Chemical Controls - Blank Rome

1

Chemical Controls

2

Chemical Controls:

Toxic Substances Control Act: Regulatory and Legislative Initiatives

Judah Prero, Assistant General CounselAmerican Chemistry Council

3

Chemical Management Update

4

Setting the Stage for 2010

5

Congressional Actions: TSCA

The Safe Chemicals Act – S 3209

The Toxic Chemicals Safety Act – HR 5820

6


New Safety

StandardSafety

determinations

Prioritization process

Minimum data sets

Hot SpotsConfidential

Business information

Safer Alternatives

Children’s Health

PIC and POPs

ratification

Animal Testing

PreemptionReporting

of Information

7


8

Congressional Actions: Product or Chemical Specific

Consolidated Land Energy and Aquatic Resources Act of 2009 (CLEAR Act) – HR 3534

Mercury Pollution Reduction Act –S 1428, HR 2190

Formaldehyde Standards for Composite Wood Products Act –

S 1660, HR 4805

9

Congressional Action: Effect Specific

Endocrine Disruptor Screening

Enhancement Act of 2010

HR 5210

Assistance, Quality and Affordability Act of 2010

(AQAA)HR 5320

10

EPA Activities: The Game Plan

New Risk Management

Actions

Increased Public Access to Chemical Information

11

EPA: Risk Management –Chemical Action Plans

Identify chemicals that pose a concern

Evaluate data to determine what actions to take to address risks

Initiate appropriate

actions

12

EPA: Risk Management

• BPA CAP – 3/10• Benzidine Dyes CAP– 8/10• Hexabromocyclododecane CAP – 8/10• NP/NPE Mixtures CAP – 8/10• Diisocyanates CAP – TBD• Siloxanes CAP - TBD

13

EPA: Information Submission

• Inventory Update Rule – next reporting 2011• EDSP – Stage 2: Drinking Water Chemicals• HPV Test Rules – in development• Nanoscale Materials – Test Rules and SNURs in

development

14

EPA – Increased Access to Information

•Web access to the TSCA inventory•Chemical Identity CBI Claims policy

•CBI Declassification Initiatives

15

Questions?

[email protected]

mailto:[email protected]�

16

Chemical Controls:State Law Overview

Presented by:Heather L. Demirjian

17

Federal Inaction = State Action

• States’ Principles On Reform Of The Toxic Substances Control Act‒ December 2, 2009‒ 13 States/8 Principles

• 8 Years - @ 18 States - @ 75 Laws

• Bi-Partisan Support*

18

Regulatory Approaches

Targeted v. Broad

19

Targeted Approach

BPA

Chemicals And Products – Children

Green Cleaning

20

Broad Programmatic Approach

• California• Maine• Minnesota• Washington

21

California’s Green Chemistry Initiative

22

Green Chemistry

• Design Of Chemicals Or Chemical Processes To Reduce Or Eliminate Negative Environmental Impact

• 12 Principles‒ Waste Prevention‒ Design for Degradation‒ Minimize Accident Potential‒ Design Less Hazardous Chemical Synthesis

23

California’s Green Chemistry Laws

• Enacted September 29, 2008‒ SB 509 – Toxic Information Clearinghouse

• AB 187 – Chemicals In Consumer Products‒Cal. Health & Saf. Code § 25251, et seq.

24

California’s Green Chemistry Laws• Purpose – Reduce Or Eliminate Chemical Hazards In

Consumer Products And The Environment• Provides Mechanism For Review Of Approximately

80,000 Chemicals Sold, Used Or Distributed In California

• Model/Precedent For Treatment Of Chemicals In Commerce

• World Where Products Are Benign By Design• Sustainability – An Overall Goal Of CalEPA

‒ Life-Cycle Thinking• Green Chemistry Initiative

25

California’s Green Chemistry Regulations

• Draft Conceptual Flow Chart – February 23, 2010• Why Flow Chart?

‒ To Meet January 1, 2011 Deadline To Implement Regulations

‒ First Of Three Steps Toward Development Of Regulations:

(1) Show Overall Conceptual Process In Flow Chart and

Receive Public Comment Before Moving Forward(2) Outline of Regulatory Language(3) Full Regulatory Language

26

27

28


• September 13, 2010 – Draft Proposed Safer Consumer Product Alternatives Regulations

• Green Chemistry Alliance • “[R]egulatory Proposal That Is Completely

Unworkable And That Will Have Serious Detrimental Impacts On California’s Economy, Public Health And The Environment.”

29


• November 16, 2010 – Revised Draft Proposed Regulations

• Applies To “All Consumer Products Placed Into The Stream of Commerce In California”

• Responsible Entity And Duty To Comply‒ Manufacturer‒ Retailer

• Failure To Comply List• Information Posted To Department’s Website

30


• Chemical And Product Data And Information

• Chemical Identification And Description Information

• Information Describing Types, Categories And Classes Of Products Containing Chemicals Of Concern

• Identification Of Intentionally Added Chemicals/Chemical Ingredients And Quantities

• Market Presence Information• Description Of End Of Life

Management Program For Product

Department Can Request/Require That Responsible Entity Provide Information Pertinent To A Product Placed In The Stream Of Commerce Or To A Chemical Contained In That Product

31

California’s Green Chemistry Regulations• Article 2: Chemical Prioritization Process

‒ “All Chemicals That Exhibit A Hazard Trait And Are Reasonably Expected To Be Contained In Products Placed Into The Stream Of Commerce In California”

‒ Chemicals Of Concern List (12/21/2011)• Relative Degree Of Threat• Exposure Potential• Reliable Information Substantiating Threat And

Exposure• Scope Of State And Federal Regulatory Programs Or

International Trade Agreements Regulating Chemical• Department Resources

32


• Article 2: Chemical Prioritization Process –Continued

• Department Can Only Consider:‒ Carcinogens/Reproductive Toxins‒ Chemicals Identified As Category 1A Or 1B Mutagens

In Annex VI To Regulation (EC) No. 1272/2008 Of European Parliament And Council

33


• Article 3: Product Prioritization Process‒ Applies To All Products That Contain A Chemical Of

Concern And Are Reasonably Expected To Be Placed Into The Stream of Commerce As A Consumer Product In California

‒ Children’s Products, Personal Care Products, Household Cleaning Products

34


• Article 3: Product Prioritization Process –Continued‒ Priority Products List - Products Determined To Be Of

Highest Priority‒Degree Of Threat Due To Chemical Of Concern

To Public Health Or Environment• Volume Of Product In Stream Of Commerce And Product’s Estimated

Contribution To Volume Of Chemical In Stream Of Commerce

• Potential Exposure To Chemical Of Concern During Useful Life and End-Of-Life Disposal

• Type And Extent Of Consumer Use That Could Result In Public Exposure

• Product Uses Or Management/Disposal Practices That Could Result In The Release Of A Chemical Of Concern To The Environment Which Could Result In An Adverse Impact

35


• Article 4: Petition For Inclusion Of Chemical Or Product In Prioritization Process‒ Any Person May Petition Department To Evaluate

Chemical Or Product‒ Must Submit Quality And Comprehensive Data And

Information In Support Of Petition

36

California’s Green Chemistry Regulations• Article 5: Alternatives Assessment

‒ Responsible Entity Must Perform AA For Priority Product Or Component

‒ Must Be Reviewed And Verified By Third Party With No Economic Interest In Responsible Entity

‒ AA Work Plan Within 180 Days Of Priority Product Listing• Sufficient To Support Selection Of Alternative (Or Decision To

Retain Current Product In Lieu Of Alternative) And Selection Of Appropriate Regulatory Response

• Identify Goals Of AA And Summarize Types Of Alternatives Anticipated To Be Assessed

• Identify Which Life Cycle Segments Will Be Evaluated

37


• Article 5: Alternatives Assessment – Continued• Alternatives Analysis

‒ Chemical Hazard Assessment‒ Exposure Potential Assessment‒ Multi-Media Lifecycle Evaluation‒ Product Function And Performance Analysis‒ Economic Impact Analysis

38

California’s Green Chemistry Regulations• Article 5: Alternatives Assessment – Continued

‒ AA Report• Identify All Parties Involved In Funding, Directing And Overseeing AA• Supply Chain Information• Product Information • Supporting Information• Scope Of Life-Cycle Segments• Approach And Methodology• Assessment And Comparison Of Alternatives (Alternatives Cannot

Have Greater Significant Adverse Impacts On Public Health Or Environment Than Impacts Associated With Priority Product)

• Implementation Plan• Proposed Regulatory Responses

39


• Article 6: Regulatory Responses‒ No Response Required‒ Product Information For Consumers‒ End-Of-Life Management‒ Product Sales Prohibition‒ Other‒ Exemption

40


• Article 9: Confidentiality Of Information‒ At Time Of Submission Of Information

• Assert Claim Of Trade Secret By Identifying Portions Of Information Subject To Claim

• Assert Confidentiality Claim And Disclosure Exemption Under California Public Records Act

‒ Submit Complete Copy Of Document (Including Trade Secret/Confidential Information) And Redacted Copy

41

Washington Children’s Safe Products Act

• Requires Dept. Of Ecology And Dept. Of Health To Develop List Of Chemicals Of High Concern To Children‒ Draft List – 66 Chemicals

• Manufacturers Of Children’s Products Must Notify DOE When CHCC IsPresent In Product Above Trigger Level

• Civil Penalty - $5,000/$10,000 Per Violation

• Draft CSPA Reporting Rule• Rev. Code Wash. (ARCW) §70.240.010, et seq.• www.ecy.wa.gov/programs/swfa/cspa/index.html

42

Maine Toxic Chemicals In Children’s Products Law(P.L. 2007 Ch. 643)

• Reduce Exposure Of Children/Vulnerable Populations To Chemicals Of High Concern By Substituting Safer Alternatives Where Feasible

• Requires List Of Chemicals Of High Concern

• 2 COHC Must Be Designated As Priority Chemicals By January 1, 2011

• Manufacturer/Distributor Notification To MDEP Of Product Containing Priority Chemical

43

Maine Toxic Chemicals In Children’s Products Law(P.L. 2007 Ch. 643)

• Prohibition Of Manufacture, Sale Or Distribution Of Children’s Product Containing Priority Chemical

• “Interstate Clearinghouse” With Other State/Governmental Agencies

• 38 M.R.S. § 1691 – 1699-B; CMR Chapter 880• www.maine.gov/dep/oc/safechem/index.htm

44

Michigan Green Chemistry Program

• Executive Directive No. 2006-6

‒ Encourage Research/Development

‒ Scientifically Sound And Cost-Effective

‒ Design/Manufacture/Use That Requires Or Eliminates Use/Generation Of Hazardous Substances

‒ Safer/Less Toxic/Non-Toxic Alternatives

• Green Chemistry Action Plan(September 2008)

‒ 5 Years/3 Phases

• Build Awareness

• Build The Program

• Build The Future

• http://www.michigan.gov/deq/0,1607,7-135-3585_49005---,00.html

45

State Chemical Regulation -Issues Spotlight

• Federal Preemption• Trade Secrets/Confidential Business Information• Information Exchange And Agency/Government

Cooperation• Implementation Costs• Clarity Of Standards To Identify Chemicals

Regulated• Voluntary Corporate Action• Importance Of Taking Active Role In Regulatory

Process

46

Green Chemistry – Internet Resources

• University Of Massachusetts, Lowell Center For Sustainable Production, State Chemicals Policy Database:

‒ www.chemicalspolicy.org/chemicalspolicy.us.state.database.php

• U.S. Environmental Protection Agency:‒ www.epa.gov/greenchemistry

• California Department of Toxic Substances Control, Green Chemistry

‒ http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/index.cfm

47

Chemical Controls:

Doing Business in China:New Chemical Control Laws and Regulations

Presented by:Robert V. Percival

University of Maryland School of Law

Huang JingChina University of Political Science & Law

48

49

50

Efforts to CoordinateNorth Asian Chemical

Control Policies

51

China’s Implementation of the Globally Harmonized System for Classification and Labeling of Chemicals and Mixtures (GHS)

• Safety Data Sheet for Chemical Products Content and Order of Sections (China’s Material Safety Data Sheet Standard) – entered into force Feb. 1, 2009.

• General Rules for Preparation of Precautionary Labels for Chemicals (China’s Labeling Standard) –deadline for labeling May 1, 2010.

52

China’s Implementation of the Globally Harmonized System for Classification and Labeling of Chemicals

and Mixtures (GHS) (continued)

• General Rule for Classification and Hazard Communication of Chemicals (China’s Chemical Classification Standard) – follows the GHS classification system with only minor variations

53

May 2008: China’s Ministry of Environmental

Protection (MEP) Proposes to Adopt“Measures for the

Environmental Administration ofNew Chemical Substances”

October 15, 2010:New Regulations Take Effect

54

Principal Features of Regulations

• Registration and notification is required for all new chemicals regardless of production volume.

• A minimum data set must be provided with its scope increasing with production volume.

• Re-notification is required when production volume increases significantly or the uses of a chemical change or expand.

• Risk assessments must be provided for all new chemicals produced or imported in quantities greater than one metric ton annually.

55

Three Risk Categories for New Chemical Substances

• General Chemical Substances – substances not deemed hazardous

• Hazardous Chemical Substances – substances shown by testing to pose a physical, health or environmental hazard

• Substances of Environmental Concern –substances that are persistent, bioaccumulative, or a hazard to ecological or human physical health.

56

NOTIFICATION PROCEDURES FOR NEW CHEMICALS

• Regular Notification: applies to substances for which more than 1,000 kg (1 metric ton) is manufactured or imported each year. Filing requirements are more restrictive the larger the quantity (four categories: 1-10 metric tons, 10-100 metric tons, 100-1000 metric tons & more than 1000 metric tons).

• Simplified Notification: applies to substances for which less than 1,000 kg is manufactured or imported annually.

57

NOTIFICATION PROCEDURES FOR NEW CHEMICALS (continued)

• Record notification concerning new chemical substances used for scientific research with an annual volume of less than 0.1 tons and for samples of new chemical substances imported solely for testing.

58

FOUR “SPECIAL CIRCUMSTANCES”

• New chemicals used as an intermediate or only for export with an annual volume of less than 1 ton

• New chemicals used for scientific research with an annual volume of more than 0.1 ton but less than 1 ton

• Polymers - new chemical substances with less than 2% monomer concentration or a low concern polymer

• New chemicals to be used for technological R&D require notification with annual volume of less than 10 tons in less than 2 years.

59

Registration of New Chemicals

• A “general new chemical” can be listed on the national Inventory of Existing Chemical Substances Manufactured or Imported in China (IECSC) five years after approval of the substance.

• Only Chinese-registered companies can perform registration submissions. Non-Chinese companies must use local agents or affiliates to register.

• Organizations must register any new chemical substances being manufactured in or imported to “the bonded areas and export processing areas.”

60

New Annual Reporting Requirements

• Registrants using simplified filings approved within the past year are required to report only the total amount of the chemical produced or imported.

• For hazardous substances the annual report must also include information about the use of risk control measures, release and exposure and physical and environmental risks.

61

New Annual ReportingRequirements (continued)

• For hazardous substances subject to priority management the annual report must include information on production plans for the year and the use of risk control measures.

• Registration of new chemical substances is required as a condition for examining and approving the environmental impact documents of construction projects producing, processing, or using new chemical substances.

62

September 16, 2010 MEP Implementing Documents

• Guideline for notification and registration of new chemical substances

• Supervision and inspection rules for new chemical substances

• The regular notification form and filing instructions for a new chemical substance

• The simplified notification form and filing instructions for a new chemical substance

• The scientific research record notification form and filing instructions for a new chemical substance

• The report and filing instructions on first activity of a new chemical substance

63

Criticisms of New Regulations from the Chinese Chemical Industry

• Criticize EU’s REACH Program as forming a trade barrier to chemicals from chemical-producing countries that are not members of the EU.

• The Chinese chemical industry is feeling pressured by the REACH regulations.

• Chinese Ministry of Environmental Protection spokesman believes that REACH “provides an opportunity to improve our own management of chemical substances.”

64

Enforcement and Penalties

• Companies are prohibited from manufacturing, processing, or importing a new chemical substance not covered by an applicable registration or scientific research filing.

• Fines range between 10,000 and 30,000 RMB ($1,500 to $4,500).

• The registration certificate can be canceled by the MEP if false or incomplete information is provided.

• Parties filing new chemical registrations must not have received administrative penalty in past 3 years.

65

ENFORCEMENT PROBLEMS

• Even though more than 100,000 chemical substances are commercially used in China, only 45,000 are listed on the Inventory of Existing Chemical Substances in China (IECSC).

• In 2009 only about 4,500 of the tens of thousands of Chinese companies registered their chemicals.

• Most Chinese chemical companies do not know about the registration requirements due to insufficient publicity and poor enforcement.

66

Comparison of China’s New Chemical Regulations with EU’s REACH Program

• China’s regulations focus solely on new chemical substances rather than requiring the review of already listed chemicals for possible restriction.

• China has no provisions on manufactured products that do not release chemical substances.

• China trails the EU in the issuance of guidelines for chemical safety assessments and reports.

• Chinese registrants are not required to share data with other registrants.

67

Will China’s New Chemical Regulations Influence TSCA Reform in the U.S. Congress?• The U.S. chemical industry often argues that more

stringent U.S. regulation of chemicals under TSCA will drive chemical production away from the U.S. and toward China.

• U.S. environmentalists are now citing the new Chinese chemical regulations as including the very elements that should be included by the U.S. Congress in TSCA reform (see, e.g. EDF scientist Richard Denison’s Nov. 16, 2010 blog post).

68

69

CONCLUSION:WILL “CHINA’S

REACH” EXCEEDITS GRASP?

70

Chemical Controls:New Chemical Control Laws

in Emerging MarketsPresented by:

Rachel S. Wolfe

71

INTERNATIONALCHEMICAL REGULATIONS

72

SOUTH KOREA

73

South Korea

• Relevant Law:‒ Toxic Chemical Control Act (“TCCA”)

• Government Agency:‒ Ministry of Environment (Environmental Health Policy

Division, Chemicals Safety Division, Hazardous Chemicals Division)

‒ National Institute of Environmental Research

74

Background

• The TCCA has five chapters that discuss the following:

• Framework Plan for Hazardous Chemical Control• New Chemical Notification and Risk Assessment• Safe Control of Toxic Chemicals, Banned or

Restricted Chemicals, Responses to Chemical Accidents

• Supplementary Provisions• Penalty Provisions

75

TCCA Definitions

• Toxic Chemicals‒ Harmful to human health or the environment

• Observational Chemicals‒ Likely to be harmful to human health or the

environment• Restricted or Banned Chemicals

‒ Severely harmful to human health or the environment• Accident Precaution Chemicals

‒ High acute toxicity, explosive hazard, etc., and therefore present a high risk during an accident

76

Chemical Self-Confirmation• A manufacturer or importer of chemicals must submit a

chemical self-confirmation sheet to MOE prior to manufacturing or import.‒ Confirmation of new chemicals, toxic chemicals, observational

chemicals, or restricted chemicals

77

Assessment of New and Existing Chemicals

• New chemicals: chemicals produced/introduced in South Korea for the first time (approximately 400 kinds per year)‒ New chemicals are assessed for acute oral toxicity,

genetic toxicity, biodegradability, fish acute toxicity, daphnia toxicity, and algae toxicity

• Existing chemicals: approximately 983 chemicals have been evaluated (as of 2006)‒ Risk assessment for hazardous chemicals‒ Chemical management plans based on survey of

toxicity, distribution, and emissions of chemicals

78

Regulation of Chemicals• Toxic Chemicals

‒ Required to register‒ Regulation on importation‒ Regular/irregular facility inspection‒ Post-management for toxic chemical handlers (reporting annual

results, and record keeping requirements)• Restricted Chemicals

‒ Required to obtain business permission‒ MOE provides guidance for managing restricted chemicals during

storage, transportation, and distribution‒ Prior authorization for import is necessary

• Accident Precaution Chemicals‒ Emergency preparedness plan for facilities of a certain size‒ Accident reporting

79

TAIWAN

80

Background

• Relevant Law:‒ Toxic Chemical Substances Control Act (“TCSCA”)

• Government Agency:‒ Environmental Protection Agency (“EPA”)

81

Toxic Chemical Substances Control Act• The TCSCA sees to the management of manufacture,

import, export, sale, use, storage, transport, and disposal of toxic chemicals.

• The TCSCA ensures toxic chemicals are only handled by authorized operators, and appropriately handled, transported and disposed of.

• The entire process is supervised from “cradle to grave.”

82

List of Regulated Chemicals• Taiwan’s List of Regulated Chemicals Draws on the

toxic management laws of the United States, Europe, and Japan.

• In order to prevent environmental pollution and protect human health, methods of categorization, grading and positive list management were adopted in risk management, drawing on control methods used by other nations including the US Toxic Substances Control Act, the European List of Notified Chemical Substances (ELINCS), and Japan's Laws Regarding the Evaluation of Chemical Substances and Regulation of their Manufacture.

83

Four Classes of Toxic Chemicals• Among the 259 toxic chemicals currently listed by the

EPA, 79 are Class I, 89 are Class II, 64 are Class III, and 77 are Class IV. A total of 45 of these substances are banned and 137 are restricted to use with a permit. As for chemicals not yet listed as regulated substances, the EPA continually collects, analyzes and assesses data according to the Principles for Screening and Identifying Toxic Chemical Substances.

• International trends are also referred to and each year more substances are reviewed and added to the list of regulated chemical substances.

84

Bans and Restrictions• The Toxic Chemical Substances Control Act

implements bans and restrictions to promote reductions of toxic chemical substances and ensure safe consumption.

• To understand the environmental status of toxic chemicals, since 1999 the EPA has been carrying out investigation projects on the flow of toxic chemicals in the environment for ten consecutive years. This has resulted in the collection of 15,865 sets of data up to the year 2009.

85

The Philippines

86

The Philippines

• Relevant Law:‒ Toxic Substances and Hazardous and Nuclear Wastes

Control Act of 1990 (Republic Act 6969)

• Government Agency:‒ Department of Environment and Natural Resources –

Environmental Management Bureau

87

Background• In 1990, the Philippine Congress enacted the Toxic

Substances, Hazardous and Nuclear Wastes Control Act, commonly known as Republic Act (RA) 6969, a law designed to respond to increasing problems associated with toxic chemicals and hazardous and nuclear wastes.

• RA 6969 mandates control and management of import, manufacture, process, distribution, use, transport, treatment, and disposal of toxic substances and hazardous and nuclear wastes in the country.

88

Application for Import Clearance

89

Philippine Inventory of Chemicals and Chemical Substances (“PICCS”)

• PICCS is a list of existing industrial chemicals and chemical substances used, sold, distributed, processed, manufactured, stored, exported, treated, or transported in the Philippines.

90

Pre-Manufacture Pre-Import Notification Process (“PMPIN”)

• New chemical substances (those not listed on the PICCS) must undergo the PMPIN process.

• Companies must first notify DENR-EMB of their intent to manufacture, import, distribute, or use a new chemical substance.

91

PMPIN Assessment• After receiving the PMPIN notification and appropriate form, the DENR-

EMB, through its Chemical Review Committee, subjects the new chemical to an assessment using the following criteria:

‒ Hazard identification‒ Exposure assessment‒ Dose response assessment‒ Risk characterization‒ Risk management

• After the PMPIN assessment, the DENR-EMB will take one of the following actions:

‒ Issue a PMPIN Compliance Certificate, which serves as a clearance to manufacture or import a new chemical;

‒ Include the new chemical in on a chemical priority list, if it poses unreasonable risks to public health and the environment; or

‒ Return the notification to the company, if the information submitted is incomplete or inaccurate.

92

Philippine Priority Chemicals List (“PCL”)

• PCL is a short list of chemicals that have been determined to pose unreasonable risks to public health, workplace, and the environment.

93

Chemical Control Order (“CCO”)

• CCO is a policy instrument used by the DENR to prohibit, limit or regulate the use, manufacture, import, export, transport, processing, storage, possession and wholesale of priority chemicals that are determined to be regulated, phased-out, or banned because of the serious risk posed to the environment.

94

Japan

95

Japan

• Relevant law:‒ Chemical Substances Control Law (“CSCL”)

• Government Agencies:‒ Ministry of Health, Labor and Welfare (“MHLW”)‒ Ministry of Economic Trade and Industry (“METI”)‒ Ministry of the Environment (“MOE”)

96

Background

• The CSCL regulates the manufacture and import of persistent, bioaccumulative and toxic chemical substances, such as PCBs.

• New chemical substances cannot be manufactured or imported into Japan until the pre-manufacturing evaluation by METI, MHLW, and MOE has occurred.

97

Pre-manufacturing evaluation

• Hazard-based assessment is conducted prior to the manufacture or import of new chemical substances.

• Four subject areas are evaluated by METI, MOE, and MHLW:‒ Biodegradation;‒ Bioaccumulation;‒ Long-term toxicity for human health;‒ Long-term toxicity for plants and animals.

98

Monitoring and Regulation• Based on the pre-manufacturing evaluation, METI,

MOE and MHLW classify a substance in one of the following categories:‒ Class I Specified Chemical Substances‒ Class II Specified Chemical Substances‒ Type I Monitoring Chemical Substances ‒ Type II Monitoring Chemical Substances‒ Chemical substance not subject to regulations‒ Chemical substance for which the classification is unclear.

• If the results of the evaluation are unclear, then additional test results will be required.

99

CSCL Amendments

• Important amendments:‒ In 2003, the CSCL was amended to provide reduced

notification requirements for low volume production of new chemical substances.

‒ In 2009, the CSCL was amended to strengthen the risk management of all chemical substances, including “existing chemical substances”.

100

CANADA

101

Canada

• Relevant Laws:‒ Canadian Environmental Protection Act (“CEPA”)‒ New Substances Notification Regulations (“NSNR”)

• Government Agencies:‒ Health Canada‒ Environmental Canada

102

Background• CEPA provides for the assessment and/or

management of the environmental and human health impacts of new and existing substances. This includes products of biotechnology, marine pollution, disposal at sea, vehicle, engine and equipment emissions, fuels, hazardous wastes, environmental emergencies and other sources of pollution.

• Any person who intends to import or manufacture a new substance in Canada must submit a notification to the NSNR Program prior to importing or manufacturing the substance.

103

New Substance

• Substances not present on the Domestic Substances List (“DSL”) are considered to be “new” and are subject to notification.

• Any company or individual who plans to import or manufacture a substance subject to notification under the Regulations must provide Environment Canada with a New Substances Notification (NSN) package containing all information prescribed in the Regulations prior to import or manufacture.

104

The DSL

• The DSL is a compilation of substances that were in Canadian commerce between 1984 and 1986 or that were added to the DSL in accordance with the Canadian Environmental Protection Act, 1999 (CEPA 1999).

• The DSL undergoes regular revisions as new substances qualify for listing through the New Substances assessment process.

105

New Substances Notification (“NSN”) Package

• When Environment Canada receives a NSN Package from a company or individual proposing to import or manufacture a new substance, a joint assessment process is carried out with Health Canada to determine whether there is a potential for adverse effects of the substance on the environment and human health.

• The assessment time limit is typically 60 days, but it varies from 5 to 120 days depending on the type of substances and quantities which the companies want to import or manufacture.

106

AUSTRALIA

107

Background

• Relevant Law:‒ Industrial Chemicals (Notification and Assessment) Act

of 1989

• Government Agency:‒ National Industrial Chemicals Notification and

Assessment Scheme (“NICNAS”) (administered by the National Occupational Health and Safety Commission)

108

NICNAS• NICNAS’s activities include:

‒ Assessing industrial chemicals that are new to Australia for their health and environmental effects, before use or release into the environment;

‒ Assessing chemicals that are already in use in Australia (known as “existing chemicals”) in response to concerns about their safety on health and environmental grounds; and

‒ Making risk assessment and safety information on chemicals and their potential occupational health and safety, public health and environmental risks widely available to workers, the public, industry and other governmental agencies.

109

Registration with NICNAS

• All importers and/or manufacturers of industrial chemicals for commercial purposes must register with NICNAS, regardless of the quantity of industrial chemicals imported and/or manufactured in that registration year.

• There are three tiers of registration. A company’s registration tier is determined by the total value of industrial chemicals imported and/or manufactured each year.

110

Australian Inventory of Chemical Substances (“AICS”)

• AICS is the legal device that distinguishes new from existing chemicals.

• Any chemical not included in AICS is regarded as a new industrial chemical unless it is outside the scope of the Industrial Chemicals (Notification and Assessment) Act 1989 or is otherwise exempt from notification. New industrial chemicals must be notified and assessed before being manufactured or imported into Australia.

• Chemicals on the AICS can be imported or manufactured in Australia without first being notified to NICNAS as New Chemicals.

• AICS has confidential and non-confidential sections.

111

Listing of New Chemicals on AICS• All certificate-assessed chemicals are included on

AICS five years of the certificate date. For the interim five years, chemicals are not listed on AICS.

• At the end of five years, the company, which is the holder of the certificate for the assessed chemical is given the opportunity to put the chemical on the confidential section of AICS.

• For a chemical to be listed on the confidential section, an application to NICNAS is required. There are some minimum data requirements for the application.

• An assessed chemical can be listed on the non-confidential section of AICS prior to the five year period.

112

Existing Chemical Assessments

• Whereas each new industrial chemical undergoes an assessment before being imported or manufactured in Australia, most of the 38,000 already present in Australia (i.e. existing chemicals) have never had an independent assessment of their potential risks.

• Priority Existing Chemical (“PEC”)

113

THANK YOU