Food Safety

Over the last 5 years the Almond Alliance has been a voice  for the almond industry with respect to advocating the  impact of  The  Food   Safety   Modernization Act (FSMA) rules.  This has included numerous activities including meetings, testifying at workshops, submitting multiple rounds of  comments and  co-hosting tours  at various  almond  operations  including  huller/shellers.  The  Alliance  was  part   of an almond industry delegation which met  with FDA  in June  2016 and  reiterated concerns over  the  challenges associated with implementation of the  final  rules. In October the Almond Alliance participated on an FDA tour hosted by the California Department of  Food  & Agriculture which included Stephen Ostroff, M.D., Deputy Commissioner for Foods  and  Veterinary Medicine,  who  replaced Mike  Taylor,  at Parreira  Almond Processing Company/RPAC.

There  were  several  major  areas of concern the  Almond Alliance had with the  final rules which were  highlighted with FDA.

  • Almond huller/shellers  are  performing  the   same  low   risk  harvest  activities regardless of  ownership and  should all  be  considered farms subject to the Produce Safety  rule. As of today they  can be considered a primary production farm, a secondary activities farm or  a facility due  to ownership requirements within the  farm definition. FDA  recently announced that they  are  considering revising the  farm definition  and  we  have  advocated  for an  activities  based approach versus an ownership approach as ownership does not  change  the risk of the activities being performed at a huller/sheller.
  • Almonds have a pasteurization program that serves as a definitive control point through the  handlers who  are subject to outgoing requirements of the  Federal Marketing Order and therefore should be eligible for the commercial processing exemption allowed under  the Produce Safety  rule.
  • There are challenges to meet the current written assurance  requirements for the commercial processing exemption which was discussed in detail with FDA.

FDA acknowledged our concerns, along  with those  of many  other industry groups, and is considering revising the farm definition, has extended some compliance deadlines, and  has released  draft guidance designed to help  businesses  comply with FSMA requirements. The Almond Alliance is working with the  Almond Board and  regulatory  counsel to interpret the  rules,  as well  as develop implementation training materials and tools.

Almond Alliance Participates in CDFA’s California Produce Tour for FDA

The California Department of Food and Agriculture (CDFA) hosted a three-day tour of the California Produce Industry October 11-13 for a number of Food and Drug Administration (FDA) officials including Stephen Ostroff, M.D., Deputy Commissioner for Foods and Veterinary Medicine, who replaced Mike Taylor. Additional FDA attendees included Jeff Farrar, Director of Intergovernmental Affairs and Partnerships, Barbara Cassens, Director at US Department of Health & Human Services, and Kathleen Lewis, Director, San Francisco District. Patrick Kennelly, Chief, Food Safety Section, with the California Department of Public Health, was also in attendance.

We’d like to thank CDFA’s Natalie Krout Greenberg, Director, Division of Inspection Services and Steve Patton, Branch Chief, Inspection and Compliance for inviting us to participate in their California Produce Tour.

We appreciate Paul Parreira, Paul Parreira Jr. and Chris Parreira for hosting the tour of both Parreira Almond Processing Company and RPAC,LLC.

During the tour the Almond Alliance highlighted the challenges of implementing the Food Safety Modernization Act (FSMA) rules as it relates to huller/shellers and Tim Birmingham, Quality Assurance and Industry Services with the Almond Board of California (ABC) provided an in depth overview of the almond industry pasteurization program.
There were several major areas of concern the Almond Alliance had with the final rules which were highlighted with FDA.

  • Almond huller/shellers are performing the same low risk harvest activities regardless of ownership and should all be considered farms subject to the Produce Safety Rule. As of today they can be considered a primary production farm, a secondary activities farm or a facility due to the ownership requirements within the farm definition. FDA recently announced that they are considering revising the farm definition and we have advocated for an activities based approach versus an ownership approach as ownership does not change the risk of the activities being performed at a huller/sheller.
  • Almonds have a pasteurization program that serves as a definitive control point through the handlers who are subject to outgoing requirements of the Federal Marketing Order and therefore should be eligible for the commercial processing exemption allowed under the Produce Safety rule.
  • There are challenges to meet the current written assurance requirements for the commercial processing exemption which was discussed in detail with FDA.

FDA acknowledged our concerns, along with those of many other industry groups, and is considering revising the farm definition. Additionally FDA has released draft guidance designed to help businesses in complying with the FSMA rules and has extended certain compliance dates.

The Almond Alliance will continue working with the ABC and regulatory counsel to interpret the rules, comment on FDA’s guidance documents and the farm definition if FDA does revise the farm definition as well as develop implementation training materials and tools.

FDA Releases Draft Guidance and Compliance Date Extensions

Over the last 5 years the Almond Alliance has been a voice for the almond industry with respect to advocating the impact of The Food Safety Modernization Act (FSMA) rules.  This has included numerous activities including meetings, testifying at workshops, submitting multiple rounds of comments and co-hosting tours at various almond operations including huller/shellers. The Alliance was part of an almond industry delegation which met with FDA in June and reiterated concerns over the challenges associated with implementation of the final rules.  Ongoing contact with the FDA has focused on recommendations to reconsider and to clarify some of the aspects of the final rules.

There were several major areas of concern the Alliance had with the final rules. FDA’s development of a secondary activities farm that is based on ownership was the primary concern voiced by the Alliance and others as this impacted intermediate harvest operations including huller/shellers, and in the produce industry packing houses, making it so that operations performing the same low risk harvest activities were subject to different rules and requirements.

Another major area of concern was the feasibility of utilizing the commercial processing exemption for the Produce Safety rule, as the final scope of the Produce Safety rule was expanded to include exports and also required written assurances from the party performing the “kill step”. With almond exports this would be virtually impossible to obtain, especially at the grower and huller/sheller level. The almond industry has gone to great lengths to mandate a pasteurization program under the Almond Board requirements which ensure food safety — and this should have been recognized by FDA in the final rules.

FDA acknowledged our concerns, along with those of many other industry groups, and has released draft guidance designed to help businesses in complying with the Preventive Controls for Human Food Rule and Animal Food Rules under FSMA, as well as certain compliance date extensions.

Draft Guidance Documents Open for Comment

The guidance documents are open for comment and the Alliance will be working with the Almond Board and regulatory counsel on drafting comments to these guidance documents.

Draft Guidance for Industry for Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities is aimed at helping food businesses determine which of the FSMA rules apply to their operations.

Draft Guidance for Industry #239 – Human Food By-Products for Use as Animal Food will assist facilities that manufacture, process, pack or hold human food and then subsequently provide the human food by-products for use as animal food in determining what requirements in the Preventive Controls for Animal Food rule apply to their human food by-product. Common examples of human food by-products used for animal food include wheat middlings, grain products from grain milling, and vegetable pulp.

FDA is planning on hosting a webinar later in September to discuss these draft guidances in more detail

FDA released 5 of 14 Chapters of a Draft Guidance document, titled, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.”

Compliance Deadlines Extended

Additionally, FDA announced compliance deadline extensions on certain aspects of four of the final rules. According to FDA, certain compliance dates have been extended to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the FSMA rules. It is also an important to note that the FDA is considering further refinement to the farm definition to address concerns over ownership requirements.

Extending compliance dates for certain provisions concerning written customer assurances  

  • All four rules contain “customer provisions” for modified requirements (or, in the case of the Produce Safety rule, an exemption) when food safety controls are applied downstream and certain conditions are satisfied. For example, the customer provisions in some of the rules allow a manufacturer/processor that does not control a hazard requiring a preventive control to rely on its customer to control the hazard.
  • The manufacturer/processor must disclose in documents accompanying the food that it is not processed to control the hazard and must obtain a written assurance from the customer that the customer will manufacture the food in accordance with applicable food safety requirements or sell only to someone that agrees to do so.
  • This final rule provides entities with an additional two years to comply with the customer assurance requirements while FDA considers the best approach to address feasibility concerns.
  • The compliance dates for these requirements are different for each rule, with the earliest date being September 19, 2018 for large human food facilities.

Extending compliance dates for facilities that only pack and/or hold raw agricultural commodities that are produce and/or nut hulls and shells

  • Compliance dates for facilities that are covered by the two Preventive Controls rules for human and animal food, including CGMPs, and are solely engaged in packing and/or holding produce raw agricultural commodities (for example, some packing houses) are extended to align with the compliance dates for farms conducting similar activities under the Produce Safety rule.
  • This extension includes facilities that hull, shell, pack and/or hold nuts.
  • The earliest compliance date is January 26, 2018.

Extending compliance dates for certain facilities that would qualify as secondary activities farms except for the ownership of the facility

  • The FDA is extending the compliance dates for operations that would be secondary activities farms except that they do not meet the ownership criterion in the definition of a secondary activities farm.
  • For example, some operations that might otherwise qualify as secondary activities farms own the primary production farm, rather than being owned by the primary production farm as currently required. Or they are not owned by (and do not own) the primary production farm but are majority owned by the same entity as the primary production farm.
  • The extension is applicable only to an operation satisfying all of the following requirements: (1) the operation is not located on a primary production farm; (2) the operation is devoted to harvesting, packing, and/or holding of raw agricultural commodities; and (3) the operation is under common ownership with the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested packed, and/or held by the operation.
  • FDA is considering future rulemaking to modify the definition of a farm in order to address ownership issues.
  • The earliest compliance date is January 26, 2018.
Disclaimer: This document is provided for informational purposes only and does not constitute legal advice. Almond Alliance of California does not advise on the application of law to an individual’s or company’s specific circumstances. Although we go to great lengths to make sure our information is accurate and useful, we recommend you consult a lawyer if you want professional assurance that our information, and your interpretation of it, is appropriate to your particular situation.
FSMA: Determining if Your Huller/Sheller is a Farm

The Food Safety Modernization Act (FSMA) rules are pretty clear for growers who will be subject to the Produce Safety Rule and for Handlers/Processors who will be subject to Preventive Controls for Human Food but for huller/shellers it’s going to be a mixed bag in terms of which rules apply. For huller/shellers the first step is to determine if you meet either definition of farm; if you meet either definition of farm you are subject to the Produce Safety Rule.

Primary Production Farm: Operation under one management in one general (but not necessarily contiguous) location devoted to the growing of crops, the harvesting of crops, the raising of animals, or any combination of these activities. In addition to these activities, may also pack or hold raw agricultural commodities (RACs).

Interpretation: If you own a huller/sheller on land that grows almonds you may meet the definition of primary production farm. We have asked FDA what constitutes “growing”? Can 7-10 trees qualify? The answer is that they will take a “reasonable approach”; so 10 trees would likely not qualify but if you have an acre that would likely be considered reasonable for meeting the requirement of “growing” a crop. FDA has also indicated that the produce grown on the primary production farm does not have to necessarily be the produce being hulled and shelled; you could grow walnuts on the land where your almond huller/sheller is located and still qualify as a farm. You should do a full assessment of all activities taking place in your operation to ensure that these activities don’t meet FDA’s definitions transforming a raw ag commodity into a processed food.

Secondary Activities Farm: is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.

Interpretation: If you own a huller/sheller that is not on land that is growing produce (off-farm) and over 50% of the almonds being hulled/shelled are owned by huller/sheller ownership you are secondary activities farm. This is going to allow for most if not all huller/sheller cooperatives to meet the definition of secondary activities farm. For non-cooperative huller/shellers your ability to meet the secondary activities will depend on the ownership of the product and operation and the activities taking place in your operation.

Click Here to view the latest presentation from FSMA regulatory counsel presented at the 2016 Almond Conference to assist in helping you determine if your huller/sheller is a farm and to ensure that you have considered activities that may qualify your operation as a mixed-type facility which would be subject to both Produce Safety and the registration requirements and aspects of the PC Rule for Human Food. You can also view FDA’s Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities: Guidance for Industry. 

If you determine that you are a huller/sheller meeting EITHER of these definitions, and are not engaged in activities that make you are mixed type facility you are subject to the Produce Safety Rule and can CANCEL your FDA Registration. When you cancel your registration it will ask for a comment as to why you are cancelling and you can reply: “We meet the primary production farm definition per the FSMA rules” or “We meet the secondary activities farm definition per the FSMA rules.”

THIS DOES NOT CHANGE THE FACT THAT YOU NEED TO REGISTER WITH THE CALIFORNIA DEPARTMENT OF PUBLIC HEALTH; HULLER/SHELLERS STILL NEED TO REGISTER WITH THE STATE.

If you determine your huller/sheller meets either farm definition you will also be exempt from Preventive Controls for Animal Feed. However, if you perform activities that FDA’s has determined is processing, such as grinding almond hulls or shells at the huller/sheller that is then shipped and used for animal feed, you will be subject to provisions of the Preventive Controls Rule for Animal Feed and will have to register with FDA.

Off-Farm Huller/shellers that do not meet either definition of farm will have to register their facility with FDA and will be required to be in compliance with some aspects of the Preventive Controls Rules for Human Food and Animal Feed. Each of the PC rules has a GMP component and a preventive controls and hazard analysis component (among other components). Hulling and shelling is exempt from GMPs of the PC for Human Food Rule but huller/shellers will have to have a food safety plan that includes preventive controls and hazard analysis. For the PC rule for animal food huller/shellers that have to register will have to comply with storage and distribution GMPs.

We will be working with the Almond Board and FSMA regulatory counsel to develop tools needed to be in compliance with these requirements however Almond Alliance’s current GMP guidelines and Almond Hull Quality Assurance Plan are a good starting point and gets industry a good portion of the way to where they need to be.

Off-Farm Huller/shellers who have to register will also need to have a Preventive Controls Qualified Individual trained to develop the food safety plan. PCQI training tailored to almond huller/shellers and handlers will be offered April 24-26 by the Almond Board of California. Contact staff@almondalliance.org to RSVP for the training

In addition to working with the California Department of Food & Ag (CDFA) on the PC rule for animal food we are currently working with CDFA on implementation of the Produce Safety Rule which will apply to growers and huller/shellers who meet either farm definition. We will keep our members apprised moving forward.

Disclaimer: This document is provided for informational purposes only and does not constitute legal advice. Almond Alliance does not advise on the application of law to an individual’s or company’s specific circumstances. Although we go to great lengths to make sure our information is accurate and useful, we recommend you consult a lawyer if you want professional assurance that our information, and your interpretation of it, is appropriate to your particular situation.

FSMA Supplemental Rules Released – Almond Industry Comments Heard!

On September 29th the Food and Drug Administration (FDA) released the re-proposals for four of the seven Food Safety Modernization Act (FSMA) rules, called “supplements”, which we are happy to report address a number of the concerns raised by the almond industry in the initial comment period. They aren’t perfect but they are certainly a step in the right direction. Comments on the supplements are due December 15th and must focus only on the areas contained in the supplements.

Almond Alliance and the Almond Board of California (ABC), through our memorandum of agreement, are in the process of reviewing, assessing, and developing comments on the supplements. As we did with the initial comment period, we are working with a number of other organizations including participation in United Fresh’s FSMA coalitions and seeking counsel from The Acheson Group.

FDA has made key revisions in the proposed supplements that address specific concerns voiced by Almond Alliance and the ABC during the initial comment period.  During a recent ABC Almond Quality & Food Safety Committee meeting a presentation was given by Jennifer McEntire, Ph.D, Vice President & Chief Scientific Officer with The Acheson Group providing details on the proposed modifications in the supplements and their potential impacts on the almond industry.

You may view The Acheson Group Presentation Here.

Farm Definition

For both the human and animal food rules FDA has revised their proposed definition of “farm”. The definition of farm and its implications on the rules is an area Almond Alliance commented heavily on due to the fact the huller/shellers will be subject to different requirements based on whether they meet the definition of farm or not. In the supplement, FDA will no longer differentiate between activities conducted by a farm on its own product versus activities conducted by that farm on products from another farm. Ultimately, this means that a farm would no longer be required to register as a food facility merely because it packs or holds raw agricultural commodities grown on another farm. Almond Alliance commented that the requirement to register as a food facility when performing low risk harvest activities on other farms raw ag commodities (RAC) was not risk based. This revised definition, acknowledges this fact and will possibly allow more huller/shellers to qualify as a farm under the FSMA rules. However, while the revised definition is better, it’s still not perfect. Questions still remain around the definition of farm specific to FDA’s requirement that the basic purpose of the farm is to produce RACs, and whether a huller/sheller meets that requirement if they aren’t physically on land that is producing a RAC.

Operations that meet the definition of farm may qualify for exemptions from or have modified requirements under the various FSMA rules. Additionally, revisions to the definitions of “covered activity”, “harvesting”, “holding” and “packing” have been made so that they can apply to operations meeting the newly proposed farm definition.

Grower Cooperatives

In Almond Alliance’s original comments we asked FDA how they view a grower cooperative relative to the definition of “farm”. FDA is seeking comment on whether “on-farm” packinghouses under cooperative ownership by multiple growers should be considered under the same ownership as any or all of the growers’ farms, for the purposes of this regulation. Almond Alliance supports cooperative ownership being considered under the same ownership as any or all of the growers’ farms, for the purposes of this regulation as cooperatives are performing the same low risk harvesting activities as an individual huller/sheller who may meet the proposed definition of farm.

Produce intended for commercial processing with a “kill step”

In the original proposed Produce Safety Rule FDA proposed allowing variances from requirements of the Produce Safety rule if a “State or a foreign country determines that…the procedures, processes and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated”. The ABC commented the same consideration for a variance should be given to produce that is subject to a pathogen reduction step under any U.S. government framework such as the mandatory pasteurization program for California almonds administered through the Federal Marketing Order overseen by USDA. FDA is acknowledging that produce intended for commercial processing with a “kill step” is exempt from Produce Safety however there are still some additional record keeping requirements to establish and keep documentation of the identity of the recipient of the covered produce that performs the commercial processing. This is an area which we may again repeat our comments, since the supplemental proposal did not include a listing of commodities that may/may not be excluded.

Water Testing & Manure Usage

Updates were made to the microbial quality standard for water that is used during growing of produce that use a direct application method to be consistent with EPA standards for recreational water. The updates also allow a farm to meet agricultural water testing requirements using the farms own test results or data collected by a third party.

FDA has removed the 9-month minimum application interval for use of raw manure and has indicated that more research is needed. They anticipate the research to take 5 years.

Human Food GMP Exemptions

In the supplement FDA has acknowledged the validity of their current exemption for establishments solely engaged in harvesting, storage, or distribution of one or more RACs. AHPA commented that the same or a similar exemption should be considered for the final preventive controls for human food rule.

FDA is proposing in the supplement that the same RAC exemption should apply to activities commonly

conducted on nuts at a facility that is not a farm or farm-mixed type facility by specifying that subpart B does not apply to hulling, shelling, and drying nuts (without manufacturing/processing, such as roasting nuts). Regardless of whether a huller/sheller ultimately ends up meeting the definition of farm or not, as proposed they will be exempt from GMPs. Logically, one would conclude that the exemption from GMPs, which are a pre-requisite for preventive controls, indicates that huller/shellers are also exempt from preventive controls for human food. We will be seeking clarification from FDA that this is in fact their intention. This is a huge shift in thinking from the original proposed rules, and a huge win for the almond industry.

Finished Product Testing For Human Food

In the supplement FDA has indicated that finished product testing will not be mandatory but rather it can be used to verify the adequacy of preventive controls if a facility determines it is appropriate. Furthermore, the economic analysis provided in the supplement indicates that FDA does not foresee many facilities using finished product testing.

Environmental Monitoring For Human Food

In the supplement FDA has proposed that environmental monitoring be required where post-process contamination is a significant hazard. This requirement will apply to almonds and facilities that are subject to the preventive controls for human food. As proposed, this will likely apply to almond handlers but will not apply to almond huller/shellers. Since FDA does not define what that monitoring should consist of, this is an area which ABC is likely to seek clarification given the fact that procedures for Environmental Monitoring have been developed specifically for the almond industry.

Preventive Controls for Animal Food

In the comments submitted by Almond Alliance for the initial proposed rule, we commented heavily that this rule should not apply to food facilities producing a by-product used as animal food (e.g. almond hull/shell) as there is no data to suggest there are known risks or benefits of these requirements.

FDA has heard our comments and as re-proposed in the supplement, human food operations that produce a by-product used as animal food that are subject to the human food rules under FSMA should not be subject to preventive controls for animal food.

If you meet the definition of farm, there is an exemption from the animal food rule. If an operation is subject to the preventive controls for human food there is now a section detailing basic GMP requirements for human food facilities that hold and distribute human food byproducts for animal food which are equivalent to those detailed in the animal food rule for storage and distribution. These are intended to mitigate risks of comingling with garbage, a physical hazard, and chemical hazards.

As with all FSMA rules the devil is in the details! Almond Alliance and the ABC will continue reviewing the rules and will work within our respective industry committees for comments and feedback. In addition, we will be watching to see what Guidance documents are developed in conjunction with the final FSMA regulations, since that is where FDA will provide more specific industry-related interpretation.