7674 Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Rules and Regulations 

EPA APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE TEXAS SIP 

Name of SIP provision Applicable geographic or nonattainment area 

State 

submittal/ 

effective 

date 

EPA approval date Comments 

*******

On-Road Mobile Source Emissions Inventory and Motor 

Vehicle Emissions Budget 

Update.

Beaumont/Port Arthur, TX ..... 12/10/2012 2/4/2013 [Insert citation of 

publication in Federal Register].

MOVES update to motor vehicle emissions budgets. 

[FR Doc. 2013–02237 Filed 2–1–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. CDC–2011–0007] 

42 CFR Part 71 

RIN 0920–AA37 

Foreign Quarantine; Import 

Regulations for Infectious Biological 

Agents, Infectious Substances, and 

Vectors 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) within 

the Department of Health and Human 

Services (HHS) is issuing this final rule 

amending the regulations regarding the 

importation of infectious biological 

agents, infectious substances, and 

vectors. The amendments improve 

HHS/CDC’s ability to prevent the 

introduction, transmission, or spread of 

communicable diseases into the United 

States. 

DATES: The final rule is effective April 

5, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Robbin Weyant, Ph.D., Director, 

Division of Select Agents and Toxins, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE., MS 

A–46, Atlanta, GA 30333. Telephone: 

404–718–2000. 

SUPPLEMENTARY INFORMATION: The 

preamble is organized as follows: 

I. Background 

II. Statutory Authority 

III. Responses to Public Comments 

A. Definitions 

B. Infectious Biological Agent 

C. Biosafety 

D. Permit Exemptions 

E. Transportation 

F. Subsequent Transfer 

G. Miscellaneous 

IV. Required Regulatory Analyses Under 

Executive Orders 13563 and 12866 and 

Regulatory Flexibility Act 

V. Other Administrative Requirements 

A. Paperwork Reduction Act of 1995 

B. Executive Order 12988, Civil Justice 

Reform and Executive Order 13132, 

Federalism 

C. Plain Language in Government Writing 

I. Background 

On October 14, 2011, we published a 

proposed rule in the Federal Register 

(76 FR 63891) to clarify regulatory 

definitions, ensure adequate biosafety 

measures, increase oversight through 

inspections, to address permit 

exemptions and transportation 

requirements, and to describe an appeal 

process. The proposed rule provided a 

60-day public comment period that 

ended on December 13, 2011. 

This final rule contains provisions 

that apply to a variety of entities 

including academic institutions and 

biomedical centers, commercial 

manufacturing facilities, Federal, State, 

and local laboratories, including clinical 

and diagnostic laboratories, research 

facilities, exhibition facilities, and 

educational facilities. 

II. Statutory Authority 

This final rule is issued under the 

authority of Section 361 of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

264). This provision authorizes the 

Health and Human Services (HHS) 

Secretary to make and enforce such 

regulations as in her judgment are 

necessary to prevent the introduction, 

transmission, or spread of 

communicable diseases from foreign 

countries into the States or possessions 

of the United States and from one State 

or possession into any other State or 

possession. For purposes of carrying out 

and enforcing such regulations, the HHS 

Secretary may authorize a variety of 

public health measures, including 

inspection, fumigation, disinfection, 

sanitation, pest extermination, 

destruction of animals or articles found 

to be sources of dangerous infection to 

human beings, and other measures. 

The Foreign Quarantine regulations 

(42 CFR part 71) set forth provisions to 

prevent the introduction, transmission, 

and spread of communicable disease 

from foreign countries into the United 

States. Part 71, Subpart F (Importations) 

contains provisions for importation of 

etiological agents, hosts, and vectors (42 

CFR 71.54), requiring persons to obtain 

a permit issued by the CDC before 

importing, or distributing after import, 

any of these materials. 

III. Responses to Public Comment 

We received nine comments from 

academic, private and government 

facilities. The comments are discussed 

below. 

A. Definitions 

Commenters requested clarification 

about whether the definition of ‘‘vector’’ 

should (1) include an exemption for 

animals meant for a zoo, (2) address 

pelts or other objects meant for museum 

use or (3) limit the definition to the 

importation of live animals. Prior to 

entry into the United States and 

regardless of the purpose for the 

importation, a permit will continue to 

be required for any live animal or 

animal product (e.g., a mount, rug, or 

other display item composed of the 

hide, hair, skull, teeth, bones, or claws 

of an animal) unless (1) the animal or 

animal product is not known to transfer 

or to be capable of transferring an 

infectious biological agent to a human 

or (2) the animal product has been 

rendered noninfectious. The 

documentation may include a statement 

from a treating veterinarian, statement 

from a medical facility, medical 

certificate, or in the case of an animal 

product, documentary evidence, such as 

a veterinary or taxidermy certificate, 

describing how the material had been 

treated to render it noninfectious. Any 

live animal or animal product imported 

for scientific, educational or exhibition 

purposes (e.g., bats and bat products) 

will also continue to require a permit, 

unless accompanied by documentation 

indicating that the animal or animal 

product is not known to transfer or to 

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Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Rules and Regulations 7675 

be capable of transferring an infectious 

biological agent to a human or the 

product has been rendered 

noninfectious. 

The terms ‘‘educational purpose,’’ 

‘‘exhibition purpose’’ and ‘‘scientific 

purpose’’ are defined in 42 CFR 71.1. 

‘‘Scientific purpose’’ means ‘‘use for 

scientific research following a defined 

protocol and other standards for 

research projects as normally conducted 

at the university level. The term also 

includes the use for safety testing, 

potency testing, and other activities 

related to the production of medical 

products.’’ ‘‘Educational purpose’’ 

means ‘‘use in the teaching of a defined 

educational program at the university 

level or equivalent.’’ ‘‘Exhibition 

purpose’’ means ‘‘use as a part of a 

display in a facility comparable to a 

zoological park or in a trained animal 

act. The animal display must be open to 

the general public at routinely 

scheduled hours on 5 or more days of 

each week. The trained animal act must 

be routinely scheduled for multiple 

performances each week and open to 

the general public except for reasonable 

vacation and retraining periods.’’ 

One commenter urged HHS/CDC to 

modify the definition section to include 

a new definition for the term ‘‘infectious 

substance.’’ The commenter indicated 

that defining the term ‘‘infectious 

substance’’ in the context of applicable 

transportation standards and 

requirements for dangerous goods and 

hazardous materials would clarify HHS/ 

CDC’s expectations regarding the 

packaging and shipping of these 

materials and help applicants to better 

understand and address these issues. 

We agree with the commenter and are 

replacing the definition of ‘‘infectious 

material’’ with an ‘‘infectious 

substance’’ definition, which states ‘‘any 

material that is known or reasonably 

expected to contain an infectious 

biological agent.’’ This definition for 

‘‘infectious substance’’ is consistent 

with the definitions found in the 

Department of Transportation (DOT) 

regulations set forth at 49 CFR Part 171– 

180 (‘‘A material known or suspected to 

contain a pathogen:—a microorganism 

(including bacteria, viruses, parasites, 

fungi) or other agent, that can cause 

disease in humans or animals’’) and 

World Health Organization (WHO) 

Transport of Infectious Substances 

Standard (‘‘For the purposes of 

transport, infectious substances are 

defined as substances which are known 

or are reasonably expected to contain 

pathogens. Pathogens are defined as 

microorganisms (including bacteria, 

viruses, rickettsiae, parasites, fungi) and 

other agents such as prions, which can 

cause disease in humans or animals’’). 

A commenter recommended defining 

the term ‘‘biosafety measures,’’ which is 

used several times in the proposed 

regulatory language, to help importers 

prepare for use of these requirements 

and to assist in agency review of such 

measures before the issuance of a 

permit. The commenter recommended 

that ‘‘biosafety measures’’ be defined as 

‘‘standard microbiological practices, 

special practices, safety equipment 

(primary and personal protective 

equipment) and laboratory facilities 

(secondary barriers) as noted in the 

current edition of Biosafety in 

Microbiological and Biomedical 

Laboratories (BMBL) and additional 

safeguards as provided in the NIH 

Guidelines for recombinant and 

synthetic DNA if appropriate for the 

substance or material for which such 

measures are implemented.’’ We made 

no changes based on this comment. 

While the commenter provided 

excellent references, we believe that 

citing only these references is limiting 

since there are other references that 

provide useful recommendations for 

safely working with a variety of human 

pathogens (i.e., Occupational Safety and 

Health Administration (OSHA) 

regulations, World Health Organization 

guidance, etc.). 

B. Infectious Biological Agent 

One commenter noted that she was 

not aware of any medically important 

fungal agents that are communicable 

(transmissible from person to person), 

with the possible exception of 

dermatophyte agents (Epidermophyton, 

Microsporum, and Trichophyton). The 

commenter argued that the hazardous 

characteristics of dermatophyte agents 

are not sufficiently severe to merit 

regulation of these agents through the 

import permit mechanism. The 

commenter suggested that the regulatory 

text be clarified to list the fungal agents 

that would be regulated. The commenter 

further reasoned that Coccidioides 

species, Histoplasma capsulatum, and 

Blastomyces dermatitidis should no 

longer require an import permit since 

they do not cause communicable 

disease and are not transmissible from 

person to person. We made no changes 

based on this comment. Section 71.1 

(Scope and definitions) of Title 42, Code 

of Federal Regulations defines 

‘‘communicable disease’’ as ‘‘an illness 

due to a specific infectious agent or its 

toxic products which arises through 

transmission of that agent or its 

products from an infected person or 

animal or a reservoir to a susceptible 

host, either directly, or indirectly 

through an intermediate animal host, 

vector, or the inanimate environment.’’ 

All examples cited by this commenter 

meet this definition of the term 

‘‘infectious biological agents’’ because 

each of the fungi cited are capable of 

causing communicable disease. 

C. Biosafety 

One commenter was interested in 

knowing specifically how HHS/CDC 

will ‘‘work with’’ entities to address 

safety issues. The commenter 

questioned if this will entail providing 

additional financing to bring importers 

into compliance, or is this ‘‘offer to 

work with’’ the importer a distinctive 

part of the permit issuance process. 

HHS/CDC’s statement in the preamble 

to the proposed rule that it was willing 

to work with an entity whose biosafety 

measures were found to be inadequate 

was neither an offer to provide financial 

assistance nor a distinctive part of the 

permit issuance process. It was simply 

a statement that, rather than simply 

deny a permit, HHS/CDC would be 

willing to assist an applicant to achieve 

compliance with the import regulations. 

If an importer is unable to address the 

inadequate biosafety measures 

identified, the importer would not 

receive a permit to import the infectious 

biological agent, infectious substance, or 

vector requested. 

D. Permit Exemptions 

Diagnostic Specimens 

One commenter proposed to replace 

the term ‘‘diagnostic specimen’’ with 

the phrase, ‘‘exempt human specimen or 

exempt animal specimen’’, consistent 

with DOT Hazardous Materials 

Regulations and the International Air 

Transport Association Dangerous Goods 

Standards. We made no changes based 

on this comment since the proposed 

replacement language limits the 

specimens to human and animals and 

does not include environmental 

samples. 

Another commenter stated that the 

proposed rule leaves too much 

speculation about what is potentially 

infectious material. The commenter 

suggested that a standard which was 

more closely aligned with the WHO 

standard for biological materials and 

infectious substances would provide 

more clarity. We agree with the 

commenter and have replaced the 

definition for ‘‘infectious material’’ with 

an ‘‘infectious substance’’ definition 

that closely aligns with definitions 

found in the DOT regulations and WHO 

standards. 

Even though we did not receive a 

comment regarding bats, we clarified 

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7676 Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Rules and Regulations 

that these materials should not be 

exempted since people become infected 

with germs either through direct or 

close contact with bats or their 

droppings. Specifically, bats are known 

carriers of germs that cause disease in 

humans, including internal and external 

parasites, fungi, bacteria, and viruses. 

The most significant of these germs are 

Nipah virus and viruses that cause 

diseases such as Ebola, Marburg 

Hemorrhagic Fever, Sudden Acute 

Severe Respiratory Syndrome (SARS), 

and rabies. 

Genomic Material 

One commenter requested that the 

importation and subsequent transfer of 

positive stranded viral RNA be 

considered in this Part. The commenter 

reasoned that if this material could be 

used to recover an infectious agent, its 

importation and subsequent transfer 

would be, for all intents and purposes, 

identical to the importation and 

subsequent transfer of an etiological 

agent. The commenter also reasoned 

that if the intent was the extraction of 

the genetic information only, and the 

recipient had no intention to retrieve 

the infectious agent from the nucleic 

acid preparation, then the need for the 

permit would seem not to be warranted. 

We made no changes based on this 

comment since positive stranded viral 

rRNA genomic material would meet our 

proposed definition as a ‘‘component of 

such microorganism or prion that is 

capable of causing communicable 

disease in a human.’’ It should be noted 

that our proposed rule already contains 

an exemption for genomic materials 

certified by the importer to be incapable 

of producing infectious biological 

agents. 

E. Transportation 

One commenter argued that the 

regulations should place the 

responsibility for compliance with all 

applicable laws and regulations 

concerning the packaging and shipment 

of infectious substances on the shipper 

since the only thing related to shipping 

that could be practically mandated for 

the recipient would be to open the 

shipment in a manner consistent with 

the expected hazard and report any 

spillage/leakage. The commenter stated 

that the importer could be required to 

obtain some type of affirmation from the 

shipper to the effect that the shipment 

is done in compliance with applicable 

regulations. We agree with the 

commenter insofar as the commenter 

suggests that the shipper comply with 

all applicable legal requirements 

relating to the packaging, labeling, and 

shipment of infectious substances, such 

as those found at 49 CFR part 173 and 

standards issued by the International 

Civil Aviation Organization (ICAO). We 

disagree with the commenter, however, 

insofar as the commenter suggests that 

the importer should bear no legal 

responsibility under these regulations 

for actions taken by the shipper on the 

importer’s behalf. Accordingly, under 

these regulations the importer, as the 

initiator of the Import Permit request, 

must implement measures to ensure that 

the shipper will package, label, and ship 

the requested infectious substance, 

infectious biological agent, or vector in 

a manner that is safe and in compliance 

with all applicable legal requirements. 

Another commenter suggested that we 

amend the statement ‘‘The importer is 

in compliance with all applicable laws 

concerning the packaging and shipment 

of infectious substance’’ to include ‘‘and 

regulations’’ in the statement. The 

commenter also recommended that 

guidance be provided on the HHS/CDC 

Web site to clarify HHS/CDC’s 

expectations regarding the packaging 

and shipping of infectious substances. 

We agreed with the commenter that the 

statement should be revised to include 

all laws and regulations. Therefore, we 

changed the language to read, ‘‘The 

importer takes measures to help ensure 

that the shipper complies with all 

applicable legal requirements 

concerning the packaging, labeling, and 

shipment of infectious substances.’’ To 

clarify HHS/CDC’s expectations 

regarding the packaging and shipping of 

infectious substances, we have posted 

guidance regarding our expectations on 

the HHS/CDC import permit Web site at: 

http://www.cdc.gov/od/eaipp/faq.htm. 

F. Subsequent Transfer 

One commenter requested 

confirmation that an importer may still 

seek authorization for subsequent 

transfers of the items within the United 

States through the initial permit 

application. We confirm that an 

importer may still seek authorization for 

subsequent transfers of items within the 

United States in the initial permit 

application. 

G. Miscellaneous 

Cost 

One commenter believed that there 

would be a significant cost to 

implement the HHS/CDC inspection 

program. The commenter stated it 

should be an institutional responsibility 

to ensure that an appropriate biosafety 

plan is in place. The commenter 

believed if an institution does not have 

a biosafety office or plan; it should not 

have the permit to import items that 

may pose any kind of risk. We agree that 

an entity that does not have a biosafety 

plan should not have a permit to import 

items that have the potential to pose a 

risk to public health and safety. 

Since 2009, we have refined the HHS/ 

CDC import permit database to include 

better descriptions of material being 

imported, the biosafety level of the 

laboratory where the work will be 

performed, and the type of work to be 

conducted (e.g., diagnostic, research). 

To estimate the number of facilities that 

would require a biosafety inspection 

under this Part; we first identified those 

facilities that had previously applied to 

import agents which are capable of 

causing serious or potentially lethal 

disease in humans via the aerosol route. 

From that list, we deleted those 

facilities already receiving periodic 

biosafety inspections from either HHS/ 

CDC or the U.S. Department of 

Agriculture’s Animal and Plant Health 

Inspection Service (USDA/APHIS) 

under the HHS or USDA Select Agent 

Regulations (42 CFR part 73, 9 CFR part 

121, or 7 CFR part 131) and concluded 

that approximately 25 facilities would 

need to be inspected per year to verify 

that they have in place the appropriate 

biosafety measures. Since we already 

review documents regarding biosafety 

and have a staff of fully trained and 

experienced biosafety inspectors, and 

based on our review of recent permitting 

activity, we believe the projected travel 

costs to perform these inspections will 

be less than 1% of the current budget for 

the HHS/CDC’s Division of Select 

Agents and Toxins. We also plan to 

coordinate these inspections with those 

we are already conducting under the 

Federal Select Agent Inspection 

Program to recognize greater 

efficiencies. 

Internet Site 

One commenter suggested that HHS/ 

CDC maintain on its internet site the 

current permit preparation guidance 

text so that permit applicants will have 

ready access to information regarding 

their responsibilities under the 

regulations, separate from the 

regulations themselves. We agree with 

this commenter and will review our 

Web site content on a regular ongoing 

basis to ensure that the content is 

consistent with the regulations and easy 

to find. 

Alternatives Considered 

In the proposed rule we discussed the 

alternative approaches we considered in 

development of this rulemaking in order 

to reduce burden for clinical/diagnostic 

laboratories or small businesses selling 

manufactured goods. 

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Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Rules and Regulations 7677 

First, we noted that, from HHS/CDC’s 

Select Agent inspection program, 

specific biosafety measure 

implementation issues were identified 

in 81 of the 316 entities inspected by 

CDC since 2003. Some of the biosafety 

measure implementation issues were 

serious enough to require the 

suspension of registration or other 

restrictions on biological work at these 

facilities. We noted that USDA/APHIS 

had identified similar biosafety issues. 

Because of these issues, we proposed to 

require specific biosafety measures to be 

implemented by the applicant. 

Second, we considered proposing a 

requirement that applicants develop and 

maintain a written biosafety plan 

commensurate with the hazard posed by 

the infectious biological agent, 

infectious material, and/or vector to be 

imported, and the level of risk given the 

intended use including what elements 

of the plan are essential to prevent 

exposures and dramatically reduce the 

incidence of laboratory acquired 

infections and protect the public health 

and the environment. We acknowledged 

that most, if not all, importers of 

etiological agents already have such 

biosafety plans. We based this on our 

experience with import permit 

submissions that address Section G 

(Receiving Laboratory Capabilities) of 

the permit application. We specifically 

sought comment from the public 

concerning the cost and burden of 

requiring a formal a written biosafety 

plan. We did not receive any comments 

specifically addressing the cost and 

burden of requiring a formal written 

biosafety plan. 

Finally, we proposed exemptions to 

allow importers to import certain 

material that is already approved or 

authorized by another Federal agency or 

material that has been determined not to 

be an infectious biological agent. 

IV. Required Regulatory Analyses 

Under Executive Orders 12866 and 

13563 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This rule is 

being treated as ‘‘not significant’’ under 

EO 12866. It clarifies regulatory 

definitions, insures adequate biosafety 

measures, increases oversight through 

inspections, addresses permit 

exemptions and transportation 

requirements, and describes an appeal 

process when the permit request is 

denied. Thus, the rule has not been 

reviewed by the Office of Management 

and Budget (OMB). 

Based on past experience, we estimate 

that there will be approximately 2,000 

applications for both import and 

distribution permit requests each year 

and that the average response time to 

complete the application is 20 minutes. 

We believe that the burden has been 

limited to requesting only essential 

information on the application, 

verifying information, when required, 

by telephone, and mailing information 

to the appropriate parties. 

With regard to the new requirement to 

have biosafety measures in place, our 

current experience from reviewing the 

information submitted for the import 

permit applications addressing Section 

G (Receiving Laboratory Capabilities) 

(e.g., detailed description of any 

required personal protective equipment 

(PPE)), and laboratory equipment (i.e., 

biosafety cabinets, autoclaves) that 

ensures materials are properly handled 

and contained indicates that the vast 

majority of importers of etiological 

agents already have instituted such 

biosafety measures. Based on our review 

of applications received between March 

2011 and January 2012, we estimate that 

98% (632 out of 644) of the applicants 

possess written biosafety plans and 

already follow standard biosafety 

practices and procedures. 

With regard to whether HHS/CDC will 

inspect an import facility, as noted 

above, HHS/CDC will use the following 

specific criteria to determine which 

entities are to be inspected: (1) facilities 

that request to perform research with 

imported agents that would need to be 

conducted in a biosafety level (BSL) 3, 

BSL–4, animal biosafety level (ABSL) 3, 

ABSL–4 or BSL–3 Agriculture 

laboratory as described in the BMBL 

(e.g., Mycobacterium tuberculosis used 

in aerosol studies required at BSL–3), 

and (2) facilities that have not been 

inspected by either HHS/CDC or USDA/ 

APHIS under the Federal Select Agent 

Regulations. 

Since 2009, we have refined the HHS/ 

CDC import permit database to include 

better descriptions of material being 

imported, the biosafety level of the 

facility where the work would be 

performed, and the type of work to be 

conducted (e.g., diagnostic, research). 

To estimate the number of facilities that 

would require a biosafety inspection, we 

first identified those facilities that 

applied to import agents to use in 

research, which may cause serious or 

potentially lethal disease after 

inhalation. From that list, we removed 

those facilities already subject to 

periodic biosafety inspections under the 

Federal Select Agent Regulations. We 

concluded that approximately 25 

facilities would need to be inspected per 

year to verify that they have in place the 

appropriate biosafety measures. To 

minimize additional burdens on 

inspected facilities, we will be 

contacting those facilities that received 

a permit in 2012, and would meet the 

criteria for requiring an inspection, 3 

months prior to the expiration of the 

facility’s import permit to initiate the 

renewal process. We plan to inspect 

these facilities once in a two year 

timeframe, assuming that no significant 

biosafety problems are identified. 

We also anticipate that there will be 

minimal increased cost to HHS/CDC to 

implement these changes since we 

already review documents regarding 

biosafety and have a staff of fully 

trained and experienced biosafety 

inspectors. Based on our review of 

recent permitting activity, we believe 

the projected travel costs to perform 

these inspections will be less than 1% 

of the current budget for the HHS/CDC’s 

Division of Select Agents and Toxins. 

We also plan to coordinate these 

inspections with those we are already 

conducting under the Federal Select 

Agent Inspection Program to recognize 

greater efficiencies. 

Regulatory Flexibility Act 

Under the Regulatory Flexibility Act, 

as amended by the Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA) (5 U.S.C. 601 et seq.), 

agencies must consider the impact of 

regulations on small entities and 

analyze regulatory options that would 

minimize a rule’s impacts on these 

entities. Alternatively, the agency head 

may certify that the proposed rule will 

not have a significant economic impact 

on a substantial number of small 

entities. The U.S. Small Business 

Administration defines a small business 

concern as one that is independently 

owned and operated, is organized for 

profit, and is not dominant in its field. 

Depending on the industry, eligibility 

for classification as a small business is 

based on the average number of 

employees for the preceding twelve 

months or on sales volume averaged 

over a three-year period. For example, a 

business is considered small if its 

annual revenue ranges between $2.5 to 

$21.5 million for services provided or 

the number of its employees range from 

100 to 500 depending on the particular 

product being provided. Based on this 

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7678 Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Rules and Regulations 

definition, HHS/CDC does not 

anticipate that these regulatory changes 

will have a significant economic impact 

on a substantial number of small 

businesses or other small entities. HHS/ 

CDC estimates that only 100 

applications out of the approximately 

2,000 applications that we receive each 

year will be from small businesses. We 

received no comments to the proposed 

rule concerning the cost and burden of 

the proposed rule on small businesses. 

V. Other Administrative Requirements 

A. Paperwork Reduction Act of 1995 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), HHS/CDC has 

determined that the Paperwork 

Reduction Act does apply to 

information collection and 

recordkeeping requirements included in 

this rule. We note that the information 

collection and recordkeeping 

requirements are already approved by 

OMB under OMB Control Number 

0920–0199, expiration 1/31/2014. There 

are no new information collection or 

recordkeeping requirements in this rule. 

Since 2003, HHS/CDC has denied 2 

applications for permits. HHS/CDC 

proposes to provide applicants with an 

opportunity for a written appeal in the 

event that the HHS/CDC denies a 

request for a permit to import infectious 

biological agents, infectious substances, 

or vectors under this part. Under the 

proposal, an applicant who wishes to 

make such an appeal would have 30 

calendar days after receiving the denial 

to submit the appeal in writing to the 

HHS/CDC Director. The appeal must 

state the factual basis for the appeal and 

provide any supporting documentations 

to justify the appeal (e.g., documents 

that demonstrate the facility has the 

appropriate biosafety measures in place 

for working safely with requested 

imported material). HHS/CDC would 

then issue a written response, which 

would constitute final agency action. 

HHS/CDC estimates the time to prepare 

and submit such a request is four hours. 

We received no comments regarding 

this process. 

B. Executive Order 12988, Civil Justice 

Reform and Executive Order 13132, 

Federalism 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform, and Executive Order 13132, 

Federalism. This rule: (1) Preempts all 

State and local laws and regulations that 

are in conflict 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. 

C. Plain Language in Government 

Writing 

Pursuant to Presidential 

Memorandum of June 1, 1998 Plain 

Language in Government Writing (63 FR 

31885), Executive Departments and 

Agencies are directed to use plain 

language in all proposed and final rules. 

HHS/CDC believes it has used plain 

language in drafting of this final rule. 

We received no comments from the 

public to the proposed rule in this 

regard. 

List of Subjects in 42 CFR Part 71 

Airports, Animals, Communicable 

diseases, Harbors, Imports, Pesticides 

and pests, Public health, Quarantine, 

Reporting and recordkeeping 

requirements. 

Dated: January 28, 2013. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

For the reasons stated in the 

preamble, the Centers for Disease 

Control and Prevention, U.S. 

Department of Health and Human 

Services, amends 42 CFR Part 71 as 

follows: 

PART 71—FOREIGN QUARANTINE 

■ 1. The authority citation for part 71 

continues to read as follows: 

Authority: Secs. 215 and 311 of Public 

Health Service (PHS) Act as amended (42 

U.S.C. 216, 243); secs. 361–369, PHS Act, as 

amended (42 U.S.C. 264–272). 

■ 2. Revise § 71.54 to read as follows: 

§ 71.54 Import regulations for infectious 

biological agents, infectious substances, 

and vectors. 

(a) The following definitions apply to 

this section: 

Animal. Any member of the animal 

kingdom except a human including an 

animal product (e.g., a mount, rug, or 

other display item composed of the 

hide, hair, skull, teeth, bones, or claws). 

Diagnostic specimen. Specimens of 

human and animal matter (including 

tissue, blood, body discharges, fluids, 

excretions or similar material), or 

environmental samples. 

Genomic material. Deoxyribonucleic 

acid (DNA) or Ribonucleic acid (RNA) 

comprising the genome or organism’s 

hereditary information, that may be 

single-stranded or double-stranded, and 

in a linear, circular, or segmented 

configuration and may be positive sense 

(same polarity as mRNA), negative 

sense, or ambisense (mixture of the 

two). 

Infectious biological agent. A 

microorganism (including, but not 

limited to, bacteria (including 

rickettsiae), viruses, fungi, or protozoa) 

or prion, whether naturally occurring, 

bioengineered, or artificial, or a 

component of such microorganism or 

prion that is capable of causing 

communicable disease in a human. 

Infectious substance. Any material 

that is known or reasonably expected to 

contain an infectious biological agent. 

Select agents and toxins. Biological 

agents and toxins that could pose a 

severe threat to public health and safety 

as listed in 42 CFR 73.3 and 73.4. 

Vector. Any animals (vertebrate or 

invertebrate) including arthropods or 

any noninfectious self-replicating 

system (e.g., plasmids or other 

molecular vector) or animal products 

(e.g., a mount, rug, or other display item 

composed of the hide, hair, skull, teeth, 

bones, or claws of an animal) that are 

known to transfer or are capable of 

transferring an infectious biological 

agent to a human. 

(b) Unless excluded pursuant to 

paragraph (f) of this section, a person 

may not import into the United States 

any infectious biological agent, 

infectious substance, or vector unless: 

(1) It is accompanied by a permit 

issued by the Centers for Disease 

Control and Prevention (CDC). The 

possession of a permit issued by the 

CDC does not satisfy permitting 

requirements placed on materials by the 

U.S. Department of Agriculture that may 

pose hazards to agriculture or 

agricultural production in addition to 

hazards to human health. 

(2) The importer is in compliance 

with all of the permit requirements and 

conditions that are outlined in the 

permit issued by the CDC. 

(3) The importer has implemented 

biosafety measures commensurate with 

the hazard posed by the infectious 

biological agent, infectious substance, 

and/or vector to be imported, and the 

level of risk given its intended use. 

(4) The importer takes measures to 

help ensure that the shipper complies 

with all applicable legal requirements 

concerning the packaging, labeling, and 

shipment of infectious substances. 

(c) If noted as a condition of the 

issued permit, subsequent transfers of 

any infectious biological agent, 

infectious substance or vector within 

the United States will require an 

additional permit issued by the CDC. 

(d) A permit is valid only for: 

(1) The time period and/or term 

indicated on the permit, and 

(2) Only for so long as the permit 

conditions continue to be met. 

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Federal Register / Vol. 78, No. 23 / Monday, February 4, 2013 / Rules and Regulations 7679 

(e) A permit can be denied, revoked 

or suspended if: 

(1) The biosafety measures of the 

permit holder are not commensurate 

with the hazard posed by the infectious 

biological agent, infectious substance, or 

vector, and the level of risk given its 

intended use; or, 

(2) The permit holder fails to comply 

with all conditions, restrictions, and 

precautions specified in the permit. 

(f) A permit issued under this part is 

not required for an item if: 

(1) It is a biological agent listed in 42 

CFR Part 73 as a select agent and its 

importation has been authorized in 

accordance with 42 CFR 73.16 or 9 CFR 

121.16. 

(2) With the exception of bat or 

nonhuman primate specimens, it is a 

diagnostic specimen not known by the 

importer to contain, or suspected by the 

importer of containing, an infectious 

biological agent and is accompanied by 

an importer certification statement 

confirming that the material is not 

known to contain or suspected of 

containing an infectious biological 

agent, or has been rendered 

noninfectious. 

(3) With the exception of live bats or 

bat or nonhuman primate products, it is 

an animal or animal product being 

imported for educational, exhibition, or 

scientific purposes and is accompanied 

by documentation confirming that the 

animal or animal product is not known 

to contain (or suspected of containing) 

an infectious biological agent or has 

been rendered noninfectious. 

(4) It consists only of nucleic acids 

that cannot produce infectious forms of 

any infectious biological agent and the 

specimen is accompanied by an 

importer certification statement 

confirming that the material is not 

known to contain or suspected of 

containing an infectious biological 

agent. 

(5) It is a product that is cleared, 

approved, licensed, or otherwise 

authorized under any of the following 

laws: 

(i) The Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 301 et seq.), or 

(ii) Section 351 of the Public Health 

Service Act pertaining to biological 

products (42 U.S.C. 262), or 

(iii) The Virus-Serum-Toxin Act (21 

U.S.C. 151–159). 

(6) It is an animal or animal product 

listed in 42 CFR Part 71 and its 

importation has been authorized in 

accordance with 42 CFR 71.52, 71.53, or 

71.56. 

(g) To apply for a permit, an 

individual must: 

(1) Submit a signed, completed CDC 

Form 0.753 (Application for Permit to 

Import Biological Agents or Vectors of 

Human Disease into the United States) 

to the HHS/CDC Import Permit Program. 

(2) Have in place biosafety measures 

that are commensurate with the hazard 

posed by the infectious biological agent, 

infectious substance, and/or vector to be 

imported, and the level of risk given its 

intended use. 

(h) Issuance of a permit may be 

contingent upon an inspection of the 

importer’s facility by the CDC to 

evaluate whether the importer’s 

biosafety measures (e.g., physical 

structure and features of the facility, and 

operational and procedural safeguards) 

are commensurate with the hazard 

posed by the infectious biological agent, 

infectious substance, and/or vector, and 

the level of risk given its intended use. 

(i) Denial, suspension, or revocation 

of a permit under this section may be 

appealed to the CDC Director. The 

appeal must be in writing, state the 

factual basis for the appeal, and be 

submitted to the CDC Director within 30 

calendar days of the denial, suspension, 

or revocation of the permit. HHS/CDC 

will issue a written response to the 

appeal, which shall constitute final 

agency action. 

[FR Doc. 2013–02391 Filed 2–1–13; 8:45 am] 

BILLING CODE 4163–18–P 

LEGAL SERVICES CORPORATION 

45 CFR Part 1611 

Income Level for Individuals Eligible 

for Assistance 

AGENCY: Legal Services Corporation. 

ACTION: Final rule. 

SUMMARY: The Legal Services 

Corporation (‘‘Corporation’’) is required 

by law to establish maximum income 

levels for individuals eligible for legal 

assistance. This document updates the 

specified income levels to reflect the 

annual amendments to the Federal 

Poverty Guidelines as issued by the 

Department of Health and Human 

Services. 

DATES: Effective date: This rule is 

effective as of February 4, 2013. 

FOR FURTHER INFORMATION CONTACT: Kara 

Ward, Assistant General Counsel, Legal 

Services Corporation, 3333 K St. NW., 

Washington, DC 20007; (202) 295–1596; 

karaward@lsc.gov. 

SUPPLEMENTARY INFORMATION: 

Section 1007(a)(2) of the Legal 

Services Corporation Act (Act), 42 

U.S.C. 2996f(a)(2), requires the 

Corporation to establish maximum 

income levels for individuals eligible for 

legal assistance, and the Act provides 

that other specified factors shall be 

taken into account along with income. 

Section 1611.3(c) of the Corporation’s 

regulations establishes a maximum 

income level equivalent to one hundred 

and twenty-five percent (125%) of the 

Federal Poverty Guidelines. Since 1982, 

the Department of Health and Human 

Services has been responsible for 

updating and issuing the Federal 

Poverty Guidelines. The figures for 2013 

set out below are equivalent to 125 

percent (125%) of the current Federal 

Poverty Guidelines as published on 

January 24, 2013 (78 FR 5182). 

In addition, LSC is publishing charts 

listing income levels that are two 

hundred percent (200%) of the Federal 

Poverty Guidelines. These charts are for 

reference purposes only as an aid to 

grant recipients in assessing the 

financial eligibility of an applicant 

whose income is greater than 125 

percent (125%) of the applicable 

Federal Poverty Guidelines amount, but 

less than 200 percent (200%) of the 

applicable Federal Poverty Guidelines 

amount (and who may be found to be 

financially eligible under duly adopted 

exceptions to the annual income ceiling 

in accordance with sections 1611.3, 

1611.4 and 1611.5). 

List of Subjects in 45 CFR Part 1611 

Grant programs—law, Legal services. 

For reasons set forth in the preamble, 

the Legal Services Corporation amends 

45 CFR part 1611 as follows: 

PART 1611—ELIGIBILITY 

■ 1. The authority citation for part 1611 

continues to read as follows: 

Authority: Secs. 1006(b)(1), 1007(a)(1) 

Legal Services Corporation Act of 1974, 42 

U.S.C. 2996e(b)(1), 2996f(a)(1), 2996f(a)(2). 

■ 2. Revise Appendix A to part 1611 to 

read as follows: 

Appendix A to Part 1611—Income 

Level for Individuals Eligible for 

Assistance 

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