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U.S. FDA Announces Reinspection Fees Fiscal Year 2018

The U.S. Food and Drug Administration (FDA) recently published the hourly rates for the reinspection of food facilities during fiscal year (FY) 2018.  The cost of reinspection for a domestic facility is $248 per hour, a $27 increase from FY 2017.  The cost for a foreign facility is $285 per hour, the same as in FY 2017.

The total cost of a reinspection depends upon the amount of time FDA performs inspection-related duties.  This may involve preparation for the inspection, travel to and from the facility being inspected, the physical examination of the premises, and any sample analysis or lab work required.  Reinspection fees can quickly add up to thousands of dollars, especially for facilities in countries where travel alone can take a day’s time. To avoid these potentially high reinspection fees, it is prudent to take measures to ensure that proper food safety procedures are in place when FDA inspects a food facility the first time.

What is a reinspection?

When a food facility registers with FDA, it grants FDA permission to inspect the facility at any given time. Initial FDA food facility inspections are of no cost to the facility and may occur due to routine reasons, a facility’s level of potential risk to public health, or as a response to a problem or complaint.

If FDA discovers certain food safety violations during an initial inspection, the Agency may decide it needs to return at a later date to evaluate whether the facility implemented appropriate corrective actions.  This second evaluation is considered a reinspection (also sometimes referred to as a “compliance follow-up inspection”).

The frequency at which initial FDA inspections occur may continue to increase in response to mandates under the 2011 Food Safety Modernization Act (FSMA).  FSMA directs FDA to inspect domestic facilities at a rate determined by the risk its products pose to public health.  High-risk facilities are to be inspected every three years, while low-risk facilities are to be inspected every five years.  FSMA also directed FDA to increase its annual inspection of foreign facilities. FDA provides foreign facilities with notice that an inspection of the facility will occur.  Domestic facilities may receive no notice at all.  Regardless, it is crucial for all facilities to take steps to be prepared for the initial FDA inspection at all times.

What factors could warrant a reinspection?

FDA’s most recently published data on commonly occurring inspection violations at food facilities indicates food safety issues that FDA may likely search for while inspecting a facility. The most frequent violations in FY2016 included:

  • Lack of Effective Pest Exclusion / Screening – FDA cites a facility for not taking effective preventative measures against pest presence in food processing areas or not implementing controls to protect food from contamination due to pests.
  • Sanitation Monitoring – FDA cites a facility for failing to effectively monitor sanitation practices and conditions consistently.
  • Floors, Walls, and Ceilings – FDA cites a facility for being constructed in a way that inhibits proper sanitation and repair of the floors, walls, and ceilings.
  • Importer Verification – FDA cites a seafood importer for failing to document verification of a supplier’s compliance with Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations.
  • HACCP Plan Implementation – FDA cites a facility for failing to implement procedures established in its written HACCP Plan. It is important to note that following the compliance date in September 2016, FDA is now likely to also check for proper implementation of Hazard Analysis and Risk-based Preventative Control (HARPC) Plans at most food facilities.

Several violations in the above list were just as frequent in 2015 as they were in 2016.  Registrar Corp urges food facilities to examine these issues and take the appropriate measures to prevent FDA citations for these and similar food safety problems.

Proper preparation for an initial inspection may reduce the chance of FDA citing a facility for violations that can cause return visits. Having a third party trained in FDA inspections review your facility for violations is often an invaluable business decision. Poor results from an initial inspection not only can result in an expensive reinspection, but also in Warning Letters and other public information that could damage a brand’s reputation. While there may be costs associated with third-party assistance, it is likely more affordable than the alternative.

Registrar Corp offers a Mock FDA Inspection service in which our Food Safety Specialists identify potential food safety problems and educate staff on FDA expectations.  This Mock FDA Inspection service is included as part of Registrar Corp’s U.S. Agent service at no charge, aside from lodging and travel expenses.

For questions or assistance with FDA compliance, call Registrar Corp at +1-757-224-0177.  Additionally, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Australia Receives Systems Recognition with U.S. FDA

As of April 2017, the U.S. Food and Drug Administration (FDA) officially recognizes the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System, granting it systems recognition.  Australia is the third country to make this arrangement with FDA—the first being New Zealand in 2012, and the second being Canada in 2016.

This recognition allows importation of Australian-produced foods into the United States without the extensive requirements imposed by FSMA’s Foreign Supplier Verification Program.  Instead of conducting detailed hazard analyses and verification activities as is required from food from other countries, U.S. importers now may simply verify that the producing firm is in good standing with the Australian Department for that type of product.

What is Systems Recognition?

Systems recognition is an arrangement where FDA agrees upon a similarity between its own Food Safety System and that of another country seeking this arrangement, where both provide similar protection and monitoring of food products. The concept is based upon the idea that Food Safety Systems adhering to similar standards will produce similar outcomes—ideally the production of safe food.

What are the Benefits of Being Recognized by FDA?

FDA’s Food Safety Modernization Act (FSMA) introduced extensive new food safety regulations for both food facilities and U.S. importers of food products. While still subject to FSMA, food facilities in recognized countries and domestic importers of food manufactured in recognized countries benefit from modified requirements.  As more faith is granted to the Food Safety Systems of recognized countries, these parties may see less FDA intervention as a result.

Under FSMA, food facilities that manufacture, process, pack, or hold food for U.S. consumption are required by FDA to have written food safety plans.  One component of this plan is a supply-chain program that mandates facilities to conduct verification activities on their suppliers, such as onsite audits.  As opposed to conducting these audits themselves, facilities with suppliers in recognized countries are able to verify suppliers through an inspection conducted by that country’s food safety authority within one year of the required audit date, potentially saving resources on travel and personal expenses.

FSMA also requires U.S. importers to create a Foreign Supplier Verification Program (FSVP) for each of their foreign suppliers, involving hazard analysis, risk evaluation, supplier verification, and corrective action.  Systems recognition allows importers to forgo certain aspects of the FSVP rule, such as hazard analysis and verification, as long as they continue to monitor and find that each supplier is compliant with its country’s Food Safety System.  As a result, importers are able to save time and effort as well as travel expenses when importing food from recognized countries. This may provide facilities in recognized countries an advantage over competition, as US importers may be more apt to import from facilities that require less work under FSVP.

Use Registrar Corp’s free FSMA Wizard for information on how FSMA rules affect your specific country and facility.

How Does a Country Become Recognized?

In order to meet systems recognition, a country’s governmental Food Safety System must undergo a review of its compliance history by FDA. The Agency will examine data on past refusals of admission, import alerts from products originating in that country, and other areas of concern.  Following this review, the interested country will hold a consultation with FDA to outline its goals for achieving systems recognition and the steps that need to be taken to move forward in this process.

If the country is still interested in becoming recognized after the consultation, its regulatory agency or authority must complete the International Comparability Assessment Tool (ICAT) to determine whether or not its Food Safety System meets ten standards outlined by FDA.  Upon its completion, FDA will review the ICAT along with the data collected during the initial review.  If deemed that the interested country satisfies these standards, FDA will take the steps toward arranging an in-country assessment of the country’s system to attempt to finalize the systems recognition process.

Can I Still Export To The US If My Country Is Not Recognized?

While there are benefits to being recognized, systems recognition is entirely voluntary and is not required to export food to the United States.  A company interested in exporting food to the U.S. must still complete all of the steps necessary for complying with FDA regulations.

If you represent a company looking to export or import food to the United States, Registrar Corp can assist in complying with FDA’s requirements promptly and correctly.  For more information on FDA requirements or Registrar Corp’s services, please call +1-757-224-0177.  Additionally, 24-hour live chat assistance is available at www.registrarcorp.com/livehelp.

 

One Month Until FDA’s FSVP Deadline; Tools for Compliance by Registrar Corp

Many U.S. importers are required to comply with the U.S. Food and Drug Administration (FDA) Foreign Supplier Verification Program (FSVP) rule by May 30, 2017.

Finalized in November 2015 under the Food Safety Modernization Act (FSMA), FDA’s FSVP rule requires “FSVP Importers” to perform certain activities to verify that the food they import is produced in a manner that meets U.S. safety standards. If you are unsure whether you are considered an FSVP Importer, Registrar Corp’s free FSMA Wizard can assist you in determining your potential requirements.

Evaluating and Approving Suppliers

FDA’s FSVP rule requires that FSVP Importers import only from approved foreign suppliers, although they may import from an unapproved supplier on a temporary basis.  To approve a supplier, an FSVP Importer must consider the supplier’s compliance with FDA food safety regulations, including whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.

Comments in the final rule regarding this requirement reflect industry concern that FDA’s website and compliance databases can be hard to navigate.  To evaluate a supplier’s compliance using FDA’s website, an FSVP Importer has to search each of FDA’s applicable databases for each individual supplier.  Registrar Corp’s FDA Compliance Monitor allows users to easily evaluate food facilities’ FDA compliance statuses.  The Monitor compiles data on FDA Import Alerts, Warning Letters, Import Refusals, and Inspection Classifications for a user’s suppliers in a simple dashboard, which also tracks whether suppliers are approved.

Risk-Based FSVPs

FSVPs must be created by a “Qualified Individual,” defined as an individual with the education, training, or experience necessary to perform their assigned activities and the ability to read and understand the language of any records that must be reviewed in performing an activity. An FSVP must include a hazard analysis and appropriate supplier verification activities to provide assurance that these hazards will be significantly minimized or prevented.  Examples of supplier verification activities include audits, records review, and sampling and testing.

What qualify as “appropriate” verification activities for a particular supplier depends on the types of foods being imported and the supplier’s compliance history.  Registrar Corp’s Food Safety Specialists act as Qualified Individuals and can develop or review FSVPs to ensure they are appropriate for your specific needs.

Corrective Actions

Should an FSVP Importer become aware of non-compliance by one of its approved suppliers, the importer must ensure corrective action is taken.  Registrar Corp can assist in implementing corrective actions. For example, action taken to have a foreign supplier removed from import alert may be considered an appropriate corrective action.  Registrar Corp can help facilities create and submit a petition to FDA for removal from import alert.  Additionally, labeling errors are one of the largest causes for warning letters and detentions.  Registrar Corp can review food labeling and ingredients for FDA compliance.

For more information, attend Registrar Corp’s free FSVP webinar or utilize their 24-hour online Live Help.

This article was originally published as a press release.

FDA Establishes User Fees for Accredited Third-Party Certification Program

On December 14, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 90186) that establishes user fees for the agency’s accredited third-party certification rule. Finalized in November 2015 as part of the Food Safety Modernization Act (FSMA), the rule establishes a voluntary program for certification bodies to audit foreign food facilities and provide certification when their food safety controls are up to U.S. standards.

There are essentially three steps to the accredited third-party certification program:

  1. FDA recognizes accreditation bodies.
  2. Recognized accreditation bodies accredit qualified third-party certification bodies.
  3. Accredited certification bodies audit and issue certifications for foreign food facilities and their products.

For more information on the program requirements and use of certifications, read here.

FDA’s final rule establishes two types of user fees: application and annual.

Application Fees

Application fees apply to accreditation bodies applying for FDA recognition, recognized accreditation bodies applying for renewal, and to third-party certification bodies applying for direct accreditation from FDA or a renewal of their direct accreditation. The application fees are intended to cover the costs of FDA’s review and evaluation of initial and renewal applications.  These fees must be submitted concurrently with an application and are non-refundable.  Applications will be considered incomplete until payment is made.

Annual Fees

Annual fees apply to recognized accreditation bodies.  The annual fees also apply to accredited certification bodies, whether they were accredited directly through FDA or through an accreditation body. Annual fees are intended to cover the costs of FDA’s performance monitoring efforts. Annual fees must be paid within 30 days of receiving billing.  Failure to pay FDA’s user fees may result in suspension or revocation of a participant’s recognition or accreditation.

The application fee for accreditation bodies applying for initial recognition in fiscal year (FY) 2017 will be $35,100 (81 FR 90363). This cost is slightly lower than the application fee estimated in the 2015 proposed rule.  In the future, FDA will announce the fee schedule prior to the beginning of each FY.

Circumstances under which accredited third-party audits are required are likely to be rare. These audits are only required when a facility’s product is being imported to the US as a VQIP food and in the event that FDA issues a requirement for certification of a specific food due to safety concerns. In the case that your facility does require a third party audit, Registrar Corp offers a mock inspection service to help prepare. Registrar Corp’s Food Safety Specialists will inspect all aspects of your facility, from employee hygiene to equipment maintenance to recordkeeping. Our mock inspection service is also beneficial in preparing for a routine FDA inspection.

For questions regarding FDA’s accredited third-party certification program or other final FSMA rules, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

FDA Suspends Food Facility Registration of a New York based Facility

The U.S. Food and Drug Administration (FDA) recently suspended the food facility registration of SM Fish Corp, located in Far Rockaway, NY, following a failed re-inspection and re-sampling of their ready–to-eat (RTE) seafood products. An initial inspection of the facility from June 14, 2016 to July 6, 2016 revealed that several environmental samples tested positive for Listeria. FDA requested that SM Fish Corp. recall some of its RTE products and shut down briefly to revise its cleaning and sanitation procedures, to which the facility agreed.

Following the initial inspection SCORE, a decision making body of individuals intended to ”ensure the agency engages in an integrated approach to identifying timely and efficient measures in order to help mitigate public health risks,” requested a re-inspection of SM Fish Corp. in order to ensure the problems found at the facility were resolved.

The decision to suspend the facility’s registration was made under the authority of the 2011 Food Safety Modernization Act (FMSA) after FDA’s re-inspection in August 2016 revealed a continued widespread Listeria contamination within the facility. As a result of this suspension, SM Fish Corp. is banned from marketing food in the United States. FDA may lift the suspension only when the agency determines the facility’s food no longer has reasonable probability of posing serious health issues or death to human consumers.

Facilities are often unaware of the cost and time associated with FDA re-inspections. When FDA initially inspects a food facility, it is financed by the agency, but if FDA finds reason to re-inspect, the agency may charge re-inspections fees. For facility re-inspection fees, FDA will invoice the responsible party for the direct hours; including time spent preparing and traveling, at the appropriate hourly rate. The FY 2017 hourly rates for FDA re-inspections are as follows:

  • $221 per hour for domestic facilities
  • $285 per hour when foreign travel is required

It is crucial to prepare for possible FDA inspections in order to prevent costly re-inspections that may lead to the suspension of your food facility registration. Registrar Corp can assist facilities preparing for FDA inspections. A Food Safety Specialist can perform mock FDA inspections  at the request of both foreign and domestic facilities to help identify any potential problems and help facilities to better understand FDA’s expectations. Additionally, if your foreign food facility utilizes Registrar Corp as its U.S. Agent, Registrar Corp will perform a mock inspection free of charge (other than travel and lodging expenses) when FDA issues a Notice of Inspection for that facility.

For more information or assistance regarding FDA inspections, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

Food Facilities Must Renew Their FDA Registrations Between October 1 and December 31, 2016

Registrar Corp writes to remind the food industry of an important upcoming regulatory deadline.  Under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), food facilities that manufacture, process, pack, or store food for distribution in the United States are required to renew their FDA registrations between October 1 and December 31, 2016.

Food facilities have been required to register with FDA since 2003. FSMA updated this requirement in 2011 to include biennial renewals in order to keep FDA’s registration database up-to-date.  Food facilities are now required to renew every even numbered year between October 1 and December 31.

FDA’s Registration Renewal requirement applies to both domestic and foreign food facilities registered with FDA.  Foreign facilities must also designate a U.S Agent for FDA Communications in Section 7 of their renewal.  It’s important to designate a professional knowledgeable on FDA regulations , as this U.S. Agent will have access to information submitted in the facility’s registration and may speak on behalf of the facility to FDA regarding inspections, shipments, and other regulatory matters.

Facilities must renew their FDA registration no matter when they submitted their initial registration.  A facility could have registered with FDA one month or even one day before October 1, and the facility would still need to renew.  If a facility does not renew its registration by December 31, FDA will consider the registration to be expired.  Distributing food in the United States with an expired registration is a prohibited act and may lead to detention of products or other regulatory action by FDA.

There was a 14% decrease in the number of food facilities registered with FDA from January 2014 to January 2015.  Registrar Corp believes the drop was due to facilities failing to renew their registration during the 2014 renewal period.

Registration renewals may be completed directly with FDA by mail, fax, or online, or facilities may authorize a third party individual to complete their renewal.

Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including registration, U.S. Agent requirements, food labeling, and new requirements under the Food Safety Modernization Act.  Registrar Corp’s Regulatory Specialists register and renew thousands of food facilities each year and act as the U.S. Agent for over 13,000 facilities around the world.  Contact Registrar Corp for assistance.

This article was originally published as a press release.

FSMA Roundup: An Overview of The FDA’s Seven Major Rules

In 2011, President Obama signed FSMA — a body of regulatory works that quickly became the most sweeping reform of the U.S. food safety system in over 70 years — into law. The FDA published seven major rules under FSMA, each of which created new requirements that put more responsibility on industry to prevent contamination of the U.S. food supply rather than reacting to it. This article will review all of FSMA’s seven final rules and briefly cover points of compliance, as well as compliance dates.

Preventive Controls Rules for Human and Animal Food

Proposed: January 2013 (Human) and October 2013 (Animal)
Finalized: September 17, 2015
Compliance Dates:

  • Very-small businesses (businesses that have less than $1,000,000 in total annual sales of human food, adjusted for inflation): September 2018
  • Businesses subject to the Pasteurized Milk Ordinance: September 2018
  • Small businesses (businesses with fewer than 500 full-time equivalent employees): September 2017
  • All other businesses: September 2016

The FDA’s Preventive Controls Rules apply to all facilities required to register with the FDA as a food facility, unless covered by an exemption (See page 19 of the final rule for a complete list of exemptions). A covered facility must implement a written Food Safety Plan that identifies known or reasonably foreseeable biological, chemical, and physical hazards related to foods in the facility. For each identified hazard, the Food Safety Plan must determine whether the hazard requires preventive controls and, if so, outline preventive controls to minimize or prevent that hazard.

While similar to other food safety programs, such as HACCP, ISO 22000, or BRC, these plans do not satisfy the requirement of having an FDA Food Safety Plan. A Preventive Controls Qualified Individual (QI) must create or oversee the development of a facility’s Food Safety Plan. The Preventive Controls Qualified Individual may or may not be an employee of the facility.

The Preventive Controls Rules also require covered facilities to approve their raw material and ingredient suppliers when the receiving facility has identified a hazard requiring a preventive control. In approving suppliers, facilities must consider multiple factors, including the supplier’s performance (i.e., compliance with FDA regulations, including FDA warning letters, Import Alerts, etc). Facilities can use the FDA’s public databases or a third-party tool to monitor a supplier’s status.

Produce Safety Rule

Proposed: January 2013
Finalized: November 2015
Compliance Dates: Compliance dates for the FDA’s Produce Safety rule depend on a business’s size, exemption status, and whether or not the business deals with sprouts. Click here for more information on Produce Safety compliance dates.

The FDA’s Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. The rule puts more responsibility on farms to protect their crops from contamination by creating requirements for water quality testing, raw manure application, examining grazing areas, employee health and hygiene training, and more. The rule gives special attention to sprouts due to their frequent association with foodborne illness outbreaks.

Foreign Supplier Verification Program (FSVP) Rule

Proposed: July 2013
Finalized: November 2015
Compliance Dates:

The latest of the following dates:

  • 18 Months after publication of the final rule  (May 2017)
  • For the importation of food from a supplier that is subject to the preventive controls or produce safety rules: six months after the foreign supplier is required to meet the relevant regulations.
  • For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations: the date by which it has to comply with those provisions.

The FSVP rule requires importers to verify their foreign suppliers are producing food in compliance with applicable FDA regulatory requirements. To approve a supplier, an importer must evaluate the risks posed by foods it supplies by determining potential hazards associated with each food, as well as by evaluating the supplier’s performance (i.e., FDA compliance history). Importers must then implement an FSVP for each approved supplier and each food imported from that supplier. The rule gives importers the flexibility to choose appropriate verification activities for each food and supplier. Examples of potential verification activities include annual onsite audits of a supplier’s facility, sampling and testing a supplier’s products, or reviewing a supplier’s food safety records.

The FDA defines an importer as “the U.S. owner or consignee of a food offered for import into the United States” for purposes of this rule. If there is no U.S. owner or consignee, the FDA considers the U.S. agency or representative of the foreign owner of consignee at the time of entry to be the importer.

Accredited Third-Party Certification

Proposed: July 2013
Finalized: November 2015
Compliance Dates: N/A (Voluntary)

The Third-Party Certification rule established a voluntary program for the accreditation of third-party certification bodies to conduct food safety audits and issue certifications of foreign facilities and the foods they produce. Under the program, the FDA recognizes what are called accreditation bodies, which then may accredit third-party certification bodies.

Accredited third-party certification bodies can perform two types of audits: consultative and regulatory. A consultative audit is conducted in preparation for a regulatory audit, while a regulatory audit is the basis for certification. Foreign facilities can use certification from a Third-Party Certification Body for two purposes: participation in the FDA’s Voluntary Qualified Importer Program (VQIP) or to satisfy a request by the FDA that a food exported to the U.S. be accompanied by this certification (a request that may be made if the FDA suspects a food has the potential to be harmful to U.S. consumers). When a certification body conducts a regulatory audit, it must provide the FDA with a full report on the results of its inspection. The results of a consultative audit may remain private, but a certification body is required to report to the FDA if a consultative audit reveals issues that may pose a serious risk to consumer health.

Sanitary Transportation Rule

Proposed: February 2014
Finalized: April 2016
Compliance Dates:

  • Small Businesses (businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts): April 2018
  • All other businesses: April 2017

The Sanitary Transportation rule created new requirements for shippers, receivers, loaders, and carriers that transport food in the U.S. by motor or rail vehicle to ensure food is protected during transportation, via both the design and maintenance of transportation vehicles and equipment and by taking appropriate measures to ensure food safety by maintaining proper temperature controls and protecting food from contamination. Shippers, loaders, carriers, and receivers must develop written procedures detailing how they will ensure the safe transportation of food according to their specific requirements under the rule. The Sanitary Transportation rule applies whether or not the food is offered for or enters interstate commerce.

Intentional Adulteration Rule

Proposed: December 2013
Finalized: May 2016
Compliance Dates:

  • Very-small businesses (a business [including any subsidiaries and affiliates] averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale [e.g., held for a fee].): May 2021
  • Small Businesses (a business employing fewer than 500 persons): May 2020
  • All other businesses: May 2019

As with the FDA’s Preventive Controls Rules, the  Intentional Adulteration Rule applies to all facilities required to register with the FDA as a food facility, unless covered by an exemption (see section titled “Exemptions”). The rule requires facilities to develop and implement a written Food Defense Plan that assesses vulnerabilities within the facility, identifies a mitigation strategy for each vulnerability, and identifies monitoring procedures to ensure effectiveness of the mitigation strategies. A QI must prepare a facility’s Food Defense Plan.

Complying with FSMA

Registrar Corp’s FSMA Wizard is a free tool that helps you determine your possible requirements under FDA’s Food Safety Modernization Act (FSMA).

Registrar Corp’s Regulatory Specialists can assist with new requirements under FSMA, including developing or reviewing Food Safety Plans and Food Defense Plans.  Registrar Corp’s FDA Compliance Monitor allows users to monitor their suppliers for FDA Import Alerts and Warning Letters, as required under FDA’s Preventive Controls Rules and FSVP Rule.

This article was originally published in Food Online.

FDA Finalizes Amendments to Food Facility Registration

On July 14, 2016, the U.S. Food and Drug Administration published a final rule to amend the registration of domestic and foreign food facilities. Part of FDA’s Food Safety Modernization Act (FSMA), the rule is intended to improve the accuracy of FDA’s registration database and improve efficiency with regard to FDA’s use of inspection resources.

The final rule codifies some of the self-implementing regulations that became effective upon the enactment of FSMA.  These include:

  • E-Mail Addresses: Domestic facilities must list an e-mail address for the contact person at the facility. Foreign facilities must list an e-mail address for their U.S. Agent for FDA communications.
  • Inspections: All registrations must contain assurance that FDA will be permitted to inspect the registered facility.
  • Registration Renewal: Food facilities must renew their FDA registrations between October 1 and December 31 of every even numbered year. FDA offers an abbreviated renewal process for facilities that have no information to update from their previous registration.  FDA will consider non-renewed registrations to be expired.
  • Registration Suspension: FDA may suspend a food facility registration if the agency has reasonable belief that food manufactured, processed, packed, or stored at the facility may cause serious adverse health consequences or death to humans or animals.

The final rule also mandates new amendments to update FDA food facility registration:

  • US. Agents: A facility’s designated U.S. Agent will be able to view information submitted in the facility’s FDA registration.
  • Third-Party Submitters: Food facilities may authorize a third-party individual to complete their FDA registration on their behalf. Under the final rule, an individual submitting a food facility registration that is not the owner, operator, or agent in charge of that facility must identify the name, address, and phone number of the individual who authorized the third-party submitter to submit the registration.  The submitter must also identify himself in the registration.  FDA will not confirm a registration until the owner, operator, or agent in charge of the facility confirms with FDA that it has authorized the third-party submitter to manage the facility’s registration.
  • Product Categories and Activities: The Agency plans to add four new food product categories and revised three existing food product categories for animal food.  FDA will update the Food Product Categories Guidance if it makes changes to those for human food. Facilities must now identify the type of activity conducted at the facility for each food product category identified.  FDA plans to update the Types of Activity categories in Form FDA 3537, replacing the current “Acidified and Low Acid Canned Food Processor” category with separate categories for Acidified and Low Acid foods. Facilities that engage in holding or storing products must identify the type of storage provided at a facility (Ambient, Refrigerated or Frozen). FDA plans to add a new category for Farm Mixed-Type facilities that engage in both activities that are exempt from registration under section 415 of the Food, Drug and Cosmetics Act and activities that require the establishment to be registered. The agency plans to update Molluscan Shellfish to a Food Product Category instead of an Activity Type.
  • Electronic Registration: Beginning January 4, 2020, food facilities will be required to submit food facility registrations (including renewals, updates, and cancellations) electronically. A facility may request a waiver from FDA if it is unable to submit electronically.
  • Retail Food Establishment: The rule updates the definition of a retail food establishment to include (1) The sale of food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.
  • Unique Facility Identifiers: FDA will require food facilities to list a Unique Facility Identifier (UFI) in their registration in order to verify the information provided in the registration. In the proposed rule, FDA specifically proposed to require Data Universal Numbering System (DUNS) numbers.  The agency did not finalize this requirement.  FDA will publish additional information regarding what UFIs will be recognized as acceptable for use in food facility registrations.  While DUNS numbers are not required, the final rule does state that FDA expects to recognize DUNS numbers as acceptable UFIs.  FDA expects to initiate the UFI requirement on October 1, 2020.
  • Registration Cancellations: FDA updated the circumstances under which the agency will cancel registrations. According to the final rule, FDA will cancel a registration if:
    • FDA independently verifies that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration;
    • FDA determines that the registration is for a facility that does not exist, is not required to register, or where the information about the facility’s address was not updated in a timely manner in accordance with § 1.234(a);
    • The registration was submitted by an unauthorized individual;
    • The facility’s registration has expired due to failure to renew in accordance with § 1.230(b).

In addition to updating the reasons for cancellation, FDA also finalized the proposal to accept corrective action if it is submitted within 30 days of a cancellation confirmation. If circumstances meriting possible cancellation are corrected within 30 days after notice is provided, when appropriate, FDA will not cancel the registration.

It is prudent for food facilities to stay up-to-date on U.S. FDA registration requirements in order to avoid having their registration expired, suspended, or cancelled by FDA.  Marketing food from a facility with an expired, suspended, cancelled, or otherwise invalid FDA food facility registration in the United States is a prohibited act.  Food from a facility without a valid FDA registration may be stopped at the border when being imported into the United States.

Registrar Corp can quickly and properly register a facility with FDA as well as renew or update a facility’s registration as required by FDA.  Registrar Corp can also act as a foreign facility’s required U.S. Agent.  Registrar Corp’s U.S. Agent service provides numerous benefits, including:

  • Required registration updates and biennial registration renewal.
  • Three free Prior Notice filings each year
  • Detention and inspection assistance
  • Free FDA Compliance Monitoring
  • And more

For more information about FDA registration requirements or Registrar Corp’s services, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

Registrar Corp Launches FSMA Wizard: Identify Your Requirements under FDA’s New Rules

On July 25, 2016, FDA regulatory compliance firm Registrar Corp launched the FSMA Compliance Wizard, a free tool to help food facilities, importers, and farms determine their possible requirements under FDA’s Food Safety Modernization Act (FSMA).  Enacted in 2011, FSMA is the most sweeping reform of the U.S. food safety system in over 70 years.  FSMA imposes broad new requirements on manufacturers, importers, processors, packers, and distributors of food, including requirements for supplier monitoring, the implementation of Food Safety Plans, and much more.

New requirements under FSMA involve many nuances depending on the size of a business, its functions, the types of food it handles, and even its location. Most FSMA rules offer modified requirements and a longer compliance period for small and very small businesses (terms defined differently in each rule). For instance, facilities that handle dietary supplements may be exempt from most requirements under the Preventive Controls Rule, but may still be subject to requirements under the Foreign Supplier Verification Program. Facilities in countries with food safety systems officially recognized by FDA may also be subject to modified requirements.

Registrar Corp urges each registered food facility to consider its exemption and modified exemption status carefully, as it may be more prudent to comply than seek a possible exemption. Registrar Corp’s FSMA Wizard is an excellent tool for any facility to begin the FSMA compliance process.

To use Registrar Corp’s FSMA Compliance Wizard, simply answer a series of questions regarding your facility, and the FSMA Wizard identifies specific requirements that may apply.  Possible requirements may be identified under the following FSMA rules:

  • FDA Preventive Controls for Human Food
  • FDA Preventive Controls for Animal Food
  • FDA Foreign Supplier Verification Program (FSVP)
  • FDA Produce Safety

Registrar Corp plans to add FDA’s Intentional Adulteration rule when the 2019 compliance date draws nearer.  Registrar Corp Regulatory Advisors are available 24-hours a day to answer any questions users may have throughout the process.

Visit http://www.fsmawizard.com/ to help determine your possible requirements under FDA’s Food Safety Modernization Act today.

Food Facilities Must Develop Food Defense Plans under FSMA

On May 27, 2016, the U.S. Food and Drug Administration (FDA) published its final rule for “Mitigation Strategies To Protect Food Against Intentional Adulteration,” the last of the seven major rules under FDA’s Food Safety Modernization Act (FSMA).  The rule requires most food facilities that must register with FDA to develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility.  Food Defense Plan development can be broken into three steps:

Step 1: Vulnerability Assessment

Covered facilities must assess significant vulnerabilities for each actionable step that takes place at the facility (mixing, cooking, labeling, packaging, etc.), including:

  • The potential impact on public health
  • The degree of physical access to the product
  • The ability to successfully contaminate the product

The assessment must be written and must include an explanation as to why each point, step, or procedure was or was not identified as an actionable process step.  Assessments must consider the possibility of an inside attacker.

Step 2: Mitigation Strategy Development

Once a facility identifies the vulnerabilities associated with their food operations, it must identify and implement mitigation strategies to minimize or prevent those vulnerabilities. The Food Defense Plan must include written explanations for how each strategy will sufficiently mitigate the corresponding vulnerability. An example of a mitigation strategy would be placing numbered seals on a load before transportation.  This would allow the recipient of the load to ensure the same seal was unbroken upon arrival, verifying that the load was not tampered with.  Another example would be the use of locks to limit access to vulnerable areas within the facility.

Step 3: Maintenance  

Covered facilities must monitor their mitigation strategies to ensure they are properly implemented.  A facility’s Food Defense Plan must identify its monitoring procedures and how often they will occur.  If monitoring reveals that a mitigation strategy was not properly implemented, facilities must take corrective actions.  Facilities must also conduct verification activities to ensure that both monitoring and corrective actions, if necessary, are being conducted.  Facilities must maintain records for food defense monitoring, corrective actions, and verification activities.

Required activities under FDA’s Intentional Adulteration rule must be conducted by one or more qualified individuals.  The qualified individual(s) must:

  • Prepare the Food Defense Plan
  • Conduct the vulnerability assessment
  • Identify and explain the mitigation strategies
  • Conduct reanalyses of the Food Defense Plan (required at least once every three years)

FDA defines a qualified individual as “a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under [this regulation], as appropriate to the individual’s assigned duties.” A qualified individual may be an employee of the facility or a third party.

Compliance Dates

Most covered facilities must comply with FDA’s Intentional Adulteration rule by May 27, 2019 (three years after publication of the final rule).  Small businesses (defined as businesses with fewer than 500 full-time equivalent employees) have one additional year to comply.

Very small businesses 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 (five years after publication of the final rule).  FDA defines a very small business as ” a business (including any subsidiaries and affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale.”

Exemptions

There are a few exceptions to FDA’s Intentional Adulteration rule, such as the holding of food (except food held in liquid storage tanks), food for animals, and alcoholic beverages under certain conditions.  View FDA’s final rule for a complete list of exemptions.

Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including new requirements under FSMA.  Registrar Corp’s Food Safety Specialists can develop or review a Food Defense Plan for compliance with FDA’s Intentional Adulteration rule.  For questions or assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.





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