{"id":7653,"date":"2009-02-21T00:00:00","date_gmt":"2009-02-21T05:00:00","guid":{"rendered":"http:\/\/www.farmchemicalsinternational.com\/2009\/02\/21\/toxic-substances-control-act\/"},"modified":"2019-09-16T13:47:31","modified_gmt":"2019-09-16T17:47:31","slug":"toxic-substances-control-act","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/industry-news\/toxic-substances-control-act\/","title":{"rendered":"Lei de Controle de Subst\u00e2ncias T\u00f3xicas"},"content":{"rendered":"<p>The <a target=\"_blank\" href=\"http:\/\/www.epa.gov\/lawsregs\/laws\/tsca.html\" rel=\"noopener noreferrer\">Toxic Substances Control Act <\/a>(TSCA) was enacted in 1976 to:<\/p>\n<ul>\n<li>Ensure that adequate data are developed on the effects of chemical substances on health and the environment;<\/li>\n<li>Regulate the production, distribution, use, and disposal of those chemicals deemed to present an unreasonable risk of injury to health or the environment; and,<\/li>\n<li>Provide authority to EPA to take action on those chemicals which present an &#8220;imminent hazard.&#8221;<\/li>\n<\/ul>\n<p>The regulations promulgated to implement TSCA are found in 40 CFR 700-799, and are administered by the <a target=\"_blank\" href=\"http:\/\/www.epa.gov\/oppts\/\" rel=\"noopener noreferrer\">Office of Toxic Substances<\/a> (OTS).<\/p>\n<p>Pesticides are specifically excluded from TSCA&#8217;s definition of a chemical substance, when manufactured, processed, or distributed <strong>as a pesticide<\/strong>. EPA generally considers a product to be a pesticide once it requires a Federal Insecticide, <a target=\"_blank\" href=\"http:\/\/www.epa.gov\/regulations\/laws\/fifra.html\" rel=\"noopener noreferrer\">Fungicide and Rodenticide Act<\/a> (FIFRA) Section 5 Experimental Use Permit. It is important to note that inerts and raw materials are not considered pesticides until they become part of a pesticide product. Intermediates used in the manufacture of a pesticide are not excluded from regulation under TSCA, unless they are pesticides themselves and are being used in a mixture for their pesticidal properties, or are not isolated during the manufacturing process.<\/p>\n<p>While pesticides are exempted from TSCA, fertilizers and other substances used in the growing of crops are <strong>not<\/strong> exempted. Thus, any chemical to be used for such purposes must be listed on the TSCA Inventory.<\/p>\n<p>As mentioned above, a product becomes a pesticide once it has received an Experimental Use Permit. This interpretation means that chemicals that are being tested in the laboratory or in small field trials are regulated by TSCA. However, current OTS policy is to exempt such activities from submission of risk information, notification, and recordkeeping, provided the requirements in 40 CFR 720.36 are met.<\/p>\n<p>Under Section 8(b) of TSCA, EPA is responsible for compiling and publishing an Inventory of Existing Chemical Substances. No one may manufacture or import a &#8220;new&#8221; chemical (i.e., one which is not included on the Inventory) unless a Premanufacture Notification (PMN) is submitted to EPA at least 90 days before manufacture or import commences. During this 90-day period, EPA will review data on the chemical to determine whether specific requirements must be established for its handling, use, or disposal. If EPA does not take any specific action with regard to the chemical by the end of the review period, manufacture or import may begin. A <a target=\"_blank\" href=\"http:\/\/www.epa.gov\/opptintr\/newchems\/pubs\/filenoc.htm\" rel=\"noopener noreferrer\">Notice of Commencement of Manufacture or Import<\/a> (NOC) <strong>must<\/strong> be filed with EPA no later than 30 days after either occurs. When the NOC is received, the chemical is added to the Inventory.<\/p>\n<p>As part of its premanufacture review, EPA can, under Section 5(e), require the submitter to develop data to ascertain hazards which the &#8220;new&#8221; chemical may pose, and\/or can impose controls or restrictions on its use. These requirements apply only to the company which submitted the PMN. Once a chemical is added to the Inventory, anyone may manufacture or use it without notifying EPA, and without the same restrictions or controls.<\/p>\n<p>However, EPA can use its authority under Section 5(a) of TSCA to issue <a target=\"_blank\" href=\"http:\/\/www.epa.gov\/opptintr\/newchems\/pubs\/cnosnurs.htm\" rel=\"noopener noreferrer\">Significant New Use Rules <\/a>(SNURs) which extend the limitations in Section 5(e) orders to other manufacturers, importers, and processors. This ensures that everyone is treated in essentially the same manner, and that the original PMN submitter is not put at a disadvantage compared to subsequent manufacturers, importers, and processors.<\/p>\n<p>These SNURs are framed so that noncompliance with the control measures or other restrictions in the Section 5(e) consent orders is defined as a &#8220;significant new use.&#8221; Thus, other manufacturers, importers, and processors of the substances must either observe the SNUR restrictions or submit a <a target=\"_blank\" href=\"http:\/\/www.epa.gov\/oppt\/newchems\/pubs\/snun.htm\" rel=\"noopener noreferrer\">Significant New Use Notice <\/a>(SNUN) to EPA at least 90 days before initiating activities that deviate from these restrictions. As in the case of PMNs, no activity may commence before the review period expires. During this time, EPA can either permit the new use to occur, or regulate the new submitter&#8217;s activities under Section 5(e) or 5(f).<\/p>\n<p>EPA utilizes a &#8220;generic&#8221; SNUR in regulating substances; this system allows it to efficiently prepare SNURs. Over 260 substances are so regulated and are found in 40 CFR 721.<\/p>\n<p>Under Section 8 of TSCA, EPA has the authority to obtain data (Section 8[a]) or unpublished health and safety studies (Section 8[d]) on existing chemical substances. EPA has issued two information gathering rules: Preliminary Assessment Information Rule (PAIR) and Comprehensive Assessment Information Rule (CAIR). The PAIR rule, found in 40 CFR 712, covers manufacturers and importers of specific, listed chemicals published in 40 CFR 712.30, which include several pesticides. If a chemical is manufactured or imported for both pesticidal <strong>and<\/strong> non-pesticidal purposes, it is subject to reporting under the PAIR rule.<\/p>\n<p>The CAIR rule, found in 40 CFR 704, Subparts C and D, applies to manufacturers, importers, <strong>and processors<\/strong>; as with the PAIR rule, pesticides are included if there are non-pesticidal uses for the chemicals. Currently only 19 chemicals are covered under this rule.<\/p>\n<p>If EPA is unable to obtain sufficient extant information through its Section 8 authority, it can, under Section 4, require manufacturers, importers, and\/or processors to conduct testing to fill data gaps; testing requirements are found in 40 CFR 799. To date EPA has listed 29 specific chemical test rules under Subpart B; 33 substances and mixtures which are subject to consent orders, under Subpart C; and 23 chemicals found as constituents of hazardous waste, under Subpart D.<\/p>\n<p>Under Section 8(e), persons who obtain new information that reasonably supports the conclusion that a substance or mixture which they manufacture, import, process, or distribute presents substantial risk of injury to human health or the environment <strong>must<\/strong> notify EPA within 15 working days. These notices are reviewed and an initial evaluation is prepared containing, if appropriate, follow-up questions to the submitter, referrals to other agencies, and recommended EPA follow-up. EPA has fined several companies for failure to submit timely notifications. It is important to note that EPA considers that the Agency, <strong>and not the submitter<\/strong>, has the obligation to determine whether the information &#8220;reasonably supports the conclusion that a substance or mixture&#8230;.presents a substantial risk&#8230;.&#8221; The 8(e) notices represent a company&#8217;s first review of a situation, and should be made in light of the agency&#8217;s interpretation. EPA has not promulgated regulations implementing Section 8(e); however, it has published &#8220;Environmental Protection Agency Policy Statement on Interpretation and Enforcement on Substantial Risk Notification under the Toxic Substances Control Act&#8221; (43 FR 11110, March 16, 1978) and &#8220;TSCA Section 8(e) Reporting Guide&#8221; (June 1991). The latter, which incorporates the cited Policy Statement is available through the TSCA Information Assistance Service.<\/p>\n<p>In addition to the above requirement which relates to new information, Section 8(c) requires manufacturers, processors, and distributors to keep records of <strong>allegations<\/strong> that a chemical substance or mixture has caused a significant adverse reaction to health or the environment. The allegations can be made by several sources, including employees, customers, neighbors, trade associations, etc. Employee allegations must be retained for 30 years, while those from other sources must be kept for 5 years. The TSCA 8(c) regulations are found in 40 CFR 717.<\/p>\n<p>Importers of pesticides must also be aware of their obligations under Section 13 of TSCA, which requires that each time a chemical is imported a certification be signed. As stated above, chemicals which are imported <strong>as pesticides<\/strong> are not subject to TSCA. Thus, such imports must be certified with a negative statement, as follows: &#8220;I certify that all chemicals in this shipment are not subject to TSCA.&#8221; This certification must be employed, even if the pesticide is found on the TSCA Inventory. If the chemical is not being imported for pesticidal uses, or if a sample is being imported for R&#038;D purposes, then a positive certification is required: &#8220;I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any other applicable rule or order under TSCA.&#8221;&#160;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Lei de Controle de Subst\u00e2ncias T\u00f3xicas (TSCA) foi promulgada em 1976 para: Garantir que dados adequados sejam desenvolvidos sobre os efeitos\u2026<\/p>","protected":false},"author":110,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[489],"tags":[],"class_list":["post-7653","post","type-post","status-publish","format-standard","hentry","category-industry-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - 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