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Top International News in Chemical Policy and Regulation: Americas, Middle East, China

Bergeson & Campbell, P.C.’s  much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and The Acta Group (Acta®), B&C’s affiliated consulting firm, offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.

BRAZIL

Brazilian Government Addresses Issues With Previous Take Back Legislation: In our August 2017 Global Monthly Update, as well as our “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2017,” Acta discussed Brazil’s efforts to implement “take back” legislation, which required companies to accept packaging and certain types of products at the end of their useful lives for proper disposal. On October 23, 2017, the government of Brazil published Decreto No. 9177 (Decreto) in the Diário Oficial Da União (Official Journal), essentially a corollary to the “take back” legislation established under the auspices of the National Solid Waste Policy Law (No. 12305/2010).

The rationale for the Decreto was to manage competitive disadvantages faced by those entities that failed to participate in the “take back” legislation. That is, companies and other entities that used the facilities set up by those that actively adhered to the legislation reaped the benefits of compliance often without any financial or other stake in the process. Thus, costs were disproportionally allocated. The Decreto went into effect upon its publication in the Official Gazette.

Brazilian Authority Extends Dangerous Goods Transport Regulation Deadline: The Competent Authority for the transport of dangerous goods (DG) in Brazil, the Agência Nacional de Transporte Terrestre (National Land Transport Agency, ANTT), has extended its compliance deadline for entities that transport DGs in the country. ANTT is responsible for regulating the transport of DGs on Brazilian highways and railways.

Resolution No. 5377 amended Resolution No. 5232 that was initially promulgated by ANTT on December 14, 2016. Resolution No. 5377 extended the effective compliance date from July 16, 2017, to one year from the initial publication date, December 14, 2017.

Resolution No. 5377 specifies detailed requirements for the transport of DGs by road, setting out requirements for product classification, marking and labeling of packaging, signaling of transport units, and documentation required, among other items.

CANADA

Canada Publishes Notice With Respect To Substances In The NPRI For 2018 And 2019: On January 20, 2018, Environment and Climate Change Canada published a Canada Gazette notice with respect to substances in the National Pollutant Release Inventory (NPRI) for 2018 and 2019. Under the authority of the Canadian Environmental Protection Act, 1999 (CEPA), owners or operators of facilities that meet the published reporting requirements are required to report to the NPRI. Companies that meet reporting requirements but fail to report, do not report on time, or knowingly submit false or misleading information, face penalties. Environment and Climate Change Canada suggests that facilities that in previous years did not meet the reporting criteria or were exempt should review their status to determine whether they are required to report for the current reporting year. The notice applies to the calendar years 2018 and 2019. Information pertaining to the 2018 calendar year must be provided no later than June 1, 2019. Information pertaining to the 2019 calendar year shall be provided no later than June 1, 2020.
 

CHINA

China Issues List Of Priority Chemicals For Management (First Batch): As reported in our January 11, 2018, memorandum, “China Issues List of Priority Chemicals for Management (First Batch),” on December 27, 2017, the Ministry of Environmental Protection (MEP), Ministry of Industry and Information Technology (MIIT), and National Health and Family Planning Commission (NHFPC) jointly issued the List of Priority Chemicals for Management (first batch) to control strictly chemicals that are hazardous, persistent, and harmful to the environment and human health. The List is based on the mandate issued by the Action Plan for Prevention and Control of Water Pollution signed by the State Council of the People’s Republic of China on April 2, 2015.

The List of Priority Chemicals for Management (first batch) contains 22 groups of chemicals, which is significantly less than the draft list for internal consultation, which contained 36 groups of chemicals. These chemicals include arsenic, lead, mercury, hexavalent chromium, and cadmium and its compounds; persistent, bioaccumulative, and toxic (PBT) chemicals identified according to the national standard GB/T 24782-2009 -- Identification Method of PBT Substances, and Very Persistent and Very Bioaccumulative (vPvB) Substances; carcinogenic, toxic to reproduction (CMR) chemicals and chemicals with high aquatic environmental toxicity classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and the national standard GB 3000-2013 -- Rules for Classification and Labelling of Chemicals; and chemicals manufactured or used in huge quantities in China. The List includes:

No.

Chemical Name

CAS No.

PC001

1,2,4-trichlorobenzene

120-82-1

PC002

1,3-butadiene

106-99-0

PC003

5-tert-Butyl-2,4,6-trinitro-m-xylene
(Musk xylene)

81-15-2

PC004

N,N'-Bis(methylphenyl)-1,4-benzenediamine

27417-40-9

PC005

Short-Chain Chlorinated Paraffins (SCCP)

85535-84-8

68920-70-7

71011-12-6

85536-22-7

85681-73-8

108171-26-2

PC006

Dichloromethane

75-09-2

PC007

Cadmium and cadmium compounds

7440-43-9

PC008

Mercury and mercury compounds

7439-97-6

PC009

Formaldehyde

50-00-0

PC010

Hexavalent chromium compounds

 

PC011

Hexachloro-1,3-cyclopentadiene

77-47-4

PC012

Hexabromocyclododecane

25637-99-4

3194-55-6

134237-50-6

134237-51-7

134237-52-8

PC013

Naphthalene

91-20-3

PC014

Lead compounds

 

PC015

Perfluorooctanesulfonic acid (PFOS), its salts, and perfluorooctane sulfonyl fluoride (PFOSF)

1763-23-1

307-35-7

2795-39-3

29457-72-5

29081-56-9

70225-14-8

56773-42-3

251099-16-8

PC016

Nonylphenol and nonylphenol polyoxyethylene ether

25154-52-3

84852-15-3

9016-45-9

PC017

Trichloromethane

67-66-3

PC018

Trichlorethylene

79-01-6

PC019

Arsenic and arsenic compounds

7440-38-2

PC020

Decabromodiphenyl ether (DecaBDE)

1163-19-5

PC021

Tetrachloroethylene

127-18-4

PC022

Acetaldehyde

75-07-0

The production and use of the chemicals on the List are restricted and safer alternatives of these priority chemicals are promoted. A discharge permit is required for producers and operators who directly or indirectly discharge these chemical wastes to water. A mandatory clean manufacturing audit and disclosure to the public are required for manufacturers that use or release these chemicals. These actions are existing risk control/management measures. The substances on the List were immediately added into these measures.

CHILE

New Microbial Pesticide Regulation To Be Promulgated In Chile: On January 4, 2018, Chilean Servicio de Agricultura y Ganadería (Agriculture and Livestock Service; SAG) published the “Resolución Exenta que establece condiciones y requisitos para autorizar plaguicidas microbianos” (Exempt Resolution Establishing the Conditions and Requirements for the Authorization of Microbial Pesticides; Resolución) for notice and comment. The Resolución defines the technical requirements and conditions for the assessment and authorization of microbial pesticides. SAG has recognized an increasing need for the use of such products in the country, but historically has lacked a formal process for managing such. The Resolución also establishes definitions related to microbial pesticides, categories of such for registration purposes, and technical and documentation requirements for the identification of the target microorganism(s) and its active metabolic products. With a view toward the expected long-term use of such pesticides, the Resolución provides for an examination of the substances’ biological properties and uses, the analytical methods defined for evaluation, safety information, any effects on non-target organisms, and the specific data necessary for a complete application.

The comment period expires March 3, 2018.

COSTA RICA

Costa Rican Representatives Propose Waste Law Changes To Impact Producers: The Costa Rican Asamblea Legislativa (Legislative Assembly), the unicameral legislative branch of the government, has put forth a bill to modify the Ley de Gestión Integral de Residuos (Law for Integral Waste Management (No. 8839/2010); Ley). The bill’s language would impose a variety of responsibilities on producers, distributors, and sellers of five “priority products” (electrical and electronic equipment, cells and batteries, containers and packaging, lubricating oils, and tires). Key among the responsibilities drafted for such entities is to organize and finance the collection of such product waste throughout Costa Rica, as well as ensuring compliance with applicable storage, transport, and treatment requirements already enumerated in the Ley. Further language would mandate that the management of the identified wastes is undertaken by entities that are authorized and registered for that purpose.

Costa Rican Ministry Issues Hazardous Chemicals Fee Collection Regulation: The Ministério de Salud (Ministry of Health) has promulgated Decree No. 40769-S, which establishes the regulations relating to the collection of fees for hazardous chemical registration and control. Under Chapter II, Article 3, three specific services have attendant payment requirements: “Registro, renovación del registro o uso de registro de productos químicos peligrosos” (registration, renewal of registration or use of dangerous chemical product registration), “Trámite de cambios posteriores al registro de productos químicos peligrosos” (changes to registration of such dangerous chemical products), and “Análisis para: el control de productos, la atención de denuncias o alertas relacionadas con los productos químicos peligrosos” (analysis for the control of hazardous chemicals, and management of complaints or alerts related to the same). Interestingly, all fees are specifically listed in U.S. dollars in the regulation.

Decree No. 40769-S will go into effect two months after its publication in the Official Gazette.

MIDDLE EAST

Several Middle Eastern Countries Address Chemical Substances Specific To Household Detergents: The governments of Bahrain, Oman, Saudi Arabia, and the United Arab Emirates (UAE) have notified the World Trade Organization (WTO) of their intent to implement the Gulf Cooperation Council (GCC) Standard Organization’s (GSO) Draft Technical Regulation “General Safety Requirements of Household Detergents” (Requirements) into their respective national laws.

The manifest purpose of the Requirements is to ensure a high degree of environmental protection and human safety with respect to household detergents. Such detergents are defined in Section 3.1 as “Any substance or mixture containing soaps and/or other surfactants intended for washing and cleaning processes…in any form…and marketed for or used in household, or domestic purposes.” The Requirements specifically exempts “industrial and institutional detergents as well as products with disinfectant and germicidal properties”.

Section 4 lays out the following requirements for such detergents:

  1. They shall have no harmful effects to either the consumer or the fabrics/surface or the environment when used according to the instructions on the product label;
     
  2. Its properties shall not change substantially within at least 12 months from the date of production to a point where the activity and detergency are “drastically affected,” when stored in a suitable closed container;
     
  3. The Ultimate Biodegradability of the surfactant in detergents with cleaning properties shall not be less than 60% within 28 days;
     
  4. The heavy metal/impurities content shall not exceed the following limits: 
  a. Lead: 5 ppm
 
  b. Chromium: 5 ppm
 
  c. Cadmium: 5 ppm
 
  d. Cobalt: 5 ppm
 
  e. Nickel: 5 ppm
 
  f. Antimony: 5 ppm
 
  g.  Mercury: 5 ppm
 
  h. Arsenic: 5 ppm
 
  i. 1,4 Dioxane: 30 ppm

The remaining requirements of Section 4 speak to the pH value of a 1 percent aqueous solution of the detergent, the flash point of liquid glass cleaner products, and a restriction on the intentional addition of phosphate. Section 5 details the specific testing methods to be used to ensure compliance with the items identified in Section 4, while Section 6 addresses the information that “shall be legibly and indelibly marked on each package at least in Arabic language or both Arabic and English languages.”

The Requirements will enter into the respective national laws 180 days from publication in the respective official journals/gazettes.

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The Acta Group (Acta®) is the consulting affiliate of Bergeson & Campbell, P.C. (B&C®), established to complement B&C’s legal services by providing a full-range of support for the process of marketing chemicals, biocides, and products of industrial biotechnology, nanotechnology, and synthetic biology. Acta knows that clients must function optimally in all jurisdictions in which they market and/or place products to remain competitive. We help them get there through our global reach....

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