UPDATE: 750+ SCIENTISTS HAVE SIGNED THE AIBS LETTER TO BOOST FUNDING FOR BIOLOGY AT NSF - As announced in our special alert last week (see www.aibs.org/supportnsf), the NSF Biological Sciences Directorate (BIO) received NONE of the $348 million added to the NSF budget by the Senate Appropriations Committee. BIO received a 3.4%increase while the other directorates get increases of between 12.3% and 20% in the Senate appropriations bill. The House appropriations committee does not act on the bill until mid-September, however, so community action could help improve the situation. Since our alert was issued on 8/12, more than 750 biologists from every state and US territory have signed the AIBS letter to Congress.
In the meantime, AIBS Public Policy staff have been in discussion with key congressional aides. In addition to the steps we suggested in the special alert , interested parties should request that their representatives contact the members of the VA-HUD subcommittee on appropriations (see www.aibs.org/supportnsf for list) and urge the appropriations subcommittee to provide a fair distribution of funds among the directorates. Because the House and Senate are operating under different budget resolutions this year, the House may not be able to grant as large of an increase to NSF as the Senate did. However, it is still important that the House appropriators hear from biologists so that BIO's increase will be more on par with other directorates. It is still helpful to work with your Senators, as well, since the bill has not passed the full Senate and will have to be conferenced with the House version of the bill later this fall. We will continue to provide updates on the situation in future AIBS policy updates.
BUREAU OF LAND MANAGEMENT RENEWS SCIENCE ADVISORY BOARD - On 23 July, the Bureau of Land Management the Department of the Interior bureau that manages 262 million acres of federal lands announced that it would renew its Science Advisory Board. The purpose of the Board is to advise and assist the Director of the Bureau of Land Management on issues pertaining to science and the application of scientific information in the management of public lands and their resources. The Board is comprised of up to nine members from among the following categories: Natural Resource Management, Energy and Minerals, Forestry and Rangeland Management, Biology, Ecology, and Social and Political Science. The terms of the five people currently appointed to this committee expire in mid-September. Therefore, it is expected that the bureau of land management will soon call for nominations for new committee members. if you are interested in serving on this committee, please contact Ellen Paul at firstname.lastname@example.org to be sure that relevant notices are sent to you.
WHITE HOUSE OFFICE OF SCIENCE AND TECHNOLOGY POLICY PROPOSES FEDERAL ACTIONS TO UPDATE FIELD TEST REQUIREMENTS FOR BIOTECHNOLOGY-DERIVED PLANTS AND TO ESTABLISH EARLY FOOD SAFETY ASSESSMENTS FOR NEW PROTEINS PRODUCED BY SUCH PLANTS - On 2 August 2002, the White House Office of Science and Technology Policy (OSTP) published proposed actions to address regulatory issues associated with the development and use of biotechnology-derived crops. The proposed changes to existing regulations were developed by OSTP, working with the Departments of Agriculture (USDA) and Health and Human Services (HHS) and the Environmental Protection Agency (EPA).
Comments are requested by OSTP on the proposed changes. To be assured consideration comments must be postmarked no later than September 30, 2002. Comments on this notice should be sent to OSTP by e-mail at email@example.com or by FAX at 202-456-6027.
These proposals are aimed at further reducing in commercial seed lots, bulk commodities, and processed food and feed the likelihood of the occurrence of intermittent, low levels of biotechnology-derived genes and gene products from crops under development for food or feed use until all appropriate safety standards have been met. These actions are part of the government's continuing protection of public health and the environment and efforts to enhance public confidence in the regulatory oversight of biotechnology-derived food crops and foods/feeds derived from such crops.
In developing these proposals, the U.S. government has relied on the following three principles:
- The level of confinement under which a field test of a biotechnology-derived plant is conducted should be consistent with the level of environmental, human, and animal health risk associated with the introduced protein and trait.
- If a trait or protein presents an unacceptable risk or the risks cannot be determined adequately, field test confinement requirements would be rigorous to restrict out-crossing and commingling of seed and the occurrence at any level of biotechnology-derived genes and gene products from these field tests would be prohibited in commercial seed, commodities, and processed food and feed.
- Even if a trait or protein does not present an unacceptable risk to the environment or public health, field test requirements should still minimize the occurrence of out-crossing and commingling of seed from these field tests, but intermittent, low levels of biotechnology-derived genes and gene products from such field tests could be found acceptable based on data and information indicating the newly introduced traits and proteins meet the applicable regulatory standards.
Each of the three agencies will be publishing for comment more specific guidelines, as follows:
The Food and Drug Administration (FDA) would publish for comment draft guidance on procedures to address the possible intermittent, low level presence in food and feed of new non-pesticidal proteins from biotechnology-derived crops under development for food or feed use, but that have not gone through FDA's premarket consultation process. The guidance would focus on proteins new to such plants, because FDA believes that at the low levels expected from such material, any food or feed safety concerns would be limited to the potential that a new protein could cause an allergic reaction in some people or could be a toxin. Through this guidance, FDA would encourage sponsors (domestic and foreign) to submit protein safety information once field testing was about to reach a stage of development such that there could be concerns that new non-pesticidal proteins produced in the field-tested plants might be found in commercial seed, commodities, or food/feed.
Consistent with procedures the agency has implemented or has proposed to implement for its voluntary premarket consultation process and proposed mandatory premarket notification process for foods/feeds from bioengineered plants, the agency would propose in the draft guidance to provide developers with a written response at the conclusion of its evaluation, and to make the submission and FDA's response available through its web site. FDA would propose to maintain a list on its website, consistent with confidentiality requirements, of all proteins it had evaluated and considered acceptable (or unacceptable) through this procedure. FDA would still expect developers to conduct a complete consultation with FDA prior to marketing food or feed from the plant, consistent with current practices.
The Environmental Protection Agency (EPA) would rely on its existing processes to address residues of pesticidal proteins in food, and would publish for comment guidance for individuals and organizations conducting field-testing on plant-incorporated protectants (PIPs). PIPs are pesticidal substances and the genetic material necessary to produce the substance, when produced and used in living plants, and are regulated as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA). This guidance would address broadly two issues: (1) The process for obtaining EPA review of the safety of the presence of low-level intermittent residues of PIPs in food and (2) guidance on containment controls that a person should employ when conducting experimental field trials, in order to minimize the potential occurrence of unapproved PIPs in food.
The U.S. Department of Agriculture (USDA) has strengthened field-testing controls for permits on those bioengineered traits that are not intended for commodity uses, such as pharmaceuticals, veterinary biologics, or certain industrial products. This has been accomplished by requiring specific additional safeguards as a condition of permits for confined release into the environment of such products. The potential for exposure would be mitigated through additional appropriate safeguards. These safeguards may include overall confinement procedures, performance standards, and monitoring/auditing practices for ensuring that out-crossing or commingling of non-commodity appropriate traits with seeds and commodities are prevented.
USDA would also propose, under its biotechnology regulations in 7 CFR part 340, to amend its regulations to provide criteria under which regulated articles may be allowable in commercial seed and commodities, if they pose no unacceptable environmental risk. Criteria would be announced as part of an overall updating of 7 CFR part 340, incorporating APHIS' new authorities under the Plant Protection Act and in consideration of recommendations given to USDA in the National Research Council (February 2002) report ``Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation.''
USDA will also continue and expand a critical emphasis on transparency of the regulatory process and on the use of broad internal and external scientific expertise and review as the foundation for decision-making.
NATIONAL INSTITUTES OF HEALTH PUBLISHES FINAL "JUST IN TIME" RULE FOR REVIEW OF PROTOCOLS IINVOLVING LIVE VERTERBRATES - On 7 August 2002, the National Institutes of Health (NIH) announced that it is changing the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) to permit institutions with PHS Animal Welfare Assurances to submit verification of Institutional Animal Care and Use Committee (IACUC) approval for competing applications subsequent to peer review but prior to award. This change in PHS Policy is effective as of September 1, 2002 (i.e., for all applications submitted for the May-June 2003 Advisory Council dates).
This change was proposed in March; AIBS comments supporting the changes were among the 200 that were overwhelmingly in favor of the change.
Instead of requiring protocol approval from the Institutional Animal Care and Use Committee (IACUC) prior to NIH peer review of proposals, the new policy simply requires that IACUC approval be submitted prior to the award. The purpose of the change is to enhance the flexibility of institutions and reduce the burden on applicants and IACUCs, allowing resources to be focused on substantive review of applications likely to be funded. The change, however, permits funding components to require verification of IACUC approval at an earlier date if necessary.
The announcement cautions that, "Under no circumstances may an IACUC be pressured to approve a protocol or be overruled on its decision to withhold approval. NIH peer review groups will continue to address the adequacy of animal usage and protections in their review of an application and will continue to raise concerns about animal welfare issues. However, in no way is peer review intended to supersede or serve as a replacement for IACUC approval. An institution that elects to use IACUC just-in-time bears the responsibility for supporting the role of the IACUC."
Further, "It remains incumbent upon investigators to be totally forthcoming and timely in conveying to their IACUCs any modifications related to project scope and animal usage that may result from the NIH review and award process. Should an institution find that one of its investigators disregards his/her responsibilities, the institution may, for example, determine that all animal protocols from that investigator be subject to IACUC approval before it will permit submission of an application from that investigator."
The existing PHS Policy requirement that modifications required by the IACUC be submitted to the NIH with the verification of IACUC approval remains in effect, and it remains the responsibility of institutions to communicate any IACUC-imposed changes to NIH staff.
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