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

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REGISTER issue of each week.

Rules and Regulations Federal Register

61325 

Vol. 73, No. 201 

Thursday, October 16, 2008 

1To view the proposed rule and the comments 

we received, go to http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2007-0033. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 331 

9 CFR Part 121 

[Docket No. APHIS–2007–0033] 

RIN 0579–AC53 

Agricultural Bioterrorism Protection 

Act of 2002; Biennial Review and 

Republication of the Select Agent and 

Toxin List 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: In accordance with the 

Agricultural Bioterrorism Protection Act 

of 2002, we are amending and 

republishing the list of select agents and 

toxins that have the potential to pose a 

severe threat to animal or plant health, 

or to animal or plant products. The Act 

requires the biennial review and 

republication of the list of select agents 

and toxins and the revision of the list as 

necessary. This action implements the 

findings of the second biennial review 

of the list. 

DATES: Effective Date: November 17, 

2008. 

FOR FURTHER INFORMATION CONTACT: For 

information concerning the regulations 

in 7 CFR part 331, contact Ms. Cassie 

Armiger, Program Analyst, Select Agent 

Program, PPQ, APHIS, 4700 River Road 

Unit 2, Riverdale, MD 20737–1231, 

(301) 734–5960. 

For information concerning the 

regulations in 9 CFR part 121, contact 

Dr. Frederick D. Doddy, Staff 

Veterinarian, Animals, Organisms and 

Vectors, and Select Agents, NCIE, VS, 

APHIS, 4700 River Road Unit 39, 

Riverdale, MD 20737–1231, (301) 734– 

5960. 

SUPPLEMENTARY INFORMATION: 

Background 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 provides for the 

regulation of certain biological agents 

and toxins that have the potential to 

pose a severe threat to both human and 

animal health, to animal health, to plant 

health, or to animal and plant products. 

The Animal and Plant Health Inspection 

Service (APHIS) has the primary 

responsibility for implementing the 

provisions of the Act within the 

Department of Agriculture (USDA). 

Plant Protection and Quarantine (PPQ) 

select agents and toxins are those that 

have been determined to have the 

potential to pose a severe threat to plant 

health or plant products. Veterinary 

Services (VS) select agents and toxins 

are those that have been determined to 

have the potential to pose a severe 

threat to animal health or animal 

products. Overlap select agents and 

toxins—i.e., those determined to have 

the potential to pose a severe threat to 

public health and to animal health or 

animal products—are subject to 

regulation by both APHIS and the 

Centers for Disease Control and 

Prevention (CDC), which has the 

primary responsibility for implementing 

the provisions of the Act for the 

Department of Health and Human 

Services (HHS). 

Subtitle B (which is cited as the 

‘‘Agricultural Bioterrorism Protection 

Act of 2002’’ and referred to below as 

the Act), section 212(a), provides, in 

part, that the Secretary of Agriculture 

(the Secretary) must establish by 

regulation a list of each biological agent 

and each toxin that the Secretary 

determines has the potential to pose a 

severe threat to animal or plant health, 

or to animal or plant products. 

Paragraph (a)(2) of section 212 requires 

the Secretary to review and republish 

the list every 2 years and to revise the 

list as necessary. 

In determining whether to include an 

agent or toxin on the list, the Act 

requires that the following criteria be 

considered: 

• The effect of exposure to the agent 

or toxin on animal or plant health, and 

on the production and marketability of 

animal or plant products; 

• The pathogenicity of the agent or 

the toxin and the methods by which the 

agent or toxin is transferred to animals 

or plants; 

• The availability and effectiveness of 

pharmacotherapies and prophylaxes to 

treat and prevent any illness caused by 

the agent or toxin; and 

• Any other criteria that the Secretary 

considers appropriate to protect animal 

or plant health, or animal or plant 

products. 

On August 28, 2007, in accordance 

with the Act, we published in the 

Federal Register (72 FR 49231–49236, 

Docket No. APHIS–2007–0033) a 

proposal 1 to amend and republish the 

list of select agents and toxins that have 

the potential to pose a severe threat to 

animal or plant health, or to animal or 

plant products. 

We solicited comments concerning 

our proposal for 60 days ending October 

29, 2007. We received 41 comments by 

that date. On November 16, 2007, we 

published a notice in the Federal 

Register (72 FR 64540) to reopen the 

comment period for an additional 15 

days to allow interested persons 

additional time to prepare and submit 

comments. We received an additional 

21 comments by the December 3, 2007, 

close of the reopened comment period, 

for a total of 62 comments. The 

comments we received on the proposed 

rule were from academic institutions, 

professional associations, corporations, 

nonprofit organizations, individuals, 

and representatives of State and Federal 

Government agencies. The comments 

are discussed below. 

PPQ Select Agents and Toxins 

The list of PPQ select agents and 

toxins in 7 CFR 331.3 has included 

entries for Candidatus Liberobacter 

asiaticus and Candidatus Liberobacter 

africanus. In our proposed rule, we 

proposed to add Candidatus 

Liberobacter americanus to the list and 

to remove the entry for Candidatus 

Liberobacter asiaticus. 

Many commenters supported the 

proposed delisting of Candidatus 

Liberobacter asiaticus, but opposed the 

proposed listing of Candidatus 

Liberobacter americanus, arguing that 

the presence of citrus greening disease 

in Florida makes both plant pathogens 

unlikely agents of bioterrorism. A 


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61326 Federal Register / Vol. 73, No. 201 / Thursday, October 16, 2008 / Rules and Regulations 

majority of those commenters also 

recommended that that Candidatus 

Liberobacter africanus should also be 

removed from the list of PPQ select 

agents and toxins for that same reason. 

Those commenters pointed out that in 

the field there are no apparent 

differences in the biology of the three 

plant pathogens and that there are few, 

if any, established polymerase chain 

reaction primers available to distinguish 

among them. Only one commenter 

supported the proposed listing of 

Candidatus Liberobacter americanus 

based on the assertion that it is more 

readily transmittable than Candidatus 

Liberobacter asiaticus; however, we are 

unaware of any evidence to support that 

specific assertion. 

In response to the points raised by 

these commenters, we have reevaluated 

the available science. We agree with the 

commenters that it is difficult to 

distinguish between the three plant 

pathogens. In fact, in the Citrus Health 

Response Program developed by APHIS 

and Florida regulatory officials in 

consultation with the Florida citrus 

industry and other stakeholders, the 

management responses for the three 

bacterial species are identical. Further, 

we agree that the presence of citrus 

greening disease in Florida makes them 

unlikely agents of bioterrorism, as does 

the long latency period of the disease. 

Therefore, in this final rule, in addition 

to delisting Candidatus Liberobacter 

asiaticus as proposed, we are also 

removing Candidatus Liberobacter 

africanus from the list of PPQ select 

agent and toxins and have decided not 

to list Candidatus Liberobacter 

americanus as we had originally 

proposed. 

The list of PPQ select agents and 

toxins has included an entry for 

Xanthomonas oryzae pv. oryzicola. In 

our proposed rule, we proposed to 

remove the pathovar designation (pv. 

oryzicola) from the currently listed 

organism and thus regulate both 

pathovars of Xanthomonas oryzae (i.e., 

both oryzicola and oryzae). 

Several commenters argued that the 

proposed removal of the pathovar 

designation from Xanthomonas oryzae 

pv. oryzicola is unnecessary because the 

exposure of Xanthomonas oryzae pv. 

oryzae in the United States carries low 

risk for significant and ongoing damage, 

and effective management practices and 

treatments make establishment unlikely. 

Most of these commenters also 

recommended that we remove both 

pathovars from our list. 

We agree that there are effective 

response and recovery plans in 

development for treatment and 

management of these pathovars 

(oryzicola and oryzae). However, we do 

not believe that this alone is a sufficient 

reason to remove these agents from the 

list of select agents and toxins at this 

time. Both pathovars represent a 

significant risk to U.S. rice production. 

Until we obtain more scientific 

information to allow us to better 

evaluate the potential consequences of 

removing the pathovars from the list of 

select agents and toxins, and until we 

have identified an effective test that can 

quickly and conclusively distinguish 

between the pathovars, we intend to 

regulate all pathovars of Xanthomonas 

oryzae as proposed. As more 

information becomes available, we will 

be in a better position to reevaluate the 

commenters’ recommendations. 

The list of PPQ select agents and 

toxins has included an entry for 

Peronosclerospora philippinensis. We 

proposed to add Peronosclerospora 

sacchari as a synonym of that organism 

because recent scientific research has 

shown that these two organisms are the 

same. 

One commenter did not agree with 

our proposed addition of 

Peronosclerospora sacchari as a 

synonym and cited evidence that 

Peronosclerospora philippinensis and 

Peronosclerospora sacchari may have 

differing host ranges to support his 

position. 

The evidence cited by the commenter 

is not sufficient to convince us that we 

should not add Peronosclerospora 

sacchari as a synonym of 

Peronosclerospora philippinensis. 

While we do not believe there is 

currently sufficient science to confirm 

the potential speciation pointed to by 

the commenter, we are open to 

reconsidering the issue as new data are 

published. 

We proposed to add Phoma 

glycinicola (formerly Pyrenochaeta 

glycines), which causes red leaf blotch 

of soybean, to the list of PPQ select 

agents and toxins. 

One commenter was opposed to 

listing Phoma glycinicola as a select 

agent. The commenter stated that the 

pathogen is not conducive to 

widespread movement, effective 

chemical treatments are available, and 

the advanced knowledge of plant 

pathology required to isolate the 

pathogen makes it unsuitable as a 

potential weapon of terrorism. However, 

much of the evidence cited by the 

commenter was anecdotal and did not 

provide an adequate basis for not 

including this aggressive fungus, which 

is not currently present in the United 

States, on the list of PPQ select agents 

and toxins. Therefore, we are adding 

Phoma glycinicola to the list of PPQ 

select agents and toxins as proposed. 

We will review this listing in the future 

and would consider removing this 

pathogen from the list of PPQ select 

agents and toxins should new scientific 

information become available to support 

such an action. 

We proposed to add Phytophthora 

kernoviae to the list of PPQ select agents 

and toxins based, in part, on our 

identification of this pathogen as a 

serious threat to the nursery industry 

and woodland areas. 

One commenter argued that 

Phytophthora kernoviae should not be 

listed as a select agent based on 

evidence that it is primarily a forest 

pathogen and has not been found in the 

nursery industry as initially believed; 

accordingly, the effects of exposure on 

the production and marketability of 

plant products would be minimal. 

Further, the commenter stated that 

evidence suggests that the current 

regulatory systems and surveys for 

Phytophthora ramorum could be 

effectively applied toward the control of 

Phytophthora kernoviae. 

We agree with this commenter’s point 

that current regulatory systems and 

surveys for Phytophthora ramorum 

could be effectively applied toward the 

surveillance for Phytophthora 

kernoviae. Based on this consideration 

and due to a clearer understanding of 

the epidemiology of Phytophthora 

kernoviae that suggests a reduction in 

the initially determined host range of 

the pathogen, we have decided that 

Phytophthora kernoviae should not be 

listed as a select agent. We note that a 

plant pest permit issued under our 

regulations in 7 CFR part 330 will still 

be required for the importation or 

interstate movement of Phytophthora 

kernoviae, however. 

We proposed to add Rathayibacter 

toxicus, a bacterium that causes 

gumming disease in ryegrass, to the list 

of PPQ select agents and toxins. 

One commenter supported the 

proposed listing, but recommended that 

APHIS develop a reliable diagnostic tool 

to differentiate between Rathayibacter 

toxicus and the related, non-toxic 

species Rathayibacter rathayi. This 

commenter stated it is critically 

important to be able to distinguish 

between the two species for the 

purposes of cooperative pest surveys 

and for phytosanitary certification 

purposes. We agree that it is important 

to develop a diagnostic tool to 

distinguish between these two species 

and note that the USDA’s Agricultural 

Research Service is conducting an 

ongoing research project focused on the 

identification, molecular 

characterization, and detection of 


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foreign and newly emerging domestic 

bacteria (including Rathayibacter 

toxicus). However, this is not a basis for 

not including Rathayibacter toxicus on 

the select agent list. 

Overlap and VS Select Agents and 

Toxins 

We proposed to remove 10 of the 20 

overlap select agents and toxins from 

the list in 9 CFR 121.4(b). Specifically, 

we proposed to remove three bacteria 

(Botulinum neurotoxin producing 

species of Clostridium, Coxiella 

burnetii, and Francisella tularensis), a 

fungus (Coccidioides immitis), a virus 

(Eastern equine encephalitis virus), and 

five toxins (Botulinum neurotoxins, 

Clostridium perfringens epsilon toxin, 

shigatoxin, staphylococcal enterotoxin, 

and T–2 toxin). 

One commenter was opposed to the 

removal of botulinum neurotoxins and 

botulinum neurotoxin producing 

species of Clostridium from the list of 

overlap select agents and toxins. The 

commenter argued that the presence of 

a select agent in the environment does 

not minimize the potential for its use as 

a weapon of bioterrorism, which would 

result in clear economic and societal 

consequences. 

We do not minimize the fact that 

botulinum neurotoxins and botulinum 

neurotoxin producing species of 

Clostridium can present a significant 

health risk to livestock; indeed, these 

neurotoxins are some of the most lethal 

substances known to animals, and could 

cause the death of many animals in 

large herds. However, we do not agree 

that the intentional use of botulinum 

neurotoxins would have a significant 

impact on U.S. export trade in animals 

and animal products, or have a longterm impact on U.S. agriculture. Based 

on evidence that transmissibility from 

animal to animal is negligible and that, 

historically, outbreaks of botulism occur 

periodically in the United States, we 

have determined that botulinum 

neurotoxins are a poor agroterrorism 

weapon, and we should, therefore, 

remove botulinum neurotoxins and 

botulinum neurotoxin producing 

species of Clostridium from the list of 

overlap select agents in our regulations 

in § 121.4(b). It should be noted, 

however, that botulinum neurotoxins 

and botulinum neurotoxin producing 

species of Clostridium will continue to 

be regulated by the CDC under its select 

agent and toxins regulations in 42 CFR 

part 73 due to their potential threat to 

human health. 

One commenter asked that we clarify 

which strains of vesicular stomatitis 

virus (VSV) APHIS considers to be 

exotic. 

Although we did not propose to make 

any changes in the regulations with 

respect to VSV, we agree that it would 

be helpful to clarify which subtypes of 

VSV we consider to be exotic. Two 

major serotypes of VSV, New Jersey 

(VSV–NJ or VSNJV) and Indiana (VSV– 

IN1 or VSIV), have been reported to 

cause classical vesicular stomatitis 

disease in agriculturally significant 

animals (i.e., cattle, horses, and swine) 

throughout the Americas. Two subtypes 

of the Indiana serotype, Cocal (VSIV– 

IN2 or VSIV–2) and Alagoas (VSV–IN3 

or VSIV–3), cause vesicular disease in 

livestock in Brazil and Argentina. In the 

United States, VSV has not become 

established, but domestic outbreaks of 

VSV caused by VSV–NJ and VSV–IN1 

occur sporadically in cycles. Therefore, 

we have clarified in the regulations that 

the listed VS select agent ‘‘vesicular 

stomatitis virus (exotic)’’ refers to 

Indiana subtypes VSV–IN2 and VSV– 

IN3. 

Two commenters involved in the 

development of veterinary biological 

products noted that 4 of the 10 overlap 

select agents and toxins that APHIS had 

proposed to remove from its list in 

§ 121.4 were agents that the veterinary 

biologics industry uses to manufacture 

licensed veterinary biologics or uses in 

product research and development. 

Noting that the veterinary biologics 

industry has a well-established 

relationship with APHIS’ Center for 

Veterinary Biologics (CVB), the 

commenters were concerned about what 

may happen when APHIS no longer has 

a role in regulating those agents as select 

agents or toxins. The commenters 

suggested that: 

• The agents should be removed from 

the CDC select agent list to mirror their 

delisting by APHIS; 

• CDC should exempt the use of the 

agents in the manufacture of veterinary 

biologics by CVB-licensed facilities and 

their investigation use under CVB 

supervision; 

• APHIS should keep the agents on 

the overlap list; or 

• CDC should utilize APHIS/CVB for 

oversight and inspection of CVBlicensed firms. 

We acknowledge that there will be 

some entities that produce veterinary 

biologics that will now possess select 

agents or toxins regulated only by CDC, 

so the APHIS select agent program will 

not be part of the inspection process at 

those facilities unless the facility also 

possesses VS select agents or toxins. In 

either case, however, CVB will continue 

to conduct its own compliance 

inspections and otherwise exercise 

oversight of veterinary biologics 

facilities in keeping with its 

responsibilities under the Virus-SerumToxin Act (VSTA). The compliance 

inspections conducted by CVB under 

the VSTA are separate and distinct from 

the inspections conducted under the 

select agent program, and there will be 

no disruption or change in the way CVB 

conducts those compliance inspections 

as a result of the removal of select 

agents and toxins from the overlap list. 

As for the select agent program, we note 

that the regulations administered by 

APHIS and CDC are entirely consistent 

with each other, so there will be no 

change in security requirements, 

registration procedures, restrictions, 

exemptions, etc. With respect to 

inspections and other activities 

conducted under the select agent 

program, APHIS and CDC have 

established procedures that ensure close 

coordination and consistency in the 

regulation of select agents and toxins. 

We do not, therefore, believe that it is 

necessary to make any of the changes 

suggested by the commenters in order to 

ensure the continuing efficiency and 

consistency of the regulation of select 

agents and toxins by APHIS and CDC. 

Other Comments 

Several commenters argued that the 

cost to upgrade security at existing 

facilities was prohibitive. One 

commenter stated that the cost of 

compliance with the regulations at his 

facility came to almost $150,000. Other 

commenters asserted that research 

facilities that possess, use, or transfer a 

select agent or toxin would be forced to 

close due to dramatic increases in the 

cost of research, or that research 

programs will be impeded by the 

regulatory requirements or even 

terminated because researchers and 

their institutions will not want to deal 

with the new regulatory requirements or 

be liable for violations of the 

regulations. 

In our economic analysis for the 

proposed rule, we stated that an entity 

that possesses a newly added agent will 

have to comply with the regulations, 

and may therefore incur cost. We also 

noted that the costs to comply with the 

security requirements are site-specific 

and will vary accordingly. In this final 

rule, we reiterate that compliance with 

the regulations can be achieved in a 

wide variety of ways, and while some of 

these methods can be expensive, the 

regulations do not specify how the 

physical security needs (limiting access 

to the agents) are to be met, only that 

they are to be commensurate with the 

threat that the select agent or toxin 

poses. Therefore, an entity can choose 

the most cost-effective alternative to 

meeting those needs. Often an entity’s 


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61328 Federal Register / Vol. 73, No. 201 / Thursday, October 16, 2008 / Rules and Regulations 

standard operating procedures for 

security are sufficient. Accordingly, 

research facilities that possess, use, or 

transfer a select agent or toxin may not 

be forced to close, as one commenter 

fears, due to an increased cost of 

research. 

We were required by the Act to 

establish, by regulation, standards and 

procedures governing the possession, 

use, and transfer of listed biological 

agents and toxins in order to protect 

animal and plant health, and animal 

and plant products. Those standards 

and procedures were established in an 

interim rule published in the Federal 

Register on December 13, 2002, and 

effective on February 11, 2003. To date, 

the commenters’ concerns about the 

costs or difficulties of complying with 

the regulations have failed to 

materialize. 

Several commenters argued that the 

process of registering an entity is 

excessively time-consuming and that 

the regulations entail additional 

recordkeeping requirements. One 

commenter claimed that the process of 

approval (Federal Bureau of 

Investigation (FBI) checks, security 

plans, lab and greenhouse 

modifications, training, and inspection) 

took more than 1 year. 

Registered entities must develop and 

implement a written security plan that 

provides graded protection in 

accordance with the risk of the select 

agent or toxin, given its intended use, 

and must develop and implement a 

written biosafety/biocontainment plan 

that is commensurate with the risk of 

the agent or toxin, given its intended 

use. Registered entities must also 

develop and implement a written 

incident response plan that describes 

the entity’s response procedures for 

releases, theft, or loss of a select agent 

or toxin, etc. These reporting and 

recordkeeping requirements have been 

reviewed and approved by the Office of 

Management and Budget in accordance 

with the Paperwork Reduction Act. As 

for the length of time it took the one 

commenter’s facility to become 

registered, there are a variety of factors 

that could have contributed to such a 

lengthy process, but we are unaware of 

the particular circumstances of the 

commenter’s experience. We do note 

that the necessary security risk 

assessment (SRA) checks are provided 

free of charge by the FBI and take 

approximately 45 days to complete, and 

that APHIS and CDC are committed to 

ensuring that the registration process is 

conducted as efficiently as possible. 

One commenter stated that we need a 

mechanism that would allow the timely 

delisting of a newly detected select 

agent if it is found to be widely 

distributed and ineradicable. 

Given that the Administrative 

Procedure Act provides that an agency 

may, with a showing of good cause, 

make a rule effective in less than 30 

days and without prior opportunity for 

public comment, we do not believe it is 

necessary for us to establish any new 

mechanism for delisting or otherwise 

amending the regulations. 

We received many comments that 

recommended we remove specific PPQ, 

VS, and overlap select agents from the 

lists in 7 CFR part 331 and 9 CFR part 

121. The PPQ select agents specifically 

mentioned were Ralstonia 

solanacearum, race 3, biovar 2; 

Sclerophthora rayssiae var. zeae; 

Synchytrium endobioticum; and Xylella 

fastidiosa (citrus variegated chlorosis 

strain), and the VS select agents 

mentioned were the bovine spongiform 

encephalopathy agent and Venezuelan 

equine encephalitis virus. These 

commenters supplied detailed 

information to support their position 

that these select agents should be 

delisted; in most cases, the commenters 

asserted that the continued listing of 

specific agents they considered low 

risks for bioterrorism was prohibitive 

and impeded timely research. 

Conversely, another commenter 

submitted information supporting his 

contention that the agents that cause 

scrapie and chronic wasting disease 

should be added to the list of VS select 

agents and toxins. 

We will take the information provided 

by the commenters into account as we 

continue to review our regulations and 

anticipate that we will be providing an 

opportunity in the future for affected 

entities and the general public to offer 

suggestions for adding or eliminating 

select agents and toxins to or from the 

lists in our regulations. We will use the 

information provided by the 

commenters as we consider the 

potential regulatory changes that may be 

part of our next proposed rule. 

Miscellaneous Change 

We are making one other change in 

this final rule. In the proposed rule, we 

included an explanatory footnote to the 

entry for ‘‘virulent Newcastle disease 

virus’’ in the proposed list of VS select 

agents and toxins. This footnote read: 

‘‘A virulent Newcastle disease virus 

(avian paramyxovirus serotype 1) has an 

intracerebral pathogenicity index in 

day-old chicks (Gallus gallus) of 0.7 or 

greater or having an amino acid 

sequence at the fusion (F) protein 

cleavage site that is consistent with 

virulent strains of Newcastle disease 

virus.’’ We are replacing the word 

‘‘having’’ in the proposed footnote with 

the word ‘‘has.’’ In addition, we are 

adding a sentence to further clarify the 

definition: ‘‘A failure to detect a 

cleavage site that is consistent with 

virulent strains does not confirm the 

absence of a virulent virus.’’ This 

sentence will provide additional 

guidance to entities in determining 

whether they possess a virulent strain of 

Newcastle disease virus. 

Compliance Dates 

We recognize that there may be some 

entities that are not currently registered 

under the select agents program, but 

that possess one of the PPQ select agents 

being added to the regulations by this 

final rule. The PPQ select agents we are 

adding to the regulations in 7 CFR part 

331 are: 

• Xanthomonas oryzae pv. oryzae, 

• Peronosclerospora sacchari, 

• Phoma glycinicola (formerly 

Pyrenochaeta glycines), and 

• Rathayibacter toxicus. 

In addition, although it is not likely, 

the redefinition of Newcastle disease 

virus (velogenic) to virulent Newcastle 

disease virus may lead to new 

registrants, as it is possible that 

additional entities may be in possession 

of a virulent strain of Newcastle disease 

virus that does not fit the current 

definition. 

Accordingly, entities that currently 

possess one of those four agents or a 

strain of Newcastle disease virus that we 

now define as virulent, if they are not 

already registered entities, will have to 

either transfer the organism to a 

registered entity or become a registered 

entity themselves as a result of this final 

rule. Those entities that choose to 

become registered will need time to 

come into full compliance with the 

requirements of the regulations. 

This final rule will become effective 

on November 17, 2008. On and after that 

date, any individual or entity 

possessing, using, or transferring any 

listed agent or toxin must be in 

compliance with the provisions of each 

part. 

However, to minimize the disruption 

of research or educational projects (e.g., 

teaching demonstrations) involving 

listed select agents or toxins that were 

underway as of the effective date of 

these regulations, we provide that any 

individual or entity possessing such 

agents or toxins as of the effective date 

(current possessors) will be afforded 

additional time to reach full compliance 

with the regulations in each part. 

Accordingly, by November 17, 2008, the 

responsible official at all entities that 

possess a new agent or toxin must 

provide notice to APHIS regarding their 


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Federal Register / Vol. 73, No. 201 / Thursday, October 16, 2008 / Rules and Regulations 61329 

2Making the Nation Safer: The Role of Science 

and Technology in Countering Terrorism. 

Committee on Science and Technology for 

Countering Terrorism, Division on Engineering and 

Physical Sciences, National Research Council. 

National Academy Press (2002), and USDA 

National Agricultural Statistics Service, Prospective 

Plantings, March 30, 2007, Cr Pr 2–4, http:// 

www.usda.gov/nass/PUBS/TODAYRPT/ 

pspl0307.txt. 

3Buzby, J.C. Effects of food-safety perceptions on 

food demand and global trade. Changing Structure 

of Global Food Consumption and Trade/WRS–01– 

1. Economic Research Service/USDA. 

4Ekboir, J.M. Potential impact of foot-and-mouth 

disease in California: the role and contribution of 

animal health surveillance and monitoring services. 

Davis, CA: Agricultural Issues Center, Division of 

Agriculture and Natural Resources, University of 

California, Davis, 1999. 

5 DTZ Pieda Consulting. Economic Impact of BSE 

on the UK economy. A report commissioned by the 

UK Agricultural Departments and HM Treasury. 

possession of the new agent(s) and 

toxin(s). By April 14, 2008, all 

previously unregistered entities must be 

registered. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, with the changes discussed in this 

document. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This rule has been reviewed under 

Executive Order 12866. The rule has 

been determined to be not significant for 

the purposes of Executive Order 12866 

and, therefore, has not been reviewed by 

the Office of Management and Budget. 

In accordance with the Agricultural 

Bioterrorism Protection Act of 2002, we 

are amending and republishing the list 

of select agents and toxins that have the 

potential to pose a severe threat to 

animal or plant health, or to animal or 

plant products. The Act requires the 

biennial review and republication of the 

list of select agents and toxins and the 

revision of the list as necessary. This 

action implements the findings of the 

second biennial review of the list. 

Certain pathogens or toxins produced 

by biological organisms that are released 

intentionally or accidentally can result 

in disease, wide-ranging and devastating 

impacts on the economy, disruption to 

society, diminished confidence in 

public and private institutions, and 

large-scale loss of life. People or 

livestock can be exposed to these agents 

from inhalation, through the skin, or by 

the ingestion of contaminated food, 

feed, or water. Similarly, crops can be 

exposed to biological pathogens in 

several ways—at the seed stage, in the 

field, or after harvest. 

Because of its size and complexity, 

the U.S. food and agriculture system is 

vulnerable to deliberate attacks, 

particularly with foreign diseases that 

do not now occur domestically. The 

U.S. livestock industry, with revenues 

of approximately $150 billion annually, 

is extremely vulnerable to a host of 

highly infectious and often contagious 

biological agents that have been 

eradicated from the United States, or 

have never existed here. Many of these 

animal-targeted agents could simply be 

point-introduced into herds. Given the 

increasing concentration and 

specialization in the livestock 

industries, the introduction of a VS 

select agent or toxin could cause the 

immediate halt of movement and export 

of vast quantities of U.S. livestock and 

livestock products. Crops, too, are 

vulnerable. They are grown over very 

large areas (more than 75 million acres 

of soybeans were cultivated in the 

United States in 2006, for example), 

exacerbating difficulties in surveillance 

and monitoring.2

Preparedness for a biological attack 

against people, crops or livestock is 

complicated by the large number of 

potential agents, the long incubation 

periods of some agents, and the 

potential for secondary transmission. 

All of these factors make vital the 

prevention of the misuse of biological 

agents and toxins through registration, 

biosafety, and security measures and the 

availability of incident response 

capabilities. 

Section 212(a)(2) of the Act requires a 

biennial review and republication of the 

select biological agent and toxin list, 

with revisions as appropriate in 

accordance with this law. This rule will 

implement the recommendations of the 

second biennial review of the list. 

Expected benefits and costs are 

examined in accordance with Executive 

Order 12866. Expected impacts for 

small entities are also considered, as 

required by the Regulatory Flexibility 

Act. 

Benefits and Costs 

This rule updates the lists of select 

agents and toxins contained in the 

regulations in 7 CFR part 331 and 9 CFR 

part 121. The regulations require 

registration, biosafety, incident 

response, and security measures for the 

possession, use, and transfer of the 

listed select agents and toxins. The 

regulations are intended to prevent the 

misuse of those select agents and toxins, 

and therefore reduce the potential for 

those pathogens to harm humans, 

animals, animal products, plants, or 

plant products in the United States. 

Should any select agent or toxin be 

intentionally introduced into the United 

States, the consequences would be 

significant. Direct losses in agriculture 

could occur as a result of the exposure, 

such as death or debility of affected 

production animals, or yield loss for 

plants. Industry could also be affected 

through the imposition of domestic and 

foreign quarantines that result in a loss 

of markets. The Federal Government 

and State governments would also incur 

costs associated with eradication and 

quarantine enforcement to prevent 

further spread, and in the case of 

intentional introduction, law 

enforcement. In addition, there is the 

potential for a disruption in the 

domestic food supply, whether through 

contamination, consumer perception, or 

both. Past food safety incidents have 

shown that consumer perceptions (both 

domestic and international) about an 

implicated food product and about the 

producing country or sector’s ability to 

produce safe food are slow to recover 

and can have a lasting influence on food 

demand and global trade.3 As such, the 

benefits of the rule are the avoided 

losses of animals or plants that could be 

attacked by these organisms or toxic 

materials (because of the reduced risk of 

release of the select agents and reduced 

likelihood of exposure for susceptible 

animals or plants), the avoided public 

and private costs of eradication, and the 

avoided negative effects on products 

and markets. 

The costs associated with the 

outbreak of a select agent can be very 

high, as demonstrated, for example, by 

the losses to agriculture and the food 

chain from the foot-and-mouth disease 

(FMD) outbreak in the United Kingdom 

(UK) in 2001. Those costs amounted to 

about £3.1 billion ($4.7 billion). In 1999, 

it was estimated that the potential 

impacts of an FMD outbreak in 

California alone would be between $8.5 

and $13.5 billion.4 The bovine 

spongiform encephalopathy (BSE) crisis 

in the UK (which has a cattle industry 

about one-tenth the size of that in the 

United States) is another example. It has 

been estimated that the total resource 

costs to the UK economy as a result of 

BSE in the first 12 months after the 

onset of the 1996 crisis were in the 

range of £740 million to £980 million 

($1.2 to $1.5 billion), or just over 0.1 

percent of the gross domestic product of 

the United Kingdom.5 In addition, the 

UK lost its entire export market for beef. 

These are examples of consequences 

of natural or accidental disease 

introduction. Deliberate introduction 

greatly increases the probability of a 

select agent or toxin becoming 

established and causing wide-ranging 

and devastating impacts on an economy, 

disruption to society, diminished 

confidence in public and private 

institutions, and possible loss of life. 


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61330 Federal Register / Vol. 73, No. 201 / Thursday, October 16, 2008 / Rules and Regulations 

The entities most likely to be affected 

by this rule include research and 

diagnostic facilities, Federal, State, and 

university laboratories, and private 

commercial and non-profit enterprises. 

An entity that possesses, uses, or 

transfers listed select agents or toxins is 

required to comply with the select agent 

regulations. The regulations require 

registering the possession, transfer, or 

destruction of select agents or toxins. In 

addition, the entity is also required to 

ensure that the facility where the agent 

or toxin is housed has adequate 

biosafety and containment measures, 

that the physical security of the 

premises is adequate, that all 

individuals with access to select agents 

or toxins have appropriate training to 

handle such agents or toxins, and that 

complete records concerning activities 

related to the select agents or toxins are 

maintained. 

The changes to the PPQ select agent 

list include the addition of four 

organisms to the list, the removal of two 

organisms from the list, and technical 

changes for organisms currently listed. 

An entity that possesses a newly added 

agent or toxin will have to comply with 

the select agent regulations, and may 

therefore incur costs. These primarily 

involve becoming registered, 

maintaining an inventory of the agents 

and toxins, and limiting access to the 

agent or toxin to those individuals who 

are qualified, have a need to have access 

to a select agent or toxin, and have an 

SRA conducted by the FBI. This rule 

does not change the process for 

obtaining the agents or toxins (i.e., a 

permit is required regardless of whether 

an organism is listed as a select agent) 

or the bio-containment requirements as 

set forth in the existing permitting 

process. Necessary SRA checks are 

performed free of charge by the FBI and 

take approximately 45 days to complete. 

Limiting access to the listed agents or 

toxins can be achieved in a wide variety 

of ways. Some of these methods can be 

very expensive. For example, installing 

new state-of-the-art electronic 

surveillance equipment can run into the 

thousands of dollars even for a 

relatively small space. However, in most 

instances the physical security needs 

can be met with far less rigorous 

methods. Often an entity’s standard 

operating procedures for security are 

sufficient. Because many entities deal 

with select agents or toxins in an area 

that is fully contained within a larger 

structure, a lack of entry control 

equipment may not affect the level of 

graded protection. It should also be 

noted that only that portion of a given 

entity affected by select agent or toxin 

operations is required to be secured. 

The select agent regulations do not 

specify how the physical security needs 

(limiting access to the agents) are to be 

met, only that they need to be adequate 

for the situation. Therefore, an entity 

can choose the most cost-effective 

alternative to meet those needs. 

The changes should affect only a very 

small number of entities. The plant pest 

permit database maintained by APHIS 

indicates that very few entities currently 

possess any of the agents that are being 

added to the PPQ list. It is estimated 

that less than a total of 10 entities will 

be affected by changes to the plant list. 

In addition, most of the entities that do 

possess the newly added agents are 

already registered due to their 

possession of other listed select agents 

or toxins. After this rule goes into effect, 

entities will no longer be required to 

maintain records and security for those 

agents and toxins that are being 

removed from the select agent lists by 

this rule. However, the entities are still 

required to maintain select agent 

records for 3 years past the time they 

were regulated under 7 CFR part 331 or 

9 CFR part 121. Additionally, permits 

are still required under 7 CFR part 330 

or 9 CFR part 122 for those agents and 

toxins that have been removed from the 

lists. These changes should have little 

impact. 

The changes to the VS select agent list 

include the removal of agents, the 

redefinition of an agent, and technical 

changes to the nomenclature used for 

some agents in the list to be consistent 

with current scientific literature. The 

agents that will be removed are overlap 

select agents and toxins regulated by 

both USDA and HHS. Any entity that is 

in possession of the overlap select 

agents and toxins that are to be 

removed, and that does not possess any 

other overlap agents or toxins or any of 

the APHIS select agents or toxins, will 

subsequently possess HHS-only agents 

and toxins and will thus continue to be 

subject to select agent regulations as 

administered by HHS. In addition, the 

organisms that will be removed from the 

lists of select agents and toxins 

(Botulinum neurotoxin producing 

species of Clostridium, Coxiella 

burnetii, and Francisella tularensis; the 

fungus Coccidioides immitis; and 

Eastern equine encephalitis virus) will 

continue to be subject to the regulations 

under 9 CFR part 122. The redefinition 

of Newcastle disease virus (velogenic) to 

virulent Newcastle disease virus may 

lead to new registrants. It is possible 

that additional entities may be in 

possession of a virulent strain of 

Newcastle disease virus that does not fit 

the current definition. However, these 

strains have not been circulating in the 

United States since the 1970s. Those 

entities most likely to be in possession 

of virulent Newcastle disease virus are 

those already in possession of 

Newcastle disease virus (velogenic) and 

therefore already registered. Therefore, 

these changes should have little impact. 

Alternatives Considered 

The alternative to this rule would be 

to leave the regulations unchanged. In 

this case, the lists of select agents in 7 

CFR part 331 and 9 CFR part 121 would 

remain unchanged. However, APHIS 

has conducted reviews of these lists and 

concluded that changes are necessary to 

ensure that the lists contain those 

biological agents and toxins that have 

the potential to pose a severe threat to 

both human and animal health, to plant 

health, or to animal and plant products. 

These reviews were conducted in 

accordance with the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002, which 

requires a biennial review and 

republication of the select biological 

agent and toxin list, with revisions as 

appropriate. Therefore, this alternative 

was rejected. 

Conclusion 

This rule will update the PPQ, VS, 

and overlap select agent lists. The 

regulation of select agents is intended to 

prevent their misuse and thereby reduce 

the potential for those agents and toxins 

to harm animals, animal products, 

plants, or plant products in the United 

States. Should any select agent or toxin 

be intentionally introduced into the 

United States, the consequences could 

be significant. Consequences could 

include disruption of markets, 

difficulties in sustaining an adequate 

food and fiber supply, and the potential 

spread of disease infestations over large 

areas. In any animal or plant disease 

outbreak, the Government would incur 

costs of eradication. Industry would be 

affected through the imposition of 

domestic and foreign quarantines that 

result in a loss of markets and the 

destruction of animals or plants found 

to be infected with the disease. Even 

though entities may be compensated for 

the destroyed property, repopulating 

(flocks, herds, fields, etc.) can take time, 

with additional losses incurred due to 

idle capital and lost markets. In 

addition, there is the potential for a 

disruption in the domestic food supply, 

whether through contamination, 

consumer perception, or both. Such a 

disruption can have a lasting influence 

on food demand and global trade. 

The entities most likely to be affected 

by this rule are those laboratories and 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 73, No. 201 / Thursday, October 16, 2008 / Rules and Regulations 61331 

1A virulent Newcastle disease virus (avian 

paramyxovirus serotype 1) has an intracerebral 

pathogenicity index in day-old chicks (Gallus 

gallus) of 0.7 or greater or has an amino acid 

sequence at the fusion (F) protein cleavage site that 

is consistent with virulent strains of Newcastle 

disease virus. A failure to detect a cleavage site that 

is consistent with virulent strains does not confirm 

the absence of a virulent virus. 

other institutions conducting research 

and related activities that involve the 

use of the newly added select agents 

and toxins. The impact of these changes 

is expected to be minimal, however. 

Indications are that very few entities 

currently possess any of the agents or 

toxins that are being added to the list of 

select agents and toxins. Moreover, after 

this rule goes into effect, entities will no 

longer be required to maintain records 

and security for those agents and toxins 

that are being removed from the select 

agent lists by this rule. However, the 

entities are still required to maintain 

select agent records for 3 years past the 

time they were regulated under 7 CFR 

part 331 or 9 CFR part 121. 

Additionally, permits are still required 

under 7 CFR part 330 or 9 CFR part 122 

for those agents and toxins that have 

been removed from the lists. Other 

changes do not affect what select agents 

or toxins are listed but rather the 

nomenclature by which those agents 

and toxins are identified, and therefore 

should have no economic impact on 

holders of those organisms or toxic 

materials. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

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.) 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Preempts 

all State and local laws and regulations 

that are inconsistent with this rule; (2) 

has no retroactive effect; and (3) does 

not require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Paperwork Reduction Act 

This final rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

List of Subjects 

7 CFR Part 331 

Agricultural research, Laboratories, 

Plant diseases and pests, Reporting and 

recordkeeping requirements. 

9 CFR Part 121 

Agricultural research, Animal 

diseases, Laboratories, Medical research, 

Reporting and recordkeeping 

requirements. 

■ Accordingly, we are amending 7 CFR 

part 331 and 9 CFR part 121 as follows: 

Title 7—[Amended] 

PART 331—POSSESSION, USE, AND 

TRANSFER OF SELECT AGENTS AND 

TOXINS 

■ 1. The authority citation for part 331 

continues to read as follows: 

Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, 

and 371.3. 

■ 2. In § 331.3, paragraph (b) is revised 

to read as follows: 

§ 331.3 PPQ select agents and toxins. 

* * * * * 

(b) PPQ select agents and toxins: 

Peronosclerospora philippinensis 

(Peronosclerospora sacchari); 

Phoma glycinicola (formerly 

Pyrenochaeta glycines); 

Ralstonia solanacearum, race 3, biovar 

2; 

Rathayibacter toxicus; 

Sclerophthora rayssiae var. zeae; 

Synchytrium endobioticum; 

Xanthomonas oryzae; 

Xylella fastidiosa (citrus variegated 

chlorosis strain). 

* * * * * 

Title 9—[Amended] 

PART 121—POSSESSION, USE, AND 

TRANSFER OF SELECT AGENTS AND 

TOXINS 

■ 3. The authority citation for part 121 

continues to read as follows: 

Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, 

and 371.4. 

■ 4. In part 121, footnotes 1 through 14 

are redesignated as footnotes 2 through 

15, respectively. 

■ 5. In § 121.3, paragraph (b) is revised 

to read as follows: 

§ 121.3 VS select agents and toxins. 

* * * * * 

(b) VS select agents and toxins: 

African horse sickness virus; 

African swine fever virus; 

Akabane virus; 

Avian influenza virus (highly 

pathogenic); 

Bluetongue virus (exotic); 

Bovine spongiform encephalopathy 

agent; 

Camel pox virus; 

Classical swine fever virus; 

Ehrlichia ruminantium (Heartwater); 

Foot-and-mouth disease virus; 

Goat pox virus; 

Japanese encephalitis virus; 

Lumpy skin disease virus; 

Malignant catarrhal fever virus 

(Alcelaphine herpesvirus type 1); 

Menangle virus; 

Mycoplasma capricolum subspecies 

capripneumoniae (contagious caprine 

pleuropneumonia); 

Mycoplasma mycoides subspecies 

mycoides small colony (MmmSC) 

(contagious bovine 

pleuropneumonia); 

Peste des petits ruminants virus; 

Rinderpest virus; 

Sheep pox virus; 

Swine vesicular disease virus; 

Vesicular stomatitis virus (exotic): 

Indiana subtypes VSV–IN2, VSV–IN3; 

Virulent Newcastle disease virus 1

* * * * * 

■ 6. Section 121.4 is amended as 

follows: 

■ a. By revising paragraph (b) to read as 

set forth below. 

■ b. By removing paragraph (d)(3). 

■ c. In paragraph (f)(3)(i), by removing 

the words ‘‘Botulinum neurotoxins,’’ 

and ‘‘Francisella tularensis,’’. 

§ 121.4 Overlap select agents and toxins. 

* * * * * 

(b) Overlap select agents and toxins: 

Bacillus anthracis; 

Brucella abortus; 

Brucella melitensis; 

Brucella suis; 

Burkholderia mallei; 

Burkholderia pseudomallei; 

Hendra virus; 

Nipah virus; 

Rift Valley fever virus; 

Venezuelan equine encephalitis virus. 

* * * * * 

§ 121.5 [Amended] 

■ 7. In § 121.5, paragraph (a)(3)(i) is 

amended by removing the words 

‘‘Newcastle disease virus (velogenic)’’ 

and adding the words ‘‘virulent 

Newcastle disease virus’’ in their place. 

§ 121.6 [Amended] 

■ 8. In § 121.6, paragraph (a)(3)(i) is 

amended by removing the words 

‘‘Botulinum neurotoxins,’’ and 

‘‘Francisella tularensis,’’. 


rwilkins on PROD1PC63 with NOTICES
61332 Federal Register / Vol. 73, No. 201 / Thursday, October 16, 2008 / Rules and Regulations 

§ 121.9 [Amended] 

■ 9. In § 121.9, paragraph (c)(1) is 

amended by removing the words 

‘‘Botulinum neurotoxins,’’ and 

‘‘Francisella tularensis,’’, and by 

removing the words ‘‘Newcastle disease 

virus (velogenic)’’ and adding the words 

‘‘virulent Newcastle disease virus’’ in 

their place. 

Done in Washington, DC, this 3rd day of 

October 2008. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E8–23887 Filed 10–15–08; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

8 CFR Parts 214 and 248 

[CIS No. 2429–07; DHS Docket No. USCIS– 

2007–0056] 

RIN 1615–AB64 

Period of Admission and Extension of 

Stay for Canadian and Mexican 

Citizens Engaged in Professional 

Business Activities—TN 

Nonimmigrants 

AGENCY: U.S. Citizenship and 

Immigration Services, DHS. 

ACTION: Final rule. 

SUMMARY: The Department of Homeland 

Security (DHS) is amending its 

regulations to allow an increased period 

of admission and extension of stay for 

Canadian and Mexican citizens who 

seek temporary entry to the United 

States as professionals pursuant to the 

TN classification, as established by the 

North American Free Trade Agreement 

(NAFTA or Agreement). This final rule 

increases the maximum allowable 

period of admission for TN 

nonimmigrants from one year to three 

years, and allows otherwise eligible TN 

nonimmigrants to be granted an 

extension of stay in increments of up to 

three years instead of the current 

maximum of one year. In addition, this 

rule grants the same periods of 

admission or extension to TD 

nonimmigrants, the spouses and 

unmarried minor children of TN 

nonimmigrants to run concurrent. The 

rule also removes the mention of 

specific petition filing locations from 

the TN regulations and replaces the 

outdated term ‘‘TC’’ (the previous term 

given to Canadian workers under the 

1989 Canada-United States Free Trade 

Agreement) with ‘‘TN.’’ This rule will 

reduce the administrative burden of the 

TN classification on USCIS, and will 

ease the entry of eligible professionals to 

the United States. 

DATES: This final rule is effective 

October 16, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Paola Rodriguez Hale, Adjudications 

Officer, Business and Trade Services, 

Office of Service Center Operations, 

U.S. Citizenship and Immigration 

Services, Department of Homeland 

Security, 20 Massachusetts Avenue, 

NW., 2nd Floor, Washington, DC 20529, 

telephone (202) 272–8410. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. NAFTA and the TN Classification 

NAFTA and the NAFTA 

Implementation Act, Public Law 103– 

182, redesignated section 214(e) of the 

Immigration and Nationality Act (INA) 

to create the ‘‘trade NAFTA’’ (TN) 

nonimmigrant classification and 

provide for the temporary entry of 

qualified business persons from each of 

the countries that signed the Agreement. 

The TN nonimmigrant classification 

permits qualified Canadian and 

Mexican citizens to seek temporary 

entry as business persons to engage in 

professional business activities at a 

professional level in the United States. 

8 CFR 214.6(a). DHS regulations 

currently require that TN 

nonimmigrants may be admitted to the 

United States for a period not to exceed 

one year. 8 CFR 214.6(e). The 

regulations further provide that TN 

professionals may apply for extensions 

of stay for a maximum period of one 

year. 8 CFR 214.6(h)(1). 

B. Proposed Rule 

On May 9, 2008, DHS published a 

notice of proposed rulemaking in the 

Federal Register at 73 FR 26340 

proposing a change in the period of 

admission and extension of stay granted 

to TN nonimmigrants from Canada and 

Mexico engaged in professional 

business activities. The notice also 

proposed granting the same period of 

admission or extension of stay to TN 

dependents (TD nonimmigrants), 

removing outdated references to specific 

filing locations and prior requirements, 

and replacing the outdated term TC 

with the current TN term. Written 

comments to the proposed rule were 

due on or before June 9, 2008. 

In this final rule, DHS is adopting the 

proposed rule with no changes. The 

proposed rule was, and this final rule is, 

intended to improve the administration 

of the TN program and make it more 

flexible and attractive to Canadian and 

Mexican professionals and to employers 

in the United States. Currently, DHS 

regulations require TN nonimmigrants, 

to either seek readmission in TN status 

or apply for extensions of stay annually 

if they wish to remain in the United 

States beyond the period of their initial 

admission. 8 CFR 214.6(h). This 

requirement involves the annual 

submission of documentation and 

payment of filing fees. By removing 

these types of administrative 

requirements on TN employees and 

their U.S. employers, DHS will further 

the intent of NAFTA to facilitate the 

entry of eligible professionals into the 

United States. 

II. Comments Received in Response to 

the Proposed Rule 

DHS received 80 comments in 

response to the proposed rule. The 

majority of commenters (76) supported 

this rulemaking. Many of these 76 

commenters suggested additional 

changes or enhancements to the TN 

classification regulations which were 

not part of the proposed rule. Two 

commenters opposed the proposed rule. 

One of these two commenters asked 

questions about lawful permanent 

residence and educational opportunities 

for aliens in the TN classification, but 

did not express an opinion on the 

proposed rule. The second of these two 

commenters simply complained about a 

perceived slight to U.S. workers 

contained in another public comment. 

Many of the received comments raised 

issues that are beyond the scope of this 

rulemaking but will be mentioned 

briefly as part of this disposition of the 

comments. 

A. Increase to Three Years for 

Admissions and Extensions of Stay 

Comments on period of admission: 

The overwhelming majority of the 

commenters supported increasing the 

period of admission and extensions of 

stay granted to TN nonimmigrants from 

one to three years. Only two 

commenters opposed this proposal 

because they thought that jobs should be 

offered to U.S. workers rather than to 

foreign nationals. One commenter stated 

that the U.S. economy is suffering and 

jobs should thus be reserved for U.S. 

workers. The other commenter stated 

that the United States is presently 

flooded with immigrants and the TN 

program should be shut down while the 

country sorts out the problems with 

illegal immigrants present in the United 

States, and also made additional 

comments about aliens, politicians and 

the U.S. government in general. 


rwilkins on PROD1PC63 with NOTICES