FDA publishes amendments to original UDI proposal

The U.S. Food and Drug Administration (FDA) recently announced that it is amending the implementation timeline associated with its previously proposed unique device identification (UDI) rule. The updated proposal was published in the Federal Register on November 19.

The UDI is a numeric or alphanumeric code that includes a device identifier, which is specific to a particular model, as well as a production identifier, which includes information about a specific device's manufacturing, such as the lot or batch number, serial number and expiration date.

Under the FDA's new proposal, the label and package of any class I, class II, or unclassified medical device that is "implantable, life-supporting or life-sustaining" must bear a UDI within two years of the announcement of the final rule. The proposal would also require permanent marking of a UDI directly on the surface of certain devices, including those that are implantable.

The amendment to the agency's original proposal was necessitated by section 614 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which mandated that the FDA implement final regulations within two years of the UDI rule's finalization.

Class III devices, as well as those licensed under the Public Health Services Act, are affected only with regard to the direct marking requirement, as the original proposal required them to be labeled with a UDI within one year of the final rule's publication, which puts them in compliance with the new proposal's two year requirement.

Federal officials are currently soliciting input on the new rule from industry stakeholders and the public. The comment period ends on December 19.

According to the FDA, the UDI system will facilitate more accurate reporting of potential problems with medical devices, allow more effective management of recalls and help combat counterfeiting in the supply chain.

Country-of-origin labeling lawsuit intensifies with filing of amended complaint

This blog previously discussed the details of a lawsuit filed in federal court in September by a number of associations linked to the food industry. The case centers on how country-of-origin labeling (COOL) requirements are being implemented.

The plaintiffs – including the Ranchers-Cattlemen Legal Action Fund (R-CALF USA) and the Made in the USA Foundation – are seeking to abrogate a ruling by a World Trade Organization (WTO) dispute settlement board, which found that the way COOL regulations are being implemented in the United States constitutes a disadvantage for foreign producers and a violation of WTO rules.

In their lawsuit, plaintiffs allege that the WTO panel's ruling is legally void in the United States, as the nation entered the organization on the explicit condition that any WTO rulings found to be inconsistent with U.S. law would have no effect on the country. The suit also contends that U.S. Agriculture Secretary Tom Vilsack and U.S. Trade Representative Ron Kirk failed to meet their responsibility to uphold U.S. sovereignty by agreeing to negotiate a compromise on COOL.

This month, the groups behind the lawsuit filed an amended complaint, which added new plaintiffs to the case and introduced additional causes of action. Joining the suit are several regional cattlemen's associations, two individuals associated with R-CALF USA and the Organization for Competitive Markets.

The groups added a request that the court prevent Secretary Vilsack from allowing meat derived from animals born, raised and slaughtered in the United States to be labeled as a product of multiple countries.

The U.S. government has still not formally responded to this lawsuit. Counting from the date the amended complaint was filed – November 13 – the administration has 60 days to respond.

This blog will continue to highlight developments in this case, as well as other events and trends that relate to enterprise-level labeling issues.

Regulations are only one piece of the public safety puzzle

At times during the recent election, the political rhetoric seemed to suggest that there were only two possibilities: Total government control over all business practices that would bring the economy to a halt or a complete lack of regulation that would result in utter chaos.

As is often the case with politically charged interpretations of policy issues, reality shows that regulatory conditions must fall somewhere between the two extremes.

Too much government involvement really does make the economy less efficient and can constrain growth. At the same time, it is imperative for the government to maintain a stable regulatory framework that provides support and certainty for the nation's business leaders and aspiring entrepreneurs.

This includes protecting companies from themselves. For instance, when manufacturers are allowed to cut too many corners, it can result in the development of serious consumer safety issues that damage the reputation of U.S. brands.

Companies must be proactively involved in protecting public safety

In many areas, it is simply unrealistic to expect government agencies to be able to fully ensure public safety without significantly affecting the high level of operational freedom that allows U.S. businesses to compete in the global economy.

In a consummate example of this fact, The Associated Press (AP) recently reported on a regulatory failure involving imported jewelry that was tainted with cadmium.

The AP's Justin Pritchard reports that, following a "children's jewelry sweep," the Consumer Product Safety Commission (CPSC) discovered six of the items it collected were hazardous by the agency's standards. However, it failed to pursue recalls or warn consumers about the health risk, claiming that none of the items met the legal definition of a "children's product."

In addition, the regulatory organization allowed Wal-Mart and another retailer to pull unsafe jewelry from their shelves without contacting consumers who had previously purchased identical items.

According to Pritchard, the CPSC pointed to its "limited resources" as an explanation for its shortcomings. This is somewhat valid, as the agency's staff numbers less than 600, although it is charged with regulating thousands of different products.

Furthermore, the agency's limited legal authority makes it difficult for regulators to compel any company to conduct a product recall.

This underscores the point that private-sector companies must be actively involved in pro-safety efforts, or the infiltration of hazardous substances into U.S. consumer supply chains will be inevitable, leading to public outrage and a sprawling, reactionary expansion of product regulation.

In a statement to the APEC Toy Safety Initiative in Hong Kong, CPSC Chair Inez Tenenbaum asserted that "all of us should be committed to keeping hazardous or toxic levels of metals out of surface coatings and substrates of toys and children's products."

She went on to assert that the failure of voluntary efforts by industry would, in fact, lead to further regulatory developments.

Better labeling processes could provide an opportunity for compromise

When companies in a given sector are able to demonstrate that they have the capacity and desire to keep dangerous materials away from the public, it decreases the impetus for further government regulation.

However, in order for such a situation to be seen as acceptable by politicians and the public, companies will need to bolster the credibility of their claims to be capable of providing security in the absence of extensive government regulation.

The implementation of enterprise-class labeling solutions can facilitate industries' efforts to prove that effective self-regulation of supply chains is possible. When all shipments are securely marked with barcodes, companies can ensure that counterfeit and unsafe components are kept out of their distribution systems. Also, in the event that safety issues are uncovered, the items in question can be effectively traced back to their manufacturer, allowing companies to cut irresponsible suppliers out of their network.

21 CFR Part 801 Document

[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Proposed Rules]
[Pages 69393-69399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28015]
=======================================================================
———————————————————————–

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. FDA-2011-N-0090]
RIN 0910-AG31
Unique Device Identification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; amendment.

———————————————————————–

SUMMARY: The Food and Drug Administration (FDA) is amending its July
10, 2012, proposed rule (77 FR 40736) to establish a unique device
identification system as required by recent amendments to the Federal
Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food
and Drug Administration Safety and Innovation Act (FDASIA) was signed
into law; section 614 of FDASIA amends the FD&C Act in ways that
require modification of the timeframe for implementation of the
proposed rule’s requirements as they apply to devices that are
implantable, life-saving (life-supporting), or life-sustaining.

DATES: Submit either electronic or written comments on the amendment to
the Proposed Rule by December 19, 2012. See section VII for the
proposed effective dates of a final rule based on the amended proposed
rule.

New tire labeling regulations come into effect for European markets

With more than 500 million consumers spread across 27 countries covered by the European Union (EU), any regulations put into place by the organization should command considerable attention from companies that sell their products internationally.

Right now, it's tire manufacturers and distributors that are facing a need to update their product labels in response to new EU regulations.

On November 1, new labeling requirements officially came into effect for tires offered for sale in the European market. The new labels must reflect test results in three ratings areas: fuel efficiency, traction on wet roads and rolling noise.

In addition to ensuring that the consumer-facing labels on the tires themselves are compliant with the new standard, affected tire companies will also need to update the labels used within their supply chains to guarantee that the appropriate shipments reach the right markets, as mistakes in this area can be costly and disruptive.

U.S. also recently updated tire labeling regulations

In 2009, the U.S. Department of Transportation's National Highway Traffic Safety Administration (NHTSA) proposed new tire labels similar to those now being used in Europe. Advocates of stricter labeling standards held that the expanded labels would offer valuable information to consumers and promote the use of high-quality tires.

After a period of several years, during which personnel at NHTSA reviewed the agency's original proposal and industry stakeholders offered their input, a final rule was published in the Federal Register on December 21, 2011.

The updated labeling regulations mandate that tire manufacturers mark their products with ratings regarding fuel efficiency, traction on wet roads and tread durability.

Implementing an enterprise-class labeling solution can help a company react quickly to shifting regulatory requirements and avoid losing out on market opportunities due to an inflexible labeling process.

GMO labeling mandate rejected by California voters

Earlier this year, we discussed a ballot initiative in California – proposition 37 – that would have required food companies to explicitly label any products that contain genetically modified organisms (GMOs).

Prior polling indicated widespread support for requiring GMO labeling in California, which is often a pioneer in the development of new regulations aimed at supporting human and environmental health. However, on election day, the measure was rejected by the state's voters, with 53 percent voting against and 47 percent in favor.

Campaign finance reports show that a number of major food producers poured cash into the effort to defeat proposition 37, with about 80 companies collectively spending roughly $46 million to advance the argument that GMOs are safe and a labeling mandate would only add unnecessary costs to the distribution process.

Going forward, is the issue of GMO labeling 'here to stay?'

In the wake of proposition 37's defeat on Tuesday, Gary Hirshberg, chairman of Just Label It – an advocacy organization that supports GMO labeling – released a statement asserting that the campaign had significantly raised the profile of the issue and that it was now "here to stay."

Reuters reports that new GMO labeling initiatives are being organized in Oregon and Washington state. However, food safety advocates are also beginning to push for federal action on the subject.

President Obama's reelection will most likely make it easier for the issue to gain traction at the national level, although it is unclear whether Congressional Republicans could be successfully convinced to support new labeling regulations.

Citing the widespread adoption of GMO labeling by America's major trading partners, Hirshberg contends that it is "not a question of whether, but when" a mandate will be put in place in the United States.

In order to be prepared, companies must ensure their labeling processes allow them to quickly add or update information and print clean, complete labels at a sufficient scale and pace.

EPA's chemical testing robot could bolster calls for new regulations, labeling requirements

We have previously discussed how consumer safety advocates are currently pushing for new legislation to bolster the public health protections established by the Toxic Substances Control Act of 1976 (TSCA).

The movement's supporters allege that the TSCA provides inadequate safeguards to prevent hazardous chemicals from working their way into the supply chain. Of the tens of thousands of chemicals currently being used in American products, only a few hundred have ever been tested, according to Discover Magazine.

Furthermore, only five compounds have ever been restricted or banned. TSCA's critics say an update to the law is necessary in order to facilitate broader testing and ensure public safety.

While the gridlocked nature of the U.S. political system – and, Congress in particular – makes this an uphill battle for these groups, there is a chance that new technologies may soon disrupt the status quo and put a fresh impetus behind the drive to strengthen chemical regulations in the United States.

Specifically, a project launched in 2011 by the U.S. Environmental Protection Agency (EPA) could uncover new evidence regarding the scope of potential health risks associated with chemicals that are commonly used in the manufacture of various consumer products.

The project – Tox21 – makes use of a six-ton robot to perform basic toxicity testing at a faster rate and lower cost than was previously possible when humans had to do all the handling. This may lead to a breakthrough in our understanding of how chemicals interact with living things and each other.

In turn, this could lead to new labeling requirements being imposed on companies that produce, distribute or work with certain chemical substances. As we recently reviewed, the U.S. government is currently phasing-in an updated version of its Hazard Communication System – HSC 2012. With the possibility of further, data-driven regulatory action in the near future, chemical companies should prepare to make any changes to their labeling processes that may necessary.

U.S. chemical manufacturers and distributors face new labeling regulations

As the use of chemicals has expanded across economic sectors and national borders, a wide range of different regulatory frameworks have been created, each with its own labeling requirements.

Even within countries, businesses' labels and safety data sheets (SDS) can be held to varying standards when different parts of products' life cycles are governed by separate regulatory authorities.

For instance, the United States has the Occupational Safety and Health Administration (OSHA), Consumer Product Safety Commission, Department of Transportation and Environmental Protection Agency.

Harmonized labeling standards lead to safer distribution systems

Information about potential hazards must be available to all individuals who may be exposed to a substance, including personnel involved in distribution, end-users, emergency responders and the general public.

This necessitates a high level of consistency in the way hazards are communicated, which is why stakeholders came together to create the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

GHS is meant to provide governments with regulatory "building blocks" that can be used to construct globally compatible systems for marking materials that are hazardous when mishandled.

The Unites States is currently phasing in a new, GHS-compliant version of its Hazard Communication Standard (HCS). Concurrently, the black and white pictograms used to denote chemical safety issues are being replaced with new symbols that feature a red diamond containing an illustrative graphic.

OSHA currently offers interested parties the chance to make a side-by-side comparison of the existing HCS – put into place in 1994 – and the updated HCS.

Timeline

The agency also offers information on the phase-in of new requirements. Below, we review several need-to-know dates.

By December 1, 2013, employees must be trained on new label elements and the updated SDS format.

After December 1, 2015, distributors will be prohibited from shipping containers that have not been properly marked with a GHS label.

By June 1, 2016, employers must have updated their labeling and hazard communication programs as necessary, in addition to providing workers with training on newly identified hazards.

Meningitis outbreak could act as a catalyst for regulatory reform

This blog recently analyzed the details of a meningitis outbreak that now includes more than 280 confirmed cases spread across 16 states. There have been several notable developments on the subject.

On October 18, the U.S. Centers for Disease Control and Prevention (CDC) released a statement asserting that, in collaboration with the Food and Drug Administration (FDA), they had confirmed the presence of fungus in unopened vials taken from the New England Compounding Center (NECC), which was already believed to be the source of the outbreak.

Unsustainable liabilities may lead to bankruptcy for compounding center

The Boston Globe reports that NECC is likely to file for bankruptcy protection in the near future, due to the initiation of numerous lawsuits against the company. The facility has already suspended operations and laid off most of its employees.

The company faces at least 10 lawsuits in various jurisdictions and more are likely to follow. Experts interviewed by The Globe asserted that NECC will be unable to meet its liabilities through insurance coverage and current assets.

"You're really talking about a cascading crisis of claims," Michael Rustad, a professor at Suffolk University School of Law, told The Globe. "We're talking about hundreds of millions of dollars in potential claims."

Edward Jazlowiecki, an attorney for a patient affected by the outbreak, said he believes there is a "100 percent" chance of NECC filing for bankruptcy. Fred Pritzker, another attorney, concurred with Jazlowiecki's assessment, saying that there would be "hundreds, if not thousands, of lawsuits filed."

Implications for the pharmaceutical industry

The sheer size and impact of the meningitis outbreak and its aftermath have kept this story in the national spotlight for weeks. In the minds of many observers, it is a sign that current regulations have not kept pace with developments in the industry.

According to The Washington Post, the market for custom-mixed pharmaceuticals has grown rapidly in recent years and now includes 7,500 facilities doing $3 billion worth of business per year. However, compounding facilities operate under guidelines that were designed for small-scale pharmacies creating drugs for individuals.

The 1938 law that established the FDA strictly limited its authority to large-scale drug manufacturers. This means that compounders' products are not subject to premarket review by the FDA. Deborah Autor, the FDA's deputy regulatory commissioner, told The Washington Post that the agency's officials face legal uncertainty and industry opposition when attempting to impose comprehensive safeguards on these producers.

The Post reports that, in the wake of the meningitis outbreak, several members of Congress have vowed to introduce legislation expanding the FDA's authority to oversee the operations of compounding facilities. However, it is unclear whether or not gridlocked lawmakers will actually be able to reach a deal on a new regulatory framework for these organizations.

Updated labeling processes could lead to compromise between industry, lawmakers

The government has a responsibility to act in defense of public safety, but stakeholders in the pharmaceutical industry also have a vested interest in ensuring the integrity of their operations. Sprawling, ineffective recalls reduce public confidence in the industry and can prove severely damaging to affected brands.

One possible compromise that would serve both public and private interests would be for compounding facilities to implement a more stringent labeling process for inputs and finished products in the pharmaceutical supply chain.

This would allow the industry to maintain a large degree of control over its own operations and limit government entanglement, while establishing a more effective system for ensuring the proper handling of sensitive substances and bolstering distributors' ability to recall potentially tainted products.

As recall sprawls, beef producer waits on restoration of operating license

XL Foods' meat processing plant in Brooks, Alberta has been at the center of a public relations storm since E. coli was discovered in its products last month.

Bacteria was first discovered in the company's beef by U.S. border officials on September 3. Ten days later, beef shipments from the company were barred from entering the United States.

A recall was announced on September 16 and, since then, it has been expanded several times. The recall now encompasses more than 1,800 XL Foods products, including 1.1 million kilograms of beef exported to the United States and 20 other countries.

On September 27, the Canadian Food Inspection Agency (CFIA) revoked the Brooks plant's operating license. CFIA inspectors have since visited the Brooks plant for a "pre-inspection" visit. Lisa Gauthier, a spokeswoman for the agency, referred to this as one part of a multi-step process to ensure that the facility could safely resume operating.

Better labeling processes help companies resolve safety issues, protect brands

Martin Shields, the current mayor of Brooks, said that he was "optimistic the plant will be reopened soon."

However, Brian Mason, leader of the Alberta New Democratic Party (NDP), expressed greater concern about how the incident would affect public perception of the industry over the long-term, saying that the sprawling recall "has damaged the brand of Alberta beef in a way that has been very, very serious."

Companies do not need to accept the risk of a protracted and potentially brand-destroying recall. More effective labeling solutions that allow product tracking and traceability within the supply chain allow businesses to quickly locate tainted products. This enables fast, effective resolution of public safety concerns, which protects the affected brand and reduces the incentive for regulatory officials to intervene.