Selected tags: in vivo

EDF comments at EPA workshop on applying systematic review methodology to IRIS assessments

Rachel Shaffer is a research assistant.

Lately, much of the attention of the environmental health community has been focused on Capitol Hill and the Lautenberg-Vitter chemical safety reform bill that would amend the antiquated Toxic Substances Control Act (TSCA). Yet significant – if somewhat esoteric – developments are underway at EPA that will also have major impacts on how the safety of chemicals is assessed.  EPA has been implementing improvements to its Integrated Risk Information System, commonly known as “IRIS.” The purpose of the IRIS program is to evaluate information on the effects of potential exposures to environmental substances and provide health hazard assessments, which are then used to support regulatory decisions across the agency.  And while it isn’t directly affected by TSCA or its reform, IRIS provides both indirect and direct support to the office at EPA that does administer TSCA.  

In other words, what happens in IRIS doesn’t stay in IRIS.

So… what’s IRIS up to? Read More »

Posted in EPA, Health Policy, Health Science| Also tagged , , , | Comments closed

21st Century on the horizon for endocrine disruptor screening?

Rachel Shaffer is a research assistant. Jennifer McPartland, Ph.D., is a Health Scientist.

BPA, DDT, PCBs, PBDEs, phthalates, PFOA … Forgive the alphabet soup, but chances are you’ve heard of at least some of these endocrine-disrupting chemicals (EDCs), which have been the subject of a lot of public and media attention in the last several years. Research has begun to uncover the ways in which these chemicals can interact with the body’s hormone – or endocrine – system to disrupt various natural biological processes, including metabolism, the reproductive system, and development of the brain and nervous systems.

While the endocrine-disrupting properties of the chemicals named above have been confirmed, scientists suspect there may be many more such chemicals in our environment, in the products we use, and in our bodies.  How can we identify them?

Legislation enacted in 1996 required the U.S. Environmental Protection Agency (EPA) to develop a screening program to identify potential EDCs.  More than 10 years later, EPA finally launched the Endocrine Disruptor Screening Program (EDSP).  Testing is being conducted in two phases, or “tiers.”  In “Tier 1,” a screening battery of validated in vivo and in vitro assays is used to identify chemicals with potential to interfere with the endocrine system. Chemicals flagged in the first tier of testing are then subject to “Tier 2” testing intended to determine the specific effect and the lowest dose at which it occurs. (We should note this program is very controversial and the subject of ongoing debate, but that is not the subject of this post.)

EPA has identified an estimated 9,700 chemicals to be screened – a very daunting task given the time- and resource-intensive nature of the testing battery EPA has established.  Might there be a way to expedite the identification and testing of the more problematic chemicals? A study published earlier this year in Environmental Health Perspectives (EHP) investigates a possible approach: using in vitro high-throughput (HT) assays developed through EPA’s ToxCast and Tox21 programs to target and prioritize chemicals for further testing under the EDSP. While use of these assays poses its own challenges, might it at least help in determining an appropriate testing sequence?  Read More »

Posted in Emerging Testing Methods, Health Science| Also tagged , , , , , | Comments closed

EDF launches website on EPA’s emerging chemical testing programs

Jennifer McPartland, Ph.D., is a Health Scientist.

New approaches for evaluating chemical hazard and risk are needed to help address substantial data gaps that exist for the thousands of chemicals currently in the marketplace as well as those yet to be introduced.   EPA has been investing significant resources to create research programs dedicated to advancing new types of chemical testing and assessment approaches.  But what exactly are these approaches?  How might they improve the practice of risk assessment?  Are they appropriate for decision-making, and if so, what kinds of decision making?  What role does the public interest community have to play? 

To explore these and other important issues, EDF’s Health Program has launched a website, “Chemical Testing in the 21st Century,” that provides an  introduction to these new approaches and the programs the EPA has built around them—including their potential uses, benefits and limitations.  The website includes the following informational resources: 

  1. Chemical Testing in the 21st Century: A Primer – An introduction to EPA’s Computational Toxicology (CompTox) research initiative and its component programs, such as ToxCast; a discussion of the opportunities and challenges of these new testing programs; and a discussion of issues and needs for greater engagement by the public interest community.  
  2. Chemical Testing in the 21st Century: Webinar Series – Linked audio and video recordings of each of EDF’s three webinars (held in October) featuring EDF and EPA scientists exploring the basics of EPA’s new testing programs and the promises and challenges they present. 

We will soon be adding a page with descriptions of and links to additional resources.

Posted in Emerging Testing Methods, Health Science| Also tagged , , , , , | Comments closed

Exposing our ignorance: EPA study reveals barren exposure data landscape

Jennifer McPartland, Ph.D., is a Health Scientist.

This past November, EPA scientists published a sobering paper, “The exposure data landscape for manufactured chemicals,” in the journal Science of the Total Environment.  The paper reveals how little systematic information we have about human and environmental exposures to the thousands of chemicals in use today.

The aim of the study was “to define important aspects of the [chemical] exposure space and to catalog the available exposure information for chemicals being considered for analysis as part of the U.S. EPA ToxCast screening and prioritization program.”  Its conclusion:  “The results suggest that currently available exposure data are insufficient to provide the evidence base required to inform risk assessment and public health decision making.”  Not good, but not surprising.  Read on for more detail. Read More »

Posted in Emerging Testing Methods, EPA, Health Policy, Regulation| Also tagged , , , , , , | 1 Response, comments now closed

Avoiding paralysis by analysis: EPA proposes a sensible approach to identifying chemicals of concern

Richard Denison, Ph.D., is a Senior Scientist.  Thanks to my colleagues Jennifer McPartland and Allison Tracy for their analysis of the EPA proposal discussed in this post.

Last week, the Environmental Protection Agency (EPA) held stakeholder meetings to get public input into the criteria it will use to identify additional chemicals of concern beyond the 11 chemicals or chemical classes it has already identified.  EPA used these meetings (as well as an online forum open until September 14) as an opportunity for the public to respond to a “discussion guide” it issued in August that sets forth draft criteria and identifies data sources it intends to use to look for chemicals that meet the criteria.

The day before the EPA meetings, the American Chemistry Council (ACC) issued its own “prioritization tool” which lays out its own criteria and ranking system for identifying chemicals of concern.  This post will make a few observations about EPA’s proposal.  My next post will provide a critique of ACC’s proposed tool.

EDF and the Safer Chemicals Healthy Families coalition strongly support EPA in this endeavor – both for what it is, and for what it is not.    Read More »

Posted in EPA, Health Policy, Regulation| Also tagged , , , , , , , , , , , , , | Comments closed

Chemical safety evaluation: Limitations of emerging test methods

Jennifer McPartland, Ph.D., is a Health Scientist. Richard Denison, Ph.D., is a Senior Scientist.

Parts in this series:      Part 1     Part 2     Part 3     Part 4

This is the fourth in a series of blog posts on new approaches that federal agencies are exploring to improve how chemicals are evaluated for safety.  In this post, we’ll discuss a number of current limitations and challenges that must be overcome if the new approaches are to fulfill their promise of transforming the current chemical safety testing paradigm.  Read More »

Posted in Emerging Testing Methods, Health Science| Also tagged , , , , , , | Comments closed

Testing for endocrine disruption: Are we there yet?

Cal Baier-AndersonCal Baier-Anderson, Ph.D., is a Health Scientist.

After long delays, the EPA’s Office of Pesticide Programs recently issued endocrine disruptor screening test orders for dozens of high-priority pesticide ingredients.  Endocrine disruptors are chemicals capable of interfering with the action of hormones that regulate biological processes such as development, growth, reproduction and metabolism.  The test orders require pesticide manufacturers to evaluate their chemicals using a specific battery of tests.

Identifying which chemicals are endocrine disruptors can help protect people and the environment from harmful exposures.  So, with test orders now in the hands of pesticide manufacturers, will we finally get the data we need? Read More »

Posted in Emerging Testing Methods, Health Science| Also tagged , , , , , , | 2 Responses, comments now closed

Using ChAMP to Advance Alternative Testing Technologies

Cal Baier-Anderson, Ph.D., is a Health Scientist and Richard Denison, Ph.D., is a Senior Scientist.

Many of the screening-level hazard data being collected and analyzed under ChAMP that pertain to human health are derived from traditional laboratory animal studies.  The National Academy of Sciences (NAS) recently offered a "new paradigm for toxicity testing" in its 2008 report Toxicity Testing in the 21st Century: a Vision and a Strategy.  Can ChAMP hazard data be used to facilitate the development of new testing strategies?  Read More »

Posted in EPA, Health Science, Regulation| Also tagged , , , | Comments closed

Questionable risk decisions under ChAMP: Chlorobenzenes Category

Cal Baier-Anderson, Ph.D., is a Health Scientist and Richard Denison, Ph.D., is a Senior Scientist.

Our analysis of EPA's risk decision under ChAMP for this category of toxic chemicals vividly illustrates how EPA has failed to adopt a health-protective approach to its screening of HPV chemicals.  Rather, it misclassifies or understates these chemicals' hazards, asserts that existing regulations are sufficient even when they are quite old or do not cover identified exposures, and naively assumes that children will not be as exposed as adults to consumer products used in the home unless they are intended for their use.  Finally, this case demonstrates that manufacturers are not reporting to EPA even readily available information on their chemicals' uses.  Read More »

Posted in EPA, Health Policy, Regulation| Also tagged , , , , , , , | 1 Response, comments now closed

The Next Mile Marker on the Road to High Throughput In Vitro Screening?

John BalbusJohn Balbus, M.D., M.P.H., is Chief Health Scientist.

A new paper by Shaw et al., published in May in the Proceedings of the National Academy of Sciences, “suggests a generalizable and scalable method for the systematic characterization and comparison of novel nanomaterials” using high throughput in vitro tests.  Does this mean that the National Academy of Sciences’ vision for toxicity testing in the 21st century – proposed for conventional chemicals – is already here for nanomaterials?  Not quite.  Read More »

Posted in Emerging Testing Methods, Health Science, Nanotechnology| Also tagged , , | Comments closed
  • About this blog

    Science, health, and business experts at Environmental Defense Fund comment on chemical and nanotechnology issues of the day.

    Our work: Chemicals

  • Categories

  • Get blog posts by email

    Subscribe via RSS

  • Filter posts by tags

    • aggregate exposure (10)
    • Alternatives assessment (3)
    • American Chemistry Council (ACC) (55)
    • arsenic (3)
    • asthma (3)
    • Australia (1)
    • biomonitoring (9)
    • bipartisan (6)
    • bisphenol A (19)
    • BP Oil Disaster (18)
    • California (1)
    • Canada (7)
    • carbon nanotubes (24)
    • carcinogen (22)
    • Carcinogenic Mutagenic or Toxic for Reproduction (CMR) (12)
    • CDC (6)
    • Chemical Assessment and Management Program (ChAMP) (13)
    • chemical identity (30)
    • chemical testing (1)
    • Chemicals in Commerce Act (3)
    • Chicago Tribune (6)
    • children's safety (23)
    • China (10)
    • computational toxicology (11)
    • Confidential Business Information (CBI) (52)
    • conflict of interest (4)
    • consumer products (48)
    • Consumer Specialty Products Association (CSPA) (4)
    • contamination (4)
    • cumulative exposure (4)
    • data requirements (46)
    • dermal exposure (1)
    • diabetes (4)
    • DNA methylation (4)
    • DuPont (11)
    • endocrine disruption (28)
    • epigenetics (4)
    • exposure and hazard (49)
    • FDA (8)
    • flame retardants (20)
    • formaldehyde (15)
    • front group (13)
    • general interest (22)
    • Globally Harmonized System (GHS) (5)
    • Government Accountability Office (5)
    • hazard (6)
    • High Production Volume (HPV) (22)
    • in vitro (14)
    • in vivo (11)
    • industry tactics (41)
    • informed substitution (1)
    • inhalation (18)
    • IUR/CDR (27)
    • Japan (3)
    • lead (6)
    • markets (1)
    • mercury (4)
    • methylmercury (2)
    • microbiome (3)
    • nanosilver (6)
    • National Academy of Sciences (NAS) (20)
    • National Institute for Occupational Safety and Health (NIOSH) (7)
    • National Institute of Environmental Health Sciences (NIEHS) (5)
    • National Nanotechnology Initiative (NNI) (7)
    • National Toxicology Program (1)
    • obesity (6)
    • Occupational Safety and Health Administration (OSHA) (3)
    • Office of Information and Regulatory Affairs (OIRA) (4)
    • Office of Management and Budget (OMB) (16)
    • Office of Pollution Prevention and Toxics (OPPT) (3)
    • oil dispersant (18)
    • PBDEs (16)
    • Persistent Bioaccumulative and Toxic (PBT) (22)
    • pesticides (7)
    • phthalates (17)
    • polycyclic aromatic hydrocarbons (PAH) (5)
    • prenatal (6)
    • prioritization (35)
    • report on carcinogens (1)
    • revised CSIA (3)
    • risk assessment (69)
    • Safe Chemicals Act (24)
    • Safer Chemicals Healthy Families (33)
    • Significant New Use Rule (SNUR) (20)
    • Small business (1)
    • South Korea (4)
    • styrene (6)
    • Substances of Very High Concern (SVHC) (15)
    • systematic review (1)
    • test rule (17)
    • tributyltin (3)
    • trichloroethylene (TCE) (3)
    • Turkey (3)
    • U.S. states (14)
    • vulnerable populations (1)
    • Walmart (2)
    • worker safety (23)
    • WV chemical spill (11)
  • Archives