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Legal Requirements of an ERA

Risk assessment is useful to society because it offers a rational means to look at

and compare risks due to environmental chemicals as well as biological and physical
hazards. Countries with advanced environmental policies have included ERA in their
legal and administrative framework. The U.S. leads in that effort and is a good example
to cite. Federal agencies such as the US Environmental Protection Agency (US EPA), US
Good and Drug Administration (FDA), US Department of Defense (DOD) and US
Department of Energy (DOE), and state agencies such as the California Environmental
Protection Agency (Cal/EPA), routinely use risk assessment in making decisions for
diverse areas as toxic waste cleanup, pesticide registration and labeling, standards setting
for air pollutants, and the permitting of facilities. US federal laws such as Comprehensive
Environmental Response, Compensation and Liability Act (CERCLA), Resource
Conservation and Recovery Act (RCRA), Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), Clean Air Act Amendments of 1990 (CAA-90), and Toxic Substances
Control Act (TSCA) contain provisions where risk assessment may be appropriate or
required. Similarly, implementation of California state laws, such as the Toxic Air
Contaminant Identification and Control Act (AB 1807), Safe Drinking Water and Toxic
Enforcement Act of 1986 (Proposition 65), and Birth Defect Prevention Act (SB 950)
require risk assessment activities. Risk assessment can provide some basis for reaching
both chemical-specific and site-specific regulatory decisions.
In countries where environmental policies and administration are not as advanced as
those of the U.S. Federal government and the State of California, ERA is seldom part of
neither the legislative nor executive issuances. One developing country with a relatively

long history of environmental policy making has required risk assessment via
administrative fiat. In the Philippines, a risk assessment is required for environmentally
critical projects and incorporated as part of the legally required environmentally impact
statement submitted by project proponents to government to acquire an Environmental
Compliance Certificate (ECC). During the scoping stage of the formal EIA process, a
determination is made if an ERA is required. The basic criteria for determining such a
need for a proposed project are the presence of:

Materials or chemicals that are toxic, flammable, reactive/explosive and

hazardous or have deleterious effects to humans, animals, plants and ecosystems;

Structures (e.g. dams, mining pits, tailing ponds), the failure of which could
endanger life, property or environment.

Threshold levels are set for these substances (but not for the structures), above which
an ERA with corresponding prescribed details is required.
For proposed undertakings requiring an ERA, the format of the report shall contain at
least the following information:
1. Information relating to the operator and the establishment
2. The scope of analysis employed in the report
3. Information relating to every hazardous substance or situation present in the

4. The consequences of major accidents, the probability of its occurrence, and an

estimation of the risk
5. The safety management system for the establishment
6. Linkage with off-site emergency plan
The ERA report will comprise the safety management plan of the Environmental Impact
Statement (EIS) for the proposed project.