Category: Regulation

EU logoAs various articles on this blog (Search: EU) have demonstrated over the past couple of years, the EU has been more proactive than the U.S. in targeting potential health and environmental risks posed to consumers by nanomaterials and seeking to generate and compile relevant and helpful information with an eye toward appropriate regulation.  The EU scientific panel is now calling for comments on opinions of the EU Scientific Committee on Consumer Safety (SCCS) on several nanosubstances used as sunscreens in cosmetics.

The opinions posted for comment indicate what is known about these substances and point to the gaps in the studies.  For example, with regard to dermal absorption of titanium dioxide nanoparticles, SCCS states, in part: 

            “[T]here is a body of open literature on this subject. The evidence from these studies supports the conclusion that TiO2 nanoparticles are unlikely to penetrate across the skin to reach viable cells of the epidermis. . . . Studies have also shown that TiO2 nanoparticles do not penetrate the (simulated) sunburnt skin.

            - Despite the extensive database showing a general lack of TiO2 nanoparticle absorption via the dermal route, there are a few gaps in the knowledge. For example, it is not clear whether TiO2 nanoparticles will be able to penetrate through cuts and bruises, or over repeated or long term applications of a sunscreen formulation.

            - A number of studies have indicated that TiO2 nanoparticle can enter the hair follicles and sweat glands, and that they may remain there for a number of days. This is a scenarioin which TiO2 nanoparticles are likely to get and remain in a close proximity to the living cells for a length of time. A photocatalytic nanoparticle in such a situation may cause . . . potential harmful effects when exposed to sunlight. . . . [M]ore data would be needed to justify the use of those TiO2 nanoparticles in skin applications that have a considerablelevel of photocatalytic activity.”  (Scientific Committee on Consumer Safety SCCS,Opinion on Titanium Dioxide (nano form), p. 97)

The document also indicates the need for study of the potential of these substances of the nano-related properties of the substances to be mutagenic or genotoxic.  (p. 97-98)

These few small examples of the more extensive information contained in the opinions gives a sense of where the SCCS’s attention is currently on nanosubstances in cosmetics, which is one of the most pervasive uses of nanosubstances in consumer use.  With study of such materials moving along in laboratories around the world, it is essential that the information be collected and evaluated to determine what risks, if any, may be presented to consumers by the nanoscale properties of the substances.  The EU is moving in the right direction.

All of the SCCS opinions are available at

http://bit.ly/hVulJJ

 

NASA stock photos

NASA stock photos

It’s a busy time for potential regulators of nanomaterials.  This post will point to some of the recent activities, in the United States and abroad.

 The Organization for Economic Cooperation and Development’s (OECD) Cooperative Chemical Assessment Program (CoCAP) has long been working to assess the hazards of chemicals across international lines.  OECD has now decided that CoCAP has served its purpose and must be replaced by a different organization at the end of 2014.  One reason for the change is that the activities of the EU’s REACH program and research in the United States have become the primary assessment mechanisms, rendering CoCAP’s current activities unnecessary.  The new program is still in the planning stages, but will involve the development and implementation of new methodologies.

This sounds like progress.  As this blog often has noted, nanotechnology assessment has received more attention in the international arena than in the United States, and this is another example of an international organization moving forward.

A summary of CoCAP may be accessed at:

http://www.oecd.org/env/ehs/risk-assessment/oecdcooperativechemicalsassessmentprogramme.htm

 A report of the announcement to replace CoCAP appeared in

Rick Mitchell, Multi-Nation Group to Replace Program That Weighs High-Volume Chemical Hazards, 28 Toxics L. Rep. (BNA) 707 (June 27, 2013) (by subscription)

Speaking of the EU, the European Commission is seeking suggestions on better applying the REACH assessment to nanomaterials.  The official document seeking comments states:

“Specifically, the policy initiative shall provide clearer REACH requirements for nanomaterials to ensure that industry demonstrates safe use in the registration dossiers in accordance with the aims of REACH Article 1(1) ‘to ensure a high level of protection of   human health and the environment, including the promotion of alternative methods for assessment of hazards of substance, as well as the free circulation of substances on theinternal market while enhancing competitiveness and innovation’.”

The Commission is reaching out to all interested stakeholders to provide “the best possible evidence base for its work.”

The official announcement, with information on submitting comments, is available at:

http://ec.europa.eu/environment/consultations/nanomaterials_2013_en.htm

In another demonstration of international cooperation, the United States and Canada have developed a uniform classification system for industrial nanomaterials.  The U.S.-Canada Regulatory Cooperation Council’s (RCC) working group has been involved in this process since 2011 as part of a broader initiative to bring about uniformity in addressing nanotechnology.  This latest step is part of a continuing process.  This blog has previously discussed the work of the RCC here.

Here in the United States, EPA has issued its final significant new use rules (SNURs) for 17 substances, mostly constituting substances at the nanoscale, which will go into effect on August 26, 2013.  Fifteen of the seventeen SNURs are based upon TSCA section 5(e) consent orders issued by EPA and reflect the substance of the orders.  With regard to the other two SNURs, “EPA determined that one or more of the criteria of concern . . . were met.”  (Final Rule, p. 6)  In the Final Rule, EPA responded to various comments, including those directed at workplace safety.  This blog will address those comments at a later date.

The Final Rule is available at:

https://www.federalregister.gov/articles/2013/06/26/2013-15032/significant-new-use-rules-on-certain-chemical-substances

nano 3The National Nanotechnology Initiative (NNI) recently held a Stakeholder Workshop for the purpose of assessing and strategizing in anticipation of the next version of the NNI Strategic Plan, a draft of which is due in late 2013 or early 2014.  Stakeholders from industry, government, and academia attended the workshop.  Participants considered questions related to technical challenges; commercial nanotechnology; environmental, health, and safety considerations; infrastructure needs; and ethical, legal, and societal implications of nanotechnology.

On the subject of environmental, health, and safety considerations, one report from the workshop indicated that NIOSH officials have recommended folding these matters into the other goals, rather than maintaining a separate approach.  The officials noted that of the $1.65 billion in federal funding allocated in FY2013 for nanotechnology research and development, environmental, health, and safety initiatives constituted only 7.6% of those funds.

Some of the other issues addressed, according to the report were:

1.  Improving communication among researchers.

2.  Balancing availability of research with confidentiality of proprietary information.

3.  Developing a common dose metric for research.

This news report may be found by subscription at:

Robert Iafolla, Include Safety, Environmental Concerns in Strategic Plan, Nano Researcher Say, 115 BNA Daily Env’t Rep. A-8 (June 14, 2013), available at

http://www.bloomberglaw.com/document/XE9G8OHO000000?campaign=bnaemaillink&issue=20130614&jcsearch=bna%2520a0d9h7q4n9&js=0&sitename=bna&subscriptiontype=bnaden#jcite

 

Whatever steps may be necessary to ensure that environmental, health, and safety concerns are at the forefront of the discussion about nanotechnology should be made a priority.

 

A detailed presentation of the Questions for Stakeholders for discussion at the 2013 NNI Strategic Planning Stakeholder Workshop, with further links, may be found at:

http://nano.gov/sites/default/files/questions_for_stakeholders_final_numbered.pdf

nano 5This blog has regularly addressed the quandary of whether existing regulatory laws are sufficient to deal with the risks of the marketing and use of nanomaterials or if additional legal frameworks are necessary.  Three European environmental groups have determined that additional safeguards are indeed required. 

On November 13, 2012, the Geneva-based Center for International Environmental Law (CIEL), Friends of the Earth Germany (BUND), and London-based ClientEarth proposed a draft EU regulation in response to a European Commission report published in October 2012, Second Regulatory Review on Nanomaterials.  The groups argued that the Commission insufficiently addressed problems with the European Union’s REACH.

The Commission had concluded that nanomaterials did not require separate EU regulations, declaring that REACH provided the “best possible framework for the risk management of nanomaterials when they occur as substances and mixtures.” (High Time to Act: A Proposal for a “Nano Patch” for EU Regulation, at 3).

Attorneys for the environmental groups attacked REACH’s inherent loopholes and the lack of safety assessment before nanomaterials are placed on the market – two substantial issues whose appraisal was glaringly absent in the Commission’s Regulatory Review. 

Specifically, the groups argued that REACH provided regulators and the public with little to no information regarding the dangers and risk management of nanomaterials.  The environmental groups’ proposed “nano patch” on REACH aims to close these loopholes by employing the following mechanisms:

·        Documenting the hazards and risks in all relevant regulatory frameworks

·        Registering the nanomaterials and requiring operators to report the quantities of substances and their uses in the produced, distributed or imported nanoform

·        Labeling nanomaterials found in consumer products, including adding the suffix “nano” to the name of the ingredient

Some may find the proposed “nano patch” to be a bit oppressive and chilling to the progression of nanotechnology, but we just don’t know enough yet about the environmental and health effects of public consumption of nanomaterials. Regulation of some degree – but what degree – is clearly called for.  And while the United States has been the leader in some areas of regulation, it appears that for the time being, the EU may be the frontrunner in the nanontechnology regulatory race. Perhaps the U.S. should lace up and catch up. 

The draft EU regulation from the environmental groups – High Time to Act: A Proposal for a “Nano Patch” for EU Regulation – is available at:

http://www.ciel.org/Publications/Nanopatch_EU_Nov2012.pdf.

This post was written by guest blogger Holly Frey.  See her information here.

 

The Canada-U.S. Regulatory Cooperation Council (RCC) has announced a pilot program to examine the differences between risk assessment practices for nanomaterials in both countries with the goal of identifying and sharing the best practices.  The RCC was initiated in 2011 by President Obama and Prime Minister Harper to coordinate the risk assessment practices of the two countries on a scale broader than nanotechnology.  Within the RCC, the Nanotechnology Working Group has focused specifically on looking into the potential risks of nanomaterials.

The Nanotechnology Work Plan generated by the RCC Nanotechnology Working Group states the following as the desirable outcome of the Group’s efforts:

“Share information and develop common approaches [between the two countries], to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc.  Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.”

The stated purpose of the common approaches would be to “help ensure consistency for industry and consumers in both countries.”

The Working Group sees its ultimate task as the development of “a model framework providing key elements and approaches to regulating products and applications of emerging technologies with respect to potential impacts on the environment, human health, food or agriculture.”

All quite worthy goals.  But as with so many efforts to understand the potential health and environmental risks of nanomaterials, this effort has its pluses and minuses.

The best features of the RCC initiative are international governmental cooperation and sharing of expertise and experience.  But some of the same frustrations evident in the nanotechnology risk assessment and regulatory arena still exist.  For example, we are still looking at a protracted process of risk assessment, followed by a protracted process of developing regulations.  As part of that, the group must still agree upon a taxonomy and risk assessment goals and specific procedures.  And most certainly there will be fragmentation and duplication of efforts between North America and the rest of the world.

It’s still a good idea.  But let’s not expect too much too soon.

The Nanotechnology Work Plan is available at

http://www.trade.gov/rcc/documents/Nanotechnology.pdf

 

usalawyerstoday.com

Sometimes the Government  just might work as it was intended.

In an earlier post, I reported on a lawsuit brought by a coalition of environmental and consumer safety groups requesting declaratory and injunctive relief under the Administrative Procedure Act to force the FDA to respond to a 2006 petition seeking action by the agency to assure the safety of members of the public exposed to nanomaterials, particularly nanoparticles in sunscreens.  On May 14, 2012, the coalition voluntarily dismissed its action, International Center for Technology Assessment v. Hamburg, a case that had been brought in federal court for the Northern District of California (No. 11-6592).

In other posts on this blog, I have reported on the draft guidances recently issued by the FDA on the safety of nanomaterials in food, food packaging, and cosmetics, as well as the upcoming International Cooperation on Cosmetics Regulation (ICCR), to be hosted by the FDA.  The coalition has withdrawn its lawsuit because the FDA has in fact finally responded to the earlier petition by issuing the draft guidances.  Although attorneys for the coalition have emphasized that the FDA’s response does not propose all the relief the coalition sought in its lawsuit, at the present time the FDA is showing interest in the safety of engineered nanomaterials in products within the agency’s jurisdiction.  The lawsuit had sought, among other things, regulation of these nanomaterials.  But the FDA guidance documents made recommendations for voluntary measures by industry, not new regulation.  This, of course, leaves open the possibility of a future lawsuit challenging the steps taken – or not taken – by the FDA in furtherance of the safety initiatives.

Our high school civics classes teach us that the tripartite structure of the federal Government is intended to allow the various parts of the Government to act as a check on the actions or inactions of the other parts.  In recent years, the judicial system has been much maligned.  In the matter of nanomaterials and the FDA, the threat of judicial intervention – being told by the courts what it should do – was likely one (and only one) motivation for the FDA to pursue a safety agenda for nanomaterials.  Instead of needlessly consuming resources at this stage, the coalition withdrew its lawsuit when the FDA moved forward on this subject.  So let’s give a hand all around for the Government working as it was intended.

The withdrawal of the coalition’s lawsuit was reported by

Pat Rizzuto, Coalition Withdraws Lawsuit Against FDA Following Agency’s Release of Guidance, 100 Daily Env’t Rep. (BNA) A-15 (May 24, 2012) (by subscription)

Earlier I reported that the FDA had recently shown some intense interest, per its recent draft guidance document, in the safety of food and food packaging products containing nanomaterials.  In contrast, the FDA seemed to merely urged caution to the cosmetics industry about nanoparticles in their products.  Now, however, the FDA appears to be on the move toward giving nanomaterials in cosmetics their fair amount of attention.

In July, the FDA will host the International Cooperation on Cosmetics Regulation (ICCR), which is expected to include cosmetics regulators fromCanada, the EU,Japan,Brazil,China,Australia, and other countries.  The conference is scheduled to include opportunities for participation by the industry and any other interested parties.  Nanomaterials represent only one item on the agenda (which includes alternatives to animal studies and regulation of trace elements of substances such as lead).

The conference’s interest in nanoparticles in cosmetics will be focused on methods to characterize nanoparticle ingredients with safety in mind.  The primary interest is in the use of nanoscale titanium dioxide and zinc oxide in sunscreen products.

T he upside to the attention FDA is giving to nanoparticles in cosmetics is that it begins a long process of deciding how to determine safety, whether to regulate, and whether new regulations for nanoparticles in sunscreens and other cosmetics will be necessary.  Recently, the FDA postponed the effective date of new labeling for sunscreens until after the current summer season.  Perhaps information learned about nanosubstances in sunscreens will make its way onto those new labels, or at least some version of the labels in the future.

Another upside is the use of an international forum including not just regulators, but industry attendees and others to identify the issues raised by nanoparticles in cosmetics.  A theme of this blog has been the need for a “same-page” approach in the international commercial arena.

The downside is the long slog of regulatory information gathering and activity – and sometimes inactivity.  And it is altogether possible that the various jurisdictions will go their own ways in approaching the subject.

After the ICCR meets in July, I will report on the proceedings.  For access to the official announcement of the conference, and for information from the FDA on previous ICCR conferences, reports, and other materials, see

 http://www.fda.gov/Cosmetics/InternationalActivities/ConferencesMeetingsWorkshops/InternationalCooperationonCosmeticsRegulationsICCR/default.htm

The FDA is on the move.  OnApril 20, 2012, it issued two draft guidances pertaining to the effects of nanotechnology on food and cosmetics.  In the cosmetics document, the FDA cautions safety and does little more.  But in the food safety document, the FDA moves in the directing of setting forth steps to be taken by food manufacturers to prove the safety of any food and food packaging using nanotechnology.  This heightened scrutiny for food products containing nanoparticles is an affirmative move on the part of the FDA to regulate nanotechnology.

 In the April 20 food safety guidance document, the FDA states:

 “The manufacturing process of a food substance is considered for the purposes of safety assessment only insofar as it may affect the properties and safety of the finished product.”

 The FDA goes on to say that “[t]he particle size distribution of a food substance may affect its ability to be absorbed by the body or to migrate from food packaging into food.”  The FDA explicitly states that manufacturing processes involving nanotechnology are included within the scope of the guidance document.

 The FDA states that it does not intend to judge any substances containing nanoparticles as being harmful – or not – but that use of nanotechnology in food may warrant certain assessments in determining the safety of the food.  The FDA states:

 “The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit examination. . . . For example, so-called nano-engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.”

In other words, safety assessments in this area should be based on criteria for food substances in the nanometer range, and that could require new and different assessment methodologies.  However, the FDA has said that it will continue to regulate nanotechnology products under its existing statutory authorities, e.g. regulations on food color, additives, and packaging.

So does the guidance represent a step forward?  I think it does, if for no other reason than it explicitly recognizes that there may be discrete safety issues raised by the use of nanotechnology in food.  The guidance is not self-executing; it is currently available for public comment.  It represents a step in the right direction.  Its recommendations are preliminary, it seems to me.  Going forward, further consideration needs to be given to the issues it raises to determine if regulation specific to products using nanotechnology is warranted.  This should be only the beginning.

 

The draft guidance is Draft 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, available at

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm300661.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=food%20ingredients%20and%20packaging%20guidance%202012&utm_content=2

 

 

white-house-south-2007-djIn my most recent entry, I noted that the National Academies would be releasing a report by the end of January that focuses on researching the health and safety aspects of nanotechnology.  The report, A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, was released January 25 in prepublication (i.e. uncorrected) copy.  A download, with significant restrictions, is available at http://www.nas.edu/catalog.php?record_id=13347

The study was initiated by EPA, which asked the National Research Council of the National Academies to conduct an independent study with the goal of developing a research strategy.  The report sets forth a conceptual framework for research on the environmental, health, and safety impacts of engineered nanomaterials (ENMs).

 The report explains why ENMs are difficult to place into a system of risk analysis.  In this blog, I’ve discussed the fact that the tiny size of nanomaterials gives them characteristics and risks different from the same materials in larger dimensions.  The report points out the vast diversity of characteristics of ENMs, as well as the fact that those characteristics may behave differently depending upon the environment in which the materials are located, including changing characteristics as the nanoparticles migrate.  Furthermore, the uncertainty about risks in all sectors – among developers, regulators, and consumers – demands a uniform strategy for assessing risks.  The report points out that little research has been done to date, notwithstanding the fact that even more complex ENMs will soon be available.

In other words, we needed a research protocol for identifying, analyzing, and managing the environmental, health, and safety hazards of ENMs yesterday.

One of the most significant points made in the report was the identification of “critical research gaps” that must be addressed.  Examples of some of the gaps:

More is known about inhalation risks than other routes of exposure because of earlier research on the effects of particle inhalation on the human body.

Basic information is lacking on the chemical and physical properties of the ENMs currently out there.

Gaps in knowledge exist regarding how ENMs move through and interact with the human body and in the environment.

How research is conducted in the laboratory must be modified to provide accurate information about the risks.  Standard testing protocols must be developed.

 The report goes on, and in the months to come I will look at various aspects of the report in individual posts on this blog. 

 Consistent with its findings, the report recommended changing the structure of the National Nanotechnology Initiative (NNI), which is too vast and fragmented to be effective in the ways that are critical.  The NNI’s authority covers essentially only coordination functions.  The report recommends that the entity that manages and implements the report’s strategy be one with “top-down” management and budget authority over the research.  This may not be the NNI at all.  The report notes that the NNI’s objective of promoting the development and uses of nanomaterials may conflict with its role in identifying and appropriately managing the risks of the technology.  Accordingly, the report recommends separating those objectives and restructuring the NNI.

It’s another beginning.  The follow-up report, in which the committee promised to assess progress toward the goals set forth in this report, isn’t due for a couple of years.  In the meantime, ENMs will continue to proliferate.  My recommendation is that all sectors exercise all due caution until more is known.

prod liab imageIt had to happen sooner or later.  And it’s happening now.  A coalition of nonprofit consumer safety and environmental groups brought an action on December 21 in federal district court in California against the Food and Drug Administration (FDA).  The action seeks an order for declaratory and injunctive relief under the Administrative Procedure Act to require the FDA to respond to a petition filed with the FDA in 2006 which sought action by the agency to assure the safety of the public exposed to nanomaterials, particularly sunscreen products.  The requested relief is detailed on pages 3-4 of the petition.  The lawsuit is International Center for Technology Assessment v. Hamburg (N.D. Calif., CV 11-6592).

The coalition includes the International Center for Technology Assessment (ICTA) as lead plaintiff for Friends of the Earth, Greenpeace, Food and Water Watch, the Center for Environmental Health, the Action Group on Erosion, Technology and Concentration (ETC Group), the Institute for Agricultural and Trade Policy, and several other groups.

Among other things, the petition detailed the status of research on and knowledge of the risks of nanomaterials, both relating to consumer products and the environment.  This information included studies that have indicated some of the ways that engineered nanoparticles may harm living cells through new channels of exposure.  Moreover, in 2007, the FDA’s own Nanotechnology Task Force issued a report recommending that the FDA issue guidance to manufacturers using nanomaterials and take steps to improve scientific knowledge of nanotechnology.

In the weeks to come, we will be anticipating the response from the FDA, which may very well insist that it has undertaken the efforts sought by the petitioners.  There are several other legal strategies that the FDA could employ, including claiming the lack of legal authority to put into place some or all of the relief sought in the petition or the need for interagency coordination.

The greatest significance of this lawsuit is that it puts nanotechnology into the courts.  This may be the first time, but it certainly won’t be the last time.

The 80-page petition is available at

http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf

The 2007 Nanotechnology Task Force report is available at

http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm