Scientific & Technical Support: Data Waivers
Regulatory agencies require scientific data to assess the potential
human health
and
environmental effects associated with product use as part of the
registration process. Data waivers are sent to regulatory agencies for the
purpose of explaining why
generating scientific data would not be possible, or
why the scientific studies are not needed due to existing available data.
TSG’s scientists help determine when sufficient data is available to support
a data waiver from requirements for
toxicity,
ecotoxicity and exposure
assessment studies on chemicals. Our consultants will identify and assemble
the appropriate supporting information to present a rationale requesting a
waiver from the requirement in a clear and logical written document.
 |
|
| Key Contacts | |
 Gary Burin |
 Beth Mileson |
 Saadia Eltayeb |
 Amy Roberts |
TSG’s consultants are highly knowledgeable of the registration requirements for disinfectants regulated by both PMRA and TPD. TSG provides comprehensive product registration services, from determining data obligations and developing compliant labels, to compiling and submitting the registration application.
The goals of EPA's TSCA IUR program are to collect quality screening-level, exposure-related information on chemical substances in commerce in the United States and to make that information available for use by EPA and the public. The IUR data are used to support risk screening, assessment, priority setting and management activities at EPA and constitute the most comprehensive source of basic information on chemicals in commerce available to EPA.
TSG has offices throughout North America and Europe, including Sacramento, CA, Washington, DC, Canada, United Kingdom, Spain and Slovenia. Through these locations and our affiliates, TSG works with companies in 36 countries worldwide including China, Japan, Australia, New Zealand and Latin America.
REACH (Registration, Evaluation, Authorization and restriction of Chemicals) is an EU Regulation that came into effect on June 1st, 2007, imposing strict guidelines on the manufacture or import of chemicals, preparations and articles in or to the EU.
Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65, was approved by voters to address the growing concerns about exposure to toxic chemicals. Proposition 65 requires California to publish a list of chemicals, updated at least once a year, known to cause cancer, birth defects or other reproductive harm. Proposition 65 also requires California businesses to post notification about significant amounts of chemicals in the products they sell, in their homes or workplaces, or that are released into the environment.