Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. APHIS-2008-0023]

RIN 0579-AC31

Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule; notice of public forums.

SUMMARY:

We propose to revise our regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to bring the regulations into alignment with provisions of the Plant Protection Act. The revisions would also update the regulations in response to advances in genetic science and technology and our accumulated experience in implementing the current regulations. This is the first comprehensive review and revision of the regulations since they were established in 1987. This rule would affect persons involved in the importation, interstate movement, or release into the environment of genetically engineered plants and certain other genetically engineered organisms.

DATES:

We will consider all comments that we receive on or before November 24, 2008. We will also consider comments made at public forums to be held in Davis, CA; Kansas City, MO; and Riverdale, MD.

ADDRESSES:

You may submit comments by any of the following methods:

•

Federal eRulemaking Portal:

Go to

http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0023

to submit or view comments and to view supporting and related materials available electronically.

•

Postal Mail/Commercial Delivery:

Please send two copies of your comment to Docket No. APHIS-2008-0023, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2008-0023.

•

Public Forums.

Written and oral comment will be accepted at three public forums held during the comment period. See

Public Forums

below.

Reading Room:

You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.

Other Information:

Additional information about APHIS and its programs is available on the Internet at

http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5710.

For information about the public forums, contact: Dr. T. Clint Nesbitt, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1238; (301) 734-5673.

SUPPLEMENTARY INFORMATION:

Public Forums

In order to provide additional opportunities for the public to comment on the proposed rule, APHIS will hold public forums in three locations: Davis, CA; Kansas City, MO; and Riverdale, MD (see

Meeting Locations

below). These informal forums are designed to engage interested individuals from the public and elicit comments related to the proposed rule. The format will consist of informational posters and comment stations. Attendees will be able walk through the forum during the open hours and interact with other attendees and APHIS personnel. Short welcoming remarks will be given by APHIS personnel at 4:30 p.m. and again at 6 p.m. (local time), but there is no set schedule for each poster station, so the public may come and go at any time during the forum period. Participants will have the opportunity, if desired, to record brief oral comments with a court reporter or to submit comments in writing, following directions provided at the comment stations. A transcript of the oral comments and a copy of any written comments submitted at the public forums will be placed in the rulemaking record and will be available for public inspection.

The purpose of these public forums is to allow the public a venue in which to interact with APHIS representatives and to allow APHIS to solicit further information from the public. Comments received at these public forums will be added to this Docket.

Dates:

The public forums will be held in Davis, CA, on October 28, 2008; in Kansas City, MO, on October 30, 2008; and Riverdale, MD, on November 13, 2008. Each public forum will be held from 4 p.m. to 7 p.m., local time.

Meeting Locations:

The public forums will be held at the following locations:

USDA Riverside, Oklahoma City Memorial Conference Rooms B, C, and D, 4700 River Road, Riverdale, MD, 20737. For directions or facilities information, call (301) 734-8010.

Walter A. Buehler Alumni & Visitors Center, Alpha Gamma Rho Hall, University of California, Davis, CA, 95616. For directions or facilities information, call (530) 754-9195 or visit

http://www.alumnicenter.ucdavis.edu/.

Hilton Kansas City Airport, Shawnee Room A, 8801 NW 112th Street, Kansas City, MO, 64153. For directions or facilities information, call (816) 891-8900 or visit

http://www.hiltonkci.com/.

Table of Contents

I. Introduction

II. Background

A. APHIS Role in Federal Regulation of Genetically Engineered Organisms

B. Current Regulations in 7 CFR part 340

C. Plant Protection Act Authority to Regulate Plant Pests, Noxious Weeds, and Biological Control Organisms

III. Proposed Rule

A. Proposed Regulatory Scope (§ 340.0 Scope and General Restrictions)

1. Genetically Engineered Organisms Subject to 7 CFR part 340

2. Deleting the List of Organisms Which Are or Contain Plant Pests

3. Regulating Whole Organisms, Parts, and Nonliving Products

B. Permits for Authorizing Importation, Interstate Movement, and Release Into the Environment of Certain GE Organisms

1. Elimination of the Notification Procedure

2. Revisions to Permit Procedures

3. Permit Types and Environmental Release Categories (§ 340.2(b))

4. Permit Application Information Requirements (§ 340.2(c))

5. Permit Conditions (§ 340.3)

6. Elimination of Courtesy Permits

C. Conditional Exemptions from Permit Requirement (§ 340.4, § 340.5)

D. Petitions for Nonregulated Status (§ 340.6)

E. Compliance, Enforcement, and Remedial Action (§ 340.7)

1. Ensuring Compliance with Permits and Exemption Activities

2. Low Level Presence of Regulated GE Plants in Seed or Grain

F. Administrative Changes

1. Confidential Business Information (§ 340.8)

2. Time Frames for APHIS Action on Permit Applications and Petitions

3.

Duration Period for Permits

G. Definitions and Miscellaneous Changes

IV. Required Analyses

A. National Environmental Policy Act

B. Executive Order 12866 and Regulatory Flexibility Act

C. Executive Order 12372

D. Executive Order 12988

E. Paperwork Reduction Act

F. E-Government Act Compliance

I. Introduction

The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) regulates the safe introduction (environmental release, interstate movement, and importation) of certain genetically engineered (GE) organisms under its regulations in 7 CFR part 340. The regulations govern the introduction of GE organisms that might be plant pests. APHIS has amended the regulations several times in an effort to respond to the need for streamlined procedures and has established clear procedures to remove GE organisms that do not pose a plant pest risk from obligations under the regulation.

The APHIS regulations have been used most frequently for permits and notifications for importation, interstate movement, or environmental releases of GE plants, although a smaller number of permits have been issued for GE microorganisms and insects. To date, APHIS has authorized more than 13,000 environmental releases of GE plants, most of which have been part of the development of improved crop varieties for agriculture. These controlled environmental releases are sometimes referred to as field tests or field trials, in recognition of their relationship to field tests done in the traditional development of plant varieties, and in this document the terms field test or field trial should be understood to mean environmental release. In addition to permits and notifications, APHIS has completed reviews in response to petitions requesting nonregulated status under these regulations. To date, APHIS has granted 74 determinations of nonregulated status, and all of these have been for GE plants (more information about these is posted at

http://www.aphis.usda.gov/brs/not_reg.html

). Many of these plants have since been used to develop plant varieties that have become part of the options that growers have for agricultural production in the United States and other countries. The APHIS determinations of nonregulated status have been for the GE plant(s) and their progeny. The GE plant with nonregulated status can be used subsequently in plant breeding programs or in agriculture just like other plant lines. A GE plant that has received nonregulated status can be bred with another GE plant with nonregulated status, and the resulting progeny which could contain multiple GE traits still retains nonregulated status.

The bulk of APHIS-authorized introductions have been crop plants bearing genes which confer resistance to certain insects or tolerance to certain herbicides. Although the current program has been effective in ensuring the safe environmental release, interstate movement, and importation of certain genetically engineered organisms, technological advances have led to new uses and questions about how the current regulations and APHIS authorities will be used to maintain appropriate oversight. Advances in technology have created possibilities for new and different traits, such as those that would produce a compound for pharmaceutical or industrial use. In addition, researchers have been producing organisms that may not fall under the scope of our current regulations and are also beginning to focus more on perennial plants, such as grasses or trees, which may be capable of establishing and persisting outside the site of introduction.

APHIS is proposing to revise its regulations in order to respond to emerging trends in biotechnology, to address the current and future needs of the agency, to continue to ensure a high level of environmental protection, to improve regulatory processes so that they are more transparent to stakeholders and the public, to more efficiently use agency resources and to eliminate unnecessary regulatory burdens.

Given the diversity of U.S. agriculture, the USDA Advisory Committee on Biotechnology and 21st Century Agriculture recently in its March 2008 consensus report encouraged the continuing support of coexistence among various agricultural production systems in U.S. agriculture. APHIS concludes that the changes it is proposing will continue to support coexistence in U.S. agriculture.

In addition, APHIS is proposing changes to the regulations to reflect provisions of the 2008 Farm Bill recently enacted. Section 10204 of Title X of the Food, Conservation, and Energy Act of 2008 (Farm Bill) requires the Secretary of Agriculture to take action on each issue identified in the document entitled “Lessons Learned and Revisions under Consideration for APHIS' Biotechnology Framework,” and where appropriate, promulgate regulations. APHIS is proposing certain regulatory changes concerning permit application information requirements, permit conditions, records, and reports that address many of the considerations outlined in Section 10204.

APHIS is also aligning this proposed rule with recommendations arising from the 2005 audit of the USDA Office of Inspector General entitled “Controls Over Issuance of Genetically Engineered Release Permits.”

II. Background

A. APHIS Role in Federal Regulation of Genetically Engineered Organisms

Under the Coordinated Federal Framework for Regulation of Biotechnology,

1

USDA works with the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) to ensure that the development and testing of biotechnology products occur in a manner that is safe for plant and animal health, human health, and the environment. USDA and EPA are the agencies responsible for protecting U.S. agriculture and the environment. EPA is responsible for the human health, animal health, and environmental safety issues raised by any pesticidal substance produced in genetically engineered (GE) organisms. FDA has authority over the safety of the whole food product other than the pesticidal components regulated by EPA.

1

The Coordinated Framework is described in a notice published in the

Federal Register

on June 26, 1986 (51 FR 23302). The notice may be viewed at

http://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf

.

B. Current Regulations in 7 CFR Part 340

APHIS administers regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests” (referred to below as the regulations). The current regulations govern the introduction (importation, interstate movement, or release into the environment) of certain GE organisms termed “regulated articles.” Regulated articles are essentially GE organisms which might pose a risk as a plant pest.

APHIS first promulgated these regulations in 1987 under the authority of the Federal Plant Pest Act of 1957 (FPPA) and the Plant Quarantine Act of 1912 (PQA), two acts that were subsumed into the Plant Protection Act (PPA, 7 U.S.C. 7701

et seq.

) in 2000, along with other provisions.

Under the current regulations, a GE organism is a regulated article if it is a plant pest or if the Administrator has reason to believe it is a plant pest; more specifically:

“if the donor organism, recipient organism, or vector or vector agent belongs to any genera or taxa designated in § 340.2 and meets the definition of plant pest, or is an unclassified organism and/or an organism whose classification is unknown, or any product which contains such an organism, or any other organism or product altered or produced through genetic engineering which the Administrator determines is a plant pest or has reason to believe is a plant pest.” (Definition of

regulated article,

§ 340.1)

In other words, APHIS regulates the introduction (importation, interstate movement, and environmental release) of GE organisms if (1) any of the recipient, genetic donor, or vector organisms are plant pests or of unknown classification or (2) the Administrator has determined or has reason to believe the GE organism is a plant pest. As constructed the regulations apply to GE microorganisms, insects, and other traditional types of plant pests and to any GE plants if plant pest organisms (bacterial and viral plant pathogens) are the donor organisms and vector agents used in the creation of these GE plants.

Taxa containing “known plant pests” are those listed in current § 340.2. Current regulations also include a petition procedure (§ 340.5) which allows petitioners to ask APHIS to add or subtract taxa from the list in § 340.2. That list has not been amended since it was established in 1987.

As defined under the current regulations and the PPA, most plants are not plant pests, with the exception of a few parasitic plant species, such as striga, witchweed, and dodder.

The primary procedure for regulation under the PPA is the issuance of a permit, which is an authorization by the Secretary to move plants, plant products, biological control organisms, plant pests, noxious weeds, or articles under conditions prescribed by the Secretary. The PPA also authorizes the Secretary to determine which classes of the above articles must have a permit to be moved. Conditions associated with those permits can be tailored to achieve the appropriate level of regulatory control to make it unlikely that actions under the permit would result in the introduction or dissemination of a plant pest or noxious weed.

APHIS currently uses a permit and notification system to authorize importation, interstate movement and release into the environment (currently referred to as “introductions”) of certain GE organisms. Under the current regulations, all regulated articles are eligible for the permitting procedure, but only certain plants are eligible for the notification procedure. Currently, most regulated GE plants are introduced under notification, which is a streamlined procedure. Examples of GE plants introduced under the notification procedure are those GE plants altered to be resistant to certain insects or herbicides. GE plants that do not meet the notification eligibility criteria and all other GE organisms, such as microbes and insects, must be introduced under the permit procedure in current § 340.4. In recent years, APHIS has processed most notifications and permits through its electronic, e-permitting system that is accessible by the internet at

http://www.aphis.usda.gov/permits/learn_epermits.shtml

.

In making a regulatory determination for a permit or notification for a GE organism subject to the part 340 regulations, APHIS makes such a determination on whether the actions under notification or permit are unlikely to result in the introduction or dissemination of a plant pest. This determination takes into account various risk factors, including, among other things, a low risk that the GE organism or its progeny can persist, reproduce, and establish without human assistance. Other risk factors that would support an “unlikely” determination would be minimal availability of suitable hosts or habitats for the organism and low risk that the organism may cause damage to plants and plant products.

Regarding the risk of introduction or dissemination of the GE organism as a plant pest, an “unlikely” determination takes into consideration both the nature of the organism (i.e., low risk that the organism or its progeny can persist, reproduce, establish, and spread without human assistance)

and

any additional mitigations that are placed upon the organism that restrict its movement and make its unauthorized introduction or dissemination unlikely.

The notification procedure was first added to the regulations in 1993, and then amended in 1997 to allow a broader range of plant species to be eligible for the procedure. The notification procedure was designed to be a streamlined procedure with the eligibility criteria and performance standards already built into the regulations. Over the past decade, APHIS has typically authorized 700-1200 notifications per year.

As part of the notification procedure, applicants must adhere to performance standards set forth by APHIS for proper confinement of the GE plants. The goal of proper confinement is to ensure that the GE plants do not persist in the environment. Under the notification procedure applicants provide information about the introduction sufficient for APHIS to evaluate eligibility for the procedure and impacts on the environment. This information includes information on the plant species, introduced gene(s), location(s), and anticipated time frame for the introduction.

For notifications, the eligibility criteria and the performance standards stated in the regulations must be met, but APHIS does not prescribe how the performance standards must be met. For example, one of the performance standards in § 340.3(c)(5) requires that “The field trial must be conducted such that (i) The regulated article will not persist in the environment, and (ii) No offspring can be produced that could persist in the environment.” The responsible person might meet this standard in a field trial by isolating the regulated GE plants at a sufficient distance to preclude gene flow from the GE plant to sexually compatible plants in the vicinity. Another design protocol might meet the same performance standard by planting the GE plant at a time in the growing season when surrounding plants of the same species would not be biologically capable of being fertilized by pollen from the GE plant (temporal isolation).

The regulations in current § 340.3(e) specify that the APHIS notification procedure must be completed within 30 days for environmental release and importations and within 10 days for the interstate movement of a regulated article. If APHIS completes the review process and finds that all regulatory requirements have been met, the notification is authorized in a process termed “acknowledgement,” and the applicant can proceed with the introduction under the terms of the notification. Notifications are valid for one year from the date of introduction.

Approximately 10% of APHIS authorizations are done under the permitting procedure. The permitting procedure, found in § 340.4 of the current regulation, describes the types of permits, information required for permit application, the standard permit conditions, and administrative information (e.g., time frames, appeal procedure, etc.). Permits include specific conditions that must be followed by the permit holder. Standard permit conditions are listed in the regulation, and APHIS can supplement these with additional conditions as necessary. The current regulations specify the amount of time that APHIS is allotted for review of complete permit applications: 60 days for permits for importation and interstate movement; 120 days for environmental release.

Some regulated articles are conditionally exempt from the requirement for permits when moved interstate under the conditions stipulated in the regulation. Conditional exemptions currently exist in the regulations for the interstate movement of certain GE bacteria (

Escherichia coli, Bacillus subtilis

), fungi (

Saccharomyces cerevisiae

), as well as the plant species

Arabidopsis thaliana.

APHIS established these conditional exemptions from interstate movement permit by amending the regulations in 1988 and 1990.

APHIS forwards the applications for all permits, and notifications, with any confidential business information redacted, to State regulators in the States to which regulated articles will be moved and/or in which environmental release is planned. This is done to notify States of the requested action and to allow States to review and comment on proposed releases or importations or movements.

The current regulations also include various provisions and prescribed standards for containers, marking, and identity that apply to shipments of regulated articles. For example, there are instructions regarding how to label containers of imported regulated articles with the nature of the contents, origin and destination, and other information, and detailed instructions on what materials (plastic, metal, etc.) and dimensions may be used for containers of regulated articles.

Under the current regulations, APHIS may also grant “nonregulated status” to a GE organism in accordance with the procedure described in § 340.6. A determination of nonregulated status means that the organism is no longer subject to the part 340 regulations, and therefore there is no longer any requirement for APHIS authorization under part 340 for a permit or notification when the GE organism is imported, moved interstate, or released into the environment.

C. Plant Protection Act Authority to Regulate Plant Pests, Noxious Weeds, and Biological Control Organisms

Under the provisions of the PPA, Congress has granted the Secretary of Agriculture authority to develop regulations in order to detect, control, eradicate, suppress, prevent, or retard the spread of plant pests or noxious weeds. The PPA grants the Secretary authority to regulate the movement into and through the United States of any plant, plant pest, plant product, biological control organism, noxious weed, article, or means of conveyance, in order to prevent the introduction or dissemination of

plant pests

and

noxious weeds.

The current regulations were promulgated under former statutes, i.e., the FPPA and PQA, which provide USDA authority to regulate articles that present a risk of

plant pest

introduction or dissemination. In addition to the provisions of the FPPA and PQA, the PPA incorporates authority that previously was under the Noxious Weed Act of 1974. In order to best evaluate the risks associated with these GE organisms and regulate them when necessary, APHIS needs to exercise its authorities regarding noxious weeds and biological control organisms, in addition to its authority regarding plant pests.

The definition of plant pest in the PPA is broad and includes living organisms that could directly or indirectly injure, damage, or cause disease in any plant or plant product (7 U.S.C. § 7702(14)). Under the PPA, organisms which could be plant pests include:

• Protozoans

• Non-human animals

• Parasitic plants

• Bacteria

• Fungi

• Viruses or viroids

• Infectious agents or other pathogens

• Any article similar to or allied with any of the above articles.

The definition of noxious weed in the PPA includes:

* * * any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment. (PPA § 7702(10))

An important distinction between noxious weeds and plant pests is that noxious weeds under the PPA are always plants or plant products. Plant pests are usually not plants (with the exception of certain parasitic plants such as dodder, striga, and witchweed), but are other types of organisms that harm plants.

III. Proposed Rule

A. Proposed Regulatory Scope (§ 340.0

Scope and general restrictions

)

We propose to better align the regulations with the PPA authorities in order to ensure that the environmental release, importation, or interstate movement of GE organisms does not pose a risk of introducing or disseminating plant pests or noxious weeds. Although the current program has been effective in ensuring the safe environmental release, interstate movement, and importation of genetically engineered organisms, technological advances have led to the possibility of developing GE organisms that do not fit within the plant pest definition, but may cause environmental or other types of physical harm or damage covered by the definition of noxious weed in the PPA. Therefore, we consider that it is appropriate to align the regulations with both the plant pest and noxious weed authorities of the PPA.

1. Genetically Engineered Organisms Subject to 7 CFR part 340

We are proposing to revise the scope of the regulations in § 340.0 to make it clear that decisions regarding which organisms are regulated remain science-based and take both plant pest and noxious weed risks into account. The proposed scope of the regulations states that genetically engineered organisms whose importation, interstate movement, or release into the environment would be subject to the regulations are:

Genetically engineered plants if:

(i) The unmodified parent plant from which the GE plant was derived is a plant pest or noxious weed, or

(ii) The trait introduced by genetic engineering could increase the potential for the GE plant to be a plant pest or noxious weed, or

(iii) The risk that the GE plant poses as a plant pest or noxious weed is unknown, or

(iv) The Administrator determines that the GE plant poses a plant pest or noxious weed risk.

Genetically engineered non-plant, non-vertebrate organisms if:

(i) The recipient organism can directly or indirectly injure, cause damage to, or cause disease in plants or plant products; or

(ii) The GE organism has been engineered in such a way that it may increase the potential for it to be a plant pest: or

(iii) The risk that the GE organism poses as a plant pest is unknown, or

(iv) The Administrator determines that the GE organism poses a plant pest risk.

Under the current regulations, there is no explicit statement of the relative responsibilities of the Administrator and regulated parties in determining whether an organism met the definition for

regulated article

and therefore would be subject to the regulations. Under the proposed regulations, the responsible person for a GE organism could correctly apply the criteria in § 340.0 to determine whether the GE organism is subject to the regulations. Alternatively,

the Administrator could determine any GE organism to be regulated after determining that the GE plant poses a plant pest or noxious weed risk.

In many cases, it will be very straightforward for a responsible person to apply these criteria and determine that a GE organism is subject to the regulations. For example, the GE organism would clearly be subject to the regulations if the recipient organism were a plant pest or noxious weed. A GE organism would also clearly be subject to the regulations if there was little data or previous experience available concerning the recipient organism's plant pest or noxious weed potential, or the type of modification, with the result that it is difficult to do a reliable evaluation of the risks that the GE organism may be a plant pest or noxious weed.

In other cases, it may not be readily apparent to the responsible person for a GE organism whether or not the organism falls within the scope of § 340.0 and is regulated. For this reason, persons who are not sure about whether a GE organism falls within the regulations or who maintain that a particular GE organism is not subject to the regulations based on their belief that it is not an organism within the scope of § 340.0 may consult with APHIS.

A GE organism may be within the scope of the regulations based on the information available at the time of the determination, which is usually less information than is available when the Administrator evaluates, for example, whether a regulated GE organism should be considered for an exemption from the requirement for a permit, or should be considered for a determination of nonregulated status (see discussion of § 340.6 below regarding nonregulated status). In other words, this scope determination has one purpose (to determine whether regulation is necessary at all) and is based on one level of knowledge about a GE organism, while determinations regarding such things as necessary permit conditions or exemptions or nonregulated status have a different purpose and are based on a different level of knowledge about a GE organism.

It is important to note that while a GE organism may be within the scope of the regulations due to certain identified plant pest or noxious weed risks, it may also be within the scope of the regulations if there is not enough information about the GE organism's potential plant pest or noxious weed risks to make a decision regarding those risks. At the early stages of developing a GE organism, there may not be sufficient information available about the organism to clearly determine the potential associated plant pest or noxious weed risks. Unknown risks might lead to a determination by the Administrator that a GE organism should be subjected to regulatory oversight if APHIS lacks familiarity with the non-transformed recipient organism or the introduced trait.

The proposed scope makes it clear that the mere act of genetic engineering does not trigger regulatory oversight or mean that a GE organism will pose risks as a plant pest or noxious weed. Instead, it clarifies that APHIS would subject a GE organism to regulatory oversight based upon known plant pest and noxious weed risks of the parent organisms, or based upon the traits of the GE organism, or based upon the possibility of unknown risks as a plant pest or noxious weed when insufficient information is available.

Consultation With APHIS Regarding the Scope of These Regulations

The criteria described in the scope should help developers form a reasonable expectation as to whether their GE organism is within the scope of the regulations, based on the nature of the parent organisms, the engineered traits, and the amount of information available regarding the organism and similar organisms.

APHIS anticipates that initially the range of GE organisms that the Administrator may determine to be covered by the proposed regulatory scope will be broad. This will be due to both an initial measured implementation of the revised regulatory oversight as well as to the application of the scope criteria to the transformed organisms and recipient traits. Over time, the range of GE organisms subject to oversight is expected to decrease as APHIS becomes more familiar with these organisms and receives information from which it can reach a conclusion that these GE organisms or groups of organisms do not present increased or unfamiliar plant pest or noxious weed risks. Because the Administrator may make such a determination at any time the Administrator receives information that a GE organism is within the scope, APHIS expects that developers will seek early consultation with APHIS on whether the regulatory scope covers their GE organism. Since it is generally necessary for research or business plans to include, as early as possible, elements addressing regulatory processing, approval, and compliance, it will be in the interest of the developers to determine the regulatory status of their GE organism prior to contemplating its movement or environmental release. Therefore, APHIS will offer to consult with a developer of a GE organism regarding whether the GE organism is within the scope of the proposed regulations.

After consultation and review of available information, the Administrator will respond in writing as to whether the Administrator has determined that the GE organism is within the scope of the regulations. APHIS plans to make information publicly available by posting and maintaining information on its Web site about the determinations it makes pursuant to this consultation process to help the public and regulated entities understand which organisms are subject to the regulations.

We welcome suggestions from the public on the most appropriate ways to provide administrative guidance to the public on the issue of which GE organisms are within the scope of the regulations. The Agency is especially interested in ways which will balance transparency with the efficient use of Agency resources in conducting consultations and communicating information to the public regarding which GE organisms are within the scope of the regulations.

Organisms Specifically Excluded From the Scope of the Regulations

Specifically excluded from the proposed regulatory scope are GE microorganisms that are regulated as biological control organisms by the EPA under provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). APHIS concludes that there is no need for such GE organisms to be evaluated by both agencies. EPA is already evaluating the environmental safety of such organisms with respect to their impact on the entire environment, including plants. We also propose to retain an exclusion from the current regulations for GE microorganisms where the recipient microorganism is not a plant pest and which have resulted from the addition of genetic material from a donor organism where the material is well characterized and contains only non-coding regulatory regions.

Effect of Noxious Weed Authority on the Scope of the Proposed Regulations

The definition of noxious weed encompasses plants that pose risks akin to plant pests, because it includes “any plant or plant product” that can “injure or cause damage to crops * * * other interests of agriculture * * * or the environment”, but also includes plants that can pose harm to non-plant organisms, such as humans. Therefore

evaluation of noxious weed risk expands what we can consider, while still including those risks examined under the plant pest approach. When considering risks associated with a GE plant, we would continue to consider whether it can harm plants, as well as whether it can cause the other types of physical harm or damage described in the definition for noxious weed.

The first consideration in determining if a plant is a noxious weed is identifying what direct injury or damage (physical harm) the plant causes. If direct harm or damage is established, the next consideration is to evaluate any indirect damage the plant may cause to interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment. In general, federally listed noxious weeds are plants that are likely to be aggressively invasive, have significant negative impacts, and are extremely difficult to manage or control once established.

The distinction between a weed and a noxious weed warrants emphasis. “Weeds,” in the broadest sense of the word, could include any plant growing where and/or when it is unwanted; even plants that are desirable in some settings may be considered weeds in others. In a narrower sense, weeds are invasive, often non-native, plants which impact natural and managed ecosystems, often with significant negative consequences due to lost yields, changes in management practices, altered herbicide use, etc. Only a fraction of these problematic weeds are considered to be so invasive, so harmful, and so difficult to control that Federal regulatory intervention to prevent their introduction or dissemination is justified, and these are the focus of the regulatory controls placed on them by APHIS. However, any weed, and virtually any plant or plant product, can be evaluated by APHIS to determine whether its characteristics and potential impacts warrant its listing as a noxious weed.

APHIS currently lists 98 aquatic, terrestrial, or parasitic plant taxa as noxious weeds. The species included in the list illustrate the kinds of plants APHIS considers to be sufficiently invasive, damaging, and difficult to control to be deemed noxious weeds. Table 1 describes some specific examples from the Federal noxious weed list and the kinds of impacts noxious weeds can have, to illustrate the types of effects APHIS will be looking for when evaluating whether GE plants reviewed under part 340 have any potential noxious weed traits. The experience and precedents developed by the APHIS-PPQ noxious weed program provide a guide for the regulation of plants that may be noxious weeds, and we intend to apply it to the consideration of GE plants in the same way.

Table 1—Examples of Impacts Caused by Federally Listed Noxious Weeds

Impact

Description of impact

Example species

Lost productivity of crop fields

Noxious weeds may directly compete with crop plants for limited resources, dramatically reducing yields

Cogongrass (

Imperata cylindrica

) infests over 20 crop species; it releases chemicals into the soil that suppress crop growth and causes damaging puncture wounds to plant roots, bulbs, and tubers. Other examples include Benghal dayflower (

Commelina benghalensis

), red rice (

Oryza

spp.), and kikuyugrass (

Pennisetum clandestinum

).

Parasitic damage to crops

Parasitic plants can cause significant reductions in yield by attaching themselves to a host plant, removing nutrients and ultimately killing it

Federally listed noxious parasitic plants include the dodders (

Cuscuta

spp.)—with common names like strangleweed, devil's-guts, hellbine, and witch's hair—and witchweed (

Striga

spp.), which causes devastating losses in corn, sorghum, and rice.

Reduced productivity of pasture

Grazing animals may avoid noxious weeds and consume the more favorable pasture species, resulting in increased noxious weed populations at the expense of more favorable species. Noxious weeds may also outcompete desirable pasture species

Serrated tussock (

Nassella trichotoma

) has heavily infested large areas, leaving them completely incapable of supporting livestock.

Injury to humans or livestock

Many noxious weeds are toxic, harming humans or livestock either when consumed or by direct contact

Cape tulip (

Homeria

spp.) contains a cardiac glycoside, which can be fatal to livestock. Contact with giant hogweed (

Heracleum mantegazzianum

) causes painful skin blisters. Three-cornered jack (

Emex australis

) and devil's thorn (

Emex spinosa

) both bear spiny fruits that can cripple or cause injury to livestock or other animals.

Unchecked overgrowth

Noxious weeds may be capable of completely dominating the landscape and preventing the use of cultivated or pasture lands for agriculture

Mile-a-minute vines (

Mikania cordata

and

M. micrantha

) can entirely smother fields and forests in a dense, tangled mass of vines. A single plant of the aquatic weed giant salvinia (

Salvinia

spp.) can blanket 40 square miles in 3 months, and produce an underwater mat 3 feet thick.

Physical obstructions

Growth rate and habit of some noxious weeds may physically hamper the movement of livestock and humans, or interfere with navigation of waterways

Certain mesquites (

Prosopis

spp.), jointed prickly pear (

Opuntia aurantiaca

), and African boxthorn (

Lycium ferocissimum

) form impenetrable thickets filled with thorns or needles, blocking the movement of grazing animals, injuring them or preventing access to food and water.

Disruption of water flow

Aquatic noxious weeds may disrupt water flow, adversely affecting irrigation, drainage and flood control canals, city water intakes, and recreational water use

Notable examples include hydrilla (

Hydrilla verticillata

), giant salvinia (

Salvinia

spp.), and Chinese waterspinach (

Ipomoea aquatica

). Dense mats of oxygen weed (

Lagarosiphon major

) can completely shut down operation of hydroelectric plants.

Habitat alteration

Noxious weeds may severely alter water quality by changing oxygen and nutrient content, may dramatically lower local water tables, or could so significantly outcompete or overgrow other vegetation resulting in a complete ecological shift of the habitat

Infestation of lakes and ponds with hydrilla (

Hydrilla verticillata

) can alter aquatic ecosystems so drastically that native plants are entirely eliminated, rendering the habitat unsuitable for fish and other wildlife.

As discussed above, APHIS' determination that a plant is a noxious weed is based on notable physical harm or injury caused by the plant. The elements of the noxious weed definition include a number of interests that might be damaged by noxious weeds including not only plants but irrigation, navigation, the natural resources of the United States, the public health, the environment and interests of agriculture. Often APHIS quantifies the physical harm or injury in terms of economic losses. Loss in commodity value due to the presence of noxious weeds in seeds, for example, is a consequence of the anticipated physical damage that would be caused if the seed containing a noxious weed were distributed and planted; the economic loss is never simply the result of market preference to have commodities free of certain noxious weed seeds in and of itself, in the absence of any potential physical damage or harm. APHIS does not consider significant economic effects alone that are not linked to physical damage to be sufficient to determine a plant is a noxious weed.

Certainly, some noxious weeds can cause physical harm to the health of humans or livestock and other animals. In general, these impacts occur when individuals come into direct contact with the noxious plants or plant parts, which may cause physical injury or are toxic or otherwise harmful when consumed. Conceivably, noxious weeds growing in crop fields could potentially threaten public health, for example, if toxic parts of the noxious weeds are harvested and inadvertently enter the food supply. If such toxic or otherwise harmful noxious weed parts were found in food and caused the food to be “adulterated” within the meaning of the FFDCA, FDA could take regulatory action against the food.

Whereas APHIS has no direct role in evaluating the safety of foods, the agency plays an important supporting role in safeguarding the food supply by protecting the health of plants and animals at the farm level. When evaluating whether a particular GE plant may be a noxious weed because it poses a public health risk when growing in the environment, APHIS considers toxicity and other food safety information, including the type reviewed by EPA and FDA. In the case of GE plants, APHIS would not assess the safety of the GE plant for human or animal consumption, but would consider available information about toxicity and other food safety information in assessing noxious weed risk posed by the plants growing in the environment.

It should be noted, moreover, that most GE plants that APHIS has been regulating in the past, such as varieties of GE corn and soybeans modified with common agronomic traits, do not qualify as “noxious weeds”. But with the increasing diversity of both agronomic and non-agronomic traits being engineered into plants it is appropriate to place regulatory controls upon GE plants proportionate to the likelihood that they may present a noxious weed risk until the potential risk can be appropriately evaluated.

How Non-Plant, Non-Vertebrate GE Organisms Fall Within the Scope of the Regulations

The proposed revision of the regulations retains control for potential plant pest risks posed by non-plant, non-vertebrate GE organisms. We would continue to explicitly use the plant pest provisions of the PPA for regulating non-plant, non-vertebrate GE organisms which align with the taxa listed in the PPA definition of plant pest. In its reviews of GE non-plant and non-vertebrate species, APHIS will continue to assess GE insects, fungi, bacteria, and other non-plant, non-vertebrate organisms for their potential to pose risks as plant pests.

The scope of the regulations as defined above makes it clear that it is the Administrator, and not the public, who determines whether a non-plant organism is within or outside the proposed scope of the Part 340 regulations. APHIS welcomes public comment on the proposed concise criteria that the Administrator would consider when concluding that a GE organism is not a plant pest. We envision providing additional information on the Administrator's interpretation on such criteria at the time of the final rule or in subsequent administrative guidance.

GE Vertebrate Animals Do Not Fall Within the Scope of the Regulations

Although the PPA definition of plant pest includes the potential for a nonhuman, vertebrate animal to be considered a plant pest, APHIS decided at this time that there are no demonstrated risks or pending GE animal developments indicating that it is necessary for the proposed regulations to evaluate vertebrate GE animals as potential plant pests. Because other statutory authorities exist for addressing GE animals, APHIS could guard against any plant pest risks that might be presented by GE vertebrate animals without directly regulating them under the regulations in part 340. On the other hand, we propose to regulate GE invertebrate animals under part 340 because many classes of invertebrates include known plant pests (e.g., insects, arachnids, nematodes, gastropods, etc.).

How GE Biological Control Organisms (BCOs) Fall Within the Scope of the Regulations

The PPA defines biological control organism (BCO) as “any enemy, antagonist, or competitor used to control a plant pest or noxious weed” (7 U.S.C. 7702(2)). The PPA gives the authority to regulate plant pests and noxious weeds, not specifically biocontrol organisms. APHIS recognizes that BCOs may have the potential to affect populations of noxious weeds or plant pests, or become plant pests themselves. To fall within the scope of the proposed regulations, the GE BCO would have to pose a threat as a plant pest or noxious weed. There are relatively few examples today of GE BCOs, but these may become more common in the future. For example, some researchers are developing GE biological control pink bollworms that

are sterile, which achieve their controlling effect by reducing the ability of fertile, non-GE pink bollworms to produce offspring. Such GE pink bollworm BCOs would fall within the scope of the proposed regulation, because they are plant pests. Although there are currently no examples of using GE plants as BCOs, such a GE plant would be evaluated under the proposed regulations to evaluate whether it is a noxious weed or a plant pest.

Currently, the federal regulation of microbial BCOs is regulated by EPA under FIFRA, and this covers GE as well as non-GE microorganisms used to mitigate the effect of pests. Unlike the PPA, which limits the definition of BCO only to organisms used to control plant pests and noxious weeds, FIFRA covers microorganisms used as biological control for any pest. APHIS considers it duplicative to have these regulations include GE microbial BCOs under its scope since FIFRA already adequately covers them, so APHIS is proposing that the regulatory scope language in § 340.0(d) would explicitly exclude GE microorganisms if they are already being regulated as BCOs by EPA under FIFRA. We are proposing to only regulate GE BCO macro-organisms that fall under the proposed regulatory scope (APHIS-PPQ currently regulates the macro-organism non-GE BCOs used to control plant pests and noxious weeds pursuant to other regulations). APHIS welcomes public comment on this aspect of its proposal.

Intrastate Movements of GE Organisms Between Contained Facilities and Activities in Contained Facilities Do Not Fall Within the Scope of the Regulations

Under the current regulations, certain GE organisms are only regulated by APHIS if they are imported, moved interstate, or released into the environment. The regulations do not govern intrastate movements between contained facilities such as laboratories, nor do they govern such activities as creating GE organism in a contained research laboratory. The proposed revision does not change this aspect of the regulations.

2. Deleting the List of Organisms Which Are or Contain Plant Pests

In § 340.2 of the current regulations, there is a list of taxa that are considered to be plant pests. Under the proposed scope, this list is not needed because we would not use taxonomic classification of donor and recipient organisms to determine if a GE organism is regulated. When in the course of evaluating a GE organism APHIS considers whether a donor or recipient species is likely to be a plant pest or noxious weed, we would consider the most up-to-date pest information maintained by PPQ. This information is more specific than the information in the list of plant pest taxa in the current regulations, and should be more useful and reliable than static lists of taxa. APHIS welcomes public comment on deletion of the taxa list and preferred sources of plant pest and noxious weed information for use under the proposed regulations.

With deletion of this list from the regulations, there is also no longer a need for the procedure currently described in § 340.5 for amending this list.

3. Regulating Whole Organisms, Parts, and Nonliving Products

APHIS proposes to clarify the regulated status of nonliving plant products in the regulations. First, the PPA defines a plant pest only as any

living

stage of any of the articles specifically named in the plant pest definition that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product. Moreover, APHIS does not consider most GE organisms or parts of GE organisms which cannot reproduce to present a risk as plant pests or noxious weeds.

Conversely, we would regulate importation, interstate movement and release into the environment of GE seedlings, seeds, tubers, cuttings, bulbs, spores, etc., because there is a reasonable, albeit small, possibility of reproduction, establishment, and spread if these were deliberately or accidentally released into the environment without authorization.

Viable pollen from GE plants imported, moved interstate, or released into the environment would be subject to the regulations because such movements of pollen can reasonably lead to genomes becoming established in the environment. Similarly, in circumstances where an article incidentally contains viable pollen, during movement, APHIS would consider the movement regulated. There are many cases, however, when pollen may be present but is no longer capable of producing offspring, e.g., nonviable or immature pollen. In such cases, APHIS would not require permits under this part. The commercial distribution of cut flowers is one pollen movement situation that APHIS has considered in light of the regulations, especially in cases where the flowers are grown in other countries then imported only as cut flowers. APHIS considers these circumstances to pose little, if any risk, and therefore would not require permits for these activities.

The PPA defines a noxious weed as encompassing both plants and plant products. A plant product is defined as “any flower, fruit, vegetable, root, bulb, seed, or other plant part that is not included in the definition of plant; or any manufactured or processed plant or plant part.” APHIS has regulated GE organisms under part 340 for over 20 years, and there is no strong evidence to suggest the need to regulate nonliving (nonviable) plant products in most cases. However, if in a specific case the importation, interstate movement, or environmental release of nonliving products of a GE plant may pose noxious weed risks, APHIS has clear authority to address those risks by imposing permit conditions on the handling of such nonliving products of the GE organism in the permit issued for the associated living GE organism. The proposed regulations state clearly in § 340.3(b) that the Administrator may also assign permit conditions addressing nonliving plant materials associated with or derived from GE organisms when such conditions are needed to make it unlikely that the nonliving materials would pose a noxious weed risk. APHIS invites consultation from any person considering a movement or release of nonliving materials derived from a GE organism who is uncertain as to whether it would be regulated.

B. Permits for Authorizing Importation, Interstate Movement and Release Into the Environment of Certain GE Organisms

1. Elimination of the Notification Procedure

APHIS first added the notification procedure to the regulations in 1993 as an administratively streamlined procedure for certain GE plants that met the eligibility criteria described in the regulation. Rather than using customized requirements, like the permit conditions used for the permitting procedure, the notification procedure uses generalized performance standards that are described in the regulation itself. The use of the performance standards that do not vary from one notification to the next is one of the ways that the more rapid administrative turnaround was achieved. In some ways, the term “notification” has been misleading to the public, since they do not realize that sending a notification does not mean automatic authorization by APHIS.

APHIS reviews notifications to verify that the GE plant meets the eligibility criteria, and also evaluates whether the

proposed importation, interstate movement or environmental release can be done in a manner that meets the performance standards described in the regulation. In many ways, these APHIS evaluations for notifications are very similar to those done for permit applications, but the notification procedure relies on applicants agreeing to meet the performance standards described in the regulation rather than submitting an application for APHIS review describing the specific measures they will employ for the activity (as is the case for permits). With permits, but not with notifications, APHIS can accept the proposed measures or add to them and the result is a set of binding customized permit conditions.

Because the notification procedure uses only the performance standards in the regulations, it is more administratively streamlined, but the general nature of the standards has made it difficult for APHIS inspectors to determine if a notification holder is in compliance and can also make enforcement more difficult. For example, under the current regulations, one of the performance standards for notifications relevant to environmental releases states that: “The field trial must be conducted such that (1) the regulated article will not persist in the environment, and (2) no offspring can be produced that could persist in the environment.” Conversely, specific conditions which APHIS places on permits are unambiguous, easy to verify at inspection, and easier to enforce. A specific permit condition that could be used to address just part of the performance standard described above might read: “After final harvest of the GE corn plants covered under this environmental release permit, the site will be monitored every 4 weeks for the emergence of volunteer corn seedlings for one year, and any emerging volunteer plants will be devitalized before they produce pollen. Records of the monitoring and management of volunteers must be maintained by the permit holder and made available to APHIS upon request.”

APHIS employs performance standards in many of its regulations, where appropriate. For example, we propose to employ a performance standard in another part of this proposal, container requirements for shipments of GE organisms. In that case, it is possible to employ a straightforward standard that the container must not break or leak when subjected to ordinary handling in transportation. The use of performance standards under the notification procedure has some benefits, such as providing the responsible person with flexibility in how the standard is met, e.g., allowing for appropriate change in protocols used during the growing season. However, there are some disadvantages in not specifically enumerating the specific measures that constitute compliance with the regulations. The permitting procedure does not have this disadvantage, because the permit conditions specify which actions need to be taken by the responsible person to be in compliance.

APHIS considered revising the performance standards and retaining the notification procedure, but this would not have remedied its shortcomings, especially the lack of specificity that is a necessity of using broadly applicable, performance standards in the regulations.

Under the proposed regulations where all authorizations will be done under a permitting procedure, the permit conditions will provide more specific information about what procedures the permit holder must follow in order to be in compliance. In the proposed rule, we are describing in detail the types of core permit conditions that will be imposed, plus the additional permit conditions that the Administrator can place upon the permit holder in order to make it unlikely that actions under the permit would result in the introduction or dissemination of a plant pest or noxious weed.

In view of the above discussion, APHIS has determined that it would have more flexible, risk-appropriate oversight, better regulatory enforcement and improved transparency if all regulated importations, interstate movements, and releases into the environment are authorized under the permitting procedure. The use of the permitting procedure in lieu of notifications is also necessary for APHIS to address some of the recommendations arising from the OIG Report and the provisions of the 2008 Farm Bill. For example, the OIG recommendations have led to proposed provisions in the regulations that will enable APHIS to add permit conditions to require additional reports during the course of an environmental release, the submission of notices to APHIS if the permit holder decides not to conduct the environmental release, and 7-day, pre-plant notices in the case of GE plants engineered to produce pharmaceutical or industrial substances. The last recommendation is already being implemented as a permit condition, because all of these authorizations are done under the permitting procedure. The OIG recommendations cannot be implemented under the notification procedure, because under the current regulations APHIS does not have the ability to attach conditions to notifications. This provides additional justification for APHIS to propose the elimination of the notification procedure. The APHIS proposal to eliminate the notification procedure is an effective way to address several of the provisions of the Farm Bill, such as the changes to the requirements for recordkeeping and reporting.

2. Revisions to Permit Procedures

APHIS proposes to reorganize the regulations to improve the clarity of the permit application and evaluation procedures. The proposed change is more a reorganization than substantive change, and should enhance the transparency of the regulations to the public. The permitting procedure will continue to identify and obtain information relevant to evaluating the risks associated with a proposed importation, interstate movement, or release into the environment, and determine and document whether, and under what conditions, the activity should be allowed. The proposed regulations related to the issuance of permits are divided into two sections. The first is proposed § 340.2,

Procedure for permits

, which describes permit types, the procedure for permit application (including information requirements), and the Agency's administrative actions for permits. The second is proposed § 340.3,

Permit conditions

, which describes the general types of conditions that APHIS may add to a permit, and the obligations of the responsible person after permit issuance.

APHIS is proposing explicit procedures for amendment, transfer of responsibility, and revocation of permits in order to establish clear regulatory procedures that can increase efficiency yet maintain adequate safety. Currently the APHIS administrative practices to amend, transfer, and revoke permits have not been explicit in the regulation, and this addition will provide increased transparency and efficiency.

The proposed changes organize the regulations to more clearly reflect the procedural steps in the application, evaluation, and issuance of a permit (see Figure 1). First, the different types of permits (importation, interstate movement, and environmental release) are described in § 340.2(b), as are new subcategories of environmental release permits. Second, the types of information that must be submitted with a permit application are described in § 340.2(c). The permit type, as well as

the nature of the environmental release (if the permit is for a release), affect the application information requirements. Third, § 340.2(d) outlines the procedural and administrative steps of issuing a permit. Finally, the attachment of conditions to permits, which is also dependent upon permit type and release category, is described in § 340.3. Each of these permit-related sections of the proposed regulations is discussed below.

Figure 1. Schematic of activities associated with issuance and enforcement of permits, showing associated sections of the proposed regulation.

Permit Types and Environmental Release Categories (§ 340.2(b))

↓

Application Information Requirements, by Type (§ 340.2(c))

↓

Permit Evaluation Procedures (§ 340.2(d))

↓

Assignment of Permit Conditions (§ 340.3)

↓

Compliance, Enforcement, and Remediation Activities (§ 340.7)

3. Permit Types and Environmental Release Categories (§ 340.2(b))

As discussed above in the background section, APHIS currently uses two procedures—notification and permits—to authorize the importation, interstate movement and release into the environment of GE organisms considered to be regulated articles under this part. The permitting procedure can be used for all regulated articles, but the notification procedure can be used only for certain GE plants that meet the eligibility criteria described in the regulations. Whereas permits are issued with explicit permit conditions which must be met by the permit holder, notifications have generalized “performance standards” described in the regulation and therefore do not vary from one notification to the next. Currently, approximately 90% of APHIS authorizations are done under the notification procedure.

Under the proposed system, which would eliminate notifications, APHIS would continue to issue three types of permits—interstate movement, importation, and environmental release. The procedures for the first two types of permits are relatively straightforward, and the conditions usually required for these permits address risks that are very similar from one shipment to another. We propose only minor adjustments to the procedures for interstate movement and import permits. In general, deliberate release of GE organisms into the environment presents a greater risk of introducing or disseminating plant pests and noxious weeds, and thus requires more careful oversight, than shipments of GE organisms into and across the country in secure containers. Of the three permit types, only environmental release permits would be differentiated into broad risk-related categories by the Administrator. This categorization would occur prior to the detailed and specific APHIS evaluation of an individual permit application. Table 2 summarizes the relationship of the three permit types and categories that pertain to environmental release permits.

Table 2—Proposed Permit Types and Categories for Environmental Release Permits

Type

Use

Importation permit

For securely moving a GE organism into the United States.

Interstate Movement

For securely moving a GE organism from any State into or through any other State.

Environmental Release:*

Release Category A

Release Category B

Release Category C

Release Category D

Release Category E (non-plants)

For releases into the environment, outside the constraints of physical containment that are found in a laboratory, contained greenhouse, fermenter, other contained structure, or secure shipment.

* In some cases, an environmental release permit may also incorporate permits for importation or interstate movement when such movements are incidental to the environmental release.

The proposed sorting system for environmental release permits includes five categories: Four for releases of GE plants (Categories A-D) and one for releases of all other GE organisms (Category E). Releases of GE non-plant organisms (Category E) would be placed into a single category and reviewed on a case-by-case basis. APHIS considered the creation of smaller risk-related subcategories for non-plants, but APHIS has received too few permit applications to warrant the creation of these smaller groupings. Releases of plants would be grouped into four categories, as described below.

APHIS considered a tiered permitting system which would sort proposed environmental releases of plants into a number of risk-based categories. Lowest risk releases would be assigned to Tier 1, slightly higher risk releases in Tier 2, and so on. In such a system, tier assignment is analogous to a risk rating. In developing the specifics of implementing such a system in the regulations, however, APHIS found that it was challenging to pre-assign all conceivable releases into tiers representing discrete levels of risk. There are a large number of risk factors that contribute to the overall risk associated with any given release. These factors include reproductive biology and growth habit of the species, potential for gene flow to other species, phenotype engineered into the organism, familiarity with the genetic material used, safety of any expressed products, scale of the release, location, duration, experience, and compliance history of the applicant, proximity to threatened

and endangered species, and other factors.

Sorting proposed releases considering all relevant factors would lead to an unwieldy system with many risk-based categories, and would essentially require a full risk assessment prior to assigning a proposed release to the appropriate risk category. Consequently, it would be nearly impossible for applicants and the public to predict the risk tier to which a proposed release would be assigned.

APHIS proposes that the permitting system for environmental release permits would assign releases into administrative categories based upon two primary risk-related factors described below, so that the categories would identify the general types of releases of plants which share broadly similar risks and management issues. This initial administrative sorting would be followed by an evaluation that fully characterized the risk of the proposed release, which would then be the primary basis for adding necessary permit conditions. APHIS concludes that such a system could appropriately sort most releases into groupings that are alike enough that they could usually be treated similarly initially, in terms of application information requirements and evaluation of potential risks. In most cases the initial groupings would also result in a similar level of oversight of the release and conditions attached to the permit-but any final determination of the permit category, oversight and permit conditions would depend on the results of the APHIS evaluation.

Using this approach, there is no prior conclusion that every release within the same category poses the same level of risk. Likewise, releases in different categories do not necessarily pose greatly different risks. For this reason, APHIS would not refer to these groupings as “tiers,” as this implies an incremental increase in risk from tier to tier, but would instead label them as “categories” which are lettered and not numbered.

APHIS developed the proposed sorting scheme by first examining the types of releases that typically are authorized under its current regulations. APHIS then modified the categories to make them more explicitly connected to plant pest and noxious weed risks.

The two primary factors APHIS identified as most relevant to define its sorting system for environmental release permits were the (1) ability of the unmodified recipient plant species to persist in the wild and (2) potential of the engineered trait to cause harm, injury, or damage, as described in the definitions of plant pest and noxious weed. Secondary factors, which in some instances may change the initial categorization, include: how the recipient plant is commonly used (e.g., as a food or feed crop); the impact of the engineered trait on the fitness of the GE plant; and, the degree of uncertainty associated with the trait and its possible impacts.

Regarding the persistence factor, APHIS proposes to group plant species according to the risk of persistence of the plant or its progeny in the environment without human intervention. Based upon the growth habit of the plant species and presence of wild relatives in the United States, APHIS proposes to sort all plants into four groups, listed in order of increasing persistence risk:

•

Low:

Populations of the recipient plant are unlikely to persist in the environment without human intervention, and the recipient plant has no interfertile wild relatives in the United States. Examples include corn, soybeans, and cotton (except in certain areas).

•

Moderate:

Populations of the recipient plant are known to be weakly persistent in the environment without human intervention, or the recipient plant has interfertile wild relatives in the United States. Examples include alfalfa, beets, canola, rice, and tomato.

•

High:

Populations of the recipient plant are known to be strongly persistent in the environment without human intervention, or the recipient plant has interfertile wild relatives in the United States which are aggressive colonizers. Examples include creeping bentgrass, poplar, sorghum, and sunflower.

•

Severe:

The recipient plant is a Federally-listed noxious weed or is known to be similarly aggressive in its ability to colonize and persist in the environment without human intervention. Examples include hydrilla and kudzu.

These aspects of plant biology and growth habit are broad indicators of the increasing likelihood that the plant or its progeny can reproduce and spread without human intervention. “Interfertile wild relatives” includes both wild relatives in the traditional sense, as well as feral populations of the same species persisting outside agroecosystems. The distinction between “weakly persistent” and “strongly persistent,” is intended to mean survival without human intervention for one or very few generations (weakly persistent) versus several to many generations (strongly persistent). APHIS will clarify which species fall into each group by publishing lists in guidance.

Similarly, with regard to the factor for potential harm caused by introduced traits, APHIS proposes to group traits engineered into plants into four simple groupings based upon the definitions of plant pest and noxious weed. The groups are listed in order of increasing potential hazard of the engineered trait:

•

Low:

○ Any new proteins or substances produced are unlikely to be toxic or otherwise cause serious harm to humans, vertebrate animals, or invertebrate organisms upon consumption of or contact with the plant or plant parts; and

○ No morphological changes which could cause mechanical injury or damage; and

○ Introduced sequences are known not to result in plant disease, and confers no or very low increased disease susceptibility.

An example would include expression of well characterized proteins known not to be toxic or harmful, such as a marker gene that does not pose a food or feed safety concern, or expression of viral genes where it is demonstrated that no protein is produced

•

Moderate:

○ Any new proteins or substances produced are unlikely to be toxic or otherwise cause serious harm to humans or vertebrate animals upon consumption of or contact with the plant or plant parts ; or

○ Novel resistance to the application of an herbicide; or

○ Has novel ability to cause mechanical injury or damage; or

○ Produces proteins or substances that are associated with plant disease that are not prevalent or endemic in the area of release, or that confer an increased susceptibility to disease.

Examples include expression of new CRY proteins, ,mechanisms of herbicide tolerance (e.g., CP4-EPSPS, which confers glyphosate tolerance), and production of viral movement proteins.

•

High:

○ Any new proteins or substances produced may be toxic or to otherwise cause serious harm to humans or vertebrate animals, upon consumption of or contact with the plant or plant parts; or

○ Produces an infectious entity which can cause disease in plants.

Examples include mercury hyper-accumulators or production of some pharmaceutical compounds.

•

Severe:

Any new proteins or substances produced are known or likely to be

highly toxic or fatal to humans or vertebrate animals, upon consumption of or contact with the plant or plant parts.

These aspects of the engineered trait are related to harms or damages associated with plant pests or noxious weeds. This takes into consideration (1) the harmfulness of any substances produced, (2) the possibility of creating morphological changes that would cause physical injury, and (3) the likelihood of increasing plant disease, either due to risk of creating novel pests or increased inoculum source. Novel resistance to an herbicide is included in the “moderate” category due to the impacts the trait could have on the ability to manage the plant or its progeny.

The proposed use of plant growth habit and trait harm or injury as the two main factors for the initial sorting of environmental releases into categories uses the two factors to roughly approximate “exposure” and “hazard,” respectively. Thus, using a combination of these two factors alone, we propose the following initial sorting of plant-trait combinations into release permit categories (see Table 3). Once environmental releases of GE plants have been sorted into the permit categories shown in Table 3, we will review and evaluate the information submitted by the applicant to determine oversight and permit conditions. The information requested from applicants will not be limited to these factors and is, in fact, designed to allow us to evaluate any of the risks associated with noxious weeds and plant pests. In some instances, our review may result in a change to the release category assignment of a GE plant.

Table 3—Initial Sorting Into Administrative Permit Categories (A, B, C, and D) for Environmental Releases of GE Plants, Based Upon Persistence Risk of the Recipient Plant Species and Potential Harm or Damage of the Engineered Trait

Persistence *

Potential harm or damage of engineered trait

Low

Moderate

High

Severe

Low

A

A

C

D

Moderate

A

B

C

D

High

B

B

C

D

Severe

D

D

D

D

* Persistence risk of the recipient plant species.

The sorting system above presumes that there is sufficient scientific information available about the GE plant to support the categorization. For example, the phenotype conferred by inserted sequences and the growth habit of the plant species in the U.S. must be well-characterized and based upon direct empirical observation of the genetic construct in the recipient plant species. In cases where less (or nothing) is known about phenotype of the engineered trait in the recipient plant species-such as inference based upon sequence similarity, protein structure modeling, or observation of the genetic construct in other species-the release category may be changed (from A to B or B to C) as a result of this uncertainty. Similarly, lack of familiarity with the plant species' behavior in the U.S. or the techniques needed to mitigate the likelihood of its persistence could also change the release category.

APHIS considered whether to adjust the categories table to acknowledge that an engineered trait could affect (enhance or detract from) the other factor axis, namely the persistence risk of the nonmodified recipient plant. Engineered traits such as resistance to biotic or abiotic stresses could theoretically increase the fitness of the plant, and thereby increase the likelihood that it will persist in the environment without human assistance. Considering the range of persistence risks posed by all of the different plant species sorted into any one of the proposed groupings, however, APHIS has concluded that in most instances the engineered trait would not alter the likelihood of persistence enough to warrant a change in initial release category. However, in cases where the engineered trait significantly alters plant growth habit, metabolism, or reproduction to increase the likelihood of persistence in the environment, APHIS could change the release category accordingly. Examples of such changes might include converting an annual species to a perennial or converting a plant with C3 metabolism to crassulacean acid metabolism (CAM).

The proposed category system should provide a simple, transparent way for APHIS review information in applications to initially sort releases into broad, risk-related categories, which can then be more efficiently assessed for the actual risks posed by the release. However, it should be emphasized that the categories are intended only for initial sorting, and other factors are taken into account in the APHIS evaluation when determining the specific permit conditions.

APHIS intends that release Category A will be associated with a level of regulatory oversight similar to environmental release notifications under the current system, and Categories B and C with a level of regulatory oversight similar to various permits that have been issued under the current system. However, it will be much clearer to the public what types of oversight will be applied broadly within each category. As we discussed above, oversight and permit conditions with each category will be similar, though not necessarily identical, for any plant within the category. Category D was created to acknowledge the possibility that some proposed releases may pose a very high risk of introducing a highly persistent or harmful plant into the environment. To date, APHIS has never been requested to allow releases that would fall into this category. If an applicant were to propose a Category D release, APHIS would only authorize such releases after imposing extremely strict levels of oversight akin to high security quarantine far exceeding that of Category C that would ensure that the GE plants could not persist in the environment. The information requirements, permit conditions, and general levels of oversight associated with each release Category are discussed below.

This simple sorting system places GE plants into categories and provides a relatively clear, simple rationale for placement in a given category. What follows is a series of illustrations of common plant-trait combinations and the release categories to which they would be assigned:

•

Category A:

○ Bt corn producing CRY1ab toxin. The plant is unlikely to persist in the

environment and the safety of the protein has been assessed by the EPA.

○ Soybeans engineered with glyphosate tolerance conferred by CP4-EPSPS. While herbicide tolerance poses a “moderate” hazard, soybean has no interfertile wild relatives in the U.S..

•

Category B:

○ Corn producing a new CRY protein. The plant is unlikely to persist and the novel CRY protein is likely to be toxic to some species that live or feed on the plant (normally Category A), but its food/feed safety is only inferred from similarity to other CRY proteins.

○ Random “knock-out” or antisense libraries of soybean lines. While the lines may not likely produce novel proteins or substances (Category A), because of the uncertainty associated with the impacts of genetic engineering on these lines, they would be treated as Category B. Well-characterized lines taken from such libraries that do not produce new proteins would likely be treated as Category A.

○ Kentucky bluegrass engineered with glyphosate resistance conferred by CP4-EPSPS. Herbicide resistance is a “moderate” hazard and bluegrass has interfertile wild relatives in the U.S.

○ Pines producing an enzyme to enhance paper production. Pines are persistent and have interfertile wild relatives in the United States.

•

Category C:

○ Poplar engineered to produce enzymes for heavy metal bioremediation.

•

Category D:

○ Any Federally listed noxious weed that has been genetically engineered; any GE plant producing a vertebrate toxin.

Permits for Environmental Releases of Plants Making Pharmaceutical and Industrial (PMPI) Compounds

APHIS considered whether to continue to issue environmental release permits for GE plants engineered to produce pharmaceutical and industrial compounds if the GE plant species is the same as, or sexually compatible with, a species commonly used for food or feed. APHIS concludes that the proposed permitting procedure and the use of stringent permit conditions can continue to effectively minimize the risks that may be associated with the environmental release of such GE plants. APHIS will continue to impose permit conditions that take into account the issues related to the safety of proteins or other substances that these plants have been engineered to produce. Based upon APHIS experience to date, many releases of GE plants producing pharmaceutical or industrial substances would fall in Category C, and would carry the same level of oversight as current permits for PMPI.

4. Permit Application Information Requirements (§ 340.2(c))

In the proposed regulations, we provide greater detail about the basic application information requirements that need to be addressed in all permit applications, as well as additional basic information required for each permit type and the categories in the case of environmental release permits. Under the current regulation, certain areas where APHIS routinely needs information from the applicant do not become apparent until the applicant submits the permit application (and APHIS subsequently follows up for additional information). Some of the information requirements related to recordkeeping, reporting, and contractual arrangements among the permit holder and agents are new to the regulation and reflect, in part, certain provisions of the 2008 Farm Bill and also align with recommendations of USDA's OIG 2005 Report. For example, the OIG recommendations have led to provisions that will enable APHIS to require geographic coordinates for the locations of environmental releases.

The differences between the information required for an application under the current regulations versus the proposed regulations may be seen by comparing current § 340.4 to proposed § 340.2(c). Both the current and proposed application procedures require information characterizing the nature of the GE organism, including detailed molecular biology information about the expression of the introduced genetic material. They also both require information about the type of movement and/or release planned. The proposed rule requires more detail in some of these areas, and more description of the applicant's plans and methods to prevent unauthorized releases, and to respond to unauthorized releases if they occur. This information is used in part by APHIS to formulate the specific permit conditions. In cases where the permit is for environmental release, and would be in permit categories C or D according to the table in § 340.2(b)(3), a greater level of detail would be required for almost all aspects of the activity, including the recipient organism, the inserted gene(s), site location and management practices, and training and communication among the permit holder and agents involved in the activity covered under the permit. This information would also address the capability of the organism to persist or spread in the environment, or include details about how the engineered traits might be harmful.

5. Permit Conditions (§ 340.3)

Conditions are specific practices or requirements that an applicant must follow upon issuance of a permit. Under the current regulation, the permit conditions are described in the same section as the permit procedure itself. In the proposed revision, the permit conditions are enumerated in a separate section (§ 340.3) to accommodate the additional details to describe conditions for the three permit types as well as the categories of environmental release permits.

The use of permits and permit conditions gives APHIS and the responsible person a clearer understanding as to what actions must be taken for the permit holder to comply with the regulation. In the proposed regulation, APHIS has strived to provide as much transparency and predictability as possible about permit conditions while retaining sufficient flexibility so that the regulations will be adaptable in a broad range of cases.

Permits will be issued with the core permit conditions described in § 340.3(a), which are a minimum set of basic conditions for importation, interstate movement, and release. The Administrator may add to these conditions additional or expanded conditions when necessary to make it unlikely that actions under the permit would result in the introduction or dissemination of a plant pest or noxious weed.

The Administrator will assign the permit conditions in a manner that is commensurate with the risk of the individual proposed movement or release. Additional or expanded permit conditions may include, but are not limited to, specific requirements for: reproductive, cultural, spatial, temporal controls; monitoring; post-termination land use; site security or access restrictions; and management practices such as training of personnel involved in the release.

The proposed description of permit conditions elaborates on the “standard” permit conditions found in the current regulations, and the additional detail is designed to better communicate with potential applicants what the requirements are likely to be for their particular permit, and will better support administration of the program, including compliance and enforcement.

In the current regulation, only “standard” permit conditions are described, and APHIS has the authority to place other conditions upon the permit as deemed necessary by the

Administrator. The proposal for permit conditions will be more transparent to the public and this transparency will better facilitate planning by researchers, especially those who have not previously received permits from APHIS.

The proposed required core permit conditions consolidate six primary areas addressed in different parts of the current regulations to ensure compliance with the regulation and to make it unlikely that the permitted activity will result in the introduction and dissemination of a plant pest or noxious weed: Identity, shipment, unauthorized dissemination, communication and training, records, reports and notices. APHIS intends the list of specific condition areas we propose in § 340.3 to be used for all permits we issue as they apply to importation, interstate movement, and release into the environment. The required permit conditions listed in § 340.3 represent the permit conditions that we propose to apply for any type of permit. Listing them in the regulations should provide applicants with the ability to plan their activities with knowledge of the primary requirements for all activities that would have to be met to comply with the regulations.

For environmental release permits, proposed § 340.3(a)(4)(iii)(F) would also require the permit holder to notify APHIS seven days prior to initiation of the release if the release is Category C or D. For all Categories, permit holders are required to notify APHIS if they do not conduct the release.

The current regulations require environmental release permit holders to submit field test reports to APHIS within 6 months after termination of a field test. Under proposed § 340.3(a), the requirement simply states that the responsible person shall submit reports to APHIS at the times specified in the permit conditions and containing the information specified in the permit conditions.

APHIS is also proposing revision of the regulations to clarify the procedure it would use for amendment of permit conditions, transfer of a permit to a different responsible person, and revocation of an existing permit. Each of these additions to the regulations reflect current administrative practices and the incorporation of these into the regulations will make the overall system more transparent.

Currently, APHIS attaches conditions to permits at the moment the permit is issued to the applicant. Under the current regulations, the permitting procedure does not include a formal acknowledgement from the applicant prior to permit issuance that they are aware of and consent to the permit conditions. To verify that applicants are aware of and willing to abide by the conditions, APHIS proposes to add an additional administrative step in the permit procedure in § 340.2(d)(6) to support administration of the program. We are proposing to require that applicants agree prior to permit issuance that they will comply with all the permit conditions. Eventually, APHIS would build this feature into the existing ePermits system, and in the interim it would provide alternative mechanisms, such as e-mail communications, to implement this step of the permitting procedure.

APHIS is also proposing to clarify in § 340.2(h) of the regulations the procedure to be used when amendment of existing permit conditions is sought by the responsible person or required by APHIS, as well as the procedure for transfer of an existing permit to a different responsible person.

As with the current regulations, APHIS is retaining the flexibility to modify permit conditions as needed under individual circumstances. Proposed § 340.3 will increase transparency, yet still allow sufficient adaptability of the regulations for the full range of permit applications APHIS expects to receive today and in the future. APHIS recognizes that transparency and predictability for applicants must be balanced with maintaining Agency flexibility and adaptability for years to come under these regulations. APHIS encourages the public to comment on the choices we are proposing here, and we welcome suggestions for alternative approaches.

APHIS is proposing to revise the current sections of the regulations for container requirements for shipments of GE organisms (§ 340.8) and marking and identity requirements for imports of GE organisms (§ 340.7). Rather than the highly prescriptive approach in the current regulation, we will use an approach that is performance based and can be adapted to the activity that is being performed. This should provide greater efficiency for the public as well as APHIS, yet still achieve the necessary level of containment during shipments. We have reorganized this information in the regulations so that the requirements are associated with the related activity under the proposed regulation. For example, the shipping requirements for interstate movements under the conditional exemption have the requisite shipping conditions stipulated in the section for conditional exemptions. Likewise, the shipping conditions for import and interstate movement permits have been placed in the section for permit conditions, rather than retaining them in a separate section as in the current regulations. The performance-based standards we are proposing incorporates a simple performance standard in our proposed definition of secure shipment, discussed below: “Shipment of a package of sufficient strength and integrity to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.” APHIS is also proposing to require applicants to provide their proposed methods of secure shipment, and APHIS will specify the methods of secure shipment as a permit condition.

APHIS proposes to eliminate the marking and identity requirements for imports of GE organisms as a separate section of the regulations (current § 340.7). As with the container standard issue discussed above, appropriate labeling and related requirements would be highly individual depending on the organism, type of permit, and other conditions.

APHIS is proposing to include relevant tribal officials when it provides copies of permit applications to state regulatory officials. The current regulations state that APHIS provides this information to state regulatory officials.

6. Elimination of Courtesy Permits

APHIS is also proposing to eliminate the issuance of courtesy permits. Courtesy permits have been part of the regulations since their inception in 1987, but in an effort to better allocate APHIS resources, APHIS is proposing to remove this regulatory feature. The current regulations provide the ability for APHIS to issue “courtesy permits,” in order to facilitate the movement of organisms which are outside the scope of these regulations, but whose movement might otherwise be hindered because of their similarity to organisms regulated under these regulations. The issuance of courtesy permits has generated confusion in the public and especially in the research community. The application form for courtesy permits is identical to the application for other types of permits, and the courtesy permit itself looks like other permits. This has led to the widespread misunderstanding by some researchers that courtesy permits are actually required for the movement of certain organisms, or that issuance of a courtesy permit removes the requirement for applicants to have other authorizations which may be required, under plant

pest regulations such as those found at 7 CFR part 330. APHIS commits significant resources to the issuance of these courtesy permits for the movement of organisms which are not subject to the provisions of part 340. APHIS will work with researchers and relevant government regulatory officials to facilitate the transition.

APHIS will also be available for consultation by persons who formerly used courtesy permits and other persons moving similar non-regulated articles, to discuss how to facilitate their movement. We also encourage the public to comment on the proposed elimination of courtesy permits and how APHIS should work with persons moving organisms for which we might formerly have issued courtesy permits.

C. Conditional Exemptions From Permit Requirement (§ 340.4)

The PPA allows the Secretary to create “exceptions” to the permit requirement when the Secretary deems that a permit is not necessary. That is, these regulated activities are allowed, under certain conditions, without seeking prior authorization via permit. The current APHIS regulations contain such PPA exceptions, but they are referred to as “exemptions” in the regulations. The current regulations include conditional exemptions from the requirement for interstate movement permits. These conditional exemptions were established in the regulations during the first few years after the regulations were first promulgated. The last conditional exemption was established in the regulations in 1990 for the interstate movement of GE plants of the species

Arabidopsis thaliana

as long as the conditions described in the regulations are met.

In its proposed revision to the regulations, APHIS is retaining the existing conditional exemptions from interstate movement. We are also proposing a new regulatory procedure that would enable APHIS to approve new conditional exemptions more efficiently than using the procedure of notice and comment rulemaking for each individual exemption. This can be a transparent and efficient way to provide regulatory relief. This new procedure for approving conditional exemptions is described in § 340.5, and it incorporates transparent steps including scientific review, public input, and adaptability when APHIS establishes the conditions relevant to the specific conditional exemption. Conditional exemptions, by their nature, will always include conditions and continued APHIS oversight to ensure that the conditions are met.

The current regulations provide for conditional exemptions from the requirement for permits for the interstate movement of certain GE strains of the microorganisms

Escherichia coli, Saccharomyces cerevisiae,

and

Bacillus subtilis,

and the plant

Arabidopsis thaliana

in § 340.2(b), and these conditional exemptions are being retained under the proposed regulations. Conditional exemptions from permit have been part of the regulations since the first exemption was established in 1988 (for the interstate movement of certain GE microorganisms), with the addition of another conditional exemption, through rulemaking, in 1990 for certain types of GE

Arabidopsis thaliana,

one of the most commonly used plants for scientific studies and which is frequently distributed among researchers. The essential conditions for each of these conditional exemptions address the following: (1) Species of the GE organism, (2) the types of genetic modifications that are allowed or prohibited for the GE organism, and (3) the manner in which the GE organism is shipped interstate. The existing conditional exemptions for the interstate movement of microorganisms were based on APHIS' conclusion that the exemption from the requirement for permits for interstate movement of these microorganisms would “not present a risk of the introduction or dissemination of a plant pest” (53 FR 12910, p.12910).

The existing conditional exemptions for

E. coli, Bacillus subtilis, Saccharomyces cerevisiae

and

Arabidopsis thaliana

are being retained in the proposed regulations. APHIS has no information that would indicate that such conditional exemption would be result in the introduction and dissemination of a plant pest or noxious weed. The text of the conditional exemption is being updated to place the shipping requirements with the other conditions associated with the exemption, instead of the current regulatory organization that has the shipping requirements in a separate section of the regulation.

In addition to the existing conditional exemptions, APHIS is proposing a transparent and efficient petition procedure in § 340.5 whereby the Administrator may approve additional conditional exemptions from permit without having to amend the regulations. This procedure would provide for a scientific review by APHIS as well as the opportunity for public review and comment on the scientific basis for the proposed exemption and the conditions associated with the exemption. The proposed procedure would provide an adaptable means of ensuring that the regulatory oversight is proportional to the risks posed by specific activities with GE organisms.

Proposed § 340.5 describes the procedure whereby a petitioner would seek a determination by the Administrator that the importation, interstate movement, and/or release into the environment of a GE organism is not subject to the requirement to have a permit under this part. We propose that the Administrator's decision to approve an exemption would be based upon a determination that the exemption from the requirement for a permit, when conducted with the associated conditions, is unlikely to result in the introduction or dissemination of a plant pest or noxious weed. APHIS anticipates that creating this new petition procedure to allow approval of additional conditional exemptions would enhance its ability to customize regulatory oversight to be proportional to any risks associated with importation, interstate movement, or release into the environment of a GE organism.

Under the proposed procedure, petitioners have the flexibility to propose various types of conditional exemptions from the requirement for a permit: The proposal can be for one or more permit types (importation, interstate movement, or release into the environment). In addition, the petitioner can propose the relevant conditions. The Administrator may approve the proposed conditional exemption as submitted in the petition, or the Administrator may impose alternatives to the requested exemption and conditions. The Administrator would review the scientific information and evaluate potential risks relevant to the proposal, then make the relevant documents (proposal and any supporting information) available to the public for review and comment prior to the Administrator's decision.

The information needed for a petition for conditional exemption would depend on the nature of the exemption requested and the proposed conditions for exemption. For example, conditional exemptions for the interstate movement of narrowly-defined groups of organisms with restrictive associated conditions might require considerably less information to justify than exemptions for broadly defined groups of organisms or less restrictive associated conditions. In making its determination, APHIS would consider all relevant information, including information in the scientific literature, copies of unpublished studies, and reviews by other regulatory agencies.

APHIS foresees many advantages to the proposed procedure, including scientific rigor, public involvement, and regulatory efficiency. APHIS would continue to provide to the public the relevant scientific information under consideration, its environmental analysis, and the rationale for its determination. The public would also retain its ability to provide comments to the agency prior to a decision approving a new exemption. APHIS decisions regarding these newly approved conditional exemptions would be published in the

Federal Register

and maintained on a list accessible to the public.

In evaluating whether to approve a new conditional exemption, APHIS would carefully consider issues related to enforceability of the conditional exemption when proposing to approve a conditional exemption. Unlike permit conditions, which are binding on the specific responsible person, the conditions associated with the exemption would apply to anyone who conducts the activity under the conditional exemption. Before granting such a conditional exemption, APHIS would take into consideration the likelihood that such conditions would be followed and the consequences if they are not.

Conditional exemptions could be used, for example, for the importation of certain GE commodities. A person could petition for an exemption from all permits for shipments of a particular GE commodity grain under the condition that the grain is not grown, but will only be moved for direct use as food, feed, or for processing. The proposed procedure to approve new exemptions would be sufficiently adaptable that it can consider approving exemptions for the shipment of certain GE commodities that would take into account any conditions necessary to make it unlikely to result in the introduction and dissemination of plant pests or noxious weeds.

APHIS considered proposing specific criteria in the regulations that the Agency would use when evaluating potential risks of imported GE commodities which are viable propagules such as grains like corn, wheat, etc. APHIS considered that such a criterion-based system in the regulations might allow APHIS to conduct expedited reviews of imports that met the specified criteria. APHIS considered criteria such as whether the GE plant had undergone a safety review in a foreign country, whether APHIS had granted nonregulated status to something similar, and the likelihood that the commodity could be propagated (seeds, fruit with seeds, nonviable products like flour, etc.).

However, at this time APHIS is not proposing such criteria in the regulation. APHIS does not rule out the possibility of developing such a criterion-based system in the future. We welcome comments from the public on this issue.

We are also proposing regulatory procedures whereby the Administrator may revoke any exemption under this part after it is approved. As proposed, the Administrator may revoke any exemption if the Administrator receives information subsequent to approving the exemption and makes a determination based upon this information that the circumstances have changed such that the exemption is likely to result in the introduction or dissemination of a plant pest or noxious weed. A revocation may not be appealed. However, any person may file a new petition in accordance with § 340.5 regarding the same or similar organisms covered by the exemption if new information relevant to the revocation becomes available.

In addition to this procedure for completely revoking an exemption so it would be unavailable for use by any person, we propose to add a provision in paragraph (e) of the conditional exemptions section, § 340.4, under which the Administrator may revoke the right of an individual person to use an exemption without revoking the exemption for other persons. The Administrator could revoke an individual's right to use an exemption after determining that the person or any agent of the person has failed to comply at any time with any provision of this part.

D. Petitions for Nonregulated Status (§ 340.5)

The current regulations include a procedure by which anyone may petition APHIS to grant “nonregulated status” to a GE organism, which means it would no longer be subject to the regulations in part 340. This nonregulated status is different from that of regulated articles that might be conditionally exempt from the requirement for a permit when moved interstate (following the conditions specified in the regulations).

Published APHIS decisions made under the current regulations have used different ways to express the basic standard “unlikely to pose a plant pest risk” in determining whether to grant nonregulated status to a specific GE organism. In its determinations, APHIS has conveyed the basic standard of “unlikely to pose a plant pest risk” by concluding that the GE organism “poses no more of a plant pest risk than its non-genetically engineered counterpart,” “will not pose a plant pest risk”; or that there is “no plant pest risk,” or “no direct or indirect plant pest effects.” Regardless of the phrases used in its determination of nonregulated status to date, APHIS has applied the same basic evaluation criteria to each determination to conclude that the GE organism is unlikely to pose a plant pest risk and therefore is not subject to the part 340 regulations.

APHIS is proposing revisions to § 340.6 that will clarify the petition procedure, information requirements for petitions, and the standard upon which the Administrator will make a determination that a GE organism is approved for nonregulated status. Under the current regulations, the basic standard for a determination of nonregulated status of a GE organism has been related to plant pest risk. In § 340.6(b)(4) of this proposed rule, we are proposing to apply a similar basic standard derived from the proposed regulatory scope in § 340.0(a), namely, whether the GE organism is unlikely to be a plant pest or noxious weed.

The current regulations also have a provision at § 340.6 to extend a determination of nonregulated status and grant nonregulated status to a GE organism based on the similarity of the GE organism to an antecedent GE organism that has already granted nonregulated status (§ 340.6(e) “Extensions to determinations of nonregulated status”). This provision has been in the APHIS regulations since 1997 and has been used fifteen times to grant nonregulated status to additional GE plants based on similarity to their antecedents. This existing “extension procedure” was designed for APHIS to take into account the previous evaluation conducted by APHIS and thereby afford the potential for expedited evaluations of a petition for extension. The extension procedure has some administrative aspects which are streamlined but in practice the APHIS scientific reviews for extensions are similar to those of the antecedent organism.

Some members of the public have misunderstood the nature of the extension procedure, believing that APHIS has not conducted a thorough scientific review. Some members of the public have misconstrued the term “extension” to conclude that an extension would extend the duration of nonregulated status (nonregulated status is not granted with an expiration date).

For these reasons, APHIS is proposing to eliminate the extension procedure in

the regulation. APHIS sees no advantage to retaining the distinction in the regulations between reviews for antecedents and reviews for subsequent petitions for extensions. Because the proposed revisions for petition for nonregulated status provide a high degree of flexibility, a separate extension procedure is not needed in the regulation. Review of petitions under the proposed regulations will rely on previous evaluations of similar GE organisms when they exist. APHIS foresees that some evaluations for nonregulated status may require less time if previous evaluations have addressed the issues relevant to a new petition for nonregulated status.

In § 340.6 we propose some revisions to the information that the Administrator may require a petitioner to submit in consideration of the particular petition. In the current regulation, the information needs are described largely with respect to evaluating GE plants, but APHIS foresees that other GE organisms may also be suitable candidates. This provision may become more important as new commercial applications of biotechnology emerge and new types of information are needed to properly assess the risks associated with new types of GE organisms. In all of the nonregulated status requests processed to date, the subject organisms and the alterations involved did not present unanticipated or completely novel approaches and APHIS was able to make a determination based on information in the petitions. When needed, APHIS obtained additional information from petitioners, in a consultation process similar to the one proposed.

We are also proposing a regulatory procedure whereby the Administrator may revoke a previous approval of nonregulated status. This is consistent with the existing regulations and policies that the Administrator may place a deregulated GE organism back under the regulations if the Administrator concludes that the GE organism poses a plant pest risk. As proposed, the Administrator may revoke any approval of nonregulated status if the Administrator receives information subsequent to approval that the GE organism is likely to be a plant pest or noxious weed. If the Administrator revokes an approval for nonregulated status, the Administrator may approve for the same GE organism an exemption from the requirement for permit in accordance with § 340.5. The revocation, its effective date, and the reasons for it will be published in the

Federal Register

. A revocation may not be appealed. However, any person may file a new petition in accordance with § 340.5 or § 340.6 regarding the same or similar organisms covered by the revocation if new information relevant to the revocation becomes available.

Treatment of GE Organisms That Have Been Granted Nonregulated Status

Although the APHIS evaluations of GE plants that would be conducted under the proposed regulatory changes will evaluate some additional factors because of consideration of noxious weed risks, APHIS nonetheless considers this proposed revision to be sufficiently consistent with the criteria evaluated in making determinations of nonregulated status to date under the current regulations. For this reason, APHIS is proposing that all previous determinations of nonregulated status made since the early 1990s under the part 340 regulations will be automatically approved for nonregulated status under the revisions proposed here. The history of safe use of these nonregulated GE plants in agriculture in the United States and other countries gives APHIS confidence that it is appropriate to retain nonregulated status under the revised regulations for all those GE plants which have been granted nonregulated status under the existing regulations. Many of these GE plants have been incorporated into plant breeding programs and been used to develop hundreds of crop varieties that have been widely and safely used in agriculture around the world.

We also note that although the addition of the term “noxious weed” is new to the proposed regulation, previous evaluations for determinations of nonregulated status considered the concept of plant pest risk in a broad context that included consideration of potential weediness. The evaluations considered,

inter alia,

whether the unmodified plant was a weed, whether the GE plant was a weed, and whether the interbreeding of the GE plant with sexually compatible plant species would result in offspring that would be weeds. In each case in which APHIS granted nonregulated status to date, APHIS reached the conclusion that in each instance that the potential for weediness was unlikely to occur. In the case of some petitions for nonregulated status in which the GE plants were engineered with sequences derived from plant viruses, APHIS also considered in its reviews whether the genetic modification was unlikely to result in a new plant pest, in this case a plant virus (through mechanisms such as recombination or transencapsidation).

E. Compliance, Enforcement, and Remedial Action (§ 340.7)

1. Ensuring Compliance With Permits and Exemption Activities

In recent years, APHIS has strengthened its program in order to improve permit holders' compliance with the regulations, to augment the approaches used to prevent or remediate potential risks to plant health, and to utilize appropriate enforcement strategies. This proposal provides an opportunity to set forth the compliance and enforcement requirements and the tools and administrative practices APHIS may employ as part of an integrated approach to prevent the introduction or dissemination of plant pests and noxious weeds, and to support overall administration of the program. These matters are addressed in proposed § 340.7, “Compliance, enforcement, and remedial actions.” These proposed regulatory changes also reflect certain provisions of the 2008 Farm Bill and align with recommendations of USDA's OIG.

APHIS seeks to clarify that it will use the full range of enforcement authorities and penalties granted under the PPA. As described above, APHIS issues permits with specific conditions or requirements placed upon the responsible person. Proposed § 340.7 clarifies the requirement for compliance with these conditions, as well as the approaches available to APHIS to verify compliance. Such conditions may include requirements for the responsible person to establish and maintain records related to the permit, as well as allowing APHIS to review those records. This section underscores APHIS' ability to conduct inspections and audit records related to the regulated activities.

In this proposed rule, the requirements for record retention are being increased. Records indicating that a GE organism that was imported or moved interstate reached its intended destination must be retained for at least 2 years after completion of importation or interstate movement, and all other records must be retained for at least 5 years after completion of all obligations required under a relevant permit or exemption. APHIS is also proposing changes to the nature of the records that are required, a topic discussed in greater detail in section E of this document, “E. Paperwork Reduction Act.” Changes include a requirement to maintain records for activities done under a conditional exemption, as well as contracts and other information related to agreements between the responsible person and all agents that conduct activities subject to this part.

In a previous section of this proposal we discussed the types of records proposed as core permit conditions in § 340.3. We also propose to add certain recordkeeping requirements to § 340.7 that would apply not just to responsible persons exercising permits, but to all responsible persons and their agents engaged in the importation, interstate movement, or release into the environment of any GE organism that is subject to this part, including persons utilizing the conditional exemptions from permits.

In recent years, APHIS has accrued a great deal of experience in enforcing the regulations and investigating possible violations of them. This experience has helped us identify specific types of records that may not be required by the current regulations, but that are necessary for effective enforcement of the proposed regulations.

2

For example, in investigations of field trials we have found that we could not always obtain detailed maps for each planting area used during each season of the trial. This information is important for the efficient enforcement of the regulations. We also found that sometimes records of actual field trial operations over time were not sufficient to confirm that the procedures, equipment, and safeguards APHIS approved for a field trial were actually employed. That is, while existing records could generally confirm plans to use, for example, certain cleaning equipment or procedures at certain intervals, or to conduct plantings on certain dates, the records did not confirm that plans were actually carried out on the approved dates. We also found that records for some field trials did not identify which staff members or contractors were responsible for performing which duties, either during a field test or in the event of an unauthorized release that triggered the field test contingency plan. When responsibilities cannot be linked to specific individuals, it makes it very difficult to investigate possible violations. Another gap in necessary records we discovered through experience was the absence of clear written records of the responsibilities of different organizations, when several different entities were involved in a field trial. During investigations we may need to review not only any written contracts, but also any written agreements among researchers, developers, or other parties that are sharing performance of tasks required by the permit for a field trial.

2

Details of investigations that have led APHIS to propose expanded records requirements may be found in the ``Lessons Learned'' document cited above, and in investigation report documents on the APHIS Web site, e.g., ``2007 Report of LibertyLink Rice Incidents'' (

http://www.aphis.usda.gov/newsroom/content/2007/10/content/printable/RiceReport10-2007.pdf

) and ``Transcript of Technical Briefing on Rice Investigation'' (

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2007/10/0285.xml

).

The proposed regulations would allow APHIS to require these types of records. As APHIS considered the types of records needed to support the regulations it became apparent that regulations could not specify in a “one size fits all” fashion all record requirements that might be needed. Therefore, we propose to add those detailed record requirements of truly general applicability in § 340.3 and § 340.7. However, we also propose in § 340.3 that we would continue to impose any necessary additional record requirements appropriate to each permit situation as individual permit conditions.

Proposed § 340.7 also outlines the possible consequences of failure to comply with the regulations, including denial of future permits; revocation of current permits; destruction, treatment, and removal of GE organisms; issuance of penalties; and a means to settle alleged civil violations prior to the issuance of an administrative complaint.

Under this proposal, every person whose activities are within the scope of the regulations must comply with all the requirements of this part. Moreover, a responsible person can be held liable for the violation of any requirement of this part by any agent working for the responsible person (including persons contracted to conduct or carry out the environmental release on their own or on leased properties).

We propose to address remediation authority and procedures to a greater degree of detail than the current regulations. In proposed §§ 340.7(e) and (g) we explicitly state that the APHIS Administrator has the authority to take remedial actions in the event that an incident requires such actions. We also specify that the APHIS Administrator has the authority to order remedial action by others. These orders could take the form of an Administrative Order, Emergency Action Notification, or similar regulatory instrument. Additional information about these types of orders and related procedures are provided in administrative guidance on the APHIS Web site. The consequence for failure to abide by the orders of the Administrator is also described in proposed § 340.7, linking remediation to enforcement.

Finally, APHIS has clarified in the proposed regulations that in the event of a permit revocation, it may act or order action of the responsible person in the handling of the organisms, articles, or means of conveyances.

2. Low Level Presence of Regulated GE Plants in Seed or Grain

On March 29, 2007, APHIS published a

Federal Register

notice titled “Policy on Responding to the Low-Level Presence of Regulated Genetically Engineered Plant Materials” (72 FR 14649-14651; Docket No. APHIS-2006-0167. This notice described how APHIS responds when low levels of regulated GE plant materials occur in commercial seeds or grain that may be used for food or feed. This issue was also addressed in the DEIS in Issue 7. Both of these documents described how APHIS has addressed these occurrences in the past, and how the Agency intends to address them in the future. We are proposing to amend the current regulations to explicitly incorporate APHIS' low level presence policy.

As described in the DEIS, APHIS proposes to establish criteria under which the occurrence of a low level presence (LLP) of GE plant materials in seeds or grain may not be cause for agency remedial action. APHIS would still retain discretion to order corrective or remedial actions in situations that meet the non-actionable criteria, when the Administrator determines remedial action is needed to make the LLP unlikely to result in the introduction or dissemination of a plant pest or noxious weed. We propose to list criteria and describe possible enforcement actions in the regulations to improve transparency regarding how APHIS would respond to LLP in most instances. APHIS will not predetermine a specific level that is considered non-actionable as far as taking some remedial and/or enforcement action because this determination should always be made case-by-case. These criteria are intended to apply only to APHIS' decision to take or order remedial action in the event that LLP occurs. The proposed criteria are listed within the section describing the Administrator's ability to take or order remedial actions. Regardless of whether APHIS considers the LLP actionable with regard to remediation, any violations of the regulations or permit conditions could still result in any of the compliance and enforcement actions listed in the regulations, including imposing civil penalties.

APHIS is proposing a new provision in the regulations that would reflect the current policy cited above. The provision describes the criteria APHIS will use when determining that a LLP event would be non-actionable with regard to remediation, namely when the criteria support a conclusion that the

LLP is unlikely to result in the introduction or dissemination of a plant pest or noxious weed. Because the criteria are safety-based, they will be used for incidents of low level presence originating domestically (e.g., from field testing) as well as any low level presence that might be detected in import shipments that may contain organisms subject to regulation.

APHIS also considered two additional criteria, which we have not adopted in the proposed rule. First, we considered a criterion that would require that the genetic material be introduced into the plant using a method that has been demonstrated to result in integration of the new sequences into the plant genome, as defined in § 340.1. We did not include this criterion in our proposal because its relevance in the LLP context is unclear. A second criterion considered was that the genetic material engineered into the GE plant does not encode substances with whose function APHIS is unfamiliar. APHIS did not adopt this criterion since it is redundant with the proposed criteria that will be used, i.e., that the function of the introduced genetic sequences is known and that key food safety issues have been addressed.

The DEIS, in Issue 7, Alternative 3, proposed that APHIS would also consider the LLP safety criteria when deciding whether to issue a permit for environmental release, and what type and severity of permit conditions to assign to the release permit. In its evaluation of permit applications, APHIS does plan to refer to the LLP criteria, as described above.

F. Administrative Changes

1. Confidential Business Information

APHIS is proposing a new § 340.8 to provide further guidance on the manner in which confidential business information (CBI) will be addressed in the implementation of these regulations. This change will support the overall administration of the program. The proposed § 340.8 cites the relevance of the Freedom of Information Act (FOIA) and exemptions from releasing information pursuant to FOIA, namely, 5 U.S.C. 552(b)(4), and states that APHIS may exempt from disclosure to the public trade secrets and commercial or financial information obtained from a person that are privileged or confidential. Proposed § 340.8 also states how persons wishing to protect confidential business information should communicate with APHIS in permit applications, petitions, or other submissions to APHIS.

2. Time Frames for APHIS Action on Permit Applications and Petitions

Current regulations specify time frames within which APHIS must take certain actions, such as issuing permits, acknowledging notifications or issuing decisions on petitions to grant nonregulated status. APHIS experience in the last several years has shown that the time required to complete these actions has increased beyond the time frames originally stipulated in the regulations in 1987 (permits) and 1993 (petitions for nonregulated status). As stated in the current regulation, APHIS is obligated to give its reply in the stipulated time, even if required procedures are not yet complete. Therefore, APHIS proposes to include in § 340.2(d) of the regulations a statement that APHIS will generally respond in the time frames indicated. APHIS believes it is important to continue to meet the indicated time frames whenever possible, but the most important thing is to communicate the actual status of reviews and procedures with applicants rather than be obligated to reach a decision in a certain number of days despite the complexities involved with a review. APHIS is particularly seeking comment on this proposed change from persons with experience under the current time frames.

3. Duration Period for Permits

Under the current regulations, notifications for environmental release and interstate movement are valid for one year, and the duration period for a permit issued for an environmental release is not specified. Currently interstate movement permits are only valid for one year from the date of issuance, and a new import permit must be obtained for each imported shipment.

APHIS will continue to retain the flexibility of the permitting procedure to authorize environmental release permits that can be effective for any appropriate time period. In some cases, it may be most efficient to authorize environmental release permits that are valid for more than a single year. In such cases, APHIS can retain adequate oversight by performing periodic inspections and requiring periodic reports. Experience has revealed situations where field tests lasting more than one year are essential. For example, some environmental releases of GE fruit trees may take several years to evaluate the fruit production that often does not begin for several years after planting.

In order to provide greater flexibility and efficiency, APHIS is also proposing to eliminate the current restrictions in the regulation on the duration of permits for interstate movement and importation. The proposed regulations will remove the requirements that interstate movement permits are only valid for one year from the date of issuance, and that importation permits must be obtained for each individual importation. These changes should give APHIS the flexibility to issue these permits with suitable durations to meet the individual circumstances.

G. Definitions and Miscellaneous Changes

APHIS proposes to change certain definitions in § 340.1 of the regulations, to add certain new definitions, and to remove definitions for terms that are defined in the PPA or that no longer appear in the regulations.

Revised Definitions

APHIS proposes to change the definitions of the following terms in § 340.1:

Release into the environment

would read “Dispersal beyond the constraints of a contained facility or secure shipment. Synonymous with the term environmental release.”

Secure shipment

is a new term defined below. By adding reference to secure shipment in this definition, we clarify the distinction between environmental release and shipments for importation and interstate movement; any such movements which are not done by secure shipment constitute an environmental release.

Responsible person

would read “The person who has control and will maintain control over a GE organism during its importation, interstate movement, or release into the environment and assures compliance with all conditions contained in any applicable permit or exemption as well as other requirements in this part. A responsible person shall be at least 18 years of age and be a legal resident of the United States or designate an agent who is at least 18 years of age and a legal resident of the United States.” The change from the former definition is the addition of “at least 18 years of age,” added to prevent possible enforcement difficulties.

New Definitions

APHIS proposes to add definitions of the following new terms:

Confidential business information, CBI

would read “Information such as trade secrets or commercial or financial information that may be exempt from disclosure under Exemption 4 of the Freedom of Information Act (FOIA),

because disclosure could reasonably be expected to cause substantial competitive harm. USDA regulations on how the agency will handle CBI and how to determine what information may be exempt from disclosure under FOIA (5 U.S.C. 552) are found at 7 CFR § 1.12.” We propose to add this definition because APHIS has often been asked to clarify what is and is not CBI, and how it is handled. The definition describes typical types of CBI, and the language in proposed § 340.8 describes how persons submitting documents to APHIS can request that identified information be treated as CBI. There is also additional guidance on CBI contained in administrative guidance on the APHIS Web site regarding document preparation for part 340 requests. However, it is important to realize that in actual situations where someone submits a FOIA request for particular information, the APHIS FOIA Officer makes the ultimate determination as to whether particular information shall be released, in accordance with the standards of FOIA, Executive Order 12600, and 7 CFR 1.12.

Contingency plan

would read “A written plan stating how the responsible person will respond in the event of the unauthorized environmental release of GE organisms.” We propose to define this new term to describe a document mentioned in both the permit application information requirements section (§ 340.2(c)) and the permit conditions section (§ 340.3).

Exempt, exempted, exemption

would read “A determination by the Administrator that the importation, interstate movement, and/or release into the environment of an organism or class of organisms described in § 340.0(a) is not subject to the requirement to have a permit under this part. An exemption from one type of permit (e.g., interstate movement) does not remove remaining obligations to obtain other permits under this part.” We propose to add this definition for the term

exemption

to refer to situations where a regulated movement is exempt from the requirement for a permit. The proposed definition is based on language in Sec. 411(b)(1) of the PPA (7 U.S.C. 7711(c)), titled “Exception to permit requirement,” which authorizes the Secretary to issue regulations to allow the movement of specified plant pests without further restriction if the Secretary finds that a permit is not necessary.

Noxious weed

would read “Any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment.” This is the definition for noxious weed found in the PPA.

Recipient organism

would read “The organism that will receive the genetic material from a donor organism in the process of genetic engineering (once the organism is engineered it is referred to as the genetically engineered (GE) organism).” This definition is needed to properly distinguish organisms and their traits in comparisons of GE organisms to the same organisms prior to transformation.

State or tribal regulatory official

would read “State or tribal official with responsibilities for plant health, or any other duly designated State or tribal official, in the State or on the tribal lands where the importation, interstate movement, or release into the environment is to take place.” This term is used in reference to consultations with States and tribes under the regulations.

Secure shipment

would read “Shipment in a container or a means of conveyance of sufficient strength and integrity to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.”

We propose to add the following two definitions to make it clear that, when the Administrator authorizes it, a signature required under the regulations may be an electronic signature and a written document required under the regulations (e.g., a permit application) may be an electronic document.

Signature, signed

would read “The discrete, verifiable symbol of an individual which, when affixed to a writing with the knowledge and consent of the individual, indicates a present intention to authenticate the writing. This includes electronic signatures when authorized by the Administrator.”

Write, writing, written

would read “Any document or communication required by this part to be in writing may also be provided by electronic communication when authorized by the Administrator.”

Deletion of Definitions

We propose to remove the following definitions from the regulations:

courtesy permit, expression vector, introduce or introduction, regulated article, stably integrated, vector or vector agent,

and

well-characterized and contains only non-coding regulatory regions.

These definitions would be removed because the terms would no longer be used in the regulations. We propose to eliminate the term

regulated article

partly because the use of the term “article” in current part 340 is not consistent with usage in the PPA, which uses the term article to mean “any material or tangible object that could harbor plant pests or noxious weeds”—that is, things like packing materials, shipping containers, commodities, etc.—and not a plant pest or noxious weed itself. Under the current regulation, however,

regulated article

refers exclusively to certain GE organisms. Furthermore, under both the PPA and part 340, “articles” are not regulated, but rather their importation, interstate movement or environmental release is regulated. For these reasons, the term “regulated article” in the current regulations is both inconsistent with the terminology of the PPA and difficult for the public to comprehend.

We also propose to remove the definition for introduction. APHIS currently uses the term in part 340 to denote certain kinds of activities that fall within the scope of the regulation, namely importation, interstate movement, and release into the environment. The PPA, however, does not specifically define the term introduction. Therefore, to avoid confusion, instead of using the term introduction to define the different types of regulated activities, APHIS will instead refer to these specific activities themselves in the regulations, namely, the importation, interstate movement and release into the environment.

Miscellaneous Changes

We also propose to make minor miscellaneous changes to the regulations to improve their clarity and remove redundancies. For example, in addition to adding the definition for CBI discussed above, we are consolidating requirements concerning CBI, formerly contained in several sections of the regulations, into proposed § 340.8.

IV. Required Analyses

A. National Environmental Policy Act

On January 23, 2004 (69 FR 3271), APHIS published a notice of intent to prepare a draft environmental impact statement (DEIS) in accordance with the National Environmental Policy Act in connection with the regulations at 7 CFR part 340 and potential changes to those regulations. This notice identified potential issues and alternatives to be studied and requested public comment to shape the scope of the DEIS.

On July 17, 2007, APHIS published the DEIS evaluating regulatory alternatives under consideration and solicited public comment on the DEIS

(72 FR 39021-39025). The Environmental Protection Agency published a separate notice on July 13, 2007, soliciting public comment on the DEIS (72 FR 38576-38577). The notices sought comments on the quality of our analysis of potential environmental effects of the alternatives under consideration, and also sought views on how each alternative would affect areas such as the overall effectiveness of our biotechnology program, its operational efficiency, industry compliance issues, or other issues that would be associated with the implementation of an alternative.

The major elements of this proposed rule were accurately described in the alternatives contained in the DEIS and their potential environmental effects were analyzed in the DEIS. Table 4 below provides a comparison between the proposed changes to part 340 and the DEIS. We received numerous comments on the DEIS, which will be discussed fully when we publish a final environmental impact statement (FEIS). The DEIS and the comments on it were used by APHIS to inform decision makers and aid the design of this proposal. Information from the DEIS comments, along with information from many other sources, including certain provisions of the 2008 Farm Bill and recommendations from USDA's OIG, was used to inform the drafters of this proposed rule about the issues perceived to be involved in and addressed by the rulemaking. We will respond to all DEIS comments in detail in the FEIS since the agency action (revising the regulations in part 340) is still subject to change based on comments and information received on this proposed rule, and thus we cannot provide definitive and final comment responses until we issue the FEIS and the final rule.

Consideration of the DEIS comments led APHIS to refine and reorganize some of the regulatory alternatives it considered. Therefore, the presentation and discussion of the alternatives proposed in this proposal do not exactly match those described in the DEIS. The differences are primarily a matter of reorganizing and realigning some material and their corresponding regulatory alternatives, using more descriptive terms in some criteria listed in the alternatives, and choosing between regulatory alternatives that fall within the analysis of the DEIS. Accordingly, the DEIS is still consistent and applicable as an analysis of the potential environmental effects of the proposed action. However, we are interested in receiving comments on whether any of the proposed regulatory alternatives in this document do not appear to have been adequately addressed within the DEIS.

Table 4—Summary of Proposed Changes to the Regulations and Relationship to DEIS

Summary of proposed substantive changes to the regulation

DEIS issue

DEIS alternative

Redescription of which GE organisms are subject to the regulations.

1

2 (DEIS preferred alternative) or 3.

Deletion of the list of plant pest taxa in the regulations and the petition procedure to amend the list.

Clarification that APHIS has the authority to regulate nonliving materials through permit conditions in cases where such materials may pose a risk as a noxious weed.

5

2 (DEIS preferred alternative).

Revision of the application information requirements and permit conditions for all permit types.

Elimination of the current notification procedure for importation, interstate movement, and release into the environment of certain types of GE plants (permitting procedure will be used instead).

2

4 (DEIS preferred alternative).

Revision of the permitting system for environmental releases:

2

4 (DEIS preferred alternative).

• Subdivision into 5 categories of permits for environmental releases (4 for GE plants, 1 for other GE organisms).

4

2 (DEIS preferred alternative).

• Continue strict permit conditions for environmental releases of GE plants engineered to produce compounds intended for pharmaceutical or industrial uses.

6

1 (No action alternative).

Continued use of permits with appropriate conditions for single or multiple year releases.

Creation of new administrative procedures in permitting: (1) The explicit agreement of the responsible person to comply with regulatory requirements of the permit, (2) amendment of existing permit conditions, (3) transfer of permits to a different responsible person, and (4) revocation of a permit.

Elimination of the prescribed shipping container provisions in favor of a performance based approach specified as permit conditions for importation and interstate movement.

10

2 (DEIS preferred alternative).

Revision of the existing conditional exemptions for interstate movement such that the shipping standard is part of the exemption. Addition of a recordkeeping requirement for persons using the existing conditional exemptions.

Elimination of the option for APHIS to issue courtesy permits for importation, interstate movement, and environmental release of GE organisms which are not subject to the regulation.

Creation of a petition procedure for the Administrator to approve additional conditional exemptions from the requirement for a permit. This also includes a description of administrative steps if Administrator revokes an exemption, amends the conditions of an exemption, or prohibits a person from using a conditional exemption.

3

8

2 (DEIS preferred alternative).

1 (DEIS No Action alternative).

Clarification and revision of the existing petition procedure for determining nonregulated status, including elimination of the procedure to extend a previous determination of nonregulated status, and a description of the administrative steps if Administrator revokes nonregulated status.

Clarification of the actions the Administrator may take related to compliance, enforcement, and remediation.

Clarification of APHIS approach to the low level presence of regulated GE plants in seed or grain.

7

3 (DEIS preferred alternative).

Definition of Confidential Business Information (CBI) and description of administrative practices for CBI.

We received approximately 23,000 comments on the DEIS, of which more than 22,000 were variations of several form letters. There were also several lengthy and detailed evaluations of environmental, scientific, legal, cultural, and economic issues raised by the DEIS. APHIS took all comments related to regulatory changes under consideration as we developed the content of this proposed rule, and altered a number of preliminary ideas for the proposal based on comments. We will fully summarize and address the comments received on the DEIS in a Final Environmental Impact Statement to be prepared in conjunction with the publication of a final rule. In addition to specific DEIS issues that were discussed above in the Preamble, the following section summarizes and discusses those comments on the DEIS that were most directly related to the regulatory alternatives discussed in this proposed rule and the ways in which these comments affected development of the proposal.

Many DEIS commenters addressed how the regulations should use the PPA authorities regarding noxious weeds, plant pests, and biological control organisms. Most comments on the DEIS that addressed this issue stated that APHIS should expand the scope of its regulatory program beyond plant pests to include both noxious weeds and certain biological control organisms, consistent with all of the regulatory authorities of the PPA. The following opinions were expressed regarding PPA authority regarding noxious weeds and the meaning of the PPA definition of noxious weed.

Very few commenters suggested that APHIS biotechnology regulations should implement the PPA's noxious weed definition in its broadest possible sense. One commenter suggested that APHIS broadly interpret the phrase “other interests of agriculture,” in the PPA definition of noxious weed such that APHIS would consider a plant to be a noxious weed if it poses solely economic harm, i.e., in the absence of physical harm. As explained previously in this proposal, such an interpretation is not consistent with the PPA, nor with the manner in which APHIS-PPQ has implemented the noxious weed program pursuant to the PPA. Many commenters suggested that APHIS needed clear regulations or policies to describe how it will be evaluating whether GE plants pose threats as noxious weeds. APHIS agrees and has framed this proposal to clarify the issue for the public.

Some commenters stated that APHIS should acknowledge limits to its consideration of potential damage to public health in APHIS regulations, and the noxious weed definition should not be interpreted so broadly as to provide APHIS with the legal responsibility or authority to determine the food safety of GE crops or to prevent GE crops from entering the food supply. The commenters stated that Congress clearly intended the FDA to be responsible in this area.

We agree, and this proposal acknowledges FDA authority in the food safety area. However, it is important that the regulatory procedures in each agency dovetail and support each other where agency mission areas come in contact. This proposal recognizes this need for mutual agency support. When a permit for environmental release, importation, or interstate movement of a new GE organism is submitted to APHIS, we would evaluate whether there are any signs that the environmental release, importation, or interstate movement of the organism could present risks to the public health. If APHIS is concerned that there may be food safety risks associated with the GE organism, we would contact FDA. The decision on whether or how to regulate food and feed from the GE organism to address food and feed safety risks would then be FDA's. On the other hand, it is also likely that existing food safety evaluations will prove to be useful and relevant to APHIS evaluations of a GE organism. Food safety concerns are one of several factors APHIS would take into account when considering, for example, what types of permit conditions are needed for the environmental release of a GE organism, or whether activities associated with the organism should qualify for an exemption from the permit requirement.

Several commenters stated that under the current regulations APHIS has always considered noxious weed risk, or at least “weediness.” We agree that in practice, when APHIS assesses a GE plant it has always evaluated the potential weediness of the GE plant in relation to its plant pest potential. In the context of the PPA, “weediness” is more properly a noxious weed risk characteristic than a plant pest one, and the proposed revision of the regulations will more clearly align the regulations with the plant pest and noxious weed risk pursuant to the PPA. Current APHIS regulations and guidance directly address the importance of including weediness when evaluating risks associated with GE organisms. For example, when the petition procedure to grant nonregulated status was added to part 340 in 1993, the traits APHIS listed for evaluation explicitly included “weediness of the regulated article” (see current § 340.6(c)(4)).

Several DEIS commenters addressed what characteristics should trigger regulation of a GE organism, or put another way, how to set the scope of organisms subject to regulation. In the DEIS, APHIS explored many options including continuing to make its decisions primarily based upon the transformation event (also sometimes referred to as the individual transformed line, transgenic line or GE line). Some members of the public refer to this as an event-by-event approach. It is sometimes contrasted with a “trait-based” approach that focuses more on the resulting trait or phenotype of the GE organism. In a trait-based approach, a regulatory decision for an organism engineered for one phenotype would apply equally to other GE organisms if they had the same phenotype or trait, regardless of whether they were engineered with the same genes. APHIS invited comment on the relative merits of the event-by-event approach and the trait-based approach. The current regulations do not limit APHIS to one approach or the other. Many readers equated “event-by-event” with a “process-based” system and likewise equated “trait-based” regulation with a “product-based” system. Thus many comments focused on the relative merits of a product-based system versus a process-based system.

Some suggested that the trigger be “process-based”, i.e., the process of modifying the organism by recombinant DNA techniques would be the determinant. Others suggested the trigger be “product-based”, i.e., the nature of the resulting product (organism) would be the determinant for whether the organism would be subject to the regulation. Many of the comments were not actually related to the basis for the trigger, but rather to the focus of the risk assessment, with most stating that the risk assessments should be based on the biology of the organism (product-based), not the technique by which it was made (process-based). One commenter believes that the process of genetic engineering is a useful trigger, but once regulated, the characteristics of the GE organism should dominate APHIS considerations of safety.

Those supporting a process-based approach for identifying which organisms should be subject to regulation stated that each GE organism can have unintended as well as intended changes, and that these unintended changes to the organism would require that each individual resulting from genetic engineering must be assessed on a case-by-case basis.

Some commenters also suggested that this approach of APHIS assessment of each individual GE organism better protects the environment and human health than an approach that focuses primarily on the trait(s) of the GE organism.

Some commenters against process-based approach stated that this approach is illogical, on the one hand, to regulate a plant species with no known risks only because GE techniques were used to modify it, whereas on the other hand the same plant species modified by other techniques faces no additional regulatory requirements from APHIS.

Those supporting a product-based regulatory approach stated that it would be aligned with the preponderance of scientific opinion on the issue, that the characteristics of the organism should take precedence over the technique of genetic modification in the APHIS assessment of the organism. APHIS agrees that any evaluation of risk should be based on the biology of the product.

Several commenters suggested that the definition of

regulated article

would have to be reexamined and possibly redefined to reflect changes in the PPA. Commenters also stated that the term

regulated article

was problematic whether linked to specific taxa in § 340.2, under the current regulations, or linked to plants produced by particular technologies. These commenters emphasized that actions under the regulations usually amount to an investigation of whether an article (GE organism) needs to be regulated, and that predefining the subject of the investigation as a regulated article strongly implies that a decision has been made to require some regulatory oversight.

The proposed elimination of the term “regulated article” would facilitate a clearer understanding that it is not the GE organism that is regulated, but rather the importation, interstate movement, or release into the environment of the GE organism.

APHIS determined that eliminating “introduction” as a defined term would facilitate clearer understanding that the activities subject to the regulations are in fact importation, interstate movement, and release into the environment.

In the DEIS, APHIS discussed the need to regulate nonliving products of GE organisms. The preferred alternative was to have a procedure to regulate non-viable material only in certain rare circumstances when it might pose a risk. Most of the DEIS comments addressing this issue agreed that APHIS should regulate nonviable GE plant material only in certain circumstances, based on the risks posed. The few comments that provided greater detail identified toxicity risks and possible persistence in the environment of toxic nonviable plant parts or debris as the most significant risk associated with nonliving GE products. A few commenters also stated that adding a clear definition of “nonliving” or “nonviable” would aid the regulations.

APHIS has responded to these comments in this proposal by not usually regulating nonliving GE products, and by providing that when any control is needed over such a product that is associated with a living GE organism which is covered by a permit, due to toxicity or other risks, such controls would be included as permit conditions in permits issued for the associated living GE organism. We propose to provide for this by adding the following sentence to paragraph (b) of § 340.3,

Permit conditions:

“The Administrator may also assign permit conditions addressing nonliving materials associated with or derived from GE plants when such conditions are needed to make it unlikely that the nonliving materials would pose a noxious weed risk.”

We received one DEIS comment directly addressing the issuance of courtesy permits. This comment supported retaining use of courtesy permits, and stated that courtesy permits facilitate the importation of GE

Drosophila melanogaster

strains by the research community and also ease the workload for APHIS. The continued issuance of courtesy permits diverts Agency resources unnecessarily from organisms that are within the scope of the regulations. We intend to help develop informational materials for the research community and other agencies that are aware of courtesy permits to clarify that such permits are not required, and to explain this to any persons who contact us requesting courtesy permits in the future.

Several DEIS comments addressed the notification procedure and supported eliminating it. Some comments suggested that the types of organisms formerly eligible for the notification process should instead be handled through a two-tiered permitting process, with experimental permits for field trials an

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