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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 Removed 28% of Food Facility Registrations from its Database in 2017

FDA Food Facility Registration Statistics (2017)

There were 149,933 food facilities registered with the U.S. Food and Drug Administration (FDA) as of February 2, 2017.  Of those registered facilities, 70,976 (47%) were outside of the United States. See the number of registrations by country here.

The ten countries with the largest number of FDA registered food facilities remain the same in 2017 as those reported in 2016:

United States (78957)
Japan (9211)
France (7336)
Italy (6169)
China (5236)
Mexico (4499)
Canada (4169)
Spain (3208)
Republic of Korea (2393)
India (1944)

Earlier research revealed there were 207,653 food facilities registered with FDA on January 1, 2016, meaning there was a 28% decrease in the number of registered facilities between then and February 2017.  This steep drop in registered facilities is likely due to FDA removing food facility registrations that were not properly renewed by December 31, 2016 from its registration database

This drop in registered facilities is greater than the 14% drop that occurred after the 2014 renewal period.  This is likely due to new verification requirements implemented during the 2016 renewal period.  Food facilities located outside of the United States are required to designate a U.S. Agent for FDA Communications in their registration renewal.  Unlike in previous years, individuals or entities listed as U.S. Agents in 2016 were required to confirm with FDA acceptance of their designation and corresponding responsibility.  FDA did not consider a facility’s 2016 renewal confirmed unless the designated U.S. Agent affirmatively agreed in writing. If a foreign facility submitted its registration renewal but its U.S. Agent did not affirmatively agree, its registration was removed from FDA’s food facility registration database.

Manufacturing, processing, packing, or storing food for US consumption without a valid FDA registration is a prohibited act.  Many facilities do not realize that FDA removed their registrations until problems occur.  To avoid costly detentions or regulatory action, it’s prudent for all food facilities to verify that their FDA registrations were properly renewed for 2017 before continuing with business as usual.  This is especially true for food facilities located outside the U.S.  Registrar Corp will verify that your FDA food facility registration was properly renewed at no cost.  Facilities that need a U.S. Agent may retain Registrar Corp.  Simply contact Registrar Corp 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

Registrar Corp Launches FCE Wizard and SID Verifier to Assist with FDA Requirements for Food Canning Establishment

On February 14, Registrar Corp, a U.S. Food and Drug Administration (FDA) consulting firm, launched two free tools to assist food facilities in complying with FDA requirements for Low-Acid Canned and Acidified Foods.

Most facilities that manufacture, process, pack, or store food intended for consumption in the United States are required to register with U.S. FDA as food facilities. Food facilities that produce certain shelf-stable, hermetically-sealed low-acid canned or acidified foods must also obtain a Food Canning Establishment (FCE) registration.  FDA requires FCE manufacturers to file documentation for each process used in the production of Low-Acid Canned and Acidified Foods and assigns unique “Submission Identifiers” (SIDs) to each of these “Process Filings.” Common examples of foods subject to FDA’s FCE and SID requirements include canned tuna, canned roasted red peppers, and coconut water.

Registrar Corp’s FCE Wizard allows users to identify whether their products are subject to these FDA FCE and SID regulations. Users simply answer a few questions, and the FCE Wizard generates a free report indicating possible requirements for each of the facility’s products based on factors such as pH, water activity, and ingredients.

For individuals aware that their products are subject to FCE-SID requirements but uncertain if a particular SID remains valid, Registrar Corp has developed the SID Verifier.  Registrar Corp’s SID Verifier allows users to verify whether SIDs are currently on file in FDA’s database.  Manufacturers, importers, and customs brokers filing entries of Low-Acid Canned and Acidified Foods will find this tool especially helpful, as valid SIDs must be submitted as “Affirmation of Compliance Codes” (AofC) when importing these products into the United States.  Verifying SIDs before filing can help avoid time-consuming detentions and entry errors that may lead to low filer evaluations.

Registrar Corp’s team of FCE specialists provides assistance with the FCE registration process and offers guidance as to required elements, formats, and particularities of SID submissions.  For further assistance with FDA FCE and SID requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

To use Registrar Corp’s FCE Wizard, click here.
To use Registrar Corp’s SID Verifier, click here.

This blog was originally published as a press release.

FDA Removes Thousands of Expired Food Facility Registrations from its Database

On February 1, 2017, the U.S. Food and Drug Administration (FDA) removed all food facility registrations that were not properly renewed for 2017 from its registration database.  Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their FDA registrations between October 1 and December 31 of each even-numbered year.  FDA considers any registrations not renewed by the deadline to be expired and removes these registrations from its database. Once removed, registration numbers typically cannot be reinstated.  Facilities with expired registrations will need to re-register with FDA and obtain a new registration number before they manufacture, process, pack, or store food, beverages, or dietary supplements to be consumed in the United States.

14% of food facilities registered with FDA were removed from FDA’s database after the 2014 renewal period.   Registrar Corp Vice President David Lennarz predicts that the drop in registrations may be even greater this year due to new verification requirements implemented during the 2016 renewal period.  Food facilities located outside of the United States are required to designate a U.S. Agent for FDA Communications in their registration renewal.  Unlike in previous years, individuals or entities listed as U.S. Agents in 2016 were required confirm with FDA acceptance of their designation and corresponding responsibility.

Prior to this new verification step, a U.S. Agent could be designated in a foreign facility’s renewal without the U.S. Agent’s affirmative written agreement.  Many persons previously designated as U.S. Agents would have preferred to decline because a foreign facility’s U.S. Agent is liable for financial obligations, including payment of any FDA re-inspection fees related to the facility. The re-inspection fee rate for foreign facilities for Fiscal Year 2017 is $285 per hour (81 FR 50525).  FDA may bill for every aspect of a re-inspection, including time spent preparing and traveling, so the fees can quickly add up to thousands of dollars.  FDA also contacts U.S. Agents regarding shipments, inspection scheduling, and other regulatory matters.  These matters often require an immediate response.

In 2016, FDA addressed the issue by implementing the new verification procedures.  The agency does not consider a facility’s 2016 renewal confirmed unless the designated U.S. Agent affirmatively agreed in writing. If a foreign facility submitted its registration renewal but its U.S. Agent did not affirmatively agree, its registration will have been removed from FDA’s food facility registration database.

To avoid costly detentions or regulatory action, it’s prudent for all food facilities to verify that their FDA registrations were properly renewed for 2017 before continuing with business as usual.  This is especially true for food facilities located outside the U.S.  Registrar Corp will verify that your FDA food facility registration was properly renewed for 2017 at no cost.  Facilities that need a U.S. Agent may retain Registrar Corp.  Simply contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

This blog 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.

 

2016 Round Up – U.S. FDA Food Regulations

2016 proved to be a landmark year for the U.S. Food and Drug Administration (FDA).  The agency wrapped up the finalization of major rules under the Food Safety Modernization Act (FSMA), as well as finalized long-awaited rules that mandate a complete overhaul of food and beverage labeling.  This article presents an overview of the past year in FDA regulations for food and beverage companies.

FDA Finalized the Sanitary Transportation Rule under FSMA

In April, FDA published its final rule for Sanitary Transportation of Human and Animal Food.  The Sanitary Transportation Rule was the sixth major rule to be finalized under FSMA.  The rule created requirements for shippers, loaders, carriers, and receivers of human and animal food transported by motor or rail vehicle within the United States to use sanitary practices to prevent contamination of food during transportation. Most covered businesses are required to comply by April 6, 2017.   Read here to learn about specific requirements of FDA’s Sanitary Transportation rule.

Canada’s Food Safety Systems were Recognized as Comparable to the US

In May, FDA, the Canadian Food Inspection Agency, and the Department of Health Canada signed a Food Safety Systems Recognition Arrangement.  Canada’s food safety systems are now recognized as providing public health protection comparable to those of the United States.  This means that facilities exporting from Canada and importers importing from Canada benefit from certain modifications and exemptions under FSMA.  For example, importers are exempt from the FSVP requirements of conducting a hazard analysis, approving and verifying suppliers, and conducting FSVP activities for their Canadian suppliers, so long as those suppliers are in good compliance standing with their country.

FDA Finalized Changes to Food Labeling

On May 20, FDA finalized two rules that mandate significant changes to labeling of food and beverages.  Changes range from cosmetic (i.e., a larger font size for calories and serving sizes) to new additions (i.e., adding a line for added sugars and adding vitamin D and potassium as listed nutrients) to data-driven (i.e., new daily value calculations for sodium, dietary fiber, and vitamin D).  Most facilities must comply by July 26, 2018.

FDA Finalized the Intentional Adulteration Rule under FSMA

On May 27, FDA published its final rule for “Mitigation Strategies To Protect Food Against Intentional Adulteration,” the last of the seven major FSMA rules.  FDA’s Intentional Adulteration rule requires facilities registered with FDA to develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility.  A facility’s Food Defense Plan must include a vulnerability assessment, mitigation strategies for each identified vulnerability, and a plan to continuously ensure proper and effective implementation of those strategies.  Most facilities are required to comply by May 2019.  Read here to learn more.

FDA Finalized Amendments to Food Facility Registration

In July, FDA published a final rule in an effort to improve the accuracy of the agency’s registration database.  The rule, titled “Amendments to Registration of Food Facilities”, made numerous changes to FDA’s registration requirements and codified some rules that were implemented upon the enactment of FSMA (i.e., registration renewal requirements and inspection permissions).  Some amendments were immediate, such as updates to product and activity categories. Others do not take effect until 2020.  In January 2020, FDA will require food facilities to submit their registrations electronically, and in October 2020, FDA will require facilities to list Unique Facility Identifiers (UFI) in their registrations.  Read here to learn more.

FDA Opened Up The Term “Healthy” For Discussion

In September, FDA published a request for information regarding the term “healthy”.   The decision was sparked by the agency’s desire to reflect current nutrition science as well as petitioning by industry.  FDA is accepting comments through January 26, 2017.  Until the agency lands on a new definition, it is using enforcement discretion to allow manufacturers to use the term “healthy” to describe products that:

  • Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
  • Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

These are but some highlights in a busy year for FDA food industry regulators.  Registrar Corp will continue to work to keep industry updated through 2017.  For assistance with U.S. FDA regulations, 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.

This blog was originally published as an article in Food Online.

ACE Has Reduced FDA Review Times at the Ports Dramatically

On November 29, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule that establishes requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) system and other authorized systems.

FDA, along with 46 other government agencies, is implementing ACE in collaboration with U.S. Customs and Border Protection (CBP). Some requirements established in the rule include:

  • Clarification that FDA may reject an import filing for failure to provide required data elements
  • Clarification that written notice can be provided electronically by FDA to owners or consignees of FDA actions to refuse and/or subject certain products to administrative destruction
  • FDA is now allowed to provide notice of sampling directly to an owner or consignee

ACE is a “commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy.” ACE replaces the Automated Commercial System (ACS), the current commercial database used to submit data through CPB to FDA. FDA plans for ACE to be fully functional by December 29, 2016.

There are several benefits to ACE. FDA reports in the final rule that ACE has dramatically reduced the inspection and review times at U.S. ports for customs brokers and importers registered with the ACE system. The average processing time for manual review of ACS-submitted entries was about 28 hours in 2015, and that has been reduced to less than 2 hours in ACE.  The automated “May Proceed” determination has been reduced from approximately 7.1 minutes in ACS to approximately 2 minutes in ACE.  According to John Verbeten, Acting Director of Import Operations, “since July 23 when ACE became required for all FDA entries, ‘May Proceed’ determinations are now issued for 72% of entries, up from 50% before ACE.” ACE also provides cost savings to both the industry and FDA.

In June 2016, Registrar Corp published this blog to help importers and brokers avoid common errors made when filing in ACE.  Brokers and importers may receive further assistance with ACE filings by e-mailing FDA at [email protected].

For more information on regulations for importing FDA-regulated products to the United States or how Registrar Corp can assist, contact us at
+1-757-224-0177.  Live help is available 24-hours a day at www.registrarcorp.com/livehelp.

 

FDA Issues Final Guidance on its Voluntary Qualified Importer Program

On November 10, 2016, the U. S. Food and Drug Administration (FDA) announced a final guidance for its Voluntary Qualified Importer Program (VQIP). VQIP is a “fee-based program to allow the expedited review and importation of foods into the United States from importers with a proven track record of food safety and security.” FDA expects to begin accepting applications for VQIP participation on January 1, 2018. Program benefits for accepted applicants will begin on October 1, 2018.

The guidance is in a question-answer format to better explain to importers how the program will work. Some examples of questions included in the guidance are below:

Q: What are the benefits of VQIP participation?

A: There are several benefits for importers who chose to participate in VQIP. These include:

  • Expedited entry into the U.S. for foods included on an approved VQIP application
  • Examination and sampling will be limited to situations where public health is at risk
  • Expedited laboratory analysis of samples
  • Sampling will be conducted at importer’s location of choice when possible
  • Access to VQIP Importers Help Desk
  • Importer is listed on FDA’s public VQIP list

Q: Who is eligible?

A: Importers, which are defined as “the person who brings food, or causes food to be brought, from a foreign country into the United States,” are eligible to participate in VQIP so long as they meet the following criteria:

  • Importer must develop and implement a Quality Assurance Program (QAP)
  • Importer must comply with supplier verification and other requirements under FSVP and HACCP
  • Each foreign supplier of food intended for importation under VQIP must be certified under FDA’s Accredited Third-Party Certification
  • Importer must have at least three years of experience importing food to the U.S.
  • Importer and its supply chain cannot have any outstanding FDA judicial or administrative action against the food facility and no other history of non-compliance with food safety regulations.
  • Importer must have a Data Universal Numbering System (DUNS) number

Q: How do I apply?

A: Importers who wish to apply for VQIP must establish an online account on the FDA Industry Systems website. After an online account has been established, importers will submit an online “Notice of Intent to Participate” in VQIP from January 1 to May 31 each year. Complete instructions for submission of a VQIP application can be found here.  Applications must be renewed annually.

Q: Is there a user fee to participate in VQIP?

A: Yes, importers participating in VQIP are required to pay an annual fee to cover the cost of administering the program. In June 2015, FDA estimated fees would total $16,400. FDA will finalize fees for January 2018 by August 1, 2017. Fees must be paid by the beginning of the VQIP year (October 1) to receive benefits under the program.

Q: What kinds of foods are allowed under VQIP?
A: Food from both farms and facilities may be imported under VQIP so long as they are certified under FDA’s Accredited Third-Party Certification regulations for having appropriate food safety practices are allowed under VQI and are not subject to an import alert or Class 1 recall.

Q: Can the FDA revoke my participation in VQIP and how will I be notified?

A: Yes, FDA may revoke participation in VQIP for violating one or more of the program eligibility criteria, or participating in smuggling or other fraudulent activities. FDA will notify the contact person identified on your VQIP application with a “Notice of Intent to Revoke” your participation in VQIP by email.

Q: Can I obtain reinstatement of my participation in VQIP after a revocation?

A: Yes, you can obtain reinstatement of participation in VQIP after a revocation. Reinstatement may be requested after you have corrected any issues associated with your revocation. The request should include documentation of actions that have been taken to resolve the issues.

For more information on FDA’s final VQIP guidance, register for Registrar Corp’s free webinar on Wednesday, December 21.

Registrar Corp can help U.S. food importers obtain eligibility for VQIP participation. Registrar Corp’s FDA Compliance Monitor allows importers to monitor food facilities around the world for FDA Import Alerts. Registrar Corp can also help facilities obtain a DUNS number at no cost. You may contact Registrar Corp for more information at anytime by phone at 1-757-224-0177 or by 24-hour online chat at http://www.registrarcorp.com/livehelp.

 

 





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