The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of food safety laws in more than 70 years. Almond processors are required to comply with FSMA rules, as relevant to each part of the operation. 

Almond processors and some huller/shellers are covered by Preventive Controls (PC) for human food, which went into effect September 2016 for large operations. Covered operations must establish and implement a food safety system that includes an analysis of hazards and implementation of risk-based preventive controls. 

Depending on the nature of your operations, additional FSMA rules may apply to you, such as Preventive Controls for Animal Food, Sanitary Transportation of Human and Animal Food, Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals and Intentional Adulteration.

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The California Almond industry is committed to producing a safe, high-quality product. The Almond Board of California’s Almond Quality and Food Safety Committee examines issues affecting quality and safety, funds quality and safety research, and makes recommendations on how the industry can improve in its efforts to supply safe and nutritious food worldwide.

To assist almond processors in establishing the highest standards of food safety practices, a Good Management Practices (GMPs) guide is available for download. These practices meet the minimum sanitary and processing requirements. The GMPs contained within the guide have been written and organized with reference to the U.S. FDA Good Manufacturing Practices Regulations, Code of Federal Regulations (21 CFR 110).


Stockpiled almonds can be a food safety risk if not properly managed. The combination of the moisture in the crop and the condensation that occurs under tarps favors the growth of Aspergillus mold, which produces aflatoxins.

The orientation and shape of the almond stockpile can help minimize the risk of Aspergillus mold growth, as can these additional practices:

  • Place stockpiles on a firm surface, preferably one that is slightly raised to encourage moisture to run off rather than puddle around the edges.
  • Orient the long axis of piles from north to south as much as possible. Condensation and mold growth tend to be worse on the north side of piles when the long axis is oriented from east to west.
  • Smooth the tops of the piles to help minimize the concentration of moisture from condensation.
  • Use a white-on-black tarp, which is best at minimizing temperature fluctuations that lead to condensation and mold growth. Clear tarps allow the highest temperature fluctuations, but may be used on dry, in-hull product. White is intermediate between clear and white-on-black.
  • If piles are stacked too wet, open up the tarps in the daytime, when the relative humidity is lower, and close them at night, when the relative humidity is high.
  • Monitor relative humidity (rH)  during the storage period, paying particular attention to the outside of piles, where there can be significant temperature fluctuations, condensation on tarps and moisture accumulation. If the total fruit (in-hull almond) moisture is more than 9%, the rH may exceed 65% in the pile, which is the maximum rH  acceptable for almond storage.

In addition, stockpiled almonds should be kept in a storage area that is maintained to ensure cleanliness. Monitor regularly to keep pests away from stockpiled almonds.

Additional Stockpile Resources:


One of the leading concerns for the almond industry is the risk of pathogen contamination, particularly for Salmonella spp., which can occur in all stages of production and handling. An effective way to reduce the risk of product contamination within the almond production environment is with the implementation of a Pathogen Environmental Monitoring (PEM) program.

The Almond Board of California has developed a PEM manual also available in Spanish that outlines the tools and steps for planning and implementing such a program.

The first of the seven Hazard Analysis and Critical Control Point (HACCP) principles states that a hazard analysis must be conducted to assess the food safety hazards that are reasonably likely to occur and that must be controlled in order to produce a safe product. Since history has shown that Salmonella spp. are a reasonably likely food safety hazard, it is critical that an almond facility’s HACCP plan identifies, assesses, and seeks to control and mitigate that risk.

Additional available resources for implementing a PEM program include a PEM Go-to Guide (also available in Spanish) and a PEM DVD.


Hazard Analysis and Critical Control Point (HACCP) and Critical Control Points (CCPs)

In 1995, the National Advisory Committee on Microbiological Criteria for Foods convened a working group to review the HACCP document from November 1992. Comparing it to the HACCP guidance from the Codex Committee on Food Hygiene, the committee made the HACCP principles more concise; revised and added definitions; included sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan; revised and provided a more detailed explanation of the application of HACCP principles; and provided an additional decision tree for identifying critical control points (CCPs).

The HACCP Manual from the Food and Drug Administration is available for more information. Additionally, the Almond Board of California has made available an HACCP form that outlines the seven principles of HACCP. It also provides a sample process flow chart and worksheet, as well as a form to outline a unique HACCP plan. There is also a Sanitation Standard Operating Procedures (SSOP) form  available that outlines appropriate steps to take when cleaning equipment.


The health and safety of consumers is the No. 1 priority of the California Almond industry. The Almond Board of California, working with the U.S. Department of Agriculture (USDA) and food safety experts, has established an industry-wide food safety program. Food safety practices begin in the orchard and continue through almond storage, transportation and processing. Pasteurization is the final step before shipping California Almonds to customers.

The Processes

There are several pasteurization treatment processes that reduce the level of potential contamination in almonds without diminishing the product’s quality, nutritional value or sensory qualities (taste and crunch). They have all been evaluated and approved by the Food and Drug Administration (FDA), along with a technical review panel.

Oil roasting, dry roasting and blanching. These traditional processes have been shown to provide the required reduction in the level of potential contamination.

Steam processing. A short burst of steam treats the surface of the nutmeat only. This process meets USDA National Organic Program standards, and does not diminish the nutritional value and sensory attributes of almonds.

Propylene oxide (PPO). This is a surface treatment that rapidly dissipates after treatment. It is very effective at reducing potential contamination, and does not alter the nutritional and sensory characteristics of almonds.

Validation Guidelines

Considerations for Proprietary Processes for Almond Pasteurization and Treatment, v1.0, April 13, 2007

Guidelines for Using Enterococcus faecium NRRL B-2354 as a Surrogate Microorganism in Almond Process Validation

Guidelines for Validation of Blanching Processes, v1.0, April 13, 2007  

Guidelines for Validation of Dry Roasting Processes, v1.2, October 23, 2007  

Guidelines for Validation of Oil Roasting Processes, v1.0, April 13, 2007 

Guidelines for Validation of Propylene Oxide Pasteurization, v3.0, October 1, 2008

Guidelines for Validation of Propylene Oxide Treatment for In-shell Almonds, v2.0, October 1, 2008


Aflatoxins are naturally occurring chemicals produced by certain molds, mainly Aspergillus flavus and A. parasiticus. The main health concern of aflatoxins is their potential carcinogenicity. Chronic exposure to aflatoxins can increase the risk of developing liver cancer.

Aflatoxin-producing molds are common in nature, affecting a number of crops. In almonds, the source of the contamination is from the soil, previously infested almonds (mummy nuts), and navel orangeworm (NOW) or other pests. Spores of the molds can be transferred by NOW and grow on nutmeats that have been damaged. Favorable conditions for mold growth include high moisture content and high temperatures.

Because they are a carcinogen, tolerances for aflatoxins have been established by certain countries to reduce risk of exposure. When almonds are tested in the lab for aflatoxins and are found to have levels above the allowable limits by country, the consignment will have to be reconditioned or rejected, with significant monetary losses to the grower and handler.

Preventing Aflatoxins

The almond industry has programs and procedures in place to minimize aflatoxins at every stage of production — not just in response to sampling, testing and processing, but also focusing on the orchard environment, where aflatoxin contamination begins and where it must be addressed.

Growers can reduce the potential for aflatoxin growth by minimizing navel orangeworm (NOW) damage.

NOW prevention can be accomplished by:

  • Winter sanitation. The removal of mummy nuts — those that remain on the tree after harvest — before budswell, on or by Feb. 1. Mummy nuts are the prime harborage of overwintering NOW, and their removal is the most effective control method. After removal, they should be destroyed by March 15.
  • Early harvest. When almonds are harvested as soon as possible after they mature and are promptly removed from the orchard, a third generation of egg-laying is avoided.
  • Stockpile management. When in-hull almonds are stockpiled, moisture in the almonds combined with hot weather creates a breeding ground for the Aspergillus mold to grow and produce aflatoxins. Following Good Agricultural Practices will help prevent the growth of molds.
  • In-season treatment. If winter sanitation and early-harvest guidelines are followed, an in-season treatment for NOW may not be necessary. A harvest sample can help determine if treatments are required.

Complete NOW management guidelines, including treatment options, can be found on the Web at the UC IPM website.

With NOW damage to kernels minimized in the orchard, the California Almond industry can continue to provide high-quality product to all markets, and with increased surveillance for aflatoxin by handlers, key export markets that have tolerances are assured a high-quality product that meets their standards.

Aflatoxins and Market Ramifications

Because they are a carcinogen, tolerances for aflatoxins have been established to reduce risk of exposure. When almonds are tested in the lab for aflatoxins and are found to have levels above the allowable limits, the consignment has to be reprocessed or rejected, with significant monetary losses to the grower and handler.


Pre Export Checks (PEC)
One of the largest markets for California Almonds — the European Union (EU) — also has one of the lowest allowable limits for aflatoxin contamination on almonds, currently 10 ppb total, with 8 ppb B1. Increased rejections of California Almond consignments led to additional import monitoring in the EU. As of Sept. 1, 2007, the EU implemented Special Measures, which called for mandatory testing of California Almonds imported to EU member countries.  
The California Almond industry developed the Voluntary Aflatoxin Sampling Plan (VASP) which utilized comparable EU sampling protocols and testing procedures at USDA-approved laboratories prior to shipment. These procedures were considered to provide sufficient assurances such that almonds shipped with a VASP certificate were subject to approximately 5% testing upon import into Europe, whereas without a VASP certificate, almonds were subject to 100% control.
Due to the success the VASP Program, the EU took California Almonds off of Special Measures in September 2014. The California Almond industry was then able to transition to Pre Export Checks (PEC) and build upon the successful legacy of the VASP program. EU Regulation 2015/949 was published on June 19, 2015 which directs EU port authorities to subject U.S. almond consignments with a PEC certificate to less than 1% controls at the border. The PEC program was enacted for shipments to the EU after August 1, 2015. Being a voluntary program, a PEC certificate is not a requirement for import into the EU.
California Almond handlers who ship consignments classified under CN codes 0802.11 and 0802.12 for bulk inshell and shelled lots to the European Union (EU) under the PEC Program are required to sign an annual Memorandum of Understanding (MOU) with the Almond Board of California (ABC). Along with a signed current MOU, PEC participants are given a PEC Program Manual and are trained in how to use the ePEC system by ABC staff. Additionally, all PEC participates are subjected to ABC and USDA oversight to ensure program conformance.

USDA-Approved Labs for PEC Program

PEC analyses must be conducted by a USDA-approved laboratory. Only USDA-approved laboratories are authorized to input results into a PEC analysis certificate.

The participating labs have been evaluated and approved by the U.S. Department of Agriculture, Agricultural Marketing Service, Science and Laboratories Program.

View list of approved USDA labs.

PEC Addendum Letter

The Pre-Export Check (PEC) certificate program has been a tremendous success since its inception on August 1, 2015. Though we have experienced success, there has been one reoccurring minor issue, international contact information in box I.6 Person responsible for the consignment in the EU.  The Almond Board of California (ABC) understands that this information may not always be available at the time the PEC certificate is signed off by the USDA. Once the USDA signs off on the PEC certificate, it is considered permanent and cannot be adjusted.  This has caused the PEC certificate to be sent forward with box I.6 vacant. Several consignments have experienced delays at customs upon arrival due to and empty box I.6.

To mitigate this problem, ABC created the PEC addendum letter. The letter can be sent outside the PEC system as an addition to the PEC certificate. Information on the letter looks very similar to the PEC certificate but only contains the relevant fields.  Please note that this will not replace the aflatoxin analysis or Annex II (USDA signature page.)  Feedback from our European partners, government officials, local port authorities and Foreign Agricultural Service (FAS) offices have all been positive.

The new addendum letter can be downloaded here (PDF). [Note: Right-click to save the PDF to your desktop and use Adobe Acrobat to open it. This file will not preview in your internet browser.] Only fields highlighted in blue must be filled out by the shipping party (handler, trader, broker, etc.) This is a standardized letter; it needs to be consistent among suppliers. The format and wording should not be changed to avoid confusion among the import authorities. Again, the shipper only needs to fill out the blue highlighted areas.

If you have additional questions please feel free to contact Beth Van Meter (evanmeter@almondboard.com) or Julie Adams (jadams@almondboard.com).

Allergen Control

Minimizing cross contamination of allergens is an important part of overall food safety and quality. Tree nuts are among the eight most allergenic foods responsible for 90% of food allergies.

Even if an individual is not allergic to almonds, he or she may be allergic to other types of nuts. Therefore, it is very important for handlers to ensure that no other nuts — even in small amounts — are processed with or come in contact with almonds. Whenever possible, other nuts should not be processed in almond plants or with almond-processing equipment unless specific safeguards are in place to prevent cross contamination. For a complete guide to controlling allergens, review the Good Manufacturing Practices Manual’s section on allergens.

Food allergies involve an abnormal response of the immune system to naturally occurring proteins in certain foods that most individuals can eat safely. Due to numerous consumer complaints, a new food labeling law was established in 2006 — the Food Allergen Labeling and Consumer Protection Act (FALCPA).

Under FALCPA, food labels are required to clearly state if the food contains a “major food allergen,” which is identified as any ingredient that contains a protein derived from these eight foods: milk; eggs; fish; crustacean shellfish; tree nuts such as almonds, walnuts and pecans; peanuts; wheat; and soybeans.

Food manufacturers must comply with the law by identifying in plain English on their product labels the food source of any ingredient that is, or contains, protein from those eight foods listed above. FALCPA also requires manufacturers to identify the type of tree nut.

Manufacturers are also responsible for ensuring that food is not misrepresented or misbranded as a result of the presence of undeclared allergens. Handlers and manufacturers must be sure that allergens are not added intentionally to food, but not declared on the label; or may be unintentionally introduced into a food product and consequently not declared on the label. This introduction may be caused by the use of common equipment or other manufacturing processes. Manufacturers must identify and implement controls to prevent potential allergen cross-contact. 

Pesticide MRLs

Pesticide usage in the U.S. is highly regulated by the Environmental Protection Agency (EPA). It often takes EPA as long as two years to complete a full review of a new compound, and 18 months to complete the review of new uses for compounds that are already registered.

In the U.S., almonds are only produced in California, which requires additional review and approval of pesticides by the California Department of Pesticide Regulation. In some cases, CDPR requirements are stricter than EPA requirements.

The state of California also requires monthly reports from growers who use pesticides, detailing a list of pesticides applied, to which crops, the number of acres treated, the name of the compounds and the number of pounds applied. However, pesticides can only be applied by a licensed individual.

While pesticide regulations are closely monitored, there is an allowable level of pesticides in or on food, called tolerances in the United States and maximum residue limits (MRLs) globally. Only foods that meet these tolerances can be placed in the market. Globally, some customers are paying careful attention to the types of pesticides used in almond production, as well as the maximum residue limits.

The International Maximum Residue Limit Database provides a list of MRL tolerances by active ingredient and export market. The Almond Board of California provides data and background information to USDA and export markets to ensure pesticides used in almond production are approved for use. ABC also provides similar information to Codex Alimentarius, which sets international standards for food production.




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