BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD)
EPA’s earliest involvement with products of modern biotechnology came in the form of biopesticides, which can include microorganisms such as bacteria that are or are not genetically altered, called microbial pesticides; biochemical pesticides, which are naturally occurring substances that control pests by non-toxic mechanisms; and plant incorporated protectants (PIPs), which are pesticidal substances produced in plants, as a result of genetic material added to the plant.
Initial attention by EPA focusing on the requirements under FIFRA was on microbial pesticides, largely their experimental testing in accordance with experimental use permit (EUP) requirements.
The EUP regulations contained certain small scale acreage and water exemptions that seemed not applicable to microbes, which could spread and multiply beyond the test site. EPA therefore in 1984 issued an interim policy requiring that it be notified of any small scale testing of microbes that had been genetically modified or that were nonindigenous. See EPA, Microbial Pesticides; Interim Policy on Small Sale Field Testing, Notice; Statement of Interim Policy, 49 Fed. Reg. 40659 (1984).
This initiative was not finalized until 1994, after efforts in 1986, 1989, and 1993. The final regulations added new subpart C, Notification of Certain Genetically Modified Pesticides, to 40 CFR Part 172. See EPA, Microbial Pesticides; Experimental Use Permits and Notifications, Final Rule, 59 Fed. Reg. 45600 (1994). 40 CFR § 172.45 covers notification of small scale tests without adequate containment in a facility or intentional environmental introduction, where the microbe’s pesticidal properties have been imparted or enhanced by the introduction of genetic material that has been deliberately modified or are non-indigenous and have not been acted upon by USDA, unless the genetic changes involve a single gene.
EPA was embroiled early on in a number of microbial pesticide environmental releases, most notably testing of “ice-minus bacteria,” which had been genetically engineered to delete information that aids in frost formation. The approval of a field test by NIH was successfully enjoined on National Environmental Policy Act (NEPA) grounds and later an experimental use permit granted by EPA was also challenged leading to further postponement. See Foundation on Economic Trends v. Heckler, 587 F. Supp. 753 (D.D.C. 1984), aff’d and vacated in part, 756 F.2d 143 (D.D.C. 1985). The ice-minus experiment became notable for the number of challenges and vandalization of the test site, although the tests were finally conducted in April 1987. See Foundation on Economic Trends v. Thomas, 687 F. Supp. 25 (D.D.C. 1986).
Another type of biopesticide eventually became the subject of regulatory attention. Early in the 1990s EPA began to receive inquiries regarding the regulation of plants that act as pesticides and the pesticidal substances produced by such plants. Early on, such plants, which produce in the plant toxins that kill insects eating the plants, were called pesticidal plants. This terminology was later changed to “plant pesticides” to reflect the fact that EPA would not regulate whole plants but only the pesticidal materials expressed by the plants. (Materials obtained by extraction from plants can generally be regulated as other pesticides, or as biopesticides.) Importantly, plants used as biocontrol agents are exempt from FIFRA under 40 CFR § 152.20.
EPA’s formal statement of policy and proposed regulations were published in the Federal Register on November 23, 1994, including proposed exemptions from the requirement of a tolerance for three categories of such pesticides. See generally EPA, Proposed Policy; Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act, Statement of Policy, 59 Fed. Reg. 60496 (1994).
It was not until July 2001 that EPA published its final rules regulating “plant pesticides,” which were renamed PIPs because of complaints that the term “plant pesticides” still implied EPA regulation of plants themselves. The newer regulations are codified in part in Part 152, particularly 40 CFR § 152.3 in terms of key definitions, and primarily in Part 174. Both the protein and genetic material necessary to produce the protein are regulated as pesticides; the plant itself is not.
EPA has also promulgated a notice, similar to that of FDA’s discussed previously, pertaining to adventitious presence (AP). See EPA, Draft Guidance for Pesticide Registration on Small-Scale Field Testing on Low Level Intermittent Presence in Food of Plant Incorporated Protectants, Notice of Availability, 71 Fed. Reg. 57509 (2006). Similar to FDA (see above), it also has published a statement on Bt 10, which contains the Cry1Ab protein, acknowledging the safety of it. See U.S. Environmental Protection agency’s Statement on Bt10, at http://www.epa.gov/oppbppd1/biopesticides/pips/bt10_statement.htm.
EPA played a key role in the StarLink® corn Cry9C occurrence in human food (see FDA section above). Cry9C had been registered as a pesticide (PIP) in 1998 for animal feed and industrial uses such as biofuels, but ended up on human food. Since there were no tolerances or exemptions therefrom for human food, such occurrence in human food was automatically unlawful. EPA was previously unable to conclude whether Cry9C protein was a human allergen, and efforts to resolve this issue later were unsuccessful after the finding of Cry9C in human food. The StarLink® episode resulted in EPA’s saying it would no longer allow “split” registrations for human and other animal food, although this was not an unusual occurrence with respect to other pesticides.
Similar to FDA, EPA has also recently proposed that testing for StarLink® be stopped because it has been sufficiently removed from the human food supply. See EPA Draft White Paper Regarding StarLink® Corn Dietary Exposure and Risk, Availability for Comment, 72 Fed. Reg. 28977 (2007), available at http://www.epa.gov/fedrgstr/EPA-PEST/2007/October/Day-17/p20381.htm.
Since the registration of any pesticide, including PIPs, typically requires a tolerance or an exemption from the requirement of a tolerance for residues in human and other animal food, EPA has not unexpectedly exempted from the requirement of a tolerance a variety of PIP-associated substances such as nucleic acids that are part of a PIP. See 40 CFR § 174.475. Plants that are “genetically engineered” to be tolerant to herbicides are not regulated under FIFRA, although the herbicides used on them in conjunction with killing weeks are. USDA and FDA therefore play key roles in the review of herbicide-tolerant food plants.
EPA has also recently developed an advanced notice of proposed rulemaking pertaining to its establishment and production regulations regarding PIPs, given their differences from other types of pesticides. It believes that the existing regulations are centered around traditional pesticides and not PIPs; therefore, changes are needed in FIFRA’s production and production-related requirements, especially because they potentially involve lower risk situations compared to conventional chemical pesticides. See EPA, Plant-Incorporated Protectants; Potential Revisions to Current Production Regulations, Advanced Notice of Proposed Rulemaking, 72 Fed. Reg. 16312 (2007).
The first stacked PIP targeted at two different insect groups was registered in 2003, containing two Bt transgenes. See EPA, Bacillus thuringiensis Fact Sheet, at http://www.epa.gov/pesticides/biopesticides/ingredients/factsheets/factsheet_006430-006484.htm. About 20 PIPs and a number of genetically modified microbials have been registered as pesticides. See, e.g., EPA, Current & Previously Registered Section 3 PIP Registrations, available at http://www.epa.gov/pesticides/biopesticides/pips/pip_list.htm and Biopesticide Active Ingredients and Products containing them, available at www.epa.gov/pesticides/biopesticides/product_lists/bppd_products_by_AI.pdf. Current PIP EUPs are listed in http://www.epa.gov/pesticides/biopesticides/pips/current_pip_eups.htm.
