Persistent, Bioaccumulative, and Toxic PBT) Chemicals: Technical Aspects, Policies, and Practices

290 Pages·2015·15.371 MB·English

by  Adam D. K. Abelkop, John D. Graham, Todd V. Royer

Environmental Science
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“… an essential tool for policymakers and practitioners concerned with chemical man-
agement policy in the twenty-first century. It is the best available handbook explaining P
the history of PBT principles and the current state of regulatory approaches to the sub- e
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ject. It further provides a clear and comprehensive picture of the scientific and policy s
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issues that warrant attention by all parties involved in chemical management matters.” s
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“This text provides a comparative analysis of regulatory experience in considering ,

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persistence, bioaccumulation and associated toxicity in prioritization and risk
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assessment of industrial chemicals, based on input from a broad range of sources. As o Toxic (PBT) Chemicals
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a result, it provides highly relevant and recommended background reading for those
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considering options to address the essential need to more efficiently prioritize, assess c
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and manage much larger numbers of existing industrial chemicals.” m
—M.E. (Bette) Meek, Associate Director, Chemical Risk Assessment, McLaughlin Technical Aspects, Policies, and Practices
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Centre for Risk Science, Faculty of Medicine, University of Ottawa l
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Developed from the efforts of a multiyear, international project examining how per- v
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sistent, bioaccumulative, and toxic (PBT) chemicals are evaluated and managed, Per-
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Adam D. K. Abelkop
sistent, Bioaccumulative, and Toxic (PBT) Chemicals: Technical Aspects, Policies, a
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and Practices focuses on improving the processes that govern PBTs. Incorporating
d John D. Graham
science and policy literature—as well as interviews and panel discussions featuring
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experts from around the world—this book provides you with an international perspec- o Todd V. Royer
tive of PBT policies (centering on Europe, Asia, and North America), and reveals major x
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findings and recommendations for improving PBT science, laws, and policies. c

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The text includes case studies of specific chemicals, provides an introduction to the B
overall subject of toxic chemicals, and weighs in on science and policy expansion T
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for PBTs. It also provides summary tables of important PBTs, and discussions on the
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number of PBTs in commerce, weight of evidence approaches, market deselection, and
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international management. e
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K24435 i
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K24435 cvr mech.indd 1 7/7/15 12:13 PM

Persistent,
Bioaccumulative, and
Toxic (PBT) Chemicals
Technical Aspects, Policies, and Practices
Adam D. K. Abelkop
John D. Graham
Todd V. Royer
CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742
© 2016 by Taylor & Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, an Informa business
No claim to original U.S. Government works
Version Date: 20150611
International Standard Book Number-13: 978-1-4822-9878-9 (eBook - PDF)
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Contents
List of abbreviations .......................................................................................vii
Preface .................................................................................................................xi
Acknowledgments .........................................................................................xiii
Authors ..............................................................................................................xv
Contributors ...................................................................................................xvii
Chapter 1 The challenge of identifying, assessing, and
regulating PBTs ...........................................................................1
I. PBTs: An introduction ............................................................................1
II. The significance and regulatory origins of the PBT concept ............3
III. Typology of PBT policies ......................................................................12
A. Priority setting ................................................................................13
B. Information requirements .............................................................14
C. Directly discourage, control, restrict, or prohibit use ................15
IV. Purposes and scope of the book .........................................................17
V. Method ....................................................................................................18
VI. Organization of the book .....................................................................23
References .........................................................................................................23
Chapter 2 PBT determinations: Science and standard procedures ...29
I. Persistence ..............................................................................................30
A. Estimation methods for persistence .............................................31
B. Laboratory tests for persistence ....................................................32
C. Monitoring data for persistence ....................................................33
D. Improvements in methods for assessing persistence ................34
II. Bioaccumulation ....................................................................................35
A. E stimation methods for bioaccumulation ...................................38
B. Laboratory tests for bioaccumulation ..........................................38
C. Monitoring and field data for bioaccumulation .........................39
D. Improvements in bioaccumulation measurements....................40
III. Toxicity ....................................................................................................42
A. Estimation methods for toxicity ...................................................44
B. Laboratory tests for toxicity ...........................................................45
iii
iv Contents
IV. PBT determinations ..............................................................................48
A. Standard regulatory approaches ..................................................48
B. Uncertainty in PBT determinations .............................................54
References ..........................................................................................................55
Chapter 3 PBT determinations: Weight of evidence approaches
and the number of PBTs in commerce ..................................65
I. Weight of evidence ................................................................................65
A. WOE and Registration, Evaluation, Authorization, and
Restriction of Chemicals Annex XIII ...........................................67
B. Developing guidance for a WOE approach to PBTs ..................67
C. WOE and the problem of “partial” PBTs .....................................71
D. Summary and case studies ............................................................72
1. Case study: Henicosafluoroundecanoic acid .........................72
2. Case study: Siloxane D5 ............................................................74
3. Case study: Lindane (gamma-hexachlorocyclohexane) ......77
II. How many PBTs are in commerce? ....................................................79
References ..........................................................................................................84
Chapter 4 International and regional PBT policies ..............................89
I. Introduction to PBT policies ................................................................89
A. Study approach to PBT policies ....................................................89
B. Policy typology and risk management principles revisited .....90
C. International and regional PBT policies ......................................91
II. International PBT policies ....................................................................91
A. Strategic Approach to International Chemicals Management ...91
B. Stockholm Convention on Persistent Organic Pollutants .........93
III. Regional PBT policies ...........................................................................97
A. Great Lakes Binational Toxics Strategy and the Great
Lakes Water Quality Agreement ..................................................97
B. Oslo–Paris Convention for the Protection of the Marine
Environment of the North-East Atlantic ...................................101
C. EU: Registration, evaluation, authorization, and
restriction of chemicals ................................................................103
1. Registration...............................................................................106
2. Evaluation .................................................................................109
3. Authorization ............................................................................110
4. Restriction ..................................................................................117
5. SVHC identification and RMO ...............................................119
6. Case studies ..............................................................................125
7. Risk management principles ..................................................137
IV. Conclusion ............................................................................................139
References .........................................................................................................141
Contents v
Chapter 5 National PBT policies in Asia and North America ..........149
I. Introduction .........................................................................................149
II. Japan ......................................................................................................149
A. Chemical Substances Control Law of 1973 ................................149
B. Amendments to the CSCL ...........................................................151
C. Screening of chemicals for PBT properties and
prioritization for risk assessment ...............................................153
D. Monitoring PB and Class I PBT substances ..............................157
E. Class II substances ........................................................................158
F. Restriction authority .....................................................................159
G. Risk management principles .......................................................159
III. China ......................................................................................................162
A. Chemical manufacturing and regulation in China ..................162
B. Import and export of “toxic” chemicals ....................................164
C. Management of “hazardous” chemicals ...................................165
D. Risk management under the Twelfth Five-Year Plan ...............167
E. Risk management principles .......................................................168
IV. Canada ..................................................................................................169
A. Canadian Environmental Protection Act of 1999 .....................169
B. Domestic Substances List categorization ..................................170
C. Risk assessment under CEPA ......................................................172
D. Chemical Management Plan ........................................................174
E. Risk management under CEPA ...................................................176
1. Toxic Substances List ................................................................176
2. Virtual Elimination List ..........................................................178
3. Alternative risk management options ..................................179
F. Risk management principles .......................................................179
V. United States ........................................................................................181
A. Waste Minimization Prioritization Tool ....................................181
B. Emergency Planning and Community Right-to-Know Act ...183
C. Toxic Substances Control Act ......................................................184
1. New chemicals .........................................................................184
2. Existing chemicals ...................................................................185
D. TSCA reform: Chemical Safety Improvement Act ...................189
VI. Conclusion ............................................................................................192
References ........................................................................................................193
Chapter 6 Subnational and private sector PBT policies .....................203
I. Introduction .........................................................................................203
II. Subnational PBT policies ....................................................................204
A. Ontario, Canada ............................................................................206
B. California, United States ..............................................................209
C. Washington State, United States .................................................215
D. Oregon, United States...................................................................217
vi Contents
III. Programs to encourage voluntary management of PBTs ..............219
A. Government programs to encourage voluntary risk
management ..................................................................................220
1. Design for the environment ...................................................220
2. The PBT Profiler .......................................................................222
B. Private programs to encourage voluntary risk management ...222
1. Clean Production Action’s Green Screen for Safer
Chemicals..................................................................................222
2. International ChemSec’s SIN List ..........................................224
IV. Case study: State regulation, market forces, retail regulation,
and brominated flame retardants .....................................................225
A. Polybrominated diphenyl ethers ................................................226
B. Government regulation and voluntary phase-out ...................227
C. Alternatives to PBDEs ..................................................................228
D. Public concern and retail regulation ..........................................229
V. Conclusion ............................................................................................231
References ........................................................................................................231
Chapter 7 PBT determinations and policies: Findings and
recommendations ....................................................................239
I. Findings and recommendations .......................................................239
A. Findings on PBT determinations ................................................239
B. Recommendations on PBT determinations ..............................245
C. Findings on PBT policies .............................................................249
D. Recommendations on PBT policies ............................................252
II. Harmonization ....................................................................................256
III. Modernization .....................................................................................257
A. Intake fraction ...............................................................................258
B. Characterization and assessment of UVCBs and
multiconstituent substances ........................................................258
C. Development of an improved numeric scoring system
for PBTs ...........................................................................................259
D. Development of WOE training programs for regulatory
professionals ..................................................................................259
E. Uncertainty in WOE .....................................................................260
IV. Conclusion ............................................................................................260
References ........................................................................................................262
Appendix .........................................................................................................265
List of abbreviations
AA alternatives analysis
AOP Adverse Outcome Pathway
BAF bioaccumulation factor
BCF bioconcentration factor
BMF biomagnification factor
CAP Chemical Action Plan
CAS Chemical Abstracts Service
CDC Centers for Disease Control and Prevention
CEPA Canadian Environmental Protection Act
CLRTAP Convention on Long-Range Transboundary Air Pollution
CMP Chemicals Management Plan
CMR carcinogenic, mutagenic, or toxic to reproduction
CSCL Chemical Substances Control Law
CSIA Chemical Safety Improvement Act
CSR Chemical Safety Report
DDE dichlorodiphenyldichloroethylene
DDT dichlorodiphenyltrichloroethane
DEHP bis(2-ethylhexyl) phthalate
DEQ Department of Environmental Quality (Oregon)
DfE Design for the Environment
DOE Department of Ecology (Washington)
DSL Domestic Substances List
DTSC Department of Toxic Substances Control
DYNAMEC Dynamic Selection and Prioritisation Mechanism for
Hazardous Substances
EC Environment Canada
EC Half-Maximal Effective Concentration
50
ECHA European Chemicals Agency
ECOSAR Ecological Structure Activity Relationships
EDC endocrine-disrupting chemical
EPA Environmental Protection Agency
EPI Suite Estimation Program Interface Suite
EPS expanded polystyrene
vii
viii List of abbreviations
EU European Union
GHS Globally Harmonized System
GLWQA Great Lakes Water Quality Agreement
HBCDD hexabromocyclododecane
HC Health Canada
HCB hexachlorobenzene
HCBD hexachlorobutadiene
HCH hexachlorocyclohexane
IJC International Joint Commission
iT inherent toxicity
K octanol–air partition coefficient
oa
K octanol–water partition coefficient
ow
LC median lethal concentration
50
LD median lethal dose
50
LOEC lowest observed effect concentration
MCS multiconstituent substances
MEP Ministry of Environmental Protection (China)
METI Ministry of Economy, Trade, and Industry (Japan)
MOA mode of action
MOE Ministry of the Environment (Ontario)
NGO nongovernmental organization
NOEC no observed effect concentration
NPRI National Pollutant Release Inventory
OECD Organization for Economic Cooperation and Development
OPPT Office of Pollution Prevention and Toxics
OPS Overarching Policy Strategy
P overall persistence
ov
PACS Priority Assessment Chemical Substance
PAH polycyclic aromatic hydrocarbon
PBB polybrominated biphenyl
PBDE polybrominated diphenyl ether
PBiT persistent, bioaccumulative, and inherently toxic
PBT persistent, bioaccumulative, and toxic
PCB polychlorinated biphenyl
PCTS Prohibition of Certain Toxic Substances
PFCA perfluorocarboxylic acid
PFOA perfluorooctanoic acid
PFOS perfluorooctane sulfonate
pFR polymeric flame retardant
POP persistent organic pollutant
POPRC Persistent Organic Pollutants Review Committee
PSL Priority Substance List
PVC polyvinyl chloride
QSAR Quantitative Structure–Activity Relationship