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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

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.