Scale-approriate exemptions from food safety legislation?

As S510 bill is debated, more amendments and petitions are being circulated.   In one petition, the main points of contention for small farms is the establishment of new hazard analysis and risk-based preventive controls for all facilities and designation of FDA’s authority over growing and harvesting practices for produce.  For more details see posted letter from over 100 National and Multi-state organizations

Also on the post is a reference to Senator Jon Tester’s amendment to exempt small, local processing facilities with revenues below $500,000 from the bill’s hazard analysis and risk-based preventive controls requirements and traceability requirements.  Our local CFSA has more information concerning the statis of this bill and remaining work to be done!  More information can be found on the Sweet Potato – sustainable food and  farming blog of the Carolinas.

Asheville Citizen Times Article- Federal Food Safety Laws

New laws could hurt Western North Carolina food producers

By Jon Ostendorff • April 13, 2010

ASHEVILLE — New federal food safety laws could drive some small producers in Western North Carolina out of business with added costs and inspections, those in the industry say.

The Senate this week could vote on the FDA Food Safety Modernization Act, a bill that would require more U.S. Food and Drug Administration inspections of farms and processing facilities and stringent record keeping from producers. The agency also would have more power to order recalls.

Local producers and sellers said the law is written for big food companies and supposes the food supply will be more global in coming decades and not more local.

WNC is home to a growing food market, ranging from small kitchens making jams and jellies for sale at places like the French Broad Food Co-op in Asheville to an effort in Haywood County aimed at getting grocery stores to sell local produce.

Exact cost increases for small producers are unclear. But some of the figures, such as an annual government registration fee of $500 in the House version of the bill and mandated inspections that could run $95 an hour, threaten to drive producers making only a few thousand a year out of business, said Harry Hamil, co-owner of the Black Mountain Farmers Market.

He said the law is designed for big companies.

“Big can always afford the cost of increased regulations,” he said. “Small frequently cannot afford it. Small is where we get most of the growth in jobs in this economy.”

The law could have an impact at Blue Ridge Food Ventures, a food business incubator in Asheville that has helped more than 150 producers get started since 2005.

Small producers now have to use a government-approved kitchen to make their products. The new law would require them to develop what’s known as a hazard analysis and risk-based preventative control plan, similar to the plans required of large food companies. Creating a plan that the government would approve takes education and training and means additional expense.

Mary Lou Surgi, executive director of Blue Ridge Food Ventures, said she recently did a plan for juice production. It took two days in a classroom and about a week of research. A consultant can put a plan together for about

The plan requires producers to find and document any potential hazards in the food products they make and then create a process to mitigate each hazard. Producers must also document where their products are being sold to meet a traceability requirement. 

Surgi said those are great requirements for large companies buying ingredients from hundreds of places worldwide. But the small producer usually knows where he is buying his ingredients and might have grown some of them himself, which tends to mean a safer product.

Surgi said forcing a local producer to follow the same regulations as Pillsbury or Post will hurt the movement that has brought local foods to schools, hospitals and grocers.

“All that is put at risk if the only people who can afford to be legal are these megacorporations,” she said.

Others in the local food business are also concerned.

Chris Roland, grocery manger at French Broad Food Co-op, said he sells products from about 20 small vendors.

“I would hate to see us lose those small producers,” he said.

At Annie’s Naturally Bakery in Sylva, which is planning an expansion in West Asheville, owner Joe Ritota said more regulation is necessary for big producers, but small producers tend to be more careful. A mistake could cost them a market.

“These are small mom-and-pops that are doing something locally and sustainable,” he said.

The Senate debate on the law comes after a recent U.S. Department of Health and Human Services report found that the FDA inspects less than one-quarter of the nation’s food producing facilities.

The department’s inspector general found more than half of the 51,229 facilities under FDA oversight have gone uninspected in the last five years. The report noted a decrease in staffing at the FDA since 2003.

The government estimates 300,000 people are hospitalized and 5,000 die each year from contaminated food.

Hamil, who said the new regulations would kill a blueberry distribution business he has started, said he supports an amendment by Sen. Jon Tester, D-Mont., that would exempt small producers.

The small producers would continue to be regulated and inspected under current standards.

Surgi agreed.

“We all support food safety,” she said. “We just want the rules to recognize that someone making less than $50,000 in product a year incurs a lot a lot less risk that the megacorporation.”

What does FDA’s New Reportable Food Register mean to you?

The  Food and Drug Administration Amendments Act of 2007 (FDAAA) is the current law governing this register.  It was signed into law  September  2007 amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) with a new called the Reportable Food Registry (RFR-Section 417).   This section’s purpose is  to provide a “reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health”.

Who does this apply to? All facilities that manufacture, process, pack, or hold FDA-regulated food or animal feed for consumption in the U.S., and Federal, state, and local public health officials.

What needs to be reported? A reportable food is any food that has a probability of causing serious adverse health consequences or death to humans or animals. Examples include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.  Facilities must notify FDA as soon as possible, and no later than within 24 hours.

What information will need to included in the report? ( from

  • Introduction (5 minutes) – The type of report you are submitting.
  • Responsible Party / Reporter Information (4 minutes) – Your identifying information. To submit a report, responsible parties must have a Food Facility Registration Number for the Responsible Party site and the Location of Reportable Food. Please visit Registration of Food Facilities for more information on how to register for this number.
  • Location of Reportable Food (4 minutes) – The contact information for the site about which you, the responsible party are reporting; this may be the same or different from your site. This site may have discovered the problem on its own or may have been notified about the problem by another source. If you are a Federal, State, or local public health official, this section asks you to report about the location that is the current manufacturer, processor, packer, or holder of the food to the best of your knowledge.
  • Problem Origination Site (4 minutes) – You will only see this section if you indicate that you know the site at which the problem originated; that is, where the problem started. This section asks you to provide the name and any other information you might know about that site/location.
  • Product Problem (5 minutes to 15 minutes, depending on how much information you are able to provide at this time) – This section asks for a summary of the product problem, including how and when you learned about the problem, information about the suspect products (received or produced), and a description of the problem. If you have more details about any of the suspect products, you will be asked to provide them.
  • Submit report and Confirmation (5 minutes) – This section provides an opportunity to review your report before submission, instructions for attaching supplemental information to accompany your report, and provides you with an FDA-issued unique identifier number (also known as an Individual Case Safety Report number, or ICSR number) with which to identify your report. Upon submitting the report, you will have the option to send FDA additional related materials via email.

Here is the link to questions: Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendment Act of 2007

Instruction for filling out the Reportable Food Register

GAP’s Online Produce Safety Course in English & Spanish

*The next English GAPs Online Produce Safety Course will begin April 28* and will run through May 19, 2010. *Registration is now open*.  Each course is limited to 25 people. There will be a $50 fee for taking this course.
To register, follow this link to the registration page at *check* the Add to Cart Checkbox and *click* the Add to Cart Button.

I have attached a course outline that contains additional information about the course.   *Please forward this email to anyone who may be interested*.  If you have any questions about the course, please contact me at or at 315 787 2625.

Given the warm spring, we are not sure when to offer the next course since registration numbers are lower during the late spring and summer.  Please contact me if you are interested in taking a course and we can schedule one in May or June if the interest is there.  The next section dates will be posted at  under Events Calendar.

VERY IMPORTANT NEWS! For the first time, the GAPs Online Produce Safety Course will be offered in Spanish!  It will begin April 21, 2010 and end May 11, 2010.  There will be no charge for this course since it is the first offering.
To register, follow this link to the registration page at , *check* the Add to Cart Checkbox and *click* the Add to Cart Button.

I have attached a course outline that contains additional information about the course.   *Please forward this email to anyone who may be interested*.  If you have any questions about the course, please contact me at or at 315 787 2625.

The next English class will be offered April 28, 2010 will be posted at  under Events Calendar.  

 *El Programa Nacional de Buenas Prácticas Agrícolas (GAPs) de la
 Universidad de Cornell, junto con eCornell.*

Estimado Futuro Participante,

Bienvenido y gracias por su interés en el curso en línea de las Buenas Prácticas Agrícolas (BPA), la seguridad de las frutas y hortalizas frescas. El Programa Nacional de BPA en la Universidad de Cornell, con fondos de la *Iniciativa Nacional en la Seguridad Integrada de los Alimentos, CSREES, USDA, se ha unido a eCornell para presentarle este curso en línea de 3 semanas acerca de la Implementación de las Buenas Prácticas Agrícolas (BPA). Este curso le proporcionará una experiencia de aprendizaje interactiva por medio de una combinación de trabajo en clase riguroso y relevante, con debates estimulantes entre los compañeros del curso, moderación enriquecedora por un experto en la materia y un curso de estructura flexible que le permite trabajar cuando y donde le sea conveniente.

A continuación encontrará una descripción del curso (haciendo clic en el ícono “i” para obtener más información), expectativas del curso y un plan de estudios. Si tiene cualquier pregunta sobre esta información, por favor comuníquese conmigo a mi correo electrónico o llamando al 315 787 2625. Si después de leer la información proporcionada usted desea inscribirse, por favor llene el formulario de inscripción y envíelo junto con el pago del curso por la cantidad de $50.

Para inscribirse, por favor seleccione la casilla de /Agregar al carrito/ y luego haga clic en el botón /Agregar al carrito/. Se le pedirá que llene la información de su perfil de eCornell, incluyendo un nombre de usuario y contraseña. ¡Espero que disfrute del curso!


Betsy Bihn, Coordinadora del Programa Nacional BPA

*Iniciativa Nacional en la Seguridad Integrada de los Alimentos (Fondo # 2006-51110-03632) de la Investigación, Educación y Servicio de Extensión Cooperativos del Estado, Departamento de Agricultura de los Estados Unidos.

En este curso en línea usted aprenderá prácticas importantes que garantizan la seguridad de los productos frescos y de las consideraciones clave en la implementación de las Buenas Prácticas Agrícolas (BPA). Al final del curso usted desarrollará un plan para la seguridad de los productos agrícolas frescos que esquematice las actividades necesarias para implementar BPA que sean funcionales.

If you have questions, please contact:

Elizabeth A. Bihn, M.S.
National GAPs Program Coordinator
Department of Food Science
Cornell University
Office (315) 787 2625
Fax (315) 787 2216

GAPsOPSC registration information-SP

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