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What’s next for U.S. Importers under FSMA? Registrar Corp reports on recently passed and upcoming compliance deadlines

*Notice: We recently sent our subscribers two updates containing broken links to our blog.  We apologize for any inconvenience this may have caused.

The small business compliance deadline for the U.S. Food and Drug Administration (FDA) Preventive Controls Rule for Human Food passed on September 18, 2017.  Under the Foreign Supplier Verification Program (FSVP) Rule, many U.S. importers have six months from this deadline (until March 19, 2018) to implement FSVPs for foreign suppliers of human food that qualify as small businesses (defined as having fewer than 500 full-time equivalent employees).

FSVPs consist of documenting several detailed components for each foreign supplier and each category of their imported food products (i.e. chocolate confectionary, bottled oils, etc.)  In order to ensure compliance before the deadline, Registrar Corp urges importers to begin creating their FSVPs now.

What do I need to develop FSVPs?

FDA requires the following, among other things, of importers covered by the March deadline.

Documentation of supplier compliance:

Importers are required to ensure that they import from suppliers whom they have evaluated and approved through various methods that outline the potential health risks their products pose. A covered importer must ensure that a supplier is compliant with preventive controls rules, including the implementation of a food safety plan, and allergen labeling rules.  The importer must also monitor the supplier’s FDA compliance history.

Should an approved supplier be found non-compliant, FDA requires importers to take corrective actions.  These may involve facilitating the development of the supplier’s Food Safety Plan or ceasing business with them until they become compliant.

Hazard analysis of food products:

The FSVP rule requires importers to document a detailed hazard analysis of each category of food products they import from a given supplier.  The analysis should identify any known or reasonably foreseeable hazards that could pose illness or injury, as well as the potential risks involved in the supplier’s handling of the food during manufacturing procedures, storage, and transport.

The data obtained by this hazard analysis should be used to determine appropriate supplier verification activities relative to the level of risk these products pose, such as sampling or onsite audits of a food facility.

Why should I begin building my FSVPs now?

Developing the required documentation can be a lengthy process. A single supplier may need multiple FSVPs.  Importers should make efforts to ensure they comply in time to be prepared for possible inspection.  Registrar Corp saw evidence of FSVP inspections occurring within three months following the May 2017 FSVP compliance date.

Registrar Corp provides a variety of services to assist U.S. importers and their suppliers with requirements under the Food Safety Modernization Act (FSMA).  Registrar Corp’s Food Safety Team consists of Qualified Individuals who are well-versed in the development of FSVPs and Food Safety Plans.  Additionally, Registrar Corp’s FDA Compliance Monitor provides a simple solution to monitoring and approving suppliers as required under FSVP.  Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

This article was originally published as a press release.

Compliance Date Approaching for FSMA Preventive Controls Rules

September 18, 2017 marks the next compliance date under the Preventive Controls for Human and Animal Food Rules of the 2011 Food Safety Modernization Act (FSMA).  The U.S. Food and Drug Administration (FDA) will require larger animal food businesses and smaller human food businesses with fewer than 500 full-time employees to begin complying with preventive controls requirements that include the development and implementation of written Food Safety Plans.  Small animal food businesses with fewer than 500 full-time employees must implement Current Good Manufacturing Practices (CGMP) established by the animal food rule and will be expected to comply with remaining preventive controls requirements next year on September 17, 2018.

Compliance with preventive controls and CGMPs may involve considerable time and effort to achieve.  While FDA has stated that it does not plan to conduct routine inspections on these specific areas immediately, the agency has suggested that it may react in response to a food safety issue or complaint.  In order to ensure your facility is prepared for compliance at all times, Registrar Corp provides important information regarding what will be expected of covered food facilities this September.

What does compliance look like?

For larger animal food and smaller human food businesses:

Food businesses complying with preventive controls will be required to develop and implement written Food Safety Plans that feature an analysis of known or reasonably foreseeable food hazards as well as the measures required to prevent or minimize their threat to public health.  Within this plan, covered food facilities should document appropriate monitoring and verification of their specified preventive controls.  Examples include appropriate controls for Salmonella, appropriate controls for potential mycotoxins and for nutrient deficiencies or toxicities, and evidence that scientifically validates proposed preventive measures.

As part of this plan, FDA requires any covered food facility that identifies hazards needing preventive controls to develop a written recall plan.  The plan should establish detailed procedures that outline how the buyer of the food and the public will be notified of the recall and hazard in question.  It should also outline the steps that will be taken to verify that the recall is being enacted and the method that will be used to properly dispose of the recalled food.

Food Safety Plans can be complicated, and FDA requires a “Preventive Control Qualified Individual,” defined by FDA as an individual with appropriate training or job experience to effectively carry out the requirements under these regulations, to develop them.  Registrar Corp’s Regulatory Specialists possess the requisite qualifications to develop a Food Safety Plan for your facility.

For smaller animal food businesses:

Animal food facilities within this category will be required to implement and maintain CGMP standards outlined by FDA.  These standards focus upon fundamental food safety practices in regard to the manufacture of animal food.  Facilities will be required to ensure that daily operations limit possible food contamination from a variety of factors.

Staff in direct contact with food or food-contact surfaces should follow hygienic practices such as consistently washing hands and removing jewelry that could fall into batches of food.  Facility grounds should be properly maintained and free from litter and waste to exclude pests.  Additionally, the construction and layout of facilities should allow for proper cleaning, maintenance, and pest control, while taking measures to prevent potential contamination of food from factors such as condensation dripping off of pipes or fumes that need proper ventilation.

Not sure if your facility is properly following CGMP requirements?  Registrar Corp’s Food Safety Specialists can perform a Mock FDA inspection that identifies potential food safety violations and educates facility staff on FDA expectations.  Mock Inspections are included in Registrar Corp’s U.S. Agent service at no charge, aside from travel and lodging costs.

Registrar Corp assists companies with FDA compliance.  Our Regulatory Specialists are knowledgeable and experienced in the various aspects of FSMA and can help your food facility take the necessary steps to meet FDA’s extensive food safety requirements.  For more information, please call +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Has Started Inspecting U.S. Importers for FSVP Compliance

As of May 30, 2017, most U.S. importers of food and beverages for human and animal consumption are required to comply with the U.S. Food and Drug Administration’s (FDA) Foreign Supplier Verification Program (FSVP) rule.  Since the compliance deadline, Registrar Corp is aware that importers have begun receiving emails from FDA with the subject line: “FSVP Inspection Requirements, Handouts & Law.” This email informs importers of an upcoming FDA inspection to examine their compliance with FSVP requirements.  In light of these recent events, Registrar Corp provides importers with pertinent information to be prepared for a possible FSVP inspection.

What is a FSVP?

The FSVP rule requires U.S. importers of food and beverages to designate a “Qualified Individual,” defined by FDA as possessing either appropriate training or job experience reflecting the ability to develop a food safety system, to develop FSVPs for each food from each foreign supplier.  This means that multiple foods from a single supplier or multiple units of a single food from multiple suppliers each require individual FSVPs.  FSVPs require several components including hazard analysis, an evaluation of risk and supplier performance, documented supplier verification activities, and a plan for corrective actions should a supplier be found non-compliant.

In a single FSVP, a hazard analysis of the food item should be conducted, identifying any potential and foreseeable biological, chemical, or physical hazards that could cause illness or injury in the absence of preventive measures.  The importer should assess the probability and severity of the illness or injury should these measures not be implemented, while considering a diverse array of variables, such as manufacturing procedures, raw materials and ingredients, and the transportation, storage, and distribution of the food.

An evaluation of risk and supplier performance should consider the results of the hazard analysis while assessing the supplier’s food safety practices and procedures, its compliance with U.S. food safety regulations, as well as its history of correcting food safety problems to determine the level of health risk when importing from the supplier.  Importers should determine appropriate verification measures relative to the level of food safety risk the supplier poses.  Verification activities may include onsite audits, sampling, and/or review of the supplier’s food safety records.

Provided any food safety issues arise, an importer is required by FDA to take the proper steps toward correcting the issue with the supplier.  Corrective Actions may vary depending upon specific issues, and in severe cases, may require the importer ceasing business with the supplier until they are found compliant.  One such issue may be that a supplier is lacking a Food Safety Plan as required under the FSMA Preventive Controls rule.  Registrar Corp is experienced in the development of these plans and can assist the supplier in becoming compliant so both parties may continue business.

What Does a FSVP Inspection Look Like?

According to an interview with Sharon Mayl at FDA, FSVP inspections are not to be confused with traditional food facility inspections and consist of a document review. This review may examine whether an importer has detailed components required under the FSVP rule for the specified suppliers and food items.  The inspector may also look for evidence that FSVP procedures are followed between importer and supplier for the food items in question and that the importer is documenting appropriate analyses and verification activities, reviewed by a Qualified Individual.

Registrar Corp’s Regulatory Specialists can assist in developing appropriate FSVPs for your food items.  Additionally, Registrar Corp’s FDA Compliance Monitor can monitor suppliers’ compliance history as required under the rule and can serve as proof of compliance during a FDA FSVP inspection.

Registrar Corp assists food and beverage companies with FDA compliance.  For more information or assistance with specific FSVP requirements, please call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

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.





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