___________________________________________________________________________
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’ Forum
Singapore
30 March 2012
3/31/2012
LEGISLATION AND REGULATIONS
UPDATES ON CHEMICAL MANAGEMENT
IN THE PHILIPPINES
BY:
EMMANUELITA D. MENDOZA
Supervising Environmental Management Specialist
APEC Regulators’ Forum Meeting
Singapore, 30 March 2012
LAWS ON CHEMICAL MANAGEMENT
WITHIN 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 1
3/31/2012
Laws, Regulations and Policies Address the Life
the Life‐‐cycle of Chemicals
GRAVE
CRADLE
Processing / Recycling
 IMPORTATION
 Testing
Treatment
Raw Chemical
Storage
Waste
Disposal
 Handling
H dli
TRANSPORT
 Labeling
 Storage
 Loading
 Unloading
Raw Chemical
•Contingency
Measures
Waste
 Storage
USE/
MANUFACTURE
 Handling
 Storage
 Contingency
Measures
 Unintentional
generation
HANDLING/
DISTRIBUTION
PHASE OUT
Substitution/
alternative plan
 Contingency
Measures
Philippine Environmental Laws
RA 3931 ((AN
AN ACT
ACT CREATING
CREATING THE
THE NATIONAL
NATIONAL WATER
WATER AND
AND AIR
AIR POLLUTION
POLLUTION CONTROL
CONTROL COMMISSION)
COMMISSION)
PD 856 (Sanitation Code)
1975
PD 984 (Pollution Control Law)
1976
PD 1152 (Phil. Environment Code)
1977
PD
1586(EIS
(EIS
St )t )
PD 1586
S System)
System)
1978
1987
EO
Act) Act)
EO192
192(Reorganization
(Reorganization
DAO
34
RA
6969
DAO 35
RA
6969
DAO 34
1990
DAO 26
1992
• Address manufacture, import Address manufacture import
and use
• Address environmental impacts to water, air, and land
DAO 2929
DAO
RA
8749
RA 8749
RA
9003
RA 9003
1999
DAO
DAO 2000-02
2000-81
DAO 34
2000
DAO 30
2001
2003
DAO 36
01
2004
RA
9275
RA 9275
DAO
DAO
10005
2
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Republic Act 6 9 6 9
Department Administrative Orders
for IRR (92-29 and 04-36)
Memorandum Circulars
Ordinances by Local
Government Units (may supplement,
but must not contradict,
any national law)
LEGAL FRAMEWORK
A RISK BASED REGULATORY SYSTEM
REPUBLIC ACT 6969
Toxic Substances & Hazardous and Nuclear Waste Act
 RA 6969 is an Act that directs the Department of Environment
and Natural Resources (DENR) through the Environmental
Management Bureau (EMB) to establish rules, regulations,
and programs for controlling chemical substances and
hazardous wastes in the Philippines.
 The objective of the DENR is to reduce hazards and risks
to human health and the Environment from the improper
use, management, disposal, and subsequent release and
exposures to harmful substances.“
3
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DENR ADMINISTRATIVE ORDER NO. 29 Implementing Rules and Regulation of RA 6969
 Signed by DENR Secretary Fulgencio S. Factoran, Jr. on 06,
July 1992
 Regulate, restrict or prohibit the importation, manufacture,
processing, sale, distribution, use and disposal of chemical
substances and mixtures that present unreasonable risk
and/or injury to health or the environment.
 Various Provisions of the IRR (DAO 29)
Title I. General Provisions & Administrative Procedures
Title II. Toxic Chemical Substances
Title III. Hazardous Wastes
Title IV. Common Provisions
Title V. Prohibited Acts & Penalties
Title VI. Final Provisions
Title II. Toxic Chemical Substances
Existing Chemicals
Philippine Inventory of
Chemical of Chemical
Substances (PICCS)
New Chemicals
Small Quantity Importation (SQI)
Pre-Manufacturing
and Pre-Importation
Notification (PMPIN)
Regulated
Chemical
Control Order
(CCO)
Priority
Chemical List
(PCL)
4
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REGULATORY CONTROL
FOR CHEMICAL MANAGEMENT
A. INVENTORY OF EXISTING CHEMICALS – Sec. 14 of DAO 29  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.
Year
PICCS
1995
2005
2007
2008
2009
2011
24,000
28.000
37,000
43,600
44,863
46,963
 Every year updating of the inventory of existing
chemicals in collaboration with US CAS Office
chemicals in collaboration with US CAS Office
to 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
REGULATORY CONTROL
FOR CHEMICAL MANAGEMENT
B. NOTIFICATION AND SCREENING B. NOTIFICATION AND SCREENING ‐‐ Section 17 of DAO 29
 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) Year
PMPIN
ensuring information to government authorities
2008
2009
2010
2011
162
130
128
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 substance
2. Component in percentage by weight, on a 2
Component in percentage by weight on a
product and mixture
Year
 Exemption from the PMPIN process but
require to submit MSDS/SDS, Declaration of Intent and letter covering request
SQI
2008
445
2009
447
2010
563
2011
592
REGULATORY POLICY AND CONTROL
D. PRIORITY CHEMICAL LIST – Sec. 19
Chemical
Abstra
ct
Service
s No.
Philippine Inventory of Chemicals and
Chemical Substances (PICCS)
Name
108-90-7
1,4-CHLOROBENZENE
106-93-4
1,2-DIBROMOETHANE
95-50-1
106-46-7
Chemical Abstract
Services
(CAS)/
INDEX Name
Benzene,chloroEthane,1,2-dibromo
0-DICHLOROBENZENE
Benzene,1,2-dichloro
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
7647-18-9
3-HYDROXYPHENOL
1,3-Benzenediol
ANTIMONY
PENTACHLORIDE
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
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
 List of new and existing chemicals that DENR h d t
DENR has determined to potentially i dt
t ti ll
pose unreasonable risk to public health, workplace and the environment.
 Adding new additional 20 chemicals
listed on the Revised PCL
(DAO 2005‐ 27) in reference to
international regulated chemicals and/or
with international commitment to have
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)
6
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REGISTRATION D. PCL COMPLIANCE CERTIFICATE
DAO 2007‐23
 Under the said DAO, the DENR authorizes to prescribe additional requirements and establish ib ddi i
l
i
d
bli h
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. Year
PCL
2008
303
2009
434
2010
532
2011
771
 Addresses the potential hazards and Addresses the potential hazards and
impacts of chemicals  The Certificate requires compliance with
the other applicable policies and procedures based on national laws and international treaties.
REGULATORY CONTROL
FOR CHEMICAL MANAGEMENT
E. Chemical Control Orders – Sec. 20 
Mercury & Mercury
Mercury & Mercury Compounds DAO 1997
1997-38
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 Year
that are determined to pose unreasonable risks to 2008
public health and Environment.
2009
Formulation of DAOs for the CCOs are based on 2010
international regulations and references and require 2011
stakeholders’ consultation to make it adopted local scenarios.
CCO
224
231
183
206
7

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INFORMATION GENERATION
ANALYTICAL and LABORATORY CAPACITY
RISK REDUCTION
 Ensure annual industrial administrative and substantive compliance on the provisions of chemical rules, regulations and policies
CHEMICAL MANAGEMENT PLAN
 Encourage and promote improvement on the industry’s chemical management good practices through IECs, chemical safety and substitution, among others
g
EDUCATION AND AWARENESS RAISING
ACCIDENT PREVENTION AND CONTROL
SUBSTITUTION
PLAN
PERMITTING & CLEARANCES SYSTEM
(PRIOR TO IMPORTATION)
TYPES
APPLICABLE SCOPE
PROCESSING DAYS
AT AUTHORIZED OFFICE
PICCS CERTIFICATION
All common chemicals listed at
PICCs for Inspectors of BOC’s
Information
15 working days –
EMB-Regional
Offices
SQI CLEARANCE
New chemical substances with
<1,000 tons
20 working days –
EMB Regional
Offices
PMPIN COMPLIANCE
CERTIFICATE
New chemical substances >1,000
tons
90-180 days –
EMB-Central Office
PCL COMPLIANCE
CERTIFICATE
48 Regulated chemicals excluding
the controlled chemicals per DAO
2007-23
20 days – EMBCentral Office
CCO REGISTRATION
CERTIFICATE
5 Controlled chemicals (Cn, Hg,
ODS, Asbestos, PCB)
20 days – EMBCentral Office
CCO IMPORTATION
CLEARANCE
5 Controlled chemicals (Cn, Hg,
ODS, Asbestos, PCB)
20 days – EMB –
Central Office
Different forms and documentary requirements for each type of Permitting and Clearance system
8
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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.
 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.
UPDATES
DRAFT 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.
Dibromoethane
Chlorobenzene
Trichloethene
Phosgene
Dichloroethane
Methylene…
Mercaptan
Beryllium
Ethylene Oxide
Dichlorobenzene
Diethyl Sulfate
Glutaraldehyde
Antimony
Hydrazine
Paradichlororb…
di hl
b
Vinyl Chloride…
Selenium
Perchloroethyl…
Phenic Acid
Cadmium
Chloroform
Benzene
Trichloroethyle…
Phthalic…
Arsenic
Formaldehyde
Chromium
Lead
0
 Lead is one of the widely used chemical in the Philippines 2
0
(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 substances
bt
 This Draft CCO for lead & lead compounds applies to the
importation, distribution, manufacture, storage, transport and the
use of lead and lead compounds, and disposal of lead wastes. The
use of lead in paints and its limits are still for discussion.
50 100 150
9
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UPDATES
CHEMICALS 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 enforcement
the 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.
UPDATES
DRAFTING 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 proposed.
d
 Current deliberation at the Technical Working Group in Congress on the proposed document by concerned government agencies, NGOs and other stakeholders
10
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COMPLIANCE AND ENFORCEMENT
 On‐Site Inspection and Compliance of Industrial facility premises and
of Industrial facility premises and Observation of its operations
 Desk Review of Reports/Records CCO Quarterly thru Self Monitoring Reports  Review of the submitted post‐requirements
Collection of samples and testing
 Determination of violations, technical conference and corresponding sanctions
and penalties under MC 2003‐003 (Graduated Fines and Penalties)
Local Networking and Coordinating
Mechanisms Related to Chemical Management
Environmental Policies
(IATAC)
Memorandum of
Agreements
On all aspects of
regulatory and policy
requirements
on Chemical
Management
DENR
Environmental and
Health (IACEH)
p
of Health
Department
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
Conditions
and
d OSHC
Agricultural
Chemicals (PPTAC)
DA- Fertilizer and Pesticides
Authority
Phil. Council for
National Economic
Sustainable Devt(PCSD) Development Authority
Globally Harmonized
System (NGHSICC)
Department of Trade &
Industry
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DENR – EMB International Participation DENR –
& Collaboration Serving as Focal Point
Treaties and
g
Agreements
On all aspects of
risk
assessment
and sound
management
of chemicals
Montreal Protocol and
Vienna Convention
Ozone Depleting Substances
(1988 and 1991 )
Kyoto Protocol
GHG/ Climate Change
(1994/1997)
Rotterdam Convention on
PIC 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)
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
p
y building
g
with limited capacity
and resources

Tracking/monitoring and
enforcing the provisions of
permits and
various issued p
clearances
Structural flaw of
 Sustaining the promotion,
implementation to perform the IECs, research for safe
demands of chemicals-related alternative chemicals.
tasks


Insufficient knowledgeable
and skilled manpower to
address on various toxic
chemical related issues
Cross-cutting


Very dynamic and flexible
policies
issues and
overlapping concerns on toxic
chemicals in products
Strong Private-NGOGovernment Partnerships
with accountabilities and
responsibilities
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Overview of Chemical Management and Initiatives
Regulatory
Policy &
Control
PICCS
Administrative
& Supports to
O
Operations
ti
SDS
PMPIN/SQI
Code of Practice
PCL
CCO
Database
Compliance to
other envt’l
laws
Capability
Monitoring
IECs
Building
Voluntary Initiatives
and
Pollution Control
EMS
Cleaner
Production
Pollution
Control
Research
BAT/BEP
Supports and
g
Linkages
Various
Interagency
Committees
Montreal
Protocol
Kyoto
Protocol
Rotterdam
Convention
Stockholm
Convention
Chemical
Weapons
Contact us at (632) 920-22-63/(632) 928-88-92
Related
Laws and
Policies’
can
R l t dL
dP
li i ’ Information
I f
ti
be downloaded from www.emb.gov.ph
PICCS Verification at emb.gov.ph
13