Hot Topics

Regulatory News

Back To News

 

Regulatory News

USEPA releases it's update inventory of sources and environmental releases of dioxin-like compounds in the United States for external review.
The USEPA has released an update inventory of sources and environmental releases of dioxin-like compounds in the United States for external review. This update estimates of annual releases to land, air and water of dioxin-like compounds indicated an approximate 89% reduction between 1987 and 2000 in the United States from all known sources combined. Between 1987 and 1995, the leading source of dioxin-like compound emissions was municipal waste combustion, but it became the third ranked source in 2000. The leading source of dioxin-like compound emissions in 2000 was burning of domestic refuse in backyard burn barrels.

To learn more about this update and how it may impact you business, contact us.

EPA Posts Stage 2 Disinfection Byproduct Rule
The EPA is proposing the Stage 2 Disinfectants and Disinfection ByProduct Rule (DBPR) to reduce potential cancer, reproductive, and developmental risks from DBP's. The ruling focuses on monitoring and reducing two classes of DBP's: total trihalomethanes (TTHM) and haloacetic acids (HAA5). These two groups of DBP's are used as indicators of the various byproducts that may also be present in water. According to the EPA, a reduction in TTHM and HAA5 indicates a reduction in total DBP's. The Stage 2 DBPR is designed to reduce the level of exposure from disinfectants and DBP's without undermining the control of microbial pathogens. The Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) will be finalized and implemented simultaneously with the Stage 2 DBPR to ensure that drinking water is microbiologically safe at the limits set for disinfectants and DBP's. The Sapphire Group has been actively engaged in examining the association between disinfection byproducts and reproductive toxicity and in assisting the chlorine industry in objectively evaluating the health data and scientific rationales used by the EPA to support the major propositions in these proposed rules.

Click Here To View Full Document...

 Nasal Dosimetry Study to Determine Non-Cancer Assessment for Ethyl Acrylate
The Sapphire Group, Inc. has recently been engaged by the Basic Acrylic Monomer Manufacturers, Inc.(BAMM) to develop a non-cancer risk assessment for ethyl acrylate (EA) for the determination of safe exposure levels for workers and the general public. EA is an important acrylic monomer used in the manufacture of a variety of polymers and copolymers, which are ingredients in latex paints, binders, caulks, lubricating oils, plastics and other products.

Under the Hazardous Organic National Emissions Standard for Hazardous Air Pollutants of the USEPA, predicted concentrations of EA emitted from industrial facilities are being compared to acceptable chronic exposure concentrations. The goal of this project is to derive a Reference Concentration (RfC) for EA using a measure of an internal dose in the target tissue (the nasal epithelium).

In order to study the exposure differences between humans and rats, the scientists at Sapphire are combining the use of Computational Fluid Dynamics (CFD) and PBPK modeling. This represents a state-of-the-science approach for estimating target tissue dose within the nasal passages of rats and humans. CFD-PBPK modeling represents a relatively new quantitative tool for assessing the dose and response of chemicals that affect the nasal cavity. Past approaches relied on the extrapolation of dose between rats and people for chemicals like EA and did not take into account the real differences in the actual architecture of a human nasal cavity versus that of a rat.

Therefore, the resulting RfC from this new methodology provides a more accurate measurement and will allow the determination of exposure criteria that will remain health protective, while at the same time not overly restrictive. The results of this work are intended to be published in a peer-reviewed scientific journal and will be presented to the USEPA. The Sapphire Group anticipates that the results from the CFD-PBPK models will be used in a similar fashion by other regulatory agencies and that this approach will impact a number of other products in which the nasal cavity is the sensitive tissue.

Click Here To View Full Document...

FDA Issues Action Plan for Acrylamide in Food
The FDA has developed a draft action plan for acrylamide in food and has submitted that plan for input and comments from the public, academia, industry and specific scientific experts. It is currently testing a limited number of foods at the Center for Food Safety and Applied Nutrition.

The FDA's plan is designed to address some of the uncertainties about the impact of acrylamide on public health. The plan calls for more information on which foods form acrylamide and the amount of acrylamide that is formed. The plan will examine dietary exposure to acrylamide, the bioavailability of acrylamide, its potential to cause cancer and the potential to cause germ cell mutations as well as the biomarkers of exposure. The Sapphire Group has been actively engaged in this issue, and is able to assist organizations in the evaluation of their products as well as understand the implications of the FDA action plan and other related activities.

Click Here To View Full Document...

Voluntary Children’s Chemical Evaluation Program
In December 2000, the EPA announced the Voluntary Children's Chemical Evaluation Program (VCCEP). The program is a pilot effort in which 23 chemicals (such as acetone, benzene and toluene) that have been previously been detected in environmental and biomonitoring programs will be examined closer as to the risks associated with children. Under this program companies and/or consortia volunteer to develop exposure assessments, toxicity assessments and identify data needs to assess the potential exposure and risks to children. The program is designed as a three tiered approach with Tier 1 (Peer Consultation Document) due this December.

The Sapphire Group is currently helping several organizations through the VCCEP process. Combining the integration of data with their expert knowledge and understanding how a chemical acts once inside the body allows The Sapphire Group to provide the clearest understanding of the effects of these chemicals. For the most part, children’s exposure and risk assessment are based on extrapolation of data from studies of adults. However, it has been shown that children are not just small adults; for example, their metabolism operates at a higher rate. Included in the overall assessment is careful consideration of not only metabolism, but also kinetics of distribution, absorption and excretion.

For more information on this ongoing regulatory initiative, contact The Sapphire Group.

Click Here To View Full Document...

Second List of Priority Chemicals for Guideline Development by the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances is Released
The National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances (NAC/AEGL), established by USEPA under the Federal Advisory Committee Act (FACA), develops AEGLs on an ongoing basis to assist with Federal, State, and other organization needs for short-term hazardous chemical exposure information. This list of 371 priority chemicals is a composite of numerous priority lists of acutely toxic chemicals and represents the selection of chemicals for AEGL development by the NAC/AEGL during the next several years at an anticipated rate of at least 30 chemicals per year. There are 137 chemicals on this list of 371 priority chemicals that are considered a higher priority, based on considerations of toxicity, volatility, presence on numerous organization chemical lists, and other factors. These chemicals are planned to be addressed prior to the other listed chemicals.

An initial listing of 85 priority chemicals was published in the Federal Register of May 21, 1997 (62 FR 27733)(FRL-5713-7), to facilitate participation by the public in the AEGL process. It is believed that publication of this second tier list of chemicals will provide individuals and organizations with ample time to gather existing data and information and, where appropriate, to develop new data and information on the acute toxicity of the chemicals listed herein, for the consideration of the NAC/AEGL.

For more information on this ongoing regulatory initiative, contact The Sapphire Group.

Click Here To View Full Document...

RETURN TO TOP OF PAGE