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FDA seeks input on cosmetic microbiological product safety



Also, CPSC adopts testing & certification rules; Russia readies to join WTO; INDA asks for input on a disaster relief initiative.



By Jessica Franken, INDAu2008Director of Government Affairs



Published December 2, 2011
Related Searches: nonwoven nonwovens INDA Legal / Regulatory
The Food and Drug Administration (FDA) Nov. 1 announced its intent to hold a public stakeholder meeting and accept written comments regarding its plans to develop guidance documents addressing the microbiological safety of cosmetic products.

The agency cited concerns about adverse events related to microbial contamination describing reports of infections involving eye-area cosmetics, alcohol-free mouthwash and contaminated skin lotions. Although current law and guidance address various aspects of cosmetic safety and labeling, and the agency's Bacteriological Analytical Manual (BAM) outlines preferred laboratory procedures for microbiological analyses; it has yet to issue specific guidance addressing cosmetic microbiological safety.

The FDA now contemplates developing such a document and is asking its stakeholders for input on a wide range of issues, including: microbiological testing of cosmetics; types of preservative systems and how to test their effectiveness; the identity and prevalence of microorganisms that pose specific health risks in finished products; routes of exposure to micro-organisms and the corresponding infective doses; product and packaging characteristics that affect microbial growth and risk of infection; consumer subpopulations that may be at greater risk of infection from cosmetic products; adverse events associated with microbial contamination of cosmetics; and any other areas where FDA guidance may be useful.

The public meeting was held on Nov. 30 and the agency is accepting written comments until Jan. 30, 2012.INDA will attend the public meeting, and may also submit written comments.Those with feedback should contact Jessica Franken, INDA's director of government affairs at 703-521-0545 or jfranken@inda.org. To review the FDA's Nov. 1 Federal Register notice, visit www.gpo.gov.


CPSC adopts final rules on component testing, and testing/certification of children's products
The Consumer Product Safety Commission (CPSC) Oct. 19 approved two long-anticipated final rules related to testing and certifying children's products under the Consumer Product Safety Improvement Act (CPSIA).

The first one, which goes into effect on Feb. 8, 2013, outlines the protocols for meeting the law's mandatory third-party testing for all children's products and certain non-children's items (i.e. those already covered by an existing CPSC rule, ban or standard). It covers a range of topics including initial certification, periodic evaluation, testing after a material change, and safeguarding against the exercise of undue influence on a third party conformity assessment body. The Commission deferred action on defining the specific elements of a "reasonable testing program" for non-children's products, noting the challenges in drafting a regulation that applies to many different types of goods and manufacturing processes that provide sufficient guidance for manufacturers.

Consumer advocates cheered the approval of the testing and certification rule. "These rules will go a long way toward preventing unnecessary harm to our children, as well as avoiding costly recalls," said Ami Gadhia, senior policy counsel for Consumers Union in an Oct. 19 statement."People might assume independent safety tests were already required for toys. But the reality is, too often, dangerous toys aren't discovered until there's a tragedy."

The second regulation spells out requirements and conditions for using component part testing to meet the CPSIA requirements for lead and phthalate content. The final version makes a number of changes to the Commission's May 2010 proposal intended to reduce the burdens of finished product testing, most significantly permitting an importer to rely on test reports or certification from a foreign manufacturer to certify a product. The component part testing regulation goes into effect Dec. 8, 2011.

To read the CPSC's final rule on "Testing and Labeling Pertaining to Product Certification," and also the Comission's final rule on "Conditions and Requirements for Relying on Component Part Testing or Certification," visit www.gpo.gov.


Russia Closes in on WTO Accession
A World Trade Organization (WTO) Working Party Nov. 10 approved a package of terms and conditions that Russia must meet in order to join the global trade body, clearing the way for WTO countries to approve a formal invitation for Russia's membership during an upcoming ministerial conference later this month.

Russia is the largest economy that is not part of the WTO multilateral trading system, and the move brings to conclusion accession negotiations that began some 18 years ago. As part of this deal, Russia agrees to implement a number of liberalization measures including widespread tariff reductions, and various commitments related to transparency, intellectual property, technical barriers to trade and more.President Obama (who was 32 when this process began) called the completion of the Russian accession talks"a significant day for U.S.-Russia relations, and for our commitment to a growing, rules-based global economy."

Russian officials intend to ratify its accession package quickly, said lead negotiator Maxim Medvedkov, and expect to officially join the WTO in early 2012.However, there will likely be delays before U.S. businesses will be able to take advantage since Congress must first enact Permanent Normal Trade Relations (PNTR) status with Russia. As it stands, the timing of the Capitol Hill action is unclear, although the Obama Administration has expressed the hope it will happen in 2012.


During this holiday season, INDA asks members to weigh-in on industry disaster relief initiative
In this season of giving, INDA needs your help in creating a nonwovens industry disaster relief/rebuilding-giving initiative. By completing a brief online survey about the products and other contributions your company could donate, you will take the first step toward helping people suffering from the misfortune of disasters.

The program would consist of a partnership with a reputable charity that would coordinate the logistics and distribution of donated nonwoven products and other contributions. Participation will be easy, will cost members nothing beyond the donated products and contributions, and will create new marketing and public relations opportunities for participating companies and the industry overall.Most importantly, it will enable the nonwovens industry to make a meaningful and collective impact in the lives of those devastated by disasters.

For this to happen, INDA needs input.Interested parties are asked to take a few minutes to complete a two-question survey found at www.zoomerang.com/Survey/WEB22DUTDLZQX3. (You may wish to coordinate responses with the department of your company responsible for giving.)