White Papers
Reducing Cross Border Liability in the Supply Chain (DRI Aug 2012) - Mark A. Kinzie
Two new standards from the Organization for International Standardization, ISO 10377 and ISO 10393 will guide manufacturers to create safe products and to execute product recalls. Several countries will adopt them as regulatory compliance measures, and they will become benchmarks for best practices across supply chains in multiple jurisdictions. This paper describes how applying these standards also reduces exposure to liability and enhances product integrity.
EU Provides New Industry Guidance for Product Recall - Mark A. Kinzie
In March 2012, the European Commission provided new guidelines for producers and distributors to implement any type of corrective action, including a product recall. Here is an overview of the EU's New Industry Guidance for Product Recall.
Solutions to Tackle the Growing Exposure to Product Regulations in Multiple Jurisdictions – Mark A. Kinzie and Patricia A. Hietter
Understanding the hazards in a product and how they are controlled by the supply chain yields immeasurable certainty over regulatory compliance. This article suggests a comprehensive solution to complying with product safety regulations before the sale, reporting product incidents when they occur, and removing products from the market during a corrective action. Thus, product suppliers need not chase regulatory developments to reduce exposure. Instead, product suppliers should understand the hazards inherent in their product. This article appeared in the 2012 edition of The International Comparative Legal Guide to: Product Liability; published by Global Legal Group Ltd, London at http://www.iclg.co.uk/practice-areas/product-liability/product-liability-2012
ISO 10377 Provides Guidance to Create Safe Products - Mark A. Kinzie
Safety, especially product safety, can mean different things to different people. To an engineer, it's hazard analysis. To a risk manager, it's loss control. To a regulator, it's compliance. To a lawyer, it's liability. To the working group that created ISO 10377, it was orchestrating all views into one practical methodology that will turn out a safe, reliable consumer product every time. This has been the endeavor of the ISO Project Committee 243 ("PC 243") on consumer product safety, and its accomplishment has been the First Draft Form of ISO 10377, Consumer Product Safety: Practical Guidance for Suppliers.
US-EU Organic Trade Agreement – Lori A. Hardaway
Organic food trade between the United States and the European Union will become harmonized by Summer 2012. A new arrangement for organic food reciprocity between the two countries begins June 1, 2012. This article provides a short recap of this agreement.
New Industry Standard Governs Safe Food from the Farm - Mark A. Kinzie
A new Technical Specification has been released by the International Organization for Standardization (ISO). This new standard will guide the detection, management, and control of food safety hazards, beginning with the hygienic environment on the farm.
ECADA Reforms CPSIA - Mark A. Kinzie
In August 2011, Congress passed the Enhancing CPSC Authority & Discretion Act of 2011, which changed that application of the existing CPSIA to product manufacturers in several ways.
State Standards for Honey - Lori A. Hardaway
There have been rash of arrests and enforcement actions in Chicago, Philadelphia and the Pacific Northwest for illegal importation of honey. The 'honey laundering' scheme falsified the origin of the honey claiming the honey was from Thailand or the Philippines thus avoiding millions in duties and taxes. In addition, much of the honey was found to be tainted with additives such as corn syrup and cane sugar or antibiotics not approved in honey production. Because the U.S. Food and Drug Administration has not made the setting of honey standards a priority, individual states, with the help of trade groups, are setting their own standards.
The Blurry Line Between Beverages and Dietary Supplements: The FDA Position - Lori A. Hardaway
That the beverage industry has been an area of rapid growth is no surprise to anyone. Beginning about 20 years ago with the introduction of Red Bull, the market has seen the onslaught of products touting increased energy, promoting relaxation, and a host of other health benefits. These products usually claim to be dietary supplements, but the Food and Drug Administration (FDA) does not agree. Hence, the blurry line.
ISO 10377 Industry Standard on Consumer Product Safety Approaches First Draft Approval - Mark A. Kinzie
ISO 10377 is the first guidance standard on consumer product safety. This article describes the standard in its current form, its key concepts, current ISO participating countries, and its anticipated completion date..
Solutions to Manage Cross-Border Liability in the Supply Chain - Patricia A. Hietter & Mark A. Kinzie
The ability to control product liability may seem non-existent when a product is made and sold over multiple jurisdictions. Yet, liability control does exist. It just does not take a traditional, one-dimensional form. Instead, a combination of tools must be employed and some of them must be used in tandem with one another. This article explores those tools and how they may be effective, or ineffective, against other suppliers, distributors, and retailers in the supply chain.
The Regulations of Hazardous Substances in the U.S. - Patricia A. Hietter & Mark A. Kinzie
Several federal agencies regulate substances and materials in consumer, commercial, and industrial chemical products. Depending on the federal statue and the regulatory scheme, controlled and banned chemical substances are governed by multiple key regulations that identify individual hazardous substances or the product into which its ingredients are placed.
Canada’s Consumer Product Safety Act Becomes Law - Patricia A. Hietter & Mark A. Kinzie
On December 15, 2010, the Canada Consumer Product Safety Act (CCPSA or Act) received Royal Assent and is now law. The Governor in Council has not set the effective date for the CCPSA, but it could be as early as the second quarter of 2011.
Food Safety Modernization Act - Patricia A. Hietter and Mark A. Kinzie
On January 4, 2011, President Obama signed into law the Food Safety Modernization Act ("FSMA"), which overhauls the long-standing Federal Food, Drug, and Cosmetic Act by establishing new regulations to improve food safety. This White Paper discusses three main provisions of the Act.
Two New International Standards Will Reflect Best Practices in Product Safety - Mark A. Kinzie
Two industry standards are in their formative stages to develop practical guidelines that will allow mid~sized companies supplying consumer products to establish their own internal product safety program and to implement and operate a product recall.
The Changing Landscape of Canada’s CPSA - Patricia A. Hietter and Mark A. Kinzie
Canadian consumer product safety law is changing. On June 9, 2010, the Government of Canada introduced Bill C-36, the Canada Consumer Product Safety Act (CCPSA), which would radically revamp Canada?s existing consumer product regulatory regime through a variety of measures.
Identification Systems in Food Traceability - Mark A. Kinzie
The tracking mechanism for food products in the supply chain must be reliable, manageable, dynamic, and cost-effective. Identifying the origin of food ingredients and food sources is of prime importance to consumers, particularly where food products may be faulty and risk consumer protection. Traceability enables consumers with targeted and accurate information about food products during different stages from processing to distribution and facilitates the withdrawal of food from the market during a recall or quality audit.
Evaluating & Measuring the 6 Hazards in the Federal Hazardous Substances Act - Mark A. Kinzie and Patricia A. Hietter
Six (6) unique hazards each are given a specific definition and evaluation under the Federal Hazardous Substances Act ("FHSA"). A product requires labeling under the FHSA If two (2) events occur. Regulations issued under FHSA specify the tests a manufacturer must perform to evaluate a product for a specific hazard.
Four Things to Know About New CPCSC Regulations - Mark A. Kinzie
On May 7, 2010, the Consumer Product Safety Commission (CPSC) gave notice of its proposed regulations establishing the publicly accessible and searchable database on the safety of consumer products, as required by Section 212 of the Consumer Product Safety Improvement Act of 2008 (CPSIA).
FDA Will Change Front of Pack Food Labeling
The FDA is aiming to change the Front of Pack (“FOP”) food labeling. In its recent Notice, the FDA established a docket to collect data that will establish a scientific foundation for decision-making on nutrition symbols and FOP labeling.
Game Change: CPSC Retailer Injunction & Product Safety Program - Mark A. Kinzie
On March 2, 2010, the United States District Court for the Northern District of California entered its order and consent decree against Daiso directing the retailer to pay $2.05 million in civil penalties and permanently enjoining the retailer from importing in the United States... any toy or other consumer product intended primarily for children 12 years of age or younger.
New Restrictions Emerging on the Use of Bisphenol-A (BPA) in Consumer Product - James M. Meister
In 2009 many new legislative initiatives began to restrict or ban BPA in consumer products in state, national, and international jurisdictions. This 2009 Product Safety Letter publication identifies these legislative initiatives, which ones were successful, and existing restrictions placed on the use of BPA.
Transparency and Value in Product Recall and Section 15 Reporting - Mark A. Kinzie
Transparency can serve the best interest of the manufacturer during a product recall. Value from this transparency adds certainty to a company’s operating and financial positions, builds trust in a company, and reduces regulatory action and tort liability. This 2009 DRI In-House Quarterly publication discusses this transparency and demonstrates how to create value during a product recall.
Multi-Jurisdictional Recall Authority for Consumer Products - Mark A. Kinzie and Tricia A. Hietter
In 2009, Averture prepared a one-page Limited Guide to Recall Authority existing in Australia, Canada, China, the European Union, and the United States. Presented here is the research supporting that Limited Guide as of January 2010. A copy of the one-page Limited Guide is attached.
Canada & The Recall of Consumer Products - Gerald R. Gardner and Mark A. Kinzie
Product recalls have been voluntary under Canadian law, but several tools provide for effective recalls. This 2009 Defense Research Institute publication identifies these tools, existing Canadian regulations governing product recalls, and new consumer product legislation that will change recall protocol in Canada.
Product Warnings for Medical Devices - Lori A. Hardaway and Mark A. Kinzie
Four essential steps to analyze and prepare safety messages for medical devices are discussed in this paper.
Medical Devices & Preemption ? Riegel v. Medtronic - Lori A. Hardaway
In early 2008, the U.S. Supreme Court held that Class III medical devices granted a PMA by the U.S. FDA are preempted from suit under state common law. This Paper discusses the case, its implications, and the specific category of medical devices affected by the case.
Wyeth v Levine - Expanded Liability for Pharmaceutical Manufacturers - Lori A. Hardaway
In Wyeth v. Levine, the United States Supreme Court held that federal law did not pre-empt the plaintiff’s state law claim for failure to warn. Specifically, the Supreme Court rejected Wyeth’s argument that Levine’s failure to warn claims were preempted by federal law because the language on the drug label had been approved by the FDA.
Food Safety Enhancement Act of 2009 - Luann C. Battersby and Mark A. Kinzie
The Food Safety Enhancement Act of 2009 proposes to amend the long-standing Food, Drug and Cosmetic Act to establish new food safety regulations governing recalls, inspections, quality systems, labeling, and traceability. This paper discusses key provisions in the proposed legislation.
Product Safety in a Global Market - James M. Meister and Mark A. Kinzie
Compliance with governing regulations is but one aspect of the overall product safety regimen. This becomes more difficult when a product is sold in several countries, particularly when coordinating overlapping regulatory requirements for performance testing, use of hazardous substances, and assessing health and safety risks. This paper identifies a few of these international regulations.
Warnings About Hazardous Substances - James M. Meister and Mark A. Kinzie
Chemical products typically require warnings about their hazardous substances and their effect on human health. The difficulty is knowing when a chemical ingredient is so hazardous that it requires a warning. This paper explores that threshold and proposes a systematic analysis from which these warnings may be made.
US Manufacturers Compliance Requirements for REACH - EU’s New Identification and Control of Hazardous Substances - James M. Meister
In June 2007, the EU’s Registration, Evaluation, Authorisation, and Restriction of Chemicals went into effect in all EU Member States. U.S. Manufacturers must comply with this new regulation where they sell into or manufacture in EU. This paper gives a brief synopsis of this regulation’s 800-page requirements.
Post Sale Duty to Warn May Place Burden on Manufacturers - Patricia A. Hietter
Product manufacturers may have a post-sale duty to warn about product hazards depending on the law of the jurisdiction where the product was designed, manufactured, and sold. This 2009 Product Safety Letter publication identifies the current requirements for such a warning in each jurisdiction.
Component Part Manufacturing and Bulk Supplier Liability - Mark A. Kinzie
In 1999, the ABA produced a 50-state compendium reflecting the state of the law governing component parts. Here, three states are presented, which were originally authored by the Group’s lawyers.
CPSIA: The Consumer Product Safety Improvement Act of 2008
On July 31, 2008 the U.S. House and Senate approved the Consumer Product Safety Improvement Act of 2008 (H.R. 4040) by wide margins (House 494-1; Senate 89-3)("CPSIA"). The Improvement Act has been characterized as the most sweeping change to the U.S. Consumer Product Safety Commission ("CPSC") since its creation in 1972.
NanoParticles and Hazard Communication ? Selected Abstracts
In 2007, a number of studies were published in peer-reviewed journals discussing the hazards associated with nanoparticles and the coming requirements to capture and communicate those hazards to product users. This Paper identifies a few of those studies.
Safety Messages 101: Warnings Content for Consumer Products - Mark A. Kinzie
The content of a warning is only as reliable as the infrastructure supporting the design and manufacturing of the product. Highly defensible warnings are those that have successfully marshaled the manufacturer’s existing work into their product’s safety message. In this 2009 Product Safety Letter publication, the author briefly describes the process for analyzing product hazards and creating safety messages that communicate those hazards. A checklist for these steps is provided.
The Rule for Admissibility. NTSB Safety Reports and Use in Litigation - Mark A. Kinzie
Under federal statutes, the NTSB safety report created following an aircraft accident is inadmissible at trial. Certain caveats allow some or all of the report into evidence. This 1989 Matthew Bender publication discusses the safety report, its original purpose, and the rule for admitting the paper into evidence at trial.
Solving Solution Structures of Physiologically Relevant Proteins by NMR Spectroscopy - Lori A. Hardaway
In the last decade, high resolution magnetic resonance (NMR) spectroscopy has become the technique of choice to study protein solution structure and dynamics at the molecular level. This 1992 Annual Review publication summarizes the NMR protocol for realization of the three-dimensional solution structure of physiologically relevant proteins given the restraints of the NMR technique.
Amide Hydrogen Exchange of the Central B-chain Helix within the T- and R- States of Insulin Hexamers - Lori A. Hardaway
A comparative analysis of the H-NMR spectra of human insulin shows that in the presence of the allosteric ligand, phenol, the tertiary structure of the protein is altered as evidenced by the rate of amide hydrogen-deuterium exchange. This 1994 paper exemplifies the exchange rates of two amides from this helix, which decrease by approximately 400-fold as a result of this ligand induced conformational transition.
BioIndustry in Arizona - Lori A. Hardaway and Judith G. Shelling
This 2001 Economic Development Paper identifies the use and recommendations for bioindustry development in Arizona.