U.S. FDA—FSMA Update July 2018

Food Safety Modernization Act

Most of the U.S. FDA rules under the Food Safety Modernization Act (FSMA) are finalized and compliance dates are in effect. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The law also provides the FDA with new enforcement authority designed to achieve stronger compliance and allow the FDA to better respond when problems occur. Imported food are now held to the same standards as foods produced in the United States.

Here, we provide a summary of several important deadlines and requirements.

  1. Registration and renewal of food facilities – (FFR)
  2. Preventive controls for human and animal food – (PCHF Rule)
  3. Foreign supplier verification programs – (FSVP Rule)
  4. Prevention of intentional adulteration of the food supply – (IA Rule)

FDA REGISTRATION AND RENEWAL PROCESS

As part of the registration process, facilities must consent electronically that FDA will be permitted to inspect the facility under circumstances permitted by the Federal Food, Drug and Cosmetic Act. When facilities receive notification of an FDA inspection, they must reply within 24-48 hours.

FSMA requires facilities to renew their FDA registrations during each even numbered year. Food facilities must renew their registration with the FDA between October 1 and December 31 2018. If a registration is not renewed by December 31, 2018, the registration will be removed by the FDA from the system and require a new registration. Foreign shipments to the United States may be refused entry if a food facility is not renewed prior to the deadline.

Register-FDA will renew your food facilities as part of our annual US Agent service. There is no need to pay an additional fee for this service. To ensure your facility is properly renewed, please ensure your account is paid-in-full by the invoice due date.

RULES ON PREVENTIVE CONTROLS FOR HUMAN AND ANIMAL FOOD

Preventive Controls Overview

Under this rule, food facilities are required to establish a hazard analysis and risk-based preventive controls plan (HARPC), also known as a food safety plan, that identifies and analyzes potential hazards and specifies risk-based preventive controls that minimize or prevent identified hazards. Each Food Safety Plan must be developed by a Preventive Controls Qualified Individual (PCQI), defined as “someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system (FDA.gov),” and must be kept in the records of a given food facility. The Food Safety Preventive Controls Alliance (FSPCA) offers in-person and online training that the FDA recognizes as meeting the PCQI requirement. Dates, locations, and languages can be found here.

Preventive Controls Deadlines

Compliance deadlines for most businesses have already passed. Very small businesses, defined as businesses with under 1 million dollars in average annual sales of human food or under 2.5 million dollars of average annual sales of animal have until September 17, 2018 to comply. Most food facilities that manufacture, process, pack, or store human or animal food for U.S. consumption must follow this rule.

Preventive Controls Enforcement and Requirements

Most U.S. food importers must verify that their foreign suppliers meet applicable FDA food safety requirements, including these Preventive Controls requirements and are requesting Food Safety Plans form their suppliers. During an FDA PCHF or PCAF inspection, auditors will also review a facility’s written Food Safety Plan.

Developing a Food Safety Plan can be complex and potentially time consuming. Although the FDA does not require a specific format for the Food Safety Plan, the FDA built a free online tool that links ingredients to known hazards and related preventive controls. It is prudent for food businesses to begin developing their plans as soon as possible. You can find the link to the FDA’s free Food Safety Plan builder here. If you need assistance, please contact one of our specialists at info@register-fda.com.

RULE ON FOREIGN SUPPLIER VERIFICATION PROGRAMS

Foreign Supplier Verification Program Overview

The Foreign Supplier Verification Program (FSVP) rule, requires U.S. importers must have a written FSVP plan developed by a qualified individual and documenting that the FSVP importer completed risk-based activities verifying that the food they import into the United States is produced in a manner that is consistent with U.S. safety standards. FSVPs must include an analysis of hazards associated with imported products and their suppliers and a plan for conducting verification activities, such as annual supplier audits, testing and sampling imported products, or reviewing a supplier’s PCHF Food Safety Plan. Importers are also required to monitor and document the FDA compliance status of each of their suppliers by reviewing FDA warning letters, import alerts relating to food safety, and other FDA enforcement actions.

Foreign Supplier Verification Program Deadlines

Importers’ deadlines are based on factors such as the size of a foreign supplier, the nature of the importer, and whether the foreign supplier must meet various regulatory requirements. The deadlines for complying with this rule passed for most importers in May 2017 and March 2018. There are a few importer categories that have compliance dates between now and July 2020.

Foreign Supplier Verification Program Enforcement and Compliance

FDA has begun inspecting importers for FSVP compliance. FSVP inspections are based upon a review of records. Though such inspections may take place at an importer’s place of business, FDA may also ask that an importer provide FSVP records electronically or by some other remote means that quickly delivers records to the agency.

Please contact a specialist at info@register-fda.com to learn more about FSVP and how we can assist you in meeting your importers’ requirements.

RULE FOR MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION

Intentional Adulteration Overview

Under this rule, most food facilities that are required to register with FDA must develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility. Food Defense Plans should identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification to prevent acts that are intended to cause wide-scale harm.

Intentional Adulteration Deadlines

Most covered facilities must comply with FDA’s Intentional Adulteration rule by May 27, 2019. Small businesses (defined as businesses with fewer than 500 full-time equivalent employees) must comply by May 27, 2020. Very small businesses (businesses with less than $10,000,000 in average annual revenue) are exempt from most requirements under FDA’s Intentional Adulteration rule. In qualify for this exemption, businesses must provide records to FDA proving their very small business status by May 27, 2021.

Small Entity Compliance Guide (SECG)

Small Entity Compliance Guidance for Human and Animal Food facility registrations issued by FDA, May 25, 2018

The U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The SECG explains which types of food facilities are required to register with the FDA, when and how to register. The guide also outlines the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. Note that it is the food facility that must be registered, not related trading companies. Continue reading

Foreign Supplier Verification Program Rule – May 2018

Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA) rule on Foreign Supplier Verification Programs (FSVP) requires a U.S. importer of food to develop, maintain, and follow a Foreign Supplier Verification Program for Importers of Food for Humans and Animals (FSVP) (80 FR 74225) to ensure that each food it imports meets FDA food safety standards.

Who is covered?

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US Agent & Registration Information for Food Facilities

When a food company wants to export food products to the United States, they must first register with the U.S. FDA. All food facilities that engage in manufacturing/processing, packing, or holding of food for human or animal consumption in the U.S. If food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted, the food will be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food. Trading companies that do not come into contact with the food do not need to be registered. Continue reading

Accredited Third-Party Certification Program

The FDA named ANSI-ASQ National Accreditation Board as the first recognized accreditation body under the Accredited Third-Party Certification Program. Accredited Third-Party Certification is a voluntary program in which FDA recognizes “accreditation bodies” that will have the responsibility of accrediting third-party “certification bodies.” The certification bodies will conduct food safety audits and issue certifications of foreign food facilities.

These certifications will help eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food.
The Agency’s imported food goal is to address potential safety issues before the food reaches the United States and ensure that imported foods are produced in accordance with the same safety standards as those required of U.S. foods.

For more information, visit the FDA’s site.