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The Regulatory Framework

As the pesticide industry and its sales have continued to grow, so has awareness of the need for increasingly sophisticated regulation.

In the early 1900s, the responsibility for regulating pesticides was given to the Food and Drug Administration. In 1947, Congress passed the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), giving the U.S. Department of Agriculture responsibility for an industry-wide regulatory program, with similarities to the one we know today. In 1970 responsibility for administering FIFRA was transferred to a newly created Environmental Protection Agency (EPA). 

At the time of this transfer of authority, there was also a major shift in policy. Initially, FIFRA required “the reasonably safe use” of pesticides in agricultural production, and the primary purpose of the law centered on the desire to protect farmers from fraudulent marketing claims. Beginning in 1970, the mandate was to control pesticide use in order to reduce “ unreasonable risks” to human health and to the environment. The 1972 amendments to the law set up a registration process that requires a determination of safety for legal sale of a pesticide product by the manufacturer.

At this point, of course, there were a wide variety of pesticide products already in the marketplace. The law allowed those pesticides that had been “registered” before 1972 to be grandfathered or presumptively registered until such time as the registration process could re-review the chemicals against more up-to-date safety criteria.

To this day, the game of catch up with re-review of older generation pesticides absorbs much of the energy and resources of the regulatory program. Numerous deadlines have been set and missed in this regard, and the Congressional Research Service reported in 1996 that 2004 was the expected target date for completing work that was previously slated for completion in 1997.1

 

The most recent updating of the federal pesticide regulatory system and the underlying criteria for registering pesticides came with passage of the Food Quality Protection Act of 1996 (FQPA). Described by the EPA as “the first major modernization of the nation's pesticide/food safety laws in over 30 years,”2   FQPA is meant to better incorporate the consideration of risk to children and other sensitive groups or subpopulations and to create incentives for bringing new, hopefully safer pesticides to market. (See box on FQPA.)

Today, under authorities in FIFRA as well as the Federal Food, Drug and Cosmetic Act, EPA registers pesticide products for use on one or more specific crops. The registration is, in essence, a license to sell and distribute the product. It is the critical component for setting out the acceptable conditions on use of a pesticide. 

 

Pesticide Safety under the Food Quality Protection Act

Before a pesticide can be registered for use on a food crop, EPA must set a tolerance for the maximum amount of pesticide residue that can remain on that crop while in commerce. A tolerance is an enforcement level to identify the misuse of a pesticide. Before registering a new chemical, or registering a new use for an existing chemical, EPA must make a legal finding that the pesticide poses a "reasonable certainty of no harm." Several factors must be addressed before a tolerance can be established, including:

* the aggregate, non-occupational exposure from the
pesticide (exposure through diet, from using
pesticides in and around the home and from drinking
water); 

* the cumulative effects from pesticides that produce
similar effects in the human body; 

* whether there is increased susceptibility to infants
and children, or other sensitive sub-populations,
from exposure to the pesticide; and 

* whether the pesticide produces an effect in humans
similar to an effect produced by a naturally occurring
estrogen or produces other endocrine-disruption
effects. 

US EPA, 3 

 

With pesticides, the story of unexpected movement through the environment and unpredicted consequence has been told so often that the safest prediction becomes unexpected movement and unpredicted consequence.

William H. Rodgers, Jr. 4

Under the regulatory process, EPA requires pesticide makers to submit data on a particular chemical, its target and intended uses, its toxic effects and how it may behave in the environment. For pesticides that will be used on food products, studies of the residues of applied pesticides that may remain on the crop are also required. EPA reviews this voluminous data and makes a registration determination for each proposed "pesticide use."

EPA can and does register pesticides that pose a variety of environmental and public health problems. The Agency's mandate, under FIFRA, is not to deny registrations for pesticides that pose potential problems but to prevent “unreasonable risks to man and the environment, taking into account the economic, social, and environmental costs and benefits of the use of the pesticide.”5

Though the pesticide maker, in theory, carries the burden of proof in making the case that the pesticide does not pose unreasonable risks, as a practical matter the law's risk and benefit balancing imposes a significant burden on EPA. EPA must show not only an adverse effect from the expected pattern of use but also that the associated risks outweigh the economic and other benefits of pesticide use and cannot be mitigated sufficiently through means other than denial of the registration.

One source estimates that complete toxicologic data are available for only about 100 of the approximately 600 active pesticide ingredients. Reproductive and developmental toxicity data are often particularly deficient.

California Physicians for Social Responsibility and California Public Interest Research Group Charitable Trust 6

As a part of the registration process, EPA must concur with the language that will be used on the label for each pesticide use, and the Agency may specify conditions and restrictions on application rates, timing, approaches and the like. The Agency also sets allowable pesticide residue levels or “tolerances” for animal feed and for raw and processed foods.

In making its decisions, EPA is empowered to classify pesticides as “restricted” or “nonrestricted.” Those classified as "restricted use" pesticides must be applied by or under the “direct supervision” of a “certified” applicator. (Interestingly, direct supervision under the law does not necessitate the supervisor's physical presence during use.) Use of a pesticide in a manner inconsistent with requirements on the label is a violation of the law.

EPA also has the authority to suspend or cancel the registration of a pesticide if subsequent information suggests that use of a given pesticide would pose “unreasonable risks,” and the Agency has, in a number of instances, instituted “special reviews” of pesticides on the market to determine if the registration should be disallowed or altered. The process of cancellation is somewhat arcane and the extent of evidence of harm required by EPA is substantial. With detailed hearing and appeals schedules, cancellation proceedings can last four to eight years or even longer. 

When the evidence of risks from a given pesticide begins to mount, EPA revisits registration decisions and conditions. Frequently, the Agency resorts to label changes that lower the application rates or geographically restrict the use to areas considered less vulnerable to contamination problems. Another approach is to classify a problem pesticide as restricted in order to keep the chemical in the hands of users with some degree of training. In a few instances, several or even all uses of a particular product may have to be canceled.

EPA and the many states that have adopted pesticide laws similar to EPA's can take action against pesticide users for illegal pesticide use. The presence of the federal Agency in the field, however, is far less than pervasive.

Thus, it may not be surprising to learn that EPA's primary point of leverage seems to rest with the registrant who is seeking to obtain or hold onto a pesticide registration. Despite the fact that registration, re-registration and special reviews can be highly technical, tedious and cumbersome,  these processes can be of critical importance to those who are concerned with the pesticide use in their communities. 

With the passage of the FQPA and its new requirement to look at cumulative risk from pesticide exposures, the registration process has become a powerful lever for dealing with water quality problems.

Prior to passage of the 1996 law, EPA's approach to looking at risk from pesticides was, in many ways, narrow and restricted.  Now, however, when EPA sets acceptable "tolerances" for pesticide residues in food, it must consider the cumulative impact of total pesticide exposures -- including the pesticide burden that people are exposed to in their water, the risks associated with parent compounds as well as metabolites, and the risks from other parents and degradates that can inflict harm through "common mechanisms of toxicity."  

If EPA -- prodded by interested activists -- truly considers water and all other exposures from each pesticide or group of pesticides in its regulatory decisions, the impact could be profound.

For pesticides that appear frequently or at significant levels in drinking water supplies, this can mean that the acceptable tolerances will be very low.  If the pesticide in question cannot be used in the field without exceedance of the tolerance, then some or even all uses of the pesticide would have to be canceled or denied.  (See Section Six for hints on how to affect EPA's tolerance-setting process.)
1.  Schierow, Linda Jo, Congressional Research Service, Pesticide legislation:  Food Quality Protection Act of 1996 (P.L. 104-170), 1996.

2.  US EPA, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs Annual Report for 1996, 1996.

3. US EPA, Pesticide Registration Factsheet, available at <http://www.epa.gov/pesticides/citizens/registration.htm>, 1999.

4. Rodgers, William H. Jr., Environmental Law, 1994.

5.  Federal Insecticide, Fungicide, and Rodenticide Act as amended by the Food Quality Protection Act of August 3, 1996, Sec. 2, (bb).

6. California Physicians for Social Responsibility and California Public Interest Research Group Charitable Trust, Generations at Risk, available at <http://www.labridge.com/PSR/gar/>, 1998. Citation is to D.D. Weisenburger, in Human Pathology,1993.

 



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The url for this page is http://www.foe.org/safefood/groundwater/one3.html
Posted January 7, 2000
Copyright Friends of the Earth, 2000
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