Tracking the FSMAby Kristina Hernandez, Esq.

For Companies Importing Food into the US

What is the FSMA• The FSMA, or the Food Safety

Modernization Act is a comprehensive Act that was signed into law in 2011. It is the first major amendment in almost 75 years to the food safety regulations of the Food Drug and Cosmetic Act.

• It is comprised of 4 separate Titles

TITLE I: IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

TITLE II: IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS

TITLE III: IMPROVING THE SAFETY OF IMPORTED FOOD

TITLE IV: MISCELLANEOUS PROVISIONS

• TITLE III is the most relevant to imported foods, but some provisions in other titles are also relevant, and will be discussed in this presentation (such as Sec 201).

• The FSMA will have immense ramifications for companies that import food to the US as well as for domestic companies that use foreign suppliers in their domestic product.

• The FSMA is large in scope, but its primary purpose can be summed up in one sentence, it seeks transform the US food safety system from a reactive one to a proactive one – to prevent food safety breaches, not just address them after they have occurred.

Implementation of the FSMA

• The FSMA will take several years to fully implement

• Though the Act was signed into law in January of 2011, its full implementation will require FDA to promulgate various regulations

• And although it was passed by the US Congress, it will have a profound effect on food systems outside the US because it regulates foods imported into the US and imposes various new requirements on these imported foods.

the meat and bones

the FSMA

the regulations

How long will it take to implement the FSMA

• In the Act itself, Congress established specific implementation dates, some provisions took effect immediately, others were given specific future dates

• Some authorities will go into effect quickly, such as mandatory recall authority, while others require FDA to prepare and issue regulations and guidance documents – these will take longer to implement.

• It will take several years before FSMA is fully implemented and the process will be dynamic, as FDA will work with stakeholders in developing many of the requirements. FDA will also need proper funding to carry out its authority and enforce these regulations.

• Implementing FSMA will be a complex process and companies should invest in help from consultants or attorneys who can help them understand and comply with FSMA as it slowly becomes integrated into the US and foreign food system

Special concern for medium to

small food companies• While most large companies may be able to undertake the extra work mandated by FSMA, these new

requirements could overwhelm small- and mid-sized companies, making it harder for them to compete.

• “The costs to small- and mid-sized importers will likely become severe in coming years, regardless of any exemptions that FDA might hand out to them,” said Benjamin England, chief executive of FDA IMPORTS.COM. “These companies simply don’t have the relations with foreign suppliers necessary to implement the statutory language. This will cost U.S. jobs, reduce competition, and produce more very large food companies, which is not necessarily better when it comes to food safety,” he added.

• One of the main ways this can happen is through product detention. Running afoul of FSMA requirements can result in products being placed on the FDA Import Alert list. The Import Alerts instruct import inspectors, investigators, and compliance officers to automatically detain or detain without physical inspection all imports of affected products from the listed manufacturer, shipper, grower, or even geographic area. Once a product or company is placed on the list, it can be very challenging to convince the FDA that the violation has been corrected. While the Import Alert List is not new, FSMA does impose many new requirements, so there will be more opportunities for companies to violate a requirement and end up on an Import Alert List.

• However, there are consultants, attorneys and companies available to help, medium and small food companies comply with FSMA.

• For example, FDA Solutions Group based in Miami,, Florida and attorney Marc Sanchez, just to name a couple

Funding is also an issue

Not only will it take several years and stakeholder input to flesh out the implementation of FSMA, but funding will also be a challenge.

The funding FDA has available through the annual budget cycle and fees impacts the number of employees they 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. But without additional funding, FDA will be challenged in implementing the legislation fully without compromising its other responsibilities.

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Implementation delays, caused in part by funding shortages, have even spurred two groups to file a law suit in federal court against FDA and the Office of Management and Budget for delays in implementing FSMAIn August of 2012, the Center for Food Safety and the Center for Environmental Health filed their joint petition. The lawsuit seeks a court order that requires FDA to enact the FSMA regulations by a court-imposed deadline and prevents OMB from delaying FDA compliance with that deadline. In December of 2012, FDA filed a motion to have the law suit dismissed, stating that although it was behind schedule in adopting the mandated regulations, the agency’s broad role in regulating a $450 billion domestic and imported food business requires additional time."The enormity and scope of the task given to FDA cannot be overstated," the FDA said in a motion filed Friday in U.S. District Court for the Northern District of California.

With so much uncertainty about the FSMA, do I need to do

anything right now?• Companies should take a nuanced approach to compliance,• on the one hand, there is no need to become overwhelmed and

thus paralyzed by the sheer volume, novelty, and scope of FSMA – FDA and others are preparing resources to help companies wrap their minds around this comprehensive Act and the regulations that will follow

• But by the same token, companies cannot continue with business as usual, the law will bring about changes for all food companies and companies should invest resources into compliance, because the FSMA represents a sweeping change to the US and even foreign food systems. it will change the way food businesses operate, both those in the US and those that want market share in the US

Record Keeping…one area in particular that may catch many companies off guard, is record keeping

• Many companies believe they create and maintain the proper records and have a good document control system in place to support their food safety programs.

• But these may not be enough. “These companies need to go back and really understand how their standard operating procedure is being implemented and consistently executed across all their facilities. They need to understand that anything going back two years will be fair game.” said Dr. Craig W. Henry, PhD, director of enterprise risk services-business risk at Deloitte & Touche LLP

• Under FSMA Section 201, the FDA is required to significantly increase the frequency of its domestic and foreign inspections. “FDA inspectors are limited, and they can only spend so much time in plants during routine inspections. But by looking at records, they can identify areas for further investigation,”

• On-site inspections are burdensome, but inspecting records is less burdensome, therefore, the FDA may begin asking for extensive records – for example, not just the certificate of a third-party audit, but also the entire audit itself. “

• The key concept is “business continuity” of the entire supply chain—from field to restaurant or retail grocer. “The challenge for industry now is validating the integrity of the food safety systems being used to supply their upstream supply chain,” Dr. Henry said. Instead of relying on third parties to certify ingredients, companies will need to be more aggressive and invest more time and money, especially if the external supply chain is important to their brand. “They really need to make sure they know what’s going on and not assume all is well, especially with FDA inspections picking up,” he said.

In the first year, 2011, FDA has…

Below is a brief summary of what FDA accomplished in 2011:

- Issued interim final rules on criteria for administrative detention and used this authority three times

- issued interim final rules on prior notice of imported food.- Issued guidance to the seafood industry on food safety

hazards and to the dietary supplement industry regarding new dietary ingredients.

- Conducted extensive domestic and foreign outreach to all stakeholders to receive input in developing the proposed preventive control rules.

- Established the Produce Safety Alliance and the Food Safety Preventive Controls Alliance.

- Met the FSMA mandate for foreign food safety inspections, and is well on its way to meeting the 5-year inspection frequency mandate for high-risk domestic food facilities.

- Continued to build State-Federal and global partnerships.

In the second year, 2012, FDA has…

Below is a brief summary of what FDA accomplished in 2012:

Because the records access provisions of FSMA (Section 101) which amend section 414(a) and 704(a)(1)(B) of the FD&C Act became effective on passage in 2011, FDA decided to issue an interim final rule to expedite industry’s understanding of and compliance with records access provisions. In addition to the interim final rule, FDA also published draft guidance and questions and answers for industry. The FSMA amendment simply expands FDA’s former records access beyond records related to the specific suspect article of food 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.

• FSMA requires FDA to issue a number of reports to Congress on various topics. FDA issued its latest report, “Report to Congress on FDA Foreign Offices,” in February, 2012. The report describes the Agency’s progress in establishing its foreign offices – 13 to date – as well as their accomplishments and the challenges faced by FDA in the increasingly globalized marketplace it oversees. 

• FDA announced the types of foods that will be part of the pilot projects on product tracing.

• A Frequently Asked Question and Fact sheet describe how FDA identifies a high-risk facility and how this approach will be updated.

• FDA announced that it had submitted to the Office of Management and Budget for review a survey it intends to field of 1,400 state and local agencies to assess state and local food safety capacity. FDA is required under FSMA to make a report to Congress on the needs for enhancement in the areas of staffing levels, laboratory capacities and information technologies at the state and local levels.

• FDA released an updated draft guidance to notify industry of additional food categories that may be included in the food facility registration form as mandatory fields, as provided by FSMA, including food categories that were previously listed in the form as optional fields.

In the second year, 2012, FDA also…

• FDA announced the availability of the FSMA domestic and foreign facility reinspection, recall and importer reinspection fee rates. These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013.

• FDA released an updated Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories. This guidance represents FDA’s conclusion on the necessity of food product categories in food facility registrations submitted to the FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as added by section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by section 102 of the FDA FSMA.  

• On October 22, FDA announced its updated food facility registration system is available for biennial registration renewal. Registrants can submit registration renewals to FDA using the online food facility registration module or paper Form FDA 3537. The agency is offering technical assistance online and through the help desk.

• On November 26, FDA announced that to protect the public health, it had suspended the food facility registration of Sunland Inc., a producer of nuts, and nut and seed spreads. The fact that peanut butter made by the company had been linked to an outbreak of Salmonella Bredeney that sickened more than 41 people in 20 states, coupled with Sunland’s history of violations, led FDA to make the decision to suspend the company’s registration. This was FDA’s first use of its registration suspension authority under section 102 of FSMA.

• FDA announced the availability of the FSMA domestic and foreign facility reinspection, recall and importer reinspection fee rates. These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013.

• FDA released an updated Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories. This guidance represents FDA’s conclusion on the necessity of food product categories in food facility registrations submitted to the FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as added by section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by section 102 of the FDA FSMA.  

• On October 22, FDA announced its updated food facility registration system is available for biennial registration renewal. Registrants can submit registration renewals to FDA using the online food facility registration module or paper Form FDA 3537. The agency is offering technical assistance online and through the help desk.

• On November 26, FDA announced that to protect the public health, it had suspended the food facility registration of Sunland Inc., a producer of nuts, and nut and seed spreads. The fact that peanut butter made by the company had been linked to an outbreak of Salmonella Bredeney that sickened more than 41 people in 20 states, coupled with Sunland’s history of violations, led FDA to make the decision to suspend the company’s registration. This was FDA’s first use of its registration suspension authority under section 102 of FSMA.

• FDA issued updated Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide, to reflect the FSMA amendments to the FD&C Act. It contains information regarding: who is required to register and who may be exempt; how often facilities must register and renew registrations; when FDA may suspend a registration; and how facilities may submit their registrations and registration renewals to FDA.  

• On December 10, FDA and New Zealand’s Ministry for Primary Industries signed an arrangement recognizing each other’s food safety systems as comparable to each other. This arrangement complements the expanded import tool kit mandated under FSMA and leads the way to a new level of regulatory cooperation to enhance food safety while facilitating trade between the two countries. This is the first time that FDA has recognized a foreign food safety system as comparable.

Most important as of December

2012While this presentation cannot address every applicable component of the

FSMA for your business, here are three areas that are almost certainly amongst the most pressing and relevant right now

1) Determine if the FSMA applies to you, and what parts apply to youFSMA governs food products regulated by the FDA; it does not apply to meat, poultry or egg products

regulated by the USDA. The new law grants additional power to, and also places additional requirements on, the FDA. However, certain provisions of FSMA will not apply to some companies.

2) The biennial facility registration Food companies must register with the FDA biennially, between October 1 and December 31 of each

even-numbered year. There is no fee.

3) Adjust your record keeping systemFood companies must maintain, for not less than 2 years, records documenting the monitoring of the preventive controls, instances of nonconformance material to food safety, the results of testing and other means of verification, corrective actions, and the efficacy of preventive controls and corrective

actions. These records must be made available to FDA upon request.

4) Foreign Importer Verification ProgramUnder the FSMA, effective January 4, 2013, importers must verify the safety of the food offered for

import using the new Foreign Supplier Verification Program (FSVP). (The requirement doesn't apply to firms that import products from foreign suppliers subject to low-acid canned food regulations, seafood

or juice HACCP.) Under this plan, every subject importer must establish a program through which it verifies that its foreign supplier complies with HARPC or Standards for Produce Safety, and also verifies that that the food is not adulterated and misbranded because it fails to disclose the presence of major food allergens. Importers must maintain records for two years that substantiate compliance with this

requirement. Importers that fail to comply with this verification program violate FDCA and are prohibited from importing food into the United States.

2013• FDA Issues Two Major Proposed FSMA Rules

on January 4, 2013 

• Preventive Controls for Human Food: Fact Sheet on the Proposed Rule 

• Standards for Produce Safety: Fact Sheet on the Proposed Rule

Proposed Rule for Produce Safety

FDA has released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety. These rules are two of the proposed rules that are key to the preventive food safety approach established by the Food Safety Modernization Act. The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow.

• Proposed Standards for Produce Safety• The proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal

consumption, or destined for commercial processing that will reduce microorganisms of public health concern. The proposed rule is based on science and risk-analysis, and therefore focuses on areas of risk, most noticeably: 

• agricultural water;• biological soil amendments;• health and hygiene;• domesticated and wild animals; and• equipment, tools and buildings.• The proposed produce rule is the result of extensive outreach by FDA with consumers, government, industry,

researchers, and many others. The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. The produce rule is aimed at being flexible for different-sized farms, at complementing conservation laws and rules, and at not conflicting with laws and rules for organic farming.

• Certain farms would be exempt from most of the requirements if their sales average less than $500,000 per year during the last three years (adjusted for inflation) and their sales to qualified end-users exceed their sales to others during the same period.

• The exemption can be revoked under certain circumstances. In addition, farms whose average annual value of food sold during the previous three-year period is $25,000 or less would not be covered by the rule. Such farms would still be responsible for the safety of their produce. In addition, states and foreign countries can seek variances from provisions of the rule because of local growing conditions.

• While the effective date for this rule would be 60 days from publication of the final rule, the general compliance date would be two years after the effective date. For small businesses, the compliance date would be three years after the effective date, and for very small businesses four years after the effective date. Additional time would be allowed for compliance with certain water requirements.

Preventative Controls for Human Food

The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. A number of exemptions and modified requirements have been established.

• The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise.

• The rule proposes each covered facility to prepare and implement a written food safety plan, which would include the following:

• hazard analysis;• risk based preventive controls;• monitoring procedures;• corrective actions; • verification; and• recordkeeping

Further Presentations to Follow

To contact me, please email me at Kristy0703@gmail.com