RESEARCH SECURITY IN THE POST-9/11 ENVIRONMENT

The USA PATRIOT Act and related legislation have altered the landscape for research at U.S. universities. Driven by a concern that research-generated information and materials used in research experiments could be used by terrorists to attack the American population, the Federal government has extended its regulation of research activities at universities and private laboratories. The effects of this new regulatory regime will be felt especially by the biological sciences, and some branches of chemistry, computer science, and physics.

At present, the likely direct impact of the emerging regulatory environment will be in two areas: (1) new regulations with respect to how certain biological and chemical agents are handled in laboratories, and new restrictions on who may have access to laboratories that contain such agents; and, (2) restrictions written into federally funded contracts and grants that place limits on the publication of research results, and that impose citizenship requirements on participation in research programs. University research may also be indirectly impacted by the difficulties foreign graduate students, postdoctoral scholars, and research collaborators confront in gaining timely entry into the United States as a result of a slowdown in the visa issuing process.

The regulatory atmosphere since 9/11 remains volatile and subject to change. Faculty who work in fields likely to be affected by security-related regulations can find information about possible regulatory changes and read current directives in the Research Advocate from the campus Research Administration and Compliance Office (http://rac.berkeley.edu/ra/list.html) and on the EH&S website (http://ehs.berkeley.edu/healthsafety/selectagent.html).

Select Agents

Select Agents Defined

A Select Agent is one of approximately 40 viruses, bacteria, rickettsiae, fungi, and toxins that are considered to potentially pose substantial harm to human health. The list of select agents in 42 CFR 73 is available at: http://www.cdc.gov/od/sap/docs/salist.pdf. Certain strains of organisms and quantities of toxins are exempt from the regulations. For information about exemptions, contact the Campus Biosafety Office at 643-6562.

In order to comply with the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, UC Berkeley is required register the possession, use, and transfer of select biological agents and toxins. In addition, the PATRIOT Act creates a class of "restricted persons" who may not possess, ship, transport, or receive any biological agent or toxin that is listed as a select agent. Under the terms of the Act, these "restricted persons," who include criminals and aliens from certain countries, are now specifically prohibited from having access to select agents.

Campus Procedures for Select Agents: The EH&S office is responsible for administering UC Berkeley's compliance with federal regulations pertaining to select agents. (See http://ehs.berkeley.edu/healthsafety/selectagent.html.) EH&S has developed a select agent packet of checklists, forms and templates to help guide PIs who wish to conduct research with select agents. In order to lawfully possess select agents, PIs must contact the Campus Biosafety Office (643-6562) who will work with them to file an application to the appropriate federal agency.

Background checks: Staff authorized to work with or be in a facility holding select agents must pass background checks by the U.S. Department of Justice (DOJ). People from certain "countries of interest" as defined by the DOJ will not pass the background check and may not be authorized. Please check with the UCPD for information related to background checks.

Export Controls
http://research.chance.berkeley.edu/echome.cfm
http://www.spo.berkeley.edu/Policy/exportcontrol.html

Export control laws are federal regulations that control the conditions under which certain information, technologies, and commodities can be transmitted overseas to anyone, including U.S. citizens, or to a foreign national on U.S. soil for reasons of national security or protection of trade. The laws are implemented by both the Department of Commerce through its Export Administration Regulations (EAR) and the Department of State through its International Traffic in Arms Regulations (ITAR). Most exports do not require government licenses.

Export regulations apply whether or not the recipient is funded by a grant, contract, or other agreement, and apply whether or not the EAR or ITAR are explicitly cited in the award document. If a researcher accepts export-controlled technology or information from a government agency or from industry, the researcher is subject to ITAR or EAR regulations.

Fundamental Research Exclusion for Universities

Most UC Berkeley research activities are excluded from export controls because of a general exception for "fundamental research" under export control regulations. The term "fundamental research," as used in the regulations, includes basic or applied research in science and/or engineering at an accredited institution of higher learning in the U.S. where the resulting information either is ordinarily published and shared broadly in the scientific community or where the resulting information has been or is about to be published.

University research is disqualified as fundamental research if (1) the institution accepts any restrictions on the publication of the research other than limited prepublication reviews by research sponsors to prevent inadvertent divulging of proprietary information or to insure that publication will not compromise patent rights of the sponsor; or (2) the research is federally funded and specific access or dissemination controls regarding the resulting information have been accepted by the university or the researcher.

Publication Restrictions
UC Berkeley Policy Guidelines Governing Openness and Freedom to Publish: http://www.spo.berkeley.edu/policy/ucmemos/publish.html

University of California and campus policy preclude agreeing to publication restrictions, other than a short delay to permit a review for patent purposes. Exceptions to the publication policy may be granted only by the Chancellor under very limited circumstances.

The academic community is concerned that federal agency awards for research viewed as relevant to terrorism will incorporate grant and contract clauses requiring pre-publication review, and withholding from publication material the agencies consider to be "sensitive but unclassified." Official federal policy, post-9/11, has continued to encourage open basic research and has reaffirmed that "where the national security requires control, the mechanism for control of information during federally-funded fundamental research…is classification" (NSDD 189).

As of this moment, a new regime of publication regulation based on the "sensitive but unclassified" designation has not emerged, but university and academic associations widely believe that increased publication restrictions are in the offing.

Investigators presented with grant or contract provisions that restrict publication or require prior approval of either publication, dissemination of research results, or of project personnel should seek advice from the Sponsored Projects Office as soon as possible. The campus will make every attempt to work through issues of publication and other restrictions so as not to impede the research enterprise. Unfortunately, there may also be some situations in which, in spite of best attempts, the campus will not be able to procure a license or get research sponsors to drop unacceptable restrictions. While it is hoped that will occur on only the rarest of occasions, there may be some circumstances in which it will be necessary to decline research support.

Research Restrictions on Foreign Nationals

As defined by the federal government, the "export" of research may include transmitting technology to an individual other than a U.S. citizen or permanent resident within the United States. Even a discussion with a foreign researcher or student in a campus laboratory is considered a "deemed export." Export controls preclude the participation of all foreign nationals in research that involves covered technology without first obtaining a license from the appropriate government agency.

The above regulation may come into direct conflict with University of California policy which currently forbids discrimination in employment based on citizenship, including discrimination in access to and participation in University laboratories. It has been the practice of the Sponsored Projects Office to refuse to accept any extramural contract or grant that contains restrictive language with respect to either publication or employment.