Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Proposed Rules 63891 

(b) You must maintain records of the 

following information for each 30 day 

period: 

(1) Hours of operation. 

(2) Production rate of nitric acid, 

expressed as 100 percent nitric acid. 

(3) NOX mass emissions. 

(c) You must maintain records of the 

following time periods: 

(1) Times when you were not in 

compliance with the emissions 

standards. 

(2) Times when the pollutant 

concentration exceeded full span of the 

NOX pollutant monitoring equipment. 

(3) Times when the volumetric flow 

rate exceeded the high value of the 

volumetric flow rate monitoring 

equipment. 

(d) You must maintain records of the 

reasons for any periods of 

noncompliance and description of 

corrective actions taken. 

(e) You must maintain records of any 

modifications to CERMS which could 

affect the ability of the CERMS to 

comply with applicable performance 

specifications. 

(f) For each malfunction, you must 

maintain records of the following 

information: 

(1) Records of the occurrence and 

duration of each malfunction of 

operation (i.e., process equipment) or 

the air pollution control and monitoring 

equipment. 

(2) Records of actions taken during 

periods of malfunction to minimize 

emissions in accordance with section 

60.72a(b), including corrective actions 

to restore malfunctioning process and 

air pollution control and monitoring 

equipment to its normal or usual 

manner of operation. 

§ 60.77a Reporting. 

(a) The performance test data from the 

initial and subsequent performance tests 

and from the performance evaluations of 

the continuous monitors must be 

submitted to the Administrator at the 

appropriate address as shown in 40 CFR 

60.4. 

(b) The following information must be 

reported to the Administrator for each 

30 day period where you were not in 

compliance with the emissions 

standard: 

(1) Time period. 

(2) NOX emission rates (lb/ton of acid 

produced). 

(3) Reasons for noncompliance with 

the emissions standard; and description 

of corrective actions taken. 

(c) You must also report the following 

whenever they occur: 

(1) Times when the pollutant 

concentration exceeded full span of the 

NOX pollutant monitoring equipment. 

(2) Times when the volumetric flow 

rate exceeded the high value of the 

volumetric flow rate monitoring 

equipment. 

(d) You must report any modifications 

to CERMS which could affect the ability 

of the CERMS to comply with 

applicable performance specifications. 

(e) As of December 31, 2011 and 

within 60 days after the date of 

completing each performance 

evaluation or test required under this 

subpart, you must submit the relative 

accuracy test audit data and 

performance test data by successfully 

submitting the data electronically to 

EPA’s Central Data Exchange (CDX) by 

using the Electronic Reporting Tool 

(ERT) (see http://www.epa.gov/ttn/chief/ 

ert/ert_tool.html/). 

(f) If a malfunction occurred during 

the reporting period, you must submit a 

report that contains the following: 

(1) The number, duration, and a brief 

description for each type of malfunction 

which occurred during the reporting 

period and which caused or may have 

caused any applicable emission 

limitation to be exceeded. 

(2) A description of actions taken by 

an owner or operator during a 

malfunction of an affected source to 

minimize emissions in accordance with 

60.72a(b), including actions taken to 

correct a malfunction. 

[FR Doc. 2011–26089 Filed 10–13–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 71 

[Docket No. CDC–2011–0007] 

RIN 0920–AA37 

Foreign Quarantine; Etiological 

Agents, Hosts, and Vectors 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) within 

the U.S. Department of Health and 

Human Services (HHS) is issuing this 

Notice of Proposed Rulemaking (NPRM) 

to revise the regulations that cover the 

importation of etiological agents and the 

hosts and vectors of human disease. The 

changes are proposed to improve CDC’s 

ability to prevent the introduction, 

transmission, or spread of 

communicable diseases into the United 

States. 

DATES: To be assured consideration, 

comments must be received on or before 

December 13, 2011. Comments received 

after the close of the comment period 

will be considered to the fullest extent 

possible. 

ADDRESSES: You may submit comments, 

identified by Regulatory Information 

Number (RIN) 0920–AA37 in the 

heading of this document, by any of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: SAPcomments@cdc.gov. 

Please include the RIN number in the 

subject line of the message. 

• Fax: 404–718–2093. 

• Mail: Division of Select Agents and 

Toxins, Centers for Disease Control and 

Prevention, ATTN: Importation 

Regulations, 1600 Clifton Road, NE., MS 

A–46, Atlanta, Georgia 30333. 

• Hand Delivery/Courier: Division of 

Select Agents and Toxins, Centers for 

Disease Control and Prevention, ATTN: 

Importation Regulations, 1600 Clifton 

Road, NE., MS A–46, Atlanta, Georgia 

30333. 

Instructions: All submissions received 

must include the agency name and RIN 

for this rulemaking. All relevant 

comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received or to download an 

electronic version of the NPRM, go to 

http://www.regulations.gov. Comments 

will be available for public inspection 

Monday through Friday, except for legal 

holidays, from 9 a.m. until 5 p.m. at 

1600 Clifton Road, NE., Atlanta, GA 

30333. Please call ahead to 1–866–694– 

4867 and ask for a representative in the 

Division of Select Agents and Toxins to 

schedule your visit. Our general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet as they are 

received and without change. 

FOR FURTHER INFORMATION CONTACT: 

Robbin Weyant, PhD, 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 to this notice of proposed 

rulemaking is organized as follows: 

I. Background 

A. HHS/CDC Authority 

II. Proposed Changes to 42 CFR 71.54 

A. Section Heading & Definitions 

B. Biosafety and Inspection Provisions 


tkelley on DSK3SPTVN1PROD with PROPOSALS
63892 Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Proposed Rules 

C. Permit Exemptions 

D. Transportation 

E. Appeals Process 

III. Required Regulatory Analyses and 

Executive Order 12866, and the 

Regulatory Flexibility Act 

IV. 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 

A. HHS/CDC Authority 

This NPRM is proposed 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 of 

these materials. 

II. Proposed Changes to 42 CFR 71.54 

This document proposes to revise the 

regulations that cover the importation of 

etiological agents and the hosts and 

vectors of human disease (42 CFR 71.54) 

as described below. We will consider 

comments that are received within 60 

days of publication of this notice in the 

Federal Register. 

A. Section Heading and Definitions 

The heading for 42 CFR 71.54 would 

be changed from ‘‘Etiological agents, 

hosts, and vectors.’’ to ‘‘Import 

Regulations for Infectious Biological 

Agents, Infectious Material, and 

Vectors’’ to clarify proposed changes 

discussed below. Under the proposed 

changes, only the following infectious 

biological agents, materials, and vectors 

would require a permit issued by the 

CDC Director prior to entry into the 

United States, or subsequently being 

transferred within the United States: 

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 material. Any material 

which is known or suspected to contain 

a biological agent infectious to humans. 

Vector. Any animals (vertebrate or 

invertebrate) including arthropods or 

any noninfectious self-replicating 

system known to transfer or capable of 

transferring an infectious biological 

agent to a human (e.g., a mosquito). 

We also propose to remove the term 

‘‘host’’ because we believe ‘‘host’’ means 

the same as the current proposed 

definition for ‘‘vector.’’ However, CDC is 

interested in comments concerning the 

removal of the term ‘‘host’’ from the 

proposed language. CDC is also 

interested in comments concerning the 

scope of the definition for ‘‘vector’’ and 

whether it should be limited in some 

manner to exclude animals intended to 

be exhibited in zoos or mounted 

animals or hides intended for museum 

displays while remaining broad enough 

to include mosquitoes that carry the 

malaria parasite Plasmodium between 

humans. 

B. Biosafety and Inspection Provisions 

The key principle in selecting the 

appropriate safeguards for the conduct 

of the microbiological research is ‘‘risk 

assessment.’’ Risk assessment is a 

process used to identify the hazardous 

characteristics of a known infectious 

agent or potentially infectious agent or 

material, the activities that can result in 

exposure to such an agent, the 

likelihood that such exposure will cause 

a laboratory-acquired infection (LAI), 

and the probable consequences of such 

an infection. The information identified 

through risk assessment is used to guide 

the selection of appropriate 

microbiological practices, safety 

equipment, and facility safeguards 

(biosafety measures) that, when used 

properly, can prevent exposures and 

dramatically reduce the incidence of 

LAIs. Risk assessment is a common first 

step in an overall risk-management 

process. 

The safe possession and work with 

infectious biological agents, infectious 

material, and vectors requires that 

importers have the appropriate biosafety 

measures in place for imported material. 

Accordingly, CDC proposes that import 

regulations clearly state that the 

applicant have biosafety measures that 

are commensurate with the hazard 

posed by the infectious biological agent, 

infectious material, and/or vector to be 

imported, and the level of risk given its 

intended use. These biosafety measures 

may be entity-wide, laboratory-specific, 

or agent-specific. CDC believes 

importers engaged in microbiological 

research and related activities utilizing 

safe laboratory practices, safety 

equipment, and facility safeguards will 

reduce the incidence of LAIs and other 

incidents and will protect the public 

health and environment. 

In developing the appropriate 

biosafety measures, importers working 

with infectious biological agents, 

infectious material, and vectors should 

use the appropriate microbiological 

practices, safety equipment, and facility 

safeguards that, when used properly, 

can prevent exposures and dramatically 

reduce the incidence of LAIs. An 

applicant should consider: (1) The CDC/ 

National Institutes of Health (NIH) 

publication, ‘‘Biosafety in 

Microbiological and Biomedical 

Laboratories’’ (BMBL), including all 

appendices. Copies may be obtained at 

the CDC Web site at http:// 

www.cdc.gov/ and (2) The ‘‘NIH 

Guidelines for Research Involving 

Recombinant DNA Molecules (NIH 

Guidelines).’’ Copies may be obtained 

from the NIH Web site at http:// 

oba.od.nih.gov/rdna/ 

nih_guidelines_oba.html. 

To implement CDC’s inspection 

authority as provided under 42 U.S.C. 

264(a), CDC proposes that prior to CDC 

issuing a permit, it may inspect the 

applicant’s facility to evaluate whether 

the importer’s implementation of its 

biosafety measures (e.g., physical 

structure and features of the facility, and 

operational and procedural safeguards) 

are effective and commensurate with the 

risk posed by the infectious biological 

agent, infectious material, and/or vector, 

and the level of risk given its intended 

use. 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), and 

(2) that have not been inspected by 

CDC’s Select Agent Program. 

Even though CDC is proposing that 

the import regulations specifically state 

a requirement for appropriate biosafety 

measures as a prerequisite for the 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Proposed Rules 63893 

issuance of a permit, we believe, based 

on our experience with import permit 

submissions addressing the capabilities 

of the receiving laboratories, that most, 

if not all, importers of etiological agents 

already have written biosafety plans. 

Based on permit applications submitted 

to CDC between March 1, 2011, and July 

22, 2011, the total number of applicants 

with adequate written biosafety plans 

was 632 out of 644 or 98%. Based on the 

content of those plans, CDC is confident 

that each of them would meet the 

requirement for appropriate biosafety 

measures of this NPRM. If an importer’s 

biosafety measures were found to be 

inadequate, CDC would offer to work 

with the entity to address any biosafety 

issues prior to denying the permit. 

C. Permit Exemptions 

Select Agents and Toxins 

Currently, in accordance with 9 CFR 

part 121 and 42 CFR part 73 (Select 

Agent Regulations), only individuals or 

entities registered with the CDC or U.S. 

Department of Agriculture, Animal and 

Plant Health Inspection Service’s 

(APHIS’) Select Agent Program can 

legally import select agents (i.e., 

biological agents and toxins that could 

pose a severe threat to public health and 

safety) into the United States. A select 

agent may only be imported under the 

conditions described in 9 CFR 121.16 

and 42 CFR 73.16 and must be 

authorized by APHIS or CDC prior to 

importation. Therefore, we are 

proposing that importation of select 

agents in accordance with the Select 

Agent Regulations be exempted from the 

requirement to have an additional 

import permit under 42 CFR 71.54. 

Diagnostic Specimens 

As defined by the proposed rule, a 

diagnostic specimen is any specimen of 

human or animal matter (including 

tissue, blood, body discharges, fluids, 

excretions or similar material), or an 

environmental sample. CDC’s policy 

regarding diagnostic specimens is that 

only diagnostic specimens that are 

known to contain, or are suspected of 

containing, an infectious biological 

agent require a permit issued by the 

CDC Director prior to entry into the 

United States or subsequent transfer 

within the United States. CDC proposes 

to clarify this policy in the regulation by 

adding a provision that a permit is not 

required for a diagnostic specimen not 

known by the importer to contain, or 

suspected by the importer of containing, 

an infectious biological agent and the 

specimen is accompanied by an 

importer certification statement 

confirming that the material is not 

known or suspected to contain an 

infectious biological agent. Importers 

would not be required to perform 

confirmatory tests on these specimens, 

only certify in writing that they have no 

reason to believe that the samples 

contain an infectious biological agent. 

Examples of these types of diagnostic 

specimens not known by the importer to 

contain, or suspected by the importer of 

containing, an infectious biological 

agent may include urine samples 

submitted for urine drug screens or 

serum samples submitted for cholesterol 

testing. 

Genomic Material 

Genomic material from infectious 

biological agents can consist of 

Deoxyribonucleic acid (DNA) or 

Ribonucleic acid (RNA). The nucleic 

acid comprising the genome may be 

single-stranded or double-stranded, and 

in a linear, circular or segmented 

configuration. Single-stranded viral 

genomes may be positive sense (same 

polarity as mRNA), negative sense, or 

ambisense (mixture of the two). Viral 

genomes which consist of positive sense 

RNA are infectious when the purified 

viral RNA is applied to permissive cells 

in the absence of any viral proteins. In 

some cases, viral genomes which are 

composed of double-stranded DNA are 

also infectious (e.g., genome of 

Cercopithecine Herpesvirus 1 (Herpes B 

virus)). If genomic material being 

imported does not encode for infectious 

and/or replication competent forms of 

an infectious biological agent then a 

permit is not required. For example, a 

permit would not be required for RNA 

obtained from negative stranded RNA 

viruses or for genomic DNA isolated 

from bacteria. As such, CDC proposes to 

clarify this policy by adding a provision 

in the regulation that a permit is not 

required for 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. Importers would not be required 

to perform confirmatory tests on these 

specimens, only certify in writing that 

they have no reason to believe that the 

samples can produce infectious forms of 

any infectious biological agent. 

Regulated Products 

CDC proposes to exempt material 

contained in certain products from the 

requirement to obtain a CDC Permit for 

importation into the United States or 

subsequent transfer within the United 

States. If the material is contained in a 

product that is cleared, approved, 

licensed, or authorized under the 

provisions of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 301 et 

seq.), Section 351 of the Public Health 

Service Act pertaining to biological 

products (42 U.S.C. 262), or the VirusSerum-Toxin Act (21 U.S.C. 151–159), 

CDC has determined that it is unlikely 

that material in these products would 

present a risk of the introduction, 

transmission, or spreading of a 

communicable disease. This exemption 

would include all investigational 

products for which an Investigational 

New Drug application (IND) is in place 

with the U.S. Food and Drug 

Administration (FDA). Examples of 

products that have been cleared, 

approved, licensed, or authorized by the 

FDA include FDA-licensed live 

attenuated vaccines and diagnostic test 

kits authorized for marketing or 

investigational use. Examples of 

products for Section 351 of the Public 

Health Service Act pertaining to 

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

the Virus-Serum-Toxin Act (21 U.S.C. 

151–159) include vaccines, antibody 

products, and blood products. 

CDC proposes to clarify this policy by 

adding a provision in the regulation that 

a permit is not required for a product 

that is cleared, approved, licensed, or is 

otherwise authorized under the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

301 et seq), Section 351 of the Public 

Health Service Act pertaining to 

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

the Virus-Serum-Toxin Act (21 U.S.C. 

151–159). 

D. Transportation 

During the importation of the 

infectious biological agents, infectious 

material, or vectors, the importer must 

be in compliance with all applicable 

laws concerning the packaging and 

shipment of infectious substances, 

including the following: 

• Agriculture (9 CFR parts 92, 94, 95 

96, 121, 122, and 130), 

• Occupational Health and Safety 

Administration (29 CFR 1910.1030), 

• Transportation (49 CFR parts 171 

through 180), and 

• Postal Service (39 CFR part 111). 

As such, CDC proposes to clarify this 

policy by adding the language ‘‘The 

importer is in compliance with all 

applicable laws concerning the 

packaging and shipment of infectious 

substances’’ at § 71.54(b)(4). 

E. Appeals Process 

Since 2003, CDC has denied 2 

applications for permits. CDC proposes 

to provide applicants with an 

opportunity for a written appeal in the 


tkelley on DSK3SPTVN1PROD with PROPOSALS
63894 Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Proposed Rules 

event that the CDC Director denies a 

request for a permit to import infectious 

biological agents, infectious material, 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 

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). CDC would then 

issue a written response, which would 

then constitute final agency action. CDC 

invites comments on this process. 

F. Alternatives Considered 

In researching the proposed changes, 

we reviewed how U.S. Department of 

Agriculture/Animal and Plant Health 

Inspection Service (USDA/APHIS) 

regulates the importation plant and 

animal products and the Federal Select 

Agent Program regulates the possession, 

use, and transfer of select agents and 

toxins. We learned that HHS/CDC 

identified, through its Select Agent 

Program inspection program, specific 

biosafety measure implementation 

issues in 81 of the 316 the 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. USDA/APHIS has identified 

similar biosafety issues. 

Thus, in the proposed rule, import 

regulations clearly state that the 

applicant have biosafety measures that 

are commensurate with the hazard 

posed by the infectious biological agent, 

infectious material, and/or vector to be 

imported, and the level of risk given its 

intended use. The safe possession and 

work with infectious biological agents, 

infectious material, and vectors requires 

that importers have the appropriate 

biosafety measures in place for imported 

material. These biosafety measures may 

be entity-wide, laboratory-specific, or 

agent-specific. HHS/CDC believes 

importers engaged in microbiological 

research and related activities utilizing 

safe laboratory practices, safety 

equipment, and facility safeguards will 

reduce the incidence of LAIs and other 

incidents and will protect the public 

health and environment. HHS/CDC also 

considered a requirement that the 

applicant must develop and implement 

a written biosafety plan that is 

commensurate with the hazard posed by 

the infectious biological agent, 

infectious material, and/or vector to be 

imported, and the level of risk given its 

intended use, including what elements 

of the plan are essential to prevent 

exposures and dramatically reduce the 

incidence of LAIs and protect the public 

health and environment. However, we 

believe that most, if not all, importers of 

etiological agents already have such 

biosafety plans based on our experience 

with import permit submissions 

addressing Section G (Receiving 

Laboratory Capabilities) of the permit 

application. The total number of 

applicants estimated to have biosafety 

plans from March 2011 to the present is 

632 out of 644 or 98%. CDC would be 

interested in comments concerning the 

cost and burden of formalizing a written 

biosafety plan. 

Finally, we also provided exemptions 

to allow importers to import certain 

material that is already approved or 

authorized by another agency or 

material that has been determined not to 

be an infectious biological agent. We 

believe this will reduce burden for 

clinical/diagnostic laboratories or small 

business selling manufactured goods. 

III. Required Regulatory Analyses 

Under Executive Orders 13563 and 

12866 

Executive Orders 13563 and 12866 

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 

has been designated a ‘‘significant 

regulatory action’’ although not 

economically significant, under section 

3(f) of Executive Order 12866. 

Accordingly, the rule has been reviewed 

by the Office of Management and 

Budget. 

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 proposed 

requirement to have in place biosafety 

measures, our current experience with 

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. In fact, based on the 

review of applications received since 

March 2011, we estimated 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 CDC will 

inspect an import facility, as noted 

above, 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 BSL– 

3, BSL–4, ABSL–3, ABSL–4 or BSL–3 

Agriculture laboratory as described in 

the BMBL (e.g., Mycobacterium 

tuberculosis), and (2) that have not been 

inspected by CDC’s Select Agent 

Program. 

Since 2009, we have refined the 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 we anticipate 

would require a biosafety inspection; we 

first identified those facilities that 

applied to import ‘‘BSL–3 agents’’ for 

research. From that list, we deleted 

those facilities already receiving 

periodic biosafety from either CDC or 

APHIS inspections due to their 

registration with the Federal Select 

Agent Program and concluded that 

approximately 25 facilities would need 

to be inspected per year to verify that 

they have in place the appropriate 

biosafety measures that are 

commensurate with the risk posed by 

the infectious biological agent, 

infectious material, and/or vector, and 

the level of risk given its intended use. 

We based our estimate on fact that the 

remaining facilities would not need to 

be inspected based on our current 

experience with reviewing the 

information contained in the import 

permit applications which address in 

detail the capabilities of receiving 

laboratories (description of any required 

personal protective equipment and 

laboratory equipment (biosafety 

cabinets, autoclaves), which if used 

properly ensures materials are properly 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Proposed Rules 63895 

handled and contained). We therefore 

anticipate that this requirement will 

impose only a minimal burden on 

importers. However, we believe that the 

addition of this requirement is 

important to ensure that current and 

future importing facilities have and 

maintain the appropriate biosafety 

measures for working safely with 

imported infectious agents by inspecting 

these facilities. HHS/CDC’s belief in the 

importance of including a requirement 

that importers are subject to an 

inspection to verify the implementation 

of appropriate biosafety measures is 

based on our eight years of experience 

in the area of select agent regulatory 

oversight. While 100% of entities 

registered for the possession, use, or 

transfer of select agents and toxins (42 

CFR part 73) had appropriately filled 

out their application and had an 

adequate written biosafety plan, HHS/ 

CDC identified, through its Select Agent 

Program inspection program, specific 

biosafety measure implementation 

issues in 81 of the 316 the entities 

inspected by HHS/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. 

USDA/APHIS has a similar experience 

with those Select Agent entities for 

which it has principle oversight. Thus, 

we have learned from inspecting entities 

registered with the HHS/CDC’s Select 

Agent Program that the ‘‘trust’’ approach 

to accepting information received from 

paperwork is ineffective. We found that 

the information provided in the 

paperwork did not always match the 

biosafety practices that are employed by 

the facility. As such, we believe that 

HHS/CDC’s Permitting Program should 

adopt a parallel program to verify 

biosafety measures. 

We also anticipate that there will be 

no cost to CDC to implement these 

recommended changes since we already 

review documents regarding biosafety 

and have a staff of fully trained and 

experienced biosafety inspectors. 

Finally, we believe the projected travel 

costs to perform these inspections will 

be at no additional cost to CDC since we 

plan to coordinate these inspections 

with those we are already conducting 

under the Federal Select Agent 

Inspection Program. 

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. As discussed above, CDC does 

not anticipate that this NPRM will have 

a significant economic impact on a 

substantial number of small businesses 

and other small entities. Of the entities 

impacted by this rule, CDC estimates 

that approximately 100 applications 

received out of 2000 applications are 

from small businesses. 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, size standard eligibility 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, 

annual receipts may not exceed $2.5 to 

$21.5 million for services provided or 

maximum number of employees may 

range from 100 to 500 depending on the 

particular product being provided. 

Based on this definition, we did not 

consider universities or major 

pharmaceutical companies as small 

businesses. CDC would be interested in 

comments concerning the cost and 

burden of this proposed rule, especially 

from an importer that might be 

considered a small business or entity or 

from the private sector. 

IV. 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 information 

collection and recordkeeping 

requirements included in this proposed 

rule 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 the proposed rule. 

In the past, CDC has denied 

applications for permits. Thus, in this 

rule, CDC proposes to provide 

applicants with an opportunity for a 

written appeal in the event that the CDC 

Director denies a request for a permit to 

import infectious biological agents, 

infectious material, 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 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). CDC would then 

issue a written response, which would 

then constitute final agency action. CDC 

estimates the time to prepare and 

submit such a request is 4 hours. CDC 

invites comments on this process. 

B. Executive Order 12988, Civil Justice 

Reform and Executive Order 13132, 

Federalism 

This proposed 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. 

CDC believes it has used plain language 

in drafting of the proposed rule and 

would welcome any comment from the 

public 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: June 20, 2011. 

Kathleen Sebelius, 

Secretary. 

For the reasons stated in the 

preamble, the Centers for Disease 

Control and Prevention, U.S. 

Department of Health and Human 

Services, proposes to amend 42 CFR 

part 71, subpart F, as follows: 

PART 71—FOREIGN QUARANTINE 

1. The authority citation for part 71 

continues to read as follows: 

Authority: 42 U.S.C. 243, 248, 249, and 

264–272. 

2. Revise § 71.54 to read as follows: 

§ 71.54 Import Regulations for Infectious 

Biological Agents, Infectious Material, and 

Vectors. 

(a) Definitions: 

Animal. Any member of the animal 

kingdom except a human. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
63896 Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Proposed Rules 

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 may be singlestranded 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 material. Any material 

which is known or suspected to contain 

a biological agent infectious to humans. 

Select agents and toxins. Biological 

agents and toxins that could pose a 

severe threat to public health and safety 

listed in 42 CFR 73.3 and 73.4. 

Vector. Any animals (vertebrate or 

invertebrate) including arthropods or 

any noninfectious self-replicating 

system known to transfer or 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 material or vector unless: 

(1) It is accompanied by a permit 

issued by CDC. The possession of a 

permit issued by 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 permit requirements and 

conditions. 

(3) The importer has implemented 

biosafety measures commensurate with 

the hazard posed by the infectious 

biological agent, infectious material, 

and/or vector to be imported, and the 

level of risk given its intended use. 

(4) The importer is in compliance 

with all applicable laws concerning the 

packaging and shipment of infectious 

substances. 

(c) If noted as a condition of the 

issued permit, subsequent transfers of 

any infectious biological agent, 

infectious material 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. 

(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 materials, 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 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) It is a diagnostic specimen not 

known by the importer to contain, or 

suspected by the importer of containing, 

an 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. 

(3) 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. 

(4) 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). 

(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 CDC Import Permit Program. 

(2) Have in place biosafety measures 

that are commensurate with the hazard 

posed by the infectious biological agent, 

infectious material, 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 material, 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. CDC will 

issue a written response to the appeal, 

which shall constitute final agency 

action. 

[FR Doc. 2011–26656 Filed 10–13–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF DEFENSE 

GENERAL SERVICES 

ADMINISTRATION 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

48 CFR Parts 24 and 52 

[FAR Case 2010–013; Docket 2010–0013; 

Sequence 1] 

RIN 9000–AM02 

Federal Acquisition Regulation; 

Privacy Training, 2010–013 

AGENCY: Department of Defense (DoD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Proposed rule. 

SUMMARY: DoD, GSA, and NASA are 

proposing to amend the Federal 

Acquisition Regulation (FAR) to require 

contractors to complete training that 

addresses the protection of privacy, in 

accordance with the Privacy Act of 

1974, and the handling and 

safeguarding of personally identifiable 

information. 

DATES: Interested parties should submit 

written comments to the Regulatory 

Secretariat at one of the addresses 

shown below on or before December 13, 

2011 to be considered in the formation 

of the final rule. 

ADDRESSES: Submit comments in 

response to FAR case 2010–013 by any 

of the following methods: 

• Regulations.gov: http:// 

www.regulations.gov. Submit comments 

via the Federal eRulemaking portal by 

inputting ‘‘FAR Case 2010–013’’ under 


tkelley on DSK3SPTVN1PROD with PROPOSALS