From: Laurel Hopwood <[log in to unmask]>
Reply-To: Biotech Forum <[log in to unmask]>
Date: Wed, 19 Sep 2001 07:19:40 -0400
To: [log in to unmask]
Subject: regional EPA officials object to pending EPA biotech rules

Some EPA officials, mainly in regional offices around the country, appear
to be concerned about EPA's failure to truly regulate GE crops.  Read on...

          REGIONAL OFFICIALS OBJECT TO PENDING EPA BIOTECHNOLOGY RULES
_______________________________________________
                                         Date: September 7, 2001 -


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.


Source: Inside EPA via InsideEPA.com
Date: September 7, 2001
Issue: Vol. 22, No. 36
© Inside Washington Publishers

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