Monday, March 7, 2011
Wednesday, February 23, 2011
On February 10th, the implication of this new directive was immediately apparent when five companies were notified by the US EPA that the identities of 14 chemicals were not eligible for confidential treatment under TSCA. The companies have until the 31st day after the notification to challenge the order in federal court or the chemical identities will be disclosed.
This action has sparked new opposition from industry and trade associations. In the past, many have claimed that industry has been guilty of overusing claims of CBI for many of their chemicals and products, which is why the policy revisions are necessary. However, others contend that releasing too much information could negatively impact innovation within the chemical industry by endangering proprietary secrets and formulations to competitors.
Revising TSCA policy to increase the public’s knowledge is a good step, but a proper balance between secrecy and transparency is needed to ensure that actual trade secrets remain confidential while the public is still made aware of chemicals that have been linked to health and safety concerns.
Thursday, January 27, 2011
As discussed in the press release, nine states will introduce general chemical regulation state policies, approximately 17 states will announce restrictions or bans on bisphenol a in certain products, 8 states will introduce policies to ban cadmium in children’s products, 3 states will announce policies to reduce exposure to decabromodiphenyl ethers, and 11 states will be calling on Congress to overhaul the federal chemicals policy and TSCA.
State chemical regulation is nothing new. Over 70 chemical regulations have been passed in 18 states, ranging from laws concerning the ban of bisphenol A in consumer products to the concentration of contaminates in drinking water. When there is a deficit in federal chemical regulation in response to new science and emerging contaminants, States will fill in the gaps themselves. However, many of the State laws or guidelines are directly in response to public perception of the risks, despite if the science establishes that a risk actually exists.
The existence of laws concerning the same chemical or contaminant in different states makes it very difficult for industries with nationwide production to properly comply. Federal laws are needed to create uniform chemical regulation, which would decrease compliance confusion and create more realistic guidelines based on science and not perceived risk. The first step in more unified chemical regulation would be the overhaul and revision of TSCA. Hopefully, Congress will take note of the sudden influx of state chemical regulations and take chemical regulation reform off the back-burner and allow it to move forward.
Monday, January 10, 2011
Back in September, Science News & Views discussed the retraction of the original 1998 article by Wakefield et al. that linked autism to the MMR vaccine and how despite the overwhelming evidence to the contrary, this article managed over the next decade to instill a fear in parents causing them to turn away from standard vaccinations. After the article was retracted and the medical license of Andrew Wakefield, the main researcher behind the study, was revoked, a United Kingdom journalist, Brian Deer, continued the investigation. His analysis was published in the British Medical Journal and provided details on the deliberate falsification of data used in the study for the purpose of suing the vaccine manufacturer.
Deer’s investigation showed that the errors in the Wakefield study were not the result of incorrect statistics, faulty analysis, or poor design. No, this study was a clear case of fraud. It is unsettling that one fraudulent study could have such an impact on the scientific world. When the study was published, the results were circulated by the media and parents understandably became alarmed. The number of children being vaccinated declined, resulting in resurgence in cases of measles and mumps. Despite Wakefield and his study being discredited, the belief that there is a link between the MMR vaccine and autism is so strong that the controversy has continued. The strength of this erroneous conviction is in part due to the media coverage of the issue.
It is the media’s job to report on new science, and they cannot be faulted for reporting Wakefield’s results when they were released in 1998. However, when the weight-of-evidence backed by numerous studies strongly began to favor the lack of an association between vaccines and autism, many of the media still reported on the supposed link citing Wakefield’s results and quoting activists with no scientific background who still claimed to be authorities on the subject and declared that there was ‘proof’ of the link. This is undoubtedly due to the reporters trying to provide a balanced story with viewpoints from both sides. While the media cannot have known that Wakefield falsified his data, the fact that this vaccine scare has lasted over a decade and negatively impacted the health of children proves that scientific news reporting should consider employing a weight-of-evidence approach and not allow another publicity-seeking fraud to cause an unnecessary and harmful health scare.
Monday, December 13, 2010
By itself, a report like this sounds alarming, but it becomes less worrisome when certain factors are considered. While there have been many scientific articles suggesting a possible association between BPA and adverse health effects, there are also many others that do not find any significant health consequences to the public, especially at low concentrations. In addition, regulatory agencies in the United States and Europe have not deemed BPA to be a health threat under conditions of intended use.
Another important consideration is that this report was published by the non-profit groups themselves and not in a scientific journal, which means that it did not undergo an independent peer-review process. In particular, there is information in the report which is puzzling. For example, the statement that one receipt contained 2.2% BPA by weight is difficult to believe given the molecular weight of BPA. The report also indicated that people are being exposed from handling the receipts and currency, but only very small amounts of BPA are presumably absorbed through the skin. The hypothetical absorbed concentration would then be converted to a biologically inactive metabolite and eliminated from the body. Therefore, no adverse health impacts would have occurred. Finally, the CDC has conducted biomonitoring surveys of the United States and found that consumer exposure (which would include all potential exposure routes including receipts and currency) to BPA is low.
While it is interesting to learn that small amounts of BPA can be found on thermal paper products and dollar bills, the new information should not change the current regulatory viewpoint that BPA is not a public health threat given the biological insignificance of the concentrations. However, the authors’ call for revisions to TSCA legislation, no matter how unrelated it may be to the substance of their article, is still a necessary step for modernizing chemical regulation given the increased need to understanding of exposure and risk as they relate to chemicals in consumer products.
Monday, December 6, 2010
Saying that TSCA is “working well” has been argued against by both non-profit groups and the chemical industry. The numerous hearings during 2009 provide support that revisions to 34-year old TSCA should be considered a priority and should not be delayed. As chemical regulations in the European Union and Canada continue to change and modernize with the advancement of science and technology, the United States runs the risk of falling behind in scope and relevancy. In addition, individual states, such as California, are developing their own regulatory initiatives which could result in a patchwork of regulations across the United States and cause enormous difficulties with compliance for industries with nationwide production and distribution.
Monday, November 29, 2010
The debate over the toxicity of unlisted chemicals in scented products is not new. A number of non-profit groups have rebuked companies, often in the cosmetics industry, for not disclosing the entirety of their ingredients claiming that their products negatively impact public health. Industries that produce fragrances and International Fragrance Association have responded that their products are safe and that the fragrances are within acceptable limits.
Presently, fragrance formulations are protected as trade secrets or Confidential Business Information, but this may soon change as one of the goals of the proposed TSCA revision is to increase transparency. Therefore, claims of Confidential Business Information will be denied if the chemical is already on the publicly available TSCA Chemical Substances Inventory or is submitted under TSCA Section 8(e) as part of a health and safety study. Full chemical disclosure on product labels is also being discussed by many campaigns. While not all industries will be affected by the TSCA revisions (e.g., cosmetic are regulated by the FDA), many companies will find themselves burdened with providing in-depth toxicity data on their chemicals and the development of more detailed labels.
It is true that some people are sensitive to certain smells, not necessarily only artificial fragrances, and may develop headaches or other mild, temporary effects. Generally, this occurs when exposed to a high concentration of a scented product and not with normal application. However, the fact still remains that unlisted chemicals in scented products are an issue in the media and in legislation. As suggested by the proposed TSCA revisions, the chemical regulation landscape is changing. Whether it is Confidential Business Information or product labels, companies need to (1) have a full appreciation of the potential health impacts of the chemicals in their products, (2) stay informed on the changes to these regulations, and (3) learn how to comply with the regulations relevant to their industry.