On April 23, the agency sent the White House Office of Management and Budget (OMB) its draft final rule revising existing federal waste regulations for solvent-contaminated industrial wipes and laundered shop towels. OMB review is generally the last significant step before a rule can be finalized and released.
Although no concrete details are available, it is expected that the final rule will establish conditions under which single-use wipes used in industrial settings will be exempt from onerous hazardous waste regulations and users exempt from the related onerous handling and disposal requirements. Meanwhile, laundered shop towels, which are currently subject only to much looser and often conflicting state regulations, will be brought into the federal regime and be conditionally exempt from the definition of solid waste.
Most know that INDA has been actively involved in this EPA rulemaking for many years, working closely with the Secondary Materials and Recycled Textiles Association (SMART) to ensure the rule addressed unnecessary and onerous regulatory burdens applicable to single-use industrial wipes. More recently, it was concerns voiced by INDA/SMART during a March 2011 EPA “Town Hall” meeting about the rule’s status that ultimately propelled agency officials to push up its timeline for completion to this summer.
While the White House budget office has no firm deadline for completing its assessment, OMB reviews typically last between 60-90 days, meaning a final rule could be published as early as late June/early July 2012. As always, INDA will keep members posted about any major developments as they unfold and will release details about the final rule when it has been published.
FDA Cosmetics Regulation
Lawmakers and regulators in Washington have taken a keen interest in the cosmetics industry recently, with Congress currently considering several bills that would grant the Food and Drug Administration (FDA) additional authority to regulate personal care products. The Health Subcommittee of the House Committee on Energy and Commerce held a hearing on March 27, “Examining the Current State of Cosmetics.”
Those testifying described a growing need for reform due to increasing numbers and types of products on the market, including many from other countries whose regulatory regimes differ dramatically from the U.S., as well as the growing use of nanotechnology and prevalence of “cosmeceuticals,” which have many characteristics similar to drugs.
Even industry agrees that something needs to be done. “While cosmetic products remain among the safest in commerce, the existing system for regulating our industry is overdue for a makeover,” says Lezlee Westine, president and CEO of the Personal Care Products Council (PCPC), which for several years has been advocating for reform.
There are currently three proposals in Congress, each proposing a different approach and each supported by different interest groups. The Safe Cosmetics Act (H.R. 2359) introduced June 24, 2011, by Rep. Jan Schakowsky (D-IL 9th), Ed Markey (D-MA 7th) and Tammy Baldwin (D-WI 2nd) requires product registration and directs the FDA to establish labeling requirements and safety standards and to issue guidance on good manufacturing practices. It has attracted strong support from various consumer, public health, medical and environmental advocacy groups but with only Democratic sponsors, appears unlikely to move forward in Washington’s highly partisan environment.
Representatives Frank Pallone (D-NJ 6th) and John Dingell (D-MI 15th) introduced the Cosmetics Safety Enhancement Act (H.R. 4262) on March 26. It too requires product registration and directs the FDA to issue good manufacturing practices, but also establishes “serious adverse effect” reporting and grants the FDA recall authority. Again, with only Democratic sponsors, this bill will not likely escape from the subcommittee.
On April 18, Rep. Leonard Lance (R-NJ 7th) introduced the Cosmetic Safety Amendments Act of 2012 (H.R. 4395), which is supported by various industry groups like the PCPC. This bill would require personal care product manufacturers to register all manufacturing facilities, submit ingredient statements to the FDA and report serious unexpected adverse events. The bill also would establish a federal ingredient review process, require FDA to promulgate regulations establishing best practices for the cosmetics industry and preempt similar state legislation, creating national uniformity for cosmetics regulation. With industry support and a Republican sponsor, if any bill moves, it will be this one.
The FDA is also considering what action it can and should take on cosmetics whether Congress grants it new authority or not. In November, FDA held a public stakeholder meeting looking at whether existing guidance addressing cosmetic microbiological safety is in need of an overhaul. During the meeting, agency officials noted they were looking closely at updates to the Cosmetic Good Manufacturing Practice Guidelines/Inspection Checklist (2008) and the Chapter 23, “Microbiological Methods for Cosmetics,” of its Bacteriological Analytical Manual (BAM). FDA also accepted stakeholder input regarding whether new guidance needs to be developed. Personal care products representatives touted the industry’s safety record and indicated a willingness to collaborate with the agency to the extent that changes are made. It is unclear when FDA will release draft guidelines.
On April 20, the FDA released its draft “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products,” which provides guidance to industry and other stakeholders on FDA’s current thinking on the safety assessment of nanomaterials in cosmetic products. The FDA developed the guidance “to industry and other stakeholders in identifying the potential safety issues of nanomaterials in cosmetic products and developing a framework for evaluating them.”
Good360 Names Fiorina Board Chair
INDA’s new charitable giving initiative partner Good360 announced April 18 that former CEO and president of Hewlett Packard Carly Fiorina will chair its board of directors. Fiorina appeared on CNBC’s Squawk Box that day to discuss her new position and the work of Good360, a non-profit that focuses on funneling company products and other donations to charities. Fiorina called the Good360 model a “no-brainer,” since it allows businesses to use excess inventory to benefit organizations in need while diverting goods from landfills. She also touted Good360’s logistics and warehousing capabilities and commended corporate donors including INDA’s own Johnson & Johnson for their work with Good360.
A video of Fiorina’s appearance can be found at: http://video.cnbc.com/gallery/?video=3000084889.