With the rise of nanotechnology it is important to determine if they should be considered new chemicals. The EPA has communicated that it will determine on a case by case basis whether a nano substance will qualify as “new”.
How will EPA determine what is considered a New Substance?
Section 3(2)(A) of TSCA defines what is a chemical substance. Traditionally the definition is based on molecular identity such as the structural and composition features and number of atoms in the molecule
Things to consider is when two substances:
Have the same molecular formula but have different atom connectivities
Same molecular formulas and atom connections but have different spatial arrangements of atoms
Have same types of atoms but have different crystal lattices
Are different allotropes of the same element
Are different isotopes of the same element
Under FR 73 No. 18 Nanoscale Materials Stewardship Program January 28, 2008 will assist in
Helping the EPA gather existing data
Identify and encourage use of risk management practices in developing and commercializing nanoscale materials
Encourage development of test data needed to provide the scientific foundation for regulatory policy decision
Encourage responsible development of nanoscale materials
Program participants will include those who manufacturer, import, physically or chemically modify, use engineered nanoscale materials. Researchers who develop or study nanoscale materials may also participate.
Under section 5(h)(3) of TSCA all new chemicals to be manufactured or imported into the US must first go though a review process by he EPA. There are a few exemptions written in to law that shorten or bypass the Pre-Manufacture Notice (PMN) process. One of these exemptions is the Research and Development (R&D) exemption.
The R&D Exemption can only be used if a company manufactures or processes the substance in small quantities solely for the purpose of scientific experimentation or analysis.
A small quantities are those not greater than reasonably necessary for R&D.
There is no application to use the R&D exemption. However there are requirements regarding procedures and record keeping.
R&D substances can not be distributed to consumers and the R&D must be conducted in a laboratory using prudent laboratory practices or under the supervision of a technically qualified individual.
Those claiming an R&D exemption have the burden of proving their eligibility and should be prepared to justify the claim.
If a company wishes to distribute and R&D substance to another company then it must:
notify the company that the substance is for R&D use only,
Provide notice of any possible health or environmental risks
Establish that adequate notification is the responsibility of the manufacturer so that any new data about possible risks will be communicated to the company receiving the R&D material.
Documentation that must be kept by the manufacturer
Copies of information reviewed todetermine the need to make a notification of risk
Documentation of the nature and method of notification (labels or written notices)
Documentation of prudent lab practices
Names and addresses of any persons that the substance is distributed to
You must submit a PMN 90 days before you intend to manufacture the substance for a purpose other than research and development.
Under section 5 of TSCA all new chemicals to be manufactured or imported into the US must first go though a review process by he EPA. There are a few exemptions written in to law that shorten or bypass the Pre-Manufacture Notice (PMN) process. One of these exemptions is the Low Volume Exemption (LVE).
Originally instituted in 1985, the LVE was restricted to substances produced in quantities less than 1000 kg/year. In 1995 the volume limit was raised to 10000 kg/year.
Under the LVE, the substance will undergo a 30 day review.
More than on manufacturer or importer can hold an LVE for the same substance. If the EPA thinks that the cumulative amount of the two manufacturers/importers creates unreasonable higher risk then they can withdraw the exemption or make other arrangements with the manufacturer/importer.
LVE chemicals are not added to the TSCA inventory and should be treated as a “New Chemical” for anyone that will manufacture or import the substance.
Section 5 of TSCA says that any New Chemical or chemical subject to the Significant New Use Rules need to be evaluated by the EPA. So who exactly has to report?
Any person who intends to manufacture or import a new chemical substance into the US for commercial purposes.
If a person contracts a manufacturer to manufacture or produce a new chemical substance and specifies the identity and controls the amount produced then that person should submit a notice to the EPA.
If its unclear who should submit a notice then the EPA should be contacted to determine who the submitter should be.
When several persons are involved in the importation process then the notice should be made by the principal importer
Determining whether a chemical substance is on the Inventory
A “New Chemical” is any chemical substance that is not currently listed on the Inventory
A chemical is listed on the public portion of the Inventory by a specific chemical name and a Chemical Abstract Service (CAS) Registry Number
If a chemical is confidential then it is listed in the public portion by a TSCA Accession Number
Just because a chemical has a Chemical Abstracts Service (CAS) registry number does NOT mean that it is listed on the TSCA inventory
Requirements for submitting a PMN
As of 1/6/10 you must complete PMN forms using e-PMN Software and submit them through the Central Data Exchange or on a CD.
You can no longer submit by paper!
The PMN must be submitted at least 90 days prior to the manufacture or import of the chemical
If the PMN is not challenged within the 90 day review period then the PMN has been accepted and a Notice of Commencement of Manufacture or Import must be submitted within 30 days of the new chemical substance being manufactured or imported.
Exemptions from filing a PMN. Each one of these exemptions has its own qualifying criteria which will have to be covered in another post.
Low Volume Exemption
Research and Development
Low Releases and Low Exposures (LoREX)
Test Marketing Exemption (TME)
EPA does not review under TSCA tobacco and certain tobacco products, nuclear materials, munitions, food, food additives, drugs, cosmetics, and substances used solely as pesticides. These fall into the jurisdiction of other federal laws and should be handled accordingly.