Checks and Balances on Chemicals - The Indian chemical industry is very diverse and covers basic chemicals and their intermediates, petrochemicals, fertilizers, paints, pesticides, bulk drugs and pharmaceuticals. It also contributes significantly toward the industrial and economic growth of the nation.

One of the significant fallouts of the European Reach regulation is the reactionary approach by several countries of setting up equivalent or similar regulations to counterbalance the cross-frontier trade position. The major concerns regarding chemicals are their presence in the food chain; indiscriminate use of chemicals in consumer products, such as toys and cosmetics; worker safety; hazardous waste handling, its storage and disposal; and minimization of volatile organic compounds.

Increasing consumer awareness and proactive initiatives by voluntary organizations have stepped up pressure for governments to formulate policies that can ensure adequate checks and balances on the chemical industry and safeguard the general population from potential chemical hazards.

Existing Laws in India

About 15 acts and 19 rules govern chemicals in India. These can be classified into the following groups:

• Import and export

• Manufacturing of chemicals
• Transportation of chemicals
• Consumers' interest in using chemicals
• Protection of human health and environment

Regulations have been framed for each of these groups. However, the Environment (Protection) Act of 1986 serves as an umbrella to link regulations without interfering with the autonomy of other rules. Various ministries and regulatory agencies at the national and state level are responsible for implementing the laws.

India has woken up to the need for regulatory policies to protect human health and the environment from the hazards posed by chemicals. The Ministry of Environment and Forest (MoEF) has for the first time created electronic waste management rules, which will take effect May 1. These rules recognize producers' accountability for recycling and reducing e-waste.

The Indian government is also proposing to adopt the Globally Harmonized System (GHS) of classification and labeling of chemicals. The highlights of the policy have been discussed with the various stakeholders and the MoEF is set to finalize the framework of this regulation that could be implemented early next year. With India set to implement the new GHS rules in phases, the industry is expecting radical revision of laws on handling and storage of hazardous chemicals.

Drawbacks of the Indian Regulatory System

• No single nodal agency or ministry ensures proper implementation of the existing regulations.
• None of the ministries or departments have prepared databases of the chemicals addressed by them in respect to their proper classification and identification, properties, applications and uses, labeling, and handling.
• There is little primary or secondary research carried on the effect of chemicals (toxicity, exposure and antidotes) on the environment and human safety.
• There is little effort to collate data of accidents during manufacture, transportation or use of chemicals.

Thus, a comprehensive chemicals management framework with clearly defined objectives and assigned responsibilities is a necessity if India is to align its chemical policy with those being developed and implemented by other nations.

The Way Forward

It would be advantageous if chemicals management could be brought under a single nodal agency, for the administration of the proposed Indian chemical policy and to provide technical and scientific support. This could be the receiving body for information submitted during notification on the intrinsic properties of the chemicals, and it could maintain a comprehensive central database on all notified chemicals.

This agency also could support state governments in effective enforcement of the Indian chemical policy. The agency would provide access to non-confidential information for the general public and establish an efficient and secure data exchange network with state governments for commercially sensitive information.

It may also be necessary to consider comprehensive, dedicated legislation for uses and restrictions of chemicals with a view to meeting the objectives stated above. The legislation could incorporate some of the existing regulations, and the respective administrative agencies could be brought under the proposed nodal agency. Another objective would be to gradually merge all existing regulations dealing with various chemicals - industrial chemicals, plant protection chemicals, biocides, cosmetics, chemicals used for the preparation of pharmaceuticals - into one umbrella policy, i.e. the Indian chemical policy.

Before the establishment of the nodal agency, it may be necessary to carry out a feasibility study and a cost/benefit analysis of the proposed regulatory framework.

Possible Implementation Strategy

Considering that any legislation in this regard must simultaneously account for the survival and sustenance of the Indian industrial units working at various scales of operations, and that upstream suppliers and downstream users will have to adjust the design of products, processes and technologies, a phased approach can be considered.

Learning from the trend of existing chemical regulations and, most importantly, in order to reduce the burden on the Indian chemical industry while not compromising the objectives of the proposed policy, the following implementation measures can be considered:

Phase 1: Identify "very hazardous" and high volume use chemicals for notification and registration.

Every chemical manufacturer submits a notification to the nodal agency or its authorized body providing basic information on the identity and volume of the chemical. The notification period could be for one year from the date the proposed policy is implemented by the government of India.

• Non-Indian companies that export these chemicals into India shall have to comply with the proposed policy through a legal representative in India.
• After the notification period, an inventory shall be available from the nodal agency or its authorized body for all the chemicals put on the Indian markets.
• All the notifiers of similar chemical substances shall be in one group, known as a data sharing group (DSG).
• Evaluation of the inventory by the expert chemical committee at the nodal agency or authorized body could lead to the identification of very toxic substances that shall have to be taken up for the advanced process of registration.
• Registration would involve submitting detailed information on physico-chemical, toxicological and eco-toxicological properties of the substance.

Phase 2: Expand the list of substances from "very hazardous" to "hazardous" and proceed as above.

• Notification and registration of products (preparations and articles) containing the hazardous chemicals beyond a specified percent.
• Identify chemicals for banning or restricting their use with authorization.

Phase 3: Expand the list of substances to all chemicals.

Leveling the Playing Field

India's proposed chemical policy and the globally harmonized system (GHS) of classification and labeling of chemical substances will trigger staggered phase out of all toxic chemicals and thus reduce hazards arising from these toxic chemicals. Some of the salient points of India's draft GHS rules are:

• Responsibilities in the supply chain will be prescribed.
• All dangerous goods will have to have a UN number and proper shipping name according to their assigned hazard classification and composition.
• Suitable labeling and packaging will have to be used, along with updated safety data sheets.
• People engaged in the handling, storage and transport of dangerous goods will have to be trained.

In addition, the proposed chemical policy will restrict deliberate relocation of production of toxic chemicals from other countries to India, as similar requirements will exist in India and thus such operations will not have any perceived advantages of moving to India. It will create a level playing field for Indian companies competing with other international suppliers of chemicals.