lane, Room 1061; Rockville, MD 20852.

To submit comments online, go to , choose "submit a comment" from the task bar, enter the docket number FDA-2010-N-0085 in the "keyword" space, then select "search."


The FDA Food Safety Modernization Act, Senate Bill 510, has been approved by the Senate Health, Education, Labor and Pensions Subcommittee.

If passed, the bill would give the Department of Health and Human Services the authority to:

* Suspend the registration of a food facility.

* Assess fees to pay for food facility reinspection, food recalls and the voluntary qualified importer program.

The bill would require USDA to create:

* Preventive programs to promote food safety and security.

* Regulations on sanitary food transportation.

* A policy on managing food allergy risks in schools.

* Inspection programs based on the risk profiles of food processors or food.

* Capacity to track and trace raw agricultural commodities.

The bill would direct USDA to work with the Centers for Disease Control and Prevention to improve food-borne illness surveillance.

It would also require the Environmental Protection Agency to help local governments to assess, decontaminate and recover from an agricultural or food emergency.

The bill would also provide for:

* Foreign supplier verification.

* A voluntary qualified importer program.

* Inspection of foreign facilities registered to import food.

-- Congressional Research Service

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