Biotechnology Project
Center for Science in the Public Interest
. Comments to USDA on Regulation of Plants Engineered to Produce Pharmaceuticals and Industrial Compounds

Docket No. 03-031-1
Regulatory Analysis and Development
Station 3C71
4700 River Road Unit 118
Riverdale, MD 20737-1238

Re: Comments on Federal Register Notice Dated March 10, 2003 (68 FR 11337).

May 9, 2003

The Center for Science in the Public Interest ("CSPI")(1) hereby submits the following comments to the Animal and Plant Health Inspection Service ("APHIS") regarding the questions raised in the Federal Register notice dated March 10, 2003 (68 FR 11337). Those questions requested comments on the certain aspects of the regulatory process surrounding the commercial production of pharmaceuticals and industrial compounds in a plant.

I. Transparency and Public Participation are Essential to the Regulatory Process for Plants Engineered to Produce Pharmaceuticals and Industrial Compounds.

The Federal Register publication of APHIS's permit conditions for growing plants engineered to produce pharmaceuticals and industrial compounds in 2003 is a positive step toward increasing the transparency of the permitting process. APHIS should strive to make all policies governing the permitting process accessible to the public in a similar manner.

Although access to information about the regulatory process is an essential part of transparency, access to information such as that contained in the March 10, 2003 Federal Register notice is not enough to establish a truly transparent process. The public is entitled to detailed information about each individual permit and an opportunity to comment on those permits before they are issued.(2) Thus, to make APHIS' regulatory process more transparent, the following measures should be implemented:

1. When an application for an APHIS permit is received, that application (without any genuine confidential business information ("CBI")) should be made available to the public in the USDA reading room (and on the APHIS website, if practicable). APHIS should require that the applicant justify each individual CBI claim in the application as part of its submission and promptly rule on those claims. If APHIS determines that any information is entitled to protection from disclosure as CBI, that determination should be made public with the non-CBI portions of the application.

2. Before a permit is issued, the public should be given the opportunity to provide comments on the application. APHIS should identify for the public the time period to submit comments. APHIS should not issue the permit until it has reviewed and responded to the public's comments.

3. APHIS should announce on its web site when each permit is issued. In addition, APHIS should place in the USDA reading room and post on the APHIS website a copy of the issued permit, any correspondence with the applicant regarding that permit, and any decision documents explaining the terms and conditions of the permit (or the reasons for denying the permit). By providing the public with access to those documents, any interested party will be able to understand the legal obligations of the applicant when they released the plant into the environment.

If APHIS implements the steps set forth above, then the regulatory process for plants engineered to produce pharmaceuticals and industrial compounds will become significantly more transparent and public.

II. APHIS Needs to Increase the Measures Used to Monitor and Ensure Compliance with APHIS Permits.

The permits APHIS issues will not protect humans and the environment if the applicants don't abide by the conditions imposed by those permits. To ensure that confinement requirements achieve their goals and that applicants comply with all permit conditions, APHIS should implement the following enforcement and compliance system:

1. Before any person is allowed to grow a plant engineered to produce a pharmaceutical or an industrial compound, that person should be required to attend government-sponsored training and then become certified as a licensed grower of those crops. APHIS should establish a training course for such persons that explains containment and segregation requirements as well as the legal obligations that might be imposed by permit. Only certified growers should be allowed to plant, tend, and harvest crops producing pharmaceuticals and industrial compounds.

2. Each APHIS permit should require extensive documentation of compliance with permit obligations. That documentation should be sent to APHIS on a regular basis for review to ensure that all permit requirements are complied with. APHIS inspectors should also be allowed to review all documentation required by the permit in the field.

3. Each APHIS permit should require the applicant to hire a government-approved third-party auditor. That auditor should be responsible for assessing the applicant's compliance with its permit obligations. The auditor should inspect the site on a regular basis, interview the certified grower and employees of the applicant, review documentation, and conduct scientific analysis of sample plants in the designated fields, the buffer zones, and neighboring fields. The auditor should be required to provide compliance reports to APHIS after each critical milestone is reached (at planting stage, at midseason, at harvest, at post-harvest, and in subsequent years). Each report should be provided to APHIS in two forms: 1) an unredacted version that includes CBI; and 2) a redacted version that can be released to the public. APHIS should make each auditor report available to the public in the USDA reading room (and on the APHIS website, if practicable), within two weeks of receipt of the report. Only genuine CBI as determined by USDA should be excluded from the report released to the public.

4. APHIS should inspect each site that grows plants engineered to produce pharmaceuticals and industrial compounds at least four times a year. Those inspections should be unannounced and involve a physical inspection of the site, interviews with key personnel, discussions with the third-party auditor, and review of relevant documentation. In addition, on at least two of those inspections, APHIS should inspect neighboring fields and take crop samples for biological analysis to confirm that confinement conditions are working effectively. The sample analysis is necessary to confirm that none of the experimental genes have escaped beyond the site.

III. Additional Components of a Rigorous and Robust System for Regulating the Human Health and Environmental Risks of Crops Producing Pharmaceuticals and Industrial Compounds.

In addition to the suggested changes to APHIS' regulatory system that would increase transparency and ensure compliance, there are other essential components needed in the regulatory system before releasing plants engineered to produce pharmaceuticals and industrial compounds can be deemed safe. Those components are the following:

1. An APHIS permit should be issued only after a thorough environmental assessment of the potential risks from growing that crop. Before a permit is issued, the government should conduct a thorough environmental assessment of the potential effects of growing the pharmaceutical or industrial compound in the crop, including the effects from gene flow of the introduced gene and the effects of the transgenic protein on living species other than humans. The environmental assessment should comply with the National Environmental Policy Act, although for each individual permit, there may or may not be the need for an Environmental Impact Statement or an Environmental Assessment.

2. Each APHIS permit should require strict biological and physical confinement measures. All permits should contain enforceable conditions requiring state-of-the-art confinement procedures. Those mandatory permit conditions should include isolation distances, geographic restrictions (such as not growing engineered corn in parts of the country where commodity corn or seed is grown), physical barriers (such as fences or greenhouses), the use of distinguishable varieties of the crop, biological confinement (such as male sterility) and so forth. The permit should also require extensive segregation procedures that ensure that none of the harvested materials can co-mingle with crops destined for human or animal consumption. When using a food crop, the permit should have several redundant levels of confinement, even at the field trial level.

3. For pharmaceuticals and industrial compounds produced in food crops, there should be a mandatory pre-market food-safety approval process by FDA's Center for Food Safety and Applied Nutrition. Although confinement measures need to be strictly adhered to, they will never result in 100% containment over the long term. Thus, before any pharmaceutical or industrial compound is grown commercially in a food crop, FDA should conduct a thorough food-safety analysis to ensure that inadvertent human exposure to the transgenic crop will not result in any health risks. If additional legal authority is needed to implement this requirement, FDA should ask Congress to provide such authority.(3)

CSPI appreciates the opportunity to submit comments on the issues raised in the Federal Register notice. If USDA would like additional information about these comments, I would be happy to meet with you at your convenience.


Gregory Jaffe
Director, Biotechnology Project
Center for Science in the Public Interest
202-332-9110, Ext. 369

1. CSPI is a nonprofit education and advocacy organization that focuses on improving the safety and nutritional quality of our food supply and on reducing the damage caused by alcoholic beverages. CSPI seeks to promote health through educating the public about nutrition and alcohol; it represents citizens' interests before legislative, regulatory, and judicial bodies; and it works to ensure advances in science are used for the public good. CSPI is supported by the 900,000 member-subscribers to its Nutrition Action Healthletter and by foundation grants. CSPI receives no funding from industry or the federal government.

2. The APHIS decision that growing plants producing pharmaceuticals will require permits, even at the commercial stage, is commendable. Unfortunately, that policy eliminates any opportunity for public input, since the current system only provides public input when an applicant submits a petition to deregulate a crop at the commercial stage of production. Given the public's strong interest in pharmaceutical applications of agricultural biotechnology, APHIS needs to change its current policy to allow public involvement in the permitting process. There is no scientific, technical or public policy justification for providing public comments for plants engineered to produce food but not providing the public with the opportunity to comment on plants engineered to produce pharmaceuticals.

3. Although this last part of the regulatory system does not involve APHIS, it is essential to the safe use of applications of biotechnology using food crops. Without Food and Drug Administration involvement, the APHIS regulatory system will not be able to ensure the safe growing of food crops that produce pharmaceuticals and industrial compounds.

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