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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 December 9, 2014, EPA published a decision on a request for a waiver from testing under 40 CFR Part 766. More specifically, the Agency denied a request from Nation Ford Chemical (NFC) for a waiver from testing Chloranil (2,3,5,6-Tetrachloro-2,5-cyclohexadiene-1,4-dione). Regulations under 40 CFR Part 766 require that specified chemical substances be tested to determine if they are contaminated with Halogenated dibenzo-p-dioxins (HDDs) or Halogenated dibenzofurans (HDFs) and that the results of such tests be reported to EPA. However, the regulations allow for exclusion or waiver from these requirements if an appropriate application is submitted to and approved by the Agency. EPA received an application for a waiver from these testing requirements from NFC, which it subsequently denied on October 17, 2014.

Also on December 9, 2014, EPA published a notice announcing its receipt of test data submitted pursuant to test rules issued by the Agency under TSCA Section 4 for three chemical substances identified in the notice. For each of the three substances, the notice provides the chemical uses, the applicable test rule and the test data received, as required under TSCA Section 4(d).

On December 10, 2014, 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 October 6, 2014 to October 30, 2014. It reported the receipt of 52 PMNs and 26 NOCs.

On December 16, 2014, EPA published a final significant new use rule (SNUR) for seven ethylene glycol ethers, also known as glymes. This rule will require persons who intend to manufacture (including import) or process any of the seven ethylene glycol ethers for an activity that is designated as a significant new use by this rule to notify the Agency at least 90 days before commencing such manufacture or processing. According to EPA, the required notifications will provide the Agency with the opportunity to evaluate the intended uses and, if necessary, to protect against potential unreasonable risks from that activity before it occurs. This final rule is effective February 17, 2015.

On December 17, 2014, EPA proposed to revoke the SNUR for two chemical substances which were the subject of PMNs P-89-576 and P-89-577. The Agency issued the SNUR based on a TSCA Section 5(e) consent order designating certain activities as significant new uses. EPA has since received test data for the chemical substances and is proposing to revoke the SNUR.

On December 23, 2014, EPA withdrew SNURs for 30 chemical substances which were the subject of PMNs. The Agency published these SNURs using direct final rulemaking procedures, which require EPA to take certain actions if an adverse comment is received. The Agency received adverse comments regarding the SNURs identified in this document. Therefore, it is withdrawing the direct final rule SNURs identified in this document, as required under the direct final rulemaking procedures. This document took effect on December 26, 2014.

On December 29, 2014, EPA published a final rule to add nine benzidine-based chemical substances to the existing SNUR on benzidine-based chemical substances. With respect to both the newly-added benzidine-based chemical substances and the previously-listed benzidine-based chemical substances, this rule makes inapplicable the exemption relating to persons that import or process substances as part of an article. The Agency also promulgated a SNUR for Di-n-pentyl phthalate (DnPP) and a SNUR for Alkanes, C12-13, chloro. These actions require persons who intend to manufacture (defined by statute to include import) or process these chemical substances for an activity that is designated as a significant new use to notify the Agency at least 90 days before commencing such manufacture or processing. According to EPA, the required notifications will provide the Agency with the opportunity to evaluate activities associated with a significant new use and, if necessary, to protect against potential unreasonable risks, if any, from that activity before it occurs. This final rule is effective on February 27, 2015.

On January 7, 2015, EPA published proposed SNURs for 13 chemical substances which were the subject of PMNs. This action would require persons who intend to manufacture (including import) or process any of the chemical substances for an activity that is designated as a significant new use by this proposed rule to notify the Agency at least 90 days before commencing that activity. According to EPA, the required notification would provide the Agency with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. Comments must be received on or before March 9, 2015.

On January 14, 2015, EPA published a notice announcing its receipt of test data submitted pursuant to test rules issued by the Agency under TSCA Section 4 for two chemical substances identified in the notice. For each of the substances, the notice provides the chemical uses, the applicable test rule and the test data received, as required under TSCA Section 4(d).

On January 15, 2015, EPA published a proposed SNUR for 2,4-Toluene diisocyanate, 2,6-Toluene diisocyanate, Toluene diisocyanate, unspecified isomers, and related compounds as identified in this proposed rule. The proposed significant new use is any use in a consumer product, with a proposed exception for use of certain chemical substances in coatings, elastomers, adhesives, binders and sealants that results in less than or equal to 0.1 percent by weight of Toluene diisocyanate in a consumer product. In addition, EPA proposed that the general SNUR article exemption for persons who import or process these chemical substances as part of an article would not apply. Persons subject to the SNUR would be required to notify the Agency at least 90 days before commencing any manufacturing or processing. According to EPA, the required notification would provide the Agency with the opportunity to evaluate the intended use and, if necessary, to protect against potential unreasonable risks, if any, from that activity before it occurs. Comments on this proposed SNUR must be received on or before March 16, 2015.

On January 21, 2015, EPA proposed to amend a SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses. For this SNUR, the Agency also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles. In addition, EPA also proposed to amend a SNUR for perfluoroalkyl sulfonate (PFAS) chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets. Persons subject to these SNURs would be required to notify the Agency at least 90 days before commencing such manufacture or processing. According to EPA, the required notifications would provide the Agency with the opportunity to evaluate the intended use and, if necessary, to protect against potential unreasonable risks from that activity before it occurs. Comments must be received on or before March 23, 2015.

References:

Environmental Protection Agency. “Decision on Request for Waiver from Testing.” Federal Register 79 (9 December 2014): 72984-72985. http://www.gpo.gov/fdsys/pkg/FR-2014-12-09/pdf/2014-28824.pdf Environmental Protection Agency. “Receipt of Test Data under the Toxic Substances Control Act” Federal Register 79 (9 December 2014): 73070-73071. http://www.gpo.gov/fdsys/pkg/FR-2014-12-09/pdf/2014-28821.pdf

Environmental Protection Agency. “Certain New Chemicals; Receipt and Status Information.” Federal Register 79 (10 December 2014): 73297-73301. http://www.gpo.gov/fdsys/pkg/FR-2014-12-10/pdf/2014-28944.pdf

Environmental Protection Agency. “Ethylene Glycol Ethers; Significant New Use Rule” Federal Register 79 (16 December 2014): 74639-74647. http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29429.pdf

Environmental Protection Agency. “Proposed Revocation of Significant New Uses of Metal Salts of Complex Inorganic Acids” Federal Register 79 (17 December 2014): 75111-75113. http://www.gpo.gov/fdsys/pkg/FR-2014-12-17/pdf/2014-29575.pdf Environmental Protection Agency. “Significant New Use Rules on Certain Chemical Substances; Withdrawal” Federal Register 79 (23 December 2014): 76900-76901. http://www.gpo.gov/fdsys/pkg/FR-2014-12-23/pdf/2014-30023.pdf Environmental Protection Agency. “Benzidine-Based Chemical Substances; Di-n-pentyl Phthalate (DnPP); and Alkanes, C12-13, Chloro; Significant New Use Rule” Federal Register 79 (29 December 2014): 77891-77911. http://www.gpo.gov/fdsys/pkg/FR-2014-12-29/pdf/2014-29887.pdf

Environmental Protection Agency. “Proposed Significant New Use Rule on Certain Chemical Substances” Federal Register 80 (7 January 2015): 838-845. http://www.gpo.gov/fdsys/pkg/FR-2015-01-07/html/2014-30829.htm Environmental Protection Agency. “Receipt of Test Data under the Toxic Substances Control Act” Federal Register 80 (14 January 2015): 1913-1913. http://www.gpo.gov/fdsys/pkg/FR-2015-01-14/pdf/2015-00507.pdf

Environmental Protection Agency. “Toluene Diisocyanates (TDI) and Related Compounds; Significant New Use Rule” Federal Register 80 (15 January 2015): 2068-2077. http://www.gpo.gov/fdsys/pkg/FR-2015-01-15/pdf/2015-00474.pdf Environmental Protection Agency. “Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule” Federal Register 80 (21 January 2015): 2885-2898. http://www.gpo.gov/fdsys/pkg/FR-2015-01-21/pdf/2015-00636.pdf Key Words:

By Nathan Kongprachaya

The control of business-related activities (the manufacture, import, export and possession for professional use) of chemicals in Thailand is mainly regulated through the Hazardous Substance Act B.E. 2535. Six government agencies - the Department of Agriculture, the Department of Fisheries, the Department of Livestock Development, the Food and Drug Administration, the Department of Industrial Works, and the Department of Energy Business - oversee the control of their respective hazardous substances and each has the authority to promulgate and/or amend regulations as established by the Hazardous Substance Act through departmental notifications. Hazardous substances in Thailand are categorized into four types (Type 1, 2, 3 and 4) according to their control requirements. Type 1 hazardous substances are subjected to the least stringent regulations while all activities germane to Type 4 substances are prohibited.

Based on the Hazardous Substance Act, Thailand adopted the UN GHS revision 3 on March-12, 2012 through the Notification of Ministry of Industry on Hazard Classification and Communication System of Hazardous Substances B.E. 2555. Manufacturers and importers of hazardous substances (defined as either a substance or a mixture) must comply with the requirements annexed to the Notification as follows:

  1. Evaluate product against the criteria for 16 classes of physical hazards, 10 classes of health hazards, and 2 classes of environmental hazards;
  2. Apply correct labeling;
  3. Prepare safety data sheets.

These requirements shall be complied with within 1 year after the notification was published in the Government Gazette for substances (March 12, 2013) and within 5 years for mixtures (March 12, 2017).

While there are six authoritative agencies that are responsible for their respective list of hazardous substances, only hazardous substances under the responsibility of Department of Industrial Works are currently classified to conform to the GHS classification. The remaining authorities are working to classify their substances to align with revision 3 of the UN GHS.  

The Thai FDA under the Ministry of Public Health is drafting a notification to classify the substances under its oversight (consumer products) to comply with GHS classification, similar to that of the Department of Industrial Works’ hazard classification and communication system. The comment period for this proposed regulations concerning GHS-compliant classification of hazardous substances will end on January 20, 2015.

References:

Hazardous Substance Act B.E. 2535

http://www.ratchakitcha.soc.go.th/DATA/PDF/2535/A/039/21.PDF

Hazardous Substance Act (No. 2) B.E. 2544

http://www.ratchakitcha.soc.go.th/DATA/PDF/00027042.PDF

Hazardous Substance Act (No. 3) B.E. 2551

http://www.ratchakitcha.soc.go.th/DATA/PDF/2551/A/038/23.PDF

Consolidated List of Hazardous Substances

http://www.ratchakitcha.soc.go.th/DATA/PDF/2556/E/125/6.PDF

GHS Classification of Hazardous Substances

http://ghs.diw.go.th:8080/GHSThaiUser/jsp/search.jsp

Notification of Ministry of Industry titled, “Hazard Classification and Communication System of Hazard Substances” B.E. 2555 (2012)

http://www.ratchakitcha.soc.go.th/DATA/PDF/2555/E/048/15.PDF

Current Regulations and Proposed Amendments (Ministry of Public Health)

http://www.fda.moph.go.th/psiond/download/provincial/ประชุม24_250156/1_ภญ.ขวัญจิต_สถานการณ์กำกับดูแลวอ2556.pdf

End of Comment Period for Classification of Hazardous Substances

http://gsi.nist.gov/global/index.cfm/L1-7/L2-28/A-413/R-57CC0B84_1E98_E411_B3D5_005056993DBD

By Kelsey Squelch

The Health and Safety Reform Bill is currently before Parliament in New Zealand, intended to replace the Health and Safety in Employment Act (HSE). The new act, entitled Health and Safety at Work (HSW) Act would amend the Hazardous Substances and New Organisms (HSNO) Act. If the Bill is passed, the HSNO will no longer be given power to create regulations. Instead, the Environment Protection Agency (EPA) would be given the authority to make legally binding notices. These notices would be a tertiary level instrument that would be part of the legislative framework in order to manage hazardous substances. If the EPA is granted authority to create notices, it would no longer be necessary to go through the Cabinet to change regulations making the process of changing and updating regulations much easier. Issuing notices will be the responsibility of the EPA Board and need to be signed by the chair of the EPA. Each new notice will be announced in the New Zealand Gazette.

On December 2, 2014 the EPA made consultation documents on five proposal notices available via their website. The consultation documents are a set of information on four proposed EPA notices (hazard classification system, labelling, safety data sheet, and packaging) and information on the fifth EPA Notice proposal: the enforcement officer qualification proposal.  

In April 2012, the Government established the Independent Taskforce on Workplace Health and Safety (the Taskforce). The Taskforce had the task of assessing the management of hazardous substances and occupational health. The finding of their assessment was that there was not enough focus on broad occupational health issues. They also found that the current approach of dealing with hazardous substances was much too complex. The Taskforce believed the complexity was adversely impacting human health. After the assessment, the Government announced the “Work Safer” reform. A key component of the reform was the Health and Safety Reform Bill. The reform would make many changes to the duties of the HSNO regulations. Though many duties would change under the reform, the following would remain under the HSNO regulation:

  • Assessment and approval of all hazardous substances
  • Classifying all hazardous substances
  • Setting controls (EPA controls) that apply to all hazardous substance, including controls for labelling, safety data sheets, and packaging
  • Setting environment controls, disposal controls, non-working controls, and content controls

The overall drive of the reform is to make dealing with hazardous substances a safer process by simplifying and aligning the new standards with international requirements. The proposals are designed to imitate the standards adopted by the major trading partners of New Zealand. Aligning New Zealand’s standards with their international trading partners is intended to simplify the trade in hazardous substances. New Zealand is choosing to align their standards with that of the United Nations Globally Harmonised System of Classification and Labelling (GHS).

EPA Classification Notice

Currently, the information to determine a hazardous substance covered by the HSNO Act can be found in the Hazardous Substance (Minimum Degree of Hazard) Regulations 2001. The classification system for hazardous substances can currently be found in the Hazardous Substance (Classification) Regulations 2001. These regulations provide classification criteria for degrees and types of hazardous materials, as well as, providing the outline of the current classification system New Zealand. The current classification system uses a combination of numbers and letters. The system that is used currently in New Zealand is unique to the country. The intention of the EPA Classification Notice is to update and consolidate the classification criteria currently outlined in the regulations mentioned before. In doing so, the current HSNO classification numbering system will be discontinued. If the reform is adopted, New Zealand would adopt the fifth revision, of the GHS. A transition period would be allotted if the reform is adopted, in which guidance material would be made available that would include the current HSNO classification system and the GHS system.

EPA Notice for Labelling

The current HSNO labelling requirements can be found in the following:

  • Hazardous Substance (Identification) Regulations 2001
  • Hazardous Substances (Emergency Management) Regulations 2001
  • Hazardous Substances (Disposal) Regulations 2001
  • Group standards

Along with the requirements outlined in the above regulations, two labelling codes are found in:

  • “Labelling of Hazardous Substances”, Prepared by Responsible Care New Zealand
  • “Product Labelling and Documentation Code for Agricultural Compounds and Veterinary Medicines”, prepared by AGCARM

The EPA Notice would consolidate and replace the requirements currently found in the regulations described above. Like the EPA Classification Notice, the EPA Notice for Labelling will be formatted to be consistent with New Zealand’s major international trading partners. The responsibility to comply with the EPA Notice would be entirely of the importers and manufacturers of hazardous substances. Like the EPA Classification Notice, there would be a transition period if the reform is passed.

EPA Notice for Safety Data Sheets

The HSNO requirements for safety data sheets (SDS) are currently found in the following:

  • Hazardous Substances (Identification) Regulations 2001
  • Hazardous Substances (Disposal) Regulations 2001
  • Hazardous Substances (Emergency Management) Regulations 2001
  • Hazardous Substances (Disposal) Regulations 2001
  • Group standards

The current regulations are performance-based and the group standards follow GHS requirements. Along with the regulations and group standard, a code of practice for SDS was prepared by Responsible Care New Zealand to provide aid on creating an SDS. The EPA Notice for Safety Data Sheets looks to provide specific requirements for the format, content, supply and revision of SDS. The requirements that will be outlined in the notice will be consistent with GHS requirements. Importers and manufacturers would have the responsibility of ensuring their SDS comply with the requirements. The requirements, though, for workplace SDS would be found under the new HSW legislations. There will also be a two year transition period if the Reform is adopted.

EPA Notice for Packaging

Packaging requirements are currently found in the following and largely based on the UN Model Regulations:

  • Hazardous Substances (Packaging) Regulation 2001
  • Group standards

The proposed EPA Notice for Packaging has hopes to rationalize and consolidate the different packaging regulations. Along with that, the notice will remove inconsistencies that lie between the current regulations. As with the other proposals mentioned, a two year transition period would be allotted.

EPA Notice for HS Enforcement Officer Qualifications

There are 85 different agencies listed in the HSNO Act that are given power to enforce hazardous substance requirements. The qualifications of an officer can be found currently in Section 100(1) of Regulation 7 of the Hazardous Substances and New Organisms (Personnel Qualifications) Regulations 2001 (PQ Regulations). Many agencies find the current requirements difficult to meet. As a result, the agencies have only a few or no HSNO-warrant enforcement officers. If the reform is passed the EPA Notice for HS Enforcement Officer Qualification will revoke the PQ Regulations and simplify the qualification requirements. Unlike the other proposals, the EPA Notice for HS Enforcement Officer Qualifications would not have a transitional period if the reform is adopted.

New Zealand is looking to reform its current Hazardous Substances and New Organisms (HSNO) Act in hopes to simplify and align better with its major trading partners. If the Reform is passed the EPA will establish regulations in the form of notices. The EPA has released five proposal notices with hopes to release more. They are asking for the public’s feedback on the proposed notices by February 20, 2015.  

References:

Reform of Hazardous Substances Management under the HSNO Act, Proposal for an EPA Notice for Enforcement Officer Qualification:

http://www.epa.govt.nz/Publications/EPA_Notices_Discussion_EO_Quals_.pdf

Reform of Hazardous Substances Management under the HSNO Act, Proposals for EPA Notices for Classification, Labelling, SDS and Packaging:

http://www.epa.govt.nz/Publications/EPA_Notices_Discussion_Class_Labelling_SDS_Packaging.pdf

EPA website:

http://www.epa.govt.nz/consultations/hazardous-substances/Pages/notices-consultation-documents.aspx

By Melissa Campbell

The Office of Environmental Health Hazard Assessment (OEHHA) has proposed to repeal the current Article 6 regulation and adopt new regulations in Article 6 of Title 27 of the California Code of Regulations. These new regulations enhance Proposition 65 in a number of ways. The “right-to-know” purposes would be enhanced and more specific guidance on the safe harbor warnings will be provided. A section will be added to the regulations addressing the responsibilities for providing warnings for businesses in commerce and retail.

For background purposes, OEHHA maintains a list of chemicals known to cause reproductive toxicity or cancer. Proposition 65 requires businesses to provide a warning when they are knowingly causing an exposure to such chemicals. These chemicals are prohibited from entering any sources of drinking water. Under the current Article 6 regulations, a warning is described as “clear” if it communicates that the chemical is known to the State of California to cause cancer and/or reproductive harm in a clear way. The warning is described as “reasonable” if the method employed to convey the warning is reasonably calculated to make the message available to the individual prior to exposure. Currently, however, Article 6 lacks the specificity in the safe harbor warning to ensure that the public receives information about the possible exposures to these chemicals.

OEHHA plans to address many of these issues in the proposed regulatory action. Clarification will be made in regards to the relative responsibilities of manufacturers and other parties in distribution for providing warnings for products that will be sold in retail. The current requirements for “safe harbor” warnings will be changed so that more useful information will be present to the public about the exposures to these chemicals. This information includes how to avoid and reduce exposures, which, in turn, furthers the “right-to-know” purposes of the statue. The regulatory proposal will also provide more specificity for the minimum elements of a “clear and reasonable” warning for exposures. These exposures include those from products (including food) and those from environmental settings. More compliance assistance will also be provided. Overall, the access to more detailed information will promote public health and safety in a more efficient and meaningful way.

The new content of the Article specifies the content that is required for the warnings. This includes a symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold, black outline. The symbol may be printed in black and white and should be placed to the left of the text of the warning. The size must be no smaller than the height of the word “WARNING.” This word must be in bold, capital letters. For exposures to carcinogenic chemicals, the following statement must be added: “This product can expose you to a chemical(s) known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov/product.” For exposures to reproductive toxicants, the following statement must be added: “This product can expose you to a chemical(s) known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov/product.” For exposures to both carcinogenic and reproductive toxicants, the following statement must be added: “This product can expose you to a chemical(s) known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov/product.” When the name(s) of chemicals are required to be included in the warning, the following statement must be added: “This product can expose you to a chemical(s) such as [name(s) of chemicals] that is known to the State of California to cause cancer (or birth defects or other reproductive harm or cancer and birth defects or other reproductive harm.) For more information, go to www.P65Warnings.ca.gov/product.” The chemicals that must be included in this warning are acrylamide, arsenic, benzene, cadmium, carbon monoxide, chlorinated tris, formaldehyde, hexavalent chromium, lead, mercury, methylene chloride, and phthalate(s).

Once the regulation changes are finalized, there will be a two year transition period. A public hearing will be held on March 25, 2015. This hearing will be open to any person who wishes to provide statements or arguments relevant to the action described in the notice. The public is encouraged to write comments in regards to these new regulations. Written comments must be received by OEHHA by April 8, 2015. These will then be posted on the OEHHA website following the public hearing.

http://oehha.ca.gov/prop65/CRNR_notices/WarningWeb/NPR_Article6.html

http://oehha.ca.gov/prop65/CRNR_notices/WarningWeb/pdf/ProposedArticle6_strikethrough.pdf