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EPA's New Chemicals Program (NCP), which is in the Office of Pollution Prevention and Toxics (OPPT), is EPA's program for management of potential risk from chemicals new to commerce and is mandated by CFR#5 of the Toxic Substances Control Act (TSCA). Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by CFR#5 of the TSCA to provide the Environmental Protection Agency (EPA) with notice before initiating the activity.
For a substance to be included in the TSCA Chemical Substance Inventory, a pre-manufacture notice, (PMN) must be submitted at least 90 days prior to the activity. Some commercial uses, as well, can be made of substances not on the Inventory, and several of them require exemption requests to the Agency (low volume exemption, LVE, low release and low exposure exemption, LoREX,test marketing exemption, TME. No prior request need be made if the substance is a polymer which meets certain requirements or if it is to be used for research and development. Drop-status reports on PMNs currently under review by the Agency are available through this document.
The TSCA, enacted by Congress in 1976, gives EPA broad authority to identify and control substances that may pose a threat to human health or the environment. The New Chemicals Program functions as a gatekeeper which can identify conditions to be placed on the use of a new chemical before it is entered into commerce; alternatively, it can in some conditions entirely prohibit new chemicals from entry into commerce; it takes these actions based on its estimation of the unreasonableness of risk.
The New Chemicals Program functions as a "gatekeeper" which can identify conditions, up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce. Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by Section 5 of TSCA to provide EPA with notice before initiating the activity. This premanufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical.
For more information: The Toxic Substances Control Act Hotline ([email protected]) is available to answer general questions about the PMN process or filing a PMN form. The TSCA hotline operates Monday through Friday, from 8:30 a.m. to 5:00 p.m. Eastern time. Call (202) 554-1404. FAX requests for documents are received every day, at all times, on (202) 554-5603.
Why does EPA regulate a new chemical and not a similar chemical already on the market? This issue is sometimes referred to as a "new chemical bias." Generally, it is a question of the standard EPA must meet before it can take a regulatory action. Before 1976, there was no comprehensive chemical law like TSCA to require the review of new chemicals. Under TSCA, industrial chemicals in commerce in 1975-1977 were "grandfathered" into the Inventory without considering whether the chemicals were hazardous. Once on the Inventory, a substance is considered an "existing" chemical and for EPA to control its use, a legal finding has to be made that the chemical will present an unreasonable risk to human health or the environment. This is a standard which requires EPA to have conclusive data on that particular chemical. By comparison, newly introduced chemicals can be regulated under TSCA based on whether they may present an unreasonable risk and this finding of risk can be based on data for structurally similar chemicals.
This difference can result in situations in which existing chemicals (often of similar or greater toxicity) might not be controlled whereas the Agency would act to control a similar new chemicals under the PMN program. EPA continues to work to lessen this apparent inequity between its regulation of new and existing chemicals. This lack of controls on the older chemicals may cause a misunderstanding that, because there are fewer (or no) requirements, they are considered safer than the new, regulated chemicals.
EPA deals with the concerns raised by existing chemicals through seeking testing which can enable management of the concerns (this work is discussed more fully at the home pages of the Chemical Information and Testing Branch, (CITB) and the Existing Chemical Program). CITB estimates that, of the 70,000 chemical substances on the Inventory, approximately 15,000 are in commerce at this time. In its Existing Chemical Program, EPA screens and selects from among the 15,000 chemicals in commerce those which appear to be of greatest concern to human health and the environment. The Agency then uses a variety of approaches to reduce risks from chemicals that appear to pose problems. Besides the possibility of rules promulgated under CFR#6 of the TSCA, these approaches include voluntary agreements, alone or in combination with regulatory approaches; regional, federal, state and local partnerships; dissemination of risk management information to assist the selection of safer substitutes; emphasis on pollution prevention and innovative control technology to reduce exposure and environmental release; use of chemical emission data from the Toxics Release Inventory (TRI) to help address site-specific chemical concerns; refined risk assessment and cost/benefit analysis; and the challenge to industry to meet its own Product Stewardship and Responsible Care goals.
A current voluntary mechanism EPA, with industry partners, is using to respond to concerns on proper balance in its regulation of new and existing chemicals is the Environmental Technology Initiative for Chemicals (ETI), more fully described in its own page. ETI seeks to reduce barriers to innovation in the development of new chemicals by extending new chemical protections to analogous existing chemicals. This effort depends on agreements, entered into as partnerships/MOU with concerned industry. It can take note of innovative control technology, benefits conferred by the chemicals, and/or industry agreement to extend some protection to all members of a class in acceptance of PMN for a new member of that class.
The TSCA Inventory is available in paper form as well as on computer tape, diskettes, or CD-ROM. The TSCA Inventory in paper form was updated in 1990 and does not reflect additions to the Inventory since then. The electronic-medium Inventories are updated every six months. EPA does not provide searches of the non-confidential TSCA Inventory, but there are a number of ways you can research whether a chemical is listed on the non-confidential portion of the TSCA Inventory:
A copy of the TSCA Inventory can be purchased from the Government Printing Office (GPO) or the National Technical Information Service (NTIS):
Many public libraries and company libraries have copies of the TSCA Inventory. In addition, the Inventory is available at federal depository libraries. To find the closest federal depository library, call your local library or look in the Directory of U.S. Government Depository Libraries. Assistance in determining whether a chemical substance is on the TSCA Inventory is available on a fee basis from at least two organizations: the Chemical Abstracts Service (CAS) and Dialog. To request assistance, phone CAS at (800) 848-6538 or Dialog at (800) 334-2564. Other companies may offer similar services in the future; contact the TSCA Assistance Information Service or at (voice) 202-554-1404, (fax) 202-554-5603 for an up-to-date list. GPO: (202) 512-1800: 1985 TSCA Inventory (paper form) Order # 055-000-00254-1 Price $161.00 Canada, USA, Mexico
Rest of World $201.25; 1990 Supplement (paper form) Order # 055-000-00361-1 Price $24.00 Canada, USA, Mexico Rest of World $30.00 or through the GPO Web site: http://www.access.gpo.gov -- click "information for sale" -- search Toxic Substances Control Act, TSCA.
NTIS: (703) 487-4650 TSCA Inventory: searchable CD-ROM database, includes also SARA Title III data order number is PB96-502596HDY. Price: $140.00 Canada, US, Mexico
$280.00 Rest of World. NTIS also sells the TSCA Inventory only on personal computer diskettes: price is $140.00 Canada, US, Mexico, $280.00 Rest of World and on 9-track magnetic computer tape: Order # PB95503108 Price $360.00 (January 1995) or through the NTIS Web site: http://www.ntis.gov/index.html
Cornell University has posted an extract of the Public Inventory at www.pdc.cornell.edu/issearch/tscasrch.htm for Cornell Unversity users. Though the University's posting does not have the standing of the Inventory made available by government providers, it can be useful.
The identity of an existing chemical that has been claimed as confidential business information will not be listed on the public portion of the TSCA Inventory. In these cases, EPA will search the confidential portion of the TSCA Inventory for you if you demonstrate, in writing, a bona fide intent to manufacture or import the chemical substance.
For more information about submitting a Notice of Bona Fide Intent to Manufacture or Import (bona fide) inquiry, see 40 CFR CFR#720.25 or contact the TSCA Assistance Information Service.
In some cases, a manufacturer will want to use reactants whose identities are held confidential by their suppliers from the manufacturer. In certain other cases, a potential importer wants to bring into the US a substance whose identity is known only to its foreign manufacturer. In these cases a letter of support from the domestic manufacturer or foreign reactant manufacturer sent directly to EPA, giving complete chemical identity, health and safety information, etc., can be used for CFR#5 notification.
A new chemical is eligible for addition to the TSCA Inventory after the PMN review has been completed. The company that submitted the PMN must provide a Notice of Commencement of Manufacture or Import (NOC) (EPA Form 7710-56) to EPA within 30 days of the date the substance is first manufactured or imported for nonexempt commercial purposes. After a NOC is reviewed, the chemical will be listed. Once a substance is listed on the TSCA Inventory, it is considered an existing chemical.
In considering use of an existing chemical, a user will need to determine whether the substance is subject to other rules under the TSCA. For this, consult the Chemicals on Reporting Rules Database (CORR), available as an electronic database from the TSCA Hot Line. New rules which control use of a substance will be notified in the Federal ReA new chemical is eligible for addition to the TSCA Inventory after the PMN review has been completed. The company that submitted the PMN must provide a Notice of Commencement of Manufacture or Import (NOC) (EPA Form 7710-56) to EPA within 30 days of the date the substance is first manufactured or imported for nonexempt commercial purposes. After a NOC is reviewed, the chemical will be listed. Once a substance is listed on the TSCA Inventory, it is considered an existing chemical.
In considering use of an existing chemical, a user will need to determine whether the substance is subject to other rules under the TSCA. For this, consult the Chemicals on Reporting Rules Database (CORR), available as an electronic database from the TSCA Hot Line. New rules which control use of a substance will be notified in the Federal Register.gister.
Risk managers within the Agency assess whether potential risks associated with exposure to a new chemical are reasonable in light of the expected benefits of use of the chemical (unreasonable risk), and whether and how any potential risk can be controlled. Agency risk managers are provided with an estimate of potential risk by EPA toxicologists, chemists, biochemists, engineers, and experts in other disciplines who work together to predict the potential risks to humans or the environment from each new substance. In doing so, they draw on information and data submitted with the PMN form, other information available to the agency, and exposure and release modeling. Risk is predicted as a function of hazardousness of the substance and expected exposure to it:
Hazard x Exposure = Risk
There is no defined base data set required before PMN, and the TSCA does not require prior testing of new chemicals. Consequently, less than half of the PMNs submitted include toxicological data. In these cases, OPPT scientists assess the chemical's structural similarity to chemicals for which data are available - called structure-activity relationship (SAR)- to help predict toxicity. When information available to the New Chemicals Program is not adequate to make predictions of toxicity, data will be required as part of PMN. The New Chemicals Program has issued a document called Chemical Categories which describes information often sought for chemicals of frequently-submitted types, and which can be useful to intending submitters in planning appropriate information to submit.
One outcome of the PMN review is the negotiation of a section 5(e) consent order, which allows the PMN submitter to manufacture or import the new substance under specified conditions (e.g., use of worker protective equipment or release controls). EPA may develop a consent order based on a finding of potential unreasonable risk or substantial exposure. A section 5(e) consent order is not binding, however, on other companies that may manufacture or import the substance. Consequently, after signing a section 5(e) consent order, EPA generally promulgates a significant new use rule(SNUR).
By assessing new chemical substances before they are manufactured or imported, the New Chemicals Program is actively carrying out EPA's strategy to prevent pollution before it can occur. The program also supports development of safer chemical substances by minimizing or eliminating regulatory burdens on new chemicals if they will replace riskier substances already in the marketplace.
The New Chemicals Program strongly encourages industry efforts to prevent pollution. One of the ways this is accomplished is through the PMN form - Part 1, Part 2, which requests industry to voluntarily provide information about the pollution prevention attributes of the new chemical and about steps taken to reduce exposures to or releases of chemical substances. During the PMN review, EPA carefully considers this information in evaluating potential risks and benefits. A guidance document on how to report pollution prevention activities is included as an attachement to the PMN form is included as an attachment to the Premanufacture Notice (PMN) Instruction Manual. The New Chemicals Program has an initiative to recognize new substances which will allow pollution prevention (P2, and makes awards yearly for useful innovations.
As with all the exemptions to full PMN reporting, the low release and low exposure (LoREX) chemicals exemption was designed to support EPA's overall pollution prevention strategy. The LoREX exemption, because it is available only for materials whose exposure is controlled at very low levels, encourages companies to develop manufacturing, processing, use, and disposal techniques which minimize exposures to workers, consumers, the general public, and the environment.
Since 1979, EPA's New Chemicals Program has reviewed almost 30,000 new chemical substances. This figure includes nearly 22,000 PMNs that have undergone full review and approximately 5,500 low-volume, test-market and polymer exemptions. In that time, the agency has taken action to prevention potential risks to people and the environment from nearly 2,700 new substances.
New Chemicals Program Activities Through December 31, 1996
Type of Submission Number Submitted Time Period Premanufacturing Notices 24,545 7/1/79-12/31/96 Test Marketing Exemption Applications 822 7/1/79-12/31/96 Low-volume exemptions 3,528 6/10/85-12/31/96 Polymer exemptions* 2,124 1/4/85-12/31/96 Total............27,125
Regulatory Action Number Issued Section 5(e) orders 738 SNURS 589 Section 5(f) actions 4 PPMNs withdrawn in face of action 944 Voluntary testing actions 871 Total cases regulated** 3,046
* Since 5/30/95 individual reporting for exempt polymers has not been required, reporting is now on a yearly basis on 1/31 of the following year.
** Total does not include order-related SNURs, as these are already counted under Section 5(e) orders.
New Chemicals Program
EPA'S POLICY REGARDING NOTICES DECLARED INCOMPLETE
DUE TO CHEMICAL IDENTITY/NOMENCLATURE ERRORS
In its promulgation of the PMN rule amendments in 1995, EPA discussed its approach to dealing with chemical nomenclature issues in PMN submissions, and stated its intention to return notices declared incomplete by EPA as provided in 40 CFR section 720.65(c)(1) due to failure to meet the nomenclature requirements found at 40 CFR section 720.45(a). In reviewing statistics gathered since the PMN rule amendments were published, the Agency found that 30% of all section 5 notices submitted to EPA were declared incomplete due to chemical identity/nomenclature errors.
This information was conveyed by EPA officials to PMN submitters for the last two years at CMA/SOCMA meetings and through newsletters, and more recently, in letters to submitters who made these type of errors in their submissions.
Since the rate remained unchanged, EPA decided the situation was unacceptable; therefore, it implemented a policy of rejecting all notices that contain chemical identity/nomenclature errors and returning them to submitters for resubmittal. The Agency will no longer help submitters complete their notices except in cases where the procedures outlined in the PMN rule amendments have been followed. We recommend that submitters consider how to avoid such errors in the future so as not to suffer delays in subsequent submissions.
In recognizing that some companies would need some help as they adapted to this change, training seminars were conducted by Agency chemists in two locations, Newark, N.J. and Washington, D.C., to help companies improve their ability to submit notices which satisfy chemical identity/nomenclature requirements. A third such seminar is being considered for March/April 1998 in the Washington/Baltimore area.
Material presented at these seminars can be found below. It does not yet include the chemical structures the chemists used as graphic examples for helping submitters when filling out certain PMN pages; however, handouts used in these sessions, including these graphics, can be obtained from the TSCA Hotline at 202-554-1404.
In cases where problems arise that have policy implications, please contact Anna Coutlakis at 202-260-3592. .