TSCA Premanufacture Notices Filing Information - Fees, Filing and Other PNM Information

TSCA Premanufacture Notices Filing Information - Fees, Filing and Other PNM Information

What information must be submitted about new chemical substances?

PMN submissions require all available data on chemical identity, production volume, byproducts, use, environmental release, disposal practices, and human exposure. If the identity of some reactants for substance synthesis, or of the substance itself is unknown to the manufacturer, a letter of support can be used to enable the Agency to have full identity information.

Submissions must be made on EPA form 7710-25 - Part 1, Part 2. A graphic of the form, with annotations, has been developed for its internal use by the 3M Company, and a copy is available here. EPA also requires that the following information be submitted with the PMN: all existing health and environmental data in the possession of the submitter, parent company, or affiliates, and a description of any existing data known to or reasonably ascertainable by the submitter. Information frequently requested by the New Chemicals Program for chemicals of commonly submitted types is identified in the Chemical Categories document. All of this information is considered by Agency risk assessors to determine whether the likely risk is unreasonable.

The Program can require submission of any additional data, including development of data through testing, when the information included with the PMN, coupled with that available to its risk reviewers from internal archivesl is not adequate to clarify for them whether the likely risk is unreasonable. The Instruction Manual for Premanufacture Notification of New Chemical Substances explains all reporting requirements. When you request a PMN form, the instruction manual is included. Both are available from the TSCA Assistance Information Service. A document is available on how to avoid incomplete PMNs. A chemistry assistance manual has also been written by Agency personnel, it is available in several forms:

• The Manual has been published in hardcover by John Wiley and Sons as Premanufacture Notification: Chemistry Assistance for Submitters by Steven C. DeVito and Carol A. Farris (ISBN: 0-471-19151-5). It can be ordered through 1-800-225-5945 at a price of $45.00.
• Photocopies of the Manual are available from the TSCA Hot Line under the title: Chemistry Assistance for Premanufacture Notification Submitters
• The manual can also be obtained from the Internet through the TSCA Hotline.

Note to submitters: if, during the CFR#5 notice review period, you receive or become aware of the existence of reasonably ascertainable test data or other information, which adds to or makes more complete the determination of the potential unreasonableness of risk, you are obliged to send that information to the address shown on the CFR#5 notice form within ten days of its receipt, but not later than five days before the end of the review period. If such information becomes available within five days of the end of the review period, you must inform your EPA contact by telephone.

This obligation is described at 40 CFR CFR#720.40(f), and includes additional toxicological information, details on manufacture, processing, use, and disposal; likely worker exposures and environmental releases; and facts on innovations and improvements in product chemistry and safety practices.

What is the fee for submitting a PMN?

The fee for most PMN submissions is $2,500.00. The fee is reduced under certain conditions: (1) if your company qualifies as a small business (sales, including those of subsidiary/parent companies, are less than $40 million/year), the fee is $100.00; (2) if a PMN for an intermediate substance is submitted with a final product PMN, the fee for the intermediate substance is $1,000.00; and (3) if a consolidated PMN, as approved by a prenotice coordinator, is filed for multiple chemicals (no more than 6) that are related, the total fee is $2,500, except that for a small business it is $100.00.

When several product PMNs have been consolidated, the Agency will consider consolidation for intermediates used in their syntheses where those intermediates are used at parallel stages in their syntheses.

For information about PMN fees see 40 CFR CFR#700, or contact the TSCA Assistance Information Service.

How does EPA handle proprietary information submitted in a PMN?

Under section 14 of TSCA, EPA is required to protect from disclosure confidential business information (CBI) that is explicitly claimed by a submitter. Substantiation of a CBI claim is not required at the time a submission is made.

Substantiation of CBI claims for chemical identity is required when a Notice of Commencement of Manufacture or Import is submitted. OPPT reviews such CBI claims to determine whether they meet the legal definition of CBI. If the answer to any of the following questions is "no," a submission probably will NOT meet the legal definition of CBI when reviewed by OPPT.

• Is the information that is claimed as confidential known only to the company that is making the CBI claim?
• Has the company made reasonable efforts to ensure that the information is and will remain confidential?
• Is the information obtainable only from the submitter?
• Is disclosure of the information likely to cause substantial harm to the company's competitive position?

How are you notified of the outcome of the PMN review?

When EPA receives your PMN form, you will be sent an acknowledgement letter that includes the PMN number assigned to your submission and the date the PMN review began. If the agency has any concerns about the substances, you will be notified before the end of the review period. Otherwise, you will receive no subsequent notification, and you are free to manufacture or import the substance the day after the review period ends.

Many submitters want to know what is happening for their substances at intermediate points in the review process. As noted in the process description, a tentative decision to drop consideration for a substance can be made well before the end of the review period. Current status reports on notices submitted to EPA under CFR#5 are posted to this home page within 14 days of the decision being made. You can access a report directly or you can contact the TSCA Hot Line on (voice) 202-554-1404, (fax) 554-5603 and they will access this status page for you. Please note that even though a "drop" decision may already have been made early in the review period, under TSCA that decision remains tentative until the review period ends, and you may not manufacture before the that period (the length of which is set by statute) has expired.

The company that submitted the PMN must provide a Notice of Commencement of Manufacture or Import (EPA Form 7710-56) to EPA within 30 days of the date the substance is first manufactured or imported for nonexempt commercial purposes.

What are the possible outcomes of PMN review?

Possible Outcomes of PMN Review Include Consent Orders and SNURs, Injunctions under CFR#5(f) Almost 90 percent of the PMNs submitted to the program complete the review process without being restricted or regulated in any way. However, if the agency determines that a new chemical substance may pose a risk to health or the environment, or that there will be substantial exposure to humans or the environment, and that toxicological information is insufficient, CFR#5(e) of the TSCA allows EPA to (1) enter into a consent order permitting the PMN submitter to manufacture or import the new substance under specified conditions expected to mitigate exposure while information is being developed or permit the PMN submitter to suspend the review period while developing additional test data or (2) to issue a significant new use rule (SNUR) which limits the ability of individuals to initiate a new use of a chemical without Agency review. There are 2 types of CFR#5(e) consent orders - risk-based and exposure based:

1. Risk-based: a risk-based order is issued if the Agency determines that a new chemical substance may pose a risk to health or the environment, and that toxicological information is insufficient.
2. Exposure-based: in the absence of a risk finding and sufficient toxicological data and faced with the potential for substantial human or environmental exposure-- CFR#5(e) of the TSCA allows EPA to enter into a consent order to collect data that will better characterize the substance's toxicity and risk or which can allow manufacture or import under specified conditions until the information is submitted.
   
   Generally, a consent order will be followed by a Significant New Use Rule (SNUR) controlling the PMN-identified use of the new chemical substance by others than the submitter, and/or controlling initiation by anyone of other uses than those identified by the submitter.
   
   In cases where the agency determines that a new substance will present an unreasonable risk, section 5(f) of the TSCA allows EPA to issue an injunction to prohibit the manufacture, processing, or distribution in commerce of the substance.