Federal Register / Vol. 72, No. 136 / Tuesday, July 17, 2007 / Proposed Rules 39021 

1Names of qualified certified applicators 

may be obtained from State departments of 

agriculture. 

* * * * * 

Treatment Manual. *** 2

2The Gypsy Moth Program Manual may be 

viewed on the Internet at http:// 

www.aphis.usda.gov/ppq/manuals/ 

online_manuals.html. 

* * * * * 

3. In § 301.45–2, paragraph (a)(1) 

would be revised to read as follows: 

§ 301.45–2 Authorization to designate and 

terminate designation of generally infested 

areas. 

(a) * * * 

(1) The area is subject to a gypsy moth 

eradication program conducted by the 

Federal government or a State 

government in accordance with the 

Eradication, Suppression, and Slow the 

Spread alternative of the Final 

Environmental Impact Statement (FEIS) 

on Gypsy Moth Suppression and 

Eradication Projects that was filed with 

the United States Environmental 

Protection Agency on January 16, 1996; 

and, 

* * * * * 

4. In § 301.45–4, paragraph (b) would 

be amended by revising the last 

sentence to read as follows: 

§ 301.45–4 Conditions governing the 

interstate movement of regulated articles 

and outdoor household articles from 

generally infested areas. 

* * * * * 

(b) * * * The articles must be 

safeguarded by a covering adequate to 

prevent access by any gypsy moth life 

stages. 

* * * * * 

5. In § 301.45–7, a new sentence 

would be added after the last sentence 

to read as follows: 

§ 301.45–7 Assembly and inspection of 

regulated articles and outdoor household 

articles. 

* * * An owner who wants to move 

outdoor household articles interstate 

may self-inspect the articles and issue 

an OHA document in accordance with 

§ 301.45–5(e). 

§ 301.45–8 [Amended] 

6. In § 301.45–8, paragraph (c) would 

be amended by removing the words 

‘‘officer in charge’’ and adding the 

words ‘‘State Plant Health Director’’ in 

their place. 

7. Section 301.45–12 would be 

amended as follows: 

a. By revising paragraph (a)(1) to read 

as set forth below. 

b. In paragraph (a)(2), by removing the 

word ‘‘; or,’’ from the end of the 

sentence and adding the words ‘‘or with 

stipulations agreed on in the 

compliance agreement between the 

certified applicator and the 

Administrator.’’ in its place. 

c. By removing paragraph (a)(3). 

§ 301.45–12 Disqualification of qualified 

certified applicator to issue certificates. 

(a) * * * 

(1) Such person is not certified by a 

State and/or the Federal government as 

a commercial certified applicator under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (7 U.S.C. 136i) in a 

category allowing the application of 

restricted use pesticides. 

* * * * * 

Done in Washington, DC, this 11th day of 

July 2007. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E7–13774 Filed 7–16–07; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 340 

[Docket No. APHIS–2006–0112] 

RIN 0579–AC31 

Introduction of Organisms and 

Products Altered or Produced Through 

Genetic Engineering 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice of availability of draft 

environmental impact statement and 

request for comments. 

SUMMARY: We are evaluating our 

regulatory program to determine 

whether we should revise our 

regulations regarding the importation, 

interstate movement, and environmental 

release of genetically engineered 

organisms. We are seeking public 

comment on the draft environmental 

impact statement (DEIS) we have 

prepared relative to the regulatory 

revisions we are considering. The DEIS 

evaluates the alternatives we have 

identified in terms of their potential 

effects on the human environment 

compared to the effects of our current 

regulatory program. We believe our 

ongoing evaluation of these alternatives 

would benefit from the submission of 

additional views and data from the 

public, and we are especially interested 

in receiving comments on the subset of 

DEIS alternatives described in this 

notice. 

DATES: We will consider all comments 

that we receive on or before September 

17, 2007. 

ADDRESSES: You may submit comments 

addressing the draft environmental 

impact statement by either of the 

following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov, select 

‘‘Animal and Plant Health Inspection 

Service’’ from the agency drop-down 

menu, then click ‘‘Submit.’’ In the 

Docket ID column, select APHIS–2006–

0112 to submit or view public 

comments and to view supporting and 

related materials, including the DEIS, 

that are available electronically. 

Information on using Regulations.gov, 

including instructions for accessing 

documents, submitting comments, and 

viewing the docket after the close of the 

comment period, is available through 

the site’s ‘‘User Tips’’ link. 

• Postal Mail/Commercial Delivery: 

Please send four copies of your 

comment (an original and three copies) 

to Docket No. APHIS–2006–0112, 

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–

2006–0112. 

Issues in the DEIS are organized using 

10 numbered issue areas developed 

through the scoping process. When 

possible, please relate each point in 

your comment to one of these 10 issue 

areas. 

Public Meetings: APHIS intends to 

hold public meetings to encourage 

additional public comment on the DEIS. 

The locations and dates of the public 

meetings will be announced on the 

APHIS Web site (http:// 

www.aphis.usda.gov/brs/ 

brs_meetings.html) and in a future 

Federal Register notice. 

Reading Room: You may read any 

comments that we receive on this notice 

and the DEIS 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: Dr. 

Michael Wach, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road Unit 147, Riverdale, MD 20737–

1236; (301) 734–0485. 


rfrederick on PROD1PC67 with PROPOSALS
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SUPPLEMENTARY INFORMATION: 

Background 

Under the Plant Protection Act (PPA) 

(7 U.S.C. 7701 et seq.), the Secretary of 

Agriculture may prohibit or restrict the 

importation, entry, or movement in 

interstate commerce of any plant, plant 

product, biological control organism, 

noxious weed, article, or means of 

conveyance, if the Secretary determines 

that the prohibition or restriction is 

necessary to prevent the introduction or 

the dissemination of a plant pest or 

noxious weed into the United States. 

The Secretary’s authority under the PPA 

has been delegated to the Administrator 

of the Animal and Plant Health 

Inspection Service (APHIS). 

Under that authority, 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 

regulations govern the introduction 

(importation, interstate movement, or 

release into the environment) of any 

organism or product altered or produced 

through genetic engineering that is a 

plant pest or that there is reason to 

believe may be a plant pest, or any 

product that contains such an organism 

that is unclassified and/or whose 

classification is unknown. The 

regulations refer to such genetically 

engineered organisms as ‘‘regulated 

articles.’’

Current APHIS Regulations 

Current APHIS regulations for 

genetically engineered organisms are 

based on authority in the PPA to 

regulate the introduction of organisms 

that are plant pests or for which there 

is reason to believe may be plant pests. 

Applicants must submit required 

information for review by APHIS 

scientists who evaluate the potential 

risks posed by the introduction and the 

procedures that the applicant will use to 

minimize those risks. Depending on the 

nature of the genetically engineered 

organism, an applicant applies for either 

a permit or a notification. APHIS 

authorizes introductions after 

considering the organism, the nature of 

the genetic engineering, and the ways in 

which the genetically engineered 

organism is likely to interact with the 

environment. 

A notification is a more streamlined 

authorization process that is used only 

for plants with traits considered to be 

low risk. To qualify for a notification, 

the genetically engineered plant must 

meet strict eligibility requirements to 

ensure that it poses a minimal plant pest 

risk. The genetically engineered plant 

must also be grown under conditions 

designed to meet performance standards 

ensuring confinement of the regulated 

material. The remaining organisms—

including plants that are genetically 

engineered to produce pharmaceutical 

or industrial compounds—are subject to 

the permitting process. 

The permit process is designed to 

ensure the safe introduction of any 

genetically engineered organism over 

which APHIS has authority. All 

required information submitted in a 

permit application is reviewed by 

APHIS scientists. Permits will prescribe 

confinement conditions and standard 

operating procedures tailored on a caseby-case basis to maintain confinement 

of the genetically engineered organism 

throughout the course of the 

introduction. APHIS requires that all 

plants genetically engineered to produce 

pharmaceutical or industrial 

compounds be grown under extremely 

strict management protocols. These 

plants are required to be grown in a way 

that maintains confinement of the plant 

to the release area, with additional 

precautions taken to prevent the escape 

of pollen, seeds, or plant parts from the 

field test site. 

After a genetically engineered 

organism has been field tested 

extensively and the developer 

demonstrates that the organism does not 

pose a plant pest risk, the developer 

may request the deregulation of the 

organism by filing a petition for a 

‘‘determination of nonregulated status.’’

After the applicant submits the required 

data and it has been carefully evaluated, 

APHIS prepares an environmental 

assessment or, if warranted, an 

environmental impact statement (EIS) to 

analyze the potential impacts the plant 

may have on the human environment 

and seeks public comment. APHIS 

approves a petition only when it reaches 

the conclusion that the genetically 

engineered organism does not pose a 

plant pest risk. Once APHIS has 

deregulated an organism, it may be 

freely moved and planted without the 

requirement of permits or other 

regulatory oversight by APHIS. 

Deregulated status may be extended to 

genetically engineered organisms which 

APHIS determines are similar to 

previously deregulated organisms. 

Conversely, given new information, 

APHIS may determine that a previously 

deregulated genetically engineered 

organism poses a plant pest risk and 

should, therefore, be brought back under 

Agency oversight. 

The Draft Environmental Impact 

Statement 

APHIS is evaluating its regulatory 

program to determine if there is a need 

to revise its regulations in light of our 

current knowledge and experience and 

advances in science and technology. It 

is important that any regulations we 

may develop effectively carry out the 

purposes of the PPA, ensure 

environmental protection, provide 

regulatory processes that are transparent 

to stakeholders and the public, 

efficiently use Agency resources, 

minimize regulatory burdens, adhere to 

the principles of E.O. 12866, and are 

consistent with our international 

agreements, such as the World Trade 

Organization Agreement on the 

Application of Sanitary and 

Phytosanitary Measures. 

We have prepared a draft EIS (DEIS) 

evaluating all of the regulatory 

alternatives we are currently 

considering for a future proposed rule to 

revise our biotechnology regulations. A 

copy of the DEIS may be obtained 

through the Federal eRulemaking Portal 

as described under ADDRESSES above. 

When commenting on the DEIS, please 

identify which of the 10 issue areas 

identified in the DEIS each point in 

your comment addresses. 

While we invite comments on all 

alternatives in the DEIS, this notice 

identifies specific areas where we are 

particularly interested in further public 

input and data that will assist us in 

evaluating and refining these regulatory 

alternatives. We are requesting data on 

specific topics for some of the 

alternatives listed below, and we also 

welcome comments on how each 

alternative would affect areas such as 

the overall effectiveness of our 

biotechnology program, its operational 

efficiency, industry compliance, and 

other issues that would be associated 

with the development, adoption, and 

implementation of an alternative. 

The DEIS alternatives highlighted in 

this notice are discussed in depth in the 

DEIS, and readers should refer to that 

document in preparing comments in 

response to this notice. The issues from 

the DEIS for which we are especially 

seeking additional public comment are 

listed below, with some notes on the 

particular types of data or views we 

believe would be most helpful. 

DEIS Issue 1 and 5—Scope of the 

Program 

Given the rapid advances in 

biotechnology, the present scope of the 

regulations may not be of sufficient 

breadth to cover the full range of 

genetically engineered organisms and 


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the full range of potential agricultural 

and environmental risks posed by these 

organisms, including risks to public 

health. Historically, the Agency has 

relied exclusively on its authority to 

protect against plant pests as the basis 

for regulating genetically engineered 

organisms. This authority, which is 

found in the PPA, was derived from the 

Federal Plant Pest Act and the Plant 

Quarantine Act. The PPA, however, 

consolidated and redefined the 

Agency’s plant health authorities. The 

PPA authorizes the regulation of 

noxious weeds—defined as 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—and biological control 

organisms—defined as any enemy, 

antagonist, or competitor used to control 

a plant pest or noxious weed. 

Regulatory alternatives are now being 

considered with due regard for the 

revised plant health authorities of the 

PPA and in light of the many advances 

in biotechnology. 

Based on our evaluation of several 

alternatives in the DEIS, APHIS has 

made a preliminary determination that 

regulatory oversight should be enhanced 

by expanding the scope of regulations to 

utilize the range of authorities in the 

PPA, not just the plant pest provision, 

to include the authority over noxious 

weeds and biological control organisms. 

The noxious weed provision would 

allow oversight of genetically 

engineered plants by expanding the 

scope of what is regulated and by 

allowing a broader consideration of 

potential risks, including risks to public 

health. This would allow APHIS to 

consider what is known about the 

potential hazards of the introduced 

proteins and other substances to 

humans or animals, if inadvertently 

consumed or released. This information 

could, in turn, be used to develop 

appropriate regulatory safeguards in 

connection with introductions of 

genetically engineered organisms. 

APHIS has also made a preliminary 

determination that it would be 

beneficial to regulate nonviable plant 

material originating from field tests 

when there is reason to believe, based 

on scientific review, that such debris 

might be harmful to the environment if 

it were allowed to remain. Such an 

approach would allow the Agency to 

maintain regulatory control if nonviable 

material poses a hazard (e.g., potential 

food contamination). 

APHIS is interested in receiving 

comment on these preliminary 

determinations and the other 

alternatives discussed in the DEIS. In 

particular, APHIS requests comment on 

whether APHIS should broaden the 

scope of its regulations to reflect its 

authority over noxious weeds and 

biological control organisms. If APHIS 

does propose to broaden its regulatory 

scope to include consideration of 

noxious weed risk, how should 

oversight and evaluation of genetically 

engineered plants differ from what is 

done under the current plant pest riskoriented regulations? If APHIS does 

propose to establish regulations 

regarding genetically engineered 

biological control organisms, on what 

risks should the regulations be focused? 

Should APHIS tailor the scope of such 

regulations to focus on specific risks? If 

so, how? 

DEIS Issue 2—Transparent, Risk Based 

Permit System 

APHIS has always used a risk-based 

approach in regulating genetically 

engineered organisms. The Agency has 

concluded that there is public interest 

in biotechnology regulation and how 

APHIS regulates various types of 

organisms based on to risk and Agency 

familiarity with a given organism. In 

addition, there is a trend toward more 

highly varied organisms and the 

regulatory process may need greater 

flexibility and rigor to more 

appropriately regulate the increasing 

variety of organisms. Accordingly, the 

Agency is considering revising the 

regulations to make the Agency’s use of 

risk-based categories—where genetically 

engineered organisms are classified 

according to risk and familiarity so that 

oversight and confinement vary by 

category—more refined, more explicit 

and more transparent to the industry 

and the public. Redefined risk 

categories, we believe, can provide 

added flexibility, improving the 

Agency’s ability to regulate diverse 

organisms and new types of traits, and 

provide better clarity to the regulated 

community and to the public, which 

may in turn promote greater confidence 

in the regulatory system. 

Accordingly, APHIS’ has made a 

preliminary determination to adopt an 

expanded tiered permitting system 

based on potential environmental risk 

and Agency familiarity with the 

organism. A detailed example of such a 

system is described in this DEIS. The 

goals of such a tiered system would be 

to increase transparency with respect to 

how the Agency regulates various types 

of genetically engineered organisms and 

to increase regulatory flexibility such 

that the Agency could move genetically 

engineered organisms among the tiers as 

new information becomes available. For 

well characterized low-risk genetically 

engineered organisms, APHIS would 

continue to use a process similar to the 

current notification process found in 7 

CFR 340.3; however, the term 

notification would no longer be used. 

Such a process would become the 

lowest risk ‘‘permit.’’ This change 

would, we believe, increase 

transparency and avoid any potential 

confusion about the status of these 

organisms as regulated articles. 

APHIS is interested in receiving 

comment on this alternative, and, in 

particular, requests comment on the 

criteria that should be used to establish 

risk-based categories. What 

characteristics of genetically engineered 

plants should be considered in 

establishing such categories? How many 

categories should there be? Which types 

or species of plants should be assigned 

to which categories? What specific 

regulatory requirements or restrictions 

would be appropriate for each such 

category and why would they be 

appropriate? 

DEIS Issue 3—Nonregulated Status 

Once an article has been deregulated, 

APHIS does not place any restrictions or 

requirements on its use. Restrictions 

have not been deemed necessary 

because BRS risk assessments have 

concluded that the genetically 

engineered plants APHIS has 

deregulated pose no plant pest risk. 

APHIS recognizes, however, that future 

development and commercialization of 

plants with less familiar traits may pose 

new challenges for the Agency because 

even a thorough and comprehensive 

assessment may not resolve all 

unknowns regarding an article proposed 

for deregulation. These unresolved 

issues may justify continued scrutiny 

and data collection or use restrictions, 

but be of such a minor nature and 

minimal risk or concern that allowing 

planting of the article without a permit 

would be appropriate. APHIS is 

exploring the concept of a system that 

could give increased flexibility for 

handling special cases involving less 

familiar traits by creating provisions 

that allow for imposition of conditions 

for unconfined release. This could 

facilitate commercialization, while 

requiring appropriate restrictions or 

monitoring. 

APHIS has made a preliminary 

determination to propose a new feature 

for its regulatory system whereby the 

Agency would retain oversight in 

specific cases as appropriate. We 

envision, of course, that the vast 


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39024 Federal Register / Vol. 72, No. 136 / Tuesday, July 17, 2007 / Proposed Rules 

majority of organisms would be fully 

deregulated and that this determination 

would be identical to deregulation 

under our current regulations. The new 

system could include processes and 

criteria to allow release and use, with 

some restrictions, for special cases 

where there were minor risks that could 

be mitigated with conditions to ensure 

safe commercial use. 

We are therefore interested in 

receiving comments on how to manage 

genetically engineered organisms that 

present only minor unresolved risks that 

can be mitigated effectively, and on 

what factors should be considered in 

establishing appropriate mitigations. 

APHIS is also considering the use of 

new terminology to describe both 

deregulation as it currently exists and 

the more limited deregulation where 

some oversight would be retained. One 

possibility is to use the term ‘‘approval’’

to indicate that specific genetically 

engineered organisms are 

‘‘unconditionally approved.’’ This 

would be synonymous with full 

deregulation under our current 

regulations. Other genetically 

engineered organisms could be 

‘‘approved with conditions’’ but would 

remain subject to continuing regulatory 

oversight in some respects. 

Alternatively, APHIS could retain the 

term ‘‘deregulation’’ and use 

‘‘deregulation in part’’ or another term 

to refer to situations where genetically 

engineered organisms remain subject to 

regulatory oversight in some respects. 

We are interested in receiving comment 

on this potential change in terminology. 

DEIS Issue 4—Oversight of 

Pharmaceuticals and Industrial 

Substances 

Genetic engineering technology has 

advanced to the point where organisms 

can be developed that produce novel 

proteins and other substances with 

biological activity or industrial utility. 

Because the gene products made by 

such pharmaceutical and industrial 

compound producing plants may pose 

hazards not associated with proteins 

and other substances commonly found 

in the food supply, it is particularly 

important to ensure effective 

confinement measures for these plants. 

At the same time, however, the 

confinement measures prescribed for 

plants producing pharmaceutical and 

industrial compounds would be based 

on risk, not on the type of plant alone. 

The Agency has considered various 

alternatives with respect to the 

regulation of genetically engineered 

plants producing pharmaceutical 

compounds, including whether food 

crops should be used and whether they 

should be allowable for open air 

introductions. We have made a 

preliminary determination that under 

stringent conditions and with rigorous 

oversight, including due consideration 

of substantive food safety issues, food 

crops can be safely used for production 

of these compounds. 

In connection with this preliminary 

determination, the Agency seeks input 

on the need for and development of new 

or additional regulatory mechanisms to 

ensure that genetically engineered 

organisms producing pharmaceutical or 

industrial compounds are subject to 

requirements and oversight 

commensurate with the potential risks. 

We are also interested in comments 

regarding the biological characteristics 

that the Agency should consider in 

imposing safeguards. What should be 

done to ensure that such crops are 

commercialized under appropriate 

safeguards? 

DEIS Issue 6—Commercialization Under 

Multi-Year Permits 

For organisms that might be 

commercialized but that do not meet the 

criteria for deregulation, APHIS is 

considering whether a new type of 

permitting system would be more 

appropriate in terms of efficiency and 

effectiveness than the current system. In 

addition, there is much public and State 

interest in these types of plantings and 

a new mechanism may increase 

transparency and allow for greater State 

involvement. 

Based on considerations more fully 

described in the DEIS, APHIS has made 

a preliminary determination to create a 

multi-year permit for genetically 

engineered organisms, with stringent 

oversight, in cases where developers are 

not interested or would not qualify for 

deregulation but plan to produce under 

permit. This would cover situations 

where producers are able to 

commercialize with relatively small 

plantings (e.g., industrial and 

pharmaceutical plants). Regulatory rigor 

would remain high to protect the 

environment, but efficiency and 

transparency would increase. The State 

partnership would be strengthened 

under this new system. The system 

would rely on multiyear permits and 

intensive reviews of standard operating 

procedures (SOPs), as well as audits and 

inspections. Though the new system 

under consideration could be used for 

pharmaceutical and industrial plants, 

the Agency might also find it 

appropriate for other types of 

genetically engineered plants. 

We are seeking comments on such a 

system and are particularly interested in 

comments regarding new or additional 

regulatory mechanisms to ensure that 

genetically engineered organisms 

produced under multi-year permits 

would be subject to effective 

requirements and oversight 

commensurate with the potential risks. 

DEIS Issue 7—Low Levels of 

Biotechnology-Derived Genes and Gene 

Products Occurring in Commerce That 

Have Not Gone Through All Applicable 

Regulatory Reviews 

As with traditional plant breeding, 

large scale annual field testing of 

genetically engineered plants that have 

not completed all applicable reviews 

may result in materials from these trials 

occasionally being detected at low 

levels in commercial commodities and 

seeds. Current regulations do not 

expressly allow for such occurrences, 

though experience continues to show 

that such occurrences can occur. In a 

notice published in the Federal Register 

on August 2, 2002 (67 FR 50577–50580), 

by the Office of Science and Technology 

Policy, APHIS committed to conducting 

a risk-based regulatory program that 

minimizes the occurrence of these 

materials but includes safety criteria 

under which these materials would be 

allowed at low levels in commercial 

commodities and seeds. On March 29, 

2007, APHIS published a policy 

statement in the Federal Register (72 FR 

14649–14651, Docket No. APHIS–2006–

0167) to clarify how it currently handles 

cases of low-level presence of regulated 

materials in commodities and seeds. 

Based on our evaluation and 

assessment of alternatives in the DEIS, 

APHIS has made a preliminary 

determination to establish in regulations 

criteria under which the occurrence of 

regulated articles would be allowable, 

that is, considered not actionable by 

APHIS. The occasional detection of 

regulated material in commercial crops 

as seeds can occur as a result of field 

tests conducted under confinement 

conditions appropriate for notifications. 

This is due to cross-pollination and also 

commingling from shared equipment 

and facilities. In addition, such 

incidents will inevitably result from the 

importation of seeds and commodities 

from countries where such material has 

been fully approved but has not 

completed all U.S. reviews. In the 

majority of cases, this low-level 

occurrence of regulated articles will be 

of minimal risk, and this fact should be 

accounted for in any regulatory scheme 

since oversight should be commensurate 

with risk. 

APHIS is interested in receiving 

comment on this alternative, but in 

particular, requests comment on 

whether APHIS should establish a new 


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regulatory approach to address such 

incidents of low-level presence of 

genetically engineered plant material. If 

low-level presence incidents occur, 

what criteria should the Agency use to 

determine whether remedial action will 

be required, and to determine the nature 

and scope of any such remedial action? 

DEIS Issue 8—Importation of 

Genetically Engineered Commodities 

Not Intended for Propagation 

APHIS anticipates an increasing 

number of requests to import regulated 

genetically engineered organisms that 

are not intended for propagation, such 

as organisms that are intended for direct 

use as food, feed, or for processing. The 

current system of permits and 

notifications was not designed to handle 

such requests on a case-by-case basis. 

However, in anticipation of this 

increase, APHIS’ goal is to design an 

efficient system that protects U.S. 

agriculture and human health without 

erecting unnecessary trade barriers. To 

that end, the Agency has evaluated 

several different alternatives. 

Based on considerations more fully 

described in the DEIS, APHIS has made 

a preliminary determination to have a 

new regulatory mechanism to allow for 

imports of commodities for 

nonpropagative use, that is, for food, 

feed, or processing, in cases where these 

commodities might not have been 

deregulated in the United States. With 

this approach, we could establish 

criteria to ensure safety and allow for 

additional environmental review when 

appropriate. Allowing such imports 

without prior deregulation would not 

obviate the need to comply with 

requirements at other agencies, such as 

FDA and EPA. 

APHIS is interested in receiving 

comment on this alternative and, more 

specifically, comments as to the 

commodity characteristics and other 

data that APHIS should consider when 

determining the appropriate safeguards 

for commodities coming in for 

processing or to be used directly as food 

or feed. 

DEIS Issue 9—Interstate Movement of 

Well-Studied, Low Risk Organisms 

Currently, genetically engineered 

Arabidopsis spp. and a few other 

organisms are exempt from interstate 

movement restrictions under 7 CFR 

340.2 because they are well understood 

and extensively used in research. Based 

on considerations more fully described 

in the DEIS, APHIS is considering 

whether to expand the current 

exemption from interstate movement 

restrictions to other well-studied, lowrisk, genetically engineered research 

organisms. Such a change would create 

a consistent, risk based approach to 

organisms with similar risk profiles. 

Are there other genetically engineered 

organisms that should also be exempt 

from regulation in the same or similar 

manner as genetically engineered 

Arabidopsis spp.? Which organisms, if 

any, should be considered for such an 

exemption? Should the quantity of 

seeds or plant material being moved be 

considered in any exemption? In 

connection with such an exemption, 

should there continue to be some 

limited regulatory oversight, and what 

should be the nature and scope of such 

oversight? 

As noted above, we are interested in 

receiving comments on all of the issues 

presented in the DEIS and particularly 

on the issues and alternatives outlined 

above. 

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 12th day of 

July 2007. 

Bruce Knight, 

Under Secretary for Marketing and Regulatory 

Programs. 

[FR Doc. 07–3474 Filed 7–13–07; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 354 

9 CFR Parts 130 and 156 

[Docket No. APHIS–2006–0028] 

RIN 0579–AC44 

User Fees; Updates and Clarifications 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: We are proposing to amend 

our Agricultural Quarantine and 

Inspection Services user fee regulations 

to update an address that appears in 

several places. We are also proposing to 

make several nonsubstantive changes to 

the Veterinary Services user fees 

regulations to correct errors and to 

clarify the services covered by certain 

existing user fees. These proposed 

changes, which do not affect any 

existing fees, are necessary to ensure 

that the user fee regulations are up-todate and ensure their clarity. 

DATES: We will consider all comments 

that we receive on or before September 

17, 2007. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov, select 

‘‘Animal and Plant Health Inspection 

Service’’ from the agency drop-down 

menu, then click ‘‘Submit.’’ In the 

Docket ID column, select APHIS–2006–

0028 to submit or view public 

comments and to view supporting and 

related materials available 

electronically. Information on using 

Regulations.gov, including instructions 

for accessing documents, submitting 

comments, and viewing the docket after 

the close of the comment period, is 

available through the site’s ‘‘User Tips’’

link. 

• Postal Mail/Commercial Delivery: 

Please send four copies of your 

comment (an original and three copies) 

to APHIS–2006–0028, 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 APHIS–2006–0028. 

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: Mrs. 

Kris Caraher, User Fees Section Head, 

Financial Services Branch, Financial 

Management Division, MRBPS, APHIS, 

4700 River Road, Unit 54, Riverdale, 

MD 20737–1232; (301) 734–5901. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in 7 CFR, chapter III, 

and 9 CFR, chapter I, subchapter D, 

require inspection, laboratory testing, 

certification, or quarantine of certain 

plants, plant products, animals, animal 

products, or other commodities 

intended for importation into, or 

exportation from, the United States. 

Section 2509(a) of the Food, 

Agriculture, Conservation, and Trade 

Act of 1990 (21 U.S.C. 136a), referred to 

below as the FACT Act, authorizes the 

Secretary of Agriculture to collect user 

fees for agricultural quarantine and 

inspection (AQI) services. The FACT 

Act was amended on April 4, 1996, and 

May 13, 2002. 


rfrederick on PROD1PC67 with PROPOSALS