Food

Frequently Asked Questions

Questions & Answers on the Food Safety Modernization Act

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General

Federal/State Integration

Fees

Food Defense

Imports 

Inspection and Compliance

Product Tracing

Proposed Rules

Sanitary Transportation of Human and Animal Food

Scope

World Trade Organization (WTO)

More on Dockets, Guidance, Laws, and Regulations


General

G.1 How big a problem is foodborne illness in this country?
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention.  This is a significant public health burden that is largely preventable.

G.2 Why is this law needed? 
Foodborne illness is largely preventable if everyone in today’s global food chain could be held responsible and accountable at each step for controlling hazards that can cause illness. Under the new law, FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in our approach to food safety.  For example, for the first time, FDA has a legislative mandate to require comprehensive, preventive-based controls across the food supply chain.  Preventive controls include steps that a food facility would take to prevent or significantly minimize the likelihood of problems occurring.  The new law also significantly enhances FDA’s ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year. 

G.3 What are the major elements of the law?
The elements can be divided into five key areas:  

  • Preventive controls- For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. 
  • Inspection and Compliance- The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to  produce safe food; thus, the law specifies how often FDA should inspect food producers. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches. 
  • Imported Food Safety-  FDA has new tools to ensure that those imported foods meet US standards and are safe for our consumers.   For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards. 
  • Response- For the first time, FDA will have mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls. 
  • Enhanced Partnerships- The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign--to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials. 

G.4 How long will it take before our food system is made safer? 
A long-term process will be needed to build a new food safety system based on prevention.  Congress has established specific implementation dates in the legislation.  Some authorities will go into effect quickly, such as mandatory recall authority, and others require FDA to prepare and issue regulations and guidance documents.  FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.   

G.5 Does FDA have sufficient funding to implement the new rule? 
The funding we have available through the annual budget cycle and fees impacts the number of FTEs we have and will be a factor in the way that FDA handles its significant and far-ranging activities, including the way that this legislation is implemented. For example, the inspection schedule in the legislation would increase the burden on FDA’s inspection functions. Without additional funding, FDA will be challenged in implementing the legislation fully without compromising other key functions. We look forward to working with Congress and our partners to ensure that FDA is funded sufficiently to achieve our food safety and food defense goals. 

G.6 How will this law make imported food safer? 
U.S. consumers enjoy the benefit of imported foods from more than 150 countries. The Food Safety Modernization Act (FSMA) gives FDA new tools to ensure that those imported foods meet US standards and are safe for US consumers. New authorities under the Act include:

  • Importer Accountability - importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety 
  • Third Party Certification - FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with US food safety standards;
  • High Risk Foods - FDA now has the authority to require that high-risk imported foods be accompanied by a credible third-party certification as a condition of admission into this country 
  • Refusals - FDA now has the authority to refuse entry into the US of a food that has refused U.S. inspection.
  • Additional Resources are directed toward foreign inspections

FDA expects to hold briefings on the new legislation for its colleagues in embassies in Washington, and to brief the World Trade Organization on the new legislation. 

G.7 How does this Act change the way FDA regulates foods? 
This new law puts prevention up front for FDA. For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply.  Under the Act, implementation of mandatory preventive controls for food facilities and compliance with mandatory produce safety standards will be required.  FDA is in the process of developing a proposed rule that will establish science-based minimum standards for the safe production and harvesting of fruits and vegetables and will address soil amendments, worker health and hygiene, packaging, temperature controls, water, and other issues.  Food facilities will be required to implement a written preventive control plan, provide for the monitoring of the performance of those controls, and specify the corrective actions the facility will take when necessary.

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Federal/State Integration

FS.1 Does FSMA change any of the authorities over food safety currently divided between FDA and USDA?
No. However, FSMA does provide for FDA and USDA and other federal and state/local food safety agencies to work together more closely. 

FS.2 How will State, local, tribal and territorial agencies provide input into the sections of FSMA dedicated to enhanced partnerships?
Individuals from States, localities, tribes, and territories as well as affiliated organizations will have the opportunity to provide input through a series of project teams. One of the primary methods of input is through the Partnership for Food Protection (PFP). The PFP is a group of dedicated workers from Federal, State, and local governments with roles in protecting the food supply and public health. The PFP workgroups were formed following 50-state workshops in 2008 and 2010 and are working directly with members of FDA to improve food safety at all levels of government. View the Final Report from the 2012 50 State Workshop.

FS.3 How will FSMA support the vision of an Integrated Food Safety System (IFSS)?
FSMA calls for enhanced partnerships and integration with our Federal, State, local, tribal and territorial partners. The Partnership for Food Protection (PFP), of which FDA is a member, has been working to develop an integrated food safety system with strengthened inspection, laboratory, and response capacity. The Federal-State Integration team has been and will continue working closely with State, local, tribal, and territorial partners to develop and implement the IFSS. Examples of current ongoing activities include efforts to standardize training and expertise levels of inspectors. Another example of integration is the effort to develop national standards for federal, state, and local laboratories.  These national standards, including laboratory accreditation, will increase the efficiency of the laboratories in responding to outbreaks and facilitate the rapid acceptance of lab analytical data for regulatory actions. The efforts of the PFP workgroups together with the agency’s implementation of provisions of FSMA that support enhanced partnerships will further develop the IFSS. To access the full vision document for the IFSS, got to Establishing a Fully Integrated National Food Safety System with Strengthened Inspection, Laboratory and Response Capacity.

FS.4 With the current financial state of many State and local health agencies, how will State and local governments be able to assist FDA in implementing new provisions of FSMA, such as the increased inspection mandate?
FSMA is one of the top priorities in FDA at this time. The Federal-State Integration team is working to determine funding mechanisms and provide other types of support, such as training, to our State and local partners. FSMA created mechanisms for providing necessary funds to our regulatory partners to support enhanced food safety efforts, and FDA is diligently evaluating the implementation of those sections of the legislation to ensure that States and local governments are funded adequately to help implement FSMA.

FS.5 When I think of the Food Safety Modernization Act, I only think of food that people consume. What is the Federal-State Integration team doing about food for animals?
The Federal-State Integration team realizes the importance of improving animal food regulations and standards along with human food. The Federal-State Integration team has members from the Center of Veterinary Medicine at FDA and is partnering with organizations such as the Association of American Feed Control Officials to ensure that food for animals is safe.

FS.6 Considering the large task at hand, is the Federal-State Integration team going to partner with anyone else to help them implement FSMA? 
The Federal-State Integration team has engaged various associations and State, local, territorial, and tribal agencies in its implementation efforts. The Federal-State Integration team is also partnering with other Federal agencies, including the Center for Disease Control (CDC), the Department of Agriculture (USDA), and the Department of Homeland Security (DHS) to improve foodborne illness outbreak response across the nation.

FS.7 Could you elaborate more on how you are looking to engage partners, particularly NGOs, within the regulated community to conduct compliance inspection and facilitate reporting to better leverage limited governmental resources and staff?
As part of the integrated food safety system and the formation of a national work plan, FDA/ORA has formed a work group to look at how to engage partners. FDA/ORA also has a field management directive (FMD) that outlines improvements in communications between FDA and state agencies.

The Association of Food & Drug Officials (AFDO), on behalf of the FDA and in support of FSMA Section 205(c)(2) is distributing a capacity survey to state, local, tribal and territorial food and feed safety agencies. The results will assist the FDA in working with its state and local partners to enhance food safety efforts. See AFDO's press release, Food and Feed Safety Agencies to be Surveyed in Support of FSMA disclaimer iconfor additional information.

FS.8 What are some of FDA's funding mechanisms to support state and local governments in food safety activities?
FDA has recently issued two Requests for Applications (RFAs) related to emergency response/recall of foods and capacity building to undertake inspections. These RFAs were published in June 2012 and can be found at Department of Health and Human Services RFA Grant RFA-FD-12-026s and RFA-FD-12-027. These RFAs are cooperative agreements in support of FSMA Section 210(a), which authorizes FDA to provide grants to eligible entities -- State, Local, Tribal, and Territorial governments, and nonprofit food safety training entities that form partnerships with institutions of higher learning. FDA provides funding through contracts, grants, and cooperative agreements to state and local governments in several critical areas including food and feed inspections, as well as feed inspections to ensure compliance with the BSE rule, coordinating and accelerating responses to foodborne outbreaks, improving standardization of inspections, innovative food defense activities, increasing laboratory emergency response capabilities and to support food protection task force activities. In addition to funding these activities, FDA provided an additional $15 million to the states in 2011 to support continued growth and capacity building in these critical areas, and in FY12 FDA plans to provide up to $10 million to state and local partners to support manufactured and retail food program standards implementation, laboratory accreditation and increased participation in the Rapid Response Team project.

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Fees

General Questions on Fees 

F.1.1 Is there a registration fee required under FSMA?
FSMA does not require a registration fee to be paid by registered facilities.

F.1.2 Will there be a fee associated with FDA inspections?
There is no fee for an initial FDA inspection. FSMA authorizes FDA to assess and collect fees related to certain domestic food facility, foreign food facility, and importer reinspections. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems. See the Assessment of Reinspection and Recall Fees by the FDA for more information.

F.1.3 Will there be any fees connected to the new recall authority FDA now has?
FDA has authority to assess and collect fees for food recall activities associated with a recall order when a domestic food facility or importer does not comply with such order.

F.1.4 What other fees are outlined in the new law?
There are also fees that can be collected for administrative costs of the voluntary qualified importer program, for costs associated with issuing food export certifications, and for costs to establish and administer the third-party accreditation program.

F.1.5 What fees have been established?
For each fiscal year since FY2012, a fee schedule has been established for domestic and foreign facility reinspections, failure to comply with recall orders, and certain importer reinspections (please see section below). FDA publishes the fee schedule 60 days before the start of each fiscal year along with the methodology used to formulate those fees. The other fees (see F.1.4) will be established as the programs develop.

Domestic and Foreign Facility Reinspections, Failure to Comply with Recall Orders, and Certain Importer Reinspections User Fee Rates for Fiscal Year 2015

F.2.1 What is FDA announcing?
On July 31, 2014, FDA announced in a Federal Register notice the fiscal year FY 2015 fee schedule for certain domestic and foreign facility reinspections, importer reinspections, and failure to comply with recall orders.

F.2.2 Will importer reinspection fees be assessed and collected in FY 2015?
FDA is in the process of considering various issues associated with the assessment and collection of importer reinspection fees as stated in the Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act. Recognizing the particular complexities involved in these issues, FDA is not in a position to assess importer reinspection fees until the agency has resolved these issues and will not assess importer reinspection fees until the agency notifies the public. However, the fee rates set forth in the notice for FY 2015 will be used to determine any importer reinspection fees assessed in FY 2015 once the Agency begins to assess such fees.

F.2.3 What are the FY 2015 fees?
The rates are as follows: $217 an hour if no foreign travel is required and $305 an hour if foreign travel is required.

F.2.4 When do the FY 2015 fees go into effect?
The fees are effective October 1, 2014, and will remain in effect through September 30, 2015. As stated in FDA’s September 2011 Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act, because FDA recognizes that for some small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms.  FDA is currently developing a guidance document to outline the process through which firms may request such a reduction of fees. FDA does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published. 

F.2.5 Who is affected by these fees?
Only those parties in the food and feed industry whose non-compliance results in the following activities:

  • Facility reinspections – follow-up inspections conducted by FDA subsequent to a previous facility inspection that identified noncompliance materially related to a food safety requirement of the Federal Food, Drug, and Cosmetic Act (the Act). The reinspection must be conducted specifically to determine that compliance has been achieved.

  • Recalls – food recall activities performed by FDA that are associated with a recall order with which a responsible party has not complied.

  • Importer reinspections -- follow-up inspections of a food offered for import conducted by FDA subsequent to a previous inspection that identified noncompliance materially related to a food safety requirement of the Act. The reinspection must be conducted specifically to determine that compliance has been achieved. As discussed in F.2.2., these fees will not be assessed until the agency has resolved issues associated with these fees and the public has been notified by the agency. 

F.2.6 Why are these fees important? 
FSMA represents a critical step in strengthening the U.S. food safety system.  However, there are challenges and costs associated with achieving the full implementation of FSMA. The fees allow FDA to recover costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and certain importer reinspections.  Prior to FSMA, FDA bore the entire burden of these costs.

F.2.7 How does FDA plan to charge these fees?
For facility reinspection fees, FDA will invoice theresponsible party for each domestic facility and the United States Agent for each foreign facility for the direct hours, including travel, spent to perform the reinspection at the appropriate hourly rate. For recall order fees, FDA will invoice the responsible party for each domestic facility or an importer who does not comply with a recall order under sections 423 or 412 of the Act for the hours spent to cover food recall activities associated with such order. For importer reinspection fees, FDA will invoice the importer for the direct hours spent to perform the reinspection including travel. Detailed payment information will be included in the invoice.

F.2.8 Why is there only one foreign travel fee rate? Shouldn’t it be a different rate for each country depending on the distance from the U.S? For example, traveling to Canada or Mexico from the U.S. should cost less than traveling to China.
Fees are charged on an hourly basis, thus the cost of traveling to a country closer to the U.S. will take less travel time, and therefore, will account for the distance variations and costs associated. Please see the FY 2015 Fee Rate Federal Register notice for explanation of the methodology used to determine the fee rate for foreign travel.

F.2.9 Which fiscal year rate will be charged if a reinspection occurs during one fiscal year and the invoice is sent out in the next fiscal year?
The fiscal year in which the reinspection occurs dictates the fee rate to be applied. For example, if a reinspection was conducted in September, 2012 and the invoice was issued in October, 2012, the fee rate to be applied would be the FY 2012 rate. The invoice clearly itemizes the fiscal year, hours and rate used to calculate the total invoice amount.

F.2.10 Can small businesses have their fees waived?
The FY 2014 fee schedule does not contain any reduced fee rate for small business. However, as stated in F.2.4, FDA does not intend to issue invoices for reinspection or recall order fees until a guidance document to outline the process through which firms may request a reduction of fees has been published. Once published, invoices will be issued and firms can apply for reductions as outlined in the guidance. 

F.2.11 How is FDA addressing the impact of these fees in future years on small businesses?
A Federal Register notice was issued on August 1, 2011, that requested comments on the burden of the fees on small business. The notice requested public input to help the agency understand what factors it should consider in developing guidelines in consideration of the burden of fees on such businesses in future years.

F.2.12 Will States conduct FSMA-related reinspections?
Generally, FDA intends to conduct all reinspections that could result in the assessment of fees under FSMA, even in the case where an initial inspection was conducted under state contract.

F.2.13 How long does the responsible party have to pay the fees?
Payment must be made within 90 days of the invoice date.

F.2.14 What happens if the responsible party or U.S. Agent does not pay?
Any fee that is not paid within 30 days after it is due shall be treated as a claim of the United States government subject to provisions of subchapter II of Chapter 37 of Title 31, United States Code.

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Food Defense

FD.1 What is Food Defense?
Food Defense is the effort to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means. Potential contaminants include biological, chemical and radiological hazards that are generally not found in foods or their production environment. Food defense differs from food safety, which is the effort to prevent unintentional contamination of food products by agents reasonably likely to occur in the food supply (e.g., E. coli, Salmonella, Listeria).

FD.2 What will be new under the Intentional Contamination regulation?
FSMA requires FDA to issue regulations to protect against the intentional adulteration of food. For example, FDA is required to issue regulations specifying appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain from intentional adulteration at specific vulnerable points, as appropriate. In addition, FSMA requires FDA to issue regulations regarding hazards related to food, including those hazards that may be intentionally introduced, to establish standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of preventive controls. Further, FSMA requires FDA to issue regulations to establish science-based minimum standards for the safe production and harvesting and those types of fruits and vegetables that are raw agricultural commodities for which FDA has determined that such standards minimize the risk of serious adverse health consequences or death, including from hazards that may be intentionally introduced. Issuance of regulations to protect against intentional contamination will mark a shift from the current system. This shift presents a number of challenges to the agency and its stakeholders. Substantive information gathering and analysis is underway as the FDA works to analyze available data and engage stakeholders to better understand the benefits and costs of such regulation.

FD.3 FSMA mentions specific requirements for “high risk” foods. How will “high risk” foods be determined?
Efforts will be made moving forward to engage stakeholders on this issue and its relevance to regulation development. The agency’s efforts to date have focused on identifying points within the supply chain, specifically process steps, that are vulnerable to intentional contamination. The agency has collaborated with government partners and stakeholders to assess the food supply and identify effective mitigation strategies.

FD.4 Prior to passage of FSMA, were there requirements for food defense?
There were no requirements that food facilities implement mitigation strategies or measures to protect against intentional contamination. FDA has guidance, tools, and resources for industry on food defense. The guidance represents the agency’s current thinking on the measures that food establishments may take to minimize the risk that food under their control will be subject to intentional contamination. For more information on the guidance, tools, and resources available to industry, visit the FDA Food Defense page.

FD.5 What is the deadline for implementation?
The FDA is proposing the effective date for businesses subject to the new requirements to be 60 days after the final rule is published. Recognizing that small and very small businesses may need more time to comply with the requirements, the compliance dates are adjusted accordingly. Compliance Dates:

  • Very Small Businesses—a business that has less than $10,000,000 in total annual sales of food would have to comply within three years after the publication of the final rule.
  • Small Businesses—a business employing fewer than 500 persons would have to comply two years after the publication of the final rule.
  • Other Businesses—a business that is not small or very small and does not qualify for exemptions would have to comply one year after the publication of the final rule. 

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Imports

General Information on Imports

I.1.1 What are the key areas that the importer will notice that will be different under FSMA?
For the first time, importers will be specifically required to have a program to verify that the food products they are bringing into this country are safe. Among other things, importers will need to verify that their suppliers are in compliance with reasonably appropriate risk-based preventive controls that provide the same level of public health protection as those required under FSMA.

I.1.2 If a foreign facility is already registered in the U. S. will it need to renew its registration?
Yes. All food facilities that are required to register with FDA under section 415 of the FD&C Act, including foreign facilities (as defined in 21 CFR 1.227(b)(2)), must renew their registrations with FDA, as required by section 102 of FSMA. Registrants are required to submit registrations to FDA containing the information described in section 415(a)(2) of the FD&C Act, including the new information added by section 102 of FSMA.

Foreign Supplier Verification Program

I.2.1 What is the Foreign Supplier Verification Program (FSVP) and how will it work?
The FSVP requires importers to conduct risk-based foreign supplier verification activities to verify that imported food is not, among other things, adulterated and that it was produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable. 

I.2.2 Who is subject to the foreign supplier verification program?
When the foreign supplier verification program’s requirements take effect, they will apply to all importers, unless there’s an exemption. The law defines “importer” as:
(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or
(B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.

I.2.3 What food does the program’s requirements apply to?
The requirements of the foreign supplier verification program will apply to all food imported by the importer or agent of the importer, unless there’s an exemption.

I.2.4 Are any companies exempt from this requirement? 
The requirements do not apply to a facility if the owner, operator, or agent in charge is subject to, and in compliance with FDA’s seafood, juice, or low-acid canned food products requirements. The exemption relating to low-acid canned food applies only with respect to microbiological hazards. The statute also directs FDA to exempt, by notice in the Federal Register, food imported into the United States in small quantities for research and evaluation purposes or for personal consumption. The statute further directs FDA to issue implementing regulations and guidance on FSVPs.

I.2.5 Is there an exemption for small research quantities?
The law contains an exemption for food imported in small quantities for research and evaluations purposes, provided the food is not intended for retail sale and not sold or distributed to the public.

Certification

I.3.1 What is the relationship between the certification program and the foreign supplier verification program?
“Certification” differs from the “foreign supplier verification program.” Foreign supplier verification is a general requirement applicable to all food importers, unless there’s an exemption. In contrast, certification is only required in those situations where FDA requires certification. FDA must base its decision to require certification on the risk of the food, including taking into account certain factors specified in the law.

Audits

I.4.1 How will the third-party auditor accreditation program work?
Section 307 directs FDA to establish a system for the recognition of accreditation bodies that accredit third-party auditors to, among other things, issue certifications for purposes of the import certification for food. The statute directs FDA to issue implementing regulations, including provisions on conflicts of interest, financial ties, and unannounced audits, as well as model accreditation standards, including requirements for regulatory audit reports.

I.4.2 Is the accredited auditor required to notify the FDA if a condition of concern is found during a consultative audit?
The law requires that during an audit, an accredited third-party auditor or audit agent of such auditors must immediately notify FDA if they discover a condition that could cause or contribute to a serious risk to the public health.

I.4.3  Will auditors have to submit their audit reports to FDA?
An accredited third-party auditor or audit agent of such auditor will need to prepare an audit report for each audit conducted. In the case of a regulatory audit, which the law distinguishes from consultative audits, it must submit the report to FDA. The law also has a provision whereby FDA may require the submission of certain reports from a regulatory audit and can access the results of a consultative audit in accordance with its records access authority under another provision of the Federal Food, Drug, and Cosmetic Act.

I.4.4 Can a foreign government serve as a third-party auditor?
Foreign cooperatives and governments agencies are eligible for accreditation as third-party auditors.

I.4.5 What is the voluntary Qualified Importer Program (VQIP) and won’t this force FDA to rely heavily on inspections by foreign governments?
Section 302 of the statute requires FDA to establish a voluntary, user-fee funded voluntary qualified importer program (VQIP) to expedite entry into the United States of imported food from eligible, qualified importers. To be eligible to participate in VQIP, an importer must offer food for importation from a facility that has a certification by an accredited third party. FDA will qualify eligible importers to participate in VQIP based on risk considerations. The new law directs FDA to issue guidance on participation in and compliance with VQIP.

I.4.6 There are ISO standards for inspection and accreditation bodies. Will FDA allow countries that adhere to these standards automatic recognition under the accreditation and certification provisions?
In developing the model standards under the third party auditory accreditation program, there is explicit language in the law that FDA must look to standards in place on the date of the enactment of this section for guidance, to avoid unnecessary duplication of efforts and costs. FDA will continue to consider international standards and leverage with accreditation bodies in developing these standards.

I.4.7 Will there be import certification required for high-risk foods?
FDA is now working on determining how to define and identify high-risk foods.

I.4.8 Does FDA have new compliance tools for imports?
Yes. First, we will increase the number of foreign inspections we do. FDA can deny entry to an import if a foreign facility refuses an FDA inspection it can require certification for high-risk foods; and prior notice submissions will need to include, as an additional element, any country to which the food has been refused entry.

I.4.9 Will third party auditors have the same authorities and tools of FDA when qualifying imported food companies for entry into the US?
No. Accredited third-party certification bodies will not be commissioned by FDA nor will they otherwise be in the role of regulatory authority, acting on FDA's behalf. This is true regardless of whether the accredited certification body is, itself, government (i.e., public) entity.

Accreditation

I.5.1 Will in-house laboratories (set up by a company for the testing of its own foods) be eligible for laboratory accreditation per FSMA?
Valid analytical results are essential to make informed decisions that impact public health. At its heart, laboratory accreditation is about laboratories’ consistently producing valid results by focusing on assuring 1) management requirements for the operation and effectiveness of the quality management system within the laboratory and 2) technical requirements that address the correctness and reliability of the tests and calibrations performed in laboratory. FDA supports laboratories' interests in pursuing accreditation but FDA has not yet fully developed its thinking or rulemaking with regard to FSMA implementation so any interpretations of requirements are premature at this time.

Smuggled Food

I.6.1 Will FDA be targeting all smuggled food, including those foods transported in luggage for personal use?
Section 309 of FSMA 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.” While this could be interpreted to apply to a single undeclared low risk food item carried in personal luggage, FDA and DHS will focus resources on imported food that poses the greatest risk to public health.

I.6.2 How will FDA notify the public of potentially dangerous smuggled food?
FSMA provides for public notifications of harmful and dangerous smuggled food “reasonably believe[d] to [have] entered domestic commerce” and “likely to be consumed”. FDA intends to issue a press release and use other appropriate emergency communications or recall networks in order to warn consumers, distributors, and vendors about the threat.

I.6.3 How will FDA evaluate the impact of this strategy?
FDA and CBP will measure the number of food import examinations targeted to alert for smuggled food against the number of shipments where food smuggling is actually discovered and acted upon. Outcomes will be measured according to metrics developed under the strategy at regular intervals and any adjustments to strategy will be made after consideration of these results.

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Inspection and Compliance

Records and Records Access

IC.1.1 FSMA has several provisions on inspections and compliance. What will be new?
For the first time, FDA has been given an inspection mandate. The legislation requires inspections to be based on risk, and the frequency of inspections to increase. It calls for all high-risk domestic food facilities to be inspected within five years of the bill’s signing and then at least once every three years after that. Further, all other domestic food facilities are to be inspected within seven years of the bill’s signing and then at least once every five years thereafter.

IC.1.2 What about inspections of foreign facilities?
Within one year of the bill’s signing, FDA is to increase inspections of foreign facilities, and then increase that number every year for five years.

IC.1.3 For how long are records required under the new law’s “Hazard Analysis and Risk-Based Preventive Controls” provision (FSMA §103/FDCA §418) required to be kept?
This section of the new law contains a provision (FDCA §418(g)) requiring that certain records established under that section be kept for at least 2 years.

IC.1.4 Who will conduct the foreign inspections? Are there fees associated?
It is not possible at this time to answer the question about who will conduct foreign inspections. Under FSMA, FDA has the authority to assess and collect fees for some types of costs, such as re-inspection-related costs when an initial inspection has identified certain food safety problems. Under the law, there is no fee for the initial FDA inspection. FDA’s ability to collect fees is subject to sufficient appropriations for food safety activities in a given fiscal year.

IC.1.5 What records do I have to provide to FDA based on the FSMA amendments?
The manner in which you respond to a FDA records request remains unchanged. Similarly, the type of documents that you may have to provide to FDA in response to a records request remains unchanged. The FSMA amendment simply expands FDA’s former records access beyond records related to the specific suspect article of food for which FDA reasonably believes is adulterated and presents a threat of serious adverse health consequences or death to humans or animals to now include records relating to any article of food that is reasonably likely to be affected in a similar manner.

In addition, the FSMA amendment permits FDA to access records related to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animal.

Once either of the above mentioned circumstances are met, FDA may request all existing records needed to assist the agency in determining whether the circumstances, which gave rise to the records request, exist.

IC.1.6 What constitutes a “reasonable belief” that food is affected in a similar manner in the context of FDA records access?
Decisions regarding whether FDA “reasonably believes” a food is affected in similar manner so as to either be adulterated and present a threat of serious adverse health consequences or death to humans or animals or to pose a reasonable probability that the use of or exposure to such food will cause serious adverse health consequences or death to humans or animals will be made on a case-by-case basis because such decisions are fact-specific. 

IC.1.7 How does FDA identify a high-risk (HR) facility?  
See FSMA Domestic Facility Risk Categorization (FY 2012).

IC.1.8 Does the FSMA Domestic Facility Risk Categorization approach apply to all registered facilities, i.e., food and animal feed facilities? 
To date, FDA has only categorized facilities manufacturing food for human consumption as high-risk and non-high-risk under the framework established by FSMA. FDA has existing risk models that are used to prioritize work within each program operated at by the Center for Veterinary Medicine. The Agency is currently working to update these models based on the framework established by FSMA.

Recalls

IC.2.1 Under FSMA, FDA now has authority to order a mandatory recall. How will that work?
FDA anticipates that mandatory recall authority will be used in rare instances. Companies will be provided with an opportunity for an informal hearing before an order to require recall is made.

IC.2.2 Would a voluntary recall preclude an FDA mandated recall under FSMA §206/FDCA §423?
Under FDCA §423(a), FDA is required to first give a responsible party the opportunity to cease distribution and conduct a voluntary recall of an article of food. If the responsible party refuses to or does not voluntarily cease distribution or recall such food within the time and in the manner prescribed by FDA, FDA may proceed under the mandatory recall authority as set forth in FDCA §423.

IC.2.3 What is the standard and process for a mandatory recall?
FDA’s mandatory recall authority became effective when President Obama signed the FSMA into law on January 4, 2011. Section 206 of FSMA sets forth the standard for mandatory recall and procedures FDA will follow when it exercises its mandatory recall authority.

Registration

IC.3.1 Does FSMA require a food facility to submit additional registration information to FDA in order for the facility to receive a food facility registration number?
Yes. Section 102 of FSMA amends section 415(a)(2) of the FD&C Act by requiring food facilities to submit registrations to FDA containing additional information. Specifically, a registration for a domestic facility is required to contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the United States agent for the facility. All food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured/processed, packed, or held at registering facilities.

IC.3.2 Will food facilities already registered with FDA under section 415 of the FD&C Act be required to renew their registrations?
Yes. All food facilities that are required to register with FDA under section 415 of the FD&C Act must renew their registrations with FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year.

However, FDA issued a guidance document stating that because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013. See Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition).

Please check FDA’s website at www.access.fda.gov for more information, or sign-up for FSMA updates at www.fda.gov/FSMA. View additional information regarding Registration Renewal.

IC.3.3 Has the scope of who is required to register under section 415 of the FD&C Act changed?
No. At this time, the same types of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations. Those facilities are domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 103(c) of FSMA directs FDA to conduct a rulemaking to “clarify the activities that are included as part of the definition of the term ‘facility’ under such section 415 [of the FD&C Act].” The rule to clarify activities that are included as part of the definition of the term “facility” will be proposed as part of the rulemaking for the preventive controls regulation, as provided by section 103(c) of FSMA. This proposal will be published in the Federal Register when it is issued, and there will be an opportunity for public comment. For more information on preventive controls, please visit FDA’s Preventive Standards page.

IC.3.4 If a foreign facility is already registered with FDA will it need to renew its registration?

Under FSMA, all food facilities that are required to register with FDA under section 415 of the FD&C Act, including foreign facilities, are required to submit registration renewals to FDA during the registration renewal period.

IC.3.5 What form do I use to renew a food facility registration?
Registrants must use Form 3537 to register, update, or renew a registration. Facilities may register online via the Internet at www.fda.gov/furls, which operates during business hours from 7:00 am to 11:00 pm U.S. Eastern Time. Facilities may also register by mail or fax or for multiple submissions, by CD-ROM.  

IC.3.6 What information is required for food facility registration renewal?
All mandatory fields on the Form 3537 must be complete in order to renew a food facility registration. This includes new or updated fields described in question IC.3.1. If using the online renewal process, existing registration information will be displayed for review and can be edited as necessary. All information submitted, in both mandatory and optional fields, must be true and accurate, and the registrant will be required to certify that all information submitted is true and accurate at the end of the registration process. 

IC.3.7 Am I required to renew a food facility registration online?
No. Registrants can renew food facility registrations online or submit the paper Form 3537 by mail or fax. A business with multiple facilities may also renew a registration on a CD-ROM by mail.  FDA encourages online registration renewal as a cost-effective, quick, and efficient means for food facility registration renewal. With online registration renewal, a registrant may review and edit existing registration information and add information. All of the mandatory data fields are required for the system to accept the renewal submission.  After all required information has been entered, a registrant will receive confirmation of registration renewal.

Paper registration renewal likely will be a more costly and less efficient process to supply FDA with registration information and to provide food facilities with their registration renewal confirmations than online registration. As with online submissions, for paper submissions, all mandatory data fields must be completed. However, if your paper registration form contains errors or omissions, FDA will return it for corrections, which may require additional time to complete the registration process. As a result it may take longer to receive confirmation for paper registration renewals. 

IC.3.8 Is there a fee for registration, updating a registration, or renewal of registration?
No. There is no fee associated with initial registration, updating a registration, or renewing a registration. 

IC.3.9 Do new food facilities need to wait until October 1st to register?
No. The owner, operator, or agent in charge of a facility that begins to manufacture/process, pack, or hold food for consumption in the U.S. on or after December 12, 2003 must register before the facility begins such activities (21 C.F.R. 1.230). An owner, operator, or agent in charge of a facility may authorize an individual to register the facility on its behalf (21 C.F.R. 1.230). If a facility registers before October 1, 2012, the facility will still be required to renew its registration during the registration renewal period. 

IC.3.10 I have changes to my registration information now. Must I amend or update it now, or can I wait until the beginning of the first biennial registration renewal period?
The owner, operator, or agent in charge of a facility is required to submit an update to a facility’s registration to FDA within 60 calendar days of a change to any of the required registration information previously submitted under 21 CFR 1.232, except for a change of the owner (21 CFR 1.234(a)).  If a facility has a new owner, the former owner must cancel the facility’s registration within 60 calendar days of the change and the new owner must re-register the facility (21 CFR 1.234(b)). If a change occurs to a facility’s previously submitted required registration information before the start of or during the next biennial registration renewal period, a registrant may submit an update for such change as part of the facility’s registration renewal by including the update information in the registration renewal, provided that such update is submitted within 60 calendar days of the change.  If a facility submits an update to FDA before the start of the next biennial registration renewal period, the facility will still be required to submit a registration renewal to FDA during the biennial registration renewal period.

IC.3.11 Do I have to use a third-party registrar for the initial, update, renewal or cancellation of registration for my food facility?
No. FDA does not require a food facility to use a third-party registrar to submit an initial registration, update, renewal, or cancellation of a food facility registration to FDA. A food facility owner, operator, or agent in charge of the facility must register, update, renew, or cancel a registration (see section 415(a) of the FD&C Act; and 21 CFR 1.225, 1.234). The owner, operator, or agent in charge may authorize an individual to register, update, or cancel a registration on his or her behalf (except for cancellations caused by changes of ownership) (21 CFR 1.225, 1.234). The authorized individual may be, but is not required to be, the U.S. agent for a foreign facility. Foreign facilities should note that U.S. agents may charge a fee for their services, but this is solely controlled by the third-party, and there is no fee assessed by FDA for the initial, update, renewal or cancellation of registration of a food facility.

If a facility is cancelling its registration because it has a new owner, the former owner, or an individual authorized by the former owner, must cancel the facility’s registration as specified in 21 CFR 1.235 (21 CFR 1.234). 

IC.3.12 What happens if a facility fails to register?
The failure to register your facility, update required elements, or cancel a registration in accordance with 21 CFR Part 1, Subpart H  is a prohibited act under the FD&C Act (see 21 C.F.R. 1.241).  If a foreign food facility is required to register with FDA, but fails to do so, food from that facility that is being imported or offered for import into the U.S. is subject to refusal under section 801(l) of the FD&C Act.  

IC.3.13 Will a food facility be issued a new registration number during the biennial registration renewal process?
No. A food facility will not be issued a new registration number when it renews a current registration under the biennial registration renewal process.

IC.3.14 When may FDA suspend the registration of a facility registered under section 415 of the FD&C Act?
Under section 415(b) of the FD&C Act, if FDA determines that food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:

  • Created, caused or was otherwise responsible for such reasonable probability; OR

  • Knew of or had reason to know of such reasonable probability AND packed, received or held such food.

IC.3.15 When are registered facilities subject to the suspension of registration provisions?
Registered facilities became subject to the suspension of registration provisions in section 415(b) of the Federal Food Drug and Cosmetic Act on July 3, 2011; 180 days after the date of enactment of FSMA (January 4, 2011).

IC.3.16 What is the effect of such a suspension?
If the registration of a facility is suspended, no person can import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food into interstate or intrastate commerce in the United States from such facility (section 415(b)(4) of the FD&C Act). This important authority will further help FDA ensure the safety and security of our nation’s food supply.

IC.3.17 Who may issue an order to suspend a facility’s registration?
The authority to issue an order to suspend a registration or to vacate an order of suspension may not be delegated by the Secretary of Health and Human Services to any officer or employee other than the FDA Commissioner (section 415(b)(7) of the FD&C Act).

IC.3.18 Is there an opportunity for an informal hearing on suspension of registration?
FDA will provide a registrant subject to a suspension of registration order with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the suspension of registration order, unless an alternate time period is agreed upon by FDA and registrant. The registrant will have an opportunity for an informal hearing on actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. FDA will reinstate a registration if it determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration (section 415(b)(2) of the FD&C Act).

IC.3.19 What happens if it is determined that suspension remains necessary after the opportunity for the informal hearing?
If, after providing opportunity for an informal hearing, FDA determines that a suspension of registration remains necessary, FDA will require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by FDA (section 415(b)(3) of the FD&C Act).

IC.3.20 How may a suspension of registration order be vacated or modified?
Upon a determination by FDA that adequate grounds do not exist to continue the suspension actions required by a suspension of registration order, or that such actions should be modified, FDA will vacate the order and reinstate the registration of the facility subject to the order, or modify the order, as appropriate (section 415(b)(3) of the FD&C Act).

IC.3.21 Is FDA going to promulgate regulations on suspension of registration?
Yes. Section 415(b)(5) of the FD&C Act requires that FDA issue regulations to implement section 415(b) of the FD&C Act. However, food facilities became subject to the requirements of  section 415(b) of the FD&C Act, including the suspension of registration provisions, on July 3, 2011 (180 days after the date of enactment of FSMA).

IC.3.22 What changes were made to the “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”?
FDA updated this guidance document to specify additional food product categories to be included as mandatory fields in the food facility registration form. The updated guidance notes that the list of additional food product categories includes food categories that were previously included on the food facility registration form as optional fields, including food product categories for animal consumption. This guidance also describes certain FSMA amendments to section 415(a) of the FD&C Act, which provide that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3 or any other food categories, as determined appropriate by FDA, including by guidance) of any food manufactured, processed, packed, or held at such facility. FDA believes that the additional food product categories are necessary and appropriate for food facility registration and has included such categories as mandatory fields in the food facility registration form.

IC.3.23 Why did FDA make changes to “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”?
FDA believes that information about the food product categories of foods manufactured, processed, packed or held at food facilities is a key element to allow for rapid communications between FDA and facilities directly impacted by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents. Information about the categories of food a facility handles currently assists FDA in conducting investigations and surveillance operations in response to food-related emergencies. These categories also enable FDA to quickly alert facilities potentially affected by such an incident if FDA receives information indicating the type of food affected. The additional food product categories enhance the agency’s ability to respond quickly and accurately to an actual or potential bioterrorist incident or other food-related emergency. See the updated guidance, Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories, for more information.

IC.3.24 Will FDA provide further outreach or guidance on how FSMA changed food facility registration?
Yes. FDA anticipates releasing updated registration guidance materials in conjunction with the first biennial registration renewal period. Additionally, FDA intends to conduct outreach with stakeholders and make technical assistance available as this renewal period takes place.

IC.3.25 What are the dates of the biennial registration renewal period for 2012?
Section 415(a)(3) of the FD&C Act, as amended by FSMA, requires food facilities that are required to register with FDA to renew their registrations every other year during the period of time beginning on October 1 and ending on December 31 of each even-numbered year. However, FDA issued a guidance document stating that because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013. See Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition). 

IC.3.26 I do not have the Food Facility Registration PIN number that is required to access my registration in the online registration system, and therefore I am unable to renew my registration. What steps should I take? 
Due to certain confidentiality constraints and the amount of time it takes the Agency to process PIN requests, the Agency is no longer able to fulfill PIN requests for registration renewals for the 2012 renewal period. If a facility is unable to renew its existing registration by January 31, 2013 because it does not have its PIN number, the facility may create a new registration by January 31, 2013 in order to be registered in accordance with section 415 of the FD&C Act.

IC.3.27 If I create a new registration, will I retain my compliance history or shipping history associated with my facility?
Some facilities may create new registrations rather than renew existing registrations because they no longer have the PIN numbers that are needed to access their existing registrations in the online registration system. For such a facility, the Agency does not anticipate a loss of compliance history or shipping history, provided that the facility’s new registration includes the same information such as facility name and facility address. 

Administrative Detention 

IC.4.1 For administrative detention, what is the process to detain food and what if the food is perishable and can spoil?
FSMA enhances FDA's administrative detention authority by authorizing FDA to administratively detain articles of food that FDA has a reason to believe may be adulterated or misbranded. FDA intends to revise its administrative detention regulations and other relevant documents to reflect this new standard.

IC.4.2 Is compensation available for those whose products are determined to have been recalled or detained without cause?
There is nothing in FSMA that changes existing rules regarding such matters, such as, for example, the Federal Tort Claims Act.

IC.4.3 What changes did FSMA make to FDA’s administrative detention authority?
The changes made by FSMA to the criteria for administrative detention in the FD&C Act further strengthened FDA’s ability to prevent potentially unsafe food from entering commerce. Under the new criteria, FDA can order an administrative detention if the agency has reason to believe that an article of food is adulterated or misbranded. Prior to FSMA, FDA could order an administrative detention if it had credible evidence or information that the food presented a threat of serious adverse health consequences or death to humans or animals.

IC.4.4 Has FDA used its expanded administrative detention authority since the IFR published in July 2011?
FDA has effectively implemented this expanded authority three times since the IFR became effective. One of these administrative detentions led to a request to recondition the goods under FDA supervision, while another resulted in a seizure, and another terminated when the owner voluntarily destroyed the suspect food.

Additional Questions & Answers Concerning Administrative Detention

Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide
This guidance document, updated March 2013, provides updated information pertaining to the FDA’s authority to order the administrative detention of human or animal food under section 304(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 334(h)]. Congress originally established this authority in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and amended it in January 2011 as part of the FDA Food Safety Modernization Act (FSMA). 

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Product Tracing

General

PT.1.1 What is product tracing and why is it important?
In general, a product tracing system involves documenting the production and distribution chain of products so that in the case of an outbreak or evidence of contaminated food, a product can be traced back to a common source or forward through distribution channels.

Product tracing systems enable government agencies and those who produce and sell food to take action more quickly when an outbreak of foodborne illness occurs or contaminated product is identified, thus preventing illnesses. Actions include removing a product from the marketplace and alerting the public if a product has already been distributed.

Many producers, manufacturers and retailers have product tracing systems in place but they vary depending on the amount of information the system records, how far forward or backwards in the supply chain the system tracks, technologies used to maintain records and the precision with which a system can pinpoint a product’s movement.

PT.1.2 What are the FSMA requirements for product tracing?
Sec. 204, Enhanced Tracking and Tracing of Food and Recordkeeping, has two major requirements. First, FDA, working with the U.S. Department of Agriculture (USDA) and State agencies, must establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods. Second, FDA must publish a notice of proposed rulemaking to establish recordkeeping requirements for high risk foods to help in tracing products.

PT.1.3 Where can I find the statutory language for the requirements?
The statutory language for FSMA SEC 204, Enhanced Tracking and Tracing of Food and Recordkeeping, can be found on the FSMA website.

Product Tracing Pilots

PT.2.1 What did the pilots involve?
Information from the pilots will help to determine what data are most needed to trace a product that has been distributed widely in the marketplace back to a common source. Tracing product forward, such as in the case of an ingredient known to be contaminated, was also tested. Two pilots were required by the FDA Food Safety Modernization Act (FSMA)—one with the processed food sector and one with processors or distributors of raw fruits and vegetables. FSMA required that the pilots reflect the diversity of the food supply, take into account practicality for small businesses and include at least three different types of foods that have been the subject of significant outbreaks during the five-year period preceding the enactment of FSMA in January 2011. FDA also was required to consider international product tracing practices and consult with a diverse and broad range of experts and stakeholders. A report to Congress on the findings of the pilot projects and FDA’s recommendations for improving product tracing is required.

PT.2.2 Does this mean that FDA carried out the pilot studies?
No; these two pilot projects were conducted through an existing contract with the Institute of Food Technologists (IFT). However, IFT carried out the pilots at the direction of FDA, and the Agency retained the ultimate decision making authority.

PT.2.3 Did IFT consult with stakeholders before and during the pilots?
Yes, IFT involved multiple stakeholders throughout the process. IFT obtained input from the processed food and produce industry sectors and consulted with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies. IFT held three stakeholder input sessions in different geographical locations and offered opportunities for written input as well. Food industry representatives, trade associations, consumer groups, third party technology providers, academicians, and others responded to these requests.

PT.2.4 What types of industries were asked to participate in the pilot?
IFT solicited participation in the pilots. FDA indicated it wanted to include industries representing the entire supply chain—from growers to point of sale, such as a restaurant or grocery store. FSMA required that the pilots include at least three different types of foods that have been associated with significant outbreaks in the recent past.

PT.2.5 Will there be additional pilot projects beyond those required under FSMA?
FDA may decide at a later date that additional pilots or studies are needed.

PT.2.6 If I was unable to participate in these pilots, how can I provide input?
There will be additional opportunities for stakeholders to have input on improving product tracing. First, FDA is specifically requesting comments about IFT’s report on the pilot projects, along with other comments and information to help the agency as it implements the FSMA provisions about tracking and tracing and as it develops recommendations for its report to Congress. You can submit comments by (see PT.2.17). Second, FDA must publish a notice of proposed rulemaking to establish recordkeeping requirements for high-risk foods to help in tracing products; there will be a comment period during rulemaking. In addition, FDA must hold at least three public meetings during the comment period in diverse geographical areas of the U.S. to provide persons in different regions of the country with the opportunity to provide input.

PT.2.7 What foods were part of the pilots?
With input from a variety of stakeholders, the following types of foods were selected for the pilot projects:

  • Tomatoes, grown in fields and greenhouses; whole and sliced; and distributed to restaurants and other institutions like hospitals, schools and nursing homes, and through grocery stores. We looked at tomatoes because they have been involved in a number of significant and repeat outbreaks. Tomatoes represent a complex food supply chain and were identified by most industry associations as a top candidate for the produce related pilot;
  • Frozen Kung Pao-style dishes that contain peanut products, red pepper spice, and chicken were chosen because they contain multiple ingredients involved in significant outbreaks. They also offered a variety of supply chain distribution channels, and, like tomatoes, involved both domestic and imported products.
  • Jarred peanut butter and dry, packaged peanut/spice were added to the pilot projects to enhance the complexity of the pilots.

PT.2.8 What is the status of the product tracing pilots required by FSMA?
FDA has just released a report on two product tracing pilot projects conducted by the Institute of Food Technologists under an existing contract with FDA. The report can be found at this link: Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report (PDF: 5.6MB).

FDA announced the pilots on September 7, 2011, indicating that they will enhance the agency's and industry's ability to trace products through the food supply. In conducting these two pilot projects, one for processed foods and one for produce, IFT obtained input from the industry sectors and consulted with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies. The pilot report contains IFT’s recommendations to FDA, and FDA retains the ultimate decision-making authority on how to proceed. 

PT.2.9 What does IFT’s report cover?
The IFT report covers baseline studies, pilot execution using trace scenarios, use of technology, cost and benefits, domestic and global practices, findings, recommendations and suggested next steps.

PT.2.10 In the pilots, what were some of the costs to industry to implement a product tracing system?
Available data to assess costs is limited. Within the context of the pilot projects, the report estimated the costs associated with improved recordkeeping and product tracing, and costs varied greatly based on a number of factors such as using a paper-based or electronic system, scanning labels, nomenclature standardization, and electronically linking supply chain partners.

PT.2.11 In the pilots, what were found to be some of the benefits to implementing a product tracing system?

  • Product tracing systems enable government agencies and those who produce and sell food to take action more quickly when an outbreak of foodborne illness occurs or contaminated product is identified, thus preventing illnesses.
  • As part of the overall project, cost savings, driven by reductions in illness, were estimated for reducing traceback duration by 25, 50, 75, and 100 percent. The range of public health benefit per outbreak ranged from $18,000 to $14 million, depending on the characteristics of the outbreak.
  • In addition to quickly discovering which food(s) may be causing an outbreak, we may also be able to determine what foods can be eliminated from consideration, reducing economic impact on the industry.
  • Product tracing also is helpful to industry for other functions, such as inventory control.

PT.2.12 In the pilots, what enhancements did technology provide to improve tracing?
The pilot projects found that technology was no substitute for quality data. Once challenges with data quality could be overcome, significant improvements in the speed and accuracy were achieved with the aid of technology. A variety of technology solutions were explored for data capture, visualization, and analysis. 

PT.2.13 What were the IFT recommendations?
IFT has 10 recommendations:

  1. From an overarching perspective, IFT recommends that FDA establish a uniform set of recordkeeping requirements for all FDA-regulated foods and not permit exemptions to recordkeeping requirements based on risk classification.
  2. FDA should require firms that manufacture, process, pack, transport, distribute, receive, hold, or import food to identify and maintain records of Critical Tracking Events (CTEs) and Key Data Elements (KDEs) as determined by FDA.
  3. Each member of the food supply chain should be required to develop, document, and exercise a product tracing plan.
  4. FDA should encourage current industry-led initiatives and issue an Advance Notice of Proposed Rulemaking or use other similar mechanisms to seek stakeholder input.
  5. FDA should clearly and more consistently articulate and communicate to industry the information it needs to conduct product tracing investigations.
  6. FDA should develop standardized electronic mechanisms for the reporting and acquiring of CTEs and KDEs during product tracing investigations.
  7. FDA should accept summarized CTEs and KDEs data that are submitted through standardized reporting mechanisms and initiate investigations based on such data.
  8. If available, FDA should request more than one level of tracing data.
  9. FDA should consider adopting a technology platform that would allow efficient aggregation and analysis of data submitted in response to a request from regulatory officials. The technology platform should be accessible to other regulatory entities.
  10. FDA should coordinate traceback investigations and develop response protocols between state and local health and regulatory agencies, using existing commissioning and credentialing processes. In addition, FDA should formalize the use of industry subject matter experts in product tracing investigations.

For more details on IFT’s recommendations and their report, please go to Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report (PDF: 5.6MB).

PT.2.14 How will FDA use IFT’s report on the pilot projects?
The findings of the pilot projects and corresponding stakeholder input will inform FDA’s report to Congress, which will include FDA recommendations for improving product tracing. In addition, FDA will use the information from these most current pilot projects as well previous pilots studies, public meetings, and information FDA has gathered over the last several years to inform the rulemaking process to establish recordkeeping requirements for high-risk foods to help in tracing products.

Recordkeeping Requirements for High Risk Foods

PT.3.1 What is the FSMA requirement related to recordkeeping for high-risk foods?
Under section 204 of FSMA, FDA is required to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary and to establish recordkeeping requirements for these foods. The requirement is designed to enable foods to be more rapidly and effectively tracked and traced during a foodborne illness outbreak or other event.

PT.3.2 Did Congress provide any specifics about the recordkeeping requirements FDA is to establish for high-risk foods?
Yes. Congress has established certain specifics about these recordkeeping requirements, including the following:

  • they must relate only to information that is reasonably available and appropriate;
  • they must be science-based;
  • they may not prescribe specific technologies to maintain records;
  • the public health benefits must outweigh the cost of complying with the requirements;
  • they must be practical for facilities of varying sizes and capabilities;
  • to the extent practical, they may not require a facility to change business systems to comply;
  • they must allow for the maintenance of records at a reasonably accessible location, provided that the records can be made available to FDA within 24 hours of a request; and
  • they may not require a full pedigree, or a record of the complete previous distribution history of the food from the point of origin.

PT.3.3 Did Congress provide specifics about how FDA should determine what foods are high risk under this section of FSMA?
Yes. FDA must consider these factors:

  • the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;
  • the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;
  • the point in the manufacturing process of the food where contamination is most likely to occur;
  • the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
  • the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
  • the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

PT.3.4 Has FDA determined which foods are high risk?
No. In February 2014, we published a Federal Register Notice to seek comments and scientific data that will help us refine our draft methodological approach to identifying high-risk foods. After that approach is finalized, FDA will develop the list of high-risk foods.

PT.3.5 Will there be opportunity to comment on the foods FDA determines are high risk?
Yes. FDA plans to publish a list of high risk foods either before, or at the same time, that FDA issues a proposed rule. FDA will provide opportunity to comment on this list.

PT.3.6 When will FDA begin developing recordkeeping requirements for high-risk foods, as directed by FSMA?
Now that the pilot projects that were mandated by section 204(a) of FSMA have been completed, we are continuing to gather data and information as we begin to develop a proposed rule.

PT.3.7 Will FDA expand these additional recordkeeping requirements to apply to foods that are not designated as high risk?
No. FSMA specifies that additional recordkeeping requirements developed under section 204 must apply only to high-risk foods. FDA will be seeking input from stakeholders in considering whether to develop voluntary guidance for foods beyond those designated as high risk to enhance product tracing in the supply chain.

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Proposed Rules

General

PRG.1 Why did the FDA have to issue certain revised provisions?
The FDA based the previously proposed rules on the best data available and asked for public input so we could learn more about the affected industries and how to prevent foodborne illness. Stakeholder feedback is critical to the rulemaking process and has helped us identify areas of the previously published proposed rules where clarification or alteration can best protect public health while being flexible enough for the diversity of food operations covered under the law.

PRG.2 Where can I find the entire proposed rules, including what stays the same and what changes?
The FDA is placing a redline version of the codified text for the supplemental proposals in the relevant docket for each rulemaking, so you will be able to see how the proposed codified text has been modified from the original proposal.

PRG.3 Is the FDA taking comments on each of the original proposed rules or just the updates and additions?
The FDA is seeking comment only on the provisions that are contained in the supplemental proposals; we are not seeking comment on any other provisions of the previously published proposed rules. We will complete our review of public comments received thus far, and take into account comments received in response to the supplemental proposals before issuing final rules.

PRG.4 How long after the final rules are published would compliance be required?
Facilities would have from one to three years after publication of the final rules to comply with the preventive controls requirements, depending on size of the business. Depending on farm size, farmers would begin compliance with the produce safety rule in two to four years after the effective date of the final rule. They would have an extra two years to comply with certain water requirements, giving them from four to six years to comply with all the requirements of the produce rule. Importers and suppliers would, in general, have 18 months to comply with the foreign supplier verification programs, although there are exceptions for the importation of foods that are also subject to the preventive controls and produce safety rules. The compliance dates in those cases vary, depending on the rule and the size of the operation.

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Preventive Controls for Human Food Rule 

PCHR.1 Why is the proposed rule on Preventive Controls for Human Food important for public health?
High-profile outbreaks of foodborne illness over the last decade and data showing that such illnesses strike one in six Americans each year have caused a widespread recognition that we need to prevent food safety problems, not merely react once they happen. Requiring preventive measures at facilities that produce human food is an important step.

PCHR.2 What are the major differences between the FDA’s originally proposed rule for Preventive Controls for Human Food and the newly issued supplemental proposed rule?
The major differences between the originally proposed rule and the revised rule can be found in the Preventive Controls for Human Food At-A-Glance fact sheet.

The Proposed Rule for Preventive Controls as it Relates to Dairy Products Produced under the Pasteurized Milk Ordinance (PMO)

PMO.1 Do facilities operating under the PMO meet the requirements of the proposed preventive controls rule?
The preventive controls provision of FSMA (section 103) does not exempt dairy facilities that are required to register with FDA. FDA has received comments on whether and how a facility complying with the PMO or with the PMO’s voluntary HACCP program would be in compliance with the requirements of the proposed PC rule and will address this issue in the final rule.

PMO.2 Does the Preventive Controls Rule apply to dairy farms?
Establishments that meet the definition of a farm are not required to register under section 415 of the FD&C Act. However, farms, including dairy farms, that conduct manufacturing/processing activities on food not consumed on that farm are subject to registration under section 415 of the FD&C Act and would be subject to requirements of the Preventive Controls Rule unless a specific exemption applies.

PMO.3 What environmental and product testing for milk and dairy products is required under FSMA and the proposed Preventive Controls Rule?
The proposed supplemental notice on the Preventive Controls Rule includes potential requirements for environmental monitoring and finished product testing as verification activities that would be applied as appropriate to the food, the facility and the preventive control. FDA will address the comments regarding requirements for facilities processing milk or manufacturing dairy products in the final rule.

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Preventive Controls for Animal Food Rule 

PCAR. 1 Why is this proposed rule for animal food important to public health?
This proposed rule would have important public health impacts for both animals and people. It would primarily impact animal health by helping prevent foodborne illness in animals, such as from hazards like physical contaminants or chemical toxins. This proposed rule would also help address harmful nutrient imbalances in animal food, such as excessive copper in feed for sheep or insufficient thiamine in cat food. The proposed rule also would have a public health impact on people by helping prevent contamination in food for animals producing human food products and helping prevent contamination from bacteria, such as Salmonella, in pet food. Salmonella can cause foodborne illness in individuals handling contaminated pet food, especially if they have not thoroughly washed their hands afterwards.

PCAR.2 What are the major differences between the FDA’s originally proposed rule for Preventive Controls for Animal Food and the newly issued supplemental proposed rule?
The major differences between the originally proposed rule and the revised proposed rule can be found in the Preventive Controls for Animal Food At-A-Glance fact sheet.

PCAR.3 What would this proposed rule require human food facilities to do when providing a by-product for use as animal food?
Human food processors already complying with FDA human food safety requirements, such as brewers, would not need to implement additional preventive controls or Current Good Manufacturing Practice regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed CGMPs to prevent physical and chemical contamination when holding and distributing the by-product (e.g., ensuring the by-product is not co-mingled with garbage). Should a facility choose to further process the by-product (e.g., drying, pelleting, heat-treatment), it would need to comply with the preventive controls for animal food rule.

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Produce Safety Rule

PSR.1 Why is this proposed rule on produce safety necessary for public health?
Produce is an essential component of a healthy diet, and the safe production and harvesting of fruits and vegetables helps consumers to maintain healthy diets. Foodborne illness outbreaks associated with contaminated produce over the last decade have caused a widespread recognition of the need for a modern food safety system that prevents food safety problems in the first place--not a system that just reacts once they happen. The FDA’s analysis of available foodborne illness outbreak data document 131 outbreaks associated with contaminated produce between 1996 and 2010, causing more than 14,000 illnesses and 34 deaths. Therefore, the proposed FDA produce rule focuses on setting enforceable standards that are reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards and providing reasonable assurances that produce is not adulterated on account of these hazards.

PSR.2 What are the major differences between the FDA’s original proposed rule for produce safety and the newly issued produce supplemental proposed rule?
The major differences between the originally proposed rule and the revised proposed rule can be found in the Produce Safety At-a-Glance fact sheet.

PSR.3 How will the changes affect who is covered by the produce rule?
The FDA is proposing to change the coverage threshold for the rule to $25,000 in annual produce, rather than total food, sales. We estimate that an additional 4,708 farms would not be covered by the rule as a result, with 35,503 farms continuing to be covered.

PSR.4 What if farms have a hard time complying with the final requirements? Is extra time allowed?
The FDA is proposing staggered compliance dates, based on size of farm, to provide enough time for them to meet the requirements, and additional time is being provided to meet certain water requirements. Exemptions are also included for the smallest farms.

PSR. 5 What if farmers need help meeting these new requirements?
The FDA has been working with the U.S. Department of Agriculture (USDA), state agriculture departments, the Produce Safety Alliance, the Sprouts Safety Alliance and the American Farm Bureau, as well as others, to make sure there are numerous resources and technical assistance to aid farmers with implementation once the rules are finalized. The agency is planning to use a number of approaches, including guidance, and supporting training and technical assistance, to give farmers the tools they need to comply with the new regulations.

PSR.6 How does the FDA plan to determine the safe use of raw manure in growing fields?
The FDA is removing the proposed nine-month interval between the application of raw manure and the harvesting of crops. The agency is deferring its decision on an appropriate time interval until it pursues certain actions, which include reviewing data submitted in response to the supplemental proposed rule on produce safety, conducting extensive research to strengthen scientific support for a decision on the safe use of raw manure, and completing a risk assessment. 

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FSVP Rule

FSVPR.1 Why are the Foreign Supplier Verification Program (FSVP) requirements important?
Importers would be required to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food producers.

FSVPR.2 What are the major differences between the FDA’s original FSVP proposed rule and the revised proposed rule?
The major differences between the original proposed rule and the revised proposal can be found in the Foreign Supplier Verification Program At-a-Glance fact sheet.

FSVP.3 In the original proposed rule, the FDA presented two options for required supplier verification activities. Why, in the supplemental rule, did the FDA propose a different approach?
Based on public comments, the FDA is proposing an approach that provides importers the flexibility to determine appropriate verification measures based on food and supplier risks, while acknowledging the greater risk to public health posed by the most serious hazards in foods. When there is reason to believe that a hazard will cause serious injuries or deaths, a clear, rigorous verification standard is required in the form of annual on-site auditing of the supplier. Importers would only be allowed to use a different approach if they can establish that it will provide adequate assurance that the hazard is controlled.

FSVP.4 Will importers find themselves having to meet the provisions of the FVSP regulations and the regulations on preventive controls for human and animal foods?
Many of the updates to the FSVP proposal are designed to avoid duplicative regulations and inconsistent language. For example, importer facilities in compliance with the supplier verification requirements under the preventive controls rule would be deemed in compliance with nearly all of the FSVP requirements.

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Sanitary Transportation of Human and Animal Food

ST1. Why is the FDA proposing this rule?
Due to past incidents of unsanitary transportation practices for human and animal food, there have been frequent concerns about the potential for food to become contaminated during transportation. The goal of the proposed rule is to prevent practices that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food during transportation.     

ST2. How frequent are incidents of unsanitary transportation of food?
The risk of contamination from transportation is low. However, the FDA continues to receive reports of food transported under unsanitary conditions. Additionally, findings from two recent studies of the food transportation industry identified several areas of concern, including improper refrigeration, transport of food and non-food items in the same load in a manner that could result in cross-contamination, improper sanitation, and low driver awareness of food safety. One of the larger detected outbreaks of foodborne illness happened in 1994, caused by the contamination of an ice cream mix with Salmonella during bulk transport to the packing facility. This outbreak was estimated to have affected more than 224,000 persons nationwide.

ST3. If the risk of contamination from transportation is so low, is this placing too great a burden on industry?
Although it is difficult to attribute foodborne illness to contamination during transportation, the FDA does receive reports of unsanitary food transportation practices that could lead to contamination. Furthermore, the proposed rule builds on current food transportation best practices concerning cleaning, inspection, maintaining, loading and unloading, and operating vehicles and transportation equipment.

ST4. What action has the FDA taken to date to ensure the safety of food during transportation?
In 1990, Congress passed the Sanitary Food Transportation Act of 1990 and delegated primary authority to implement the law to the Department of Transportation (DOT). Upon the passage of the 2005 SFTA, the 1990 SFTA was withdrawn, and the FDA now has the lead role among federal agencies in regulating the safety of food during transport. However, both DOT and the U.S. Department of Agriculture (USDA) have a role as partners with the FDA in the broad federal food safety structure. With the update of SFTA in 2005, Congress directed the FDA to establish regulations on sanitary transportation practices for food. As part of the implementation of the 2005 SFTA, the FDA has collected information on current best practices in the food transportation industry through an Advance Notice of Proposed Rulemaking and a study commissioned to characterize current baseline practices and to identify current areas where food is at risk. This proposed rule will implement the 2005 SFTA as well as the requirement in section 111 of FSMA to issue these regulations. In April of 2010 FDA also issued guidance to provide the industry with broadly applicable recommendations for controls to prevent food safety problems during transport. This guidance and other information about regulations and guidance applicable to food transportation are available on FDA's Sanitation & Transportation Guidance Documents & Regulatory Information page. The FDA will continue to work with its federal, state, local, and territorial and tribal partners to respond to reports of food transportation under unsanitary conditions. 

ST5. What are some examples of sanitary transportation practices that would be required under this rule?
This proposed rule establishes requirements for vehicles and transportation equipment, transportation operations, training, and recordkeeping. For example, shippers would be required to inspect a vehicle for cleanliness or contamination prior to loading food that is not completely enclosed by its container. Operators of motor vehicles, railcars, and other equipment used in food transportation would be required to establish written procedures, subject to record keeping requirements, for cleaning their vehicles and transportation equipment. The FDA would be entitled to review these procedures and records. It also requires individuals who transport foods that require time/temperature control for safety to ensure the maintenance of the transportation cold chain during operations. This includes pre-cooling the vehicle, loading and unloading operations, and the transportation phase. The proposed rule would also establish procedures for the exchange of information about prior cargos, cleaning of transportation equipment, and temperature control between the shipper, carrier and receiver, as appropriate to the situation. Shippers would need this information to ensure adequate sanitation practices were used that would help prevent adulteration of transported products. For example, a carrier transporting bulk liquid non-dairy foods would want to ensure that vehicles that have previously hauled milk will not introduce allergens into non-dairy foods through cross contact.  

ST6. Does this rule apply to international motor and rail shipments?
Yes, it would apply to the transportation operations of food that will be directly transported into the United States by motor or rail vehicle and consumed or distributed in the United States. For example, the requirements of this proposed rule would apply to a person outside of the United States, such as an exporter, who ships food to the United States in an international freight container by oceangoing vessel or in an air freight container, and arranges for the transfer of the intact container in the United States onto a motor vehicle or rail vehicle for transportation in U.S. commerce, if that food will be consumed or distributed in the United States.  We would consider this person to be a shipper under this proposed rule because he would be initiating a shipment of food by motor vehicle or rail vehicle, even if doing so from abroad, that would be entering U.S. commerce. The requirements of this proposal would not apply to the transportation operations of food that may ultimately be intended for U.S. commerce, but will not be directly transported into the United States by motor or rail vehicle. 

ST7. How will the FDA pay to oversee and enforce this rule?
The FDA currently has resources to issue the rules required by FSMA but requires additional funding to fully implement the modernized food safety system envisioned by Congress.

ST8. How will the FDA enforce this new rule?
In addition to inspections the FDA will carry out itself, under the 2005 SFTA, the Department of Transportation will also establish procedures for transportation safety inspections to be conducted by DOT or state personnel. The FDA will also work with its state, local, territorial and tribal partners to help industry come into compliance with the rule. Once the proposed rule is finalized and implemented, compliance tools may include administrative actions (e.g. warning letters) and, in some instances, could include legal actions such as injunction and criminal prosecution.

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Scope

S.1 Do all sections of the law apply to pet food as well?
Yes. However, FDA is expressly authorized to modify the preventive controls requirements for facilities that are solely engaged in the production of animal foods or to exempt those facilities entirely from the preventive controls requirements. FDA would need to promulgate a regulation to accomplish such a modification or exemption.

S.2 Does the legislation apply to restaurants and food retailers?
Some but not all provisions of the law exclude restaurants and food retailers. For example, restaurants and retail food establishments are not required to register with FDA, so they are not subject to requirements for registered facilities, such as preventive controls. Other provisions could apply to restaurants and food retailers, such as the foreign supplier verification program, which applies to importers.

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World Trade Organization (WTO)  

W.1 Has the FSMA been notified to the WTO? When was it or will it be notified?
The FDA Food Safety Modernization Act was published by the Secretariat as WTO notification G/SPS/N/USA/2156 on February 14, 2011. Please see the corresponding addendum dated March 2, 2011, G/SPS/N/USA/2156/Add.1 for an internet link to the United States official public law version of the text. FDA welcomes any comments or inquiries for this notification sent to the email address: FSMAWTO@fda.hhs.gov.

W.2 Would any provisions of the law be considered “Sanitary and Phytosanitary (SPS) provisions” under the WTO SPS agreement?
The WTO Agreement on Sanitary and Phytosanitary (SPS) Measures provides that "any measure applied . . . to protect human . . . life or health . . . from risks arising from additives, contaminants, toxins, or disease-causing organisms in foods [or] beverages . . . " is an SPS measure. Because the U.S. Congress and President approved FSMA with public health protection and food safety objectives in mind, the United States has notified FSMA to the WTO SPS Committee to allow for comprehensive review by our trading partners. As implementing regulations are drafted that have the potential to impact international trade, FDA will notify them to the WTO pursuant to our transparency obligations under the SPS agreement in order to allow for Members' review and comment.

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More on Dockets, Guidance, Laws, and Regulations  

M.1 How do laws, regulations, and guidance documents differ?

  • FDA is ruled by a set of laws and routinely issues regulations and guidance documents.
  • The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress. It and other federal laws (such as the Family Smoking Prevention and Tobacco Control Act) establish the legal framework within which FDA operates.
  • FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates. FDA follows the procedures required by the Administrative Procedure Act to issue regulations. This typically involves "notice and comment rulemaking" process for public input on a proposed regulation before issuing a final regulation. FDA regulations are also federal laws, but they are not part of the FD&C Act.
  • FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA. 

M.2 What is a docket?
A docket is a collection of documents, often available for public review, that stores information related to a rulemaking or other action.
The docket folder may contain:

  • One or more Federal Register documents (rules and notices)
  • Materials specifically referenced in those documents
  • Public comments
  • Applications, petitions or adjudication documents
  • Other documents used by decision makers 

M.3 How do I locate a docket?
Log on to http://www.regulations.gov When entering your search terms on the Regulations.gov homepage, check the box in the search area that reads, "Open for comment." This selection will bring back only items that are accepting comments. Once your search results come back, you can narrow them by using the filters at the top of the screen. To limit your results to proposed rules and notices only, check the boxes by these items.

For additional information, see The Food Safety Law and the Rulemaking Process: Putting FSMA to Work.

View tutorials are also available:

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