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Registrar Corp Debuts Version 2.0 of FSMA Compliance Tool, the FDA Compliance Monitor

FDA FSMA Compliance Monitoring

Registrar Corp’s FDA Compliance Monitor, the food industry’s leading FSMA compliance tool, has been upgraded.  The new simplified layout and optimized backend drive user efficiency, making compliance with FDA’s supplier monitoring requirements easier than ever.

On the front end, users now see a series of compact rows that display an overview of supplier compliance; these rows can be further expanded to review detailed company data for each supplier.  Best of all, the system is more than 10x faster than before.

The new features are immediately available to all users at no additional cost.  Want to experience the new Monitor for yourself?  Join our free webinar walkthrough or schedule a 1-on-1 demo today.

 

What’s Next for the Monitor?

The recent redesign lays the foundation for additional features that will further automate compliance as well as increase user productivity.  The next set of rollouts will include:

  • Validation of FDA Registration Numbers
  • A repository for requesting and storing HACCP and HARPC Food Safety Plans as well as other documentation for supplier compliance
  • Enterprise integration capabilities

“We are constantly exploring ways to innovate the Monitor,” says Brendon Sampson, Manager of Registrar Corp’s FDA Compliance Monitor Department.  “User feedback is integral to delivering actionable and practical features.  We anticipate significant growth in implementing future developments.”

 

About the Monitor

Registrar Corp developed the FDA Compliance Monitor to assist companies with supply-chain monitoring requirements under the U.S. Food and Drug Administration (FDA) Preventive Controls and Foreign Supplier Verification Program (FSVP) rules.  The Monitor aggregates and supplements data from five FDA databases to supply comprehensive, up-to-date compliance reports on all FDA-regulated companies.  To verify and document suppliers’ FDA compliance, businesses can easily monitor their suppliers for:

  • FDA Inspection Classifications
  • Warning Letters
  • Import Alerts
  • Import Refusals
  • Recalls

In addition to monthly compliance reports, the Monitor automatically sends users email alerts whenever the published FDA compliance status of a supplier changes.

To learn more about how Registrar Corp’s FDA Compliance Monitor can help simplify compliance with FDA monitoring requirements, join our free webinar walkthrough on January 23.  Alternatively, you can schedule a demo or call us at +1-757-224-0177.

FDA FY 2018 Inspection Observations: 278 U.S. Importers Cited for FSVP Violations

The U.S. Food and Drug Administration (FDA) recently released its Fiscal Year (FY) 2018 Inspection Observation Data.  The data aggregates violations documented during FDA inspections from October 2017 through September 2018.  During this period, FDA cited 278 U.S. importers of food and beverages for not developing Foreign Supplier Verification Programs (FSVP), making it the most frequent inspection violation of FY 2018. This article provides an overview of what these FSVP violations mean for industry as well as the other five most commonly cited violations this year.

FSVP Violations

As of March 19, 2018, most food importers are required to develop FSVPs for their foreign suppliers and monitor their suppliers’ FDA compliance statuses.  After the first FSVP deadline in May 2017, FDA cited 108 importers for not developing FSVPs during FY 2017 inspections.  FSVP’s prominence on this year’s list of violations suggests that FDA is regularly inspecting importers for compliance.

Importers should be prepared for FDA to examine their FSVP records and verify that they are properly monitoring their suppliers.  Non-compliance with FSVP regulations may result in civil penalties.

Registrar Corp’s Qualified Individuals can assist by developing your FSVPs or reviewing your current programs for compliance.  Additionally, Registrar Corp’s FDA Compliance Monitor simplifies supplier monitoring by continuously tracking your suppliers’ FDA compliance and issuing monthly reports that support FSVP documentation requirements.  Schedule a demo to learn more.

Top Five Food Facility Violations

FDA cited registered food facilities for a variety of food safety issues this year.  Below are the top five most common food safety violations discovered by FDA in FY 2018:

  • Sanitation Monitoring – FDA cited 188 facilities for not properly monitoring sanitation conditions and practices with sufficient frequency. Facilities are required to monitor aspects such as the safety of water coming into contact with food or food contact surfaces, prevention of cross-contamination, and maintenance of hygiene facilities.
  • Pest Control – FDA cited 183 facilities for not properly excluding pests from potentially contaminating food.
  • Manufacturing, Processing, Packing, and Holding Controls – FDA cited 175 facilities for not implementing proper controls to mitigate the risk of food hazards, such as growth of microorganisms, allergen cross-contact, and contamination of food.
  • Sanitary Operations and Plant Maintenance – FDA cited 167 facilities for either not maintaining cleanliness of their facilities or not keeping them in good repair.
  • Personnel – FDA cited 161 facilities for not taking reasonable measures and precautions related to personnel. These may include failing to address hygiene and cleanliness of staff working in direct contact with food.

Food facilities should ensure compliance with the above and other good manufacturing practices.  Food safety violations discovered during an inspection may result in FDA enforcement such as Warning Letters, Import Refusals, or Import Alerts.  These compliance issues can damage a brand’s reputation and often influence the buying decisions of purchasers.

To prepare your facility for an FDA inspection, Registrar Corp can dispatch a Food Safety Specialist to conduct a Mock FDA Inspection.  Our experts will identify potential food safety issues and educate facility staff on FDA expectations during an inspection.

Preventive Controls Violations

While no individual violation of the FDA Preventive Controls rules made it to the top of the list, violations of Preventive Controls requirements in FY 2018 total 396 when combined.  These include issues such as not having a Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plan, not identifying a hazard that requires a preventive control in a HARPC Plan, not utilizing a Preventive Controls Qualified Individual (PCQI) to prepare or oversee a HARPC Plan, not implementing adequate procedures for monitoring sanitation or allergen controls, and more.

The deadlines for most facilities to comply with Preventive Controls requirements have passed, and these violations are evidence that FDA is actively inspecting facilities for compliance with the rules.  Facilities should familiarize themselves with Preventive Controls regulations to ensure they are properly accounting for all HARPC requirements and any differences from other food safety systems they may be using to draft their HARPC plans.

Alternatively, Registrar Corp’s PCQI Food Safety Specialists can assist by developing a HARPC Plan for your facility or reviewing your current plan for compliance.

For assistance with FDA food safety regulations, call Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

2018 In Review: A Year of FSMA Firsts

With most compliance deadlines having passed under the Food Safety Modernization Act (FSMA) and new requirements on the horizon, 2018 proved to be a busy year for the U.S. Food and Drug Administration (FDA).  See some of this year’s regulatory highlights below.

The Second Compliance Deadline Passed Under the Foreign Supplier Verification Program (FSVP) Rule

As of March 19, 2018, most U.S. importers of food and beverages must implement FSVPs for their foreign suppliers and monitor their suppliers’ FDA compliance statuses as required by the FSVP rule.  FDA has been regularly inspecting importers for FSVP compliance since the first deadline passed in May 2017 and cited 278 importers in Fiscal Year (FY) 2018 for failing to develop FSVPs.

FDA Issues First Mandatory Recall Under FSMA

In April 2018, FDA ordered a mandatory recall of food containing powdered kratom from Triangle Pharmanaturals LLC after the Agency discovered salmonella in four separate samples.  FSMA grants FDA the authority to require a recall when there is reasonable probability a food is adulterated or poses a serious risk to public health.  FDA ordered the mandatory recall after Triangle Pharmanaturals did not cooperate with a request to voluntarily recall their kratom products.

FDA Permits 8 New Non-digestible Carbohydrates to be Declared Dietary Fiber

Under the Revision of the Nutrition and Supplement Facts Label final rule, isolated or synthetic non-digestible carbohydrates may only be declared as “dietary fiber” on a food label if FDA determines they have a physiological benefit.  This excludes many carbohydrates commonly listed as fiber from being declared, effectively limiting certain labels’ abilities to make nutrient content or health claims.

After reviewing petitions and scientific literature on twenty-six carbohydrates, FDA intends to exercise enforcement discretion when any of eight additional fibers are declared on a label’s dietary fiber declaration.

The First Qualified Facility Attestation Deadline Passed On December 17, 2018

Under the Preventive Controls for Human Food rule, “Qualified Facilities” receive exemption from certain food safety requirements, such as the development of Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans and Supply-Chain Programs.

To take advantage of these exemptions for 2019 through 2020, most facilities were required to submit a Qualified Facility Attestation to FDA between October 1 and December 17, 2018.  A facility may be eligible to submit an attestation if it averaged less than $1,000,000 in global food sales plus the market value of unsold food inventory during the previous three years.

Facilities that did not submit an attestation prior to December 17, 2018 may be subject to the full requirements of the Preventive Controls rule.

The First Voluntary Qualified Importer Program (VQIP) Application Period Began October 1, 2018

VQIP allows eligible U.S. importers to pay an annual fee for expedited review and release of foods specified in an approved VQIP application.  FDA began accepting applications for VQIP on October 1, 2018.  To participate in VQIP, eligible importers must submit an application and pay an estimated $16,400 upon application approval.  VQIP benefits for approved importers who have paid the fee will begin on October 1, 2019.

FDA Began Collecting Fees for Food Export Certificates

As of October 2018, FDA changed the export certificate program for food.  U.S. exporters may now request a Certificate to Foreign Government or Certificate of Exportability for their food or beverage.  FDA charges a fee of $175 for the first certificate of either type, $155 for a copy, and $100 for subsequent copies of the same certificate.

Registrar Corp will continue to keep the food industry updated as we move into 2019 and encounter more changes to the FDA regulatory landscape.  For assistance with FDA regulations, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

Frequently Asked Fridays: Differentiating Between Statement and Standard of Identity

The U.S. Food and Drug Administration (FDA) requires all food, beverage, and dietary supplement labels to bear declarations called “statements of identity.”  Companies attempting to comply with this requirement will likely encounter a similar term called “standard of identity.” The two are closely related, and understanding what must be included in a statement of identity may depend upon knowledge of the standard.

What is a Standard of Identity?

A “standard of identity” defines properties, features, and specific labeling requirements to which a food product must conform in order to be identified by a specific name.  At a minimum, a standard of identity provides a description of the food’s basic nature and the name that should be used to identify it.  It may also include aspects such as optional ingredients included in the food and different forms in which the food may be prepared.

Standards of identity often reflect traditional consumer understanding and expectations of what constitutes a particular food. They are often implemented in response to situations of fraud and consumer deception. To date, FDA has established almost 300 standards of identity, many dating back to the early and mid-20th century.

For example, 21 CFR 169.150 contains the standard of identity for “salad dressing.”  Per the standard, in order to be labeled as “salad dressing”, a product must be an emulsified, semisolid food composed of at least 30% vegetable oil that contains an acidifying ingredient (e.g. vinegar or lemon juice), an egg yolk-containing ingredient, and a starchy paste prepared from specific starches or flours.  Salad dressing may also contain certain optional ingredients such as salt, spices, and citric acid, some of which have additional requirements and restrictions.

Standards of identity have recently come to the regulatory forefront due to pressure by the dairy industry for FDA to enforce the standard for “milk” on plant-based products that do not conform to the standard, such as soy milk and almond milk. FDA Commissioner Scott Gottlieb M.D. has made public statements asserting the agency’s intent to “modernize” the standards to reflect new understandings of nutrition and encourage innovation in the food industry.

What is a Statement of Identity?

A “statement of identity” is a declaration of a food’s name that must be displayed on the principal display panel (PDP) of its label.  FDA regulations establish a hierarchy regarding the naming of foods:

  1. If a food conforms to a standard of identity, then the name specified in the standard serves as the product’s statement of identity.
  2. If the product is not subject to a standard of identity, the statement of identity should be the common or usual name of the food (e.g. “crackers,” “cookies”).
  3. In the absence of a common name, the statement may use an appropriately descriptive or, if the nature of the food is obvious, a fanciful name commonly understood by the public.

Some foods may have alternate naming requirements established in separate regulations, guidance documents, or Compliance Policy Guides (CPGs).  For example, a CPG for Asian-style noodles determines that these foods may not be labeled solely as “noodles,” as they do not conform to that standard of identity.  However, the CPG permits the statement of identity to contain “noodles” if preceded by qualifying terms such as “Chinese,” “Chow Mein,” “Japanese,” or “Ramen.”

Similarly, FDA has established a CPG that allows for the labeling of foods as “chocolate” in defiance of the standard if the food contains cocoa as the flavoring ingredient and the food is one that consumers do not expect to contain a chocolate ingredient (e.g. chocolate pudding).  Other regulations impose restrictions on non-standardized foods such as peanut spreads, breaded shrimp, fish sticks, and juice blends.

Complying with FDA Statement and Standard of Identity Requirements

FDA requires a statement of identity to be prominently displayed in bold type.  It must be “in a size reasonably related to the most prominent printed matter” on all PDPs and “generally parallel to the base on which the package rests…” A product that fails to bear a compliant statement of identity is considered “misbranded.”

Additionally, a food marketed as a product that has a standard of identity but does not conform to that standard is also considered misbranded. For example, FDA issued a warning letter to Hampton Creek Foods, Inc. in 2015 for marketing a product as “mayo” that didn’t meet FDA’s standard of identity for mayonnaise.  Marketing misbranded food products in the U.S. is a prohibited act that may be met detention, refusal, and other regulatory action.

Avoid preventable food labeling violations.  Registrar Corp’s Regulatory Specialists know which products have standards of identity, their requirements, and the format for compliant statements of identity.  Registrar Corp’s label review service provides a comprehensive report of recommended revisions to your label as well as a print-ready version, compliant with FDA’s updated labeling rules.  For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Now Collecting Fees for Export Certificates for Human Food

The Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to charge fees to cover the cost of issuing export certificates for human food.  On October 1, 2018, the agency began issuing and collecting fees for two types of Export Certificates:

  • Certificate to a Foreign Government: certifies that a product (or products) may be marketed in and legally exported from the United States
  • Certificate of Exportability: certifies that an export only product meets the requirements of section 801(e)(1) of the Food Drug & Cosmetic Act and may be legally exported

These certificates are available for human food products, such as processed foods, produce, and grains that are not dietary supplements, medical foods, or foods for special dietary use.

FDA will charge $175 for the first certificate issued for a given product.  Subsequent certificates, issued for the same product in response to the same request, will be made available at a reduced rate in accordance with the following schedule:

First Certificate $175
Second certificate for the same product(s) issued in response to the same request $155
Subsequent certificates for the same product(s) issued in response to the same request $100

 

FDA will continue to provide “Certificates of Free Sale” for dietary supplements, medical foods, and foods for special dietary use at no cost.

Not sure what type of certificate you need for your product? Registrar Corp’s Regulatory Specialists can answer your questions and help you obtain an Export Certificate. Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

First FDA Voluntary Qualified Importer Program Application Period Begins October 1, 2018

The U.S. Food and Drug Administration (FDA) will begin accepting applications for its Voluntary Qualified Importer Program (VQIP) on October 1, 2018.  In a September 2018 webinar, FDA stated it intends to review around 200 VQIP applications during Fiscal Year (FY) 2019.

What is VQIP?

VQIP allows eligible importers to pay an annual fee for expedited review and release of foods specified in an approved VQIP application.  FDA will limit examination and sampling of these foods to situations where they are linked to a public health risk.

During the recent webinar, FDA estimated that participating importers may see their shipments released in as little as ten minutes.  FDA compared this to an average release of 14.5 hours if manual review is needed, or 6.7 days if documentation or analysis is needed.

How Do I Participate In VQIP?

To take advantage of these benefits, importers may submit an application to FDA that covers aspects such as the foods they wish to import under expedited review, the suppliers of those foods, and a description of procedures used to ensure the safety of foods throughout the supply-chain.  FDA may also examine the foods’ labels for compliance with certain requirements such as allergen labeling.

Among other requirements, VQIP-eligible importers must:

  • have a three-year history of food importation into the U.S.
  • be in compliance with applicable FDA food safety regulations (i.e. HACCP, HARPC, or FSVP)
  • hold a current certification issued by an FDA-accredited third-party certification body for each foreign supplier listed in the VQIP application.
  • not currently have compliance issues with FDA (i.e. Import Alerts, Class I recalls, Warning Letters, etc.) or have a history of significant non-compliance

What is the Cost to Participate in VQIP?

FDA estimates the VQIP user fee to be $16,400. The Agency states it will request payment of VQIP fees after an application has been approved.  VQIP benefits for approved importers who have paid the fee will begin on October 1, 2019.

Registrar Corp offers a variety of services to help interested parties meet VQIP eligibility requirements.  Our Regulatory Specialists can develop your FSVPs, write HARPC  and HACCP plans for your suppliers, or review current plans for compliance. Registrar Corp can also help remove a supplier from Import Alert by developing a petition to FDA. Lastly, the Registrar Corp FDA Compliance Monitor provides a simple solution to supply-chain monitoring requirements.

For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

Food Facilities Must Renew Their FDA Registrations Between October 1 and December 31

The U.S. Food and Drug Administration (FDA) requires facilities that manufacture, process, pack, or store food for U.S. consumption to renew their FDA registrations between October 1 and December 31, 2018. During the renewal process, facilities located outside of the U.S. must also designate a U.S. Agent for FDA communications. The renewal will not be considered complete until the listed U.S. Agent accepts this designation.

It should be noted that renewing a registration is distinct from updating a registration, and even food facilities that registered with FDA as recently as September 2018 will be required to renew.  Facilities should ensure they properly renew during this period so their FDA registrations remain valid for 2019.

What are the Consequences of Not Renewing?

FDA will cancel facility registrations that are not properly renewed during the impending Biennial Registration Renewal period. Failure to renew FDA registrations during the 2016 renewal period contributed to a 28% drop in the number of registered food facilities in early 2017.

Food exported to the U.S. by a facility with a canceled registration may be detained or refused at the U.S. port of entry.  Any facility that markets food for consumption in the U.S. without a valid registration may also be subject to civil or criminal penalties.

Registrar Corp, a consulting firm specializing in FDA regulatory compliance, can properly renew your registration and can act as the U.S. Agent for facilities outside the United States. As part of our registration renewal service, companies receive year-round regulatory support, including FDA compliance monitoring of their facility, detention assistance, and more.

To learn more, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.

Registrar Corp’s FDA Compliance Monitor Now Includes Recalls

Registrar Corp added recalls to their FDA Compliance Monitor.  Users can now view the recall history of their own company, their suppliers, and potential suppliers, including:

  • The description of the recalled product.
  • The recall classification (the level of health risk involved).
  • The reason for the recall.
  • The current status of the recall (ongoing, completed, etc.).

This capability will help businesses comply with the Food Safety Modernization Act (FSMA), which requires food facilities and US importers to monitor their food suppliers’ FDA compliance as related to food safety. Recalls can damage a brand’s reputation, disrupt supply chains, and delay production and are an important aspect of a facility’s compliance history.

In addition to recalls, the FDA Compliance Monitor includes the FDA inspection history, FDA import alert status, FDA warning letter history, and record of FDA-refused shipments for monitored facilities, making full compliance with FSMA’s monitoring requirements easier than ever before. Schedule a demo of the FDA Compliance Monitor now.

Users can access the FDA Compliance Monitor through MyFDA.com, a simple online portal that makes it easy for food and beverage businesses to manage their FDA compliance, including FDA registrations and prior notice submissions.

For more information about the FDA Compliance Monitor or FSVP monitoring requirements, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.

FSMA Deadline Approaching: First Qualified Facility Attestation Period Begins October 1, 2018

Very small businesses generally must comply with the U.S. Food and Drug Administration’s (FDA’s) Preventive Controls for Human Food Rule by September 17, 2018.  Under this rule, very small businesses are eligible for exemption from some of the Preventive Controls requirements, including the requirement to maintain a written Hazard Analysis and Risk-based Preventive Controls (HARPC) plan and the requirement to maintain a written Supply-Chain Program. To take advantage of these exemptions, businesses must submit their first attestation to FDA by December 17, 2018.

Who Qualifies for the Exemption

Very Small Businesses: Businesses (including all subsidiaries and affiliates collectively) that have averaged less than $1,000,000 (adjusted for inflation) in global sales of food for human consumption plus the market value of unsold food inventory per year during the previous three calendar years

Other Qualified Facilities: Though FDA has stated that it expects most facilities that qualify for the exemption to be very small businesses, other facilities qualify if they possess both of the two following characteristics:

  • Over the past three years, they have averaged annual sales of food for human consumption below $500,000 (adjusted for inflation)
  • At least half of their food sales over the previous three years have been directly to local consumers, restaurants, or retail establishments that are located in the same state, same Indian reservation, or within 275 miles of the food facility in question

Registrar Corp’s free Qualified Facility Wizard can help you determine whether your facility qualifies for the exemption.

How to Claim Eligibility for an Exemption

In order to claim eligibility for an exemption, a qualified facility must notify FDA of its status by submitting Form FDA 3942a. Using this form, the owner, operator, or agent in charge of a food facility must attest that the facility in question meets the definition of a qualified facility and that the facility is either “addressing identified hazards through preventive controls and monitoring the preventive controls,” or “complying with applicable non-Federal food safety regulations, and notifying consumers of the name and complete business address of the facility where the food was manufactured or processed (FDA.gov).”

When to Claim Eligibility

Qualified facilities that began or will begin processing, packing, or holding food before September 17, 2018 must submit the relevant form by December 17, 2018. Facilities that will begin processing, packing, or holding food on or after September 17, 2018 must submit the relevant form before beginning operations. Facilities must resubmit attestation to FDA every two years during the biennial food facility registration renewal period, which begins on October 1st and ends on December 31st of each even numbered year.

Preventive Controls Compliance for Qualified Facilities

As mentioned above, qualified facilities that attest are exempt from certain requirements of the Preventive Controls rules, but not all of them. Qualified facilities must still:

  • Refrain from selling adulterated food
  • Adhere to Current Good Manufacturing Practices (CGMPs)
  • Ensure that all individuals who manufacture, process, pack or hold food are trained in the principles of food safety and are qualified to perform their assigned duties
  • Maintain detailed records of the food safety training received by workers

A very small business that does not notify FDA of its status as a qualified facility is fully subject to the standard requirements of the Preventive Controls Rule and, generally, must develop and implement a written HARPC Food Safety Plan and Supply-Chain Program by September 17, 2018.

The Preventive Controls Rule compliance deadlines for facilities that do not meet the definition of a very small business have already passed. Thus, many food facilities that have not yet developed and implemented a written HARPC Food Safety Plan and Supply-Chain Program are likely to be in violation of FDA regulations.

Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses that do not meet the definition of a qualified facility or do not intend to notify FDA of their status as a qualified facility to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet regulatory requirements.

Assistance with Attestation and Food Safety Plans

Registrar Corp’s Food Safety Specialists are Preventive Controls Qualified Individuals (PCQIs) and can develop or review a facility’s HARPC plan for FDA compliance. Registrar Corp’s Specialists can also provide guidance on qualified facility attestation to firms that designate Registrar Corp to manage their FDA registration or act as their U.S. Agent for FDA Communications. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

The Current Implementation Status of FSMA: What’s Required Now, What’s Next, and FDA’s Enforcement to Date

The U.S. Food and Drug Administration (FDA) has finalized a number of rules under the Food Safety Modernization Act (FSMA) that address topics such as:

  • Preventive controls for human and animal food
  • Foreign supplier verification programs
  • Prevention of intentional adulteration of the food supply
  • The registration of food facilities

Many of the deadlines for complying with FSMA rules have already passed. There are also multiple upcoming deadlines that covered businesses should be aware of. A summary of several important FSMA requirements and deadlines may be found below.

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 HARPC 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.

Preventive Controls Deadlines
Different businesses face different deadlines for completing their HARPC plan. 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 food and businesses subject to the Pasteurized Milk Ordinance have until September 17, 2018 to comply. Generally, facilities that manufacture, process, pack, or store human or animal food for U.S. consumption are legally required or will soon be legally required to comply with this rule.

Preventive Controls Enforcement and Requirements
Most U.S. food importers must verify that their suppliers meet applicable FDA food safety requirements, including these Preventive Controls requirements. Therefore, a US importer may ask to review a supplier’s HARPC plan. In the event of an inspection, FDA is also likely to review a facility’s written HARPC plan.

Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet government standards. Registrar Corp’s Food Safety Specialists are PCQIs and can develop or review a facility’s HARPC plan for FDA compliance.

Rule On Foreign Supplier Verification Programs

Foreign Supplier Verification Program Overview
Under the Foreign Supplier Verification Program (FSVP) rule, U.S. importers must have a written FSVP that is developed by a qualified individual and documents that they have completed risk-based activities meant to verify that the food they import into the United States is produced in a manner that is consistent with U.S. safety standards. Among other things, 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 HARPC Food Safety Plan. As part of the supplier analysis, importers must monitor and document the FDA compliance status of each of their suppliers by tracking 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. The deadlines for other importers are scheduled to occur on dates ranging from July 26, 2018 to July 27, 2020.

Foreign Supplier Verification Program Enforcement and Compliance
FDA has begun inspecting importers for FSVP compliance. In 2017, failure to develop an FSVP was cited by FDA 108 times. 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.

Registrar Corp’s Food Safety Specialists can develop new FSVPs on behalf of importers or review existing FSVPs for compliance. Registrar Corp also offers a tool to assist with the supplier monitoring aspects of FSVP.  In order to monitor supplier compliance on their own, an importer would need to routinely search each individual FDA database for each of their foreign suppliers. In order to make this process easier, Registrar Corp developed the FDA Compliance Monitor.  Users simply submit the facility they would like to monitor and the FDA Compliance Monitor will reveal any FDA Import Alerts, Warning Letters, Import Refusals, Recalls, or Inspection Classifications related to the facility. Printable reports allow users to document the compliance of their monitored facilities per FDA’s 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.

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) have one additional year to comply. If you are unsure of whether your business qualifies as small, you can read Registrar Corp’s earlier blog post on how FSMA defines small businesses.  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 order to take advantage of this exemption, businesses must provide records to FDA proving their very small business status by May 27, 2021.

Registrar Corp’s Food Safety Specialists can develop or review a Food Defense Plan for compliance with FDA’s Intentional Adulteration rule.

Amendments to the FDA Registration Process

FSMA made significant changes to the FDA registration process. Food facilities are now required to provide an email address for registration and must assure that FDA will be permitted to inspect the facility under circumstances permitted by the Federal Food, Drug and Cosmetic Act.

Additionally, FSMA requires facilities to renew their FDA registrations during each even numbered year. For example, because 2018 is even numbered, food facilities will have to renew their registration later this year between October 1 and December 31. It is very important that facilities comply with renewal requirements. In 2017, FDA removed 28% of food facility registrations from its database. Many of these removals resulted from a failure to properly renew registration as was required in 2016.

Registrar Corp’s Regulatory Specialists can help facilities register or renew their registrations with FDA quickly and properly.

Responding to the Implementation of FSMA

FSMA imposes many complex requirements on food businesses. The deadlines for complying with these various requirements have already passed or will soon pass. Businesses should take measures to ensure that they are in compliance. One such measure would be to enlist the help of Registrar Corp’s Regulatory Specialists who have expert knowledge of FSMA and extensive experience in helping businesses comply with FDA regulations. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.