Saturday, August 9, 2008

I Know Let's Test Pesticides on Babies!

I should totally write headlines for the National Enquirer, except the one I just wrote was uttered in someone's brain over at the EPA a couple years ago.

The CHEERS study, Children's Environmental Exposure Research Study, was set to start up in 2004. An abstract attached to the second notice of the study was released by the EPA in March of 2004 and stated the following:


"The US EPA's Office of Research and Development's National Exposure Research Laboratory (ORD/NERL) proposes to conduct a two-year longitudinal field measurement study of young children's (aged 0 to 3 years) potential exposures to current-use pesticides and selected phthalates, polybrominated diphenyl ethes, and perfluorinated compounds that may be found in residential environments. The study will be conducted in Duval County, Jacksonville, Florida over a two-year period from 2004-2006. Sixty young children will be recruited into this study in two cohorts: (1) infants recruited into the study soon after birth, and , (2) children recruited into the study at approximately 12 months of age. The study involves up to six data collection events at each home during the two-year study period. During each event, environmental and biological samples will be collected to measure chemical concentrations and questionnaires will be administered to collect data that will be used to estimate aggregate exposures and to analyze the measurement data. Aggregate exposures will be estimated for the current-use pesticides and selected phthalates in the study. The data collected on the polybrominated diphenyl ethers and the perfluorinated compounds will be used to evaluate the potential magnitude for exposure and to determine the temporal and spatial variability of these chemicals in residences. The study will collect data to fill critical gaps in our understanding of very young children's exposure to chemicals in their residences. The study will help the Agency reduce uncertainty in exposure and risk assessments for children by providing data on exposure factors and validated tools for estimating children's expsure to contaminants, as well as providing much needed measurement data for model refinement. The exposure factors generated in this study will be included in the National Center for Environmental Assessment's (NCEA) Child Specific Exposure Factors Handbook. Additionally, the information will apear in the form of final EPA reports, journal articles, and will also be made publicly available in an electronic database for use by the scientific community, risk assessors, and risk managers."

Oh . . . and the poor families that were going to be asked to participate would receive just under $1000.

I keep getting the feeling that I must have skipped school the day a whole bunch of people in our country were taught about all the good things that come when you target low income minority communities in order to "collect data to fill critical gaps in our understanding of very young children's exposure to chemicals". I have a feeling it was the same class where extremely insecure men learned to beat their wives and girlfriends.

Anyways, to make a long story short everyone found out about this little study and a whole bunch of people organized themselves around this issue and shut this shit down. So that's the end of that.

Yeah right . . . come on people. This is America! We love creating chemicals, releasing them into our bodies and environment and seeing what happens. I mean it's not like they were going to hose down those babies with "current-use pesticides and selected phthalates, polybrominated diphenyl ethes, and perfluorinated compounds". They were just going to observe as they played in them. Since so there was nothing wrong with the study, why end it forever? Oh oh I know just keep it on the down low for about . . . ummmm . . . four years, because as we know better than almost any other group of people on the planet four years is just long enough for us to forget everything.

Guess what I'm going to write now? Go on . . take a guess.

"EPA is moving cautiously to launch a new study to observe the effects of children exposed to pesticides and other chemicals to replace the ill-fated Children's Health Environmental Exposure Research Study (CHEERS), which then-acting Administrator Stephen Johnson canceled in 2005 amid widespread ethical concerns" or so says an article written by Maria Hegstad and released on August 5, 2008 in the Risk Policy Report.

But don't worry the EPA has learned their lesson, they're outsourcing this one! Yea to outsourcing! I mean if big corporations aren't held responsible for the human rights and environmental justice violations in their product's chain of custody then the EPA can't be held responsible for what whoever is awarded the grant to run the re-born CHEERS study does.

Here . . . even I get tired of my own sarcasm. Read the article yourself:

Risk Policy Report
August 5, 2008

EPA Steps Gingerly To Launch New Study Exposing Children To Chemicals

EPA is moving cautiously to launch a new study to observe the effects of children exposed to pesticides and other chemicals to replace the ill-fated Children's Health Environmental Exposure Research Study (CHEERS), which then-acting Administrator Stephen Johnson canceled in 2005 amid widespread ethical concerns.

The agency late last month closed its application period for a new study to observe the effects of common household chemicals like antibacterials and disinfectants on children and toddlers. The new study, Observational Studies to Characterize the Determinants of Exposure to Chemicals in the Environment for Early-Lifestage Age Groups, is slated to begin next year.
Unlike the CHEERS study, the new study will not be performed by EPA researchers. Instead, the agency is offering a $2.5 million grant for outside scientists to design and perform the study, according to the grant notice EPA posted on the Internet earlier this year. The notice is available on InsideEPA.com.

EPA "is seeking applications proposing an observational exposure measurement study to identify and characterize the determinants of exposure for early lifestages (i.e., very young children under three years of age) to chemicals in their environment," according to the grant notice. "Very young children represent an important lifestage that may be more vulnerable to chemicals in the environment because they are physiologically and behaviorally different from adults." It is thought that children may be more exposed to household chemicals in part because they mouth objects and crawl and play on floors.

Limited information about how children are exposed to household chemicals creates uncertainty in agency risk assessments, says a source with EPA's National Exposure Research Laboratory (NERL). The observational study is intended to reduce that uncertainty, "improve exposure and risk assessments and to develop better exposure mitigation strategies," according to the grant notice.

Industry officials say they support such research because it could lead to assessments of lower risks than those calculated with more-conservative default parameters that may overestimate risk. "As an industry we support these types of studies and believe that data generated and based on sound science and transparent methodologies will continue to show the safety of these highly regulated products," says a spokeswoman with CropLife America, a trade association for agricultural companies.
EPA planned to begin CHEERS in November 2004 to collect information on children's "activity patterns" and measure their exposure to household pesticides to improve the accuracy of agency risk assessments. The agency was to pay 60 Jacksonville, FL-area families nearly $1,000 for involvement in the two-year-long exposure study (Risk Policy Report, Nov. 30, 2004).
Controversy over ethical questions relating to the study design led EPA to delay the study until April 2005, when then-acting administrator Johnson canceled it. His announcement came less than a day after Sens. Barbara Boxer (D-CA) and Bill Nelson (D-FL) vowed to delay his confirmation until he halted the study (Risk Policy Report, April 12, 2005).

Public Employees for Environmental Responsibility (PEER), an environmental group representing government employees, also attacked CHEERS four years ago. PEER launched a campaign to stop the study, focusing on three concerns in the study design: its payments to families for participation; lack of provisions to intervene if study children exhibited developmental problems or had particularly high exposure levels in their urine; and lack of requirements that participants use safe application and storage methods for chemicals in their homes.

While the new study has "similar" goals to CHEERS, it will be very different, says the NERL source, because "it is up to the applicants to develop the approach for how to collect the information." EPA designed CHEERS, which was intended to be a two-year-long study with repeated measurements. EPA also identified a community to perform CHEERS in and an approach for doing do, the source says.

"The study goals are similar, but it's up to the applicant to design the study and identify the community in which it would be performed," the source says. "It's highly unlikely it would be similar to the design of CHEERS." Since CHEERS cancellation, EPA published a document outlining ethical approaches for human observational studies (Risk Policy Report, April 15). The source notes that the grant notice "requests the applicant use that" in designing the study.
The new study design will be vetted by a specially-selected review board comprised of at least two non-EPA reviewers and one

EPA reviewer and the agency's Human Subjects Research Review Official before research begins, the source says. These precautions are not new to the agency since CHEERS, and have always been agency policy, the source says. "We want the study to be of the highest scientific quality and meet the highest ethical standards," the source says.

The research team selected to perform the new study must address some of these concerns, among others, according to the grant notice. The notice specifies that researchers must address "scientific and ethical considerations" including but not limited to "recruitment, retention, participant compensation, third-party issues, researcher-participant interactions, researcher-community interactions, communications, interventions and education."

A former member of EPA's Children's Health Protection Advisory Committee who reviewed the grant notice says it "looks like improvements have been made since CHEERS," though the source thinks it is "too soon to say" if the new study will "suffer the same controversy" that CHEERS faced. The source praises the notice for addressing many of the ethical concerns raised in the controversy over CHEERS.

"The way [the notice] is written, it looks good to me. It isn't going to allow something to come in that isn't ethical," the source says. "But it's all in the implementation. That to me is where issues may arise."

The new study will be "performed to collect data on chemical exposures under 'real-world' conditions (i.e., in the environments that people occupy while they go about their normal activities) and do not involve additional exposures to the chemicals being studied due to participation in the study," according to the grant notice. "The data collected in observational studies enhance public health by reducing uncertainties in exposure and risk assessments and by providing information that can be used to develop risk mitigation strategies and methods." The new study will be funded only by EPA, a contrast from CHEERS, which was to receive more than $2 million from the industry group American Chemistry Council -- another source of concern for PEER. The group charged that pesticide companies wanted to know children's exposure levels force EPA to drop its requirements of additional protections for small children from pesticide exposures.

EPA will fund the new study and will award it as a cooperative grant, meaning EPA researchers will collaborate with the award recipient. The agency is putting the research question out for a grant because of its limited funding for research, the NERL source says. "In a study of this size we are looking for collaborators with existing cohorts already working in existing communities," the source says, adding that experienced academic or non-profit groups would be ideal. "Obviously we are looking for the experts in the field to do this."

EPA recently extended the deadline for grant applications from July 15 to Sept. 3, to give academic responders a better chance to apply, the source says. -- Maria Hegstad

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Maybe one day the chemical industry will use a comprehensive precautionary approach in their R & D and sales departments. And maybe one day our government will stand up for our children and make them. Because I might be a little naive but don't you think it's a better plan to not ever release chemicals that could be harmful to our babies instead of using tax payer money to conduct a study that lets them play around in chemicals and then just wait and see what the consequences are?


Renee Claire

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