As with the series of Public Meetings held at the end of March 2011, last week’s Public Meeting focused on a particular aspect of the new Food Safety Modernization Act (FSMA) and offered the U.S. FDA an opportunity to listen and pose questions to industry leaders. The day-long meeting held on Wednesday, April 20th, was focused on FSMA’s preventative control requirements. Specific themes included: thresholds for small businesses; food safety documentation; and definitions of key terms, such as “low-risk,” “high-risk,” and activities that constitute on-farm manufacturing.
As Ms. Charlotte Christin of U.S. FDA explained, foodborne illness is a great public burden in the United States. Almost 75% of seafood consumed in the United States is imported, as well as large portions of the vegetable and fruit products consumed Stateside. It is therefore essential that food safety concerns be addressed. Time-old hazards are now occurring in new matrices. Couple that with the fact that our populace now has brand new food safety hazards that were unthinkable a hundred years ago, and it becomes clear that now, more than ever, U.S. FDA needs to take a preventative stance in controlling food safety hazards.
A major issue continually broached at this Public Meeting touched upon the government’s understanding of the difference between a small business and a large business. As FSMA allows for U.S. FDA to differentiate between the two and possibly create two separate sets of regulations for the two groups, this difference is crucial. Mr. Don Kraemer of the U.S. FDA explained that the administration may even create a tiered effectiveness timeline of requirements based on the size of the business, and may ultimately allow waivers for the very smallest of all businesses. U.S. FDA was urged to create detailed guidance documents to help businesses understand their new requirements.
Food safety documentation was another issue raised in multiple forums and breakout groups. While Mr. Don Kraemer explained that U.S. FDA expects that food safety documentation is already extensively created and kept among all food facilities, the question remains as to whether U.S. FDA will prescribe detailed requirements regarding timeframes, style, depth, and breadth of the records of the future. The burden, again, seemed to rest on the shoulders of small businesses who claimed, at this Public Meeting, to have less resources to be able to comply with potentially too-prescriptive regulations. Small businesses urged U.S. FDA to consider their fewer resources when writing regulations for required food safety documentation.
Another controversial topic rested among the various definitions of key terms. Indeed, as FSMA mentions “high-risk” foods in multiple aspects, it is imperative to understand what U.S. FDA will see as “high-risk” and “low-risk” foods and processes. Industry leaders were also curious as to what U.S. FDA will require as criteria and documentation for high-risk foods and feeds. Basic, fundamental terms need to be clearly defined in order for industry to ensure its compliance with the new law and future regulations.
While U.S. FDA could not provide answers in this forum, one thing is clear: there is no shortage of questions.
Registrar Corp will continue to provide critical updates as the debate progresses.
Registrar Institute, the educational arm of Registrar Corp, gives more than 10 seminars each year around the world. Earlier this month, Registrar Corp Vice President David Lennarz hosted an educational seminar for exporters and manufacturers in Vietnam to address U.S. FDA import regulations. In partnership with the Vietnam office of the American Chamber of Commerce, Mr. Lennarz discussed a range of concerns that companies face when preparing their products for sale in the United States including product labeling, prior notice, U.S. Agent, and facility registration requirements. Also addressed were the proposed requirements that international companies can anticipate according to the new Food Safety Modernization Act. Understanding all of these requirements can seem daunting for manufacturers and exporters, and our informational sessions are thorough in clarifying the complicated, technical, and variable regulations.
Below you will find Part I of this seminar entitled How to Meet U.S. Food and Drug Administration (FDA) Import Requirements:
For more informational videos from this and other seminars, subscribe to our YouTube channel. Similarly, if you would like to attend an informational seminar in your region and to have the opportunity to meet with Mr. Lennarz or any of the expert representatives at Registrar Corp, we provide a list of our upcoming sessions. Seminar registration is available at the Registrar Institute website. Although Registrar Corp provides a complete menu of services to address the various concerns of food, beverage, drug, medical device, and cosmetic industry professionals, the seminars we provide are always instructional and are not given with the intent to promote our services.
U.S. FDA held a series of Public Meetings during the week of March 28th. The first focused on the import components of the Food Safety Modernization Act (FSMA) and the second on comparability considerations. Both were held as an opportunity for U.S. FDA to gain insight from industry regarding best practices, current options, and future goals.
The import components of FSMA’s Title III proved to be largely undefined in the law as passed by U.S. Congress. Therefore, the Public Meeting held on March 29th was an opportunity for U.S. FDA to listen to suggestions and requests from industry leaders and gain information to use when defining future regulations. While no limit exists for written public input, which is due to U.S. FDA by April 29th, 2011, only a handful of industry leaders were able to gain speaking time during the one-day meeting. Those able to speak included a broad range of leaders, including those from third-party certification bodies like ANSI-ASQ, the Global Food Safety Initiative (GFSI), and GlobalGAP. During this meeting, U.S. FDA also hosted multiple breakout sessions wherein attendees could speak to U.S. FDA representatives in smaller groups focused on specific topics like the Voluntary Qualified Importer Program (VQIP), the Foreign Supplier Verification Program (FSVP), and Third-Party Certifications. U.S. FDA also heard from panels representing state governments and foreign country governments.
Similarly to the vague language of the import components, the comparability requirements are also largely undefined in the new law. The two-day Public Meeting, held from March 30 to March 31, was another opportunity for U.S. FDA to listen to the public’s opinions about how new regulations should be written regarding comparability of foreign governments. This two-day meeting hosted multiple panels and included many speakers representing foreign governments, including Canada, New Zealand, Australia, and the European Union. The U.S. FDA gave brief presentations on their past exploration in foreign government comparability test pilot programs and also heard from Ms. Mary Stanley, who spoke in detail about the USDA’s experience in certifying foreign governments in the agricultural sector. U.S. FDA listened to opinions from the National Association of Specialty Food Trade (NASFT), the U.S. Trade Office, and the United States CODEX Manager. In particular, the U.S. FDA asked many questions related to capacity building, registration of importers, particular details of comparability certification, and abilities of foreign governments to ensure that food is actually safe.
Over the three total days of Public Meetings, U.S. FDA heard varied and extensive opinions about how industry believes future regulations should be written. While U.S. FDA has undeniably large questions to answer, no clear solutions were provided. However, it is apparent that U.S. FDA has a valuable resource in the industry leaders that participated in this week’s event and had many options and concepts presented. Additionally, U.S. FDA has already scheduled another Public Meeting for April 20th, 2011, to learn more about industry’s opinions on in-facility food safety and preventative protocols. It seems U.S. FDA is listening, and as always, Registrar Corp will be actively engaged in the discussion as it develops.
Next week, we will further explain the proposed Voluntary Qualified Importer Program (VQIP) and Foreign Supplier Verification Program (FSVP) changes and what they mean for exporters, manufacturers, and other food industry professionals.
For more information about this and future U.S. FDA Public Meetings, contact us at [email protected]
Last week, employees from our Registrar Corp – Egypt office location attended the Egypt International Seafood and Fisheries Expo in Cairo. Among the crowd of over 50,000 participants, we had the opportunity to meet clients face-to-face and promote our services to seafood processors, exporters, and manufacturers eager to expand their businesses to the United States market.
EGY Seafood Expo is the first specialized exhibition for international seafood to be held in Cairo, and has opened more opportunities for industry professionals in the emerging Middle East seafood market. During the trade show, our employees learned of new policies for sustainable fishing and processing that have made Egypt and the Middle East ideal seafood manufacturers and exporters. Our employees were able to assist dozens of interested companies with questions about U.S. FDA compliance, and we returned completely inspired by the amount of inquiries we received regarding our prior notice, US Agent, and registration services.
The EGY Seafood Expo is just one of over fifty trade shows Registrar Corp employees will attend this year. For more information about when we will be attending an event near you and to schedule a meeting with our expert employees, visit our Exhibitions Page.
UPCOMING: Registrar Corp will be at INTERPHEX China 21-23 April 2011. Schedule a meeting with us today!
Over 20% of all cosmetic products sold in the United States are sold in the state of California. Many of these cosmetics were initially wholesaled elsewhere and are later transported to California for retail sale. The California Safe Cosmetics Program requires manufacturers, packers and distributors identified on the cosmetic label to file a list of all their cosmetic products that contain any ingredients identified by California as known or suspected to cause cancer, birth defects, or adverse developmental or other reproductive toxicity, including colors and fragrances. Reports must be filed even if the cosmetic product has been discontinued or reformulated since 2007. California maintains a growing list of these cosmetic ingredients and has recently added new ingredients to their list. Any cosmetic product sold in California that contains an ingredient on the California list must be reported. Failure to report is a criminal offense, so it is important to verify whether your cosmetic product contains any of these ingredients, including newly added ingredients, and to verify that your cosmetic products are properly reported.
Registrar Corp assists companies with U.S. cosmetic regulations, including helping to determine if your company’s cosmetic ingredients trigger California’s cosmetic reporting requirements. If a cosmetic must be reported, Registrar Corp can assist with filing the appropriate reports. For more information, go to: http://www.RegistrarCorp.com/California-Cosmetics
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The FDA Food Safety Modernization Act (the Act) was signed into law by President Obama on January 4, 2011. The date of signing affects the timing of enforcement for various requirements. Registrar Corp has analyzed the FDA Food Safety Modernization Act to provide industry with the following timeline of anticipated events:
Changes Effective Immediately
- FDA is granted new power to enter food facilities (except farms and restaurants) and inspect and copy records. This power may be exercised if FDA believes that there is a reasonable probability that the use or exposure to an article of food will cause serious adverse health consequences to humans or animals.
- FDA may begin the process of establishing and setting reinspection fees. FDA must specify in the Federal Register the time and manner in which assessed fees will be collected, and must set fees in accordance with a procedure that will take time to go into effect.
- FDA may issue export certificates for food, and may charge fees for such certificates.
On or before Monday, April 4, 2011:
- FDA’s web site will be updated to include a search engine that is consumer friendly. The website will provide a means by which an individual may locate relevant information regarding each article of food subject to a recall and the status of the recall.
- The Comptroller General will submit a report to Congress concerning State and local recall authority, as well as any mandatory recall authority by federal agencies other than FDA. The report will identify the agencies with the authority to require the mandatory recall of food, and evaluate frequency, effectiveness, and appropriateness. In addition, the report will include consideration of any new or existing mechanisms available to compensate persons for general and specific recall-related costs when a recall is subsequently determined by the relevant authority to have been an error.
On or before Wednesday, May 4, 2011:
- FDA will issue interim final rules concerning Administrative Detention of Food.
- FDA will issue new interim final rules concerning Prior Notice of Imported Food Shipments.
No later than July 3, 2011:
- FDA empowered to suspend food facility registration
- FDA may suspend registration (effectively closing) of any facility that:
– created, caused or was responsible for food having a reasonable probability of having adverse health consequences for humans or animals, or
– knew or had reason to know of such reasonable probability, and packed, received or held such food
- No person shall import or export food from a suspended facility, or otherwise introduce such food into commerce in the USA.
- FDA may extend the suspension of registration until it determines that adequate grounds do not exist to continue the suspension.
- FDA may require “corrective action plans” from suspended facilities.
- FDA will issue a small entity compliance guide within 180 days of issuing the interim regulations concerning facility registration.
- FDA and USDA will issue contaminant-specific and science based guidance documents regarding action levels, tolerances or regulation, based on studies to be conducted at least every two years.
- FDA will update the Fish and Fisheries Products HACCP Guidance to take into account advances in technology that have occurred since the previous publication.
- FDA will publish a guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement must document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient.
- FDA will report on the progress made in implementing a national food emergency response laboratory network. This report will be prepared in coordination with USDA, DHS, and State, local, and tribal governments, and it will be publicly available on the FDA Web site.
- FDA and USDA will establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance.
- FDA will establish a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food industry, including food retailers and food manufacturers, consumer organizations, and academia, to make recommendations to the Secretary regarding designations of the Centers of Excellence.
- FDA will develop and implement a strategy to better identify smuggled food and prevent entry of such food into the United States. This plan will be developed in coordination with DHS.
On or before October 1, 2011:
- FDA will establish pilot projects (in coordination with industry) to evaluate methods of effectively identifying recipients of food so as to prevent or mitigate a foodborne illness outbreak. The pilot projects will also address credible threats of serious adverse health consequences as a result of such food being adulterated or misbranded.
On or before October 4, 2011:
- FDA will publish a notice of proposed rulemaking in the Federal Register to promulgate regulations that further define farms and exemptions applicable to farms. Specifically, the regulations will address:
– activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, and
– activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership.
On or before January 4, 2012:
- FDA will issue new rules for produce safety. The rules will be staggered to give priority to specific fruits and vegetables based on known risks and history of incidents. FDA is required to coordinate with the USDA, Department of Homeland Security, and state agriculture authorities, and must hold a minimum of 3 public meetings in diverse geographical areas of the U.S. to obtain public input.
- FDA will issue guidance documents for producers and importers of fruits and vegetables, and will hold at least 3 public educational meetings in diverse geographical areas. Within 180 days after regulations are issued, FDA will publish an additional small entity compliance guide.
- FDA will issue guidance documents concerning protection against intentional adulteration of food.
- FDA will prepare and publish a National Agriculture and Food Defense Strategy. The strategy will be presented to Congress and available on the websites of the FDA and USDA. The plan will be revised at least every four years. An annual evaluation of each program shall be conducted to determine the effectiveness in achieving legislated intent, purposes, and objectives.
- FDA will conduct a study regarding the need for, and challenges associated with, development and implementation of a program that would require a unique identification number for each food facility and each broker that imports food into the United States. The study will include an evaluation of the costs associated with development and implementation of such a system, and make recommendations about what new authorities, if any, would be necessary to develop and implement such a system. A report of this study must be submitted to Congress by this date.
- FDA will develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs. The guidelines will be developed in consultation with the Department of Education and will be available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only.
- FDA will designate high-risk foods for which additional record-keeping requirements are appropriate and necessary to protect public health.
- FDA will complete a review of State and local capacities, and needs for enhancement. The review may include a survey with respect to staffing levels and available expertise to perform food safety functions; laboratory capacity to support surveillance, inspection, outbreak response, and enforcement activities; and information systems to support data management and sharing of food safety and defense information among State and local agencies and with counterparts at the Federal level.
- FDA will designate 5 Integrated Food Safety Centers of Excellence to serve as resources for Federal, State, and local public health professionals to respond to foodborne illness outbreaks. These centers shall be headquartered at selected State health departments
- FDA will develop additional instructions for grocery stores in announcing recalls. It will develop and publish a list of acceptable conspicuous locations and manners that shall include posting the notification near the register, providing the location of the reportable food, providing targeted recall information, and other such prominent and conspicuous locations and manners utilized by grocery stores to provide notice of such recalls to consumers.
- FDA will promulgate regulations to provide for the content of the foreign supplier verification program.
- FDA will issue guidance to assist importers in developing foreign supplier verification programs.
- FDA will develop a comprehensive plan to extend the technical, scientific, and regulatory food safety capacity of foreign governments, and their respective food industries, from which foods are exported to the United States.
- FDA will establish a system for the recognition of accreditation bodies that accredit third-party auditors.
On or before July 4, 2012:
- FDA will issue HACCP Regulations for all products except seafood and juice (which are already subject to HACCP regulations).
- FDA will report to Congress on the results of a study of the food-processing sector mandated by the statute. The study is to determine:
– the distribution of food production by size and type of operation, including the monetary values of food sold,
– the proportion of food produced by each type and size of operation,
– the number and types of food facilities co-located on farms, segregated by commodity and by manufacturing or processing activity, and
– the incidence of foodborne illness originating from each size and type of operation, and assessments of risk of foodborne illness associated with commingling, processing, transporting and storing food and raw agricultural commodities.
- FDA will issue regulations to protect against intentional adulteration of food. Farms will be exempt, except those that produce milk.
- FDA will report to Congress on the findings of the pilot projects with recommendations for improving the tracking and tracing of food.
- The reportable food registry may be enhanced. FDA may require a responsible party to submit to the Secretary consumer-oriented information regarding reportable food, including a description of the article of food, product identification codes such as UPC, SKU, lot or batch numbers, and contact information for the responsible party.
- FDA, in consultation with DHS, shall establish a qualified importer program. The program will provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such a program. It will also establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such a program.
- FDA will develop model standards, including requirements for regulatory audit reports. Each recognized accreditation body must ensure that third-party auditors and audit agents of such auditors meet such standards.
- FDA will promulgate regulations concerning third party auditors, standards, accreditation, and against conflicts of interest between an accredited third-party auditor and the eligible entity to be certified by such auditor or audited by such audit agent. The regulations must include requiring that audits performed under this Section be unannounced, a structure to decrease the potential conflicts of interest, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors, and appropriate limits on financial affiliations between an accredited third-party auditor or audit agents of such auditor and any person that owns or operates an eligible entity to be certified by such auditor.
On or before, January 4, 2013:
- FDA will submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food, and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities. The report will be prepared in consultation with DHS and USDA.
- FDA will establish a program for the testing of food by accredited laboratories, and establish a publicly available registry of accreditation bodies and laboratories accredited by a recognized accreditation body.
- FDA will publish a notice of proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that the FDA designates as high-risk foods.
- FDA will submit a report on the use of recall authority and any public health advisories issued by the Secretary that advise against the consumption of an article of food on the ground that the article of food is adulterated and poses an imminent danger to health.
- FDA will submit a report that describes the effectiveness of the Centers of Excellence and provides legislative recommendations or describes additional resources required by the Centers of Excellence.
On or before July 4, 2013:
- Only Federal laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies may conduct food testing. Accreditation must be by a recognized accreditation body on the registry, which is established by the Secretary.
On or before January 4, 2016:
- FDA may eliminate paper food facility registration, and may require that facility registration be submitted in electronic format.
The above timeline is subject to change. If you have specific questions or concerns about implementation of the FDA Food Safety Modernization Act, please contact Registrar Corp in the U.S. or contact any of Registrar Corp’s Regional Offices around the world.
The FDA Food Safety Modernization Act was enacted by the U.S. Congress and signed into law by President Obama on January 4, 2011. The law creates the most significant changes to the U.S. food production and distribution system in more than seventy years. It imposes broad new requirements on manufacturers, processors, packers and distributors of food, and grants U.S. FDA sweeping new enforcement powers. To assist food industry professionals, Registrar Corp has analyzed the new law and provides the following information that all food industry professionals should know about the new law:
1. Most of the provisions of the new law require U.S. FDA to issue regulations providing the details. The specific requirements will depend on these regulations to be issued over the next two years. Registrar Corp will provide updates as these regulations are issued.
2. Commencing in 2012, each food facility must renew its U.S. FDA registration biennially (every two years). Renewal registrations will be required during the 4th quarter of every even-numbered year (i.e., 2012, 2014, 2016, etc.). Facilities located outside the United States continue to be required to designate a U.S. Agent for U.S. FDA communications, as established by the U.S. Bioterrorism Act of 2002.
3. As part of each company’s food facility registration, the company will be required to agree to permit inspection by U.S. FDA. The law does not require U.S. FDA to inspect all facilities, but it increases the number of inspections and requires all firms to agree to an inspection upon U.S. FDA request. A company may be required to pay for any required re-inspection. This part of the law will become effective no later than July 4, 2011.
4. The law grants power to U.S. FDA to suspend a company’s food facility registration if U.S. FDA believes that food manufactured, processed, packed, received, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals. This part of the law will become effective no later than July 4, 2011. The law also grants U.S. FDA the power to order, rather than merely request, the recall of tainted food.
5. The law imposes new requirements on persons designated in food facility registrations as U.S. Agents for food facilities located outside the U.S. FDA may bill the U.S. Agent for the cost of any re-inspection conducted of the facility.
6. The law directs U.S. FDA to hire a significant number of new field staff to carry out its purposes, between now and 2014. An additional 150 employees will be hired immediately, dedicated to detecting and tracking food threats, as well as “smuggled food.” The law defines “smuggled food” as “any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead.”
7. Food facilities will be required to develop written plans for hazard analysis, preventive controls and corrective measures, to be updated with each change in operations or every three years, whichever is more frequent. These records must be available for U.S. FDA inspection. Specific regulations will be promulgated by U.S. FDA. Small businesses may be exempt from the more stringent of these requirements. A small business is defined as one with sales of less than $500,000 per year, which must be mostly to local restaurants or retailers and to consumers. The upcoming regulations will provide details.
8. Importers will be required to establish programs to verify the safety of all shipments of imported food, and U.S. FDA may require certifications of safety for each shipment. Regulations implementing these requirements are due by January 4, 2012. U.S. FDA may establish a Qualified Importer program, easing requirements for some importers, by July 4, 2012.
9. U.S. FDA will provide for the recognition of accreditation bodies that accredit laboratories, including laboratories outside the United States, with a demonstrated capability to conduct analytical testing of food products. Regulations implementing this provision are due by January 4, 2013.
10. Registrar Corp will be available to assist you as each of these new requirements take effect and as new regulations are promulgated.
To view the full text of the FDA Food Safety Modernization Act, click here.
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WASHINGTON – Today, the U.S. Senate passed a sweeping overhaul of the USA’s food safety system (S.510). The FDA Food Safety Modernization Act, which passed by a vote of 73 to 25, would greatly strengthen the U.S. Food and Drug Administration, and increase requirements on companies in the food industry.
Major points of the FDA Food Safety Modernization Act include:
- The U.S. FDA would have new powers to demand recall of tainted foods, instead of merely requesting that companies recall products.
- An increase in the number of U.S. FDA inspections of food processing plants, with an emphasis on foods that are considered most high risk.
- The U.S. FDA will have increased control over food imports, including increased inspection of foreign processing plants.
For a bill to become law in the USA, it must pass both houses of Congress (the Senate and the House of Representatives), and it must be signed by the President. The House passed a different version of the bill in July 2009. Despite today’s unusual bipartisan support and a strong push from the Obama administration, the FDA Food Safety Modernization Act could stall if it cannot be reconciled between the Senate and House of Representatives. Top House Democrats said that they would consider simply passing the Senate version to speed approval.
The Senate version requires biennial U.S. FDA food facility registration, and does not impose a registration fee.
The House version (The Food Safety Enhancement Act of 2009) requires annual U.S. FDA food facility registration and imposes a $500 registration fee.
Both versions have additional requirements for non-U.S. processors. Registrar Corp will provide you with more information when the final, reconciled bill becomes law. After it becomes law, the U.S. FDA will issue implementing regulations, which we also will advise you about, when those are promulgated.