Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Fsma for cs as


Published on

  • Be the first to comment

  • Be the first to like this

Fsma for cs as

  1. 1. Impact of FSMA on CSAs Information for those who own a Community Supported Agriculture Program By Kristina Hernandez, Esq. Food Law Consultant
  2. 2. What is FSMA• FSMA is the most sweeping reform to the US food safety law in over 70 years• It was passed in 2011, but will take several years to work out the details and even longer to fully implement because FSMA requires FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.• The stated purpose of FSMA can be summed up in one sentence, to transform the FDAs role regarding food adulteration and misbranding from a reactive to a proactive one.• Amongst other things, FSMA has expanded FDAs authority to include mandatory recall authority, something it has sought for many years.• It will also impose new food safety requirements on all aspects of the food industry, how food is grown, harvested, and processed.
  3. 3. CSAs There has been concern amongst those involved in CSAs about the impact FSMA will have on their business. Those with specific questions should seek the advice of an attorney, but below is some information that may help put FSMA in perspective for CSAs and other small food businesses. Please note that no provision in FSMA is stated or amended specifically for CSAs, however, there are provisions for „small or very small businesses‟ that will probably apply to many CSAs, because many probably qualify as a „small or very small business‟• Community Supported Agriculture consists of a community of individuals who pledge support to a farm operation so that the farmland becomes, either legally or spiritually, the communitys farm, with the growers and consumers providing mutual support and sharing the risks and benefits of food production.• Typically, members or "share-holders" of the farm or garden pledge in advance to cover the anticipated costs of the farm operation and farmers salary. In return, they receive shares in the farms bounty throughout the growing season, as well as satisfaction gained from reconnecting to the land and participating directly in food production.• Members also share in the risks of farming, including poor harvests due to unfavorable weather or pests. By direct sales to community members, who have provided the farmer with working capital in advance, growers receive better prices for their crops, gain some financial security, and are relieved of much of the burden of marketing.
  4. 4. History of CSAs• Community supported agriculture (CSA) is a new idea in farming, one that has been gaining momentum since its introduction to the United States from Europe in the mid-1980s.• The CSA concept originated in the 1960s in Switzerland and Japan, where consumers interested in safe food and farmers seeking stable markets for their crops joined together in economic partnerships.• Data collected in 2007 by the U.S. Department of Agriculture indicates that 12,549 farms in the United States reported marketing products through a community supported agriculture (CSA) arrangement.
  5. 5. FSMAs Application to Small Business• FSMA recognizes the role of small businesses in the food industry and provides for various ways to assist small businesses in meeting the new food safety requirements of the law.• Specifically for several key provisions, the law mandates “plain language” guidance documents and phased-in effective dates.
  6. 6. Extra Guidance and More Time for Implementation of FSMA provisionsRegistration• FDA will issue “plain language” guidance on registration procedures for small entities within 6 months of issuing registration rule. Section 102 of FSMA)Hazard Analysis and Preventive Controls• FDA will issue “plain language” guidance for small entities within 6 months of issuing hazard analysis/preventive control rule. (Section 103 of FSMA)• Hazard analysis/preventive control rule takes effect for small businesses 6 months after effective date, and for very small businesses 18 months after effective date. (Section 103 of FSMA)Produce Safety• FDA will issue “plain language” guidance for small businesses within 6 months of issuing produce safety rule. (Section 105 of FSMA)• Produce safety rule takes effect for small businesses 1 year after effective date, and for very small businesses 2 years after effective date. (Section 105 of FSMA)Tracking and Tracing• FDA will issue “plain language” guidance for small businesses within 6 months of issuing rule on tracking and tracing food and recordkeeping. (Section 204 of FSMA)• Rule on recordkeeping takes effect for small business 1 year after effective date, and for very small businesses 2 years after effective date. (Section 204 of FSMA)Training and Education• FDA will enter into agreement with USDA to establish competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to farmers, small food processors and small fruit and vegetable merchant wholesalers. (Section 209 of FSMA)
  7. 7. And total exemption from certain provisions Small and Very Small Business Amendment Exempts Some Producers from a) Preventive Control and b) Hazard Analysis Requirements FOR THE “SMALL AND VERY SMALL” BUSINESSES THAT ENCOMPASS THE LOCAVORE FOOD MOVEMENTSenator John Tester (D-MT) championed the causes of those who supply food to the“locavore” food movement with a controversial amendment to the FSMA. Senator Tester‟samendment exempts small and very small facilities and farmers from certain requirements inthe bill and allows them to operate by meeting lower safety thresholds.• In order to qualify for the exemptions, facilities and farms must1) meet the definition of “very small business” – which will be defined during rulemaking2) sell a certain threshold of food to qualified end users within the past three years and3) all food sold must have an average annual monetary value of less than $500,000.A “qualified end user” is defined as the consumer of a food or a restaurant or retail foodestablishment, located in the same state as a qualified facility or within 275 miles of thefacility, that is purchasing the food for sale directly to consumers at a restaurant or retail foodfacility.
  8. 8. Once deemed a “small or very small business”• These exempt facilities would have to either:1) document that they have identified the hazards associated with their facility and the food being produced there and have a monitoring program in place or2) demonstrate documented compliance with state and local requirements. Those facilities that rely on compliance with state and local requirements will also have to post a clear and conspicuous notice to consumers either on the label or at the point of purchase stating where the article was produced.• Farms that meet these thresholds would be required to display either on a label or a notice at the point of purchase the name and business address of the farm where the article was grown. The amendment specifically prohibits the FDA from requiring a new label for products produced at either facilities or farms that fall within the exemption. In the event that an exempt facility or farm is directly linked to an active investigation of foodborne illness or the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm or facility, the Secretary may withdraw the exemption.
  9. 9. Small and Very Small Businesses also receive different inspections• The Amendment also creates key limitations on the FDA‟s power with respect to inspection of small and very small businesses in two ways.1) First, it includes “direct sales,” such as those conducted at a roadside stand or farmer‟s market typically by small or very small producers, within the definition of “retail food establishment” created in the 2002 Bioterrorism Act regulations. The effect is that retail food establishments, which now include direct sales, are not required to register with the FDA.2) Further, the Amendment specifically states that nothing in the section regarding farm exemptions shall be construed to increase the FDA‟s inspection authority. Although much has been made of the issue of inspectors having access to farms, given that farms and facilities would still have to demonstrate either documented hazard analysis or documented compliance with state and local laws, some kind of inspection is still allowed by these authorities.
  10. 10. Fees• FSMA gives FDA the authority to assess and collect user fees in connection with certain aspects of FSMA (including those for costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections.• However, in recognition of the fact that fees could have a detrimental effect on certain small and very small food businesses, FDA1) Took comments on how to structure a fee schedule for small and very small businesses, and2) Provided for a means by which, in the interim, small businesses could seek reduced fees even before the official fee reductions are decided upon and published
  11. 11. Taking comments• In 2011, FDA announced the establishment of a docket to obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as set forth in FSMA.• The Agency sought public comment on what burdens these fees impose on small business, and whether and how the Agency should alleviate such burdens.• In particular, the Agency sought public comments on whether a reduction of fees or other consideration for small business is appropriate, and if so, what factors the Agency should consider for each.• In addition, the Agency sought public comment on how small business should be defined or recognized. FDA is establishing this docket in order to provide an opportunity for interested parties to provide data and share views that will inform future Agency actions with respect to these matters.• The docket has now closed, we will keep you posted on the results
  12. 12. Fees in the interim…FDA recognizes that for some small businesses the fullcost recovery of FDA reinspection or recall oversightcould impose severe economic hardship, and theremay be unique circumstances in which some reliefwould be appropriate.Thus, during FY 2012, FDA announced it would:• consider waiving in limited cases some or all of an invoiced fee based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors.• Nothing has been announced for 2013, but it is likely FDA‟s FY 2012 policy would be similar.
  13. 13. Produce• Much of FSMA deals with produce, however, under FSMA, 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.
  14. 14. Stay tuned as more information is published If you have specific questions about your CSA, please feel free to contact Kristina Hernandez, a Florida based attorney who works ininsurance and food law. She was also a volunteer on a CSA during her time in law school, House in the Woods CSA in Adamstown, MD.