Currently browsing posts about: S.510

Aug 22 2010

Effects of S. 510 on small farms: Senate staff analysis

Thanks to reader Michael Bulger for forwarding the Senate staff analysis of the impact of S. 510 on small farms.   Here’s what it says (slightly edited):

No Change in Agency for Regulated Foods: Only foods already regulated by the Food and Drug Administration (FDA) will be subject to S. 510. Section 403 maintains the existing firewall between FDA and the U.S. Department of Agriculture regulated foods and agricultural products.

No Change in Definition of Facility: Under the Bioterrorism Act of 2002, certain food businesses were considered “facilities” and had to register with FDA. Farms and restaurants were exempted. This definition is not changed in S. 510. If an entity does not need to register now, it will not need to register under S. 510.

Flexibility for Small Businesses: Small businesses are given regulatory flexibility throughout S. 510. For example, small processors are given additional time to comply with new food safety practices and guidelines created by the bill and the Secretary may modify or exempt small processors from new hazard analysis and preventive control requirements based on size and risk. The legislation also requires the FDA to publish several user-friendly small entity compliance guides to assist firms with the implementation of new practices.

Scale Appropriate Produce Safety Standards: In coordination with the Secretary of Agriculture, FDA develops science-based standards for the safe production and harvesting of fruits and vegetables. Priority is given to specific fruits and vegetables that have the highest risk of food borne illness outbreaks. Flexibility is given for different growing, production, and harvesting techniques. FDA has the discretion to limit produce safety standards for small and very small entities that produce or harvest food which pose little or no serious risk to human health. Consideration is also given to conservation and environmental standards already established by federal natural resource and wildlife agencies. Exemptions are also available for low risk commodities. FDA must minimize the burden of paperwork and, as appropriate, the number of separate standards for separate foods.

Increased Training Opportunities: The bill requires FDA to coordinate with the extension activities of the National Institute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture in educating growers and small processors about any new practices required by S. 510. Necessary funds are authorized to conduct these extension activities. The bill also provides for the training and education of state, local, and tribal authorities to facilitate the implementation of new standards under the FDA Food Safety Modernization Act. Competitive grants are made available, for up to 3 years, to support these efforts to enhance education, training, and technical assistance.

Risk-Based Traceability: The ability to trace back potentially unsafe food in the event of a food-borne illness outbreak is important. For the purpose of traceability, farms and small businesses that are not food facilities are not expected to create new records. During an active investigation of a foodborne illness outbreak, in consultation with state and local officials, the Secretary may ask a farm to identify potential immediate recipients of food if it is necessary to protect public health or mitigate a foodborne illness outbreak. Limitations are also included for restaurants, commingled agricultural commodities, direct to consumer sales, fishing vessels and products carrying an identity preserved label.

Regulatory Flexibility for Organic Foods: Throughout the bill, consideration is given to the unique agricultural practices and requirements of organic foods under the Organic Foods Production Act of 1990.

Protections for Farmers Markets, Cottage Industries and Direct Farm-to-Market Sales: Small entities that produce food for their own consumption or market the majority of their food directly to consumers or restaurants are not subject to registration or new recordkeeping requirements under S. 510. This includes food sold through farmers’ markets, bake sales, public events and organizational fundraisers.

I hope this helps to calm things down a bit.  This bill needs all the support it can get.  It’s not perfect but it is a reasonable first step, and badly needed.

Aug 14 2010

Two more analyses of S. 510 to ponder

Yesterday, I posted comments from the Consumers Federation of America about the latest version of S.510. With luck, the Senate will vote to pass this bill in September and will reconcile its version with the House bill passed a year ago.  Here are two comments based on Senator Harkins’ staff analyses:

1.  The National Sustainable Agriculture Coalition (NSAC) says that the latest version of the bill includes these improvements (my emphasis):

  • The amendment sponsored by Senator Bernie Sanders (I-VT) pertaining to farms that engage in value-added processing or that co-mingle product from several farms.  It will provide the Food and Drug Administration (FDA) with the authority to either exempt farms engaged in low or no risk processing or co-mingling activities from new regulatory requirements or to modify particular regulatory requirements for such farming operations. Included within the purview of the amendment are exemptions or flexibilities with respect to requirements within S. 510 for food safety preventative control plans and FDA on-farm inspections.
  • The amendments sponsored by Senator Michael Bennet (D-CO) to reduce unnecessary paperwork and excess regulation.  The Bennet language pertains to both the preventative control plan and the produce standards sections of the bill.  FDA is instructed to provide flexibility for small processors including on-farm processing, to minimize the burden of compliance with regulations, and to minimize the number of different standards that apply to separate foods.  FDA will also be prohibited from requiring farms and other food facilities to hire consultants to write food safety plans or to identify, implement, certify or audit those plans. With respect to produce standards, FDA will also be given the discretion to develop rules for categories of foods or for mixtures of foods rather than necessarily needing to have a separate rule for each specific commodity or to regulate specific crops if the real food safety issue involved mixtures only.
  • The amendment sponsored by Senator Debbie Stabenow (D-MI) to provide for a USDA-delivered competitive grants program for food safety training for farmers, small processors and wholesalers.  The training projects will prioritize small and mid-scale farms, beginning and socially disadvantaged farmers, and small food processors and wholesalers. The program will be administered by USDA’s National Institute for Food and Agriculture.  As is the case for all of the provisions in S. 510, funding for the bill and for this competitive grants program will happen through the annual agriculture appropriations bill process.
  • The effort championed by Senator Barbara Boxer (D-CA) to strip the bill of wildlife-threatening enforcement against “animal encroachment” of farms is also in the manager’s package.  It will require FDA to apply sound science to any requirements that might impact wildlife and wildlife habitat on farms.
  • An amendment proposed by Senator Sherrod Brown (D-OH) to amend the traceability and recordkeeping section of the bill that will exempt food that is direct marketed from farmers to consumers or to grocery stores and exempt food that has labeling that preserves the identity of the farm that produced the food. The amendment also prevents FDA from requiring any farm from needing to keep records beyond the first point of sale when the product leaves the farm, except in the case of farms that co-mingle product from multiple farms, in which case they must also keep records one step back as well as one step forward.

2.  Bill Marler provides additional information:

Here is Chairman Harkin’s mark-up and section by section summary – this is the version of the bill voted out of the HELP Committee in mid-November and here is the most recently approved version as of last night.

Senator Feinstein has not released a copy of her BPA amendment — however, she is now saying it will only be baby bottles, sippy cups, baby food, and infant formula.

Here’s the Senator Tester amendments as they were introduced in April (I’m sure the version they’re working with now looks quite different after months of negotiations, but the principle is likely the same).

Marler also points out that only foods that are already regulated by FDA will be subject to S. 510, as its Section 403 maintains the existing firewall between FDA and USDA-regulated foods and agricultural products.

Keep reading.  This is critically important legislation to help the FDA ensure food safety.