Supplier notification requirements

Because manufacturers reporting under section 313 must know the toxic chemical composition of the products they use to be able to accurately calculate releases, EPA requires some suppliers of mixtures ortrade name products containing one or more of the listed section 313 chemicals to notify their customers. This requirement has been in effect since January 1, 1989. 

This appendix explains which suppliers must notify their customers, who must be notified, what form the notice must take, and when it must be sent. 

An example would be if you sold a lacquer containing toluene to distributors who then sell the product to other manufacturers. The distributors are not in SIC codes 20-39, but because they sell the product to companies in SIC codes 20-39, they must be notified so that they may pass the notice along to their customers, as required. 

The language of the supplier notification requirements covers mixtures or trade name products that are sold or otherwise distributed. The otherwise distributes language applies to intra-company transfers. However, if the company has developed an internal communications procedure that alerts their other facilities to the presence and content of covered toxic chemicals in their products, then EPA would accept this. 

You are covered by the section 313 supplier notification Supplier notification is also required if a waste mixture contain- 

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Supplier Notification. In 1989 and subsequent years, suppliers of facilities in SIC codes 20-39 are required to develop and distribute a notice if the mixtures or trade name products that they manufacture or process, and subsequently distribute, contain listed toxic chemicals. These notices are distributed to other companies in SIC codes 20-39 or to companies that sell the product to facilities in SIC codes 20-39. tf a Material Safety Data Sheet (MSDS) is not required for the mixture or trade name product, the notification must be in written form (i.e., letter or attachment to a MSDS). Otherwise, the notice must be incorporated into or attached to the MSDS for that product. The supplier notification requirement began with the first shipment of a product in 1989 and must accompany the first shipment each year thereafter. In addition, a new or revised notice must be sent if a change occurs in the product which affects the weight percent of a listed chemical or if it is discovered that a previous notice did not property identify the chemicals or the percentage by weight. For more information on supplier notification, see Appendix E. 

Manufacturing qualifiers. Two of the entries to the section 313 chemical list contain a qualifier relating to manufacture. For isopropyl alcohol, the qualifier is "manufacturing-strong acid process. For saccharin, the qualifier simply is "manufacturing." For isopropyl alcohol, the qualifier means that only facilities which manufacture isopropyl alcohol by the strong acid process are required to report. In the case of saccharin, only manufacturers of the chemical are subject to the reporting requirements. A facility that processes or otherwise uses either chemical would not be required to report for those chemicals. In both cases, supplier notification does not apply because only manufacturers, not users, of the toxic chemical must report. 

Solutions. Two substances on the list, ammonium nitrate and ammonium sulfate, are qualified by the term solution," which refers to the physical state of these chemicals. Solid, molten, and pelletized forms of these chemicals are exempt from threshold and release determinations. Only facilities that manufacture, process, or otherwise use these chemicals in the form of a solution are required to report. Supplier notification applies only if the chemical is distributed as a solution. 

Note that you may be covered by the supplier notification rules even If you are not covered by the section 313 release reporting requirements. For example, even if you have less than 10 full-time employees or do not manufacture or process any of the chemicals in sufficient quantities to trigger the release reporting requirements, you may still be required to notify certain customers. 

Supplier notification is not required for a pure toxic chemical unless a trade name is used. The identity of the toxic chemical will be known based on label information. 

Supplier notification is also required if a waste mixture containing a toxic chemical is sold to a recycling or recovery facility. However, if the material is sent off-site as a waste for treatment or disposal, then no supplier notification is required. 

If listed toxic chemicals are present equal to or above the de minimis cut-off level, your supplier must identify the specific components as they appear in Table II and provide their percentage composition by weight in the mixture or product, tf your supplier maintains that the identity ot a toxic chemical is a trade secret, a generic identity that is structurally descriptive must be supplied on the notice. A maximum concentration level must be provided if your supplier contends that chemical composition information is a trade secret. In either case, you do not need to make a trade secret claim on behalf of your supplier (unless you consider your use of the proprietary mixture a trade secret). On Form R, identify the toxic chemical you are reporting according to its generic name provided in the notification. (See the instructions for Part III, Section 2 on page 18 for more information.) tf the listed chemical is present below the de minimis level, no notification is required. 

For each mixture ortrade name product that contains a listed toxic chemical, you will have to notify all customers in SIC codes 20-39 or distributors who in turn sell that product to firms in SIC codes 20-39. Unless you know othenvise, you should assume that the chain of distribution includes facilities in SIC codes 20-39. (The notification is limited to SIC 20-39 facilities and their suppliers because only facilities in those SIC codes are required to report releases under section 313.)... 

The standard requires the supplier to provide for the disposition of nonconforming product and for notification to the functions concerned. 

Priority substances were selected, which are considered to be of particular concern to human health and/or the environment. The suppliers of these priority substances had to provide any missing studies to complete a EU notification Base Set (Table 1). A rapporteur Competent Authority evaluates the full review dossier on behalf of the EU. The final output is a risk assessment (see Section 14), with final recommendations on how to deal with the substance i.e., it may be of no concern, require risk reduction or restriction, or further data may be needed before a decision is made. 

For FCNs, specifications serve to ensure that the substance marketed by the manufacturer/supplier identified in the notification is the same as that subjected to the safety evaluation when the FCN became effective. Several specifications may be given in an FCN. Specifications are applicable only to the manufacturer/supplier identified in the FCN and are well known to them. Thus, they are generally not included in FCN letters. As noted above, the notifier is held to the specifications and use conditions identified in the FCN. Accordingly, changes in the manufacturing process that result in new impurity profiles may require communication with the FDA and, if warranted, new FCN submissions. 

A PMN must be made to the H A, under Section 5 of TSCA, 90 d before a new chemical substance is manufactured or imported into the USA. A new substance is one not on the Chemical Substances Inventory, which is the list of existing and previously-notified substances. A notification is also required for a new use of a listed substance which is subject to a Significant New Use Rule (SNUR). Notified substances are listed in the TSCA inventory only afto- being supplied and the mandatory Notice of Commencement of Manufacture or Import is filed with the EPA. Notified substances can be placed in the confidential section of the TSCA inventory, on justified request. Howev, potential suppliers can establish from the EPA whether the substance of concern is listed and hence is not notifiable by filing a bona fide intent to manufacture or import... 

Confidentiality comes up in three very distinct ways in complying with the export notice rules. In some instances, the exporter will not know the composition of the materials to be exported because the supplier has claimed the composition as confidential. In those cases the exporter will need to obtain a certification from the suppHer saying whether export notifications are required. 

In the event of a significant change to the health hazard information on the SDS, the supplier is responsible for ensuring that the downstream users are aware that the updated SDS is available. Some positive means of contact, such as a letter or e-mail notification, stating that the SDS has been changed and the updated version is available would be required. 

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