legislation and regulations updates on chemical management...
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2012/CTI2/CD/FOR/008 Morning Session II
Legislation and Regulations Updates on Chemical Management in the Philippines
Purpose: Information
Submitted by: Philippines
APEC Chemical Regulators’ ForumSingapore
30 March 2012
3/31/2012
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LEGISLATION AND REGULATIONS UPDATES ON CHEMICAL MANAGEMENT
IN THE PHILIPPINES
BY:
EMMANUELITA D. MENDOZASupervising Environmental Management Specialist
APEC Regulators’ Forum MeetingSingapore, 30 March 2012
LAWS ON CHEMICAL MANAGEMENTWITHIN THE MANDATE OF
THREE (3) AGENCIES
• RA 3720: “foods, drugs, and cosmetics” administered by the BFAD now the Food and Drugs Administration (FDA) and revised to RA 9711 “strengthening and rationalizing the regulatory capacity of BFAD and renaming it to FDA (2009)
• PD 1144: “all types of agricultural chemicals in the Philippines”administered by the Fertilizer and Pesticide Authority (FPA)
• RA 6969: : “industrial chemicals administered by the DENR through the Environmental Management Bureau
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CRADLE
Processing / Recycling
IMPORTATION
Testing
H dli
GRAVE
Treatment
Storage
Disposal
TRANSPORT
WasteRaw Chemical
Laws, Regulations and Policies Address Laws, Regulations and Policies Address the Lifethe Life‐‐cycle of Chemicalscycle of Chemicals
Handling
Storage
TRANSPORT
Labeling
Loading
Unloading
•Contingency Measures
USE/
MANUFACTUREPHASE OUTHANDLING/
Waste
Raw Chemical
MANUFACTURE
Handling Storage
Unintentional generation
Contingency Measures
Substitution/
alternative plan
DISTRIBUTION
Storage
Contingency Measures
RA 3931 (AN ACT CREATING THE NATIONAL WATER AND AIR POLLUTION CONTROL COMMISSION)
PD 856 (Sanitation Code)
1975
PD 1586 (EIS S t )
PD 984 (Pollution Control Law)
1977
1976 PD 1152 (Phil. Environment Code)
Philippine Environmental LawsPhilippine Environmental LawsRA 3931 (AN ACT CREATING THE NATIONAL WATER AND AIR POLLUTION CONTROL COMMISSION)
PD 856 (Sanitation Code)
1975
PD 1586 (EIS S t )1977
1976 PD 1152 (Phil. Environment Code)
RA 9003
RA 8749
RA 6969DAO 34
PD 1586 (EIS System)1977
1978
1990
DAO 2000-811999
DAO 35
1992
DAO 29DAO 26
1987
EO 192 (Reorganization Act)
RA 9003
RA 8749
RA 6969DAO 34
PD 1586 (EIS System)1977
1978
1990
DAO 2000-021999
DAO 35
1992
DAO 29DAO 26
1987
EO 192 (Reorganization Act)
• Address manufacture import
2000
2003
RA 9275
DAO 30
2004
DAO 36
2001
DAO 34
DAO 10
2000
2003
RA 9275
DAO 30
2004
DAO 01
2001
DAO 34
DAO 005
Address manufacture, import and use
• Address environmental impacts to water, air, and land
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Republic Act 6 9 6 9
Department Administrative Orders
Ordinances by LocalGovernment Units (may supplement,
but must not contradict,any national law)
Memorandum Circulars
Department Administrative Orders for IRR (92-29 and 04-36)
LEGAL FRAMEWORKA RISK BASED REGULATORY SYSTEM
REPUBLIC ACT 6969Toxic Substances & Hazardous and Nuclear Waste Act
REPUBLIC ACT 6969Toxic Substances & Hazardous and Nuclear Waste Act
RA 6969 is an Act that directs the Department of Environment RA 6969 is an Act that directs the Department of Environmentand Natural Resources (DENR) through the EnvironmentalManagement Bureau (EMB) to establish rules, regulations,and programs for controlling chemical substances andhazardous wastes in the Philippines.
The objective of the DENR is to reduce hazards and risksto human health and the Environment from the improperuse, management, disposal, and subsequent release andexposures to harmful substances.“
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DENR ADMINISTRATIVE ORDER NO. 29 Implementing Rules and Regulation of RA 6969
DENR ADMINISTRATIVE ORDER NO. 29 Implementing Rules and Regulation of RA 6969
Signed by DENR Secretary Fulgencio S. Factoran, Jr. on 06,July 1992July 1992
Regulate, restrict or prohibit the importation, manufacture,processing, sale, distribution, use and disposal of chemicalsubstances and mixtures that present unreasonable riskand/or injury to health or the environment.
Various Provisions of the IRR (DAO 29)
Title I. General Provisions & Administrative ProceduresTitle II. Toxic Chemical SubstancesTitle III. Hazardous WastesTitle IV. Common ProvisionsTitle V. Prohibited Acts & PenaltiesTitle VI. Final Provisions
Title II. Toxic Chemical Substances
Philippine Inventory of Chemical of Chemical Substances (PICCS)
Existing Chemicals New Chemicals
Small Quantity
Importation (SQI)
Pre-Manufacturing and Pre-Importation Notification (PMPIN)
Chemical Control Order (CCO)
Priority Chemical List (PCL)
Regulated
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A. INVENTORY OF EXISTING CHEMICALS – Sec. 14 of DAO 29
REGULATORY CONTROLFOR CHEMICAL MANAGEMENT
Philippine Inventory of Chemicals and Chemical Substances (PICCS) is a consolidated list of all existing chemicals used, sold, distributed, imported, processed, manufactured, stored, exported, treated or transported in the economy.
Every year updating of the inventory of existingchemicals in collaboration with US CAS Office
Year PICCS
1995 24,000
2005 28.000
2007 37,000
2008 43,600
2009 44,863
2011 46,963chemicals in collaboration with US CAS Officeto match the chemicals with the correct CAS or IUPAC names.
Existing chemical and chemical substances can now viewed and checked at the website through emb.gov.ph
Exempted from PICCS are those naturally occurring substances, mixtures and non‐
chemical substances. Complete listing of PICCS is available in CD for only US$7.50 per CD
B. NOTIFICATION AND SCREENING B. NOTIFICATION AND SCREENING ‐‐ Section 17 of DAO 29Section 17 of DAO 29
REGULATORY CONTROLFOR CHEMICAL MANAGEMENT
Pre Manufacture and Pre Importation Notification (PMPIN)
Is a process of prior notification of all new chemical substances to be manufactured in or imported not listed in the PICCS.
It screen toxic chemical substances prior to its importation, use, sale and distribution in commerce.
Currently, an In‐house group reviewed and evaluated the characteristics
of new substances (previously, Interagency committee (IAC)
ensuring information to government authorities
Year PMPIN2008 1622009 1302010 1282011 119
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REGULATORY CONTROL
C. EXEMPTION FOR NOTIFICATION ‐ Section 22
Small Quantity Importation (SQI) ‐ New chemical substance (PICCS reference) manufactured, imported and distributed in quantities in less than 1,000 kg. per year
Importation of such new chemicals is used for non‐commercial or research and developmental purposes
1. Pure chemical substance2 Component in percentage by weight on a2. Component in percentage by weight, on a
product and mixture
Exemption from the PMPIN process butrequire to submit MSDS/SDS, Declaration of Intent and letter covering request
Year SQI
2008 445
2009 447
2010 563
2011 592
List of new and existing chemicals that DENR h d t i d t t ti ll
Chemical Abstra
ct Services No.
Philippine Inventory of Chemicals and Chemical Substances (PICCS)
Name
Chemical Abstract Services (CAS)/
INDEX Name
REGULATORY POLICY AND CONTROL
D. PRIORITY CHEMICAL LIST – Sec. 19
DENR has determined to potentially pose unreasonable risk to public health, workplace and the environment.
Adding new additional 20 chemicalslisted on the Revised PCL(DAO 2005‐ 27) in reference tointernational regulated chemicals and/orwith international commitment to havetotal 48 chemicals based on:
108-90-7 1,4-CHLOROBENZENE Benzene,chloro-
106-93-4 1,2-DIBROMOETHANE Ethane,1,2-dibromo
95-50-1 0-DICHLOROBENZENE Benzene,1,2-dichloro
106-46-7 1,4-DICHLOROBENZENE Benzene,1,4-dichlro-
107-06-2 1,2-DICHLOROETHANE Ethane, 1,2-dichloro-
122-66-7 1,2 DIPHENYLHYDRAZINE Hydrazobenzene
108-46-3 3-HYDROXYPHENOL 1,3-Benzenediol
7647-18-9 ANTIMONYPENTACHLORIDE
Antimony chloride
7440-38-2 ARSENIC COMPOUNDS Arsenic
1332-21-4 ASBESTOS* Asbestos
71-43-2 BENZENE Benzene
7440-41-7 BERYLLIUM COMPOUNDS Beryllium
7440-43-9 CADMIUM COMPOUNDS Cadmium total 48 chemicals based on:Primary Criteria (Persistence, Bioaccumulation potential and Toxicity), and Secondary Criteria (Quantity/volume of chemicals importation Quantity of chemicals manufactured and used)
7440-43-9 CADMIUM COMPOUNDS Cadmium
56-23-5 CARBON TETRACHLORIDE**
General Name CHLORINATED ETHERS
General Name CHLOROFLUORO CARBONS**
67-66-3 CHLOROFORM Trichloromethane
76-06-2 CHLOROPICRIN Methane, trichloronitro
18540-29-9 CHROMIUM COMPOUNDS Chromium
57-12-5 CYANIDE COMPOUNDS* Cyanide
64-67-5 DIETHYL SULFATE Sulfuric acid,diethyl ester
106-93-4 ETHYLENE DIBROMIDE 1,2 Dibromoethane
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Under the said DAO, the DENR authorizes to ib ddi i l i d bli h
REGISTRATION D. PCL COMPLIANCE CERTIFICATE
DAO 2007‐23
prescribe additional requirements and establish procedural requirements for issuance of a PCL Compliance Certificate.
The Certificate contains post requirements that state on risk management measures to protect human health and environment.
Addresses the potential hazards andYear PCL Addresses the potential hazards and impacts of chemicals
The Certificate requires compliance withthe other applicable policies and procedures based on national laws and international treaties.
2008 303
2009 434
2010 532
2011 771
REGULATORY CONTROLFOR CHEMICAL MANAGEMENT
E. Chemical Control Orders – Sec. 20
Mercury & Mercury DAO 1997-38Mercury & Mercury Compounds
DAO 1997 38
Cyanide & Cyanide Compounds
DAO 1997-39
Asbestos DAO 2000-02
PCB DAO 2004-01
ODS DAO 2004-08
Regulate, limit, gradually phase out, or ban those chemical substances that are determined to pose unreasonable risks to public health and Environment.
Formulation of DAOs for the CCOs are based on international regulations and references and require stakeholders’ consultation to make it adopted local scenarios.
Year CCO
2008 224
2009 231
2010 183
2011 206
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INFORMATION GENERATION
RISK REDUCTION
ANALYTICAL and LABORATORY CAPACITY
CHEMICAL MANAGEMENT PLAN
Ensure annual industrial administrative and substantive compliance on the provisions of chemical rules, regulations and policies
Encourage and promote improvement on the industry’s chemical management good practices through IECs, chemical safety and substitution, among others
EDUCATION AND AWARENESS RAISING
ACCIDENT PREVENTION AND CONTROL
SUBSTITUTIONPLAN
g
PERMITTING & CLEARANCES SYSTEM(PRIOR TO IMPORTATION)
TYPES APPLICABLE SCOPE PROCESSING DAYSAT AUTHORIZED OFFICE
PICCS CERTIFICATION All common chemicals listed at 15 working days –PICCs for Inspectors of BOC’s Information
EMB-Regional Offices
SQI CLEARANCE New chemical substances with <1,000 tons
20 working days –EMB Regional Offices
PMPIN COMPLIANCECERTIFICATE
New chemical substances >1,000 tons
90-180 days –EMB-Central Office
PCL COMPLIANCE CERTIFICATE
48 Regulated chemicals excluding the controlled chemicals per DAO
20 days – EMB-Central Office
Different forms and documentary requirements for each type of Permitting and Clearance system
CERTIFICATE the controlled chemicals per DAO 2007-23
Central Office
CCO REGISTRATION CERTIFICATE
5 Controlled chemicals (Cn, Hg, ODS, Asbestos, PCB)
20 days – EMB-Central Office
CCO IMPORTATION CLEARANCE
5 Controlled chemicals (Cn, Hg, ODS, Asbestos, PCB)
20 days – EMB –Central Office
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PROCEDURAL MANUAL ON HAZARDOUS WASTES (DENR AO 2004‐36)
There are 13 classifications of Hazardous Wastes covering industrial wastes, commercial wastes and trade activities.commercial wastes and trade activities.
Prohibit the entry, even in the transit, or hazardous wastes and their disposal into the Philippines territorial limits.
Management of HW through policy formulation, permitting
system, IECs and regular capacity building of generators,
transporters, waste service providers p p
and TSD facilities.
The DENR‐EMB‐ EQD is revising the Procedural Manual (already for approval) to incorporate the provisions on E‐waste, special waste and vegetable oil.
UPDATESDRAFT CHEMICAL CONTROL ORDER FOR
LEAD AND LEAD COMPOUNDS DENR 2005‐05 Identified Lead Compounds as one of the priority DENR 2005‐05 Identified Lead Compounds as one of the priority
chemicals to be controlled along with Arsenic, Cadmium, Benzene, VinylChloride, Chromium6.
Lead is one of the widely used chemical in the Philippines (electronics, paints, semiconductors, AVGAS, etc.) in relation to PCL Compliance Certificate issuance from 2008‐2010. It is the policy of DENR to minimize hazards and risks posed to human health and the environment from the use, management, disposal and subsequent releases their wastes and exposure to toxic b tdi hl b
HydrazineAntimony
GlutaraldehydeDiethyl Sulfate
DichlorobenzeneEthylene Oxide
BerylliumMercaptan Methylene …
DichloroethanePhosgene
TrichloetheneChlorobenzeneDibromoethane
20
substances
This Draft CCO for lead & lead compounds applies to theimportation, distribution, manufacture, storage, transport and theuse of lead and lead compounds, and disposal of lead wastes. Theuse of lead in paints and its limits are still for discussion.
0 50 100 150
LeadChromium
FormaldehydeArsenicPhthalic …
Trichloroethyle…Benzene
ChloroformCadmium
Phenic AcidPerchloroethyl…
SeleniumVinyl Chloride …Paradichlororb…
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UPDATESCHEMICALS LABELING & CLASSIFICATION
ADOPTING GLOBALLY HARMONIZED SYSTEM (GHS)
Draft DENR Administrative Order for GHS Adoption and Implementation
is in process of finalization. Only awaiting for the supporting Guidance
documents i.e., labeling procedure, SDS, how to classify, among others.
The DENR‐EMB has existing regulatory framework for GHS requirements
that can accommodate the concept of hazard communication through
the requirements on the use of SDS and strengthening the enforcementthe requirements on the use of SDS and strengthening the enforcement
of labels.
The Draft DAO will be implemented in seven (7) years of 4‐transition
period prioritizing CCO/PCL chemicals, high volume, under IATA
and IMDG lists of dangerous goods.
UPDATESDRAFTING OF BILL ON BANNING LEAD IN TOYS, SCHOOL SUPPLIES
A new proposed House Bill in Regulating the importation, distribution, manufacture and sale of toys, school supplies and other Childcare Articles, imposing penalties thereof and for other purposes (draft) as introduced by Reps. Susan A. Yap, Anthony A. del Rosario and Cinchona Cruz‐Gonzales
Strengthening of the Food and Drugs Administration (FDA) of DOH is dproposed.
Current deliberation at the Technical Working Group in Congress on the proposed document by concerned government agencies, NGOs and other stakeholders
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COMPLIANCE AND ENFORCEMENT
On‐Site Inspection and Compliance of Industrial facility premises andof Industrial facility premises and Observation of its operations
Desk Review of Reports/Records CCO Quarterly thru Self Monitoring Reports
Review of the submitted post‐requirementsCollection of samples and testing
Determination of violations, technical conference and corresponding sanctionsand penalties under MC 2003‐003 (Graduated Fines and Penalties)
Local Networking and CoordinatingLocal Networking and CoordinatingMechanisms Related to Chemical ManagementMechanisms Related to Chemical Management
Environmental Policies (IATAC)
DENR
Environmental and Department of HealthHealth (IACEH)
p
Tariff & Importation Tariff Commission and Bureau of Customs
Energy & Environment Department of Energy
Illegal Drugs & its Precursors
Phil. Drugs & Enforcement Agency
Occupational Safety DOLE – Bureau of Working C diti d OSHC
Memorandum of Agreements
On all aspects of regulatory and policy
Conditions and OSHC
Agricultural Chemicals (PPTAC)
DA- Fertilizer and Pesticides Authority
Phil. Council for Sustainable Devt(PCSD)
National Economic Development Authority
Globally Harmonized System (NGHSICC)
Department of Trade & Industry
requirements on Chemical
Management
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DENR DENR –– EMB International Participation EMB International Participation & Collaboration Serving as Focal Point& Collaboration Serving as Focal Point
Montreal Protocol and Vienna Convention
Ozone Depleting Substances (1988 and 1991 )
Kyoto Protocol GHG/ Climate Change (1994/1997)
Treaties and Agreements
(1994/1997)
Rotterdam Convention onPIC Procedure
Certain Hazardous Chemicals and Pesticides in International Trade (1998/ 2006)
Stockholm Convention Persistent Organic Pollutants (POPs) – 2001/2004
Basel Convention Control of Transboundary Movement of HW & disposal (1989/1993)
gOn all aspects of
risk assessment and sound
management of chemicals
SAICM & Mercury Assessment
QSP in ASGM, National Profile on Chem.Management, among others
Chemical Weapons Convention Prohibition of the Development Production, Stockpiling & Use of Chem. Weapons & Destruction (1992/1997)
Globally Harmonized System Classification & Labeling of (Ind’l) Chemicals (2002/2008)
WB/UNIDO/UNEP-GEF IPOPs Proj./Non-Com POPs
Challenges and Opportunities
Comprehensive in scope in managing toxic chemicals with limited capacity building
Tracking/monitoring and enforcing the provisions of various issued permits and p y g
and resourcesp
clearances
Structural flaw of implementation to perform the demands of chemicals-related tasks
Sustaining the promotion, IECs, research for safe alternative chemicals.
Insufficient knowledgeable and skilled manpower to address on various toxic
Cross-cutting issues and overlapping concerns on toxic chemicals in productsaddress on various toxic
chemical related issueschemicals in products
Very dynamic and flexible policies
Strong Private-NGO-Government Partnerships with accountabilities and responsibilities
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Regulatory
Policy &Administrative& Supports to
O ti
Voluntary Initiativesand
Pollution Control
Supports andLinkages
Overview of Chemical Management Overview of Chemical Management and Initiativesand Initiatives
Control Operations Pollution Controlg
PICCS
PMPIN/SQI
SDS
Code of Practice
EMS
CleanerProduction
MontrealProtocol
VariousInteragency
Committees
KyotoPCL
StockholmConvention
ChemicalWeapons
Database
Capability
Building
PollutionControl Rotterdam
Convention
KyotoProtocol
IECsMonitoring
Compliance to other envt’l
laws
CCO
Research
BAT/BEP
Contact us at (632) 920-22-63/(632) 928-88-92
R l t d L d P li i ’ I f tiRelated Laws and Policies’ Information can be downloaded from www.emb.gov.ph
PICCS Verification at emb.gov.ph