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ChemADVISOR’s Jessica Onyshko appears with her family on the Ellen Degeneres Show:

http://www.ellentv.com/videos/0-ly2o5g0v/

For more information on how to help the Onyshko family, visit:  http://www.gofundme.com/c247ig

By John J. Kowalski, CHMM

Among the most recent Environmental Protection Agency (EPA) actions under the Toxic Substances Control Act (TSCA) are the following:

On June 18, 2014, EPA published a direct final rule to modify significant new use rules (SNURs) for 36 chemical substances which were the subject of premanufacture notices (PMNs). These SNURs were previously issued using generic chemical names. This action replaced the generic chemical names with specific chemical names and Chemical Abstracts Service Registry Numbers (CASRNs), as this information is now publicly available. However, the reporting requirements for these substances did not change. These SNURs will continue to require persons to notify EPA at least 90 days before commencing the manufacture or processing of a subject chemical substance for any activity designated by these SNURs as a significant new use. According to EPA, the receipt of such notices allows the Agency to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed uses before they occur. For additional information, see 79 Fed. Reg. 34634:  http://www.gpo.gov/fdsys/pkg/FR-2014-06-18/pdf/2014-14259.pdf

Also on June 18, 2014, EPA published a notice announcing its receipt of test data for the chemical substance D-gluco-Heptonic acid, monosodium salt, (2.xi.)-, CASRN 31138-65-5. These data were submitted pursuant to a test rule issued by the Agency under TSCA Section 4. For additional information, see 79 Fed. Reg. 34740: http://www.gpo.gov/fdsys/pkg/FR-2014-06-18/pdf/2014-14245.pdf

On June 19, 2014, EPA published a direct final rule to amend the list of chemical substances that are partially exempt from reporting under the Chemical Data Reporting (CDR) rule. With this direct final rule, the following chemical substances were exempted from reporting of the information described at 40 CFR 711.15(b)(4):

  • 1,3-Propanediol, CASRN 504-63-2;
  • Oils, palm kernel, CASRN 8023-79-8; and
  • Bentonite, acid-leached, CASRN 70131-50-9.

For additional information, see 79 Fed. Reg. 35096: http://www.gpo.gov/fdsys/pkg/FR-2014-06-19/pdf/2014-14367.pdf

On July 7, 2014, EPA published two notices of receipt of PMNs and notices of commencement of manufacture or import (NOCs). The first of these two notices covered the period from May 23, 2013 to September 30, 2013. It reported the receipt of 249 PMNS and 63 NOCs. The second of these two notices covered the period from October 1, 2013 to January 30, 2014. It reported the receipt of 248 PMNS and 106 NOCs. For additional information, see 79 Fed. Reg. 38288 (http://www.gpo.gov/fdsys/pkg/FR-2014-07-07/pdf/2014-15760.pdf) and 79 Fed. Reg. 38302: (http://www.gpo.gov/fdsys/pkg/FR-2014-07-07/pdf/2014-15764.pdf), respectively.

Also on July 7, 2014, EPA published a notice announcing its receipt of test data for the chemical substance 1-Decene, sulfurized, CASRN 72162-15-3. These data were submitted pursuant to a test rule issued by the Agency under TSCA Section 4.

For additional information, see 79 Fed. Reg. 38314: http://www.gpo.gov/fdsys/pkg/FR-2014-07-07/pdf/2014-15762.pdf

On July 8, 2014, EPA published a direct final rule to promulgate SNURs for 13 chemical substances which were the subject of PMNs. Three of these chemical substances are subject to TSCA Section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture or process any of these 13 chemical substances 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. According to EPA, the required notification will provide the Agency with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. For additional information, see 79 Fed. Reg. 38464: http://www.gpo.gov/fdsys/pkg/FR-2014-07-08/pdf/2014-15874.pdf

On July 9, 2014, EPA published a direct final rule to promulgate SNURs for 43 chemical substances which were the subject of PMNs. Six of these chemical substances are subject to TSCA Section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture or process any of these 43 chemical substances 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. According to EPA, the required notification will provide the Agency with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. For additional information, see 79 Fed. Reg. 39268:  http://www.gpo.gov/fdsys/pkg/FR-2014-07-09/pdf/2014-15774.pdf

On September 2, 2014, EPA finalized SNURs for 36 chemical substances which were the subject of PMNs. 17 of these chemical substances are subject to TSCA Section 5(e) consent orders issued by EPA. These SNURs were originally proposed on February 25, 2013. This action requires persons who intend to manufacture or process any of these 36 chemical substances for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. According to EPA, the required notification provides the Agency with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. For additional information, see 79 Fed. Reg. 51899: http://www.gpo.gov/fdsys/pkg/FR-2014-09-02/pdf/2014-20783.pdf

On September 4, 2014, EPA withdrew SNURs for six chemical substances which were the subject of PMNs. The Agency published these SNURs, using direct final rulemaking procedures, on July 8 and 9, 2014. EPA subsequently received notices of intent to submit adverse comments on these rules. Therefore, the Agency withdrew these SNURs, as required under the expedited SNUR rulemaking process. EPA intends to publish proposed SNURs for these six chemical substances under separate notice and comment procedures in the near future. For additional information, see 79 Fed. Reg. 52563: http://www.gpo.gov/fdsys/pkg/FR-2014-09-04/pdf/2014-21091.pdf

On September 16, 2014, EPA published two notices of receipt of PMNs and NOCs. The first of these two notices covered the period from February 1, 2014 to March 31, 2014. It reported the receipt of 155 PMNS and 156 NOCs. The second of these two notices covered the period from April 1, 2014 to June 30, 2014. It reported the receipt of 169 PMNS and 89 NOCs. For additional information, see 79 Fed. Reg. 55450: (http://www.gpo.gov/fdsys/pkg/FR-2014-09-16/pdf/2014-22039.pdf) and 79 Fed. Reg. 55460: (http://www.gpo.gov/fdsys/pkg/FR-2014-09-16/pdf/2014-22037.pdf), respectively.

ChemADVISOR’s Dennis Deily talks with attendees at the Brazilian Chemical Trade Association, SINDIQUIM in Porto Alegre, Brazil.

ChemADVISOR’s Dennis Deily (center, in blue) talks with attendees at the Brazilian Chemical Trade Association, SINDIQUIM in Porto Alegre, Brazil.

By Weisin Chai

Following the publication of the Draft Regulation Governing Commission on New Chemical Substances and Existing Chemical Substances Registration and Examination on June 30, 2014, Taiwan's Environmental Protection Administration (EPA) released the Draft Regulation of New Chemical Substances and Existing Chemical Substances Data Registration on August 25, 2014. The former draft regulation provides the scope in appointing a professional agency to handle the registration and approval of existing and new chemical substances and the obligations of the appointing agency. On the other hand, the newly published draft regulation specifies the requirements of the registrations.

The Draft Regulation of New Chemical Substances and Existing Chemical Substances Data Registration is enacted in accordance to Article 7 (1) Paragraph 6 of the Toxic Chemical Substance Control Act (TCSCA).

There are a total of five Chapters and thirty-four Articles in the regulation. Chapter 1 shows the qualifications of the applicants. It provides definitions of terms used in the regulation. Specific descriptions are given to materials such as polymers and intermediates. The exempted substances, as noted below, are also given in Chapter 1:

  • Naturally occurring substance without further physical and chemical processing
  • Chemical substances accompanied in the machines and equipment for test-run purposes
  • Inseparable intermediates from the chemical reaction in the reaction vessel or production process
  • Chemical substances for national defense purposes
  • Chemical substances under customs supervision
  • Wastes
  • Mixtures (Reminder: the chemical substances in the mixture need to be registered)
  • Manufactured articles (If substances contained in articles are released in regular usage, the chemical components shall be registered)
  • A polymer that is applicable to the 2% Rule and listed on the Existing Chemical Substance Inventory
  • Other categories of substances announced by the central competent authority

Chapter 2 refers to details of new chemical registration. There are three types of registration, i.e. Small Quantity, Simplified and Standard Registration. The type of registration is applied based on the manufactured or imported annual tonnage and type of substance(s). The valid period(s) of registration document for each type of registration are specified. Registration is exempted for manufacture or import of polymers of low concern with annual tonnage of less than 1 metric ton. Similar to the European Union Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), joint registration is permitted and introduced in Article 11. If registered new chemicals meet the definition of Class 1, Class 2 and Class 3 Toxic Chemical Substances, prohibitions or restrictions in handling the substances may be imposed by the central competent authority. Substances manufactured between the effective dates of the regulation, i.e. December 11, 2014 to December 31, 2014, shall work on Small Quantity registration.

Chapter 3 covers the existing chemical registration. Existing chemical registration shall be done in phases. An existing chemical substance manufactured or imported in annual quantities over 100 kilograms or more shall complete Phase 1 registration between September 1, 2015 and March 31, 2016. Existing chemical substances manufactured or imported for the first time after March 31, 2016 shall be registered within the period designated by the central competent authority. Based on the situation of the Phase 1 registration, the central competent authority will announce the list of existing chemical substances subjected to the next phase of existing chemical substances standard registration. The announcement shall include the range of quantities and the designated registration period. Joint registration is also permitted for existing chemical registration.

Chapter 4 specifies information on data protection. The following data of the registered substances shall be publicly announced online:

  • Chemical name
  • Manufacture or import conditions
  • Hazard classification and labelling
  • Safe use information
  • Physical and chemical properties
  • Toxicological and eco-toxicological information
  • Hazard assessment
  • Exposure assessment

To be considered as confidential business information, the following conditions shall be met:

  • The information is not commonly known
  • The information has economic value, actual or potential, due to its secretive nature
  • Reasonable measures to maintain the secrecy has been taken

The following data may be protected as confidential business information:

  • Chemical substance identity
  • Information on manufacture or import of chemical substance
  • Chemical substance use information

The application for data protection shall be done within 3 to 6 months prior to the new/existing chemical substance registration. The data shall be protected for 5 years. Renewal can be done once.

Chapter 5 provides supplementary regulations, including registration processing time, the change of registered information, the revocation of registration, the cost of registration and so forth. The registration document and application of data protection are required to be kept for at least 5 years and 10 years respectively.

The appendices attached to the regulation are given as below:

  • Appendix 1 – Information required in Standard Registration of new chemical
  • Appendix 2 – Information required in Simplified Registration of new chemical
  • Appendix 3 – Information required in Small Quantity Registration of new chemical
  • Appendix 4 – Information published on the registration document of new chemical
  • Appendix 5 – Information required in Phase 1 Registration of existing chemical
  • Appendix 6 – Information required in Standard Registration of existing chemical
  • Appendix 7 - Information published on the registration document of existing chemical

The Draft Regulation of New Chemical Substances and Existing Chemical Substances Data Registration had been opened for public comment. If approved, the regulation shall be effective December 11, 2014.

Meanwhile, Taiwan EPA introduces a trial new and existing chemical registration tool. Several seminars are being held by the Safety and Health Technology Center (SAHTECH) in Taiwan from September 22, 2014 to October 17, 2014.

References:

Draft Regulation of New Chemical Substances and Existing Chemical Substances Data Registration

http://ivy5.epa.gov.tw/epalaw/prelaw/pre10308040.doc

Toxic Chemical Substances Control Act (TCSCA)

http://ivy5.epa.gov.tw/epalaw/search/LordiDispFull.aspx?ltype=08&lname=0010

Trial New and Existing Chemical Registration Tool

http://www.tcscachemreg.org.tw/content/login/NewsDetail.aspx?enc=avVPCIqAugiYpNq4kfzEkg==

Seminar Schedules held by Safety and Health Technology Center (SAHTECH)

http://www.sahtech.org/seminar.aspx