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Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

Recent Activities for the New Chemicals Program under the Toxic Substances Control Act

August 12, 2020 – On August 3, 2020, EPA published final significant new use rules (SNURs) for chemical substances which were the subject of Premanufacture Notices (PMNs) and proposed rules (84 FR 47923, September 11, 2019) (also known as SNUR Batch 19-5.B). The SNURs require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. This batch rule is effective 60 days after publication in the Federal Register, or October 2, 2020.

August 11, 2020 – On July 28, 2020, EPA published final significant new use rules (SNURs) for chemical substances which were the subject of Premanufacture Notices (PMNs) and proposed rules (84 FR 53663, October 8, 2019) (also known as SNUR Batch 19-6.B). The SNURs require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. This batch rule is effective 60 days after publication in the Federal Register, or September 28, 2020.

August 4, 2020 – On July 31, 2020, the EPA signed proposed new significant new use rules (SNURs) for chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 20-8.B). During the review, the EPA identified certain reasonably foreseen conditions of use that the EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under these conditions of use to submit a significant new use notice (SNUN) that the EPA would review to make a TSCA section 5 finding for the significant new use. The EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA-HQ-OPPT-2020-0304.

July 6, 2020 – On June 30, 2020, the EPA signed proposed new significant new use rules (SNURs) for chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 20-7.B). During the review, the EPA identified certain reasonably foreseen conditions of use that the EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under these conditions of use to submit a significant new use notice (SNUN) that the EPA would review to make a TSCA section 5 finding for the significant new use. The EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA_HQ-OPPT-2020-0303.

June 9 – EPA published final significant new use rules (SNURs) for chemical substances which were the subject of Premanufacture Notices (PMNs) and proposed rules (84 FR 40371; August 14, 2019) (also known as SNUR Batch 19-4.B). The SNURs require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. This batch rule is effective 60 days after today’s publication in the Federal Register, or August 10, 2020.

June 2, 2020 – On May 29, 2020, the EPA signed proposed new significant new use rules (SNURs) for chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 20-6.B). During the review, the EPA identified certain reasonably foreseen conditions of use that the EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under these conditions of use to submit a significant new use notice (SNUN) that the EPA would review to make a TSCA section 5 finding for the significant new use. The EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA_HQ-OPPT-2020-0251.

May 5, 2020 – EPA published final significant new use rules (SNURs) for chemical substances which were the subject of Premanufacture Notices (PMNs) and proposed rules (84 FR 32366, July 8, 2019) (also known as SNUR Batch 19-3.B). The SNURs require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. This batch rule is effective 60 days after today’s publication in the Federal Register, or July 6, 2020.  

May 4, 2020 – On April 29, 2020, the EPA signed proposed new significant new use rules (SNURs) for chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 20-5.B). During the review, the EPA identified certain reasonably foreseen conditions of use that the EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under these conditions of use to submit a significant new use notice (SNUN) that the EPA would review to make a TSCA section 5 finding for the significant new use. The EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA_HQ-OPPT-2020-0222.

May 4, 2020 EPA proposed significant new use rules (SNUR batch “20-1.5e”) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are subject to TSCA 5(e) Orders. The SNURs would require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. EPA will take comments on the proposed SNURs until June 3, 2020, at www.regulations.gov, docket number EPA-HQ-OPPT-2019-0596.

April 23, 2020 – EPA published final significant new use rules (SNURs) for chemical substances which were the subject of Premanufacture Notices (PMNs) and proposed rules (84 FR 27061, June 11, 2019)  (also known as SNUR Batch 19-2.B). The SNURs require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. This batch rule is effective 60 days after today’s publication in the Federal Register, or June 22, 2020.

April 2, 2020 – On March 31, 2020, the EPA signed proposed new significant new use rules (SNURs) for chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 20-4.B). During the review, the EPA identified certain reasonably foreseen conditions of use that the EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under these conditions of use to submit a significant new use notice (SNUN) that the EPA would review to make a TSCA section 5 finding for the significant new use. The EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov docket number EPA_HQ-OPPT-2020-0138.

April 1, 2020. EPA is proposing to revoke the SNUR for the chemical substance identified generically as alpha 1,3-polysaccharide, which was the subject of PMN identified as P-16-581. EPA issued a SNUR based on this PMN which designated certain activities as significant new uses.  EPA has received test data for the chemical substance and is proposing to revoke the SNUR based on these new data. EPA will take comments on the proposed revocation until May 1, at www.regulations.gov, docket number EPA-HQ-OPPT-2017-0575. 

April 1, 2020.  EPA is proposing to amend the SNURs for five chemical substances, which were the subject of premanufacture notices (PMNs) and significant new use notices (SNUNs).  This action would amend the SNURs to (1) allow certain new uses reported in the SNUNs without requiring additional SNUNs and (2) modify the significant new use notification requirements based on the actions and determinations for the SNUN submissions.  EPA is proposing these amendments based on review of new and existing data as described for each chemical substance. EPA will take comments on the proposed modifications until May 1, at www.regulations.gov, docket number EPA-HQ-OPPT-2019-0614. 

March 20, 2020 - EPA published final significant new use rules (SNURs) for chemical substances which were the subject of Premanufacture Notices (PMNs) and proposed rules (84 FR 16432, April 19 2019) (also known as SNUR Batch 19-1.B). The SNURs require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. This batch rule is effective 60 days after today’s publication in the Federal Register, or May 19, 2020.  

March 4, 2020 – On February 28, 2020, the EPA signed proposed new significant new use rules (SNURs) for chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 20-3.B). During the review, the EPA identified certain reasonably foreseen conditions of use that the EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under the conditions of use to submit a significant new use notice (SNUN) that the EPA would review to make a TSCA section 5 finding for the significant new use. The EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov docket number EPA_HQ-OPPT-2020-0094.

February 25, 2020 – On February 25, 2020, EPA issued a technical correction to two batch final Toxic Substances Control Act (TSCA) significant new use rules (SNURs), 18-1 and 18-4.  After their publication in the Federal Register of November 25, 2019 (18-1) and December 5, 2019 (18-4), EPA became aware of certain discrepancies.  In SNUR batch 18-1, for the chemical substance that was the subject of PMN P-15-114, EPA made errors in the SNUR requirements for hazard communication and protection in the workplace, resulting in inconsistencies with the same requirements in the associated TSCA Order. For SNUR batch 18-4, for one of the two chemical substances that are subject to the SNUR, EPA made a typographical error when identifying the associated PMN number in the SNUR. Additionally, for two other SNURs, language in the SNURs incorrectly refers to requirements in “the TSCA Order” rather than in the SNUR itself. This document is being issued to correct these errors.

February 3, 2020 – On January 31, 2020, the EPA signed proposed new significant new use rules (SNURs) for chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 20-2.B). During the review, the EPA identified certain reasonably foreseen conditions of use that the EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under the conditions of use to submit a significant new use notice (SNUN) that the EPA would review to make a TSCA section 5 finding for the significant new use. The EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov docket number EPA_HQ-OPPT-2019-0650.

January 9, 2020 – EPA published final significant new use rules (SNURs) for 67 chemical substances which were the subject of proposed rules (83 FR 57634; November 15, 2018) and premanufacture notice (PMN) review (also known as SNUR Batch 18-3). The Agency has already issued Orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. The SNURs require anyone intending to engage in any activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. This rule is effective 60 days after today’s publication of the rule in the Federal Register, or March 9, 2020.

December 6, 2019 – EPA proposed significant new use rules (SNURs) (also known as SNUR Batch 19-5.F) for 27 chemical substances.  Nineteen of these chemical substances are subject to TSCA 5(e) Orders and the remaining 8 of these chemical substances received a “not likely to present an unreasonable risk” determination pursuant to TSCA section 5(a)(3)(C). This action would require anyone intending to use these chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity.  EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA-HQ-OPPT-2019-0530.  Comment period ends January 6, 2020.

December 5, 2019 – EPA published final significant new use rules (SNURs) for 29 chemical substances which were the subject of proposed rules (84 FR 9999; March 19, 2019) and premanufacture notice (PMN) review (also known as SNUR Batch 18-4). The Agency has already issued Orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. The SNURs require anyone intending to engage in any activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. This rule is effective 60 days after today’s publication of the rule in the Federal Register, or February 3, 2020.

December 5, 2019 – EPA published final significant new use rules (SNURs) for 28 chemical substances which were the subject of proposed rules (83 FR 50872; October 10, 2018) and premanufacture notice (PMN) review (also known as SNUR Batch 18-2). The Agency has already issued Orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. The SNURs require anyone intending to engage in any activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. This rule is effective 60 days after today’s publication of the rule in the Federal Register, or February 3, 2020.

December 2, 2019- On November 26, 2019, the EPA signed proposed new significant new use rules (SNURs) for six chemicals substances undergoing premanufacture notice (PMN) reviews (also known as SNUR Batch 20-1.B). During the review, the EPA identified certain reasonably foreseen conditions of use that the EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under the conditions of use to submit a significant new use notice (SNUN) that the EPA would review to make a TSCA section 5 finding for the significant new use. The EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov docket number EPA_HQ-OPPT-2019-0595.

November 25, 2019 – EPA published final significant new use rules (SNURs) for 22 chemical substances which were the subject of proposed rules (83 FR 49903; October 3, 2018) and premanufacture notice (PMN) review (also known as SNUR Batch 18-1). The Agency has already issued Orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. The SNURs require anyone intending to engage in any activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. This rule is effective 60 days after publication of the rule in the Federal Register.

November 19, 2019 – On October 10, 2019, EPA issued a technical correction to the batch final Toxic Substances Control Act (TSCA) significant new use rule (SNUR) (17-1) for 145 chemical substances, which were the subject of premanufacture notices (PMNs). After publication of the final batch SNUR, in the Federal Register of August 20, 2019, EPA became aware that the Chemical Abstract Service (CAS) Registry Numbers for four chemicals - codified at 40 CFR 721.11053 (PMN P–17–0033 and P–17–0087), 721.11054 (PMN P–17–0088) and 721.11055 (PMN P–17–0101) - were incorrect.  This document was issued to correct these errors.

November 19, 2019 – EPA issued a technical correction to the final Toxic Substances Control Act (TSCA) batch final significant new use rule (SNUR) (17-3) for 19 chemical substances that were the subjects of premanufacture notices (PMNs). After publication of the final batch SNUR, in the Federal Register of September 18, 2019, EPA became aware of several errors when specifying hazard communication requirements for the chemical substance listed in the SNUR codified at 40 CFR 721.11107 (PMN P-17-0170). This document was issued to correct these errors.

November 4, 2019 – EPA proposed significant new use rules (SNURs) (also known as SNUR Batch 19-4.F) for 26 chemical substances.  Five of these chemical substances are subject to TSCA 5(e) Orders and the remaining 21 of these chemical substances received a “not likely to present an unreasonable risk” determination pursuant to TSCA section 5(a)(3)(C). This action would require anyone intending to use these chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity.  EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA-HQ-OPPT-2019-0494.

October 28, 2019 – EPA published final significant new use rules (SNURs) for eight chemical substances which were the subject of proposed rules (83 FR 43606; August 27, 2018) and premanufacture notice (PMN) review (also known as SNUR Batch 17-4). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. The SNURs require anyone intending to engage in any activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. This rule is effective 60 days after publication of the rule in the Federal Register.

October 25, 2019 –  EPA published statements of findings under section 5(g) of the Toxic Substances Control Act (TSCA) for July 2019. The document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs and SNUNs submitted to EPA under section 5.

October 15, 2019 – EPA published final significant new use rules (SNURs) for 29 chemical substances which were the subject of proposed rules (83 FR 47026) and premanufacture notice (PMN) review (also known as SNUR Batch 17-5). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. The SNURs require anyone intending to engage in any activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. This rule is effective 60 days after publication of the rule in the Federal Register.

October 11, 2019 – EPA proposed significant new use rules (SNURs) (also known as SNUR Batch 19-3.F) for 31 chemical substances.  Eight of these chemical substances are subject to TSCA 5(e) Orders and the remaining 23 of these chemical substances received a “not likely to present an unreasonable risk” determination pursuant to TSCA section 5(a)(3)(C). This action would require anyone intending to use these chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity.  EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA-HQ-OPPT-2019-0228.

October 9, 2019 - EPA revoked the significant new use rule promulgated under section 5(a)(2) of the Toxic Substances Control Act for a chemical substance identified generically as fatty acid amide, which was the subject of premanufacture notice (PMN) P-13-0267.   EPA revoked the SNUR based on human health and environmental toxicity testing for the chemical substance which demonstrated inherently low toxicity of the chemical substance. Read the revocation notice for P-13-0267.

October 8, 2019 – EPA withdrew a January 2015 proposed significant new use rule (SNUR) for the chemical substance generically described as aromatic dibenzoate, which was the subject of premanufacture notice (PMN) P-13-0270. EPA received test data for this chemical substance and, based on its review of all available scientific evidence, and, based on its review, is withdrawing the proposed SNUR. Read the withdrawal notice for P-13-0270.

October 2, 2019 – On September 30, 2019, EPA signed proposed significant new use rules (SNURs) for seven chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 19-6.B). During the review, EPA identified certain reasonably foreseen conditions of use that EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov docket number EPA-HQ-OPPT-2019-0529.

September 18, 2019 – EPA published final significant new use rules (SNURs) for 19 chemical substances which were the subject of proposed rules (83 FR 43607) and premanufacture notice (PMN) review (also known as SNUR Batch 17-3). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. The SNURs require anyone intending to engage in any activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. This rule is effective 60 days after publication of the rule in the Federal Register.

September 18, 2019 – EPA published final significant new use rules (SNURs) for 26 chemical substances which were the subject of proposed rules (83 FR 41039) and premanufacture notice (PMN) review (also known as SNUR Batch 17-2). SNURs for 27 chemical substances were originally proposed; EPA is not finalizing the proposed SNUR at 40 CFR 721.11082 on the chemical substance that is the subject of PMN P-16-0543, because the Agency is currently reviewing data submitted in support of a request to modify the underlying TSCA 5(e) Order that forms the basis for that proposed SNUR.  The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. The SNURs require anyone intending to engage in any activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. This rule is effective 60 days after publication of the rule in the Federal Register.

September 4, 2019 – On August 30, 2019, EPA signed proposed significant new use rules (SNURs) for six chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 19-5.B). During the review, EPA identified certain reasonably foreseen conditions of use that EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov docket number EPA-HQ-OPPT-2019-0495.

August 20, 2019 –EPA published final significant new use rules (SNURs) for 145 chemical substances which were the subject of proposed rules (83 FR 37455) and premanufacture notice (PMN) review (also known as SNUR Batch 17-1). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. The SNURs require anyone intending to engage in any activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. This rule is effective 60 days after publication of the rule in the Federal Register.

August 12, 2019 –  EPA published statements of findings under section 5(g) of the Toxic Substances Control Act (TSCA) for June 2019. The EPA publishes these notices on a monthly basis. The document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs and SNUNs submitted to EPA under section 5.

August 6, 2019 – EPA proposed significant new use rules (SNURs) (also known as SNUR Batch 19-2.F) for 31 chemical substances. This action would require anyone intending to use these 31 chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity.  EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA-HQ-OPPT-2019-0359.

August 1, 2019 – EPA signed proposed significant new use rules (SNURs) for 17 chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 19-4.B). During the review, EPA identified certain reasonably foreseen conditions of use that EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov docket number EPA-HQ-OPPT-2019-0442.

July 31, 2019 – EPA proposed significant new use rules (SNURs) (also known as SNUR Batch 19-1.F) for 31 chemical substances, 30 of which were the subject of premanufacture notices (PMNs) and 1 (a microorganism) that was the subject of a Microbial Commercial Activity Notice (MCAN). This action would require anyone intending to use these 31 chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity.  EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA-HQ-OPPT-2018-0777.

July 30, 2019 - EPA published a final rule modifying the significant new use rule (SNUR) for a chemical substance identified as oxazolidine, 3,3′-methylenebis[5-methyl-, which was the subject of premanufacture notice (PMN) P-03-0325, significant new use notice, (SNUN) S-17-0004 and  a proposed rule (February 8, 2018 (83 FR 5599)).  The SNUR requires persons who intend to manufacture (defined by statute to include import) or process this chemical substance for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.  This final rule is effective September 30, 2019.

July 24, 2019 -  EPA published a proposed revocation of the significant new use rule (SNUR) for a chemical substance identified generically as fatty acid amide, which was the subject of premanufacture notice (PMN) P-13-0267.  EPA received a significant new use notice (SNUN) and test data for the chemical substance and is proposing to revoke the SNUR based on the information in the submission. EPA will accept public comment on its proposal until August 23, 2019.

July 16, 2019 -  EPA published statements of findings under section 5(g) of the Toxic Substances Control Act (TSCA) for April 2019 and May 2019. The EPA publishes these notices on a monthly basis. The document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs and SNUNs submitted to EPA under section 5.

June 30, 2019 – EPA signed proposed significant new use rules (SNURs) for 3 chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 19-3.B). During the review, EPA identified certain reasonably foreseen conditions of use that EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA-HQ-OPPT-2019-0226.

June 10, 2019 -  EPA published statements of findings under section 5(g) of the Toxic Substances Control Act (TSCA) for October 2018, November and December 2018, and January through March 2019. The EPA publishes these notices on a monthly basis. The document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs and SNUNs submitted to EPA under section 5.

May 31, 2019 – EPA signed proposed significant new use rules (SNURs) for 8 chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 19-2.B). During the review, EPA identified certain reasonably foreseen conditions of use that EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA-HQ-OPPT-2019-0263.

May 31, 2019 - EPA posted six Pre-Manufacture Notices (PMNs) and associated attachments into ChemView, EPA’s electronic chemicals database. EPA chose these six cases because they were submitted recently and they will serve as examples of what is to become routine practice. Moving forward, EPA will make TSCA Section 5 (PMN, MCAN and SNUN) notices, their attachments, including any health and safety studies, any modifications thereto, an all other associated information publicly available in ChemView within 45 days of their receipt – in the form they are received by EPA.  EPA will not be reviewing CBI-sanitized filings before publishing. Learn more.

April 15, 2019 – EPA signed proposed significant new use rules (SNURs) for 11 chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 19-1.B). During the review, EPA identified certain reasonably foreseen conditions of use that EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. EPA will take comments on the proposed SNURs until May 20, 2019 at www.regulations.gov, docket number EPA-HQ-OPPT-2018-0772.

April 5, 2019 – EPA published significant new use rules (SNUR) for 13 chemical substances which were the subject of proposed rules (83 FR 52179) and  premanufacture notice (PMN) review (also known as SNUR Batch 18-5). During the review, EPA identified certain reasonably foreseen conditions of use that EPA designated as significant new uses in the final SNURs. The SNURs require anyone intending to engage in any activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity by submitting a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. The final rule is effective 60 days after publication of the final rule in the Federal Register.

March 19, 2019 – EPA issued proposed significant new use rules (SNURs) for 28 chemical substances (also known as SNUR Batch 18-4), which were the subject of premanufacture notices (PMNs). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA.  EPA will take comments on the proposed SNUR until May 3, 2019 at www.regulations.gov, docket number EPA-HQ-OPPT-2018-0697.

February 1, 2019 TSCA Section 5 New Chemical and Significant New Use Notifications: Delay in Processing Due to Lack of Authorized Funding; Extension of Review Periods

Due to the recent lapse of appropriations and the Agency shutdown, EPA is extending (pursuant to TSCA sections 5(c) and 26(c) and 40 CFR 720.75(c)) the review periods for all TSCA section 5 Premanufacture Notices (PMNs), Significant New Use Notices (SNUNs), Microbial Commercial Activity Notices (MCANs), and exemption notices that were submitted to the Agency under TSCA section 5 (15 U.S.C. section 2604) before December 29, 2018, and for which the review period had not expired as of December 29, 2018. This impacts a total of 581 new chemical notifications.

The duration of this extension period is equivalent to the duration of the time period from December 29, 2018 (i.e., the date on which certain EPA operations shutdown) and the date on which EPA operations for the TSCA New Chemicals Program fully resumed (i.e., January 31, 2019), or a total of 33 days. 

Also, during the shutdown, new notifications submitted on or after December 29, 2018, through E-PMN/CDX or other methods were not processed. Consequently, the review period for any TSCA section 5 notice submitted during the shutdown did not begin until normal operations resumed on January 31, 2019. This impacts a total of 24 new chemical notifications.

Additional Information regarding this extension can be found in the Federal Register notice.

December 10, 2018 – In response to public comments on the September 17, 2018 proposed significant new use rules for 28 chemical substances which were the subject of pre-manufacture notices (SNUR Batch 17-5), EPA has withdrawn the direct final rule and is reopening the comment period on the NPRM for 30 days to allow interested parties to submit additional comments. EPA is requesting the public to submit comments by January 9, 2019 to www.regulations.gov, docket ID number EPA-HQ-OPPT-2018-0567. Read the December 10, 2018 Federal Register notice extending the comment period. Read the November 16, 2018 Federal Register notice withdrawing the direct final rule.

December 7, 2018 – In response to public comments on the October 10, 2018 proposed significant new use rules for 28 chemical substances which were the subject of pre-manufacture notices (SNUR Batch 18-2), EPA has withdrawn the direct final rule. EPA took comment on the proposed rule through November 9th at www.regulations.gov, docket ID number EPA-HQ-OPPT-2018-0649. Read the December 7, 2018 Federal Register notice withdrawing the direct final rule.

November 19, 2018 – EPA issued proposed significant new use rules (SNURs) for 66 chemical substances (also known as SNUR Batch 18-3), which were the subject of premanufacture notices (PMNs). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA.  EPA will take comments on the proposed SNUR until December 31, 2018 at www.regulations.gov, docket number EPA-HQ-OPPT-2018-0650.

October 17, 2018 – In response to public comments on the August 17, 2018 proposed significant new use rules for 27 chemical substances which were the subject of premanufacture notices (also known as SNUR Batch 17-2), EPA has withdrawn the direct final rule and is reopening the comment period on the NPRM for 15 days to allow interested parties to submit additional comments. EPA is requesting the public to submit comments by October 30, 2018 to www.regulations.gov, docket ID number EPA-HQ-OPPT-2017-0414. Read the October 15, 2018 Federal Register notice extending the comment period. Read the October 11, 2018 Federal Register notice withdrawing the direct final rule.

October 17, 2018 – In response to public comments on the August 1, 2018 proposed significant new use rules for 145 chemical substances which were the subject of pre-manufacture notices (also known as SNUR Batch 17-1), EPA has withdrawn the direct final rule and is reopening the comment period on the NPRM for 30 days to allow interested parties to submit additional comments. EPA is requesting the public to submit comments by November 14, 2018 to www.regulations.gov, docket ID number EPA-HQ-OPPT-2017-0366. Read the October 15, 2018 Federal Register notice extending the comment period. Read the September 26, 2018 Federal Register notice withdrawing the direct final rule.

October 10, 2018 – On October 5, 2018, EPA signed proposed significant new use rules (SNURs) for 13 chemical substances undergoing premanufacture notice (PMN) review (also known as SNUR Batch 18-5). During the review, EPA identified certain reasonably foreseen conditions of use that EPA is designating as significant new uses in the proposed SNURs. The SNURs will require anyone intending to use the chemicals under certain conditions of use to submit a significant new use notice (SNUN) that EPA would review to make a TSCA section 5 finding for the significant new use. EPA will take comments on the proposed SNURs for 30 days following publication in the Federal Register at www.regulations.gov, docket number EPA-HQ-OPPT-2017-0575.

October 3, 2018 – EPA issued direct final and concurrent proposed significant new use rules (SNURs) for 26 chemical substances, which were the subject of premanufacture notices (also known as SNUR Batch 18-1). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) and section 5(f)  following passage of the amended TSCA. EPA will take comments on the proposed SNUR until November 2, 2018 at www.regulations.gov, docket number EPA-HQ-OPPT-2018-0627.

September 17, 2018 – EPA issued direct final and concurrent proposed significant new use rules (SNURs) for 28 chemical substances, which were the subject of premanufacture notices (PMNs) (also known as SNUR Batch 17-5). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA.  EPA will take comments on the proposed SNUR until October 17, 2018 at www.regulations.gov, docket number EPA-HQ-OPPT-2018-0567.

August 27, 2018 – EPA issued direct final and concurrent proposed significant new use rules (SNURs) for  10 chemical substances which were the subject of premanufacture notices (PMNs) (also known as SNUR Batch 17-4). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. Upon publication of the Federal Register notice, EPA will take comments on the proposed SNURs until September 26, 2018 at www.regulations.gov, docket number EPA-HQ-OPPT-2017-0560.  The language in these SNURs is consistent with EPA’s new strategy to reduce animal testing, required under the amended TSCA. Learn more about modifications to EPA’s legal and regulatory documents describing test requirements to reflect a preference for tiered testing using non-vertebrate testing strategies first.

August 27, 2018 – EPA issued direct final and concurrent proposed significant new use rules (SNURs) for  19 chemical substances which were the subject of premanufacture notices (PMNs) (also known as SNUR Batch 17-3). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. Upon publication of the Federal Register notice, EPA will take comments on the proposed SNURs until September 26, 2018 at www.regulations.gov, docket number EPA-HQ-OPPT-2017-0464.  The language in these SNURs is consistent with EPA’s new strategy to reduce animal testing, required under the amended TSCA. Learn more about modifications to EPA’s legal and regulatory documents describing test requirements to reflect a preference for tiered testing using non-vertebrate testing strategies first.

August 17, 2018 – EPA issued direct final and concurrent proposed significant new use rules (SNURs) for  27 chemical substances which were the subject of premanufacture notices (PMNs) (also known as SNUR Batch 17-2). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. Upon publication of the Federal Register notice, EPA will take comments on the proposed SNURs until September 17, 2018 at www.regulations.gov, docket number EPA-HQ-OPPT-2017-0414.  The language in these SNURs is consistent with EPA’s new strategy to reduce animal testing, required under the amended TSCA. Learn more about modifications to EPA’s legal and regulatory documents describing test requirements to reflect a preference for tiered testing using non-vertebrate testing strategies first.

August 1, 2018 – EPA is issuing direct final and concurrent proposed significant new use rules (SNURs) for 145 chemical substances which were the subject of premanufacture notices (PMNs) (also known as SNUR Batch 17-1). The Agency has already issued consent orders for these new chemical substances as required under section 5(e) following passage of the amended TSCA. Upon publication of the Federal Register notice, EPA will take comments on the proposed SNURs until August 31, 2018 at www.regulations.gov, docket number EPA-HQ-OPPT-2017-0366.  The language in these SNURs is consistent with EPA’s new strategy to reduce animal testing, required under the amended TSCA. Learn more about modifications to EPA’s legal and regulatory documents describing test requirements to reflect a preference for tiered testing using non-vertebrate testing strategies first.

July 23, 2018 – In response to further public comments on the February 26, 2018 proposed modification to a Significant New Use Rule for Oxazolidine, 3,3′-methylenebis[5-methyl-, EPA is reopening the comment period on the NPRM for 30 days to allow interested parties to consider the information and data added to the docket, and submit any additional comments. Data and information added to the docket further explains EPA’s risk assessment associated with the action and includes additional data and information used in the assessment. EPA is requesting the public to submit comments by August 22, 2018. Read the July 23, 2018 Federal Register notice extending the comment period.

June 20, 2018 – EPA has requested that the Office of Management and Budget (OMB) process the Agency’s information collection request (ICR) amendment for section 5 information on an emergency basis. This is necessary so that EPA can make an updated version of the Points to Consider When Preparing TSCA New Chemical Notifications guidance immediately available to submitters and the public, consistent with requirements of the Paperwork Reduction Act. Read the Federal Register notice requesting the emergency process.

February 26, 2018 – EPA extended the comment period for the proposed modification to a Significant New Use Rule for Oxazolidine, 3,3′-methylenebis[5-methyl-, which was the subject of a premanufacture notice (PMN) and a significant new use notice (SNUN). The Agency will take comment on the proposal until March 12, 2018. The proposed modification to this SNUR follows issuance of a consent order with the SNUN submitter and would amend the SNUR to (1) allow certain additional new uses as reported in the SNUN and (2) make the lack of certain worker protections, for any use, a significant new use. 
Read the Federal Register notice proposing modification to a Significant New Use Rule for Oxazolidine, 3,3′-methylenebis[5-methyl-. 
• Read the February 26, 2018 Federal Register notice extending the comment period.

October 3, 2017 – EPA issued a final significant new use rule for one chemical substance which was the subject of a premanufacture notice (PMN), P-11-482. This SNUR would require persons who intend to manufacture or process the chemical substance for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. This final rule is effective November 2, 2017.

July 10, 2017 – EPA issued the final significant new use rules (SNURs) for 29 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to consent orders issued by EPA pursuant to section 5(e) of TSCA. These SNURs would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The Agency will take comment on the SNUR until November 20, 2017.

June 1, 2017 – EPA issued the final significant new use rules (SNURs) for 37 chemical substances which were the subject of premanufacture notices (PMNs). Applicable review periods for the PMNs submitted for these 37 chemical substances all ended prior to June 22, 2016 (i.e., the date on which the President signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which amends TSCA).

February 28, 2017 – EPA issued a proposed significant new use rule for one chemical substance which was the subject of a premanufacture notice (PMN), P-11-482. This SNUR would require persons who intend to manufacture or process the chemical substance for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The Agency will take comment on the SNUR for 30 days following the date of publication in the Federal Register. This PMN was the subject of a withdrawal notice published January 19, 2017.

November 9, 2016 – EPA issued the final significant new use rules (SNURs) for 57 chemical substances which were the subject of premanufacture notices (PMNs). Applicable review periods for the PMNs submitted for these 57 chemical substances all ended prior to June 22, 2016 (i.e., the date on which the President signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which amends TSCA).

October 27, 2016 – EPA proposed significant new use rules (SNURs) for 3 chemical substancestwo isocyanates and one for functionalized carbon nanotubes - which were the subject of premanufacture notices (PMNs), P-15-276, P-15-378, and P-15-559. These SNURs would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The Agency will take comment on the SNURs until November 28, 2016.

August 15, 2016 – EPA issued a proposed Significant New Use Rule for two intermediate chemical substances, Hydrochlorofluoropropane and Hydrochlorofluoropropene (generic), that were the subject of PMNs P-14-321 and P-14-323. These SNURs would require persons who intend to manufacture (including import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing the activity. The Agency will take comment on the SNUR for 30 days following the date of publication in the Federal Register.

July 28, 2016 -- EPA is proposing changes to the existing regulations governing significant new uses of chemical substances under TSCA to update and align these regulations with revisions to the Occupational Safety and Health Administration’s Hazard Communications Standard , the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals and with changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA is also proposing changes to other general significant new use regulations. Comments are due by September 26, 2016. Read the proposal.

May 16, 2016 -- EPA published the final significant new use rules (SNURs) for 55 chemical substances which were the subject of premanufacture notices (PMNs).

April 20, 2016 - EPA proposed significant new use rules (SNURs) for 3 chemical substances which were the subject of premanufacture notices (PMNs).

March 2, 2016 -- EPA issued a Federal Register notice unilaterally extending the review period for P-14-0627 by 90 days. As part of its new chemicals review program, EPA may for good cause unilaterally extend its review of a new chemical pre-manufacture notice (PMN) for up to 90 days pursuant to section 5(c) of the Toxic Substances Control Act (TSCA). Because the Agency may need to regulate this new chemical substance, the Agency needs an extension of the review period to further investigate potential risk, examine regulatory options, and prepare the necessary documents, should regulatory action be required. The PMN included information indicating that this chemical is structurally similar to another chemical previously assessed by EPA that identified acute and chronic risks to human health and EPA is concerned that the PMN substance may present similar risks.

February 18, 2016 – EPA has extended the public comment period on its request for new available data on chlorinated paraffins to March 23, 2016. The previous request for information was published, in the Federal Register document of December 23, 2015 (80 FR 79886). Read the notice.

February 12, 2016 – EPA published the final SNURs for three very long chain chlorinated paraffin (vLCCPs—alkyl chain length of C21 and above) chemical substances that were the subject of PMNs P-12-539, P-13-107, and P-13-109.

December 23, 2015 -- EPA issued a request for new available data on the chlorinated paraffins submitted as premanufacture notices (PMNs).

December 4, 2015 -- EPA published the final significant new use rules (SNURs) for 29 chemical substances which were the subject of premanufacture notices (PMNs).

November 20, 2015 -- EPA withdrew the significant new use rules (SNURs) for P-15-221, P-15-247, and P-15-278.

October 2, 2015 -- EPA published the direct final significant new use rules (SNURs) for 30 chemical substances which were the subject of premanufacture notices (PMNs).

September 2, 2015 -- EPA removed the significant new use rule (SNUR) for substituted cyclosiloxane that was the subject of a premanufacture notice, P-14-605.

July 20, 2015 -- EPA published the updated ePMN rule which includes new requirements for submitting electronic TSCA Section 5 notices.

June 30, 2015 -- EPA published final modifications to the significant new use rules (SNURs) for 21 chemical substances that were the subject of premanufacture notices (PMNs).

June 10, 2015 -- EPA published proposed significant new use rules (SNURs) for 30 chemical substances which were the subject of premanufacture notices (PMNs).

June 5, 2015 -- EPA published the direct final significant new use rules (SNURs) for 22 chemical substances which were the subject of premanufacture notices (PMNs).

May 8, 2015 -- EPA will hold a public meeting to receive comments on the proposed TSCA section 8(a) nano rule. The meeting will be held at EPA headquarters from 9 a.m. - 4 p.m. on June 11, 2015. Learn about how to register to attend the meeting.

May 8, 2015 -- EPA published the direct final significant new use rules (SNURs) for 25 chemical substances which were the subject of premanufacture notices (PMNs).

April 9, 2015 -- EPA proposed the modification of the significant new use rules (SNURs) for 24 chemical substances that were the subject of premanufacture notices (PMNs).

March 24, 2015 -- EPA published the revocation of the significant new use rule (SNUR) for two chemical substance identified generically as metal salts of complex inorganic oxyacids, which were the subject of premanufacture notices (PMNs) P-89-576 and P-89-577.

March 6, 2015 -- EPA published the final significant new use rule (SNUR) for the chemical substance Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)- that was the subject of premanufacture notice (PMN) P-07-204.

March 3, 2015 -- EPA published an extension of the comment period for the proposed significant new use rules (SNURs) for 13 chemical substances that were the subject of premanufacture notices (PMNs).

February 2, 2015 -- EPA published direct final significant new use rules (SNURs) for 27 chemical substances that were the subject of premanufacture notices (PMNs).

January 7, 2015 -- EPA proposed significant new use rules (SNURs) for 13 chemical substances that were the subject of premanufacture notices (PMNs).

December 23, 2014 -- EPA withdrew the significant new use rules (SNURs) for 30 chemical substances that were the subject of premanufacture notices (PMNs).

December 17, 2014 -- EPA proposed the revocation of the significant new use rules (SNURs) for two chemical substances that were the subject of premanufacture notices (PMNs) P-89-576 and P-89-577.

September 4, 2014 -- EPA withdrew the significant new use rules (SNURs) for six chemical substances that were the subject of premanufacture notices (PMNs) P-14-60, P-13-270, P-13-563, P-13-617, P-13-618, and P-13-619 .

September 2, 2014 -- EPA published final significant new use rules (SNURs) for 36 chemical substances that were the subject of premanufacture notices (PMNs).

July 9, 2014 -- EPA published direct final significant new use rules (SNURs) for 43 chemical substances that were the subject of premanufacture notices (PMNs).

July 8, 2014 -- EPA published direct final significant new use rules (SNURs) for 13 chemical substances that were the subject of premanufacture notices (PMNs).

June 18, 2014 -- EPA published direct final significant new use rules (SNURs) updating the chemical identity listings for 36 chemical substances that were the subject of premanufacture notices (PMNs).

April 14, 2014 -- EPA withdrew the significant new use rules (SNURs) for four chemical substances that were the subject of premanufacture notices (PMNs) P-13-365, P-13-392, P-13-393, and P-13-471.

March 26, 2014 -- EPA withdrew the proposed significant new use rules (SNURs) for two chemical substances that were the subject of premanufacture notices (PMNs) P-12-298 and P-12-299.

February 12, 2014 -- EPA published a direct final significant new use rule (SNUR) for 35 chemical substances that were the subject of premanufacture notices (PMNs). EPA will take comments on the rule until March 14, 2014.

February 10, 2014 -- EPA proposed a significant new use rule (SNUR) for 3 chemical substances that were subject to premanufacture notices (PMNs) P-12-539, P-13-107, and P-13-109. EPA will take comments on the proposal until April 11, 2014.

February 4, 2014 -- EPA published the final significant new use rule (SNUR) for five chemical substances that were the subject of premanufacture notices (PMNs) P-12-22, P-12-23, P-12-24, P-12-25, and P-12-26.

December 5, 2013 -- EPA issued a final rule with new electronic reporting requirements for TSCA section 5 notices.

December 4 & 5, 2013 -- EPA held webinars on submitting PMNs, letters of support, joint submissions, notices of bona fide intent to manufacture, and alternative control measures using the e-PMN version 2.0 software.

November 5, 2013 -- EPA removed significant new use rules (SNURs) for three chemical substances that were the subject of premanufacture notices (PMNs) P-12-539, P-13-107, and P-13-109.

October 17, 2013 -- Toxic Substances Control Act Section 5 New Chemical and Significant New Use Notifications: Delay in Processing Due to Lack of Authorized Funding; Extension of Review Periods

Due to a lapse of appropriations and the Agency shutdown, EPA is extending (pursuant to TSCA sections 5(c) and 26(c) and 40 CFR 720.75(c)) the review periods for all TSCA section 5 Premanufacture Notices (PMNs), Significant New Use Notices (SNUNs), Microbial Commercial Activity Notices (MCANs), and exemption notices that were submitted to the Agency under section 5 of the Toxic Substances Control Act (TSCA; 15 U.S.C. section 2604) before October 1, 2013, and for which the review period has not expired as of October 1, 2013.

There is a possibility that the chemical substances submitted for review in these TSCA section 5 notifications may need to be regulated by EPA under TSCA. The Agency requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents, should regulatory action be required. Therefore, EPA has determined that good cause exists to extend, under TSCA section 5(c), the review period for each such TSCA section 5 notification.

The duration of this extension period is equivalent to the duration of the shutdown, i.e., equivalent to the number of days accruing from October 1, 2013, and the date on which this shutdown terminated on October 16, 2013, and EPA operations resumed on October 17, 2013, or a total of 16 days.

Also, during the shutdown, new notifications submitted on or after October 1, 2013, through E-PMN/CDX or other methods were not processed. Consequently, the review period for any TSCA section 5 notice submitted during the shutdown did not begin until operations resumed on October 17, 2013. Information on the duration of the furlough can be found on www.opm.gov.

September 11, 2013 -- EPA published a final significant new use rule (SNUR) for three chemical substances that were the subject of premanufacture notices (PMNs) P-10-58, P-10-59, and P-10-60.

August 7, 2013 -- EPA published a direct final significant new use rule (SNUR) for 53 chemical substances that were the subject of premanufacture notices (PMNs). EPA will take comments on the rule until September 6, 2013.

July 31, 2013 -- EPA published a final significant new use rule (SNUR) modification for a chemical substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester, which is the subject of premanufacture notice (PMN) P-85-680 at 40 CFR 721.3020.

June 26, 2013 -- EPA published a final significant new use rule (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMNs).

June 19, 2013 -- Fact Sheet Regarding Isotopes - EPA issued a fact sheet that summarizes existing guidance to help industry comply with TSCA section 5 reporting requirements for chemicals that contain isotopic modification to an element in the substance. Read the fact sheet (PDF) (2 pp, 74K).

May 31, 2013 -- EPA proposed a modification to the significant new use rule (SNUR) for a chemical substance that was the subject of premanufacture notice (PMN) P-07-601. EPA will take comments on the modification to the rule until July 1, 2013.

May 9, 2013 -- EPA published a significant new use rule (SNUR) for 15 chemical substances that were the subject of premanufacture notices (PMNs). EPA will take comments on the rule until June 10, 2013.

May 1, 2013 -- EPA published the final significant new use rule (SNUR) for a chemical substance that was the subject of premanufacture notice (PMN) P-01-384.

April 18, 2013 -- EPA proposed a significant new use rule (SNUR) for 8 chemical substances that were subject to premanufacture notices (PMNs). EPA will take comments on the proposal until May 20, 2013.

March 27, 2013 -- EPA published a technical amendment to a significant new use rule (SNUR) issued December 20, 2012, correcting a typographical error.

February 25, 2013 -- EPA proposed a significant new use rule (SNUR) for 37 chemical substances that were subject to premanufacture notices (PMNs). EPA will take comments on the proposal until April 26, 2013.

January 28, 2013 -- EPA proposed a significant new use rule (SNUR) (PDF) (5 pp, 212K) for the chemical substance that was the subject of the premanufacture notice (PMN) P-85-680.

January 23, 2013 -- EPA proposed a significant new use rule (SNUR) (PDF) (7 pp, 258K) for the chemical substances that were the subject of the premanufacture notices (PMNs) P-07-204, P-10-58, P-10-59, and P-10-60.

December 31, 2012 -- EPA withdrew significant new use rules (SNURs) (PDF) (2 pp, 217K) for the chemical substances that were the subject of the premanufacture notices (PMNs) P-07-204, P-10-58, P-10-59,and P-10-60.

December 21, 2012 -- EPA withdrew significant new use rules (SNURs) (PDF) (5 pp, 212K) for the chemical substances that were the subject of the premanufacture notices (PMNs) P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, P-11-332, P-12-298, and P-12-299.

December 20, 2012 -- EPA published a significant new use rule (SNUR) (PDF) (10 pp, 270K) for 9 chemical substances that were the subject of premanufacture notices (PMNs).

December 19, 2012 -- EPA proposed a significant new use rule (SNUR) (PDF) (5 pp, 212K) for the chemical substance that was the subject of the premanufacture notice (PMN) P-01-384.

November 2, 2012 -- EPA published a significant new use rule (SNUR) (PDF) (15 pp, 304K) for 20 chemical substances that were the subject of premanufacture notices (PMNs).

October 5, 2012 -- EPA published a significant new use rule (SNUR) (PDF) (39 pp, 482K) for 78 chemical substances that were the subject of premanufacture notices (PMNs).

September 21, 2012 -- EPA published a significant new use rule (SNUR) (PDF) (42 pp, 486K) for 107 chemical substances that were the subject of premanufacture notices (PMNs).

September 5, 2012 -- EPA is proposing to add two microorganisms (specific strains of the fungus Trichoderma reesei and specific subspecies of the bacterium Bacillus amyloliquefaciens) to the list of 10 recipient microorganisms (40 CFR 725.420) that are eligible for exemptions from full chemical notification requirements under the Toxic Substances Control Act (TSCA). Read the proposed rule.

August 15, 2012 -- EPA published a significant new use rule (SNUR) (PDF) (38 pp, 349K) for 25 chemical substances that were the subject of premanufacture notices (PMNs).

August 1, 2012 -- EPA held a webinar on the e-PMN version 2.0 software.

July 25, 2012 -- EPA withdrew a significant new use rule (SNUR) (PDF) (2 pp, 202K) for the chemical substances that were the subject of the premanufacture notices (PMNs) P-01-384, P-01-385, P-01-386, P-01-387, and P-01-388.