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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 January 23, 2015, EPA published a notice of receipt of premanufacture notices (PMNs) and notices of commencement of manufacture or import (NOCs). This notice covered the period from November 3, 2014 to November 28, 2014. It reported the receipt of 44 PMNs and 36 NOCs.

On January 27, 2015, EPA published a direct final rule amending the list of chemical substances that are partially exempt from reporting additional information under the Chemical Data Reporting (CDR) rule. This direct final rule is effective March 30, 2015, without further notice, unless the Agency receives adverse comment on or before February 26, 2015. If EPA receives written adverse comments, the Agency will withdraw the applicable partial exemption in this direct final rule before its effective date.

Also on January 27, 2015, EPA announced the availability of the Agency’s response to a petition received under TSCA Section 21. The petition was received from the Biobased and Renewable Products Advocacy Group on October 21, 2014. The petitioner requested that EPA initiate a rulemaking to amend the TSCA Section 8 CDR partially-exempted chemical list. After careful consideration, the Agency denied the petition.

On February 2, 2015, EPA promulgated significant new use rules (SNURs) for 27 chemical substances which were the subject of PMNs. Two of these chemical substances are subject to TSCA section 5(e) consent orders. This action requires persons who intend to manufacture, import, or process any of these 27 chemical substances for an activity that is designated as a significant new use by this rule to notify the Agency 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.

On February 17, 2015, EPA published a notice announcing its receipt of test data submitted pursuant to a test rule codified at 40 CFR 799.5087 for D-erythrohex-2-enonic acid, .gamma.-lactone, monosodium salt, CAS Registry Number (CAS RN) 6381-77-7. The notice provided the uses of the subject chemical and the nature of the test data received, as required under TSCA Section 4(d).

On February 20, 2015, EPA published a notice of receipt of PMNs and NOCs. This notice covered the period from December 1, 2014 to December 31, 2014. It reported the receipt of 42 PMNs and 28 NOCs.

On February 23, 2015, EPA extended the comment period, from March 16, 2015 to April 30, 2015, for the proposed SNUR that was published on January 15, 2015 concerning Toluene diisocyanates and related compounds.

On March 3, 2015, EPA extended the comment period, from March 9, 2015 to April 23, 2015, for the proposed SNUR that was published on January 7, 2015 concerning 13 chemical substances which were the subject of PMNs.

On March 6, 2015, EPA promulgated a final SNUR for the chemical substance Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)-, CAS RN 870778-34-0. This action requires persons who intend to manufacture, including import, this chemical substance for an activity that is designated as a significant new use by this final rule to notify the Agency 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.

On March 16, 2015, EPA extended the comment period, from March 23, 2015 to June 26, 2015, for the proposed SNUR that was published on January 21, 2015 concerning Long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances and Perfluoroalkyl sulfonate (PFAS) chemical substances.

On March 19, 2015, EPA published a notice of receipt of PMNs, test marketing exemption (TME) applications and NOCs. This notice covered the period from January 2, 2015 to January 30, 2015. It reported the receipt of 83 PMNs, four TME applications and nine NOCs.

On March 24, 2015, EPA revoked the SNUR for two chemical substances, identified generically as Metal salts of complex inorganic oxyacids, which were the subject of PMNs P-89-576 and P-89-577. The Agency had issued the SNUR based on a TSCA section 5(e) consent order. However, EPA received test data for the chemical substances and is revoking the SNUR.

References:

Environmental Protection Agency. “Certain New Chemicals; Receipt and Status Information.” Federal Register 80 (23 January 2015): 3584-3588. http://www.gpo.gov/fdsys/pkg/FR-2015-01-23/pdf/2015-01173.pdf

Environmental Protection Agency. “Partial Exemption of Certain Chemical Substances From Reporting Additional Chemical Data.” Federal Register 80 (27 January 2015): 4482-4485. http://www.gpo.gov/fdsys/pkg/FR-2015-01-27/pdf/2015-01279.pdf 

Environmental Protection Agency. “TSCA Section 8(a) Partial Exemption in Chemical Data Reporting; TSCA Section 21 Petition; Reasons for Agency Response.” Federal Register 80 (27 January 2015): 4486-4487. http://www.gpo.gov/fdsys/pkg/FR-2015-01-27/pdf/2015-01278.pdf 

Environmental Protection Agency. “Significant New Use Rules on Certain Chemical Substances.” Federal Register 80 (2 February 2015): 5457-5471. http://www.gpo.gov/fdsys/pkg/FR-2015-02-02/pdf/2015-01721.pdf 

Environmental Protection Agency. “Receipt of Test Data Under the Toxic Substances Control Act.” Federal Register 80 (17 February 2015): 8308-8309. http://www.gpo.gov/fdsys/pkg/FR-2015-02-17/pdf/2015-03154.pdf 

Environmental Protection Agency. “Certain New Chemicals; Receipt and Status Information.” Federal Register 80 (20 February 2015): 9262-9266. http://www.gpo.gov/fdsys/pkg/FR-2015-02-20/pdf/2015-03460.pdf

Environmental Protection Agency. “Toluene Diisocyanates (TDI) and Related Compounds; Significant New Use Rule; Extension of Comment Period.” Federal Register 80 (23 February 2015): 9427-9427. http://www.gpo.gov/fdsys/pkg/FR-2015-02-23/pdf/2015-03301.pdf 

Environmental Protection Agency. “Proposed Significant New Use Rule on Certain Chemical Substances; Extension of Comment Period.” Federal Register 80 (3 March 2015): 11361-11361. http://www.gpo.gov/fdsys/pkg/FR-2015-03-03/pdf/2015-04406.pdf 

Environmental Protection Agency. “Significant New Use Rule for Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)-.” Federal Register 80 (6 March 2015): 12083-12083. http://www.gpo.gov/fdsys/pkg/FR-2015-03-06/pdf/2015-05069.pdf 

Environmental Protection Agency. “Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule; Extension of Comment Period.” Federal Register 80 (16 March 2015): 13513-13513. http://www.gpo.gov/fdsys/pkg/FR-2015-03-16/pdf/2015-05958.pdf 

Environmental Protection Agency. “Certain New Chemicals; Receipt and Status Information.” Federal Register 80 (19 March 2015): 14374-14380. http://www.gpo.gov/fdsys/pkg/FR-2015-03-19/pdf/2015-06223.pdf 

Environmental Protection Agency. “Revocation of Significant New Uses of Metal Salts of Complex Inorganic Oxyacids” Federal Register 80 (24 March 2015): 15515-15517. http://www.gpo.gov/fdsys/pkg/FR-2015-03-24/pdf/2015-06474.pdf

 

 

By Nathan Kongprachaya

On January 5, B.E. 2558 (2015), the Department of Industrial Works issued a notification titled, “List of Hazardous Substances (No. 2)” that was subsequently published in the Royal Government Gazette on February 19, B.E. 2558 (2015). The most significant amendment to the List of Hazardous Substances is the addition of Annex 5.6 that categorizes the substances or mixtures in accordance with their hazard properties as Type 1 hazardous substances. Annex 5.6 contains 10 generic hazard properties such as explosive and flammability.    

Excerpt from Annex 5.6 – Groups of Substances Regulated by Properties (in Thai):

 

English Translation for the excerpt from Annex 5.6 – Groups of Substances Regulated by Properties

 

 

Name of Hazardous Substance

CAS No.

Hazardous Substance Type

Condition

1

Explosive

-

1

Only a substance or mixture whose production or import are not under any agency’s responsibility, such activities shall be in accordance with regulations prescribed by the Ministry of Industry

2

Flammable substance

-

1

Only a substance or mixture whose production or import are not under any agency’s responsibility, such activities shall be in accordance with regulations prescribed by the Ministry of Industry

3

Oxidizing agent or peroxide

-

1

Only a substance or mixture whose production or import are not under any agency’s responsibility, such activities shall be in accordance with regulations prescribed by the Ministry of Industry

 

Manufacturers or importers of the substances or mixtures found in Annex 5.6 of more than 1000 kilograms per year are required to notify the Thai Department of Industrial Works using form Wor Or/ Or Kor 20 (วอ./อก. ๒๐) within 60 days from the date of production or import via the department’s online system.

Moreover, manufacturers, importers, exporters and possessors of hazardous substances present in Annex 5.6 are exempted from the following notifications of the Department of Industrial Works:

  • Notification of Ministry of Industry titled “Hazard Classification and Communication System of Hazard Substances” B.E. 2555 (2012)
  • Notification of Ministry of Industry concerning appointment of safety personnel
  • Notification of Ministry of Industry titled “Storage of Hazardous Substances Under the Responsibility of the Department of Industrial Works” B.E. 2551 (2008)
  • Notification of Ministry of Industry titled “Notification of Manufacturers, Importers, Exporters and Possessors of Hazardous Substances Under the Responsibility of the Department of Industrial Works” B.E. 2547 (2004)

References:

Notification of Department of Industrial Works Re: List of Hazardous Substances B.E. 2556 http://www.ratchakitcha.soc.go.th/DATA/PDF/2556/E/125/6.PDF (in Thai)

Notification of Department of Industrial Works Re: List of Hazardous Substances (No. 2) B.E. 2558 http://www.ratchakitcha.soc.go.th/DATA/PDF/2558/E/041/12.PDF (in Thai)

Notification of Department of Industrial Works Re: Notifications of Manufacturers and Importers of Hazardous Substances in Annex 5.6

http://www.ratchakitcha.soc.go.th/DATA/PDF/2558/E/041/15.PDF (in Thai)

Notification of Department of Industrial Works Re: Exemptions from Certain Notifications

http://www.ratchakitcha.soc.go.th/DATA/PDF/2558/E/041/14.PDF (in Thai)

By Tammy J. Murphy

In the 21 March 2015 edition of the Canada Gazette, Part I, Environment Canada and Health Canada, under the Canadian Environmental Protection Act, 1999 (CEPA, 1999), published proposed regulations that would repeal and replace the current Ozone-Depleting Substances Regulations, 1998 (ODSR, 1998) and its subsequent amendments.

The proposed regulations, Ozone-Depleting Substances and Halocarbon Alternatives Regulations, would introduce new requirements to ensure that Canada, a Montreal Protocol signatory, continues to meet its international obligations.

Highlights of the new regulations include, but are not limited to, the following:

  • Implementation of the phase-out schedule, per the Montreal Protocol, for Hydrochlorofluorocarbons (HCFCs);
  • Incorporation of additional prohibitions for multiple ozone-depleting substances (ODSs);
  • Introduction of a permitting and reporting system for Hydrofluorocarbons (HFCs);
  • Allowance of transfer of Methyl bromide for exempt uses

There is a 75-day, from date of publication, public comment and/or objection period.

Additional information can be found on Environment Canada’s CEPA Registry site. The full text of the publication should be consulted for complete details.

Reference:

Canada Gazette, Part I, March 21, 2015 edition: http://canadagazette.gc.ca/rp-pr/p1/2015/2015-03-21/pdf/g1-14912.pdf

 

 

 

 

By Lily Hou, PhD., CHMM

On March 9th, 2015, the State Administration of Work Safety (SAWS), jointly with nine other administrative departments in charge of public security, environmental protection, health, quality control, transportation, etc. of the State Council, published the Catalogue of Hazardous Chemicals (2015). The 2015 Catalogue will replace the existing Catalogue (2002) on May 1st, 2015.

Background

The current Catalogue, published in 2002, is based on the UN Model Regulations on the Transport of Dangerous Goods, thus it contains mainly dangerous goods posing a significant hazard in transportation. With the implementation of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in China in 2011, the existing Catalogue became inconsistent with the new hazard classification system and a revision to align with the GHS hazard classification criteria for chemicals has been highly anticipated. The ten Chinese ministries and agencies have spent considerable effort over the past few years in developing the new Catalogue. On September 26th, 2013, the SAWS released a draft Catalogue of Hazardous Chemicals for public consultations. The public comment period ended on October 31st, 2013.

Content of the Catalogue

The new Catalogue contains 2,936 entries that are classified as hazardous chemicals, including 148 chemicals with acute toxicity, according to the 4th revised edition of UN GHS. Hazardous chemicals in the new Catalogue include pure chemicals as well as mixtures. However, chemicals with the following less hazardous categories are not included in the new Catalogue:

  • Explosives: divisions 1.5 and 1.6
  • Aerosols: categories 2 and 3
  • Flammable liquid: category 4
  • Self-reactive substances and mixtures: types F and G
  • Organic peroxides: type G
  • Acute toxicity: categories 4 and 5
  • Skin corrosion/irritation: category 3
  • Aspiration hazard: category 2
  • Hazardous to the aquatic environment, short-term: category 3
  • Hazardous to the aquatic environment, long-term: category 4

The Catalogue identifies 148 highly acutely toxic chemicals that were chosen based on the following numeric cut-off criteria: Oral LD50 <=5 mg/kg bodyweight or Dermal LD50 <=50 mg/kg bodyweight or Inhalation LC50 <=100 mL/m3 (gas) or Inhalation LC50 <=0.5 mg/L (vapor) or Inhalation LC50 <=0.05 mg/L (dust and mist).

The Catalogue contains only chemical identification information including Chinese names and CAS numbers. GHS hazard classification and labelling information will be provided in the future for the listed chemicals.

Regulatory Requirement on Chemicals in the Catalogue

This Catalogue is considered a key element for the administration of hazardous chemicals in China under the Regulations on the Safe Management of Hazardous Chemicals (Decree No. 591). Companies engaged in production, import, sale and use of the listed hazardous chemicals must comply with several requirements, including, but not limited to:

  • Manufacturers, sellers, importers and users of hazardous chemicals shall apply for a Production License, an Operation License or a Safe Use License with the SAWS.
  • Manufacturers and importers of hazardous chemicals shall register with the National Registration Center for Chemicals under the SAWS prior to manufacture or import.
  • Manufacturers and users of hazardous chemicals for certain production activities shall register with the local environmental protection authorities and acquire environmental administration registration certificates.
  • Importing and exporting the listed hazardous chemicals are subject to entry-exit inspections at a China's port-of-entry. SDS and labels that are in compliance with China GHS standards are required for the inspection.

For hyper-toxic chemicals specified in the Catalogue, additional requirements may apply. For instance, purchasers and transporters of hyper-toxic chemicals must obtain a license or permit authorizing such activities from the Ministry of Public Security prior to conducting these activities.

To learn more information on regulatory requirements for the hazardous chemicals, please refer to Regulations on the Safe Management of Hazardous Chemicals (Decree No. 591).

References:

Catalogue of Hazardous Chemicals (2015)

http://www.chinasafety.gov.cn/newpage/Contents/Channel_21111/2015/0309/247028/content_247028.htm (in Chinese)

Regulations on the Safe Management of Hazardous Chemicals (Decree No. 591)

http://www.gov.cn/zwgk/2011-03/11/content_1822783.htm (in Chinese)