This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

14649 

Vol. 72, No. 60 

Thursday, March 29, 2007 

1The Plant Protection Act is found at 7 U.S.C. 

7701 et seq. APHIS’ biotechnology regulations are 

found at 7 CFR part 340. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 340 

[Docket No. APHIS–2006–0167] 

APHIS Policy on Responding to the 

Low-Level Presence of Regulated 

Genetically Engineered Plant Materials 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice of availability of policy 

statement. 

SUMMARY: This notice describes the 

Animal and Plant Health Inspection 

Service’s (APHIS) policy for responding 

to low-levels of regulated genetically 

engineered plant materials which may 

occur in commercial seeds or grain. This 

notice is intended to provide 

clarification for the public and 

developers of genetically engineered 

plants on APHIS’ response to such 

situations. The policy statement does 

not confer any rights upon or create any 

rights for any person and does not 

operate to bind APHIS or the public, nor 

does it address how other Federal 

agencies might respond to such 

situations. 

ADDRESSES: Copies of the policy 

statement are available on the Internet at 

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

biotechnology/current_initiatives.shtml. 

Copies may also be obtained by 

contacting Dr. John Turner, Director, 

Policy Division, BRS, APHIS, 4700 

River Road Unit 146, Riverdale, MD 

20737–1238; (301) 734–8365. 

FOR FURTHER INFORMATION CONTACT: Dr. 

John Turner, Director, Policy Division, 

BRS, APHIS, 4700 River Road Unit 146, 

Riverdale, MD 20737–1238; (301) 734– 

8365. 

SUPPLEMENTARY INFORMATION: 

Background 

APHIS works to protect America’s 

agriculture and environment using a 

science-based regulatory framework that 

allows for the safe development and use 

of genetically engineered (GE) plants. 

Under the authority of the Plant 

Protection Act 1 (PPA), APHIS regulates 

the introduction (importation, interstate 

movement, and field release) of GE 

organisms in order to prevent direct or 

indirect risks to plant health and the 

environment. 

Genetic engineering is a method used 

to introduce new traits into plants by 

moving genes from one or more 

organism(s) into a second organism. GE 

plants that can tolerate herbicides, resist 

insects or viruses, or enhance nutrition 

and provide other health or 

environmental benefits are examples of 

crops currently being grown and tested. 

Plant breeding may occasionally 

result in low-level mixing of genes and 

gene products from unintended plant 

sources. This is true for both 

conventionally bred plants as well as 

biotechnology-derived plants. These 

occurrences can result from natural 

processes such as the movement of 

seeds or pollen, or human-mediated 

processes associated with field testing, 

plant breeding, or seed production. The 

mixing of low levels of GE plant 

materials may result in unauthorized 

introductions of regulated materials in, 

for example, commercial seeds and 

grain. The potential for these 

occurrences may increase with the 

expansion of GE crop research, 

development, and use. This document is 

intended to describe how APHIS 

protects agriculture and the 

environment by responding to situations 

involving a low-level mixing with 

commercial seeds and grains of genes 

and gene products from GE plants 

subject to regulation by APHIS under 7 

CFR part 340. 

Overview of the APHIS Regulatory 

System for GE Plants 

A developer wishing to introduce a 

new GE plant must obtain APHIS’ 

authorization before proceeding. 

Depending on the nature of the GE 

plant, the developer files either a 

notification or a permit application with 

APHIS. With either process, the 

developer must adhere to APHIS 

regulations and requirements to ensure, 

through appropriate measures, 

confinement of the regulated material. 

An applicant must submit required 

information on the movement, 

importation, or field release, which 

APHIS scientists review to determine 

whether to authorize the applicant’s 

request. To ensure compliance with the 

permit or notification conditions, 

APHIS performs targeted inspections 

and audits of field tests using the 

relative risk of each type of trial to 

determine the frequency and number of 

inspections performed. For example, for 

sites where developers are cultivating 

GE plants engineered to produce 

pharmaceutical and industrial proteins, 

APHIS generally inspects seven times 

throughout field testing, including 

before, during, and after the field trial. 

APHIS also maintains oversight of the 

movement of regulated plants to and 

from field trial locations. Regulated 

plants must be transported according to 

the regulations and as described in the 

permit. The methods of transport are 

subject to verification by inspectors at 

the receiving facility. This permitting 

and notification system is designed to 

restrict introductions of GE plants and 

plant materials as long as they are 

regulated by the Agency. 

Permits are generally more restrictive 

than notifications and are used for any 

type of GE plant that may pose an 

elevated risk to plant health or the 

environment or for which APHIS has 

less regulatory experience and 

familiarity, such as plants engineered to 

produce pharmaceutical or industrial 

compounds. In addition to detailed 

information on the biological properties 

of the GE plant, the permit applicant 

also must provide detailed descriptions 

of how field tests will be performed, 

including specific measures for ensuring 

confinement and reducing any potential 

risk that may be associated with the GE 

plant. Using this information, APHIS 

scientists create a set of permit 

conditions that applicants must meet 

when conducting approved field trials 

or transporting the GE plants. 

Most GE plants qualify for, and are 

field tested under, the notification 

process. The notification process is used 

only for plants and traits with which 

APHIS has a great deal of regulatory 

experience and familiarity and that do 

not pose an elevated risk for plant 


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14650 Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Rules and Regulations 

2Performance standards are found at 7 CFR 

340.3(c). 

3 Deregulation requirements are found at 7 CFR 

340.6. 

4Regulatory authority to conduct extension 

requests is found at 7 CFR 340.6(e). 

5USDA Press Release, ‘‘USDA Announces First 

Steps to Update Biotechnology Regulations,’’

January 22, 2004. 

6Coordinated Framework for Regulation of 

Biotechnology, 51 FR 23302, June 26, 1986. 

7Proposed Federal Actions To Update Field Test 

Requirements for Biotechnology Derived Plants and 

To Establish Early Food Safety Assessments for 

New Proteins Produced by Such Plants, 67 FR 

50578, August 2, 2002. 

8FDA issued its guidance in June 2006, which 

can be found at http://www.cfsan.fda.gov/∼dms/ 

bioprgu2.html#ftn7. 

9EPA released its draft guidance on September 

29, 2006, which can be found at http:// 

www.epa.gov/fedrgstr/EPA-PEST/2006/September/ 

Day-29/p16072.htm. 

health or the environment. To qualify 

for the notification process, a plant or 

trait must meet six safety-related 

eligibility criteria that center on the 

plant’s potential to pose a risk to plant 

health or the environment. To ensure 

confinement, the developer must 

perform the field test in a way that 

meets performance standards that are 

specified in APHIS’ regulations.2 If a GE 

plant does not meet the criteria for 

notification, the applicant must follow 

the permitting process. 

After a GE plant has been field-tested 

extensively and the developer can show 

that the GE plant does not pose a plant 

pest risk, the developer may file a 

petition for deregulation. The developer 

must submit extensive information 

about the plant’s biology and field test 

results. After conducting an 

environmental assessment (EA) or an 

environmental impact statement (EIS) 

and seeking public comment, APHIS 

may approve a petition for deregulation 

if it reaches the conclusion that the GE 

plant does not pose a plant pest risk.3

Alternatively, an extension process can 

be used in cases where the GE plant is 

similar to a previously deregulated 

plant. The extension process, which was 

established in 1997 and has been used 

numerous times since, is based on the 

premise that a GE plant that is similar 

to a previously deregulated plant with 

respect to plant genotype and the 

expressed protein(s) is also similar in 

terms of any potential risk. Based on a 

thorough review of information in the 

extension request, which includes data 

showing similarity, APHIS may 

conclude that the new GE plant, like the 

previously deregulated GE plant, does 

not pose a plant pest risk and therefore 

will no longer be regulated.4

APHIS’ Future Biotechnology 

Regulations 

APHIS continually evaluates its 

policies and regulations and makes 

changes as necessary as the complexity 

and scope of biotechnology continue to 

grow. One of the key changes has been 

the strengthening of the requirements 

for the field testing of certain GE plants. 

As announced in a notice in the Federal 

Register on January 23, 2004 (Docket 

No. 03–031–2; 69 FR 3271–3272) and in 

a January 2004 USDA press release,5

APHIS is preparing a draft EIS to 

evaluate the current regulatory system 

and analyze several possible changes in 

order to keep pace with science and to 

more fully utilize the authority provided 

by the PPA. APHIS will solicit public 

comments on the possible changes 

analyzed in the draft EIS. In any event, 

APHIS will continue to regulate each GE 

plant in a manner that is proportionate 

to the risks associated with that GE 

plant. 

Interagency Coordination on Low Level 

Presence 

APHIS works in concert with the U.S. 

Department of Health and Human 

Services’ Food and Drug Administration 

(FDA) and the U.S. Environmental 

Protection Agency (EPA) to provide 

regulatory oversight of the development 

of GE organisms, consistent with the 

Coordinated Framework for Regulation 

of Biotechnology 6, adopted in 1986. 

The Coordinated Framework is a 

comprehensive Federal regulatory 

policy for ensuring the safety of 

biotechnology research and products. 

APHIS is responsible for protecting 

agriculture and the environment. FDA 

has primary responsibility for ensuring 

the safety of food (including food for 

animals). EPA regulates pesticides to 

ensure they can be used without 

unreasonable adverse effects on the 

environment, and to ensure public 

safety from the use of pesticides, 

including the residue of pesticides on 

food and animal feed. 

The biological conditions of plant 

breeding, whether with conventional or 

GE plants, are such that there is a 

potential for low levels of genes and 

gene products to occasionally move 

beyond confined research sites into 

commercial seeds and grain that enter 

commerce. Recognizing this fact, the 

Federal Government, in an August 2002 

notice in the Federal Register,7

proposed measures aimed at 

strengthening the controls for 

preventing low levels of regulated 

materials from GE plants from entering 

commerce until appropriate safety 

standards have been met. The proposed 

actions to be taken by the three agencies 

were based on three fundamental 

principles: 

• The level of confinement for a field 

test must be consistent with the level of 

risk associated with the introduced 

protein or trait; 

• Field test confinement measures 

must be rigorous to restrict the low-level 

occurrence in commerce for those traits 

or proteins that present an unacceptable 

or unknown risk; and 

• Regardless of risk, field test 

requirements should minimize outcrossing and commingling of seed. 

Since the 2002 notice, FDA issued 

guidance for industry on early food 

safety assessments of new nonpesticidal 

proteins produced by new plant 

varieties intended for food use,8 and 

EPA clarified its guidance for field 

testing of plant-incorporated protectants 

(pesticides intended to be produced and 

used in a living plant).9 APHIS 

strengthened its field testing 

requirements for plants producing 

pharmaceutical or industrial 

compounds to ensure that regulated 

material from these plants is not found, 

even at low levels, in commerce. In 

addition, as discussed above, APHIS has 

initiated a process to amend its 

biotechnology regulations under 7 CFR 

part 340. As part of that process, the 

Agency will consider establishing new 

criteria to determine whether low levels 

of regulated materials would be 

acceptable in commercial seeds and 

grain based on risks to plant health, 

public health and the environment. 

Through practical experience, APHIS 

has developed a policy based on current 

regulations for responding to the lowlevel presence of regulated materials in 

commercial seeds and grain. This policy 

provides the foundation for Agency 

actions in these cases. For purposes of 

transparency, this policy is set forth 

below for the public. 

APHIS Policy on Responding to the 

Low-Level Presence of Regulated GE 

Plant Materials 

APHIS requirements for both permits 

and notifications minimize the 

likelihood that regulated GE plant 

materials will occur in commercial 

seeds and grain. APHIS’ policy is to 

respond to occurrences of regulated 

materials in commercial seeds and grain 

with remedial action that is appropriate 

to the level of risk and warranted by the 

facts in each case. In every such case, 

APHIS will initiate an inquiry to 

determine the circumstances 

surrounding the release, evaluate the 

risk attendant to the release, and 

determine what regulatory actions, 


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Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Rules and Regulations 14651 

10See 7 U.S.C. 7714; 7 CFR 340.0(b). 

11The specific criteria for GE crops planted under 

notification are found at 7 CFR 340.3. 

including remedial and enforcement 

actions, are required. 

If APHIS determines that action is not 

necessary to mitigate low-level presence 

of a regulated material in commerce to 

protect plant health or the environment, 

this determination does not preclude 

enforcement action against a company 

or individual for violation of APHIS 

regulations. APHIS will investigate and 

take appropriate enforcement action 

whenever regulated materials are 

detected in commerce. 

APHIS coordinates closely with EPA 

and FDA on investigations, risk 

evaluations, and the determination of 

what remediation measures, if any, will 

be necessary. This cooperation is crucial 

and helps to ensure that there are no 

unresolved safety issues. Any regulatory 

action taken by APHIS will not preclude 

FDA or EPA from pursuing action under 

their own authorities, as necessary, to 

ensure the safety of food as well as to 

protect human health and the 

environment from the sale, distribution, 

or use of any pesticide. 

APHIS has authority under the PPA to 

take or order remedial measures which 

include the authority to hold, seize, 

quarantine, treat, apply other remedial 

measures to, destroy, or otherwise 

dispose of regulated materials if it is 

determined that such measures are 

necessary to prevent the dissemination 

of a plant pest within or throughout the 

United States.10 Any remedial action 

taken would be determined on a caseby-case basis. Key considerations 

include the extent of the occurrence, the 

nature of the regulated material, as well 

as any potential risks to plant health or 

the environment. In any case where 

APHIS determines that an incident 

involving a GE plant would result in the 

introduction or dissemination of 

material that could pose a threat to plant 

health or the environment, remediation 

measures will be required. It is 

important to note that, due to the strict 

requirements that APHIS has developed 

in recent years for GE plants that pose 

elevated risks, such occurrences would 

be unlikely. 

There are two principal situations in 

which APHIS may determine that action 

under the PPA was not necessary. Even 

though remedial measures would not 

generally be applied in these two 

situations, applicants field testing these 

types of plants must be authorized 

through either notifications or permits 

and must follow all APHIS 

requirements. 

The first situation would be when the 

regulated material is derived from 

plants that meet all of the criteria to 

qualify for APHIS’ notification process. 

The six eligibility requirements are: 11

• The plant must not be listed on the 

Federal Noxious Weed list or be 

considered a weed in the area of 

proposed release. 

• The introduced genetic material 

must be stably integrated, which means 

the introduced DNA must remain inside 

the living cell and replicate only with 

the plant DNA. 

• The function of the introduced 

genetic material is known, and its 

presence in the regulated article does 

not result in a plant disease. 

• The introduced genetic material 

does not cause the production of an 

infectious entity, produce substances 

that are known to be, or are likely to be, 

toxic to nontarget organisms, or produce 

products intended for pharmaceutical or 

industrial use. 

• The introduced genetic sequences 

derived from plant viruses do not pose 

a significant risk of creating a new plant 

virus. 

• The plant has not been modified to 

contain certain genetic material derived 

from animal or human pathogens. In 

addition, plants containing coding 

sequences whose products are known 

agents of diseases in humans or 

nontarget animals are not eligible. 

The majority of GE plants field tested 

under APHIS regulations qualify for the 

notification process because they 

present minimal risk to plant health and 

the environment. Many of the plants 

that have been engineered for common 

traits such as pest resistance, herbicide 

tolerance, male sterility, and improved 

product quality such as delayed fruit 

ripening meet the criteria for 

notification. APHIS has extensive 

experience with these types of plants 

and has overseen thousands of field 

tests involving them. 

The second situation in which APHIS 

may not take remedial action is if the GE 

plant is similar to another GE plant that 

has already been deregulated by APHIS 

with respect to both plant genotype and 

any novel protein(s) expressed. APHIS 

will carefully assess the GE plant 

material, including the plant genotype, 

the introduced genes, and any proteins 

produced. When these are sufficiently 

similar to those of a previously 

deregulated plant, APHIS is able to 

conclude confidently that, like the 

previously deregulated plant, the new 

GE plant poses no significant safety risk 

to plant health or the environment, and 

thus, remedial action may not be 

necessary. 

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

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

371.3. 

Done in Washington, DC, this 26th day of 

March 2007. 

Bruce Knight, 

Under Secretary for Marketing and Regulatory 

Programs. 

[FR Doc. 07–1536 Filed 3–27–07; 2:00 pm] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 929 

[Docket No. AMS–FV–06–0174; FV06–929–

1 FR] 

Cranberries Grown in the States of 

Massachusetts, et al.; Increased 

Assessment Rate 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This rule increases the 

assessment rate established for the 

Cranberry Marketing Committee 

(Committee) for the 2006–2007 fiscal 

year and subsequent fiscal years from 

$0.18 to $0.28 per barrel. Authorization 

to assess cranberry handlers enables the 

Committee to incur expenses that are 

reasonable and necessary to administer 

the program. The Committee locally 

administers the marketing order which 

regulates the handling of cranberries 

grown in the States of Massachusetts, 

Rhode Island, Connecticut, New Jersey, 

Wisconsin, Michigan, Minnesota, 

Oregon, Washington, and Long Island in 

the State of New York. The fiscal year 

began September 1, 2006, and ends 

August 31, 2007. The assessment rate 

will remain in effect indefinitely unless 

modified, suspended, or terminated. 

DATES: Effective Date: This rule becomes 

effective March 30, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Patricia A. Petrella or Kenneth G. 

Johnson, DC Marketing Field Office, 

Fruit and Vegetable Programs, AMS, 

USDA, Unit 155, 4700 River Road, 

Riverdale, Maryland 20737; telephone: 

(301) 734–5243, Fax: (301) 734–5275, or 

E-mail at Patricia.Petrella@usda.gov or 

Kenneth.Johnson@usda.gov. 

Small businesses may request 

information on complying with this 

regulation by contacting Jay Guerber, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue, SW, STOP 0237, Washington, 

DC 20250–0237; telephone: (202) 720–


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