Is the Nation’s New Food Safety Law on the Cutting Block?

Is the nation’s new food safety law on Congress’s cutting block?

The 2016 election results have the food industry and regulators scrambling to determine whether – or which – government programs may be affected once President-elect Trump and a new, Republican-controlled Congress take office in January.

The short answer is that nearly every program and agency in the federal budget likely will come under review, as is always the case each fiscal year but even more so when there’s a new Administration. Donald Trump and the GOP strongly advocate cutting government spending, so it is a safe bet that the Congressional budget and appropriations committees will be focusing renewed attention on by eliminating or trimming existing programs and regulations.

How will funding for the new Food Safety Modernization Act (FSMA) fare? Right now, an educated guess will have to suffice; much depends upon appropriations choices for the U.S. Department of Agriculture, the parent agency of the Food and Drug Administration, which oversees FSMA implementation.

What we do know is that in outgoing President Obama’s final budget submission to Congress (which was declared “dead on arrival by House Republicans), the Administration sought a $25 million increase in FDA’s food safety budget to a total of $1.195 billion FY 2017. That’s down from the FY 2016 budget in which the FDA received a $1.5 billion outlay, which was higher due to FDA’s FSMA implementation.

Beyond the bare numbers, which are sure to change, the following are for possible food safety budget reductions:

  • Food safety inspections of domestic and foreign manufacturing plants. FSMA envisions a preventive-based approach to food safety that is backed by extensive and strengthened inspection procedures carried out by the agency itself and by state agriculture or public health agencies. The food industry prefers voluntary compliance, and it is possible Congress will delay stepped-up inspection and rely on industry self-compliance.
  • Compliance deadlines. Although FSMA is now fully implemented, the agency plans to emphasize education over enforcement until August 2017. For budget reasons, as well as ongoing industry challenges in achieving compliance, it may be tempting for Congress to push back the compliance deadline even more into the future.
  • Food safety research and testing. Over the past several budget cycles, the FDA and the Centers for Disease Control (CDC) have spearheaded the use of emerging microbiological technologies to more quickly pinpoint the sources of food-borne illnesses. Yet the GOP Congress has long been skeptical about government research, preferring privately funded activities, and the new Congress could take a red pen to food safety research expenditures.

Of course, there is an alternative case to be made that Congress will leave FDA funding mostly alone. Food illness outbreaks always generate headlines and, at times, huge negative publicity when there are fatalities or indications of industry malfeasance. Food safety’s importance to consumers may thus prompt legislators to refrain from sizable budget reductions. Still, with the federal deficit at record highs and a majority political party eager to bring federal spending under control, the budget for food safety regulation may be vulnerable to cutbacks when FSMA’s full impact will be just getting underway.

 

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FSMA and the Challenges for Small Business

FSMA BUSINESS COMPLIANCE DATES

April 30, 2017 — food safety verification for companies exporting product or ingredients to American-based small businesses;

August 30, 2017 — companies with fewer than 500 full-time employees;

August 30, 2018 — companies with annual sales of less than $1 million (for animal products, $2.5 million)

The big compliance date has come and gone, and food manufacturers and their suppliers are now subject to the Food Safety Modernization Act (FSMA).

Yet in many ways, the September 2016 deadline was only the start of a new countdown to compliance for small and and very small food companies and their suppliers, domestic and foreign.

Let’s take a look by examining what “compliance” actually means to the Food and Drug Administration, the agency that governs the food industry and manages FSMA:

  • ENFORCEMENT. Although FSMA is in effect for large-scale, multinational food companies, the FDA has offered industry a grace period in which education will take precedence over enforcement. Essentially, regulators are allowing manufacturers and their suppliers an extended period of time to implement the new safety law’s many requirements without fear of citation, license revocation or a mandated food recall. However — and this is a big caveat — the FDA will crack down on “egregious” FSMA violations, defined as activities that demonstrate that a food company is willfully failing to comply with the new law.
  • SMALL BUSINESS DEADLINES. The FDA’s rules offer a helping hand to small businesses in the food industry by extending compliance deadlines for nearly a year – to August 30, 2017. What constitutes a small business? Generally, the FDA says, a small business is one with less than 500 full time equivalent employees. There is also a “very small” business category, with a somewhat different definition: a company with average annual sales of less than $1 million, including the market value of inventory on hand. (For producers of animal food, the cutoff for compliance is annual sales of $2.5 million).
  • IMPORTERS. How to insure compliance for food importers is one of the trickiest aspects of FSMA. The overall intent of the law is clear: the United States wants foreign-based suppliers of food items or ingredients to be held to the same safety standards as American-based firms. Yet the various rules governing what the FDA calls the Foreign Supplier Verification Program (FSVP) have differing compliance dates tied to the size of the importing company, where it is domiciled, and what it is shipping to the U.S. Suffice it to say that if a small American company is importing food items from overseas, it must verify the foreign supplier’s compliance with FSMA standards by April 30, 2017.
  • TRAINING & ASSISTANCE. A baked-in assumption in FDA’s rules is that large manufacturers will already have been close to compliance, but that smaller firms many not possess the budget, personnel or access to training to meet FSMA’s tough new safety standards. One solution is the Food Safety Preventive Controls Alliance, comprised of government, industry and academic advisors who can assist small businesses understand FSMA’s requirements and schedules through seminars, distance learning and online and printed materials.

American manufacturing is by and large driven by small business. Of some 252,000 manufacturers of all types in 2013, according to the National Association of Manufacturers, the vast majority employed fewer than 500 people, the cutoff point for FDA compliance next year, not this year.

What these numbers suggest is that reaching the thousands upon thousands of employees and persuading them to make food safety a personal responsibility will take time, effort and patience. Thankfully, the FDA has recognized the scope of the task, and is rolling out FSMA compliance in a way that helps every business adjust to the new law.

 

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FSMA Takes Effect, Ushering in a New Era of industry Responsibility

The countdown to the Food Safety Modernization Act of 2011 is complete.

As of this weekend, large scale food manufacturing operations in the U.S. and abroad must be in compliance with the sweeping new law, known by its acronym FSMA. This follows five years of regulation writing and review by the Food and Drug Administration, many revisions, deletions and additions, and enough controversies to last a lifetime.

The prolonged process from enactment to implementation is hardly surprising in view of the scope of the new law and the huge, sprawling industry it oversees. According to the Department of Labor’s Bureau of Labor Statistics, food manufacturing in the U.S. alone consists of 32,200 processing plants and employs 1.5 million people, not even counting agricultural workers, grocery store employees or restaurants!

Following is an overview of the new regulations and what they mean to the food industry and food safety.

FSMA’S SCOPE

FSMA covers human and animal food production from harvest through distribution. Foods imported from overseas are now covered, as well. However, meat, poultry and seafood products are excluded because they are regulated by separate agencies within the Department of Agriculture (FDA’s parent agency). Also excluded are supermarkets and restaurants, which are regulated by state and local statutes.

Bakery_pastry_conveyor_belt_production_referenceThe new law’s focus is squarely on manufacturing and that sector’s vast supplier network. The rationale for this focus is that most food safety outbreaks are the result of breakdowns in the production and distribution of products. Despite the universal belief that America’s food supply is the safest in the world, each year around 48 million Americans become sick due to a foodborne illness. Some 3,000 die as a result, according to the Centers for Disease Control and Prevention.

Under old food safety regulations, first enacted in 1937, the FDA exerted a largely passive role, reacting to food illness outbreaks after the fact, and working with the industry to encourage voluntary recalls when needed.

With FSMA, that approach is changing dramatically.

KEY PROVISIONS

The basic concept underlying the new food safety law is proactive prevention. Under FSMA, regulated companies must undertake a series of internal measures to meet compliance standards and avoid contaminations. Responsibility for food safety falls more than ever on the shoulders of the firms that make and distribute our food. The law also is broadly based. It covers companies in the supplier network, all of which must be able to verify the safety of their products (such as food grade lubricants for machines) for use in food production.

The key provisions are as follows (directly from FDA’s website):

  • Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Final rule issued: Sept. 10, 2015.
  • Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. Final rule issued: Sept. 10, 2015.
  • Produce Safety: Establishes science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. Final rule issued: Nov. 13, 2015.
  • Foreign Supplier Verification Program: Importers will be required 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 U.S. food producers. Final rule issued: Nov. 13, 2015.
  • Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. Final rule issued: Nov. 13, 2015.
  • Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. Final rule issued: Apr. 5, 2016.
  • Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. Final rule deadline was May 31, 2016.

These provisions, however, don’t offer a full reckoning of what’s required to insure business compliance. For example, putting in place preventive controls for human (or animal) food will require manufacturers to have conducted a thorough hazard analysis of their facilities to identify trouble spots (hard-to-clean equipment, leaky roofs, etc.), from which a plant specific Food Safety Plan must be created. That plan requires a training requirement for the relevant employees in each facility. Moreover, the plans must be reviewed and updated every 2-3 years, and they also are subject to 24-hour notice by FDA inspectors.

During FSMA’s rollout, much concern was expressed about the ability of companies to meet these requirements, especially smaller-sized suppliers with limited budgets. As a result, there are different compliance deadlines for smaller businesses, but by September 2017, all manufacturing in the U.S. must be in FSMA compliance.

PENALTIES

No company likes being subject to a food recall. They are costly, they cause tremendous internal upheaval, and they can sabotage a company’s brands and overall reputation.

To encourage compliance, FSMA takes the threat of recalls a step further by holding company executives directly responsible for food safety breakdowns. Under the so-called Park Doctrine, the Department of Justice is able to extend civil and criminal liabilities to executives who fail to actively manage food safety practices in their organization. The significance of the Park Doctrine can not be understated. The doctrine means that businesses that food products for humans and animals now have an affirmative duty to ensure the safety of their products.

That said, and given the scope and complexity of the new requirements, the FDA’s initial post-compliance strategy is to emphasize industry education over regulatory enforcement. Experience suggests that no matter how long the lead time, many organizations procrastinate or operate in a state of virtual denial that they will be subject to the new laws. Additionally, FSMA’s requirements are very complicated, and in places, contradictory. That’s why FDA in August began issuing “guidance” documents for manufacturers on various parts of the new law, beginning with what’s expected in the area of preventive controls. Other guidance reports will be issued periodically to assist companies in understanding their regulatory obligations. A few weeks ago, additionally,

Does this mean that there’s a grace period for the industry to attain compliance? No. The FDA has made it clear that it will take enforcement action against egregious food safety violations under existing regulatory law.

ENHANCED PARTERNSHIPS

FDA’s budget for carrying out these myriad duties is still under discussion. According to latest figures, Congress has recommended an increase of $103 million in funding for the FDA (including user fee revenue) for Fiscal Year 2017, of which some $40.2 million has been set aside for increased food safety regulation. By Washington standards, that’s a paltry amount and hardly adequate for the FDA to implement industry oversight.

As an acknowledgement of limited budgets, the FDA has built into FSMA provisions that envision a larger regulatory role for state health departments and third-party inspection services. FSMA also imposes new user fees for such things as re-inspection of facilities following non-compliance findings, and for a voluntary qualified importer program.

The law also mandates an “enhanced partnership” program to help the FDA build enforcement capacity. According to the National Council of State Legislatures (NCSL), these are some of the most important collaborations FSMA envisions:

  • State and local capacity building: FSMA directs the FDA to implement strategies that bolster food safety and food defense capabilities of state and local food and health agencies;
  • Foreign capacity building: FDA must create and implement plans to to address food safety training of foreign governments, as well as technical and scientific initiatives to enhance bilateral cooperation for exporters, such as electronic data sharing, and the sharing of the latest laboratory techniques;
  • Reliance on inspections by other agencies: FDA is explicitly authorized to rely on inspections of other Federal, state and local agencies to meet its increased inspection mandate for domestic facilities. FDA also is encouraged to enter into interagency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.

 WHAT’S NEXT?

 Given the current number of food recalls, foodborne illnesses, and the changing dynamics of the food supply, it goes without saying that decades-old food safety regulations needed updating. With FSMA, prevention has taken center stage and, along with it, heightened responsibility placed on business to treat preventive food safety programs as a top management priority.

The FDA still seeks (and prefers) voluntary cooperation on the part of the food industry, but it is backing that position with a tough new standard that makes food safety vigilance mandatory. FSMA provides the agency with new enforcement tools such as mandatory recall authority and the ability to withdraw facility registration so a firm would not be able to receive, process or ship food products. While the FDA will encourage compliance through education, it will also, under the Park Doctrine, hold food company executives personally responsible for preventable safety breakdowns.

Whether the new law makes the overall food supply safer is certainly the bottom-line measure of success. It is all but certain that food recalls will plague the industry going forward. Even so, FSMA is important if for no other reason that it contains a essential food safety goal: bringing business and government into close alignment on the basic premise that food safety issues are now an over-arching, and shared, responsibility.

 

 

 

 

 

 

 

 

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FDA Issues Guidance on FSMA Preventive Controls

The Food and Drug Administration has issued a report on a key section of the Food Safety Modernization Act (FSMA): the agency’s “current thinking” on the requirement of food manufacturers to conduct a thorough hazard analysis, from which a comprehensive Food Safety Plan then must be prepared.

Specifically, the guidance report issued today involves risk-based preventive controls for human food (PCHF). The guidance is intended to help manufacturers comply with the following specific PCHF requirements in the new food safety law:

A written food safety plan (FSP);
Hazard analysis;
Preventive controls;
Monitoring;
Corrective actions;
Verification; and
Associated records.

This guidance covers the first five chapters of what will be a total of 14 chapters covering all aspects of FSMA. The remaining chapters will be rolled out periodically.

The FDA issues guidance reports on a regular basis to enable interested parties to comment, suggest and request changes to regulations. The agency refers to this guidance as its “current thinking” on the subject, not its final regulations. To download the initial PCHF guidance, go the FDA’s website.

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A Safer Food Supply?

Will the nation’s food supply be safer under FSMA?

The new Food Safety Modernization Act, or FSMA, which takes full effect in September, has a multitude of goals, but foremost of these is insuring that the nation’s food supply (human and animal) is safe – safer than it already is. Will the new law do that?

That was certainly the motivation for passage of FSMA in 2011. Congress recognized that the vast American food supply from farm to table was very safe, but also persistently vulnerable to microbiological contamination, accidents, and terrorist threats. FSMA addresses these dangers directly and indirectly. Here are three of the primary goals behind the new food safety regulations.

  1. Responding to the new realities of a global food chain. America’s food supply throughout much of its history has been largely self-contained: American growers, ranchers and manufacturers accounted for the vast majority of food items available to consumers. But it was never 100% domestic: Coffee from Africa and Central America; winter produce from Mexico; Canadian wheat, spice from Southeast Asia. As the consumer palate has become more varied and reflective of diverse cultures, our food supply is incredibly global in scale. FSMA is intended to insure that all food items and ingredients coming from overseas are subject to stringent safety protocols.
  1. foodmfgPlacing more aggressive regulations on suppliers, not just manufacturers. If the world’s food supply were envisioned as an iceberg, the portion above the water line would represent manufacturers, processors, and retailers. The portion of the iceberg below water – by far the largest segment – would represent the thousands upon thousands of suppliers that play a pivotal but often overlooked role in food safety. It’s a supply chain that is both widespread and granular in scope: it includes makers of conveyor equipment, as well as suppliers of lubricants for that equipment.
  1. Preventing food safety issues rather than relying upon government intervention only when there’s a problem, is at the very heart of FSMA, and one that should have the most immediate and beneficial impact on food safety over time. That’s because, for the first time, food manufacturers and processors, along with their supply chain partners, have clear direction in preventing food contamination by creating and maintaining a food safe environment up and down the supply line. One requirement alone – having in place a comprehensive food safety plan – is perhaps the single most significant of all of FSMA’s many regulations.

Of course, maintaining a 100 percent safe food supply is literally impossible. But as an aspirational goal, FSMA represents forward thinking on the part of the government and the food industry, both of which have an obvious, vested interest in producing and selling products that are as safe as they can possibly be.

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