The Food Safety Modernization act (FSMA) was signed into law on January 4, 2011 and while some sections of the law came into force immediately it wasn’t until September and November of 2015 that five of the core regulations were finalized. A further two core rules, the Sanitary Transportation and Intentional Adulteration rules, will be finalized on March 31 and May 31 2016, respectively.

Current Good Manufacturing Practices (cGMPs) and Preventive Control Rules

The two cGMP and preventive control final rules, one for humans and the other for animal foods, were published on September 17, 2015. The cGMP rules for humans were updated to add mandatory employee training, replaced the word must with shall, removed those items that were voluntary or made them mandatory, and required allergen cross-contact controls. The cGMP rules for animal foods were created for the first time. These rules were developed for the animal food industry, rather than leaving companies to simply apply the human cGMPs to an animal food facility. These rules also require mandatory employee training in food safety and hygiene. Compliance to these rules is one to three years, company revenue or employee numbers dependent, from publication of the final rule.

The preventive controls part of the rules requires the industry to re-evaluate food safety plans for an additional hazard, radiological, and to determine preventive control points in addition to the already established Critical Control Points (CCPs). Many of these preventive controls will involve changing food safety systems from HACCP to Hazard Analysis Risked-Based Preventive Control (HARPC). The human food industry has one to three years to comply with this rule from the date of publication, and the animal food industry has two to four years to comply. Both are dependent on the revenue or number of employees. The exception will be the supply-chain part of the preventive control rule, for which the compliance date is six months after the supplier’s cGMP and preventive control or produce safety compliance date.

The personnel who develop and verify these new HARPC food safety programs must have the knowledge and experience to perform this, or take an approved US FDA course that has been developed, for the human food business, by the Food Safety Preventive Control Alliance (FSPCA). This course is 20 hours long, has no prerequisites or tests but must be taught by an instructor that has been through the FSCPA lead instructor course. They do recommend personnel taking this course have knowledge of cGMPs and HACCP.

Operations Not Covered by the Preventive Control Rules

These rules do not apply to farms (primary production and secondary activities) and retail establishments. A primary production farm is an operation under one management, in one general location which raises crops, harvests crops and/or raises animals. These farms can pack, or hold, raw agriculture commodities (RACs) of theirs, or others. They can manufacture/process, pack or hold processed food so long as all such foods are consumed on the farm, another farm of the same management, or if the manufacturing processing falls into limited categories. A secondary activities farm is not located on a primary production farm, but is devoted to harvesting, packing and/or holding RACs. The primary production farm (or farms) that grow, harvest and/or raise the majority of the RACs must own, or jointly own, a majority interest in the secondary farm activities. There are some exemptions and modified requirements for certain facilities.

Other Exemptions and Modified Requirements for Preventive Control Rules

Seafood and juice facilities that adhere to the HACCP regulations, those involved in the manufacturing, processing, packing and holding of dietary supplements and/or alcoholic beverages at certain facilities are exempt. Low acid canned food, for microbiological hazards only, is exempt as those regulations already cover this hazard. Grain elevators and warehouses that store only RACs intended for further distribution or processing are also exempt.

There are modified requirements for qualified facilities, such as very small businesses, for facilities that only store packaged foods that are not exposed to the environment, and modified requirements for certain human food by-products used for animal foods.

Operations Not Covered by the cGMPs

For human food, the cGMPs do not apply to farms, fishing vessels that don’t require registration, solely holding and/or transporting RACs, and establishments solely engaged in the shelling, drying, packing and/or holding of nuts without additional manufacturing or processing. For animal food, they do not apply to farms that don’t have to register, solely holding and/or transporting RACs, and establishments solely engaged in the shelling, drying, packing and/or holding of nuts without additional manufacturing or processing, and those solely engaged in ginning of cotton without manufacturing or processing.

On November 27, 2015 three more rules were finalized which include the Produce Safety rule, Foreign Supplier Verification Program (FSVP) and the accredited third party certification rule.

Produce Safety Rule

This rule covers raw fruits and vegetables including nuts, with some exemptions and variances. For the produce rule there are six major sections that apply to all produce; agricultural water, biological soil amendments, domesticated and wild animals, worker training and health and hygiene and equipment, tools and buildings, growing, harvesting, packing and holding activities, and one requirement section that applies to sprouts. A majority of the elements in this rule are standard practices for safe produce but some of the practices, such as the agricultural water requirement, will have more impact than others.

Agricultural Water

No detectable level of generic E. coli would be allowed in water used for hand washing, food contact surface application, ice that is applied directly to produce and for sprout irrigation, so untreated surface water will not be allowable for these purposes. If positive E. coli is found, water is to be immediately discontinued for these uses and corrective actions must be taken before the water can be used for any of these purposes.

For water applied directly to produce other than sprouts, the generic E. coli amount is to be a geometric mean of 126 or less CFU/100 ml, with a maximum level of 410 CFU/100 ml. If criteria are not met, corrective action is to be taken as soon as possible, but no later than the following year. Farmers using non-compliant water will have three options. Treat the water, allow time for microbes to die off in the field, or allow time for microbes to die off between harvest and end storage or through washing.

Exemptions and Compliance Dates

The exemptions are; produce that is not a raw agricultural commodity, produce rarely consumed raw (as per the US FDA item list), food grains, produce used for personal or on-farm consumption and farms with a three year average value of produce sales of less than $25,000 USD.

Except for sprouts, compliance dates will be two to four years from the date of publication dependent on produce revenue, except for the water quality standards testing and record keeping requirements, which are an additional two years beyond the compliance dates for the rest of the rule. Sprout growers will have one to three years, dependent on their size, to comply with the regulations, with no additional time to meet the water requirements.

Foreign Supplier Verification Program (FSVP)

This rule applies to all importers of human and animal foods, and additives, including food packaging and other food contact materials, into the United States. Importers will be responsible for determining known or reasonably foreseeable hazards with each food. Importers must evaluate the risk of each food, based on hazard analysis and the foreign supplier’s performance. Based on this information, the importer is to approve the suppliers and establish the appropriate supplier verification activities. The importer is responsible for conducting supplier verification activities and for the corrective actions for any non-conformance of these activities. These procedures must be documented and be followed by the importer. FSVP programs will be specific to each food and supplier. This program must be re-evaluated every three years, or when new information about a hazard or the supplier’s performance is made known.

Exemptions and Modified Standards

Importers of dietary supplements and/or ingredients may be required to comply with most of the FSVP requirements, excluding the hazard analysis, but the verification procedure would require evaluation of the facility’s compliance to the dietary supplement cGMP regulations. There are modified requirements for certain foods from foreign suppliers from countries which have an equivalent program, as determined by the US FDA. There are modified requirements for very small importers whose sales ceiling is $1 million USD for human food, and $2.5 million for animal food. Importers for certain types of small supplier will also have modified requirements. These firms are qualified facilities as per the preventive control rules or produce rule, farms not covered by the produce rule and shell egg producers with fewer than 3,000 laying hens.

Exempt from the FSVP are juice, fish and fishery products (all subjected to HACCP regulations), as well as food for research or evaluation, food for personal consumption, alcoholic beverages and certain ingredients used in them. Also exempt is food imported for processing and future export, low acid canned food regarding microbial hazards, and certain meat, poultry and egg products as regulated by the United States Department of Agriculture Food Safety Inspection Service.

Compliance Dates

The importer must comply with whichever is the latest compliance date, which is 18 months from date of publication (May 27, 2017), or 6 months after the supplier is required to comply with the preventive control rule or produce safety rule. If the importer is also a manufacturer or processor that is to adhere to the supply-chain part of the preventive control rule, instead of the FSVP, then the date required by the rule is the compliance date of the supply-chain rule.

Accredited Third Party Certification

Certifications produced by this program can be used by foreign entities for participation in the Voluntary Qualified Importer Program (VQIP) and to prevent harmful produce being imported into the US. The US FDA has the option to require specific foods being imported into the US to be accompanied by a certificate produced through this program. While not required, this certification can be used for the supply-chain program or for the FSVP on-site audit verification.

As per this rule, accreditation bodies can apply to the US FDA to be reviewed and approved. Once an accredited body is approved, then certification bodies (auditors) can apply to be reviewed and approved by the accreditation body.

Certification bodies will be allowed to perform two types of audit, consultative and regulatory. The consultative audit is a gap assessment of compliance to the regulatory standard, and standard industry practices. The regulatory audit is for compliance and certification. Before this program can be implemented the US FDA proposed user fees must be finalized.

Sanitary Transportation of Food and Feed

This rule applies to shippers, carriers, and receivers who transport food that will be consumed or be transported throughout the United States (US). This rule applies to those same companies outside the US in regards to food and feed being exported to the US. This rule will not apply to the transportation of pre-packaged shelf stable foods, live animals and raw agricultural commodities when transported by farms.

The concentration of this rule is to prevent practices that create food safety risks, such as the failure to properly refrigerate foods, inadequate cleaning between loads and failure to protect food during transportation.

Compliance dates will be two years after the final rule is published for small businesses, which are those employing less than 500 people or for carriers having less than $25.5 million in annual receipts, and one year after the final rule is published for all other businesses.

Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

This proposed rule applies to both domestic and foreign facilities that manufacture, process, pack or hold food and are required to register with the US FDA. The following facilities/operations are exempted; farms, alcoholic beverages under certain conditions, feed for animals, holding foods except foods in liquid storage tanks and the packing, repacking, labeling or relabeling of food where the container that contacts the food remains intact. Very small businesses – those with less than $10 million in total annual sales – are exempt, but they require documentation to prove it.

The US FDA has identified four key activities of concern for intentional adulteration: bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling and mixing and similar activities.

Facilities with any of these activities or other qualified operations would have to perform a vulnerability assessment of the operation. Facilities need to identify the process points/steps that mitigation strategies would reduce the risk of intentional adulteration and to create a written food defence plan. The latter must include the actionable process steps to reduce intentional adulteration, the focused mitigation strategies, monitoring, correction actions, verification, training and record keeping at these steps.

Compliance dates will be three years after the final rule is published for very small businesses, two years after the final rule is published for small businesses (a business with less than 500 people) and one year after the final rule is published for all other businesses.

Based on the other rule finalization it is unlikely that these two proposed rules will be finalized exactly as proposed. Even with two rules yet to be finalised, based on the current compliance dates of all the rules, some companies will be required to comply with cGMP or part of the Preventive Control rule by September 19, 2016. For others, it is possible that full compliance with some parts of these rules, such as the water requirements in the produce rule, will not take place until almost 2022. In all areas and for all companies, there is a lot of work to be accomplished between now and the compliance deadlines.

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For more information contact:

Jim Cook
Global Food Inspection Technical Manager
Food Scientific and Regulatory Affairs Manager
t: +01 973-461-1493