10 Things You Need to Know about FSMA Right Now

    Posted by Chelsey Davis on May 1, 2015 4:23:36 PM

    10 Things You Need to Know about FSMA

    The implementation of the FDA's Food Safety Modernization Act (FSMA) is happening whether you’re prepared or not. In April, the FDA held a public meeting regarding FSMA’s implementation and rollout plan, outlining the details and deadlines for key components of the new law. As of today, here are 10 things you need to know.

    1. Preventive Controls for Human Food

    The Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food proposed rule covers most facilities that manufacturer, process, pack, or hold food for consumption in the U.S., and may also apply to other establishments such as warehouses and distribution centers. View the summary of key revisions.

    Final Rule Deadline: August 30, 2015

    Compliance Deadlines:

    • Very Small Business (a business with less than $1 million in total annual sales of human food): Three years after the publication of the final rule.
    • Small Business (a business that employs fewer than 500 persons): Two years after publication of the final rule.
    • Other Businesses (doesn’t fit into either descriptions above): One year after publication of the final rule.

    2. Preventive Controls for Animal Food

    This rule is very similar to the proposed rule for human food in that it hold facilities that manufacture, process, pack or hold animal feed and pet food to equal processing standards. View the summary of key revisions.

    Final Rule Deadline: August 30, 2015

    Compliance Deadlines:

    • Very Small Business (a business having less than $2.5 million in total annual sales of animal food): Three years after the publication of the final rule.
    • Small Business (a business that employs fewer than 500 persons): Two years after publication of the final rule.
    • Other Businesses (doesn’t fit into either descriptions above): One year after publication of the final rule.

    3. Produce Safety Rule

    This rule helps to establish standards for safe production and harvesting of fruits and vegetables, and includes standards for naturally occurring hazards, as well as those that might be introduced intentionally or unintentionally. View the summary of key revisions.

    Final Rule Deadline: October 31, 2015

    Compliance Deadlines:

    • Very Small Business (a business earning $25,000-$250,000 in annual produce sales): Four years after the effective date of the final rule.
    • Small Business (a business earning $250,000-$500,000 in annual produce sales): Three years after the effective date of the final rule.
    • All Other Farms (doesn’t fit into either descriptions above): Two years after the effective date of the final rule.
    • The compliance dates for water quality standards, and related testing and recordkeeping provisions would be an additional two years beyond the compliance dates for the rest of the final rule.

    4. Foreign Supplier Verification Program (FSVP)

    FSVP provides greater oversight into the products coming into the U.S. to ensure that “importers would be required to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food producers.”

    Generally, the FDA is asking who has financial stake to ensure the food coming in will be up to the standards that the FDA expects. If you are the U.S. owner or co-signing at the time of entry, you are the importer for purposes of this rule. If there is no owner or co-signer at the time of entry, then the FDA will look at the U.S. agent or representative for the foreign owner of co-signer.

    Final Rule Deadline: October 31, 2015

    Compliance: In general, the compliance date would be 18 months after publication of the final FSVP regulations. There would be some exceptions.

    What are the 7 components or activities that must happen for a successful Foreign Supplier Verification Program?

    5. Third-Party Certification

    This rule will be used to ensure that accredited third-party auditors and certification bodies help to improve the overall safety of food by decreasing the likelihood of harmful food reaching U.S consumers.  Read the full description.

    Final Rule Deadline: October 31, 2015

    Compliance: The FDA plans to implement this program as soon as possible after the publication of the final rule.

    6. Sanitary Transportation of Human and Animal Food

    This rule would “help maintain the safety of both human and animal food during transportation by establishing criteria, e.g., conditions and practices, training and record keeping, for the sanitary transportation of food.” Read the full description.

    Final Rule Deadline: March 31, 2016

    Compliance Deadlines:

    • Small Businesses (businesses employing fewer than 500 persons and motor carriers having less than $25.5 million in annual receipts): Two years after the publication of the final rule.
    • Other Businesses (doesn’t fit into the description above): One year after the publication of the final rule.

    7. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

    This rule will help to protect against the intentional adulteration of food, and will require facilities to implement mitigation strategies to prepare and protect the food supply chain at specific vulnerable points. Read the full description.

    Final Rule Deadline: May 31, 2016

    Compliance Deadlines:

    • Very Small Business (a business earning less than 10,000,000 in annual sales): Three years after the publication of the final rule.
    • Small Business (a business employing fewer than 500 persons): Two years after the publication of the final rule.
    • Other Businesses (doesn’t fit into either descriptions above): One year after publication of the final rule.

    8. Fees

    The FDA announced its fee rates for fiscal year (FY) 2015 for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections, authorized by the Food, Drug, and Cosmetic Act (FD&C Act), as amended by FSMA.

    The fees will remain in effect until September 30, 2015. According to the FDA's announcement, the FDA will use the following rates when charging fees in FY 2015:

    • Hourly rate if domestic travel is required: $217
    • Hourly rate if foreign travel is required: $305

    More information can be found on the FSMA Fees page of the FDA’s website.

    9. FSMA Implementation Funding

    After this latest outbreak of Listeria, it’s pretty apparent that the additional funding needed to properly implement FSMA is crucial to the safety of our food supply going forward. Earlier this year, President Obama requested an additional $109.5 million from Congress to successfully implement FSMA and keep the momentum going. However, even with the request, the total amount needed to implement FSMA correctly is estimated at $580 million and this additional funding will still only put the FDA halfway there.  

    10. Enforcement

    To enforce the rules, the FDA will use a combined approach of traditional and private litigation. Traditional practices may include a partnership with the border control on import issues, making sure that foreign ingredients and foreign products are coming in compliant with the provisions to the FSVP and to the specific rules to that particular product. The main mechanism for enforcement for this rule and any other rules is not through the FDA, however. Due to the sheer volume of products coming in to the United States, both foreign and domestic, the FDA does not have the resources to monitor them all.

    “The design and mechanism for FSMA is to be enforced by private litigation. So we will see FSMA enforced through a combination of traditional practices, such as warning letters, as well as through third-party, private litigation,” FDA attorney, Marc Sanchez advised.

    Additional Resources:

     

    Tags: FSMA