PURPOSE

The pesticide label is the primary document for conveying general and technical information from regulatory agencies and pesticide manufacturers to the agricultural community, the commercial service industry, and the general public. It is the one source where scientific review, regulatory oversight, and public policy are interwoven to achieve a common objective: to clearly and precisely convey information on handling, storing, applying, and disposing of pesticides in a manner conducive to good health and environmental stewardship.

Pesticides and the Label provides and overview of the pesticide registration process, descriptions of the individual components of the label, and discussions on how to use the information on a label properly. The pesticide label is the result of a complex and interactive system and is the key to user safety, environmental protection, and the manufacturer's warranty information.

PESTICIDE LABELS AND THE REGULATORY PROCESS

SOCIETY AND SCIENCE

Pesticides in the United States are regulated under the federal statute known as the Federal Insecticide, Fungicide, and Rodenticide Act—more often referred to as FIFRA. The U.S. Environmental Protection Agency (EPA) is the federal agency that implements and enforces the madates of FIFRA. Under this law, EPA must consider the benefits of pesticide use while also protecting human health and the environment from unreasonable adverse effects. This is know as a comparative benefit-to-risk philosophy.

Decisions on the balance between benefits and risks are reassessed in conjunction with new scientific information and changes in the views of society. This does not mean that decisions of today eventually will be proven wrong. Rather, the balance of benefits and risks is ever-changing because of improved science and the changing expectations of society.

The ebb and flow between today’s decisions and tomorrow’s expectations is the essence of the pesticide regulatory arena. All pesticides—from over-the-counter products for homeowners to sophisticated agrichemicals?exist in the marketplace because of the process that blends science, laws, economics, and public policy. From this complex and ever-changing system emerges the pesticide label.

HISTORY OF PESTICIDE REGULATIONS

The federal government has regulated pesticides since the early 1900s. Originally, pesticide regulation emphasized consumer protection from fraudulent claims about product performance. The focus now has shifted to the protection of human health and the environment. Following are brief descriptions of laws applicable to pesticides regulation.

Federal Food, Drug, and Cosmetic Act of 1906 (FFDCA, or Pure Food Law) Guaranteed the wholesomeness and truthfulness of labeling for foods, drugs, and cosmetics being offered to the public.

Insecticide Act of 1910
A consumer protection law which was intended to prevent the manufacture, sale, or transportation of impure or improperly labeled insecticides and fungicides.

FFDCA as amended in 1938
Changed FFDCA to include regulation of pesticides on food. Required the adding of color to white insecticides to prevent their accidental use in cooking.

Federal Insecticide, Fungicide and Rodenticide Act of 1947 (FIFRA)
Replaced the Insecticide Act of 1910
Required the U.S. Department of Agriculture to register all pesticides. Extended coverage to include herbicides and rodenticides. Established standards for label content.

FFDCA as amended in 1954 (The Miller Act)
Section 408 authorized the establishment of tolerances for pesticide residues in food.

FFDCA as amended in 1958
Section 409 established a general, risk-based safety standard for food additives. The Delaney clause prevented establishment of food and feed additive tolerances for any pesticide that causes cancer in laboratory animals.

FIFRA as amended in 1964
Required USDA secretary to refuse registration of pesticides that were unsafe or ineffective and to remove them from the market.
Also required that
1. All pesticide labels contain a USDA registration number;
2. The front label of all pesticides include the words caution, warning, or danger, and "Keep Out of Reach of Children";
3. All safety claims be removed from labels.

U.S. Environmental Protection Agency formed in 1970
A dramatic change in federal regulation of pesticides occurred in 1970 when Congress transferred administration of FIFRA from the U.S. Department of Agriculture to the new Environmental Protection Agency. Federal Policy shifted from the control of pesticides for reasonable safe use in agricultural production to control of pesticides for reduction of unreasonable risks to humans and the environment. The authority to establish pesticide tolerances on food was transferred from the Food and Drug Administration (FDA) to EPA. However, enforcement of tolerances was to remain the responsibility of FDA.

FIFRA as amended in 1972
Listed in greater detail specific methods and standards for control. Provisions include.
1. Use of any pesticide inconsistent with the label is prohibited.
2. Violation can result in fines and/or imprisonment.
3. Pesticides must be classified for general use or restricted use.
4. All persons applying restricted-use pesticides must be certified by their state (includes commercial applicators and farmers).
5. Pesticide manufacturing sites must be registered and may be inspected by EPA.
6. All pesticides must be registered by EPA prior to sale or distribution.
7. States may register pesticides on a limited basis for Special Local Needs.
8. Manufacturers must supply scientific evidence that a pesticide, when used as directed, will not injure humans, crops, livestock, nontarget organisms, or the environment, and that it will not produce illegal residues on or in food or feed.

Resource Conservation and Recovery Act of 1972 (RCRA)
Gave EPA authority to control the disposal of hazardous waste including many pesticides.

Endangered Species Act of 1973 (amendments: 1976, 1977, 1978, 1979, 1982)
Goal was to protect threatened and endangered species. Required that pesticide labels be designed to protect specific endangered species from adverse effects of pesticides, and established restrictions on pesticide application in endangered species habitats.

Safe Drinking Water Act of 1974 (amendments: 1976, 1977, 1979, 1980, 1984, 1986, 1988)
Designed to protect underground sources of drinking water and to require contaminant levels in problem drinking water systems.

FIFRA amended in 1975
Established Scientific Advisory Panel.
Specified that USDA must be notified when EPA intends to suspend or cancel a pesticide.

FIFRA amended in 1978
Provided for conditional registration.
Provided manufacturers ten years of exclusive rights to data generated in support of their products.
Established RPAR (Rebuttable Presumption Against Registration), now called Special Review, to reevaluate the registration of pesticide products.

Federal Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA)
A provision of the Superfund Amendments and Reauthorization Act of 1986 (SARA). The goal of this law was to increase public knowledge of and access to information about the presence of hazardous chemicals, including pesticides, in their communities and the potential for release of these chemicals into the environment.

FIFRA amended in 1988
Strengthened EPA’s authority in several major areas by
1. Requiring a substantial acceleration of the pesticide reregistration activity and the reevaluation for active ingredients registered before November 1, 1984;
2. Imposing statutory time limits for processing certain types of pesticide registration information;
3. Changing EPA’s responsibilities and funding requirements for the storage and disposal of suspended and cancelled pesticides;
4. Authorizing collection of fees to support some of these new activities.

Food, Agriculture, Conservation, and Trade Act of 1990 (1990 Farm Bill)
Required all certified private applicators of restricted-use pesticides to maintain records comparable to records maintained by commercial applicators.

Pesticide Laws and Regulations: An Overview

The authority to create federal and state pesticide laws is delegated to elected officials. Usually, the laws provide only a basic frame work and intent within which to operate. The specific mandates—called rules and regulations—are developed by a regulatory agency or agencies. Changes in federal law often result in parallel changes in state laws and regulations. State law must always meet the minimum standards assigned by federal law; however, some states may implement laws which exceed standards mandate by federal authority. Regulations developed within an agency (EPA, USDA, state regulatory offices, etc.) are subject to a rule-making process. This process involves publishing the proposed rule in either the Federal Register (if the origin of the rule is a federal agency) or the State Register (if the origin of the rule is a state agency). Such publication informs the public of proposed changes to regulations. Both registers also announce a time frame during which the public may comment on or submit revisions to the proposed document. Public participation in the process is reinforced by the Administrative Procedures Act. After the comment period ends, the agency responsible for the rule may revise the document based on input from the public. The final rule eventually is published in the same register. Federal pesticide regulations under FIFRA are contained in the Code of Federal Regulations,Volume 40, Parts 150-190.

Reasons for Pesticide Laws and Regulations

1. To provide for the proper and beneficial use of pesticides to protect public health and safety.
2. To protect the environment by controlling the uses and disposal of potentially harmful pesticides.
3. To assure safe working conditions for farm workers, commercial pest control personnel, and consumers.
4. To assure users, including homeowners, that pesticides are labeled properly, that they are appropriate for their intended use, and that they contain all instructions and precautions necessary to ensure that benefits exceed risks.
5. To encourage the use of integrated pest management systems which emphasize biological and cultural pest control techniques with selective use of pesticides.

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