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Biotechnology Activities
The OSCP Biotechnology Team provides scientific and policy expertise on biotechnology issues; coordinates EPA, interagency, and international work on biotechnology policy; and facilitates the sharing of information related to biotechnology. The Biotechnology Team participates in:
Intraagency Activities
Offices within EPA that regularly deal with biotechnology issues include:
- Office of Pollution, Prevention, and Toxics (OPPT)
- Office of Pesticide Programs (OPP)
- Office of General Counsel (OGC)
- Office of Enforcement and Compliance Assurance (OECA)
- Office of International Affairs (OIA)
- Office of Research and Development (ORD)
- Regional EPA Offices
When biotechnology issues arise, the Biotechnology Team facilitates coordination among affected offices and provides scientific policy input from a broad Agency perspective. Examples of the Biotechnology Team's intraagency activities include:
- The Biotechnology Team serves as a resource to the program offices in technical and policy areas by offering expertise and coordinating information flow among them. The Biotechnology Team keeps abreast of the newest scientific developments in biotechnology, prepares analyses of key scientific and science policy issues, and develops strategies for the development of regulations and risk assessment procedures.
- The Biotechnology Team coordinates OPPTS involvement in the biotechnology
risk assessment research program in the Office of Research and Development
(ORD). ORD seeks program office input into both the scientific soundness
of specific research projects and whether the overall risk assessment
research program is meeting OPP and OPPT regulatory needs.
- The Biotechnology Team helps ensure that EPA rules and other actions
for regulating biotechnology products are grounded in sound scientific
principles and reflect sound policy.
- A final package of rules for the regulation of plant-incorporated
protectants was published by EPA in 2001. The Biotechnology
Team played a lead role in developing the rule and continues to
work on a number of associated regulations:
- In April 2007 EPA proposed to exempt certain plant-incorporated protectants based on plant virus coat protein genes (PVCP-PIPs) from most requirements under FIFRA and to exempt residues of the protein portion of certain PVCP-PIPs (the “PVC-protein”) from the requirement of a tolerance under FFDCA. More about the proposals.
- In April 2007 EPA issued an advance notice of proposed rulemaking to announce its intent to examine compliance requirements related to production of plant-incorporated protectants. More about the notice.
- In April 2007 EPA proposed to exempt certain plant-incorporated protectants based on plant virus coat protein genes (PVCP-PIPs) from most requirements under FIFRA and to exempt residues of the protein portion of certain PVCP-PIPs (the “PVC-protein”) from the requirement of a tolerance under FFDCA. More about the proposals.
- A final regulation under the Toxic Substances Control Act for
Microbial
Products of Biotechnology was published in 1997. The Biotechnology
Team participated in the development of this rule by providing policy
advice and scientific input.
- The Biotechnology Team participates in an OPPT-led working group to address nomenclature issues related to the Toxic Substances Control Act Chemical Substance Inventory.
- A final package of rules for the regulation of plant-incorporated
protectants was published by EPA in 2001. The Biotechnology
Team played a lead role in developing the rule and continues to
work on a number of associated regulations:
Interagency Activities
Issues related to biotechnology affect more than one agency within the federal government. When this is the case, the Biotechnology Team works to ensure agencies work together and effectively communicate information on biotechnology topics. The Biotechnology Team serves as a liaison from OPPTS to other executive branch agencies on issues related to biotechnology. The team responds to requests for scientific input or advice on policy developments within the government and facilitates interagency coordination on biotechnology issues. Examples of the Biotechnology Team's interagency activities include:
- The Agricultural Biotechnology Working Group of the President's National
Economic Council addresses regulatory challenges posed by rapidly developing
biotechnologies and how these developments are being applied to potentially
new products.
- The Coordinated Framework Technical Working Group meets monthly by
conference call to discuss broad policy issues and to ensure that each
agency is fully informed of the others' activities with respect to biotechnology.
- A U.S. Biotechnology
Database Working Group
has been creating a publicly-accessible website of biotechnology products
and regulations. The site contains a database of genetically engineered
crop plants that are intended for food or feed and that have completed
all recommended or required reviews for food, feed, or planting use
in the United States. The website is expected to become accessible to
the public in 2004.
International Activities
EPA participates in a variety of international activities related to biotechnology and is fully committed to and engaged in international dialogues. EPA views participation in the international community as an opportunity to stress the critical importance of a science- and rules-based approach to evaluating the products of modern biotechnology and an opportunity to promote transparency, inclusiveness, and responsiveness in the decision-making process. The Biotechnology Team helps formulate OPPTS, EPA, and US positions on biotechnology issues and often represents OPPTS on US delegations to international meetings. EPA, along with representatives of other federal agencies, participates in:
- The Organization
for Economic Co-operation and Development
Working Group on Harmonization of Regulatory Oversight for Biotechnology
and Task Force on the Safety of Novel Foods and Feeds. Through these
groups, EPA works to ensure that high quality guidance documents are
developed. These documents include technical information on biological
traits, critical nutrients, and critical toxicants that can be used
in the regulatory review of biotechnology products.
- International discussions related to the Convention
on Biological Diversity
and the Cartagena Protocol on Biosafety. The US has signed but not ratified
the Convention on Biological Diversity. Although not a party to the
Protocol, the US is voluntarily providing information on living modified
organisms (LMOs) to the Biosafety Clearing House. The Biosafety Clearing
House provides a forum to exchange scientific, technical, environmental,
and legal information about LMOs produced through the use of biotechnology.
This forum provides greater transparency on the products that have been
approved for commercial use and the regulatory requirements of approving
countries.
- The Codex Alimentarius
Commission
and its Working Groups. This organization is the recognized international
food standards organization, institutionally related to both the World
Health Organization and the Food and Agriculture Organization. Its committees
and Working Groups deal with a complex range of food quality and food
safety issues, from food additives to pesticide residues to consumer
protection.
- The Interim Commission on Phytosanitary Measures of the International
Plant Protection Convention (IPPC).
This multilateral convention was adopted in 1952 for the purpose of
securing international cooperation in the control and prevention of
the spread and introduction of pests of plants and plant products and
to promote appropriate measures for their control. Activities addressed
by the IPPC include:
- Development and establishment of international plant health standards,
- Harmonization of phytosanitary activities through emerging standards,
- Facilitation of the exchange of official and scientific information among countries, and
- Furnishing of technical assistance to developing countries that are signatories to the IPPC.
The IPPC is recognized by the World Trade Organization as the standard-setting body for international plant quarantine issues.