Concerns from within the US's Environmental Protection Agency (excerpts):

"Once this thing is in place, there's going to be little or no control"

EPA sources say the conflict over the so-called plant incorporated pesticide (PIP) rule is indicative of a broader lack of clear rules and guidelines for inspecting and enforcing against biotech firms  and farmers, leaving the industry's environmental impacts essentially unregulated.

Regional enforcement officials are also concerned that a lack of binding requirements on manufacturers and farmers will cripple federal and state  enforcement.

Last year's debacle with Starlink seeds... "showed that our current way of regulating these crops doesn't work"

Regional officials are also becoming increasingly concerned with the potential for genetic contamination of traditional crops or even non-crop plants.
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REGIONAL OFFICIALS OBJECT TO PENDING EPA BIOTECHNOLOGY RULES
Source: Inside EPA via InsideEPA.com
Date: September 7, 2001
Issue: Vol. 22, No. 36
© Inside Washington Publishers

EPA regional officials are pressing agency headquarters to  suspend an upcoming rule governing the use and registration of genetically modified crops, arguing that a lack of enforceable provisions will cripple the federal government's ability to ensure the crops are not used inappropriately, sources close to the issue say.

EPA sources say the conflict over the so-called plant incorporated pesticide (PIP) rule is indicative of a broader lack of clear rules and guidelines for inspecting and enforcing against biotech firms  and farmers, leaving the industry's environmental impacts essentially unregulated. The rule is being promulgated under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA).

The PIP rule sets pesticide tolerance limits and use requirements  for crops that have been genetically modified to produce their own pesticides. EPA is expected to finalize most of the rule later this month.

A regional enforcement source says that if the rule is finalized, it will make it virtually impossible to develop an adequate enforcement program. "Once this thing is in place, there's going to be little or no control," the source says, arguing that "it will have to be a national problem, a big enough political problem, for EPA to get involved."

According to EPA sources, the agency first began work on the rule  in 1994. But the proposal eventually ground to halt as a result of conflicts among EPA, the Food & Drug Administration (FDA) and  the Department of Agriculture (USDA) over which agency would have  primary regulatory and enforcement authority.

As part of its last minute push to complete regulatory development, the Clinton administration published the rule in January. Although  the Bush administration pulled the rule as part of its massive regulatory review this spring, it released it July 19 largely unchanged, and expects to publish a final rule in the Federal Register Sept. 19.

But the rule has spurred "a mini revolt" among regional enforcement and pesticide officials, one source says. Specifically, the regions are concerned that the rule was developed so long ago that it would be inappropriate to complete it without providing the public with a new chance to comment on the rule.

The regional source points out that in 1994, the public was largely ignorant of the advances in biotechnology, while over the last several years public interest in the issue has exploded. Because of that, the agency would likely receive "more sophisticated comments" from the public if it is sent out for a new round of comments.

Regional enforcement officials are also concerned that a lack of binding requirements on manufacturers and farmers will cripple federal and state enforcement. While traditional pesticide rules include specific labeling requirements -- creating a legal "contract" between the user and manufacturer enforceable by EPA -- genetically modified crop rules do not include labeling rule.

Instead, the use of the modified seeds is governed by a so-called "growers agreement" between the user and the seed manufacturer. Although the grower agreements are intended to obligate farmers to follow specific rules for the use of bio-engineered seeds, the only enforcement entity is the seed producers themselves.

Of greatest concern to enforcement officials with this system is their inability to verify that farmers are abiding by specific planting restrictions that are included in the grower agreements. An agency source explains that in order to keep insects from building up resistance to the pesticides, farmers are required to plant a certain portion of their crop using traditional seeds.

But because the agreements are not enforceable, state and federal inspectors have no legal authority to inspect fields to determine whether a farmer is in compliance. "They don't even have the authority to ask the kind of questions" that would indicate a problem with compliance, one EPA source says.

The controversy over the PIP rule is also indicative of a potentially larger problem with EPA enforcement efforts in the biotech industry, agency sources say. For instance, the agency has never developed an enforcement and compliance strategy for the use of genetically modified seeds. Last year's debacle with Starlink seeds -- which were used for food despite the fact that the federal government had not yet approved their use -- "showed that our current way of regulating these crops doesn't work," one source says.

A second broader issue is a lack of clarity regarding the enforcement authorities of EPA, FDA and USDA. A lack of clear delineation has made it difficult for regions to determine when they may have authority over an issue. For instance, some crops include so-called "terminator" genes that make seeds produced by a crop unusable the next year.

One source explains that from EPA's perspective, these genes could be a possible environmental justice issue, since poor farmers often rely on seeds from the previous year to plant their fields. But USDA and FDA generally deal with terminator gene issues, and headquarters has informed the regions that they are not to become involved in the issue, the source says.

Regional officials are also becoming increasingly concerned with the potential for genetic contamination of traditional crops or even non-crop plants. One source notes that EPA has struggled for years to deal with the issue of pesticide drift from traditional pesticides, and argues that the agency should anticipate the almost certain problems which will occur as a result of genetic drift.

Regional pesticide officials were expected to meet with Assistant Administrator for Pollution Prevention & Toxic Substances Steve Johnson this week in Chicago to discuss regional concerns with the rule.