Genetically Modified Pest-Protected Plants Science and Regulation (2000) / Chapter Skim
Currently Skimming:
4. Strengths and Weaknesses of the Current Regulatory Framework
4. Strengths and Weaknesses of the Current Regulatory Framework
Pages 144-181
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 144... ...
The coordinated framework established the basis for regulation of new plant varieties produced by rDNA techniques. Although the term genetically modified is commonly used to describe these transgenic plants, it could just as easily be applied to products and plants that result from conventional plant breeding techniques (section ES.3.2)
|
From page 145... ...
In the 14 years since introduction of the coordinated framework, the lead agencies have worked to coordinate their oversight responsibilities and have resolved many of the issues that were either unforeseen or unaddressed in 1986. Hundreds of new plant varieties have been the subject of federally approved field tests, and dozens of new plant products are on the market today (section 1.5.5~.
|
From page 146... ...
.2 On the basis of its experience with the permit program, USDA has provided a number of exemptions for articles that it has determined do not pose a plant pest risk. One of the more important exemptions authorizes the introduction of certain regulated articles without a permit provided that USDA is notified in advance.
|
From page 147... ...
The policy holds that genetically modified foods should be regulated as ordinary foods are unless they contain substances or demonstrate attributes that are not usual for the product. According to FDA, most food-related issues concerning 3The FDA,s current policy on the labeling of foods derived from new plant varieties is discussed in the 1992 notice, 57 Fed.
|
From page 148... ...
The 1992 policy acknowledges that, in some cases, whole foods derived from new plant varieties, including plants developed by new genetic techniques, might fall within the scope of section 409. It is the transferred genetic material and the intended expression product of that material in the plant that could be subject to food additive regulation if such material or expression product is not generally recognized as safe (GRAS)
|
From page 149... ...
Substances present in food as a result of the presence of transferred genetic material, referred to as "expression products," will typically be proteins or substances produced by the action of protein enzymes, such as carbohydrates, fats, and oils. If the intended expression product differs significantly in structure, function, or composition from substances found ordinarily in food or if it has no history of safe use in food, it might not be GRAS and might require food additive regulation.
|
From page 150... ...
. Modern genetic techniques permit the development of plants that produce their own pesticides or are otherwise resistant to insects, viruses, and other plant pests.
|
From page 151... ...
4.2 EVALUATION OF THE ENVIRONMENTAL PROTECTION AGENCY'S REGULATION OF PESTICIDAL SUBSTANCES IN PLANTS UNDER THE 1994 PROPOSED RULE In 1994, after a long review of regulatory options and having gained valuable experience in the evaluation of proposals for field tests of several transgenic pest-protected plants, EPA announced its intention to regulate the pesticidal substances produced in such plants, but not the plants themselves, under the provisions of FIFRA and FFDCA (EPA 1994a, c)
|
From page 152... ...
EPA would capture pesticidal substances produced in plants by amending the long-standing FIFRA exemption for biological control agents and then exempting pesticidal substances that did not warrant review, with separate exemptions required under FFDCA. Although the proposal has not been finalized, the agency has been implementing its essential elements in registration actions taken since 1995.
|
From page 153... ...
Under EPA's proposed policy, both the registration and the tolerance action apply to the pesticidal substance and the genetic material necessary for its production in the plant. The proposed rule includes several exemptions from regulation as plant-pesticides (sections 1.5.3 and 3.2~.
|
From page 154... ...
The proposed rule does not assess the potential for taking advantage of monitoring systems that use federally funded insect surveys, independent crop consultants, and USDA extension agents to identify potential adverse effects associated with conventional pest-protected plants and other crops. The committee recommends that EPA should publicly reexamine the extent to which FIFRA adverse effects reporting is intended to apply to plant breeders, researchers, and seed distributors of conventional pest-protected plants who have never been subject to FIFRA or EPA jurisdiction.
|
From page 155... ...
Ultimately, the credibility of the regulatory process will depend heavily on the public's ability to understand the process and the key scientific principles on which it is based. The coordinated framework addresses several elements that contribute to a sound regulatory process.
|
From page 156... ...
It identified the lead agency and supporting agencies that would be responsible for the oversight of various classes of products (table 4.1~. The approach was explained as follows: Where regulatory oversight or review for a particular product is to be performed by more than one agency, the policy establishes a lead agency, and consolidated or coordinated reviews.
|
From page 157... ...
EPA has registered 10 pesticidal substances expressed in transgenic potato, cotton, or corn plants and has established corresponding exemptions from the requirement of a tolerance for these pesticidal substances under the agency's proposed regulations (see sections 1.5.3 and 3.2~. Seven additional pesticidal products, also considered by EPA to be subject to its jurisdiction, are exempt from FIFRA registration because they consist of coat proteins of plant viruses.
|
From page 158... ...
EPA has taken steps to clear representatives of other agencies for access to CBI in submissions made to EPA. The ability of agencies to communicate unencumbered by CBI constraints can only enhance the credibility and public acceptance of the regulatory process.
|
From page 159... ...
Each agency defines transgenic pest-protected plant products in terms consistent with its regulatory authority: pesticides for EPA, plant pests for USDA, and foods for FDA (table 4.2~. The result is that there is no uniform interagency definition of these products.
|
From page 160... ...
USDA has declared some genetically engineered plants to be "regulated articles" because of potential plant pest risk. FDA regulates foods derived from new plant varieties.
|
From page 161... ...
The scope of USDA's oversight includes "any organism which has been altered or produced through genetic engineering, if the donor organism, recipient organism, or vector or vector agent belongs to the genera or taxa designated in Section 340.2 and meets the definition of a plant pest" (USDA 1987, section 340.1~. Many plants do not automatically meet the definition of a "plant pest." Thus, the upshot of this language is that, without a specific determination to the contrary, USDA regulations cover only genetically modified plants that have inserted genetic material from plant pests.
|
From page 162... ...
reiterates the exemption of plants as biological control agents, it points out that EPA will regulate pesticidal substances expressed in the plants and the genetic material necessary for the production of the substances. The policy also clearly articulates the division of jurisdiction over the substances between EPA and FDA.
|
From page 163... ...
that establishes a process to ensure a timely exchange of information on plant-expressed pesticidal substances that are potential food allergens. The MOU should articulate a process under which the agencies can regulate potential food allergens in a consistent fashioneby EPA through tolerance setting and by FDA through food labeling.
|
From page 164... ...
USDA also requests applicants to provide human-health and ecological information; this suggests an unnecessary overlap in regulatory oversight. However, except for information pertaining to USDA's assessment of plant pest risk, the human health and ecological information that it receives is used to support its environmental assessment under NEPA, not to support its granting or denial of a permit or determination of nonregulated status under FPPA.
|
From page 165... ...
. However, where EPA and USDA assert regulatory authority over the same endpoint, the lack of clarity as to the lead agency and the differing bases for decision-making can, on occasion, lead to confusion both in the agencies and in the regulated community.
|
From page 166... ...
The foregoing example emphasizes the need for agencies to avoid inadvertent duplication or the appearance of inconsistency in decisions by increasing their coordination in developing guidance in subjects of common interest and maintaining communication on data needs that are believed to be mutually exclusive. To enhance coordination, the committee recommends that EPA, USDA, and FDA should develop a memorandum of understanding for transgenic pest- protected plant products that provides guidance to identify the regulatory issues that are the purview of each respective agency (for example, ecological risks and tolerance assessment for EPA, plant pest risks for USDA, and dietary safety of whole foods for FDA)
|
From page 167... ...
. In contrast with EPA's approach, USDA appears to have determined that resistance management, at least as related to Bt crops, is not a plant pest risk issue that would be appropriately addressed through regulation under FPPA.
|
From page 168... ...
EPA should continue to deal seriously with Bt resistance management and any other transgenic pest-protected plants that present similar concerns, but, Where regulation is not warranted, agencies should look for appropriate opportunities to promote nonregulatory mechanisms to address issues associated with transgenic pest-protected plant products, including encouraging development of voluntary industry consensus standards and product stewardship programs. 4.3.5 Consistency of Statements of Information to Support Reviews As new transgenic pest-protected plant products are developed, the kinds of information necessary to support the agencies' risk assessments and regulatory determinations continue to evolve.
|
From page 169... ...
The committee recommends that FDA should put a high priority on finalizing and releasing preliminary guidance on the assessment of potential food allergens, while cautioning that further research is needed in this area. Publication of such guidance by FDA would be helpful both to companies consulting with FDA and to companies seeking approvals from EPA, inasmuch as EPA staff depend heavily on the expertise of FDA staff on allergenicity.
|
From page 170... ...
The committee found that Appropriately, EPA, USDA, and FDA request that applicants submit similar information concerning the recipient plant, molecular methods, characterization of gene products, and selectable markers. The committee recommends that EPA, USDA, and FDA should develop a joint guidance document for applicants that identifies the common data and information the three agencies need to characterize products (for example, biology of the recipient plant, molecular biological methods used to develop the product, identification and characterization of inserted genetic material and their products, and identity and characterization of selectable markers)
|
From page 171... ...
Depending on the relevance and completeness of the existing literature, agencies may require companies to generate original data to address environmental and food safety questions. USDA and EPA do not appear to be comparably inclined to require original data to support decision-making, and therefore might not always review products with comparable rigor.
|
From page 172... ...
The strengths and weaknesses of the framework for regulation of transgenic pest-protected plant products can be examined in the context of a transparent regulatory process. The following analysis examines the transparency of the regulatory approaches taken by the three lead federal agencies from the standpoint of the regulated community, the state-level coregulator, and the public at large.
|
From page 173... ...
Other website resources listed in this index include guidance on applying for permits, making notifications, and petitioning for determination of nonregulated status and a variety of biosafety resource materials. The more traditional method of Federal Register notices to present regulations and convey regulatory decisions is also used.
|
From page 174... ...
Beyond the traditional means of communicating its regulatory decisions on new plant-pesticides through the Federal Register, EPA has used its website to improve the transparency of its regulatory program. The website provides access to pesticide fact sheets, which summarize the kinds of data and risk issues evaluated by the agency for individual active ingredients in making regulatory determinations, and it links to Federal Register notices of regulatory determinations under FIFRA and FFDCA (EPA l999b)
|
From page 175... ...
The regulated community under the proposed rule includes academic re
|
From page 176... ...
Registrants of traditional pesticides that have expanded their scope of business to include transgenic pest-protected plant products are better prepared to respond to the new regulatory coverage because of their familiarity with the existing system. More specificity on the regulatory process is available through individual staff identified on the website.
|
From page 177... ...
, so a perspective on its screening of CBI claims is not possible. Integration of Information The Internet has greatly enhanced agencies' ability to communicate their regulatory process to the regulated community and the public.
|
From page 178... ...
and employee time spent overseeing the regulatory process and interacting with agencies' staff. They also include costs associated with delays in development and commercialization of products.
|
From page 179... ...
. EPA should make explicit a process for the periodic review of its regulations on the basis of new information or changed circumstances to identify additional categories of pesticidal substances expressed in plants that should be exempt from regulatory requirements and existing exemptions that should be revoked or restricted.
|
From page 180... ...
· EPA, USDA, and FDA should develop a memorandum of understanding for transgenic pest-protected plant products that provides guidance to identify the regulatory issues that are the purview of each respective agency (for example, ecological risks and tolerance assessment for EPA, plant pest risks for USDA, and dietary safety of whole foods for FDA) ; identifies the regulatory issues for which more than one agency has responsibility (for example, gene transfer for EPA and USDA and food allergens for EPA and FDA)
|
From page 181... ...
. EPA should promptly complete the process for issuing regulations, policies and guidance that set out the review and regulatory parameters for pesticidal substances in transgenic pest-protected plants.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.