Bona fide letters

Id. at 1-21-1-22, question 102-7. See the discussion of bona fide letters in this chapter. 

Bona Fide Letters to Determine a Confidential Manufacturing Limit 399... 

To make SNURs such as the one appUcable to octanoic acid, hydrazide even more difficult to interpret, the procedure describing the bona fide letter is in another SNUR instead of one of the subparts of the SNUR regulations that have general applicability. The reference in the octanoic acid, hydrazide SNUR to determining if a use of the substance is a significant new use by following the provisions of 40 C.F.R. 721.1725(b)(1) is in fact a reference to the bona fide letter procedure set out in the SNUR for benzoic acid, 3,3 -methylenebis [6 amino-, di-2-propenyl ester]. ... 

The procedure described in 721.1725(b)(1) states that a bona fide letter to determine whether a proposed use is a significant new use must include all of the information required for a bona fide letter to determine if a substance is subject to a SNUR. These requirements include the chemical identity of the substance, a description of the research and development activities that have been conducted to date, the piupose for which the submitter intends to... 

If the ERA concludes that the submitter of the bona fide letter does have a bona fide intent to manufacture, import, or process the substance, the ERA will tell the submitter if its proposed use is subject to a SNUR. If the proposed use is not subject to a SNUR, the ERA will tell the submitter what uses are significant new uses." Notwithstanding ERA s statement in the cross-referenced SNUR that it will inform the submitter of a bona fide letter of the significant new uses, the ERA has said otherwise in at least one SNUR preamble. 

In that preamble, the ERA said that it will only reveal whether the intended manufacturing volume that the submitter of a bona fide letter says it intends to make is more or less than the confidential volume that qualifies the manufacture as a significant new use. If the submitter s volume is less, the ERA will not reveal the trigger volume. In that case the submitter must submit another bona fide letter if it later intends to increase its manufacturing volume. The practical implication is that a submitter should give the ERA the maximum potential volume it may make in the initial bona fide letter, or it will risk having to make a series of bona fide requests. 

The principal importer is the person who specifies the product and the amount to be imported, although the principal importer may not know the chemical identity of the product. If the foreign supplier does not reveal the identity of the substance to the importer, the foreign supplier can tell the ERA directly and provide information for a bona fide letter, and preserve its trade secrets. A principal importer must know that the product will be imported instead of produced domestically. If no one company meets all these criteria the importer should contact the ERA s Rrenotice Coordinator to determine who should file the SNUN. ... 

One of the two nanoparticles that was the subject of the November 2008 SNUR is a siloxane modified silica nanoparticle, and the other is a siloxane modified alumina nanoparticle. EPA explained in the SNUR that it was concerned about dermal and inhalation exposures for new uses that were not described in the PMNs filed for those substances. It suggested that a ninety-day inhalation toxicity test would help characterize the human health effects for each substance. The SNURs for these two substances say that it would be a significant new use to use either substance without specified personal protective equipment, for any use other than the uses specified in the PMNs for those substances, and to manufacture, process or use them in powder form. The preamble to the SNUR says that the PMNs do not claim confidentiality for use of these substances as additives, but the PMN for one of these substance clearly limits the kind of additive for which it was intended, but everything except the word additive is claimed as confidential. Therefore, any other entity that intends to manufacture, import, or process any nanoparticles described by the generic names for these substances should submit a bona fide letter to determine their exact chemical compositions and the specifics of what uses are significant new uses. 

Model Bona Fide Request for Inventory Listing Procedure Bona Fide Letter... 

Step 3. The MRC shaU search the publicly available TSCA Inventory and determine if the chemical substance is listed. If the substance is not on the publicly available TSCA Inventory, the MRC shall determine based on the chemistry of the substance and the generic chemical names on the confidential Inventory whether it is possible that the substance is on the confidential Inventory. If it may be on the confidential Inventory, the MRC shall confer with the requester and decide if it is appropriate to submit a bona fide letter to request confirmation from the EPA about the Inventory status of the substance. 

L. Gammaitoni, F. Marchesoni, and S. Santucci. Stochastic resonance as a Bona Fide resonance. Physical Review Letters, 74(7) 1052, 2 1995. 

At the time the Inventory Status of Nanoscale Substances was written, there were no nomenclature conventions for some nanoscale substances, carbon nanotubes in particular. The EPA said it will assist PMN filers in describing their substances until a nomenclature convention is estabhshed. It will also respond to letters requesting the Inventory status of chemicals that the suhmitter has a bona fide intent to make or import, so long as these letters comply with the requirements set out in 40 C.F.R. 720.25. ... 

Id. at 6. For a discussion of the requirements for submitting a letter stating a bona fide intent to manufacture or import a substance, see Chapter 3, The Inventory. 

To establish the bona fide intent, the potential manufacturer or importer must supply the following information to the EPA in a submittal usually referred to as a bona fide notice or letter ... 

If an importer cannot provide the chemical identity information because the identity is claimed as confidential, it can request that the foreign supplier send the information directly to EPA, referencing the importer s notice. If the information is not received within thirty days after receipt of the importer s notice, EPA will consider the bona fide notice incomplete. If the chemical substance is manufactured with a reactant that has a specific chemical identity claimed as confidential by the suppHer, the manufacturer must provide the best chemical identity information it has and must have the suppHer of the chemical reactant provide directly to EPA a letter of support with the specific chemical identity of the reactant, referencing the manufactmer s notice. If the information is not received within thirty days after receipt of the importer s notice, EPA will consider the bona fide notice incomplete. ... 

If a manufacturer, importer, or processor plans on handling a chemical that is in one of the generic categories hsted in the SNUR regulations, it may ask the EPA whether the chemical is subject to a SNUR. The manufacturer, importer, or processor has to submit a request detailing its bona fide intent to manufacture, import, or process the substance, and this is commonly referred to as a bona fide request or letter. The EPA only has to respond if it concludes that the submitter actuaUy has a bona fide intent to make, import, or process the chemical for a commercial purpose. Because of confidentiality concerns, the EPA will not respond to requests under the Freedom of Information Act. ... 

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