60008 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules 

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=APHIS2008-0023 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 


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1The 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. 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. 

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: 


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‘‘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, epermitting 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. 


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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 sciencebased 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, 


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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 


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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. 


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TABLE 1—EXAMPLES OF IMPACTS CAUSED BY FEDERALLY LISTED NOXIOUS WEEDS—Continued 

Impact Description of impact Example species 

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 nonvertebrate 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 


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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 macroorganism 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 


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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 


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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 


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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: 

Æ 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 

Æ No morphological changes which 

could cause mechanical injury or 

damage; and 

Æ 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: 

Æ 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 

Æ Novel resistance to the application 

of an herbicide; or 

Æ Has novel ability to cause 

mechanical injury or damage; or 

Æ 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: 

Æ 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 

Æ Produces an infectious entity which 

can cause disease in plants. 

Examples include mercury hyperaccumulators or production of some 

pharmaceutical compounds. 

• Severe: 

Any new proteins or substances 

produced are known or likely to be 


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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: 

Æ Bt corn producing CRY1ab toxin. 

The plant is unlikely to persist in the 


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environment and the safety of the 

protein has been assessed by the EPA. 

Æ 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: 

Æ 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. 

Æ 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. 

Æ 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. 

Æ Pines producing an enzyme to 

enhance paper production. Pines are 

persistent and have interfertile wild 

relatives in the United States. 

• Category C: 

Æ Poplar engineered to produce 

enzymes for heavy metal 

bioremediation. 

• Category D: 

Æ 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 


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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 


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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. 


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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 nongenetically 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 


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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. 


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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). 

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. 

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 


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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), 


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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 


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(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. 


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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 ‘‘traitbased’’ 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 (productbased), 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. 


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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 processbased 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 nonviable 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 and commercial permits for GE 

crops that are to be sold in commerce. 

Other comments suggested that while 

some organisms might require permits 

with minimal conditions rather than 

notifications, others with even lower 

risks could be exempted from permit 

requirements. These latter comments 

also generally suggested that some of the 

criteria in the current regulations used 

to determine eligibility for the 

notification process could be preserved 

in the new regulations as criteria to 

identify organisms that should be 

exempted from the requirement for a 

permit. One commenter stated that since 

the current ‘‘notification’’ process 

involves acknowledgment by APHIS 

and conditions as well as notification, 

changing to a system of low risk permits 

would be a de facto acknowledgment of 

the current process. To address these 

issues, APHIS is proposing to eliminate 

notifications and to handle regulated GE 

organisms that previously would have 

been eligible for notifications through a 

permitting procedure. 

We received a few comments on the 

DEIS generally related to procedures for 

reviewing permit applications. 

Comments stated that the role of States 

in reviewing or approving permit 

applications for GE crops has been very 

important and useful under the current 

regulations, and should continue in 

future regulations. Comments also 

stated the importance of scientific 

integrity in the review process, and 

emphasized the importance of 

coordinating with other agencies 

(particularly FDA and EPA review) 

when issues within their mission area 

arise during APHIS review of 

applications. 

The proposed changes to the permit 

application procedure address these 

concerns. States would have a 

continuing role in application review 

that is very similar to their existing role, 

and we have been increasing 

interactions with the relevant tribal 

authorities in recent years. 

Several comments were peripherally 

related to the DEIS issue of whether 

APHIS should establish standard or 

general permit conditions or what they 

should require. These comments 

emphasized that the purpose of permit 

conditions is to control risks not 

otherwise controlled, and that permit 

conditions must be developed in 

response to careful consideration of the 

risks presented by the particular 

permitted activity. One comment stated 

that APHIS should not require permit 

conditions that have the primary 

purpose of preventing crops from 

entering the food supply, because 

APHIS does not have the legal authority 

or scientific expertise to set them. 

We have taken these views into 

account in designing this proposed rule. 

Proposed § 340.3 describes the core list 

of general conditions that APHIS would 

impose on all permits as well as 

additional conditions for specific types 

of permits. APHIS is also making it clear 

that APHIS may also add other specific 


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conditions to a permit upon its 

issuance. Conditions are specific 

practices or requirements that an 

applicant must follow upon issuance of 

a permit. Conditions are added as a 

consequence of the APHIS evaluation 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. 

Several DEIS comments stressed that 

APHIS needs to do more to ensure that 

the permit conditions it sets are actually 

followed and enforced. The changes to 

permit procedures proposed for § 340.2 

contribute to that goal by obtaining 

written agreement from the responsible 

person that he or she, and all of their 

agents, must comply with all of the 

permit conditions before issuance of the 

permit. 

Almost all DEIS comments on 

containers or marking and identity for 

regulated articles supported 

performance standards for containers. 

Most of these commenters made the 

point that performance criteria are 

generally more adaptable and efficient 

than prescriptive criteria. Some stated 

that shipping research organisms 

interstate in enclosed containers is a 

low-risk activity that is very unlikely to 

result in release, establishment or harm. 

Some commenters stated that the type 

of container indicated by performance 

standards must be appropriate to the 

level of risk in the tiered permit system 

for the shipped GE organism. One 

commenter requested that APHIS make 

its container standards consistent with 

the International Air Transporters 

Association (IATA) requirements for 

shipping. 

The way this proposed rule deals with 

container standards is consistent with 

the above DEIS comments. 

Most of the commenters addressing 

tiered or categorized permit systems 

supported APHIS establishing a tiered 

permitting system for plants based on 

criteria that included risk and other GE 

organism characteristics. However, 

commenters also stressed that risk 

categories should be based on a trait by 

species approach, not on the basis of 

individual transformed plant line 

(referred to as ‘‘event-by-event’’ in some 

of the comments). Some commenters 

advised against using limited broad 

based categories that include many 

different species with different biologies 

and different risk factors. Several stated 

the importance of evaluating permit 

applications on a case-by-case basis, to 

avoid the risk that categorizing permit 

types could result in approval of risky 

releases that were inadvertently seen as 

‘‘routine categories.’’ 

Several commenters stated that a 

tiered permitting system should be 

flexible and allow consideration of any 

factors that seem relevant, or allow 

reclassification of a GE plant from one 

tier to another based on additional 

characterization information and agency 

familiarity with the GE plant. Some 

commenters opposed the development 

of a tiered risk-based permitting system 

because each transformation event can 

have unintended effects that must be 

assessed on a case-by-case basis, rather 

than through predefined categories. We 

have addressed these views in this 

proposed rule by changing the permit 

tier system described in the DEIS to a 

proposed permit application 

categorization system that is more 

flexible than the system described in the 

DEIS. 

In the DEIS, 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 

permitting procedure with its 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 appropriate permit 

conditions that take into account the 

issues related to the public safety of 

proteins or other substances that these 

plants have been engineered to produce. 

Numerous commenters supported 

banning the outdoor production of 

pharmaceuticals and industrial 

substances in food and feed crops. Some 

stated that food crops should not be 

used for the production of 

pharmaceuticals and industrial 

substances. 

Some commenters stated that GE 

plants used for the production of 

pharmaceuticals and industrial 

substances should be evaluated by 

criteria that are different from those 

used to evaluate crops intended for 

food. Other commenters stated that if 

such GE industrial plants were made 

from food crop species, or could spread 

genes to food crop species, they should 

be evaluated based on food safety risk, 

not the industrial product’s function, 

and approved only if they pose no food 

safety risks. However, with regard to 

evaluating food safety, several 

commenters also stated that FDA should 

be the agency evaluating these risks. 

We have not seen evidence suggesting 

that these types of organisms present 

unique or uncontrollable risks, or risks 

higher than those that may be associated 

with many other uses for GE plants. Our 

approach in this proposed rule 

addresses the other concerns cited by 

DEIS commenters. 

Many commenters were concerned 

that the outdoor cultivation of GE plants 

producing pharmaceutical and 

industrial compounds could be a source 

of gene flow to nearby non-GE plants or 

result in the co-mingling of grain with 

related crop species intended for food or 

feed. Risks associated with this scenario 

may be abated by either of two means: 

(1) Preventing such gene flow or comingling from occurring, or (2) 

establishing that if such gene flow or comingling to other plants does occur, it 

does not present an unacceptable risk of 

introducing or disseminating a noxious 

weed. 

Such gene flow can be minimized or 

substantially prevented through permit 

conditions developed for environmental 

releases of GE pharmaceutical or 

industrial plants. In many cases the 

genetic and phenotypic characteristics 

of the organism also serves to 

discourage survivability of the plant 

away from the intended site as well as 

gene flow to other plants. During the 

review prior to permit issuance, APHIS 

would also always consider the effects 

if the GE plant were likely to spread 

widely, or if large-scale gene flow to 

other plants occurred. A permit for an 

environmental release would not be 

approved if APHIS concluded there was 

a likelihood of such events causing any 

of the types of harm as described in the 

noxious weed definition. 

One DEIS comment on the issue of 

multiple-year permits stated that 

compliance agreements should be used 

instead of actual multiple-year permits. 

Another suggested that multiple-year 

permits should be limited to trait/crop 

combinations not intended for feed or 

food use. In contrast, another comment 

stated that APHIS should consider 

allowing multi-year permits for any 

product, not just GE pharmaceutical or 

industrial plants. 

Several commenters stated a riskbased opposition to multi-year permits 

and stated that crops engineered to 

produce pharmaceuticals or industrial 

compounds should always be regulated 

under an annually-reviewed permit 

system. 

This proposed rule addresses the riskbased concerns cited by commenters in 

the proposed processes for issuing 

permits and granting exemptions, 

discussed elsewhere in this document. 

We propose to allow multi-year permits 

for any type of regulated activity, when 

we determine that appropriate riskrelated conditions can be prescribed for 

those activities. We have not seen any 


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convincing evidence, in DEIS comments 

or elsewhere, that limiting use of multiyear permits to certain types of 

organisms would reduce risk or 

otherwise serve the purpose of the 

regulations. 

Of the approximately 67 comments 

received by APHIS on the interstate 

movement exemptions discussion in the 

DEIS, 30 comments appear to support 

APHIS’ preferred Alternative 2, under 

which APHIS would exempt from 

permit requirements for interstate 

movement a class of GE plants or 

organisms that are well-studied and 

present little or no environmental risk, 

as is currently done for Arabidopsis. 

However, many of these commenters 

suggested that APHIS choose an 

approach that combined this with one 

or more of the other Alternatives. 

Several commenters stated that the 

regulations should provide a procedure 

for APHIS to consider additional 

exemptions from interstate movement 

restrictions on a case-by-case basis. 

APHIS has concluded that the most 

appropriate proposal for the regulations 

at this time is to provide a clear and 

adaptable procedure whereby it would 

use a case-by-case approach to consider 

the merits of new exemptions from the 

requirement for a permit. The 

procedure, described in proposed 

§ 340.5, would allow for a transparent 

procedure in which APHIS would 

evaluate the proposed exemption, and 

the public would have an opportunity to 

review APHIS’ evaluation and provide 

comments prior to APHIS decisions on 

individual cases. The proposed 

procedure should provide the benefit of 

transparency and scientific rigor while 

affording a more streamlined and costefficient procedure that would not 

require formal amendment of the 

regulations when each new exemption 

is approved. 

Several DEIS comments addressed 

what criteria in the regulations the 

Agency could use to determine the level 

of risk assessment applied to imported 

GE commodities which are viable 

propagules. They fell into two general 

groups. Both groups stated that any 

expedited review or exemption for GE 

commodity imports needed to be 

granted based on a review of risk and a 

determination that the importation 

presented no significant risks. Beyond 

that, one group emphasized that 

commodity imports were in general 

inherently safe, and such an expedited 

system would be appropriate and would 

also greatly facilitate international trade. 

The other group was skeptical about 

inherent safety of GE commodities and 

suggested that exemptions should only 

be offered when there are procedures 

ensuring that the commodities are made 

non-viable or safeguards are in place to 

ensure that propagation will not occur. 

Some comments in this group also 

stated that such exemptions should not 

be granted for a GE commodity from any 

country until APHIS has confidence that 

the country has robust regulatory 

guidelines and assessment standards 

with strong, reliable science and 

trustworthy regulatory oversight, 

equivalent in effectiveness to the U.S. 

system. 

One comment included a general 

statement that it was important that a 

petitioner for deregulation or exemption 

should work closely with APHIS to 

develop and evaluate the management 

plan under which the subject GE 

organism would be grown if deregulated 

or exempted. APHIS agrees that its 

regulatory approach should include 

working closely with petitioners on 

their proposals for exemption, 

especially if management plans are part 

of the requisite conditions. APHIS 

would retain some degree of oversight 

and could restrict movements of a GE 

organism such that the exemption and 

its conditions are unlikely to result in 

the introduction or dissemination of a 

plant pest or noxious weed. The 

proposed procedure to approve 

additional conditional exemptions is 

sufficiently adaptable even when the 

exemption is for all forms of movement 

(i.e., importation, interstate movement, 

and environmental release). 

Very few DEIS comments directly 

addressed enforcement and compliance. 

A few comments stated that APHIS 

regulatory oversight and enforcement of 

its regulations in the past have been 

insufficient and have provided 

inadequate containment of GE crops. 

This proposed rule would strengthen 

enforcement and compliance and 

enhance the effectiveness of the 

regulations. 

Comments on the discussion in the 

DEIS of low level presence ranged from 

suggestions that APHIS should 

completely prevent such incidents by 

banning all outdoor growth of GE plants 

to suggestions that LLP is a minor 

problem needing only minimal controls, 

and does not warrant an increased 

regulatory burden to control a minor 

risk. Some commenters stated that the 

preferred alternative in the DEIS 

accepted too high a level of risk. These 

commenters generally preferred DEIS 

alternative 4, which would impose very 

strict permit conditions on all 

environmental releases to reduce the 

likelihood of LLP events. Most 

commenters agreed that APHIS should 

adopt an LLP policy that recognizes the 

wide variety of risk levels associated 

with such incidents, and that beyond 

applying general criteria APHIS should 

investigate each unauthorized release 

individually and determine actions 

based on the facts surrounding each 

incident. Some commenters stated that 

any LLP policy should clearly state that 

even if an incident was found to be nonactionable (i.e., not requiring remedial 

action), persons involved would still be 

subject to enforcement actions such as 

civil penalties if violations of the 

regulations occurred. 

APHIS has considered all these views 

in the development of this proposed 

rule and has attempted to find a 

reasonable balance. It is not warranted, 

or practical, to implement a ‘‘zero 

tolerance’’ LLP policy. Instead, we 

propose a policy that each LLP incident 

would be individually investigated, and 

APHIS would then make a decision on 

whether, or what kind of, remedial 

action is needed. In making this 

determination APHIS would use 

established criteria to rate the risks 

involved in the LLP incident. However, 

these criteria would not fully determine 

the APHIS response. In addition to 

considering the criteria, APHIS would 

evaluate any other relevant information 

regarding the LLP incident and order 

remedial action if it appears necessary. 

Also, we propose to clearly state that 

regardless of whether APHIS considers 

the LLP actionable with regard to 

remediation, any violations of the 

regulations or permit conditions can 

still result in compliance and 

enforcement actions for failure to 

comply with the regulations. 

One DEIS comment directly 

addressed timelines for APHIS to 

perform permit- and petition-related 

activities and urged APHIS to continue 

to define specific timelines for 

regulatory reviews to allow for a 

predictable regulatory review system. 

The comment stated that time frames 

are especially critical for field trial 

permitting activities since planting 

occurs during a narrow window each 

year and a delay of a month or two in 

a regulatory decision can result in a year 

delay due to the inability to timely plant 

a field trial. 

We understand the concerns, and 

have decided to keep the time frames in 

the text of the regulations. However, as 

discussed above, APHIS will view them 

as performance goals and will generally 

respond in the time frames indicated, 

rather than be obligated to respond at 

those times. In recent years, there has 

been an increase in the time required for 

APHIS review due to the increasing 

complexity of issues related to 

environmental effects, new traits, and 

unfamiliar species. In addition to 


pwalker on PROD1PC71 with PROPOSALS4
Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules 60033 

3 Global Status of Commercialized Biotech/GM 

Crops, ISAAA Briefs 37–2007, 35–2006, The 

International Service for the Acquisition of AgriBiotech Applications, Cornell University. 

4Cited in Fawcett, Richard and Towery, Dan. 

Conservation Tillage and Plant Biotechnology: How 

New Technologies Can Improve the Environment 

By Reducing the Need to Plow. Conservation 

Technology Information Center, West Lafayette, 

Indiana. 

retaining general time frames in the 

regulations, APHIS intends to discuss 

time frames with each applicant early in 

the application process, and to the 

extent possible give the applicant 

reliable time estimates based on the 

nature and complexity of the particular 

application and current APHIS activities 

and resources that are expected to affect 

the application review. 

B. Executive Order 12866 and 

Regulatory Flexibility Act 

This proposed rule has been reviewed 

under Executive Order 12866. The rule 

has been determined to be significant 

for the purposes of Executive Order 

12866 and, therefore, has been reviewed 

by the Office of Management and 

Budget. 

We have prepared an economic 

analysis for this proposed rule, which is 

summarized below. Copies of the full 

economic analysis are available by 

contacting the person listed under FOR

FURTHER INFORMATION CONTACT or on the 

Regulations.gov Web site (see 

ADDRESSES above for instructions for 

accessing Regulations.gov). The analysis 

provides a cost-benefit analysis, as 

required by Executive Order 12866, and 

an analysis of the potential economic 

effects of this final rule on small 

entities, as required by the Regulatory 

Flexibility Act. 

Background 

The adoption of genetically 

engineered (GE) crops by farmers 

worldwide has become increasingly 

widespread. The United States, 

Argentina, Brazil, Canada, and China 

are the major GE crop adopters. In 2008, 

92 percent of soybean, 80 percent of 

corn, and 86 percent of cotton acreages 

planted in the United States were 

genetically engineered (USDA NASS, 

2008). In addition to the major field 

crops, GE varieties of papaya, yellow 

squash, and zucchini were available for 

commercial production in 2008. 

Worldwide plantings of transgenic 

crops grew by 12 percent in 2007, 

reaching 282.4 million acres in 23 

countries growing biotech crops in 

2007, including 12 developing 

countries. Over the next decade, use of 

these ‘‘first-generation’’ GE crops, which 

carry traits such as insect resistance and 

herbicide tolerance, should continue to 

grow while a second generation of crops 

promises new applications and traits 

such as improved drought tolerance, 

biofuel-related enhancements, and 

quality and nutritional traits.3

The benefits associated with the use 

of some GE crops already in production 

include higher yields, lower pesticide 

costs, and overall savings in 

management time. There are also 

environmental benefits from reduced 

pesticide use. Attempts have been made 

to quantify the benefits that have 

occurred as a result of the adoption of 

GE crops and, according to a recent 

survey, farm-level net economic benefits 

worldwide from the adoption of GE 

crops were estimated to be $7 billion in 

2006 (Brookes and Barfoot 2008). Total 

net benefits, 1996–2006, were estimated 

to be $34 billion. Of this total estimated 

net welfare gains, the United States 

experienced the largest benefit, with 

$15.8 billion; followed by Argentina, 

$6.6 billion; China, $5.8 billion; and 

Brazil, $1.9 billion (Brookes and Barfoot 

2008). U.S. farmers’ welfare gains from 

the adoption of biotechnology ranged 

from 29 to 42 percent of total net 

welfare gains (Price et al. 2005; FalckZepeda, Traxler, and Nelson 2000). 

The high rate of GE crop adoption by 

farmers has been driven by an increase 

in consumption of product developed 

with the use of GE techniques. However, 

studies that quantify consumers’ 

benefits from the use of biotechnology 

are limited, as most studies tend to 

focus on the direct adopters of 

biotechnology, i.e., the producers. Price 

et al. (2006) found consumers do benefit 

from the adoption of Bt cotton. 

Overall, consumers’ gains from the 

adoption of various GE crops have been 

estimated to range from 4 to 17 percent 

of total net welfare gains (Price et al. 

2005; Falck-Zepeda, Traxler, and Nelson 

2000). 

Crop producers and consumers are 

not the only beneficiaries of recent 

advances in biotechnology. The 

providers of biotechnology have also 

benefited from the increased adoption of 

GE products. Intellectual property right 

laws have offered incentives for the 

private sector to invest in research and 

development of GE products, and as a 

result, plant breeding expenditures have 

largely shifted from the public to the 

private sector (Fuglie 2006). As private 

research spending has increased, so has 

the number of firms engaged in this type 

of research. However, consolidation and 

mergers during the 1990’s resulted in an 

industry dominated by large companies. 

Currently, 80 percent of biotech traits 

that have been approved are owned or 

co-owned by four firms (Bayer Crop 

Science, DuPont, Monsanto, and 

Syngenta) or their subsidiaries 

(Kalaitzandonakes, Alston, and Bradford 

2007). 

With regard to the beneficial effects 

for the environment of GE plants in 

commercial production, their 

production has resulted since 1996 in 

decreases in the use of pesticides by 286 

million kg and in the use of herbicides 

by 51 million kg (Brookes and Barfoot 

2008). These declines represent 7.9 

percent reductions. In terms of 

greenhouse gases, one study estimated 

cultivation using no-tillage systems 

associated with GE crops modified for 

herbicide tolerance to reduce fuel use by 

32.52 liters/ha (89 percent) compared to 

conventional methods, and 14.7 liters/ 

ha (76 percent) compared to reduced 

tillage methods (Jasa 2002). An 

American Soybean Association survey 4

showed significant reductions in tillage, 

and therefore in fuel use, by growers of 

glyphosate-tolerant soybeans. The fuel 

reductions were estimated as 1.26 

gallons per acre, or, for the 56 million 

acres of glyphosate-tolerant soybeans 

planted in 2001, 70 million gallons of 

fuel saved and associated greenhouse 

gas emissions avoided. These fuel-use 

reductions translate into reductions of 

carbon dioxide emissions of 89.44 kg/ha 

and 40.43 kg/ha, respectively. Overall in 

2006, the total carbon dioxide savings 

associated with the use of GE crops 

were 1.2 billion kg. This is equivalent to 

removing 540,000 cars from the streets 

for a year. 

Benefits of the Proposed Rule 

The proposed rule would provide 

benefits by establishing more efficient 

regulation of GE organisms and 

activities subject to part 340 and by 

continuing to provide a high level of 

protection against risks associated with 

these organisms and activities. Benefits 

would also include improved public 

understanding of and confidence in 

APHIS’ biotechnology regulatory 

responsibilities, and improved clarity 

and transparency of the regulatory 

process. Several amendments of the 

proposed rule would improve the 

efficiency of APHIS’ biotech regulatory 

process. Particular proposed changes 

that should improve the efficiency of 

the regulations include the elimination 

of courtesy permits and the 

establishment of a procedure to evaluate 

and grant requests for new exemptions 

from the requirement that GE organisms 

have a permit to be imported, moved 

interstate, or released into the 

environment. 

Approving new exemptions could be 

done without amending the regulations, 

resulting in considerable time savings 


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for regulated parties and reducing 

APHIS’ rulemaking costs. Persons using 

an exemption would also avoid the 

costs and delays associated with 

obtaining a permit for each new planned 

movement or release of a GE organism 

covered by the exemption. 

APHIS commits considerable 

resources to issuing courtesy permits 

not actually required by or needed to 

implement the part 340 regulations. 

These courtesy permits have been 

issued to facilitate the movement of GE 

organisms that are but whose movement 

may be hindered due to their similarity 

to organisms that are subject to part 340. 

By improving public awareness that 

such organisms do not need a permit 

and eliminating the courtesy permit 

process APHIS would improve 

efficiency and reduce its regulatory 

workload, and save time for regulated 

entities who would no longer make 

unnecessary courtesy permit requests. 

The Agency currently issues 

environmental release permits, 

including permits that are used for 

production of pharmaceutical and 

industrial compounds sold in 

commerce. In general, permits for 

releases of plants producing 

pharmaceutical or industrial 

compounds have been limited to a oneyear duration. However, the proposed 

regulations provide a more useful and 

efficient approach to setting appropriate 

risk-related conditions in multi-year 

environmental release permits. Under 

the proposed system, APHIS would 

likely increase issuance of multi-year 

environmental release permits, thereby 

reducing the time the regulated entities 

need to spend submitting applications 

as well as the time APHIS spends 

reviewing the permit applications. 

APHIS’ biotechnology operations 

would be aided by more clarity in terms 

of required data submissions and 

administrative procedures. More detail 

is provided regarding what applicant 

information is required for each permit 

application type, and how application 

information relates to the proposed new 

permit categories for environmental 

release permits. These changes, along 

with more clearly defined categories for 

the environmental release permits, 

would potentially reduce the time some 

entities, large or small, spend on an 

application or petition process. 

Increased efficiency benefits may be 

most helpful to smaller companies and 

public sector entities, where GE 

research is generally conducted on a 

much smaller scale than that of large 

agri-business enterprises. 

The proposal includes provisions to 

require necessary recordkeeping and 

reporting but to fine-tune this burden 

through particularized permit 

conditions to require only what is 

needed to ensure regulatory compliance 

based on individual cases. This should 

contribute to greater efficiency. 

The proposed rule’s greater clarity 

and transparency is expected to enhance 

the general public’s perception of 

APHIS regulation in this area, with 

associated benefits from increased 

support of and compliance with the 

regulations. 

In addition to the information 

provided in the regulations, APHIS 

proposes to develop new guidance 

documents to assist in the preparation 

and submission of applications. 

Costs of the Proposed Rule 

There are several cost areas associated 

with the proposed rule. Costs associated 

with the proposed rule that regulated 

entities would incur include costs of 

learning and adapting procedures to 

changed requirements, providing more 

or different information in permit 

applications, and additional 

recordkeeping for some entities. The 

additional recordkeeping burden is 

discussed below in the Paperwork 

Reduction Act section. Annual costs 

resulting from the additional 

recordkeeping may be estimated as the 

salary and associated costs for 640 

additional hours of recordkeeping 

divided among 160 respondents. 

Many provisions of the proposed 

regulations are revisions of the current 

regulations, and it is not expected that 

familiarization costs would be 

substantial. However, estimates of these 

costs are not available and therefore 

APHIS invites public comment on the 

costs the regulated community may 

incur with respect to rule 

familiarization and changes to their 

application systems. 

Costs to APHIS are currently incurred 

in the regulatory assessment and review 

of submitted materials. Because the new 

permit process is largely similar to the 

current process, it is expected that 

ongoing permit processing costs to 

APHIS would remain essentially 

unchanged. As a start-up cost to change 

the permit system to accommodate 

requirements of the proposed rule, 

APHIS may potentially incur a one-time 

additional cost of $500,000. However 

the current system is adaptable to the 

new regulations and it is not anticipated 

that there would be any efficiency loss 

during the transitional period. APHIS 

would also potentially incur 

incremental costs conducting outreach 

activities for the proposed rule, 

developing guidance documents to 

ensure that the regulated community is 

familiar with the requirements of the 

rule, and providing staff training that 

may be necessary. Because of the new 

definition of the scope of the 

regulations, APHIS may devote more 

resources to consultations with 

regulated parties if they request 

consultation to determine whether 

particular GE organisms are or are not 

subject to the regulations. Such 

consultation should decrease after the 

first year or two of implementation, as 

such determinations of regulated status 

accumulate and become the basis for 

guidance of general applicability. 

Initial Regulatory Flexibility Analysis 

In accordance with the Regulatory 

Flexibility Act of 1980 (Pub. L. 96–354), 

this analysis considers the economic 

impact of the proposed rule on small 

businesses, small organizations, and 

small governmental jurisdictions. 

Section 603 of the Act requires that the 

initial regulatory flexibility analysis 

(IRFA) be made available for public 

comments. This section addresses the 

IRFA requirements, as stated in Sections 

603(b) and 603(c) of the Act. 

Reasons Action Is Being Considered 

APHIS is taking action to amend 7 

CFR part 340, which was promulgated 

in 1987 under the authority of the 

Federal Plant Pest Act of 1957 and the 

Plant Quarantine Act of 1912. These 

acts were subsequently subsumed 

within the Plant Protection Act (PPA) of 

2000, and the proposed revisions would 

bring part 340 in alignment with this 

Act. Advances in biotechnology and 

accumulation of oversight experience by 

APHIS have also made it necessary to 

revise and update the regulations, and 

in addition, the 2008 Farm Bill (The 

Food, Conservation, and Energy Act of 

2008) enacted most recently contains 

provisions that need to be incorporated 

into the proposed rule. The proposed 

changes would improve the regulatory 

process by providing greater 

transparency, flexibility, and efficiency. 

Objective and Legal Basis for the Rule 

The objectives of this rule are to 

amend part 340 to provide consistency 

with the PPA authorities and to 

incorporate updates and improvements 

to provide a more efficient regulatory 

process while controlling potential risk 

to plant health and the environment. 

The PPA authorizes the Secretary of 

Agriculture to implement programs and 

policies designed to prevent the 

introduction and spread of plant pests 

and diseases. Specifically, the Secretary 

of Agriculture is given the authority 

under the PPA to prevent the 

importation or dissemination of plant 

pests and noxious weeds. To do so, the 


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Secretary may regulate the importation, 

interstate movement, and release into 

the environment of any plant, plant 

product, biological control organism, 

noxious weed, article, or means of 

conveyance that could potentially 

spread plant pests or noxious weeds. 

Description and Estimate of the Number 

of Small Entities Regulated 

The proposed rule may affect a wide 

range of public and private 

biotechnology research facilities, GE 

crop and seed production, food 

processors, grain processors, and paper 

producers that fall into various 

categories of the North American 

Industry Classification System (NAICS). 

For the purpose of this analysis and 

following the Small Business 

Administration (SBA) guidelines, the 

potentially affected entities are 

classified within the following sectors: 

Agriculture, Forestry, Fishing and 

Hunting (Sector 11), Manufacturing 

(Sectors 31–33), Wholesale Trade 

(Sector 42), Retail Trade (Sector 44 and 

45), Transportation (Sectors 48 and 49), 

and Professional, Scientific and 

Technical Services (Sector 54). 

For the Agriculture, Forestry, Fishing 

and Hunting sector, the subsectors of 

Crop Production, Animal Production, 

Forestry and Logging, and Support 

Activities for Agriculture and Forestry 

are potentially affected by this rule. The 

proposed rule may affect a wide range 

of establishments in the Crop 

Production category. Establishments in 

this category are considered small by 

SBA standards if annual sales are not 

more than $0.75 million. According to 

the 2002 Census of Agriculture, 97 

percent of the farming businesses are 

considered small. Potentially affected 

crop-producing industries, with their 

NAICS codes in parentheses, are as 

follows: Soybean Farming (111110); 

Oilseed Farming (except soybean) 

(111120); Dry Pea and Bean Farming 

(111130); Wheat Farming (111140); Corn 

Farming (111150); Rice Farming 

(111160); Oilseed and Grain 

Combination Farming (111191); All 

Other Grain Farming (111199); Potato 

Farming (111211); Other Vegetable 

(except potato) and Melon Farming 

(111219); Orange Groves (111310); 

Citrus (except orange) Groves (111320); 

Apple Orchards (111331); Grape 

Vineyards (111332); Strawberry Farming 

(111333); Berry (except Strawberry) 

Farming (111334); Tree Nut Farming 

(111335); Fruit and Tree Nut 

Combination Farming (111336); Other 

Noncitrus Fruit Farming (111337); 

Mushroom Production (111411); Other 

Food Crops Grown Under Cover 

(111419); Nursery and Tree Production 

(111421); Floriculture Production 

(111422); Tobacco Farming (111910); 

Cotton Farming (111920); Sugarcane 

Farming (111930); Hay Farming 

(111940); Sugar Beet Farming (111950); 

Peanut Farming (111960); and All other 

Miscellaneous Crop Farming (111970). 

Some aspects of animal production 

may be affected because some GE plants 

are used for animal feeds and may have 

enhanced nutritional value or other 

benefits. In terms of animal production, 

potentially affected entities include 

ones within the following industries: 

Beef Cattle Ranching and Farming 

(NAICS 112111); Cattle Feedlots (NAICS 

112112); Hog and Pig Farming (NAICS 

112210); Sheep Farming (NAICS 

112410); Goat Farming (NAICS 112420); 

and Apiculture (NAICS 112910). Except 

for Cattle Feedlots, entities in all of 

these industries are considered small by 

SBA standards if annual sales are not 

more than $0.75 million. Cattle Feedlot 

establishments are considered small by 

SBA standards if annual sales are not 

more than $2 million. According to the 

2002 Census of Agriculture, 93 percent 

of Cattle Feedlot businesses, 99 percent 

of Beef Cattle Ranching and Farming 

businesses, 81 percent of Hog and Pig 

Farming businesses, 99 percent of Sheep 

and Goat farming businesses, and 99 

percent of Apiculture businesses are 

considered small. 

For the Forestry and Logging 

subsector the potentially affected 

establishments are classified within 

Timber Tract Operations (NAICS 

113110); Forest Nursery and Gathering 

of Forest Products (NAICS 113210); and 

Logging (NAICS 113310). 

Establishments in the category of 

Timber Tract Operations and Forest 

Nursery and Gathering of Forest 

Products are considered small by SBA 

standards if annual sales are not more 

than $6.5 million and establishments in 

the category of Logging are considered 

small if employment is not more than 

500. According to the 2002 Survey of 

Business Owners, 99 percent of 

establishments in the Logging category 

are considered small. Neither the 

Census of Agriculture nor the Economic 

Census tracks revenue for 

establishments classified within Timber 

Tract Operations and Forest Nursery 

and Gathering of Forest Products. 

In terms of Support Activities for 

Agriculture and Forestry, the potentially 

affected establishments are classified 

within Cotton Ginning (NAICS 11511); 

Soil Preparation, Planting, and 

Cultivating (NAICS 115112); Crop 

Harvesting (NAICS 115113); Postharvest 

Crop Activities (NAICS 115114); Farm 

Management Services (115116) Support 

Activities for Animal Production 

(NAICS 115210); and Support Activities 

for Forestry (NAICS 115310). 

Establishments in these categories are 

considered small by SBA standards if 

annual sales are not more than $6.5 

million. However, neither the Census of 

Agriculture nor the Economic Census 

reports revenue for these 

establishments. 

Entities that may be directly affected 

by the proposed rule in the 

Manufacturing Sector are classified 

within Ethyl Alcohol Manufacturing 

(NAICS 325193); Pesticide and Other 

Agricultural Chemical Manufacturing 

(NAICS 325320); Pharmaceutical 

Preparation Manufacturing (NAICS 

325412); and Medicinal and Botanical 

Manufacturing (NAICS 325411). 

Establishments in the Ethyl Alcohol 

Manufacturing category are considered 

small if they employ not more than 

1,000 persons and those in the category 

of Pesticide and Other Agricultural 

Chemical Manufacturing (NAICS 

325320) are considered small if they 

employ not more than 500 persons. For 

both the Pharmaceutical Preparation 

Manufacturing (NAICS 325412); and 

Medicinal and Botanical Manufacturing 

(NAICS 325411) categories, 

establishments are considered small if 

they employ not more than 750 persons. 

According to the 2002 Economic 

Census, 98 percent of the establishments 

in the Chemical Manufacturing Sector 

had fewer than 500 employees and 99 

percent had fewer than 1000. Therefore, 

businesses in the chemical 

manufacturing are predominantly small 

by SBA standards. 

In terms of Wholesale Trade, entities 

that would be potentially affected may 

be found in the following categories: 

Fresh Fruit and Vegetable Merchant 

Wholesalers (NAICS 424480); Other 

Grocery and Related Products Merchant 

Wholesalers (NAICS 424490); Grain and 

Field Bean Merchant Wholesalers 

(NAICS 424510); Other Farm Product 

Raw Material Merchant Wholesalers 

(NAICS 424590); Farm Supplies and 

Merchant Wholesalers (NAICS 424910); 

and Flower, Nursery Stock, and Florists’ 

Supplies Merchant Wholesalers (NAICS 

424930). Establishments in the above 

categories are considered small by SBA 

standards if they employ not more than 

100 persons. According to the 2002 

Survey of Business Owners, 97 percent 

of the establishments in this category 

employed fewer than 100 people and 

are considered small by SBA standards. 

Retail Trade, establishments that 

would be affected by the rules are in the 

following categories: Nursery and 

Garden Centers (NAICS 444220); 

Supermarkets and Other Grocery Stores 

(NAICS 445110); Fruit and Vegetable 


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5The size determination was made using public 

information about these entities. This information 

was primarily obtained from the entities’ Web sites. 

Markets (NAICS 445230); All Other 

Specialty Food Stores (NAICS 445299); 

Food (Health) Supplement Stores 

(NAICS 446191); Warehouse Clubs and 

Superstores (NAICS 452910); and Florist 

(NAICS 453110). Establishments in the 

Nursery and Garden Center, Fruit and 

Vegetable Markets, All other Specialty 

Food Stores, Food (Health) Supplement 

Stores; and Florist categories are 

considered small by SBA standards if 

annual sales are not more than $6.5 

million. Supermarkets and Other 

Grocery Stores are considered small by 

SBA standards if annual sales are not 

more than $25 million. While the 

Economic Census reports total annual 

sales, the Census does not provide a 

breakdown of these establishments by 

revenue categories. 

In terms of the Transportation sector, 

the potentially affected entities are in 

the category Farm Product Warehousing 

and Storage (NAICS 493130). 

Establishments in this category are 

considered small by SBA standards if 

annual sales are not more than $23.5 

million. However, the Economic Census 

reports only total revenue for all 

establishments in this category. 

In terms of Professional, Scientific 

and Technical Services, establishments 

in the category of Research and 

Development in the Physical, 

Engineering, and Life Sciences (NAICS 

54170) may be affected. Establishments 

in this category are considered small by 

SBA standards if they employ not more 

than 500 persons. According to 2002 

Economic Census, 82 percent of the 

establishments in this category are 

considered small. 

Although information was not 

available on the business sizes for all 

potentially affected establishments, 

based on the foregoing information we 

can assume that the majority of the 

entities that may be affected by the 

proposed rule are small by SBA 

standards. 

Given the aforementioned, a review of 

entities that have made application 

requests to APHIS shows that of the 420 

applicants for the last 6 years, 263 were 

universities and colleges and public and 

private research institutions. The 

remainder of the applicants fall under 

various NAICS classification codes 

specified above but given time 

constraints their business size could not 

be readily determined. We were able to 

ascertain that the 263 institutions (63 

percent) are large by SBA standards as 

they fall under NAICS code 54170 

Research and Development in Physical 

Science. Establishments in this category 

are considered small by SBA standards 

if they employ not more than 500 

persons. Even though the 2002 

Economic Census suggests that 82 

percent of the establishments in this 

category are considered small, the 

majority of applicants to APHIS are 

large by SBA standards.5

Description and Estimate of Compliance 

Requirement 

The proposed rule would require 

additional and modified information 

collections through recordkeeping, 

reporting, and notifications to APHIS 

when certain events occur. The 

proposed application process requires 

certain new information. The current 

and proposed rules both require 

submission of reports following an 

environmental release or field test, but 

the proposed requirement is more 

specific about the contents of such 

reports. Both the current and proposed 

rules require APHIS to be notified if an 

unauthorized release occurs or if during 

release the GE organism is found to have 

characteristics substantially different 

from those anticipated by the permit. 

The proposed rule is more specific 

about the types of records that must be 

kept for importations, interstate 

movements, and environmental 

releases, where the current regulations 

left more of these details to be specified 

only in permit conditions. In terms of 

record retention requirements, the 

proposed rule spells out a 2-year 

retention for records indicating that a 

GE organism imported or moved 

interstate reached its intended 

destination, and a 5-year retention for 

all other required records. By providing 

more specific information on what 

records are required, the proposed rule 

should alleviate some current burden 

that may result from persons keeping 

unnecessary records. In addition, APHIS 

has established the Biotechnology 

Quality Management System (BQMS), 

which is a voluntary compliance 

assistance unit within USDA APHIS. 

BQMS would facilitate the regulatory 

efforts of USDA APHIS by conducting 

outreach activities and providing 

compliance assistance to the regulated 

community. This would lessen any 

burden of the proposed rule to the 

regulated community. 

Duplication, Overlap, and Conflict With 

Existing Rules and Regulations 

APHIS has identified areas where the 

proposed rule will need to be closely 

coordinated with other Federal rules 

and statutory authorities. Coordination 

has been an important aspect of the 

daily implementation of the current 

regulation, and APHIS foresees 

additional areas for coordination under 

the proposed rule. In particular, APHIS 

will coordinate with the Food and Drug 

Administration (FDA) and the 

Environmental Protection Agency 

(EPA). FDA regulates GE organisms 

under the authority of the Federal Food, 

Drug and Cosmetic Act and the Public 

Health Service Act (42 U.S.C. 262 et 

seq.), as appropriate. The EPA regulates 

plant-incorporated protectants under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) and certain 

biological control organisms under the 

Toxic Substances Control Act (TSCA). 

As examples of areas that need 

coordination, some of the plantincorporated protectants regulated by 

EPA are also subject to APHIS 

requirements under the PPA. Also, FDA 

is the primary U.S. agency responsible 

for ensuring the safety of commercial 

food and food additives, and FDA 

authority extends to any nonpesticidal 

substance that may be introduced into a 

new GE plant and that is expected to 

become a component of food. The 

proposed regulations would clarify the 

regulatory scope and procedures used 

by APHIS relative to these other 

agencies and improve the coordination 

process. 

Significant Alternatives to the Rule 

APHIS considered several significant 

alternatives during development of this 

proposed rule. We have compared the 

selected alternatives to others that were 

not selected to evaluate their feasibility 

and to consider whether any 

alternatives provide ways to minimize 

significant economic impacts on small 

entities. We have not identified any 

selected alternative that imposes 

disproportionate costs on small 

businesses, or any non-selected 

alternative that would both achieve the 

regulatory purposes and reduce costs for 

small businesses. 

The selected alternative regarding the 

scope of the regulatory oversight was to 

add considerations of noxious weed risk 

in addition to evaluating plant pest 

risks, and to use genetic transformation, 

coupled with a determination by the 

Administrator as to whether a GE 

organism met certain risk-based criteria, 

as the trigger for regulation. Other 

alternatives considered included 

continuing to base the scope of 

regulation only on plant pest risks, or 

trying to develop a set of solely traitbased criteria that could be used to 

predict what articles would be regulated 

without the need for determinations by 

the Administrator. The first of these 

alternatives could have resulted in costs 

from damages caused by a GE plant with 


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noxious weed aspects that was not 

regulated under the plant pest risks 

standard. The second alternative was 

not considered technically feasible, and 

could also have resulted in costs for 

persons who erroneously decide their 

GE plant is not within the scope of the 

regulations, but are overruled by a later 

determination by the Administrator that 

the GE plant is regulated. 

The selected alternative for providing 

transparency and predictability to the 

permitting system was to establish 

permit categories for environmental 

releases of plants based on newly 

devised criteria. We also considered 

evaluating all requests for 

environmental release permits on a 

case-by-case basis, without categories. 

This alternative would have resulted in 

less predictability for applicants, and 

likely would have increased their costs 

for information collection because 

applications known to be in a particular 

category can contain less information 

about non-relevant areas. 

The selected alternative regarding the 

duration period for permits was to make 

multi-year permits for interstate 

movement and importation more 

feasible by removing the one-year limit 

for interstate movement permits and the 

requirement to obtain a new importation 

permit for each imported shipment. We 

also considered alternatives to maintain 

either the current or alternative specific 

time limits for such permits. These 

alternatives would have resulted in 

additional costs for applicants who 

would have to reapply for permits, 

rather than having the original permit 

issued with an appropriate duration. 

C. Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

D. Executive Order 12988 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. If this proposed rule is 

adopted: (1) No State or local laws or 

regulations would be preempted by this 

rule; (2) no retroactive effect will be 

given to this rule; and (3) administrative 

proceedings will not be required before 

parties may file suit in court challenging 

this rule. 

E. Paperwork Reduction Act 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection or recordkeeping 

requirements included in this proposed 

rule have been submitted for approval to 

the Office of Management and Budget 

(OMB). The information collection or 

recordkeeping requirements in current 7 

CFR part 340 have been approved under 

OMB Control No. 0579–0085. Please 

send written comments to the Office of 

Information and Regulatory Affairs, 

OMB, Attention: Desk Officer for 

APHIS, Washington, DC 20503. Please 

state that your comments refer to Docket 

No. APHIS–2008–0023. Please send a 

copy of your comments to: (1) Docket 

No. APHIS–2008–0023, Regulatory 

Analysis and Development, PPD, 

APHIS, Station 3A–03.8, 4700 River 

Road Unit 118, Riverdale, MD 20737– 

1238, and (2) Clearance Officer, OCIO, 

USDA, room 404–W, 14th Street and 

Independence Avenue SW., 

Washington, DC 20250. A comment to 

OMB is best assured of having its full 

effect if OMB receives it within 30 days 

of publication of this proposed rule. 

This proposed rule contains certain 

information collection and 

recordkeeping requirements that would 

apply to persons and their agents 

engaged in the importation, interstate 

movement, or release into the 

environment of any GE organism that is 

subject to the regulations. The majority 

of the requirements would apply to 

persons moving GE organisms under a 

permit issued by APHIS, but some 

requirements also apply to persons 

engaged in regulatory activities with GE 

organisms even when no permit is 

required, e.g., when they are exempted 

from the interstate movement permit 

requirement. 

The proposed information and 

recordkeeping requirements are found 

in § 340.3, Permit conditions, and in 

§ 340.7, Compliance, enforcement, and 

remedial action. Permit conditions for 

individual permits issued under the 

regulations may also require that certain 

records relevant to the particular 

movement must be kept. 

The proposed permit conditions for 

shipments imported or moved interstate 

include maintaining records of the same 

types of information that the current 

regulations require to be on the package 

labeling of such shipments (nature and 

quantity, sender, destination, permit 

number, etc.) We believe that most 

persons shipping or importing GE 

organisms already maintain such 

records as part of normal business 

practices. 

The proposed permit conditions for 

environmental releases include keeping 

records of all protocols or guidelines 

used to direct any environmental 

release. The current regulations already 

require persons conducting an 

environmental release under permit or 

notification to create and submit to 

APHIS a field test report, and in many 

cases the protocol or guidelines would 

normally be included in these field 

reports. This proposed change would 

require that the protocols or guidelines 

be kept in all cases as distinctly 

identifiable records, which may cause 

some increase in recordkeeping burden. 

In some particular environmental 

release cases where higher risk levels 

make it necessary, the proposed rule 

would allow APHIS to add a special 

permit condition requiring the permit 

holder to maintain and make available 

to APHIS written manuals or protocols 

describing how specified permit 

conditions will be met, such as 

management practices used for the 

environmental release, training, 

communications, and identity 

preservation systems. This would be 

used in cases where it is deemed 

necessary to provide specific guidance 

in addition to the proposed general 

condition for all permits (i.e., that the 

holder must keep records related to 

permitted activities of sufficient quality 

and completeness to demonstrate 

compliance with all permit conditions 

and requirements under this part). 

Another proposed permit condition 

would require permit holders to develop 

and keep a written contingency plan to 

respond to any unauthorized 

environmental release. Both of these 

recordkeeping requirements would be 

added because some researchers or 

developers were found to be unclear 

about what management and 

communications practices were needed 

to prevent unauthorized releases, and 

also about their responsibilities and the 

measures they must take in the event of 

an unauthorized release. 

The proposed procedure to apply for 

an environmental release permit 

requires applicants to submit a great 

deal of information characterizing the 

nature of the GE organism, the type of 

movement and release planned, plans 

and methods used to prevent 

unauthorized releases, and other 

matters. Most of the same information is 

obtained through the current 

application process, which allows the 

Administrator to require an applicant to 

submit any additional information that 

is needed for adequate evaluation of the 

application. The proposed application 

procedure is more specific in describing 

what information is required, and may 

result in a slight increase in the amount 

of information submitted with the 

average application. 

The reporting burden for permit 

holders under the proposed rule would 

be similar to the burden under the 


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current regulations. In both cases they 

must submit reports of all field tests to 

APHIS, report any unauthorized 

releases, and submit any additional 

reports required as individual permit 

conditions in their permits. 

The current regulations do not specify 

record retention periods, although some 

permits APHIS issued included specific 

retention requirements as permit 

conditions. This proposal would require 

that records associated with an 

importation or interstate shipment must 

be retained for at least 2 years after 

completion of the movement, and all 

other records (e.g., regarding 

environmental releases) must be 

retained for at least 5 years after 

completion of all obligations required 

under a relevant permit or exemption. 

We are soliciting comments from the 

public (as well as affected agencies) 

concerning our proposed information 

collection and recordkeeping 

requirements. These comments will 

help us: 

(1) Evaluate whether the proposed 

information collection is necessary for 

the proper performance of our agency’s 

functions, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of our 

estimate of the burden of the proposed 

information collection, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

information collection on those who are 

to respond (such as through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology; e.g., permitting 

electronic submission of responses). 

Estimate of burden: Public reporting 

burden for this collection of information 

is estimated to average 2 hours per 

response. 

Respondents: Public and private 

biotechnology research facilities, GE 

crop and seed producers, food 

processors, grain processors, and paper 

producers that fall into various 

categories of the North American 

Industry Classification System. 

Estimated annual number of 

respondents: 160. 

Estimated annual number of 

responses per respondent: 2. 

Estimated annual number of 

responses: 320. 

Estimated total annual burden on 

respondents: 640 hours. 

Copies of this information collection 

can be obtained from Celeste Sickles, 

the Agency Information Management 

Specialist, at (301) 851–2908. 

F. E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this proposed rule, please contact 

Mrs. Celeste Sickles, the Agency 

Information Management Specialist, at 

(301) 851–2908. 

List of Subjects in 7 CFR Part 340 

Administrative practice and 

procedure, Biotechnology, Genetic 

engineering, Imports, Packaging and 

containers, Permits, Plant diseases and 

pests, Noxious weeds, Transportation. 

Accordingly, we propose to revise 7 

CFR part 340 to read as follows: 

PART 340—IMPORTATION, 

INTERSTATE MOVEMENT, AND 

RELEASE INTO THE ENVIRONMENT 

OF CERTAIN GENETICALLY 

ENGINEERED ORGANISMS 

Sec. 

340.0 Scope and general restrictions. 

340.1 Definitions. 

340.2 Procedure for permits. 

340.3 Permit conditions. 

340.4 Conditional exemptions from the 

requirement for a permit for interstate 

movement. 

340.5 Petition for new conditional 

exemptions from the requirement for a 

permit. 

340.6 Petition for nonregulated status. 

340.7 Compliance, enforcement, and 

remedial action. 

340.8 Confidential business information. 

340.9 Costs and charges. 

Authority: 7 U.S.C. 7701–7772 and 7781– 

7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 

371.3. 

§ 340.0 Scope and general restrictions. 

(a) In order to prevent the 

unauthorized introduction or 

dissemination of a plant pest or noxious 

weed, no person shall import, move 

interstate, or release into the 

environment genetically engineered 

organisms described in paragraph (b) of 

this section, unless the importation, 

interstate movement, or release into the 

environment: 

(1) Is authorized under a permit 

issued by the Administrator in 

accordance with § 340.2, or 

(2) Is exempt from the requirements 

for a permit in accordance with § 340.4 

or § 340.5, or 

(3) Is approved for nonregulated 

status in accordance with § 340.6 or has 

previously been approved for 

nonregulated status pursuant to former 

regulations under this part, or 

(4) Is excluded in accordance with 

paragraph (d) of this section. 

(b) Genetically engineered organisms 

whose importation, interstate 

movement, or release into the 

environment is subject to the 

regulations in this part are: 

(1) 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. 

(2) 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. 

(3) Opportunity to consult APHIS. 

Any person may contact APHIS to 

discuss how the criteria of this 

paragraph apply in the case of a 

particular GE organism or group of 

organisms. 

(c) The Administrator may issue 

permits for the importation, interstate 

movement, or release into the 

environment of certain genetically 

engineered organisms described in 

paragraph (a) of this section. These 

permits may include such requirements 

or conditions as the Administrator 

deems necessary to prevent the 

unauthorized introduction or 

dissemination of a plant pest or noxious 

weed. The Administrator may also 

designate certain exemptions from the 

requirement to obtain permits. The 

Administrator may also approve for 

nonregulated status a genetically 

engineered organism described in 

paragraph (a) of this section for which 

a determination has been made by the 

Administrator that the organism is 

unlikely to be a plant pest or noxious 

weed. 


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(d) Genetically engineered 

microorganisms that are regulated as 

biological control organisms under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act are not subject to the 

regulations in this part. Genetically 

engineered microorganisms where the 

recipient microorganism is not a plant 

pest and which has resulted from the 

addition of genetic material from a 

donor organism where the material is 

well characterized and contains only 

non-coding regulatory regions are not 

subject to the regulations in this part. 

§ 340.1 Definitions. 

Terms used in the singular form in 

this part shall be construed as the 

plural, and vice versa, as the case may 

demand. The following terms, when 

used in this part, shall be construed, 

respectively, to mean: 

Administrator. The Administrator of 

the Animal and Plant Health Inspection 

Service (APHIS) or any other employee 

of APHIS to whom authority has been, 

or may be, delegated to act in the 

Administrator’s stead. 

Animal and Plant Health Inspection 

Service (APHIS). An agency of the 

United States Department of 

Agriculture. 

Confidential business information, 

CBI. 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. 

Contained facility, contained 

structure. A physical structure designed 

to minimize release into the outdoor 

environment. Examples of contained 

structures include, but are not limited 

to, laboratories, containment 

greenhouses, bioreactors, and 

fermenters. 

Contingency plan. A written plan 

stating how the responsible person will 

respond in the event of the 

unauthorized environmental release of 

GE organisms. 

Donor organism. The organism from 

which genetic material is obtained for 

transfer to the recipient organism in the 

process of genetic engineering. 

Environmental release. See definition 

of Release into the environment. 

Exempt, exempted, exemption from 

permit. 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. 

Genetic engineering. The genetic 

modification of organisms by 

recombinant DNA techniques. 

Genetically engineered, GE. A term 

applied to organisms that have been 

produced by genetic engineering, e.g., 

GE organisms, GE plants. 

Import and importation. To move 

into, or the act of movement into, the 

territorial limits of the United States. 

Inspector. Any employee of the 

Animal and Plant Health Inspection 

Service, U.S. Department of Agriculture, 

or other person, authorized by the 

Administrator, in accordance with law 

to enforce the provisions of this part. 

Interstate movement. Movement from 

any State into or through any other 

State. 

Means of conveyance. Any personal 

property used for, or intended for use 

for, the movement of any other personal 

property. This specifically includes, but 

is not limited to, automobiles, trucks, 

railway cars, aircraft, boats, freight 

containers, and other means of 

transportation. 

Nonregulated status. A determination 

by the Administrator that an organism 

described in § 340.0(a) is not subject to 

any of the regulatory requirements of 

this part. 

Noxious weed. 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. 

Organism. Any active, infective, or 

dormant stage or life form of an entity 

characterized as living, including 

vertebrate and invertebrate animals, 

plants, bacteria, fungi, mycoplasmas, 

mycoplasma-like organisms, as well as 

entities such as viroids, viruses, or any 

entity characterized as living, related to 

the foregoing. 

Permit. A written authorization by the 

Administrator for the importation, 

interstate movement, and/or release into 

the environment of a GE organism under 

this part. 

Person. Any individual, partnership, 

corporation, company, joint venture, 

society, association, or other legal 

entity. 

Plant. Any plant (including any plant 

part) for or capable of propagation, 

including trees, tissue cultures, plantlet 

cultures, pollen, shrubs, vines, cuttings, 

grafts, scions, buds, bulbs, roots, and 

seeds. 

Plant pest. Any living stage of any of 

the following that can directly or 

indirectly injure, cause damage to, or 

cause disease in any plant or plant 

product: A protozoan, a nonhuman 

animal, a parasitic plant, a bacterium, a 

fungus, a virus or viroid, an infectious 

agent or other pathogen, or any other 

living stage similar to or allied with any 

of these organisms. 

Plant product. 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. 

Recipient organism. 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). 

Release into the environment. 

Dispersal beyond the constraints of a 

contained facility or secure shipment. 

Synonymous with the term 

environmental release. 

Responsible person. 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. 

Secure shipment. 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. 

Signature, signed. 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. 

State. Any State of the United States, 

the District of Columbia, American 

Samoa, Guam, Northern Mariana 

Islands, Puerto Rico, the Virgin Islands 

of the United States, and any other 

Territories, Possessions, or Districts of 

the United States. 

State or tribal regulatory official. State 

or tribal official with responsibilities for 

plant health, or any other duly 

designated State or tribal official, in the 


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State or on the tribal lands where the 

importation, interstate movement, or 

release into the environment is to take 

place. 

United States. All of the States. 

Write, writing, written. Any document 

or communication required by this part 

to be in writing may also be provided 

by electronic communication when 

authorized by the Administrator. 

§ 340.2 Procedure for permits. 

(a) General. A permit is required for 

the importation, interstate movement, or 

release into the environment of any GE 

organism that is subject to this part, as 

described in § 340.0, The responsible 

person seeking a permit for the 

importation, interstate movement, or 

release into the environment of such 

organisms shall submit a written 

application for a permit to APHIS in 

accordance with paragraph (c) of this 

section and obtain the permit prior to 

the importation, interstate movement, or 

release into the environment. 

(b) Types of permits. The 

Administrator may issue the following 

three types of permits under this part. 

(1) Import permit. Import permits are 

for secure shipment via any means of 

conveyance from outside the United 

States into contained facilities within 

the United States. 

(2) Interstate movement permit. 

Interstate movement permits are for 

secure shipment via any means of 

conveyance from a contained facility in 

any State into or through any other State 

to another contained facility. 

(3) Environmental release permit. 

Environmental release permits are for 

the environmental release of GE 

organisms. In cases in which 

importation and interstate movements 

will occur incidental to an 

environmental release, the importation 

and interstate movements will also be 

authorized under the environmental 

release permit. 

(c) Permit application information 

requirements. Applicants must submit 

to APHIS sufficient information about 

the specific nature of the GE organism 

and the particular proposed permit 

conditions, so that the Administrator is 

able to consider whether the proposed 

importation, interstate movement, or 

release into the environment is likely to 

result in the introduction or 

dissemination of a plant pest or noxious 

weed. The basic information required in 

permit applications is described in this 

paragraph. The type and level of detail 

needed for the Administrator to issue a 

permit may vary by type of permit. For 

environmental releases, application 

information will be used to sort 

proposed releases of GE organisms into 

administrative categories described in 

paragraph (d) of this section. Applicants 

should consult with APHIS prior to 

applying for permits in order to obtain 

further guidance as to what additional 

information the Administrator may 

require to be submitted with the 

application. 

(1) Information required in all permit 

applications. Each application must 

include all of the following information, 

and any other information specified for 

individual types of permits as described 

in this paragraph: 

(i) The name, title, and contact 

information (e.g., mailing address, email, telephone and fax numbers) of the 

responsible person; 

(ii) The type of permit sought 

(importation, interstate movement, or 

environmental release, and if the permit 

is for environmental release, which 

category); 

(iii) Information necessary to identify 

and characterize the GE organism(s) for 

which a permit is sought, including: 

(A) The scientific names of all donor 

and recipient species plus any 

designations used for the GE 

organism(s) (e.g., strain, line, variety); 

(B) The form of the GE organism (e.g., 

seeds, rootstocks, tubers, spores, larvae, 

eggs) and the amount (e.g., numbers, 

total weight or volume); and a 

description of any biological material 

accompanying the GE organism under 

permit (e.g., culture medium, or host 

organisms, etc.); 

(C) The anticipated phenotype of the 

GE organism and the nature of the 

inserted sequences or other genetic 

modification intended to confer the 

phenotype; 

(D) Intended uses of the GE organism 

after the termination of the importation, 

interstate movement, or environmental 

release (e.g., contained research in 

laboratories or containment 

greenhouses, culturing, propagation, 

breeding, processing for analysis or 

manufacture, sale and distribution for 

consumption); and 

(E) Description of how the GE 

organism will be marked, labeled, or 

otherwise identified during the 

importation, interstate movement, or 

environmental release; 

(iv) The proposed time frame 

(estimated start and duration) within 

which the importation(s), interstate 

movement(s) or environmental 

release(s) will occur; 

(v) Description of how permit 

requirements will be communicated to 

persons having contact with the GE 

organism under permit; 

(vi) Description of any training given 

to persons having contact with the GE 

organism under permit, including but 

not limited to detailed information on 

how this training will facilitate 

compliance with conditions imposed 

under the permit and any other 

regulatory requirements under this part; 

and 

(vii) A certification statement signed 

by the responsible person that certifies 

that the application information is 

correct. 

(2) Additional information required in 

all applications for importation permits, 

interstate movement permits, and all 

environmental release permits that 

include importation or interstate 

movement. 

(i) The location(s) of the origin(s) and 

destination(s), including information on 

the addresses, and contact details of the 

sender(s) and recipient(s), if different 

from the responsible person. 

(ii) A description of the method of 

secure shipment. 

(iii) A description of the manner in 

which packaging material, shipping 

containers, and any other material 

accompanying the GE organism will be 

disposed. 

(3) Additional information required in 

all environmental release permit 

applications. Information should 

address the persistence risk and 

potential harm of the GE organism in 

the environment, including but not 

limited to: 

(i) A description of how the 

phenotype of the GE organism differs 

from the phenotype of the recipient 

organism, particularly with respect to 

potential interactions with and its 

likelihood of persistence in the 

environment. 

(ii) The location and size of all 

proposed release sites, including area, 

geographic coordinates, addresses, and 

contact information of a person at each 

release site, if different from the 

responsible person. Include information 

about the ecology and agronomy of each 

site, including but not limited to: 

(A) Presence of any wild or cultivated 

species that are sexually compatible 

with the GE organism; 

(B) Presence of any Federally-listed 

threatened or endangered species that 

could interact with the GE organism 

during the release; 

(C) Presence of any designated critical 

habitat, or habitat proposed for 

designation, in the area of the release 

site; and 

(D) Land use history of the site and 

adjacent areas. 

(iii) A description of the site 

management practices and control 

procedures designed to make it unlikely 

that there will be unauthorized 

introduction or dissemination of the GE 

organism beyond the proposed area and 


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the permit time frame of release. Each 

of the descriptions shall include: 

(A) Description of the methods and 

stages of transport of the GE organism 

from a contained facility to the 

environmental release site, and any 

storage methods used at the site; 

(B) Description of methods of 

planting, inoculation, or release; any 

reproductive or cultural controls; 

methods of treatment and harvest used 

for the GE organism; and a proposed 

plan for monitoring the site for pests, 

diseases, and effects on other organisms 

during the time the GE organism is 

released; 

(C) Description of the methods and 

stages of transport of the GE organism 

from release site back into contained 

facilities, or methods of devitalization at 

the site(s) of the environmental release; 

(D) Description of the cleaning, 

disinfection, or other methods used to 

make it unlikely that unauthorized 

dissemination of the GE organism into 

the environment could occur via means 

of conveyance and other articles (e.g., 

planters, harvesters, containers); 

(E) Description of any post-release 

land use practices, including any 

monitoring plans to ensure that the GE 

organism or its progeny are unlikely to 

reproduce and disseminate in the 

environment after the termination of the 

release (e.g., managing volunteer 

plants); and 

(F) Description of the contingency 

plans associated with the release. 

(d) Administrator action on permit 

applications. An initial review should 

generally be completed by APHIS 

within 15 days of the receipt of the 

application for importation or interstate 

movement permits, and within 30 days 

for environmental release permits. An 

application will be considered complete 

when the Administrator determines that 

it includes all information required by 

this section and any additional 

information that the Administrator 

determines is needed for review. If 

necessary after its initial evaluation of 

an application, APHIS will notify the 

applicant in writing if the submitted 

application information is incomplete, 

and the applicant will be provided the 

opportunity, without prejudice, to 

revise the application information to 

meet the needs for administrative 

processing and scientific review. Once 

the Administrator has determined that 

an application is complete, the 

Administrator will commence review. 

The APHIS review should generally be 

completed within 60 days after it is 

determined to be complete for 

importation and interstate movement 

permits, and within 120 days after it is 

determined to be complete for 

environmental release permits. 

(1) Administrative categories for 

environmental releases. The 

Administrator will use the following 

categories to efficiently administer the 

program and tailor regulatory oversight 

in a manner that is commensurate with 

risk. Environmental releases of GE 

plants are assigned to one of four 

categories (A–D), using the factors 

described in (i–iv). A fifth category (E) 

is for environmental releases of all nonplant organisms; applications in this 

category will be reviewed on a case-bycase basis. 

(i) Initial sorting into categories. The 

Administrator will use the following 

factors to initially sort environmental 

releases into administrative categories. 

(A) Persistence of the nonmodified 

plant, ranked as follows: 

(1) 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. 

(2) 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. 

(3) 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. 

(4) 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. 

(B) Potential harm or damage of the 

engineered traits, ranked as follows: 

(1) 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 

(i) No morphological changes which 

could cause mechanical injury or 

damage; and 

(ii) Introduced sequences are known 

not to result in plant disease, and 

confers no or very low increased disease 

susceptibility. 

(2) 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; or 

(i) Novel resistance to the application 

of an herbicide; or 

(ii) Novel ability to cause mechanical 

injury or damage; or 

(iii) 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. 

(3) 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 

(i) Produces an infectious entity 

which can cause disease in plants. 

(4) 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. 

(C) Environmental releases will be 

initially sorted into administrative 

categories A–D as shown in Table 1, 

based upon the persistence risk and 

potential harm described in paragraphs 

(d)(1)(i)(A) and (B) of this section. 

TABLE 1 TO § 340.2(d)(1)—INITIAL SORTING INTO PERMIT ADMINISTRATIVE 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 


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TABLE 1 TO § 340.2(d)(1)—INITIAL SORTING INTO PERMIT ADMINISTRATIVE 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—Continued 

Persistence * 

Potential harm or damage of engineered trait 

Low Moderate High Severe 

Severe .............................................................................................................................. D D D D 

* Persistence risk of the recipient plant species. 

(2) Modification of initial sorting 

based upon additional considerations. 

Following initial sorting using the 

factors described in paragraph (1)(i) of 

this section, the Administrator may 

reassign the environmental release to a 

different category based upon one or 

more of the following factors: 

(i) How the recipient plant is used; 

(ii) Whether the added trait 

significantly alters the persistence risk 

of the GE plant; 

(iii) Whether the gene function is 

known and based upon empirical 

observation of the added trait in the 

same species; and 

(iv) Any other information the 

Administrator deems relevant to the risk 

of introduction or dissemination of a 

plant pest or noxious weed. 

(3) APHIS review and assignment of 

permit conditions. The Administrator 

will conduct a review and assign 

appropriate permit conditions so that 

the proposed activity will be conducted 

in a manner that makes it unlikely to 

result in the introduction and 

dissemination of a plant pest or noxious 

weed. 

(4) State or tribal review and 

comment. The Administrator will 

submit for notice and review a copy of 

the permit application and any permit 

conditions to the appropriate state or 

tribal regulatory official. Comments 

received from the state or tribal 

regulatory official may be considered by 

the Administrator prior to permit 

issuance. 

(5) Site inspection. Prior to and after 

permit issuance, an inspector may 

inspect the sites or the means of 

conveyance associated with the 

proposed importation, interstate 

movement, or release into the 

environment. The responsible person 

must allow any such inspections. 

(6) Issuance of a permit. The 

Administrator may issue a permit if the 

Administrator concludes that the 

actions allowed under the permit are 

unlikely to result in the introduction or 

dissemination of a plant pest or noxious 

weed. 

(i) Prior to the issuance of a permit, 

the responsible person must agree in 

writing, in a manner prescribed by the 

Administrator, that the responsible 

person and all agents of the responsible 

person will comply with the permit 

conditions. The Administrator will deny 

the permit application if the responsible 

person does not agree that both the 

responsible person and all of his or her 

agents will comply with all of the 

permit conditions. 

(ii) If a permit is issued, the permit 

will include specific permit conditions 

required by the Administrator in 

accordance with § 340.3. If a permit is 

denied, within a reasonable time 

thereafter the applicant will be informed 

in writing of the reasons why the permit 

was denied and will be given the 

opportunity to appeal the denial in 

accordance with the provisions of 

paragraph (g) of this section. 

(e) Denial or revocation of a permit. 

Permits may be denied or revoked in 

accordance with this paragraph. 

(1) Denial. The Administrator may 

deny an application for a permit if: 

(i) The Administrator cannot 

conclude based on the application that 

the actions proposed under the permit 

are unlikely to result in introduction or 

dissemination of a plant pest or noxious 

weed; or 

(ii) The Administrator receives 

information apart from the application 

that precludes a conclusion by the 

Administrator that the actions proposed 

under the permit would be unlikely to 

result in the introduction or 

dissemination of a plant pest or noxious 

weed; or 

(iii) The Administrator determines 

that the responsible person or any agent 

of the responsible person has failed to 

comply at any time with any provision 

of this part. This would include failure 

to comply with the conditions of any 

permit issued. 

(2) Revocation. The Administrator 

may revoke a permit if: 

(i) The Administrator receives 

information subsequent to issuing a 

permit and makes a determination based 

upon this information that the 

circumstances have changed such that 

actions under the permit would be 

likely to result in the introduction or 

dissemination of a plant pest or noxious 

weed; or 

(ii) The Administrator determines that 

the responsible person or any agent of 

the responsible person has failed to 

comply at any time with any provision 

of this part. This would include failure 

to comply with the conditions of any 

permit issued. 

(f) Notice of revocation. The 

Administrator may revoke, either orally 

or in writing, any permit which has 

been issued. If the revocation is oral, the 

Administrator will communicate the 

revocation and the reasons for it in 

writing as promptly as circumstances 

allow. 

(g) Appeal of denial or revocation of 

permit. Any person who has been 

denied a permit or had a permit revoked 

may appeal the decision in writing to 

the Administrator within ten days after 

receiving the written notification of the 

revocation or denial. The appeal shall 

state all of the facts and reasons upon 

which the person relies to assert that the 

permit was wrongfully revoked or 

denied. The Administrator will grant or 

deny the appeal, in writing, stating the 

reasons for the decision as promptly as 

circumstances allow. Upon request of 

the applicant, a hearing may be held to 

resolve any conflict as to any material 

fact. Rules of practice concerning such 

a hearing will be adopted by the 

Administrator. This administrative 

remedy must be exhausted before a 

person can file suit in court challenging 

the denial or revocation of a permit. 

(h) Amendment or transfer of permits. 

Permits issued under this part may only 

be amended or transferred in 

accordance with this section. 

(1) Amendment at responsible 

person’s request. Where circumstances 

have changed so that a responsible 

person desires to have the permit 

amended, such responsible person must 

submit a written justification and 

provide supporting information to 

APHIS. The Administrator will review 

the amendment request, and may amend 

the permit. Prior to issuance of an 

amended permit, the responsible person 

must agree in writing that he or she and 

all of his or her agents will comply with 

the amended permit and conditions. 

(2) Amendment initiated by APHIS. 

The Administrator may amend any 


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permit and its conditions at any time, 

upon determining that the amendment 

is needed to make it unlikely that 

actions under the permit would result in 

the introduction or dissemination of a 

plant pest or noxious weed, or to ensure 

that the permit is in compliance with all 

of the requirements of this part. As soon 

as circumstances allow, the 

Administrator will notify the 

responsible person in writing of the 

amendment to the permit and the 

reason(s) for it. The responsible person 

must agree in writing to comply with 

the permit and conditions as amended 

before the Administrator will issue the 

amended permit. If the responsible 

person does not agree in writing to 

comply with the amended permit and 

conditions, the existing permit will be 

revoked. 

(3) Transfer of permits. Permits issued 

through this part may only be 

transferred by the Administrator in 

response to a request by both the 

responsible person and the proposed 

transferee, or in the case of a deceased 

responsible person, the deceased 

responsible person’s legal representative 

and the proposed transferee. Such 

transfer may occur if the Administrator 

determines that: 

(i) The proposed transferee meets all 

of the qualifications of a responsible 

person under this part; 

(ii) The proposed transferee has 

provided adequate written assurances to 

the Administrator that the proposed 

transferee and all of his or her agents 

will meet the terms and conditions of 

the permit, including any outstanding 

mitigation requirements or 

commitments under this part, and that 

the proposed transferee agrees to 

assume all responsibility and liability 

associated with permit activities and 

responsibilities; and 

(iii) The proposed transferee has 

provided such other information as the 

Administrator determines is necessary 

to the processing of the request for 

transfer of permit. 

§ 340.3 Permit conditions. 

(a) Core permit conditions. Permits 

will be issued with the permit 

conditions below, which are a minimum 

set of basic conditions. The 

Administrator may add 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. 

(1) Permit conditions for all permit 

types. 

(i) Identity. The identity of the GE 

organism shall be maintained at all 

times, in order to maintain control of 

the GE organism, keep it distinct from 

other organisms, and minimize 

unintended mixing of the GE organism 

with other organisms. Conditions for 

maintaining the identity of the GE 

organism include, but are not limited to: 

(A) Marking, labeling, or otherwise 

identifying all GE organisms during the 

course of the permit; and 

(B) Having the ability to account for 

all GE materials associated with the 

permit. 

(ii) Communication and training. The 

responsible person shall effectively 

communicate any and all conditions, 

activities, actions, and contingency 

plans associated with the permit to all 

his or her agents and any other persons 

participating in permit-related activities, 

in order to ensure all persons comply 

with all requirements under this part. 

Conditions for communicating and 

training include, but are not limited to: 

(A) Establishing, implementing, and 

maintaining the means to effectively 

communicate to all his or her agents and 

any other persons participating in 

permit-related activities; 

(B) Providing a copy of the permit and 

conditions to all agents involved in a 

permit; and 

(C) Training all agents and any other 

persons participating in permit-related 

activities to effectively conduct tasks 

required under the permit. 

(iii) Records. In addition to any other 

records required by this section or 

§ 340.7(b), records, related to permitted 

activities of sufficient quality and 

completeness to demonstrate 

compliance with all permit conditions 

and requirements under this part, must 

be maintained. 

(iv) Notice. The responsible person 

shall notify APHIS orally within 24 

hours of discovery, and subsequently in 

writing within 5 business days of 

discovery, in the event of an 

unauthorized importation, interstate 

movement, or release into the 

environment of a GE organism regulated 

under this part. 

(2) Additional permit conditions for 

interstate movement permits, 

importation permits, and environmental 

release permits which include either an 

interstate movement or importation. 

(i) Shipment. The GE organism must 

be transported in such a way as to 

minimize the likelihood of the 

unauthorized release of the GE 

organism. Conditions include, but are 

not limited to: 

(A) Ensuring that the GE organism is 

transported in such a way that it is a 

secure shipment, as defined in § 340.1; 

and 

(B) Treating or disposing of all 

packaging material, shipping containers, 

and any other material accompanying 

the GE organism in such a manner as to 

make it unlikely to result in the 

organism’s unauthorized importation, 

interstate movement, or release into the 

environment. 

(ii) Records. In addition to any other 

records required by this section or 

§ 340.7(b), the following records shall be 

maintained: 

(A) Information identifying the 

general nature and quantity of the 

organism being shipped; 

(B) Name and address of sender, 

owner, or person shipping the organism; 

(C) Name, address, and telephone 

number of recipient; 

(D) Any invoices, packing lists, or 

bills of lading used for the shipment; 

(E) The shipper’s name and 

identifying shipper’s mark and number; 

and 

(F) A description of any containers 

that were used to transport the GE 

organisms, and a copy of any label used 

on these containers during transport. 

(3) Additional permit conditions for 

import permits, and environmental 

release permits which include 

importation. 

(i) Port(s) of Entry. The GE organism 

shall be presented for entry only at a 

port(s) specified in the permit. 

(ii) Records. In addition to any other 

records required by this section or 

§ 340.7(b), the responsible person shall 

maintain records that identify the 

country and locality where the GE 

organism was collected, developed, 

manufactured, reared, cultivated or 

cultured. 

(4) Additional permit conditions for 

environmental release permits. 

(i) Environmental release controls. 

Sufficient controls shall be applied 

during the environmental release of the 

GE organism to make it unlikely to 

result in the unauthorized release of the 

GE organism into the environment. 

Conditions include, but are not limited 

to: 

(A) Taking adequate precautions as 

described in the permit to ensure that 

the GE organism is not inadvertently 

released in transit between contained 

facilities and the location of 

environmental release; 

(B) Developing and being prepared to 

implement a written contingency plan 

to respond to any unauthorized 

environmental release; 

(C) Following any and all required 

reproductive, cultural, spatial, and 

temporal controls, such as isolation 

distances, buffer zones, and flower 

removal, as described in the permit, and 

monitor to ensure that the controls are 

maintained throughout the duration of 

the release; 


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(D) Cleaning equipment used in the 

environmental release in order to 

remove or devitalize any viable GE 

organism the equipment may carry, as 

described in the permit; 

(E) Devitalizing or moving into a 

contained facility any viable GE 

material remaining at the termination of 

the environmental release, when 

applicable, as described in the permit; 

and 

(F) Managing and monitoring the area 

of release after the termination of the 

environmental release and removing or 

devitalizing any GE organisms which 

persist after the release, as required in 

the permit. 

(ii) Records. In addition to any other 

records required by this section or 

§ 340.7(b), the following records shall be 

maintained for each release: 

(A) All protocols or guidelines used to 

direct any environmental release of the 

GE organism; and 

(B) All environmental release reports 

for the organism. At a minimum such 

reports must include the APHIS 

reference number for the environmental 

release, methods of observation used 

during the environmental release, 

resulting information, and analysis 

regarding all deleterious effects on 

plants, nontarget organisms, or the 

environment, and any notices sent to 

APHIS of any unusual occurrence 

during the environmental release. 

(iii) Reports and Notices. In order for 

the Administrator to monitor the 

progress of the environmental release, 

and to evaluate compliance with 

required permit conditions, permit 

conditions will include, but are not 

limited to: 

(A) The responsible person shall 

submit periodic reports and notices to 

APHIS at the times specified in the 

permit and containing the information 

specified within the permit; and 

(B) The responsible person shall 

notify APHIS orally within 24 hours of 

discovery, and subsequently in writing 

within 5 business days of discovery, in 

the event that the GE organism is found 

to have characteristics substantially 

different from those listed in the permit 

or if any circumstances occur which 

may increase the risk of disseminating 

a plant pest or noxious weed. 

(C) The responsible person shall 

notify APHIS in writing if the 

authorized release will not be 

conducted. 

(D) Within 28 days after the initiation 

of the release, the responsible person 

shall report to APHIS in writing the 

final release site coordinates; number of 

GE organisms actually released; any 

information related to the expected 

date(s) and quantities of GE organisms 

for subsequent planned releases to be 

done under this permit. 

(E) The responsible person shall 

provide APHIS with a final report that 

includes information related to any 

occurrences during the release that 

might result in the dissemination of a 

plant pest or noxious weed. 

(F) For categories C and D, permit 

holders shall provide APHIS with 

written notice no less than seven days 

prior to the planned initiation of the 

release. 

(G) For categories C and D, permit 

holders shall provide APHIS with a 

report no less than 21 days prior to 

release termination (e.g., harvest of GE 

plants) that describes the anticipated 

date(s) of termination. 

(b) Standard for additional permit 

conditions assigned by Administrator. 

The Administrator will assign the 

permit conditions described above in a 

manner that is commensurate with the 

risk of the individual proposed 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 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. 

§ 340.4 Conditional exemptions from the 

requirement for a permit for interstate 

movement. 

(a) General. Certain GE organisms 

described in paragraph (b) of this 

section may be moved interstate without 

a permit under this part, if they meet the 

shipping conditions enumerated in 

paragraph (c). 

(b) Conditional exemptions from the 

requirement for a permit for interstate 

movement of certain organisms. A 

permit for interstate movement will not 

be required for the following genetically 

engineered organisms provided that 

they meet the requirements of this 

paragraph and paragraph (c). 

(1) Escherichia coli genotype K–12 

(strain K–12 and its derivatives), sterile 

strains of Saccharomyces cerevisiae, or 

asporogenic strains of Bacillus subtilis, 

provided that the introduced genetic 

sequences: 

(i) Are maintained on a 

nonconjugation proficient plasmid, and 

the organism does not contain other 

conjugation proficient plasmids or 

generalized transducing phages; 

(ii) Do not cause the production of an 

infectious entity; 

(iii) Are not carried on an expression 

vector if the cloned genes code for: 

(A) A toxin to plants or plant 

products, or a toxin to organisms 

beneficial to plants; or 

(B) Other factors directly involved in 

eliciting plant disease (e.g., cell wall 

degrading enzymes; or 

(C) Substances acting as, or inhibitory 

to, plant growth regulators. 

(2) Arabidopsis thaliana provided that 

the introduced genetic sequences: 

(i) Do not cause the production of an 

infectious entity; 

(ii) Are not derived from an animal or 

human pathogen; 

(iii) Do not encode products that are 

toxic to vertebrates; 

(iv) Do not encode products known to 

or likely to be causal agents of disease 

in vertebrates; and 

(v) Do not encode products intended 

for pharmaceutical or industrial use. 

(c) Shipping conditions. Organisms 

that meet the criteria described in 

paragraph (b) of this section must be 

shipped as follows: 

(i) The container and means of 

conveyance must provide secure 

shipment to make it unlikely that the 

introduction or dissemination of the 

organisms will occur while in transit. 

(ii) The container must contain a 

document which includes the following 

written information: 

(A) Names and contact details for the 

sender and recipient, and 

(B) A statement that the contents are 

genetically engineered and are eligible 

for interstate movement without permit 

under this part, but are not exempt from 

permit requirements under this part if 

the organism is imported or released 

into the environment; 

(iii) The responsible person shall 

notify APHIS orally within 24 hours of 

discovery, and subsequently in writing 

within 5 business days of discovery, in 

the event of an unauthorized release 

into the environment of a GE organism 

regulated under this part. 

(d) Revocation of an exemption from 

requirement for permit. The 

Administrator may revoke any existing 

conditional exemption. The 

Administrator may revoke a conditional 

exemption if the Administrator receives 

information subsequent to approving 

the conditional exemption and makes a 

determination based upon this 

information that the circumstances have 

changed such that the conditional 

exemption is likely to result in the 

introduction or dissemination of a plant 

pest or noxious weed. The revocation, 

its effective date, and the reasons for it 

will be published in the Federal 


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Register. 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 revocation if 

new information relevant to the 

revocation becomes available. 

(e) Revocation of a person’s use of a 

conditional exemption from 

requirement for permit. The 

Administrator may revoke the right of 

any person to use a conditional 

exemption from the requirement for a 

permit under this part after determining 

that the person or any agent of the 

person has failed to comply at any time 

with any provision of this part. This 

would include failure to comply with 

the conditions of any permit or 

exemption. 

(1) Appeal of revocation of a person’s 

use of a conditional exemption. Any 

person who has had the right to use a 

conditional exemption revoked may 

appeal the decision in writing to the 

Administrator within ten days after 

receiving the written notification of the 

revocation. The appeal shall state all of 

the facts and reasons upon which the 

person relies to assert that the use of the 

conditional exemption was wrongfully 

revoked. The Administrator will grant 

or deny the appeal, in writing, stating 

the reasons for the decision as promptly 

as circumstances allow. Upon request of 

the applicant, a hearing may be held to 

resolve any conflict as to any material 

fact. Rules of practice concerning such 

a hearing will be adopted by the 

Administrator. This administrative 

remedy must be exhausted before a 

person can file suit in court challenging 

the revocation. 

§ 340.5 Petition for new conditional 

exemptions from the requirement for a 

permit. 

(a) General. Any person may petition 

to initiate the procedure for establishing 

a new conditional exemption from the 

requirement for a permit under 

§ 340.0(b)(1) of this part. The 

Administrator may initiate the 

procedure without filing a petition. All 

petitions and all actions by the 

Administrator to establish a new 

conditional exemption will be evaluated 

according to the standards for petition 

approval or denial contained in 

paragraph (b)(4) of this section. 

(b) Petition submission and 

evaluation procedure. To petition for a 

new conditional exemption from the 

requirement for a permit under this part, 

a petitioner must submit a written 

petition to the Administrator. 

(1) The petition must contain 

information that supports a conclusion 

that use of the conditional exemption is 

unlikely to result in the introduction or 

dissemination of a plant pest or noxious 

weed. The information shall include the 

following: 

(i) Description of the biology of the 

organism prior to genetic engineering. 

(ii) Detailed description of the genetic 

changes made to the organism. 

(iii) Detailed description of the 

phenotype of the GE organism, 

including known and potential 

differences from the recipient organism 

that could change the likelihood that the 

GE organism will pose a risk as a plant 

pest or noxious weed. Examples of 

relevant information include, but are 

not limited to: 

(A) Growth habit and reproduction of 

the GE organism; 

(B) Potential host range or geographic 

area of distribution; 

(C) Potential for other organisms to 

pose risks as plant pests or noxious 

weeds if they acquire the trait from the 

GE organism (e.g. via sexual 

reproduction, horizontal gene transfer); 

(D) Susceptibility of the GE organism 

to disease or damage by pests; 

(E) Pathogenicity of the GE organism 

and/or ability of the GE organism to 

cause damage or injury to plants or 

plant parts; 

(F) Toxicity, allergenicity, and/or 

ability of the GE organism to damage or 

injure other organisms; 

(iv) A detailed description of 

proposed condition(s) to be associated 

with the exemption and how the 

conditions would make the exemption 

unlikely to result in the introduction or 

dissemination of a plant pest or noxious 

weed. 

(v) Any relevant experimental 

information, published references, or 

scientific information which support the 

conclusions of the petition; 

(vi) All reports required under 

§ 340.3; 

(vi) Any information known to the 

petitioner that the GE organism may 

pose a risk as a plant pest or noxious 

weed; 

(vii) Any other information that the 

Administrator believes to be relevant to 

a determination that the proposed 

conditional exemption from the 

requirement for a permit for the 

importation, interstate movement, or 

release into the environment of the GE 

organism is unlikely to result in the 

introduction or dissemination of a plant 

pest or noxious weed. 

(viii) A signed certification by the 

petitioner that, to the best knowledge 

and belief of the petitioner, the petition 

includes all information on which to 

base a determination, and that it 

includes all information known to the 

petitioner which is unfavorable to the 

petition. 

(2) Insufficient information. If, upon 

initial review of the petition, the 

Administrator concludes that there is 

insufficient information upon which to 

make a determination on the petition, 

the petitioner will be sent a written 

notice indicating what additional 

information may be required. 

(3) Public notice. The Administrator 

should generally complete the review of 

the complete petition within 180 days, 

then publish a notice in the Federal 

Register of the availability of documents 

related to APHIS’ assessment of the 

proposed conditional exemption. This 

notice will specify that comments will 

be accepted from the public on the 

proposal. 

(4) Petition approval or denial 

standard. The Administrator will assess 

the GE organism and the conditions of 

the requested exemption to determine 

whether the requested exemption from 

a permit for importation, interstate 

movement, or release into the 

environment would be unlikely to result 

in the introduction or dissemination of 

a plant pest or noxious weed. The 

Administrator will also consider 

whether any conditions not contained 

in the petition would be needed to 

ensure that the requested exemption 

would be unlikely to result in the 

introduction or dissemination of a plant 

pest or noxious weed. After completing 

review of the available information and 

any public comments received on it, the 

Administrator will furnish to the 

petitioner and publish in the Federal 

Register one of the following responses: 

(i) Approve a conditional exemption 

from requirement for a permit. The 

approval of a conditional exemption 

from the requirement for a permit will 

state which GE organism(s) may be 

imported, moved interstate, and/or 

environmentally released without a 

permit under this part, as well as the 

conditions relevant to the exemption. 

The Administrator may also add 

additional conditions not proposed in 

the petition, if the Administrator 

concludes that additional conditions are 

needed to ensure that the conditional 

exemption would be unlikely to result 

in the introduction or dissemination of 

a plant pest or noxious weed. 

(ii) Deny a conditional exemption 

from requirement for a permit. The 

Administrator will deny a petition if the 

Administrator cannot conclude that the 

proposed exemption would be unlikely 

to result in the introduction or 

dissemination of a plant pest or noxious 

weed. The Administrator’s written 

decision will set forth the reason for the 

denial. 


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(c) Appeal of decision. Any person 

whose petition under § 340.5 has been 

denied may appeal the decision in 

writing to the Administrator within ten 

days after receiving the written 

notification of the decision. The appeal 

shall state all of the facts and reasons 

upon which the person relies to show 

that the decision should be changed. 

The Administrator will grant or deny 

the appeal, in writing, stating the 

reasons for the decision as promptly as 

circumstances allow. Upon request of 

the applicant, a hearing may be held to 

resolve any conflict as to any material 

fact. Rules of practice concerning such 

a hearing will be adopted by the 

Administrator. This administrative 

remedy must be exhausted before a 

person can file suit in court challenging 

the decision. 

(d) Amending an exemption after 

approval. The Administrator may 

amend conditions to any conditional 

exemption approved under this section. 

The Administrator may amend a 

conditional exemption if the 

Administrator determines based on 

information received subsequent to the 

approval of the exemption that the 

exemption needs to be amended to 

ensure that the exemption would be 

unlikely to result in the introduction or 

dissemination of a plant pest or noxious 

weed, and that additional conditions 

can successfully mitigate that risk. The 

Administrator may also amend a 

conditional exemption if needed to 

ensure that the exemption is in 

compliance with all of the requirements 

of this part. The amended conditional 

exemption and the reasons for it will be 

published in the Federal Register. The 

addition of conditions may not be 

appealed. However, any person may file 

a new petition in accordance with 

paragraph (a) of this section regarding 

the same or similar organisms covered 

by the amended exemption if new 

information relevant to the amended 

exemption becomes available. 

(e) Revocation of an exemption from 

requirement for permit. The 

Administrator may revoke any 

conditional exemption under this 

section. The Administrator may revoke 

a conditional 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 conditional 

exemption is likely to result in the 

introduction or dissemination of a plant 

pest or noxious weed. 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 this 

section regarding the same or similar 

organisms covered by the revocation if 

new information relevant to the 

revocation becomes available. 

(f) Revocation of a person’s use of a 

conditional exemption from 

requirement for permit. The 

Administrator may revoke the right of 

any person to use a conditional 

exemption from the requirement for a 

permit under this part after determining 

that the person or any agent of the 

person has failed to comply at any time 

with any provision of this part. This 

would include failure to comply with 

the conditions of any permit or 

exemption. 

(1) Appeal of revocation of a person’s 

use of a conditional exemption. Any 

person who has had the right to use a 

conditional exemption revoked may 

appeal the decision in writing to the 

Administrator within ten days after 

receiving the written notification of the 

revocation. The appeal shall state all of 

the facts and reasons upon which the 

person relies to assert that the use of the 

exemption was wrongfully revoked. The 

Administrator will grant or deny the 

appeal, in writing, stating the reasons 

for the decision as promptly as 

circumstances allow. Upon request of 

the applicant, a hearing may be held to 

resolve any conflict as to any material 

fact. Rules of practice concerning such 

a hearing will be adopted by the 

Administrator. This administrative 

remedy must be exhausted before a 

person can file suit in court challenging 

the revocation. 

(2) [Reserved] 

§ 340.6 Petition for nonregulated status. 

(a) General. Any person may petition 

to initiate the procedure for approving 

nonregulated status under this part for 

a GE organism. The Administrator may 

initiate the procedure without filing a 

petition. All petitions and all actions by 

the Administrator to initiate the 

procedure for approving nonregulated 

status will be evaluated according to the 

standards for petition approval or denial 

contained in paragraph (b)(4) of this 

section. 

(b) Petition submission and 

evaluation procedure. To petition for 

approval of nonregulated status, a 

petitioner must submit a written 

petition to the Administrator. 

(1) The petition must contain 

information that supports a conclusion 

that the GE organism is unlikely to be 

a plant pest or noxious weed. The 

information shall include the following: 

(i) Description of the biology of the 

organism prior to genetic engineering. 

(ii) Detailed description of the genetic 

changes made to the organism. 

(iii) Detailed description of the 

phenotype of the GE organism, 

including known and potential 

differences from the recipient organism 

that could change the likelihood that the 

GE organism is unlikely to be a plant 

pest or noxious weed. Examples of 

relevant information include, but are 

not limited to: 

(A) Growth habit and reproduction of 

the GE organism; 

(B) Potential host range or geographic 

area of distribution; 

(C) Potential for other organisms to 

pose risks as plant pests or noxious 

weeds if they acquire the trait from the 

GE organism (e.g. via sexual 

reproduction, horizontal gene transfer); 

(D) Susceptibility of the GE organism 

to disease or damage by pests; 

(E) Pathogenicity of the GE organism 

and/or ability of the GE organism to 

cause damage or injury to plants or 

plant parts; 

(F) Toxicity, allergenicity, and/or 

ability of the GE organism to damage or 

injure other organisms; 

(iv) Any relevant experimental 

information, published references, or 

scientific information which support the 

conclusions of the petition; 

(v) All reports required under § 340.3; 

(vi) Any information known to the 

petitioner that the GE organism may 

pose risk as a plant pest or noxious 

weed; 

(vii) Any other information that the 

Administrator believes to be relevant to 

a determination that the GE organism is 

unlikely to be a plant pest or noxious 

weed. 

(viii) A signed certification by the 

petitioner that, to the best knowledge 

and belief of the petitioner, the petition 

includes all information on which to 

base a determination, and that it 

includes all information known to the 

petitioner which is unfavorable to the 

petition. 

(2) Insufficient information. If, upon 

initial review of the petition, the 

Administrator concludes that there is 

insufficient information upon which to 

make a determination on the petition, 

the petitioner will be sent a written 

notice indicating what additional 

information may be required. 

(3) Public notice. The Administrator 

should generally complete the review of 

the complete petition within 180 days, 

then publish a notice in the Federal 

Register of the availability of documents 

related to APHIS’ assessment of the 

proposal for nonregulated status. This 

notice will specify that comments will 

be accepted from the public on the 

proposal. 


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(4) Petition approval or denial 

standard. The Administrator will assess 

the GE organism to determine whether 

the GE organism is unlikely to be a plant 

pest or noxious weed. After completing 

review of the available information and 

any public comments received on it, the 

Administrator will furnish to the 

petitioner and publish in the Federal 

Register one of the following responses: 

(i) Approve nonregulated status. The 

approval of nonregulated status will 

state which GE organism(s) have been 

determined to have nonregulated status. 

(ii) Deny nonregulated status. The 

Administrator will deny a petition if the 

Administrator cannot conclude that the 

GE organism is unlikely to be a plant 

pest or noxious weed. The 

Administrator’s written decision will set 

forth the reason for the denial. 

(c) Appeal of decision. Any person 

whose petition under § 340.6 has been 

denied may appeal the decision in 

writing to the Administrator within ten 

days after receiving the written 

notification of the decision. The appeal 

shall state all of the facts and reasons 

upon which the person relies to show 

that the decision should be changed. 

The Administrator will grant or deny 

the appeal, in writing, stating the 

reasons for the decision as promptly as 

circumstances allow. Upon request of 

the applicant, a hearing may be held to 

resolve any conflict as to any material 

fact. Rules of practice concerning such 

a hearing will be adopted by the 

Administrator. This administrative 

remedy must be exhausted before a 

person can file suit in court challenging 

the decision. 

(d) Revocation of nonregulated status. 

The Administrator may revoke any 

approval of nonregulated status of a GE 

organism. The Administrator may 

revoke an approval of nonregulated 

status if the Administrator receives 

information subsequent to approving 

the nonregulated status and makes a 

determination based upon this 

information that the circumstances have 

changed such 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 this section 

regarding the same or similar organisms 

covered by the revocation if new 

information relevant to the revocation 

becomes available. 

§ 340.7 Compliance, enforcement, and 

remedial action. 

(a) Access for inspection. Inspectors 

shall have access to inspect any relevant 

premises, facility, location, storage area, 

waypoint, materials, equipment, means 

of conveyance, and other articles related 

to importation, interstate movement, 

and environmental releases of GE 

organisms regulated under this part. 

(b) Access to audit and review 

records. Inspectors shall have access to 

audit and review all records required to 

be maintained under this part. 

(c) Required records. Responsible 

persons and their agents engaged in the 

importation, interstate movement, or 

release into the environment of a GE 

organism subject to the regulations of 

this part are required to establish and 

keep the following records. 

(1) All records required as a condition 

of a permit or a conditional exemption 

approved under the procedure 

described in § 340.5. 

(2) Address and any other information 

needed to identify all contained 

facilities where the GE organism was 

stored or utilized, and all locations 

where the GE organism was released 

into the environment; 

(3) A record identifying which APHIS 

permit, if any, authorized the 

importation, interstate movement, or 

release into the environment; 

(4) A record identifying which 

exemption under this part, if any, 

authorized the importation, interstate 

movement, or release into the 

environment; and 

(5) Copies of contracts between the 

responsible person and all agents that 

conduct activities subject to this part for 

the responsible person, and copies of 

other records (e.g., e-mails, telephone 

records) for such agreements made 

without a written contract. 

(d) Record retention. Records 

indicating that such 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. 

(e) Enforcement. (1) Failure of any 

person to comply with any of the 

requirements of this part may result in 

any or all of the following: 

(i) Denial of a permit request by that 

person; 

(ii) After the issuance of a permit, 

revocation of a permit and destruction, 

treatment, or removal of the GE 

organism, or other measures as deemed 

appropriate or necessary by the 

Administrator; 

(iii) Criminal and/or civil penalties, 

and 

(iv) Remedial or other measures as 

determined appropriate and necessary 

by the Administrator. 

(2) The Administrator may seek a civil 

penalty as well as impose and require 

corrective action plans, remedial 

measures or other measures as 

determined appropriate and necessary 

by the Administrator. 

(3) Prior to the issuance of a 

complaint seeking a civil penalty, the 

Administrator may enter into a 

stipulation in which the responsible 

person agrees to take certain remedial 

actions or other measures in addition to 

or in lieu of a stipulated civil penalty, 

in accordance with 7 CFR § 380.10. 

(f) Liability for acts of an agent. For 

purposes of enforcing this part, the act, 

omission, or failure of any agent for a 

responsible person as defined in § 340.1 

of this part may be deemed also to be 

the act, omission, or failure of the 

responsible person. 

(g) Remedial action. The 

Administrator may hold, seize, 

quarantine, treat, apply other remedial 

measures to, destroy, or otherwise 

dispose of any GE organisms subject to 

this part, in order to ensure the GE 

organisms are unlikely to result in the 

dissemination of a plant pest or noxious 

weed. Accordingly, the Administrator 

may order the responsible person for an 

active or revoked permit or any other 

person, through an Emergency Action 

Notification or other administrative 

order, to apply remedial measures to a 

GE organism or means of conveyance 

carrying a GE organism subject to 

regulation by this part. The 

Administrator’s determination of 

whether or not to require or order 

corrective and/or remedial action in a 

given situation does not affect, 

influence, restrict, or in any other way 

limit the Administrator’s determination 

on whether or not to seek criminal or 

civil penalties or order other 

compliance or enforcement 

requirements as deemed necessary or 

appropriate by the Administrator to the 

given situation. 

(1) Failure of a person to comply with 

the Administrator’s order for corrective 

and/or remedial action authorizes the 

Administrator to take corrective and/or 

remedial action and recover from the 

person the costs of any care, handling, 

application of remedial measures, 

devitalization, or disposal incurred by 

APHIS in connection with the corrective 

and/or remedial actions taken. 

(2) Low level presence (LLP) remedial 

action. The Administrator may order 

remedial action for any unauthorized 

release into the environment of GE 


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60048 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules 

1 ‘‘Subject to regulation’’ may include situations 

where a GE organism granted nonregulated status 

subsequently had that status revoked in accordance 

with § 340.6(d). 

2The Department’s provisions relating to 

overtime charges for an inspector’s services are set 

forth in 7 CFR part 354.0. 

organisms, including situations 

involving a low-level mixing of GE 

plants and materials subject to 

regulation 1 under this part with 

commercial seed and grain. In some LLP 

situations the Administrator may 

determine not to order remedial action, 

if the Administrator determines that the 

low-level mixing is unlikely to result in 

the introduction or dissemination of a 

plant pest or noxious weed. These 

determinations will be made in the 

same way, based on the same factors, 

regardless of whether the LLP originates 

domestically or is found in import 

shipments that may contain organisms 

subject to regulation. The factors the 

Administrator will consider that would 

support a decision not to order LLP 

remedial action include, but are not 

limited to, determinations that: 

(i) A GE plant of the same species 

expressing nearly identical proteins or 

substances has already been approved 

for nonregulated status under this part; 

or 

(ii) All of the following statements are 

true with regard to the GE plant or 

plants subject to the regulations under 

this part. 

(A) The function of the introduced 

genetic sequences is known and its 

expression in the GE plant is unlikely to 

pose plant pest or noxious weed risk; 

(B) Introduced genetic sequences do 

not cause the production of an 

infectious entity; 

(C) Any genetic sequences derived 

from plant viruses are non-coding 

regulatory sequences of known function; 

or, if sense or antisense genetic 

sequences, they are derived from viruses 

prevalent and endemic in the United 

States that infect plants of the same host 

species and do not encode a functional 

noncapsid gene product responsible for 

cell-to-cell movement of the virus. 

(D) The GE plant is not expected to 

establish outside of a managed 

ecosystem, and has no sexuallycompatible, wild relatives in the United 

States; 

(E) The GE plant does not produce 

new substances that are known or likely 

to be toxic to non-target organisms, does 

not contain genetic sequences from 

animal or human pathogens, and does 

not encode products known or likely to 

be causal agents of disease in animals or 

humans. 

(F) If the GE plant is a food or feed 

crop, then at least one of the following 

must be true: 

(1) The U.S. Environmental Protection 

Agency has established a tolerance or an 

exemption from tolerance for any plantincorporated protectant expressed by 

the GE plant, or 

(2) Key food safety issues of the new 

protein or other substance have been 

addressed, or, 

(3) No new protein or substance is 

produced. 

§ 340.8 Confidential business information. 

In accordance with the Freedom of 

Information Act (FOIA) and exemptions 

from releasing information pursuant to 

FOIA, namely, 5 U.S.C. 552(b)(4), 

APHIS may exempt from disclosure to 

the public trade secrets and commercial 

or financial information obtained from a 

person that are privileged or 

confidential. Persons wishing to protect 

confidential business information in 

permit applications, petitions, or other 

submissions to APHIS under this part 

should do so in the following manner. 

If there are portions of a document 

deemed to contain trade secret or 

confidential business information, each 

page containing such information must 

be marked ‘‘CBI Copy.’’ A second copy 

of each such document must be 

submitted with all such CBI deleted and 

marked on each page where the CBI was 

deleted: ‘‘CBI Deleted.’’ In addition, 

those portions of the document which 

are deemed ‘‘CBI’’ must be identified in 

an attachment to the document, which 

also must justify how each piece of 

information requested to be treated as 

CBI is a trade secret or is commercial or 

financial information and are privileged 

or confidential. 

§ 340.9 Costs and charges. 

The services of the inspector related 

to carrying out this part and provided 

during regularly assigned hours of duty 

and at the usual places of duty will be 

furnished without cost.2 The U.S. 

Department of Agriculture will not be 

responsible for any costs or charges 

incident to inspections or compliance 

with the provisions of this part, other 

than for the services of the inspector. 

Done in Washington, DC, this 1st day of 

October 2008. 

Charles D. Lambert, 

Acting Under Secretary for Marketing and 

Regulatory Programs. 

[FR Doc. E8–23584 Filed 10–6–08; 9:30 am] 

BILLING CODE 3410–34–P 


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