Finalized in July 2013 after nearly 30 years, the rule creates the opportunity for disposable wipes to be exempted from certain onerous hazardous waste requirements. While states are not required to adopt provisions affecting disposables, eight have already done so, and the majority of others say they plan to do the same.
INDA is tracking state adoption and weighing-in with officials but will use the new committee to give association members the information and tools to monitor and influence activity in states critical to their businesses and to communicate key details to customers.
If you are interested in participating in this new committee, please email INDA Director of Government Affairs Jessica Franken at firstname.lastname@example.org to express your interest. INDA expects to hold the first conference call of this committee in the early fall.
Manufacturers Lobby Congress to Pass Miscellaneous Tariff Bill
The National Association of Manufacturers Miscellaneous Tariff Bill (MTB) Coalition (of which INDA is a member) June 17 sponsored a Capitol Hill day for manufacturers to urge Congressional lawmakers to pass the highly-anticipated duty relief legislation. U.S. businesses turned out in force, visiting over 40 lawmaker offices to "deliver a clear message" that passage of the measure is long overdue. Companies highlighted the economic harm the 500+ day delay has caused and told lawmakers that by letting the MTB expire, they were effectively raising taxes on manufacturers.
As regular readers know, the MTB provides critical import duty relief on hundreds of essential manufacturing inputs that are not available in the U.S., including viscose rayon staple fibers. Congress allowed the duty relief benefits to lapse at the end of 2012, forcing U.S. manufacturers to absorb the additional costs throughout the year and affecting their ability to compete.
Fortunately, the feedback from Congressional offices on the impact of MTB relief was overwhelmingly positive. Unfortunately, there was no clear timeline offered as to when the legislation might move forward.
The Generalized System of Preferences (GSP) is another valuable, though lesser-known, trade promotion program that Congress has failed to reauthorize. It promotes economic growth in the developing world by providing preferential duty-free entry for approximately 4,800 products from over 100 designated beneficiary countries and territories. It expired on July 31, 2013, and bills to renew the program introduced in both chambers at the end of the last year have stalled.
Manufacturing groups generally support the extension of the GSP, which reduces the cost of imports needed to produce goods domestically. On several occasions since its enactment in 1976, Congress has renewed GSP after it expired and provided for the retroactive refund of tariffs. Supporters are hopeful that will be the case this time as well, although Congress has not indicated what path it will take.
As we have said repeatedly, the best way to ensure Congress acts is to emphasize to your representatives the importance of these measures to your company's competitiveness. If you would like to send a message to your Congressional lawmakers encouraging them to support the MTB, contact INDA's Director of Government Affairs Jessica Franken directly at email@example.com to request a template letter and instructions for sending it. INDA will continue to keep its members posted about developments as they unfold.
FDA Releases Guidance Documents on Nanotechnology
The Food and Drug Administration (FDA) June 24 released four guidance documents on the use of nanotechnology in FDA-regulated products: one a general guidance, and three others that address nanotechnology in animal food, and of likely interest to INDA members, cosmetics and food ingredients and food packaging. The increasing use of nanomaterials in a range of products led the FDA to produce the guidances primarily because the “materials can have chemical, physical, and biological properties that differ from those of their larger counterparts.” In announcing the guidelines, the FDA said it will try to take a prudent scientific approach to assess each product on its own merits and is not making broad, general assumptions about the safety of nanotechnology products. “Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products,” said FDA Commissioner Margaret A. Hamburg.
The general guidance document titled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” finalizes a draft released in 2011 and describes the factors that the FDA will use in determining whether a product involves the application of nanotechnology. While the guidelines do not strictly define “nanoparticles,” industry groups generally consider nanoparticles ones that are less than 100 nm wide (a nanometer is one billionth of a meter.) The guidance states that the FDA will consider size and performance in making its determination as to whether a material is a nanoparticle. As for size, the FDA will consider whether “a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range.” As for performance, the FDA will look at whether the material's or product's “properties or phenomena, including physical or chemical properties or biological effects,” behave like a nanomaterial, even if slightly bigger in size. The guidance is available here:
The guidance addressed to the cosmetics industry, also a final document, is titled “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products,” and “is intended to assist industry and other stakeholders in identifying the potential safety issues of nanomaterials in cosmetic products and developing a framework for evaluating them.” Nanomaterials can be used to affect the look and feel of cosmetics and in the guidance, the FDA expresses concern that “traditional testing methods that have been used to determine the safety of cosmetic ingredients and finished products may not be fully applicable due to a nanomaterial's distinctive properties and behavior.” The FDA notes that traditional toxicology testing in particular may not be effective with nanomaterials and encourages manufacturers to meet with the FDA to discuss appropriate test methods. The guidance is available here:
The guidance covering nanomaterials in food and food packaging, titled “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives,” is also a final guidance. The guidance is directed to food producers considering or implementing “a significant change in manufacturing process for a food substance already in the market.” The guidance is available here:
As noted, the last document describes the industry use of nanomaterials in foods for animals.
The guidance documents reflect the FDA’s current thinking regarding the use of nanomaterials. In each of the guidance documents, the FDA urges companies to consult with the government before launching nanotechnology products; however, because the documents are nonbinding recommendations, compliance by a manufacturer is voluntary.