FAQ
GENERAL
What regulatory services does CERM offer?
CERM offers a wide range of services, from preparation and support of TSCA New Chemical submissions to HPV support to MSDS preparation. We are a dynamic company that takes pride in our abilities to help our clients with their needs.
How Does CERM handle confidentiality issues?
CERM takes confidentiality very seriously. We know that much of our clients' information is sensitive and work to ensure that we handle it accordingly. We will enter into a one-on-one confidentiality agreement with our clients and will work to meet any specific requests and needs.
Can you provide upfront quotes?
Yes. CERM can provide upfront cost estimates and scopes of work for individual projects. We also have several generalized quotes that can be provided upon request.
P2 ASSESSMENT
What is a P2 Assessment?
A P2 Assessment or Pollution Prevention Framework assessment, is a screening level process for looking at hazard, exposure, and risk of a chemical substance in the absence of complete data. The assessment is done using US EPA developed models and methods also used during PMN review. The P2 assessment is an integral part of the US EPA Sustainable Future program.
What do I need to supply for a P2 Assessment?
For the hazard assessment you only need to supply structural information. Any additional data you may have, including physical properties, ecotoxicity, biodegradation, mammalian toxicity, etc. can be helpful to the assessment, but are not required. For the exposure and risk assessment some manufacture and use data would be needed as well. The data needed for the P2 Assessment is similar to that which would be part of a PMN.
How long does a P2 Assessment take?
Typically a full P2 hazard, exposure and risk assessment takes approximately 4 – 6 weeks, but for an extra fee, we have a rush service.
Can CERM help with part of a P2 Assessment?
Yes. If you only need assistance with a specific portion of the assessment (hazard, exposure, or risk), or just a final review, we are happy to do that.
SUSTAINABLE FUTURES WORKSHOP
Who should attend the workshops?
The Sustainable Futures Workshop can be helpful to a variety of chemical industry professionals, including those in Environmental Health and Safety, up through R and D. Essentially anyone that works with chemicals can find some use in the program. We have also found that regulators who may be unfamiliar with the SF program have found the workshop informative.
What background do I need?
Little formal background training is actually needed to understand the tools and methods employed in the workshop. However, most attendees tend to come from chemical engineering or toxicological backgrounds; however, many scientists and technologists with diverse backgrounds have attended our workshops.
How often do you have workshops?
We try to have at least 2 workshops per year. In some cases, we have been able to have as many as 4 to 6. The number is based on the interest and availability of co-sponsor workshop sites.
Where can I find the software used in the workshops?
All the software and methods used at the SF workshops can be found linked from the US EPA’s Sustainable Futures homepage located at http://www.epa.gov/opptintr/sf/ (Exit Disclaimer). All of the software is freely available from the US EPA.
TOXICOLOGY
Does the E.P.A. require any specific toxicity data for a PMN (PreManufacture Notice) submission?
No, the EPA does not require toxicity testing for an initial PMN submission, and most submissions do not have data. However, if the structure or class of a chemical causes concern at the EPA, they may require testing.
Does the EPA rely on computer models for the human health assessment portion of the Pollution Prevention (P2) Assessment?
Although OncoLogic can make a prediction for cancer hazard, this has to be supplemented by other data on chemical analogs, if available. The rest of the human health assessment is based on a careful analysis and interpretation of all available toxicological data for chemical analogs. Therefore, it is extremely important to pick analogs that are both chemically similar and have adequate data.
If there are no available chemical analogs with data, can you still do a P2 Assessment?
Yes. Sometimes, a human health assessment can be based solely on the chemical properties.
MSDS PREPARATION
Does an MSDS require new data?
No, an MSDS is only required to explain existing health and hazard data, it does not require new data.
Does a PMN require an MSDS?
No, although if one is available, it should be included with the PMN. However, an MSDS can be useful to help the EPA evaluate what precautions a manufacturer will take to mitigate hazard.
Is there a required format for an MSDS?
There is no specific format for an MSDS, as long as all the required information is included. However, OSHA recommends the 16-part ANSI standard format.
Who can author an MSDS?
Anyone can prepare an MSDS. However, a correct MSDS requires chemical expertise to correctly identify the compound and understand its properties, as well as a toxicology background to properly interpret relevant data on health.
Does OSHA allow the identity of a chemical to be kept secret as part of CBI?
Yes, but the criteria are very strict.
PMN SOLUTIONS
What is a PMN?
PMN stand for PreManufacture Notice. This is one of the potential required submissions prior to manufacture or import of a non-exempt New Chemical Substance. The Manufacturer or Importer of record is required to file a PMN (or another type of notification) 90 days prior to the first domestic manufacture or import of an NCS for commercial purposes.
Who is required to file a PMN?
In most cases the PMN will be filed by the Manufacturer or Importer of record for the NCS. In certain cases, a collaborative submission may be needed. However, the signee of the submission will be considered the manufacturer or importer of record.
During what stage of product development should I file a PMN?
A PMN (or any other New Chemical regulatory submission, such as an application for exemption from full PMN reporting) would likely need to be filed before commercialization of a new product.
Do I need to file a PMN for a product undergoing Research and Development?
No. The EPA provides a Research and Development exemption (R&D Exemption) for small quantities of a substance in the R&D process. The definition of R&D activities is somewhat broadly defined and more information can be found on the EPA website. However, a reasoned evaluation by someone familiar with the R&D Exemption may be useful.
What type of data does EPA require for a PMN submission?
The PMN submission will need to include name and identity information as a well as information on domestic manufacture, processing and use of the substance. It is from these data, both identity and use, that EPA will determine if they feel there is a potential for unreasonable risk to human ehath or the environment.
How do I know if I need to file a PMN?
Any industrial chemical substance that is intended for use in the US, or in certain cases for export, is likely regulated in some way under the US EPA TSCA regulatory framework. This may mean that a PMN would be required.
How long does CERM require to prepare a PMN?
In most cases a 4 - 6 week turnaround time can be expected. However is can be affected by the complexity of the chemical and the manufacturing process.
Do I need to include an MSDS with a PMN?
No but including hazard information with a submission can be helpful In particular if there is a potential hazard that may require PPE or an exposure control to aid with mitigation.
If my chemical has a high hazard, will EPA automatically reject it?
No. EPA uses a risk based approach that combined hazard and exposure to determine potential risk. A chemical with high hazards may require additional mitigation or PPE to reduce risk, but the vast majority of chemical substances can have a successful submission.
What types of outcomes can I expect?
The best outcome for a PMN is a "drop from further review", which means tat EPA has reviews the substance and determined that there is a low potential for risk and is not suggesting regulation for the substance or requesting additional information. With this outcome, manufacture can proceed without issue after te 90 day review period expires (or shorter review for certain other types of filings). Other potential outcomes include a "Significant New Use Rule" or "Consent Order" which means that the agency may have some concerns for the substance. Additionally, they agency can place the substance under "standard review" which means that there are some additional questions/data that the agency would like before making a determination.
