Each year, according to the findings of a Center for Disease Control and Prevention study, 48 million people (1 in 6 Americans) get sick, 128,000 people are hospitalized, and 3,000 people die as the result of food-related diseases. Instead of reacting to this news on a yearly basis, the U.S. Food and Drug Administration (FDA) decided to do something about it (although not fast enough, some would say) by enacting the Food Safety Modernization Act (“FSMA”). This law, which went into effect on January 4, 2011, aims to protect public health and ensure food safety by placing a greater emphasis on prevention, compliance, and enforcement.

We’ve summarized the seven foundational rules of FSMA for you below. The compliance elements which food facility owner/operators, growers, suppliers, importers, consignees, carriers, and/or accreditation/certification bodies should, at a minimum, incorporate into their 2017 actions plans are highlighted in red (information regarding compliance deadlines for different size-based categories of business can be viewed here). Diaz Trade Law has extensive advising clients on FDA matters and welcomes the opportunity to help your company get FSMA compliant.   

Foundational Rule Key Requirements and/or Elements Applicable to Food Facilities, Growers, Suppliers, Importers, Consignees, Carriers, and/or Accreditation/Certification Bodies Compliance

Deadlines
Preventative Controls for Human Food cGMP standards (now explicitly applicable to foods posing allergen cross-contact issue)

Food Safety System with written Food Safety Plan:

A.       Hazard Analysis (biological, chemical, physical)

B.       Risk-based Preventative Controls (if hazard):

–          Take corrective action to minimize/prevent threat

–          Monitor/verify (possible product testing and environmental monitoring)

–          Supply chain program for raw materials and ingredients

–          Recall plan and record keeping

 General:

9/19/16

 

Small Business:

9/18/17

 

Very Small Business:

9/17/18

 

Caveats*
Preventative Controls for Animal Food cGMP standards

Food Safety System with written Food Safety Plan:

A.       Hazard Analysis (biological, chemical, physical)

B.       Risk-based Preventative Controls (if hazard):

–          Corrective action to minimize/prevent threat

–          Monitor/verify (possible product testing and environmental monitoring)

–          Supply chain program for raw materials and ingredients

–          Recall plan and record keeping

 General

9/19/16 (CGMP)

9/18/17 (PCAF)

 

Small Business:

9/18/17 (CGMP)

9/17/18 (PCAF)

 

Very Small Business:

9/17/18 (GCMP)

9/17/19 (PCAF)

 

Caveats*

 
Standards for Produce Safety Criteria for evaluating the microbial quality of water used for work tools/surfaces and food

–          Corrective action if contamination detected

Criteria for applying untreated biological soil amendments (manure)

Standards for treatment of soil amendments (composting)

Measures designed to reduce sprout contamination

–          Corrective action if contamination detected

Measures designed to manage grazing animals in such a way as to reduce the inadvertent contamination of growing areas

Measures deigned to combat the risk of contamination pursuant to the provision of health and hygiene training to farm workers

Measures deigned to avoid the inadvertent contamination of equipment, tools, and buildings

 General:

1/27/18

1/1/20 All produce types – all farms sizes are eligible for a qualified exemption requirement in 112.6(B)(1) (Label Statement)

 

Large Business

1/26/17 Sprouts

1/26/18 Large Farms except certain water requirements

1/1/20 remaining water requirements

1/26/22 non-sprout agricultural requirements

 

Small Business:

1/26/18 Eligible for qualified exemption to comply with other requirements in 112.6 and 112.7

1/26/18 Sprouts

1/28/19 Eligible for qualified exemption to comply with other requirements in 112.6 and 112.7

1/26/21 remaining water requirements

1/26/23 non-sprout agricultural requirements

 

Very Small Business:

1/1/20 Very Small Farms Except certain water requirements

1/26/22-remaining water requirements

1/26/24 non-sprout agricultural water requirements

 

Caveats**
Foreign Supplier Verification (“FSVP”) Programs Verification that foreign suppliers produce food in a manner that provides the same level of public health protection as the preventative control or produce safety regulations,

Ensure imported food is neither adulterated nor misbranded with respect to allergen labeling

Written procedures to ensure imported food comes only from previously approved suppliers

Verify, for each covered foreign supplier and imported food, the absence of biological, chemical, and/or physical hazards

–          If present, develop/implement control and/or take corrective action

 General

5/30/17

3/18/19 Importer of human food Grade “A” milk and milk Products

 

Large Business

5/30/17

3/19/18 -Importer of Animal Food

6-26/18 Required to comply with Produce

 

Safety Rule

3/18/19

 

Small Business

3/19/18 Importer of human/ Animal food comply with PCHF

6/26/18 Importer required to comply with sprout requirements

3/18/19 Importer Animal food

7/29/19 Importer required to comply with Produce Safety and or eligible for qualified exemption

7/27/20 Produce Safety and or eligible for qualified exemption

 

Very Small Business

3/18/19 Importer of Animal food / Human Food

7/29/19 Farm Producing sprouts and eligible for a qualified exemption under Produce Safety Rule and other sprout requirements

3/17/20 Importer of animal food

7-27-20 Produce Safety and or eligible for qualified exemption

 

Caveats***
Accredited Third Party Certification (“3CAP”) Voluntary program for the ISO/IEC-based accreditation of third party certification bodies (i.e., auditors) to conduct food safety audits and issue certifications of foreign facilities and the human/animal foods produced therein. Two types:

A.       FDA Recognized Accreditation Bodies (governmental or private sector)

B.       Third Party Certification Bodies (governmental or private sector)

–          Perform consultative or regulatory audits

–          Can be used by importers to establish eligibility for VQIP

Model Accreditation Standards

User fees for accreditation bodies

  

 

 

 

N/A

 

 

 

 

 

 

 

Caveats ****
Sanitary Transportation of Food Rules, standards, inspections, and record keeping requirements  to safeguard against contamination during motor or rail transportation both in the U.S. and abroad,

Vesting of primary responsibility for compliance with shipper, unless otherwise agreed

 General:

4/6/17

 

Small Business:

4/6/18

 

Very Small Business:

N/A
Mitigation Strategies to Protect Food Against Intentional Adulteration Preparation and implementation of food defense plan by domestic and foreign companies required to register with FDA as food facilities under the Federal food, drug, and cosmetic (FD&C) Act, with an eye to preventing intentional adulteration of food intended to harm public health (including acts of terrorism)

A.       Vulnerability assessment of all process steps for each food

B.       Mitigation strategies applicable to all process steps and for each food

–          Corrective action, if failure

–          Training and recordkeeping

 General:

7/26/19

 

Small Business:

7/26/20

 

Very Small Business:

7/26/21

* PC Human supply chain compliance deadline is 3/17/17 (general)/9/18/17 (small) or six months after supplier is required to comply with applicable rule. PC Animal supply chain compliance deadline is 9/18/17 (general)/9/17/18 (small) or six months after supplier is required to apply with applicable rule.

**Farms have additional two years to comply with certain water-related requirements. Separate compliance date for sprouts.

*** Very small importers and importers of food from very small suppliers are subject to modified requirements.

**** 3PAC provisions are effective as of the date of the final rule but cannot be implemented until the publication of the forthcoming Model Accreditation Standards.

These rules change the game, in a way that moves both compliance risk and enforcement potential to a whole new level, for the farms, ranches, facilities, logistics providers, and accreditation bodies that directly or indirectly comprise the US food industry.

The most crucial aspects of adapting to and managing this new reality entail (i) mastering the who, what, when, and where associated with the FSMA and (ii) developing and implementing the appropriate action(s). Based on our prior experience working with clients on FDA issues, the best advice we can provide entities coming within the scope of the FSMA is, as a matter of default operating orientation, to get the PICTURE:

“P” – Be Proactive – The FSMA shifts the compliance and enforcement paradigm from being reactive to being proactive. Don’t get caught flat-footed.

“I” – Stay Informed – The FSMA introduces new standards and practices and has lots of moving parts. There is already a lot of information out there, some of it good, some of it questionable. Identify and rely on trusted and experienced sources to help you navigate your company to a secure position.

“C” – Get Compliant – This is the heart of the FSMA. Write the plan and/or take the measures required for your company. If you find this confusing or overwhelming, retain the assistance of counsel with demonstrated FDA experience.

“T” – Train – The FSMA establishes extensive training opportunities. These are in addition to the wealth of educational resources and guidelines otherwise available on FDA websites. Use these to your advantage, in the spirit of reasonable care.

“U” – Use Good Judgment – The written compliance activities required of entities coming within the ambit of the FSMA can, to the extent they provide insight into company-specific procedures and practices, inadvertently create liability exposure. Be judicious in balancing compliance and confidential operating information. Always, as a hedge against undesired downstream FOIAs, characterize documents filed with the FDA as business proprietary. If you have doubts or questions in this regard, give us a call. We have the experience and knowledge to help.

“R” – Recordkeeping – It’s required. And knowing what’s required to keep could save you a lot of time and money down the road.

“E” – Embrace Technology – Whether video, GPS, water quality test kits, etc., there is an almost never-ending tide of technological applications that can be harnessed for the purpose of better ensuring your company’s compliance. It’s never been easier to work smart – and efficiently. Which goes a long way to avoiding costly issues with FDA.

In its fleshed out form, the FSMA is a far-reaching and complicated body of regulation whose standards and procedures should not be taken lightly. The dictates of prudent practice and reasonable care weigh in favor of retaining expert counsel. Let us know if you have any questions!

Updated on September 6, 2018.