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FDA Extends FSMA Compliance Dates; Issues Draft Guidance

In August, Food and Drug Administration (FDA) made three major Food Safety Modernization Act (FSMA) announcements as follows: FDA extended the compliance dates for certain provisions across four FSMA rules, which impact almond growers, huller/shellers, and handlers. Details of these extensions  can be found here and here. FDA released five of 14 chapters of a Draft Guidance document, titled, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.” FDA released a Draft Guidance document titled, “Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities: Guidance for Industry.” Guidance documents are often used by FDA to represent its current thinking on a topic or interpretation of a regulation, and to provide industry with useful information related to implementation and compliance. FDA is soliciting comments on these draft documents. The comment period will be open for 180 days from the date of publication, with comment periods ending on February 21, 2017, and February 22, 2017, respectively for the draft guidance documents listed above. Almond Board of California (ABC)  will be working with industry and the Almond Alliance of California (AAC) to draft and submit comments. According to FDA, certain compliance dates have been extended to address concerns about the practicality of compliance with certain provisions, to consider changes to the regulatory text, and to better align compliance dates across the FSMA rules. Numerous trade associations and industry groups, including ABC and AAC, have voiced concerns over implementation as well as how FDA has determined which facilities fall under the Produce Safety Rule, and which fall under the Preventive Controls Rule. It is encouraging to see FDA take industry input into consideration and extend the compliance periods in order to allow guidance document development. It is also an important development that FDA is considering further refinement of the farm definition; this was a significant concern raised by the almond industry since the implications were that some companies would be subject to the Produce Safety Rule, while another company engaged in the same activity would be subject to the Preventive Controls rule, simply due to ownership issues. A summary of key changes to compliance dates is shown below: *1Companies must still comply with original compliance date for Food Safety Plan and Preventive Controls. The compliance date has been extended by two years only for provisions concerning required written customer assurances. ABC is working with Hogan Lovells, our FSMA technical consultants, to better understand the compliance dates for different types of facilities in the almond industry, and will provide an update soon. Please contact Tim Birmingham by email, or phone him at (209) 343-3222 if you have questions.
Newsletter Item
// Government Affairs

New Task Force Explores Options for Productive Use of Biomass

Torrefied almond shells were added to these flower pots to test their ability to increase stability and heat resistance.Almond Board of California (ABC) is stepping up its efforts to identify more outlets for the productive use of almond by-products (hulls and shells) and woody biomass (prunings and whole trees) with investments in research, outreach policy and regulatory issues. At the same time, a new task force has been formed to advise on and oversee these efforts. The ABC Biomass Task Force is made up of technical experts in the field of biomass utilization and members of the California Almond industry. The Almond Board’s chief scientific officer, Karen Lapsley, D.Sc., is the staff representative to the new task force. The new Biomass Task Force met for the first time in October to discuss the status of both new and traditional ways of disposing of almond biomass, the collective term for both by-products and the woody material that result from tree prunings and whole-orchard removal. The task force was created because the industry recognized the need to coordinate and direct multiple areas of research already underway to find solutions that are feasible, sustainable and economically viable. The commitment by ABC to explore options and technologies and to invest in research is spurred by the growing amount of biomass resulting from larger crops in the face of shrinking markets for these materials. The California Almond industry generates about 2.5 million tons of dried biomass each crop year. With a downturn in the dairy industry, the market for hulls and shells has declined, and with the closing of cogeneration plants, the market for biomass from orchard removals is also reduced. Setting Priorities At its first meeting, task force members discussed the four priorities previously explored by ABC staff: Keep biomass in orchards. Send biomass to co-gen/next-gen processing. Investigate innovative feed uses, both for domestic consumption and for export. Explore the possibility of higher value-added and niche products and extracts. Whole-Orchard Recycling The first priority is being addressed by research that is looking at the effects of incorporating the biomass of an entire orchard on soil characteristics as well as the growth and productivity of second-generation almond trees planted in the orchard. This promising alternative has been studied by farm advisor Dr. Brent Holtz, San Joaquin County, for eight years. Supported by ABC’s Accelerated Innovation Management (AIM) program, Dr. Holtz’s ongoing research suggests that the breakdown of biomass in the soil from a whole-orchard removal results in increased organic matter, soil carbon, nutrients and microbial diversity, including beneficial fungi, as well as an increased water-holding capacity of the soil, which may be important in holding applied nutrients in the soil, thus preventing leaching into the groundwater. If ongoing studies continue to produce these results, growers will potentially save on both water and crop inputs, such as fertilizer and soil amendments. Research is also evaluating the possibility of recycling ground or composted pollinator hulls back to orchards to replace some nutrients that would otherwise be supplied by fertilizer. Hulls as Livestock Feed A highly nutritious feed for cows, almond hulls are still utilized by the dairy industry, but only about half the industry’s output of hulls is now included in dairy rations. Investigations by Almond Hullers and Processors Association (now Almond Alliance of California) suggest that dairy rations could include twice the amount of hulls currently being added. Moreover, the potential for inclusion of hulls in swine rations and other livestock species is being explored, as well as an export market for hulls as an animal feed. Value-Added Technology Of the many potential uses of by-products in various processes that were evaluated by the task force, the most promising is the use of torrefied almond shells to improve the properties of certain plastics, such as flowerpots. Torrefaction is a thermal process that converts biomass into a hardened substance. Working with a plastics company that markets packaging to the agricultural and food-packing industries, researchers with the USDA Agricultural Research Service, Western Regional Research Center, Albany, are investigating the use of torrefied almond shells to produce an ingredient for plastic packaging that potentially adds such properties as strength and heat resistance, and also creates a “green” label for the packaging products. Accelerated Innovation The Biomass Task Force is the second ABC task force to be created in recent years, following the Accelerated Innovation Managment Task Force, which was created in 2015. Both task forces are the result of changes in the conditions under which California produces, processes and markets almonds, and with an eye to the future of the industry. The Accelerated Innovation Management (AIM) Task Force advises and oversees the AIM initiatives program, which focuses on the innovative almond-farming practices that will be required to meet the future needs of the California Almond industry.
Newsletter Item
// About the Almond Board

FSMA Files: Straight Talk from the Experts, Part 2

We hope you’re enjoying our new monthly feature on the Food Safety Modernization Act! We’re back to provide another round of answers to those burning FSMA questions that we know are keeping you up at night. This month, we address the written assurance and written disclosure requirements under the Preventive Controls rule, when supplier verification is needed, and how a farm should respond if the Food and Drug Administration shows up to conduct a facility inspection. Please keep your questions coming! You can send them to Tim Birmingham at tbirmingham@almondboard.com with the subject line “FSMA Files.” Question: When does 21 C.F.R. §§ 117.136 in the Preventive Controls rule, which requires facilities to provide so-called “written disclosures” to and obtain “written assurances” from their customers, apply? Straight Talk: Typically, this provision will apply to handlers that are “facilities” and that do not pasteurize or otherwise treat the almonds they handle at their own facility, but rather send the almonds to a custom processor or a DV user for treatment. This is because you only need to comply with 21 C.F.R. §§ 117.136 if (1) you are a registered food facility and you engage in activities that require you to have a food safety plan for the foods you produce; and (2) rather than control a food safety hazard at your facility, you rely on your customer downstream to control the hazard. Explanation: The Preventive Controls rule only applies to registered food facilities that engage in certain activities. If you are a registered food facility and one of the exemptions from the rule does not apply, then you must identify potential food safety hazards that may occur with your product, and then put controls in place to prevent or mitigate the most serious hazards. The rule provides that when a manufacturer identifies a hazard requiring a preventive control, but it does not control the hazard and instead relies on an entity in its distribution chain to address the hazard, it must: Provide documentation to its direct customer that the food is “not processed to control [identified hazard]” (a “written disclosure”); and Annually obtain a written assurance from its customer that the customer is manufacturing, processing or preparing the food in accordance with the applicable food safety requirements, or will only sell the food to someone who agrees to do so. Keep in mind, however, that FDA has delayed the deadline for compliance with the “written assurance” component for two years, while it works to figure out ways to make the regulation more practical to implement. Therefore, facilities do not need to take steps to comply with the written assurance requirement at this time. (But the written disclosure requirement remains in effect). Alternatively, the regulation also provides that no written assurance or written disclosure is required in situations in which a hazard is controlled downstream if “you have established, documented and implemented a system that ensures control, at a subsequent distribution step, of the hazards in the food you distribute, and you document the implementation of that system.” With the mandatory program for reduction of Salmonella bacteria on almonds, sufficient controls and systems may already be in place, which would enable handlers to avoid additional written assurance requirements for microbiological pathogens. FDA has not yet issued guidance on the types of situations to which this provision applies or what such a system would look like. Almond Board of California (ABC) will be offering more guidance on this in the coming months. Finally, it’s important to recognize that there are a number of open questions about when and how the written disclosure and written assurance requirements apply. ABC has been engaged with FDA to adapt these requirements in a way that makes sense for the almond industry, and takes into account the mandatory pasteurization component of the marketing order. Question: Under what circumstances do I need to comply with Subpart G in the Preventive Controls rule and have a supplier verification program? Straight Talk: You need to have a supplier verification program when you are engaged in manufacturing or processing activities and you are relying on a supplier to control hazards in the materials you receive. For example, if you are making seasoned almonds and you receive pasteurized almonds and treated seasonings at your facility, you need to conduct supplier verification on your suppliers for those materials. Explanation: Subpart G – Supply-Chain Program in the Preventive Controls rule only applies to registered facilities that are engaged in manufacturing/processing activities that are covered by the rule. So your first step is to determine whether you are a “facility.” (If you are a “farm mixed-type facility,” you also need to determine whether the exemptions from the Preventive Controls rule for low-risk activities conducted on-farm apply to you. For example, if you are a farm mixed-type facility, meet the definition of a small business, and the only manufacturing/processing activity you conduct is making almond butter, then you are exempt from Preventive Controls, including Subpart G.) If you are a facility engaged in manufacturing/processing that is covered by the Preventive Controls rule, then your next step is to determine whether you rely on any of your suppliers to control food safety hazards in the ingredients, foods and materials you receive. For example, if you receive treated spices, or cheese powder to make seasoned almonds, then you likely rely on your suppliers to control food safety hazards in those foods. Likewise, if you rely upon a custom processor to pasteurize the almonds you receive, then you rely on the custom processor to control hazards in the almonds. In these circumstances, you will need to develop and implement a supply chain program to verify that your suppliers are in fact controlling the hazards in these foods. Question: What should a farm (including huller/shellers and brownskin almond handlers considered a primary or secondary farm) do if FDA shows up to perform a facility inspection? Straight Talk: If FDA seeks to perform a facility inspection on your farm, you should politely inform the inspector that you are a farm, rather than a facility, as those terms are now defined in FDA’s regulations. If you previously were registered with FDA but have recently canceled your registration, you should explain this, and also be prepared to tell the inspector why you canceled your registration. Explanation: FDA modified the “farm” and “facility” definitions as part of the FSMA rulemakings, so some operations that previously were part of FDA’s database and are on the list of operations to inspect as facilities now qualify as farms. (Conversely, be aware that some operations that previously were considered as farms may now be considered facilities.) If you have concluded that your operation is a farm, you should ensure that your operation is no longer registered with FDA through its online registration system. If FDA representatives arrive to inspect your operation, first ask them the purpose of their inspection. If FDA is inspecting for compliance with either of the regulations that apply to registered facilities (i.e., Good Manufacturing Practices and Preventive Controls), you can politely explain that your operation is a farm, rather than a facility, so it should not be inspected for compliance with those rules. Also, consider keeping a brief document explaining your farm’s reasoning for why you fall under the farm, rather than the facility, definition. You could use this as talking points with FDA if the need arises and it always is good to memorize your thinking. Bear in mind that after your Produce Safety rule compliance date (which could be as soon as January 26, 2018, for a large business), FDA may be making a visit to perform an inspection of your compliance with that rule. This column was prepared by Elizabeth Fawell and Maile Hermida, who are lawyers with Hogan Lovells US LLP in Washington, D.C. The FSMA Files column is provided for informational purposes only and does not constitute legal advice.
Newsletter Item
// Quality and Food Safety

The Almond Conference: Call for Papers

For the second time in The Almond Conference’s history, potential speakers may submit proposals to present at The Almond Conference in December on selected topics. Proposals are due by July 14 and will be considered on the following topics: Estate Planning Estate planning can be difficult, especially for farmers. To help make the process easier, this one-hour session should include high-level discussion on considerations and decisions needed for a business to survive into the future, and how those decisions may affect almond growers’ land, assets and family. Worker Safety Worker safety is a constant and never-ending concern for almond business owners and operators. This session may include components related to heat illness prevention, tractor or forklift operations, night worker safety, sexual harassment, etc. Regulatory updates and considerations almond growers or processors need to account for in their daily operations may also be a component of this session. Human Resources Topics may include hiring decisions, compliance with labor laws and employment standards, administration of employee benefits, recruitment and dismissal, etc. Labor Topics may include employment and safety (including but not limited to Cal/OSHA) laws and regulations, farm labor opportunities and constraints, and more. Succession Planning Thinking about the future of an almond operation is serious business; this session should focus on the thinking and decisions behind creating a shared vision for a family business and how to construct a plan to put that vision into action. Almond Food Safety This session should provide insight into the food safety landscape impacting almond handlers or growers, and may include topics covering consumer demands and food safety, regulatory considerations, novel approaches for pathogen control and/or application of science/technology in the food safety arena. By submitting a proposal, speakers are confirming that if selected, they have the necessary approvals, can travel to Sacramento and have the authority to present on the proposed topic. It is the speaker’s responsibility to obtain the necessary approvals from within their organization to speak about the topic outlined in the proposal prior to submitting. All selected speakers will be provided (1) free, all-access pass to The 2017 Almond Conference, being held December 5-7, 2017 at the Sacramento Convention Center. Presentations will be 60 minutes in length and includes any Q&A .Travel and hotel expenses are the responsibility of the speakers. Visit https://www.surveymonkey.com/r/AlmondConferenceSessionSubmission to submit a proposal before the Friday, July 14 deadline.  
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// About the Almond Board
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