The Health Subcommittee of the House Committee on Energy and Commerce in the US House of Representatives held a hearing in March entitled the “Examining the Current State of Cosmetics.” In his opening statement, Rep. Joseph R. Pitts, stated, “For the past several years, the industry and members of both parties have been reviewing FDA’s regulatory authority over these products. One issue under review is the need for a national uniform standard for cosmetic products and preemption of state legislation.”
Pitts said he hoped that the witnesses would share their “perspectives on several matters, including what deficiencies, if any, you currently see in FDA’s regulatory authority over cosmetics; what new authorities, if any, do you believe FDA needs in this area; and if new authorities are needed, what will be the impact on small businesses across the country?”
The witness list included Michael M. Landa, director of the Center for Food Safety and Applied Nutrition (CFSAN); Halyna Breslawec, chief scientist and EVP for science, the Personal Care Products Council; Curran Dandurand, co-founder and CEO of Jack Black Skincare; Debbie May, president and CEO, Wholesale Supplies Plus, and Michael J. DiBartolomeis, chief occupational lead, Poisoning Prevention Program & California Safe Cosmetics Program, California Department of Public Health.
“While cosmetic products remain among the safest in commerce, the existing system for regulating our industry is overdue for a makeover,” said Lezlee Westine, president and CEO of the Personal Care Products Council, which for several years has been advocating for reform. “The current process has served the public well for decades, but the time has come for us to advocate for additional safeguards as science and technology evolve.”
The Council is seeking to create formal processes for FDA to review ingredients for safety at the request of all public and stakeholder groups and to review all safety determinations made by the Independent Cosmetic Ingredient Review (CIR) Expert Panel. CIR was established in 1976 with the support of the FDA and the Consumer Federation of America. While companies do assess the safety of products and ingredients prior to marketing, creating these new processes will provide the added transparency that consumers are seeking.
The Council’s science and legal experts advocated for these and other changes during the hearing of the Health Subcommittee of the House Committee on Energy and Commerce.
“The basic statutory provisions that govern FDA regulatory authority over cosmetics today were put in place in 1938,” said Peter Barton Hutt, the former chief counsel for the FDA and longtime Harvard law lecturer on the current legal and regulatory system. “Since then, FDA and the cosmetic industry have worked together to keep pace with changing technology by the promulgation of creative regulations and the establishment of new regulatory programs.”
Despite the fact the FDA has repeatedly stated that cosmetics are the safest products they regulate, Hutt said that the increasing global nature of the industry, a desire for more transparency from consumers and other factors suggest “it is time to bring FDA’s statutory authority up to date.”
Dr. Breslawec, the Council’s chief scientist agreed with Hutt, recommending that FDA incorporate the CIR findings into its product regulatory process.
“FDA should formally recognize the findings of the CIR Expert Panel as part of the regulatory regime for cosmetics,” Breslawec said. “Science and safety are the foundation of the cosmetics industry and collectively we must remain steadfast in our commitment to safety. Acceptance and reliance on CIR findings will reaffirm that commitment.”
Through its experts, the Council offered the following specific provisions for Congress to consider which would bolster FDA’s oversight:
- Enacting into law the existing FDA voluntary programs for registration of manufacturing establishments and listing of cosmetic products and their ingredients.
- Requiring submission of reports on adverse reactions that are serious and unexpected.
- Mandating FDA regulations establishing Good Manufacturing Practices (GMPs) for cosmetics.
- Establishing programs to require FDA to review and determine the safety of cosmetic ingredients and constituents along with strong FDA enforcement.
- Requiring FDA review of all CIR determinations on cosmetic ingredient safety and either accept or reject those determinations.
- FDA establishment of a national cosmetic regulatory databank for use by other state authorities and the public.
- An unambiguous Congressional determination that, as modernized, the revised statute will apply uniformly across the country.
FDA Rejects BPA Ban in Food Packaging
The Food and Drug Administration has rejected a petition from environmentalists that would have banned the plastic-hardening chemical bisphenol-A from all food and drink packaging, including plastic bottles and canned food. The agency said that petitioners did not present compelling scientific evidence to justify new restrictions on the much-debated chemical, commonly known as BPA, though federal scientists continue to study the issue. The Natural Resources Defense Council’s petition was the latest move by public safety advocates to prod regulators into taking action against the chemical, which is found in everything from CDs to canned food to dental sealants.
About 90% of Americans have traces of BPA in their bodies, mainly because it leaches out of bottles, canned food and other food containers. Some scientists believe exposure to BPA can harm the reproductive and nervous systems, particularly in babies and small children, potentially leading to cancer and other diseases. They point to results from dozens of BPA studies in rodents and other animals.
But FDA reiterated in its response that that those findings cannot be applied to humans. The agency said the studies cited by NRDC were often too small to be conclusive. In other cases they involved researchers injecting BPA into animals, whereas humans ingest the chemical through their diet over longer periods of time. The agency also said that humans digest and eliminate BPA much more quickly than rats and other lab animals.
SOCMA Comments on Chemical Proposal
The Society of Chemical Manufacturers and Affiliates (SOCMA) acknowledged improvements to proposed changes to the chemical manufacturing area sources rule, but said serious concerns remain over the Environmental Protection Agency’s (EPA) failure to completely exempt “synthetic minors” from a key Title V provision in the rule.
The new proposal addresses several of SOCMA’s concerns, such as fixing the “family of materials” concept in a way that gives chemical companies certainty regarding the reach of the rule. On others, however, especially the Title V provision, SOCMA is concerned about EPA’s logic and the rule’s cost impact, according to the association. This rule has been a top environmental priority for SOCMA members during the past few years, leading SOCMA to file a Petition for Reconsideration of the final rule with EPA in February 2010.
EPA originally proposed to exempt all chemical manufacturing area sources from the requirement to obtain a costly Title V permit, but reversed course in the final rule. The requirement that synthetic minors get a Title V permit—which is currently stayed—would limit the speed and flexibility with which those units can respond to market opportunities. This is a major issue for SOCMA members, whose batch and specialty chemical businesses have diverse and rapidly changing product mixes.
SOCMA also expressed disappointment about EPA’s complete failure to address other issues raised in its 2010 petition, including the establishment of a “de minimis threshold” and a fairer R&D exemption.In fact, by now proposing to reduce the applicability threshold in one area, EPA will actually increase the number of facilities that will be subject to the rule.
The agency also did not address the urgent need for an extension of the October 2012 compliance deadline, which SOCMA has repeatedly raised with EPA.
Given the uncertainty about what the end result of the reconsideration process would look like—including confusion about how the concept of “family of materials” would affect the scope of the rule—SOCMA members have been understandably hesitant to begin investing significant sums of money to comply with a rule that is still a work in progress in many significant respects. EPA will be hard pressed to finalize the revised rule before the compliance date and, in fairness, should postpone the deadline until well after that rule is published.
The new proposal confirmed the rule’s apparent requirement that Leak Detection and Repair (LDAR) inspections must occur while equipment is in Hazardous Air Pollutant (HAP) service—another concern for SOCMA members. This language is especially problematic for batch processors, who may only operate equipment in HAP service for very short periods of time. It could be highly difficult for these companies to accomplish the required inspections during those narrow windows of time, especially since many of their facilities have limited operating personnel. EPA did express a willingness to change this requirement, depending on the comments it receives, which SOCMA appreciates.
In other news, SOCMA is now a member of two additional state chemical councils—the Chemical Industry Council of Illinois and the Ohio Chemistry Technology Council—in a move to further expand its state-level advocacy work.
More info: www.socma.com
|Christmas Tree Shops Recall Candles
• The US Consumer Product Safety Commission, in cooperation with Christmas Tree Shops, Union, NJ, announced a voluntary recall of holiday-themed tea light candle warmers from Nantucket Distributing Co. Inc., Middleboro, MA.
About 5,700 tea light candle warmers, manufactured in China, can catch fire because the warming bowl is positioned too close to the tea light candle, posing fire and burn hazards. The firm has received one report of the Snowmen candle warmer catching on fire causing a minor burn injury to a consumer’s hand.
This recall involves holiday-themed tea light candle warmers in the shapes of snowmen and gingerbread houses. A warming bowl with wax fragrance tablets is suspended above the tea light candle. The Snowmen model has SKU/UPC 000016005396 and the Gingerbread house model has SKU/UPC 000016005372 printed on a label on the bottom of the product. The SKUs were sold exclusively at Christmas Tree Shops in the Northeast, Mid-Atlantic and Midwest US from November 2011 through December 2011 for about $8.
More info: www.christmastreeshops.com