Background and overview

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final and compliance dates are set. 

The following are the deadlines for compliance.


General Compliance Period
(business must meet applicable definition under each regulation) 

Rule

Publication
Of Final Rule

Requirements

Deadline

Preventive Controls for Human Food

9-17-15

1 year from final rule**

9-19-16

Preventive Controls for Animal Feed

9-17-15

1 year from final rule (cGMP), 2 years

for PC**

9-19-16 (cGMP)

9-18-17 (PC)

Produce Safety

11-27-15

2 years from effective date*

1-26-18

Foreign Supplier Verification Program

11-27-15

18 months from final rule†

5-30-17

3rd Party Accreditation and Certification

11-27-15

After Model Accreditation Standards‡

-

Sanitary Transportation

4-06-16

1 year from final rule

4-06-17

Food Defense

5-27-16

3 years from effective date

7-26-19



Small Business Compliance Period
(business must meet applicable definition under each regulation)

Rule

Publication Of Final Rule

Requirements

Deadline

Preventive Controls for Human Food

9-17-15

2 years from final rule**

9-18-17

Preventive Controls for Animal Feed

9-17-15

2 years from final rule (cGMP), 3 years for

PC**

9-18-17 (cGMP)

9-17-18 (PC)

Produce Safety

11-27-15

3 years from effective date*§

1-26-19

Foreign Supplier Verification Program

11-27-15

18 months from final rule†

5-30-17

3rd Party Accreditation and Certification

11-27-15

N/A

N/A

Sanitary Transportation

4-06-16

2 years from final rule

4-06-18

Food Defense

5-27-16

4 years from effective date

7-26-20

 

 

Very Small Business Compliance Period (business must meet applicable definition under each regulation)

Rule

Publication Of Final Rule

Requirements

Deadline

PC Human Food

9-17-15

3 years from final rule§

9-17-18

PC Animal Feed

9-17-15

3 years from final rule (cGMP), 4 years for PC§

9-17-18 (cGMP)

9-17-19 (PC

Produce Safety

11-27-15

4 years from effective date*§

1-26-20

FSVP

11-27-15

18 months from final rule†

5-30-17

3PAC

11-27-15

N/A

N/A

Sanitary Transportation

4-06-16

N/A

N/A

Food Defense

5-27-16

5 years from effective date (modified requirements)

7-26-21

 

*Farms have an additional 2 years to comply with certain water-related requirements. Separate compliance date applicable to sprouts.

**PC Human: Supply Chain Program general compliance is (1) 3-17-17 (9-18-17 for small business) OR (2) six months after a supplier is required to comply with the applicable rule. PC Animal: Supply Chain Program general compliance is (1) 9-18-17 (9-17-18 for small business) OR (2) six months after a supplier is required to comply with the applicable rule.

†All importers must comply with FSVP requirements by 5-30-17 OR 6 months after their foreign suppliers’ reach their FSMA compliance deadlines, whichever is later. “Very small importers” and “importers of food from very small foreign suppliers” are subject to modified requirements.

‡ 3PAC’s provisions are effective immediately following the final rule, but can only be implemented after publication of Model Accreditation Standards, which are yet to be released by the FDA.

  • Modified compliance date for qualified facilities to retain records supporting their status.

 

Disclaimer: This document is provided for informational purposes only and does not constitute legal advice. CUC 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.

 

These final rules are the product of an unprecedented level of outreach by the US FDA to industry, consumer groups, the agency’s federal, state, local and tribal regulatory counterparts, academia and other stakeholders.

IMPORTERS in the US: FSMA applies to both US importers as the Foreign Supplier Verification Program (FSVP) requires importers to verify that the goods they import into the US meet safety standards by using a risk-based assessment. Control Union has developed a platform which clients can use to monitor, import, maintain and assess supplier’s readiness to comply with FSMA.

EXPORTERS to the US: FSMA applies to facilities that grow, manufacture, process, pack or hold food for humans or animal food. Produce farms, shippers, receivers, loaders and carriers who transport food in the US are also subject to compliance.

EXEMPTIONS:  Certain products are except from FSMA as they are already covered in other regulations. These include: Low-acid canned foods, Juice and Seafood. For further reference please refer to https://www.fda.gov/food/newsevents/constituentupdates/ucm569554.htm.