Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

A coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the U.S. District Court for the Northern District of California on December 21, 2011.  The coalition is led by the International Center for Technology Assessment (ICTA), and includes Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy. ICTA states that its lawsuit “demands” FDA respond to the coalition’s 2006 petition. The 2006 petition requested FDA take several actions, including requiring specific product labeling and health and safety testing; analyzing the environmental and health impacts of nanomaterials in products approved by FDA; and regulating sunscreens containing nanomaterials. In the December 21, 2011, complaint, the coalition states that, since 2006, “nanomaterial consumer products have continued to proliferate without oversight.” The coalition asks the court to order FDA to respond to its 2006 petition without further delay.

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On October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662), which is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications of using nanotechnology in everyday products and develop best practices for companies using nanotechnology. The legislation would authorize $48 million over three years, beginning in fiscal year 2013. In his press release, Pryor noted that the FDA already has facilities in place, such as the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas, that could conduct the scientific studies required by the bill. Pryor stated that there are over 800 known commercial uses of nanotechnology and over 1,300 consumer nanotechnology products available. The bill was referred to the Committee on Health, Education, Labor, and Pensions.

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The U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities.  FDA notes that rapid advances in innovative science have provided new technologies to discover, manufacture, and assess novel medical products, and to improve food safety and quality. To keep pace with and use these new scientific advances, FDA developed the Strategic Plan. According to the Strategic Plan, one of the ways FDA intends to support new approaches to improve product manufacturing and quality is by developing new analytical methods, including improved methods and tools to detect and measure the physical structure, chemical properties, and safety of engineered nanomaterials in FDA-regulated products. The priority area entitled “Ensure FDA Readiness to Evaluate Innovative Emerging Technologies” includes the following statement regarding nanotechnology:

As medical products are being revolutionized by cutting-edge technologies like nanotechnology, it is more critical than ever for FDA to fully understand how nanomaterials are being used in these products.  FDA has established Nanotechnology Core Centers to provide critically needed equipment and technical staff to conduct product assessment and safety research in support of regulatory decision making.  These centers will facilitate investigations on the safety of products that use nanomaterials, establish methods to assess quality and effectiveness of products that use nanomaterials, and identify standards to be incorporated in the preclinical safety assessment of products that contain nanomaterials.

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The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, “despite myriad uncertainties about the public health and environmental effects of ENMs.” According to the report, several steps are needed for an operative and mandatory regulatory structure for nanotechnology products and processes, including an agreed legal definition of what constitutes an ENM and nanotech product data. The report describes the June 9, 2011, announcement by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) of their intent to issue voluntary guidance to industry on nanotechnology products as “a small, but encouraging first step toward regulation.”

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In a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science.  NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000.  According to the press release, the projects include research on nanoparticles and their characterization. NIH states that the projects were chosen “because they were the most meritorious proposals for addressing high priority areas in cutting-edge biomedical research and regulatory science.” Dennis E. Hourcade, Ph.D., Washington University, St. Louis, will receive funding for “Characterization/Bioinformatics-Modeling of Nanoparticle:  Complement Interactions.” NIH defines regulatory science as “the development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency, and performance.”

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On September 23, 2010, the Food and Drug Administration (FDA) will hold a public workshop entitled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.” According to FDA, the purpose of the workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or using nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions. The workshop is open to the public, and the deadline for registration is September 15, 2010. Space availability permitting, on-site registration will be available on a first come first serve basis. Comments must be submitted by September 15, 2010, to be considered for the workshop discussion. All other comments are due October 22, 2010.

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On July 20, 2010, Representative Janice Schakowsky (D-IL) introduced the Safe Cosmetics Act of 2010 (H.R. 5786), which would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) “to ensure the safe use of cosmetics.” Under the bill, the Secretary of the Food and Drug Administration (FDA) would:

1. Monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and
2. Consider scale-specific hazard properties of ingredients when conducting or reviewing safety substantiation of cosmetic ingredients.

Regarding cosmetic and ingredient statements, the bill would require manufacturers to submit electronically a statement containing certain information, including “the ingredient list as it appears on the cosmetic label or insert, including the particle size of any nanoscale cosmetic ingredients.” The bill would also allow the FDA Secretary to require that:

1. Minerals and other particulate ingredients be labeled as ‘nano-scale’ on a cosmetic ingredient label or list if not less than one dimension is 100 nanometers (nm) or smaller for not less than one percent of the ingredient particles in the cosmetic; and
2. Other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.

The bill was referred to the Committee on Energy and Commerce, as well as the Committee on Education and Labor.

 

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On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review.” The purpose of the MAPP is to provide chemistry, manufacturing, and controls (CMC) reviewers within OPS with the framework by which relevant information about nanomaterial-containing drugs will now be captured in CMC reviews of current and future CDER drug application submissions.  According to the MAPP, this information “will be entered into a nanotechnology database under construction and ultimately be used to develop policy regarding these products.” Information to be collected includes whether the application contains nanomaterials; what type of nanomaterial is included in the product; whether the nanomaterial is a reformulation of a previously approved product; whether the nanomaterial is part of the drug substance or the drug product; whether the particle size was described in the application and what the reported particle size is; whether the techniques used to assess particle size are thoroughly described with respect to their adequacy; whether the nanomaterial is soluble or insoluble in an aqueous environment; and what other properties of the nanomaterial were measured and reported in the application, and how those properties were measured. The MAPP was effective June 3, 2010.

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In a March 2, 2010 letter, the Food and Drug Administration (FDA) responded to the Environmental Working Group’s (EWG) July 15, 2009, letter concerning sunscreen guidelines. EWG criticized the FDA for not having guidelines for sunscreen safety and efficacy. According to EWG, companies continue to profit by misleading consumers about the protection offered by their products. EWG urged FDA to publish a final rule for its August 2007 draft sunscreen guidelines. In its March 2, 2010, response, FDA stated that most sunscreen products are currently marketed under an over-the-counter drug monograph entitled “Sunscreen Drug Products for Over-the-Counter Human Use.” According to the letter, FDA received over 3,000 comments in response to its August 2007 draft sunscreen guidelines. FDA concludes its response by stating:

Although we understand your concern regarding the protracted nature of this process, we trust that you will appreciate the need for us to continue to fully investigate and evaluate new research and development for sunscreen products, permit adequate opportunity for public comment, and weigh all research and development fairly and with full input from FDA subject area experts as well as industry stakeholders and the American public.

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During the 68th annual meeting of the American Academy of Dermatology, on March 4, 2010, dermatologist Adnan Nasir, M.D., Ph.D., F.A.A.D., gave a presentation on nanotechnology and how nanoparticles may eventually be used in cosmetic products. According to Dr. Nasir, the cosmetic industry leads all other industries in the number of patents for nanoparticles, which have the potential to enhance sunscreens, shampoos, conditioners, lipsticks, eye shadows, moisturizers, deodorants, after-shave products, and perfumes.  Nanoparticles used in sunscreens increase protection and coverage on the skin, while being less visible than microparticles. In anti-aging products, nanotechnology may allow active ingredients to penetrate the top layer of the skin. Researchers are currently exploring nanoparticle treatments of conditions such as melanoma.  Dr. Nasir noted, however, that dermatologists are concerned about the potential health risks posed by nanotechnology, and “anxiously await” the Food and Drug Administration’s review of the safety of nanoparticles.

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According to a June 8, 2009, article, Dr. Annette McCarthy of the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition stated on June 6, 2009, at the Institute of Food Technologists’ annual meeting that the “regulatory authority is sufficient to address nanotechnology but there are further questions.” McCarthy recommended that petitions to the FDA seeking acceptance of a nanotech food additive or coloring should address its “impact on identity and toxicity.” According to McCarthy, the idea of a Generally Regarded as Safe (GRAS) standard is not out of the question. Although a company “would have a hard time today” proving that a nanotechnology is generally recognized as safe, McCarthy thinks that “two years down the line, it could be a slam dunk; it could be very simple.

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On April 28, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Oversight of Next Generation Nanotechnology, which calls for the creation of the Department of Environmental and Consumer Protection, which would oversee product regulation, pollution control and monitoring, and technology assessment. According to report author J. Clarence Davies, Ph.D., the agency would be primarily a scientific agency with a strong oversight component, in contrast to current federal agencies such as the U.S. Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), which are primarily oversight bodies. Davies stated: “New thinking, new laws and new organizational forms are necessary.  Many of these changes will take a decade or more to accomplish, but there is an urgent need given the rapid pace of technological change to start thinking about them now.”

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On March 17, 2009, the U.S. Food and Drug Administration (FDA) announced that it has completed a “proof-of-concept” study of a test that “quickly and accurately detects the presence of even the smallest amount of the deadly anthrax toxin.” According to FDA, the proof-of-concept study relies on a nanotechnology-based test platform built from tiny molecular-sized particles. The europium nanoparticle-based immunoassay (ENIA) was able to detect the presence of a protein made by the anthrax bacteria known as protective antigen (PA). PA combines with another protein, lethal factor, to form anthrax lethal factor toxin, the protein that enters cells and causes toxic effects. FDA states that its researchers showed that ENIA is capable of detecting PA in quantities that are 100 times lower than current tests, such as the enzyme-linked immunosorbent assay (ELISA). The ENIA uses nanospheres covered with thousands of light-emitting atoms of europium that emit light, which acts as a signal that PA is present. The ENIA detected PA in 100 percent of samples of mouse plasma compared to 36.4 percent through ELISA. A report on the results of this study appears in the March issue of Clinical and Vaccine Immunology.

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On March 10, 2009, the Food and Drug Administration (FDA) announced a collaboration with the Alliance for NanoHealth (ANH) and its members. According to FDA, the collaboration is intended to “help speed development of safe and effective medical products in the emerging field of nanotechnology.” Under a memorandum of understanding, FDA and ANH will work to increase the knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that could mitigate the risks associated with nanoengineered products. FDA states that all outcomes “will be placed in the public domain for the benefit of all stakeholders.” The ANH member institutions include Baylor College of Medicine; the University of Texas’ M.D. Anderson Cancer Center; Rice University; the University of Houston; the University of Texas Health Science Center at Houston; Texas A & M Health Science Center; the University of Texas Medical Branch at Galveston; and the Methodist Hospital Research Institute.

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During the February 18, 2009, Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, Dr. Jonathan Sackner-Bernstein, Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them so that FDA can learn more about the effects of nanotechnology. Sackner-Bernstein acknowledged that the companies might not be submitting products due to “uncertainty over excessive burden from regulation.”  He described FDA’s role as “an encouraging gatekeeper,” and urged companies to submit their products and test results. Deputy Director Douglas Throckmorton, FDA Center for Drug Evaluation and Research (CDER), stated:  “We are at work understanding what we have at hand, developing a full inventory of nanoscale products before we get into the guidance business.  But I will say this, we know much less than we need to on the effect of nanoscale materials on manufacturing.” Norman Alderson, FDA Associate Commissioner for Science, described the challenges of nano-engineered materials, including the lack of: standards and reference materials; toxicological and biocompatibility data for most products; and standardized physical and chemical characterization procedures.

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On January 14, 2009, the Project on Emerging Nanotechnologies (PEN) released a report entitled A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, which describes problems at the Food and Drug Administration (FDA) in regulating nano-enabled dietary supplements and offers recommendations for improving oversight. According to the report, FDA’s ability to regulate the safety of such dietary supplements “is severely limited by lack of information, lack of resources and the agency’s lack of statutory authority in certain critical areas.” The authors note that, under current law, supplement manufacturers must disclose only limited information about their products, and the information available is the result of manufacturers promoting their use of nanotechnology when marketing their products. PEN states that, according to its inventory of federal environmental, health, and safety research on nanotechnology, the U.S. government provides less than $1 million annually to study the direct impact of nanoscale materials on the gastrointestinal tract.

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On October 30, 2008, Consumers Union petitioned the Food and Drug Administration (FDA) to require a full safety assessment on the use of engineered nanoparticles, particularly in cosmetics, sunscreens, and sunblocks, and “to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.” Consumers Union cites new findings in the December 2008 issue of Consumer Reports, and states that the findings “confirm that use of certain nanoparticles is widespread in mineral-based sunscreens, and that company representatives are making erroneous assertions about these particles in their products.” Consumers Union purchased sunscreens that contain titanium dioxide and/or zinc oxide, focusing on products that, according to company representatives, do not contain nanoparticles. According to the Consumer Reports article, Consumers Union found that four of the five companies’ statements about their products, asserting that they did not contain nanoparticles, were incorrect.

The petition states:

Given the apparent widespread use of these nanoparticles of titanium dioxide and zinc oxide in sunscreens in the US, as determined by our tests, we urge the FDA to do the same [as the European Union]:  to require safety assessment data on nanoparticles used in sunscreens.  We also urge the FDA to require manufacturers to disclose the presence of nanoparticles on the label of any cosmetic or over-the-counter drug product that contain such particles, and to immediately investigate misstatements by manufacturers to Consumer Reports about absence of these nanoparticles in sunscreen products.  Furthermore, we specifically urge the FDA to investigate whether the failure to disclose the presence of nanoparticles renders these sunscreen products misbranded, within the meaning of Section 201(n) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 321(n), in violation of 21 U.S.C. § 332(b).

 

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The United States Food and Drug Administration (FDA) held its publicized Public Meeting on Nanotechnology on Monday, September 8, 2008, near its main offices in Rockville, Maryland. The meeting consisted of a plenary session led by Dr. Norris Alderson, Co-Chair of the FDA Nanotechnology Task Force, followed by separate breakout sessions for prescription and over-the-counter (OTC) drugs, cosmetics, medical devices, food and color additives (including food contact substances), and dietary supplements.  In general, the meeting yielded no new information pertinent to FDA’s nanotechnology plans or policies.

At the beginning of the meeting, Dr. Alderson and the other FDA plenary session speakers made it clear that FDA was not there to present its views on nanotechnology, or describe its activities. Rather, FDA hoped that the speakers and participants from industry, academia, and the public would provide input on the factors it should consider in providing guidance on the information and data that might be needed to demonstrate the safety and effectiveness of regulated products containing nanoscale materials. The FDA speakers also solicited information about the circumstances under which the regulatory status of a product might change if nanoscale materials were utilized in place of the macro-sized materials evaluated by FDA when the product was first cleared for marketing. In the Federal Register notice announcing the meeting, FDA posed questions, the answers to which would help to start providing the information it needed to provide guidance. For the most part, the speakers attempted to provide information on the requested subjects, although the information exchange was hampered by concerns regarding the protection of the confidentiality of commercial information. Dr. Rick Canady, FDA Senior Health Scientist, stated that FDA was hoping to have industry establish food master files, in which confidential information could be protected. FDA would become the consolidator of knowledge and the stronger knowledge base would produce better science.

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The National Institute of Standards and Technology (NIST) will hold an October 8-9, 2008, workshop regarding enabling standards for nanomaterial characterization.  According to the workshop overview, there is an “urgent need” to elevate new protocols and practices for characterizing the physicochemical properties of nanomaterials, and their in vitro and in vivo properties with respect to biological systems, to that of internationally accepted standards to accelerate research, development, risk identification, regulation, and widespread public adoption of nanotechnology. The workshop is intended to address this need on several fronts. Workshop sponsors and contributors include:  ASTM International; Food and Drug Administration (FDA); Nanotechnology Characterization Laboratory (NCL) at NCI-Frederick; National Cancer Institute (NCI); National Institute for Occupational Safety and Health (NIOSH); NIST; National Institute of Environmental Health Sciences (NIEHS); and Oregon Nanoscience and Microtechnologies Institute (ONAMI).  The workshop is limited to 100 attendees.

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In an August 7, 2008, Federal Register notice, the U.S. Food and Drug Administration (FDA) announced that it will convene a public meeting on September 8, 2008, on FDA-regulated products that may contain nanoscale materials. According to the Federal Register notice, FDA also is seeking public comments and available data “that will assist [FDA] in further implementing the recommendations of the Nanotechnology Task Force Report . . . relating to the development of agency guidances.” Written comments in response to the Federal Register notice must be received by FDA no later than October 24, 2008.

FDA states that the main objective of the public meeting “is to determine what factors [FDA] should consider in providing guidance on” the following:

• The information and data that may be needed to demonstrate the safety and effectiveness of FDA-regulated products containing nanoscale materials; and
• The circumstances under which a product’s regulatory status might change due to the presence or use of nanoscale materials (for example, making a device no longer exempt from [Section] 510(k) submission requirements).

Persons wishing to speak at the meeting must register and submit a presentation summary by September 2, 2008. Registration details are provided in the Federal Register notice.

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The Food and Drug Law Institute (FDLI) and the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) will hold a conference on February 28-29, 2008, on “Nanotechnology Law, Regulation and Policy.” Questions addressed during the conference will include:

• How is the Food and Drug Administration (FDA) going to implement its Nanotechnology Task Force Report?
• How is the Occupational Safety and Health Administration (OSHA) going to deal with nanotech issues in the workplace?
• Is Congress ready to act on nanotechnology if federal regulators don’t?
• What first and second generation nanotechnology products are already on the market, and what’s to come?
• Do Europe and Asia approach nanotechnology safety and oversight differently than the United States?
• When it comes to nanotechnology, should size make a regulatory difference?

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On November 8, 2007, the Office of Science and Technology Policy (OSTP) and the Council on Environmental Quality (CEQ) issued a memorandum regarding “Principles for Nanotechnology Environmental, Health, and Safety Oversight.” According to the memorandum, OSTP and CEQ “led a multi-agency consensus-based process” to develop principles intended to guide the development and implementation of policies for nanotechnology environmental, health, and safety oversight at the agency level.  The memorandum says that federal agencies such as the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the National Institute for Occupational Safety and Health (NIOSH) “must implement sound policies to protect public health and the environment,” and “agencies that perform nanotechnology research and development or that use nanotechnology in accomplishing their mission must provide appropriate oversight.”

The memorandum states that these agencies should follow the following principles in developing policies for environmental, health, and safety oversight related to nanotechnology:

• Purpose:  Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic, and environmental benefits, while recognizing uncertainties surrounding the evolving science and technology.  The purpose of considering environmental, health, and safety oversight approaches in the context of nanotechnology is to protect human health and the environment.
• Current Understanding:  The federal government’s current understanding is that existing statutory authorities are adequate to address oversight of nanotechnology and its applications.  As with any developing area, as new information becomes available the federal government will adapt or develop additional oversight approaches, as necessary, to address the area of nanotechnology.
• Information Development:  Adequate information should be developed with respect to the effects of nanomaterials on human health and the environment.  To the extent practicable and respecting confidential information (e.g., Confidential Business Information (CBI)), this information should be developed in an open and transparent manner by stakeholders, including the federal government and developers of nanomaterials.
• Risk Assessment and Risk Management:  The federal government should use standard oversight approaches to assess risks and benefits, and manage risks, considering safety, health and environmental impacts, and exposure mitigation.  As experience is gained, these approaches can be refined.  The federal government should strive to reach an appropriate level of consistency in risk assessment and management approaches across the government.
• International:  Recognizing the global efforts to develop nanotechnology, the federal government should proactively promote international cooperation.  The federal government should encourage coordinated and collaborative health and environmental research and test data development across the international community.  The federal government should also promote access to information across the international community.  These efforts will allow the federal government to contribute to, and take advantage of, risk assessment and risk management approaches, as appropriate, across the international community.
• Regulatory Path Forward:  In light of the “Purpose” of oversight as described above, the federal government should consider the following, to the extent permitted by law and where applicable, in establishing environmental, health, and safety regulations for nanotechnology:
  • Regulation should focus where need exists and where scientific information supports action (e.g., targeted to specific groups and classes of materials instead of a “one-size-fits-all” approach);
  • Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information;
  • Where possible, regulatory approaches should enable rather than hinder innovation;
  • Regulatory approaches should be performance based to the extent feasible and provide predictability and flexibility in the face of evolving science and technology;
  • Benefits of regulation should justify their costs;
  • Regulations should be developed in an open and transparent manner; and
  • Regulations and guidance should consider established requirements and guidance such as the following:
    • Executive Order (EO) 12866 -- Regulatory Planning and Review (Oct. 4, 1993);
    • Information Quality Act and Information Quality Guidelines: OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002);
    • National Technology Transfer and Advancement Act of 1995;
    • Office of Management and Budget (OMB) Circular A-119, Transmittal Memorandum, Federal Participation in the Development and Use of Voluntary Standards (Feb. 10, 1998);
    • OMB Final Information Quality Bulletin for Peer Review (Dec. 16, 2004);
    • OMB Final Bulletin for Agency Good Guidance Practices (Jan. 18, 2007); and
    • OMB/OSTP Memorandum:  Updated Principles for Risk Analysis (Sept. 19, 2007).

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On October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included:

• Food applications of nanoscience and nanotechnologies -- Ms. Sue O’Hagan, Confederation of the Food and Drink Industries of the European Union (CIAA);
• Consumer products applications of nanoscience and nanotechnologies -- Dr. Michael Holman, Lux Research;
• Health applications of nanoscience and nanotechnologies -- Dr. Carole Moquin-Pattey, European Science Foundation (ESF);
• Nanotechnology risk assessment: Knowns and unknowns -- Mr. Herman B.W.M. Koëter, Deputy Executive Director and Director of Science, European Food Safety Authority (EFSA);
• Nanoparticle toxicology: Scientific state-of-the-art -- Professor Ken Donaldson, University of Edinburgh;
• Nanomaterials. Risk assessment needs -- Professor Jim Bridges, Chair, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR);
• The EU perspective on policy and regulatory aspects -- Mr. Kees Brekelmans; Enterprise and Industry Directorate General, “Consumer Goods” Directorate;
• Nanotechnology and the Food and Drug Administration:  Science and Policy -- Dr. Richard Canady, U.S. Food and Drug Administration (FDA); and
• The consumer perspective on applications of nanoscience and nanotechnologies -- Dr. Sue Davies, Chief Policy Advisor, Which?.

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Yesterday the Food and Drug Administration (FDA) released a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of FDA’s ongoing review of OTC drug products. The proposed rule addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, would introduce four-star rating system for the level of UVA protection, and would require a warning statement. FDA previously delayed regulations concerning UVA protection until reliable testing methodologies could be developed. The proposed rule specifically solicits comment on “the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.”  Comments on the proposed avobenzone combinations will be due 60 days after publication of the Federal Register notice. Comments on all other parts of the proposed rule and on FDA’s economic impact determination will be due 90 days after publication in the Federal Register. In the proposed rule, FDA states that it “recognizes that more sunscreens containing small particle size titanium dioxide and zinc oxide ingredients enter the market each year.” According to the proposed rule, FDA is interested in receiving comments and data about these sunscreen ingredients and products containing these ingredients, their safety and effectiveness, and how they should be regulated.  FDA notes that it received a citizen petition “shortly before publication of this document that, among other things, raises these issues.”  FDA is currently evaluating the citizen petition, which is filed as CP17 in Docket No. 1978N-0038.  FDA encourages other parties to submit additional data or information on the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.

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The July 2007 issue of Consumer Reports includes an article entitled “NANOtechnology: Untold Promise, Untold Risk.” According to Consumer Reports, while nanotechnology “promises to be the most important innovation since electricity and the internal combustion engine,” “some applications might pose substantial risks to human health and the environment.” The article states that nanomaterials are already being used in consumer products such as car wax, computer chips, and sunscreen, and that approximately $2.6 trillion worth of goods worldwide are expected to use nanotechnology by 2014, up from $50 billion in 2006. Consumers Union (CU), the nonprofit publisher of Consumer Reports, concludes that the responsibility for protecting consumers rests mainly with government and industry.  In particular, CU believes that the government should provide more funds for risk research and regulation, and that the Food and Drug Administration (FDA) should assess safety information on nanoingredients in cosmetics, food additives, and other products before they are sold, and should require manufacturers to report health problems linked with those ingredients. The full article is available in the July 2007 issue of Consumer Reports.

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In a March 15, 2007, letter, the Senate Committee on Commerce, Science, and Transportation and the Congressional Nanotechnology Caucus requested that the Government Accountability Office (GAO) review the National Nanotechnology Initiative (NNI), which was created to accelerate the discovery, development, and deployment of nanoscale science and technology. For fiscal year 2006, NNI received $1.2 billion in research and development funding, and 22 federal agencies, including the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA), participate in NNI. According to the letter, one key expectation for NNI was “to ensure that adequate attention and research funding was made available to gain a better understanding of the potential environmental, health, and safety (EHS) risks associated with nanomaterials.” The letter states that the Committee and Caucus “are extremely concerned that this has not happened and that there is a lack of transparency with regard to how much federal attention and funding this important aspect of the initiative is receiving.”

To determine the extent to which federal agencies have undertaken EHS research and how they are prioritizing and managing this research, the Committee and Caucus ask GAO to:

•  Review the extent to which NNI-related resources have been devoted to study the EHS risks of nanomaterials;
• Identify the key areas of research for which this EHS funding has been used;
• Determine what processes the Nanotechnology Environmental and Health Implications Working Group uses to prioritize and coordinate these various EHS research efforts; and
• Review and identify any EHS-related research and regulatory activities, independent of the NNI, that EPA, FDA, CPCS, and OSHA have undertaken, the amount of funding made available for these efforts, and the extent to which information about these efforts has been communicated to the Working Group to ensure that they are considered in the overall research planning processes for the NNI.

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