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US FDA Publishes Final Rules for cGMP and Preventive Control – Human and Animal Food

Photo: Human Food
Photo: Human Food

On September 17, 2015 the United States Food and Drug Administration (US FDA) published the final rules for the Current Good Manufacturing Practices (cGMPs) and Preventive Control for Human[1] and Animal[2] foods. These are the first two of the seven major Food Safety Modernization Act (FSMA) rules to be finalized.

To simplify this, these rules apply to all facilities that manufacture, process, pack or hold food in the United States (US) and into the US. cGMPs apply to all facilities that manufacture, process, pack and hold food. There are exemptions, as noted.

1. Preventive Controls and cGMPs for Human Food

Every facility must have a written food safety plan that includes hazard analysis, preventive controls, supply-chain program, recall plan, procedures for monitoring, corrective action procedures and verification procedures. Hazard analyses must consider known, or reasonably foreseeable, biological, chemical (including radiological) and physical hazards, whether natural, unintentionally introduced or intentionally introduced for economic gain. Preventive controls are process, food allergen, sanitation and supply chain controls with a recall plan. Verification will include the validation of preventive controls, the verification of monitoring and correction action, the calibration of verification monitoring and equipment, as well as product testing and environmental monitoring for items required, such as ready to eat foods, and record reviews. The food safety plan is to be revisited every three years, or more frequently if necessary. The supply chain program involves use of approved suppliers by the receiver, determining appropriate supplier verification procedures based on the hazards, then conducting and documenting the verification. This verification can be an on site audit, sampling and testing, or a review of the relevant food safety records. The verification activity, and its frequency, will be based on the hazard and on supplier performance.

Facilities storing unexposed food are exempt from preventive control requirements, except if time / temperature control monitoring is a requirement, corrective actions and verification of the temperature controls must be performed. Very small business, defined as operations with less than $1 million USD in sales of human food plus that food manufactured, processed, packed or held without sale, have modified preventive control requirements.

These very small businesses are to attest either that they meet these qualifications, which hazards have been identified and the preventive controls implemented and monitored, or that the facility is in compliance with non-federal food safety law.

Compliance dates:

  • Very small businesses and businesses subjected to the pasteurized milk ordinance – September 17, 2018
  • Small business (<500 full time equivalent employees) – September 17, 2017
  • All other businesses – September 17, 2016

Supply-Chain program compliance will be six months after the applicable rule involving the supplier.

cGMPs for allergen cross-contamination and those voluntary cGMPs, such as training and education, are now required.

2. Preventive Controls and cGMPs for Animal Food

There are now cGMPs for animal food operations, covering personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, holding and distribution, and the holding and distribution of human food by-products for use as animal foods. These are less strict in nature than the human food requirements and many are designated as “if necessary”. Requirement for training is a cGMP for animal food.

The preventive control requirements are the same as the human food program.

Facilities storing unexposed food are exempt from preventive control requirements, except if time / temperature control monitoring is a requirement, corrective actions and verification of the temperature controls must be performed. Very small business, defined as operations with less than $2.5 million USD in sales of animal food plus that food manufactured, processed, packed or held without sale, have modified preventive control requirements.

These very small businesses are to attest either that they meet these qualifications, which hazards have been identified and the preventive controls implemented and monitored, or that the facility is in compliance with non-federal food safety law.

Compliance dates for the preventive control part of the rule:

  • Very small businesses – September 17, 2019
  • Small business (<500 full time equivalent employees) – September 17, 2018
  • All other businesses September 17, 2017

Compliance dates for the cGMP part of the rule:

  • Very small businesses – September 17, 2018
  • Small business (<500 full time equivalent employees) – September 17, 2017
  • All other businesses – September 17, 2016

Supply chain program compliance will be six months after the applicable rule involving the supplier.

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, harvest 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 this 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.

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information please visit our website http://www.sgs.com/en/Agriculture-Food/Food.aspx.

Email SGS Hong Kong Ltd. at mktg.hk@sgs.com for enquiries or visit http://www.sgsgroup.com.hk/.

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[1] https://www.federalregister.gov/articles/2015/09/17/2015-21920/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human

[2] https://www.federalregister.gov/articles/2015/09/17/2015-21921/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-food-for-animals

Content provided by SGS Hong Kong Limited
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