Federal Register / Vol. 68, No. 212 / Monday, November 3, 2003 / Rules and Regulations 62215

§ 20.6 Submission of reports. 

(a) * * * If the reporting exporter 

determines that the report forms cannot 

be received in the office specified in 

‘‘20.10 by the time specified in 

paragraph (k) of this section, the 

exporter shall transmit the information 

contained in the report forms by the use 

of FAX, telephone, or electronic 

submission. The required form must be 

subsequently submitted in accordance 

with § 20.6(k)(2). Exporters have the 

option to submit the weekly reports 

using an electronic reporting system 

(forms 97e, 98e, and 100e) which may 

be accessed via a secured Internet 

website. Reporting exporters should 

contact the Export Sales Reporting staff 

to obtain passwords and access to the 

Internet reporting site. Exporters also 

have the option of satisfying the 

requirements of Forms FAS–97, FAS–

98, and FAS–100 by submitting ASCII 

comma delimited files via e-mail to the 

ESR mailbox at esr@fas.usda.gov.

* * * * *

(k) Manner and time of reporting—(1) 

Manner. An original of all report forms, 

other than electronic forms and ASCII 

comma delimited files, must be filed 

with the office specified in § 20.10. 

* * * 

(2) Time of filing reports. Information 

required to be reported weekly (either 

via fax, telephone, or electronically) 

must be received in the office specified 

in § 20.10 no later than 11:59 p.m. 

eastern time, on each Monday or such 

other time as may be approved in 

advance by that office. * * *

■ 5. Section 20.7 is amended by revising 

the third sentence of the paragraph to 

read as follows:

§ 20.7 Confidentiality of reports. 

* * * Information from daily reports 

filed by exporters will be made available 

to the public on the following business 

day at 9 a.m., eastern time. * * *

§ 20.10 [Amended]

■ 6. Section 20.10 is amended by adding 

the phrase ‘‘FAX: (202) 690–3270 or 

(202) 690–3273’’ after ‘‘office’’.

Signed at Washington, DC, on October 22, 

2003. 

A. Ellen Terpstra, 

Administrator, Foreign Agricultural Service.

[FR Doc. 03–27590 Filed 10–31–03; 8:45 am] 

BILLING CODE 3410–10–P

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service 

7 CFR Part 205 

[Docket Number TM–03–02] 

RIN 0581–AC27 

National Organic Program; 

Amendments to the National List of 

Allowed and Prohibited Substances

AGENCY: Agricultural Marketing Service, 

USDA.

ACTION: Final rule.

SUMMARY: This final rule amends the 

U.S. Department of Agriculture’s 

(USDA) National List of Allowed and 

Prohibited Substances (National List) to 

reflect recommendations submitted to 

the Secretary by the National Organic 

Standards Board (NOSB). Consistent 

with recommendations from the NOSB, 

this final rule adds four substances, 

along with any restrictive annotations, 

to the National List, and revises the 

annotation of one substance.

EFFECTIVE DATE: This rule becomes 

effective November 4, 2003.

FOR FURTHER INFORMATION CONTACT:

Richard H. Mathews, Program Manager, 

National Organic Program, Telephone: 

(202) 720–3252; Fax: (202) 205–7808.

SUPPLEMENTARY INFORMATION:

I. Background 

On December 21, 2000, the Secretary 

established, within the National Organic 

Standards (NOS) [7 CFR part 205], the 

National List (§§ 205.600 through 

205.607). The National List is the 

Federal list that identifies synthetic 

substances and ingredients that are 

allowed and nonsynthetic (natural) 

substances and ingredients that are 

prohibited for use in organic production 

and handling. Since established, the 

National List has not been amended. 

However, under the authority of the 

Organic Foods Production Act of 1990 

(OFPA), as amended (7 U.S.C. 6501 et 

seq.), the National List can be amended 

by the Secretary based on proposed 

amendments developed by the NOSB. 

This final rule amends the National 

List to reflect recommendations 

submitted to the Secretary by the NOSB 

from November 15, 2000, through 

September 17, 2002. Between the 

specified time period, the NOSB has 

recommended that the Secretary add 

five substances to § 205.605 of the 

National List based on petitions 

received from industry participants. 

These substances were evaluated by the 

NOSB using the criteria specified in 

OFPA (7 U.S.C. 6517 and 6518) and the 

NOS. The NOSB also recommended that 

the Secretary revise the annotation of 

one substance included within 

§ 205.605. 

The NOSB has recommended that the 

Secretary add additional substances to 

§§ 205.605 and 205.606 that have not 

been included in this final rule but are 

under review and, as appropriate, will 

be included in future rulemaking. 

II. Overview of Amendments 

The following provides an overview 

of the amendments made to designated 

sections of the National List:

§ 205.605 Nonagricultural (nonorganic) 

substances allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ or 

‘‘made with organic (specified ingredients 

or food group(s)).’’

This final rule amends paragraph (a) 

of § 205.605 by adding animal 

enzymes—without Lysosyme, calcium 

sulfate—mined, and glucono deltalactone. This final rule also amends 

paragraph (b) of § 205.605 by adding 

cellulose. 

This final rule revises current 

paragraph (b) of § 205.605 by amending 

an annotation to read as follows: 

Potassium hydroxide—prohibited for 

use in lye peeling of fruits and 

vegetables except when used for peeling 

peaches during the Individually Quick 

Frozen (IQF) production process. 

III. Related Documents 

Eight notices were published 

regarding the meetings of the NOSB and 

its deliberations on recommendations 

and substances petitioned for amending 

the National List. Substances and 

recommendations included in this final 

rule were announced for NOSB 

deliberation in the following Federal 

Register Notices: (1) 65 FR 64657, 

October 30, 2000, (Animal enzymes); (2) 

66 FR 10873, February 20, 2001, 

(Calcium sulfate); (3) 66 FR 48654, 

September 21, 2001, (Cellulose, and 

Potassium hydroxide); and (4) 67 FR 

54784, August 26, 2002, (Glucono deltalactone, and Tetrasodium 

pyrophosphate). 

IV. Statutory and Regulatory Authority 

The OFPA, as amended (7 U.S.C. 6501 

et seq.), authorizes the Secretary, at 

§ 6517(d)(1), to make amendments to the 

National List based on proposed 

amendments developed by the NOSB. 

Sections 6518(k)(2) and 6518(n) of 

OFPA authorize the NOSB to develop 

proposed amendments to the National 

List for submission to the Secretary and 

establish a petition process by which 

persons may petition the NOSB for the 

purpose of having substances evaluated 

for inclusion onto or deletion from the 

62216 Federal Register / Vol. 68, No. 212 / Monday, November 3, 2003 / Rules and Regulations 

National List. The National List petition 

process is implemented under § 205.607 

of the NOS. The current petition process 

(65 FR 43259) can be accessed through 

the NOP Web site at http://

www.ams.usda.gov/nop.

A. Executive Order 12866 

This action has been determined to be 

non-significant for purposes of 

Executive Order 12866, and therefore, 

does not have to be reviewed by the 

Office of Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. The 

final rule was reviewed under this 

Executive Order and no additional 

related information has been obtained 

since then. This final rule is not 

intended to have a retroactive effect. 

States and local jurisdictions are 

preempted under section 2115 of the 

OFPA (7 U.S.C. 6514) from creating 

programs of accreditation for private 

persons or State officials who want to 

become certifying agents of organic 

farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in 

§ 2115(b) of the OFPA (7 U.S.C. 

6514(b)). States are also preempted 

under §§ 2104 through 2108 of the 

OFPA (7 U.S.C. 6503 through 7 U.S.C. 

6507) from creating certification 

programs to certify organic farms or 

handling operations unless the State 

programs have been submitted to, and 

approved by, the Secretary as meeting 

the requirements of the OFPA. 

Pursuant to § 2108(b)(2) of the OFPA 

(7 U.S.C. 6507(b)(2)), a State organic 

certification program may contain 

additional requirements for the 

production and handling of organically 

produced agricultural products that are 

produced in the State and for the 

certification of organic farm and 

handling operations located within the 

State under certain circumstances. Such 

additional requirements must: (a) 

Further the purposes of the OFPA, (b) 

not be inconsistent with the OFPA, (c) 

not be discriminatory toward 

agricultural commodities organically 

produced in other States, and (d) not be 

effective until approved by the 

Secretary. 

Pursuant to section 2120(f) of the 

OFPA (7 U.S.C. 6519(f)), this regulation 

would not alter the authority of the 

Secretary under the Federal Meat 

Inspection Act (21 U.S.C. 601 et seq.), 

the Poultry Products Inspections Act (21 

U.S.C. 451 et seq.), or the Egg Products 

Inspection Act (21 U.S.C. 1031 et seq.), 

concerning meat, poultry, and egg 

products, nor any of the authorities of 

the Secretary of Health and Human 

Services under the Federal Food, Drug 

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

seq.), nor the authority of the 

Administrator of the Environmental 

Protection Agency (EPA) under the 

Federal Insecticide, Fungicide and 

Rodenticide Act (7 U.S.C. 136 et seq.). 

Section 2121 of the OFPA (7 U.S.C. 

6520) provides for the Secretary to 

establish an expedited administrative 

appeals procedure under which persons 

may appeal an action of the Secretary, 

the applicable governing State official, 

or a certifying agent under this title that 

adversely affects such person or is 

inconsistent with the organic 

certification program established under 

this title. The OFPA also provides that 

the U.S. District Court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601 et seq.) requires agencies 

to consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

is to fit regulatory actions to the scale of 

businesses subject to the action. Section 

605 of the RFA allows an agency to 

certify a rule, in lieu of preparing an 

analysis, if the rulemaking is not 

expected to have a significant economic 

impact on a substantial number of small 

entities. 

Pursuant to the requirements set forth 

in the RFA, the Agricultural Marketing 

Service (AMS) performed an economic 

impact analysis on small entities in the 

final rule published in the Federal 

Register on December 21, 2000. AMS 

has also considered the economic 

impact of this action on small entities 

and has determined that this final rule 

will have an impact on a substantial 

number of small entities. However, 

AMS has determined that the impact on 

entities affected by this rule will not be 

significant. The effect of this rule will be 

to allow the use of additional substances 

in agricultural production and handling. 

This action relaxes the regulations 

published in the final rule and provides 

small entities with more tools to use in 

day-to-day operations. The AMS 

concludes that the economic impact of 

this addition of allowed substances, if 

any, will be minimal and entirely 

beneficial to small agricultural service 

firms. Accordingly, the Administrator of 

the AMS hereby certifies that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

Small agricultural service firms, 

which include producers, handlers, and 

accredited certifying agents, have been 

defined by the Small Business 

Administration (SBA) (13 CFR 121.201) 

as those having annual receipts of less 

than $750,000 and small agricultural 

producers are defined as those having 

annual receipts of less than $5,000,000.

The U.S. organic industry at the end 

of 2001 included nearly 6,600 certified 

crop and livestock operations, including 

organic production and handling 

operations, producers, and handlers. 

These operations reported certified 

acreage totaling more than 2.34 million 

acres, 72,209 certified livestock, and 

5.01 million certified poultry. Data on 

the numbers of certified handling 

operations are not yet available, but 

likely number in the thousands, as they 

would include any operation that 

transforms raw product into processed 

products using organic ingredients. 

Growth in the U.S. organic industry has 

been significant at all levels. From 1997 

to 2001, the total organic acreage grew 

by 74 percent; livestock numbers 

certified organic grew by almost 300 

percent over the same period, and 

poultry certified organic increased by 

2,118 percent over this time. Sales 

growth of organic products has been 

equally significant, growing on average 

around 20 percent per year. Sales of 

organic products were approximately $1 

billion in 1993, but are estimated to 

reach $13 billion this year, according to 

the Organic Trade Association (the 

association that represents the U.S. 

organic industry). In addition, USDA 

has accredited 85 certifying agents who 

have applied to USDA to be accredited 

in order to provide certification services 

to producers and handlers. A complete 

list of names and addresses of 

accredited certifying agents may be 

found on the AMS NOP Web site, at 

http://www.ams.usda.gov/nop. AMS 

believe that most of these entities would 

be considered small entities under the 

criteria established by the SBA. 

D. Paperwork Reduction Act 

Pursuant to the Paperwork Reduction 

Act of 1995, the existing information 

collection requirements for the NOP are 

approved under OMB number 0581–

0181. No additional collection or 

recordkeeping requirements are 

imposed on the public by this final rule. 

Accordingly, OMB clearance is not 

required by section 350(h) of the 

Federal Register / Vol. 68, No. 212 / Monday, November 3, 2003 / Rules and Regulations 62217

Paperwork Reduction Act, 44 U.S.C. 

3501, et seq., or OMB’s implementing 

regulation at 5 CFR part 1320. 

E. Discussion of Comments 

The proposed rule was published in 

the Federal Register on May 22, 2003, 

with a ten-day comment period ending 

on June 2, 2003. Eighteen comments 

were received on TM–03–02. All 

comments on the proposed rule were 

posted on the NOP website. 

Commenters on proposed rule TM–

03–02 were consumers, producers, 

processors, the NOSB, certifying agents, 

food industry organizations, and trade 

organizations. The comments received 

were for amending the National List of 

Allowed and Prohibited Substances by 

adding to: § 205.605(a): Calcium sulfatemined, and glucono delta-lactone; and 

to § 205.605(b): animal enzymes-without 

Lysosyme, cellulose, and terasodium 

pyrophosphate. The commenters were 

also for amending the annotation for 

potassium hydroxide as follows: 

Potassium hydroxide-prohibited for use 

in lye peeling of fruits and vegetables 

except when used for peeling peaches 

during the Individually Quick Frozen 

(IQF) production process. 

We received five comments on 

Calcium sulfate-mined, all of which 

were in support of adding it to the 

National List. Two of the commenters 

requested that the annotation be 

changed to the NOSB recommendation 

‘‘allowed from non-synthetic sources 

only.’’ They felt this annotation would 

cover the mined calcium sulfate as well 

as any other naturally derived forms, 

should they become commercially 

available. This substance will be added 

to the National List as published in the 

proposed rule because it would be 

redundant to state ‘‘from non-synthetic 

sources only’’ because the sub-section 

heading is ‘‘Nonsysthetics allowed.’’

Five comments were received in favor 

of adding Glucono delta-lactone to the 

National List. Four of the commenters 

requested it be added with the following 

annotation: ‘‘produced through 

microbial fermentation of carbohydrates 

only.’’ This annotation would disallow 

the use of oxidation of D-glucose with 

enzymes, but enzymes are allowed in 

§ 205.605(a). Accordingly, this 

annotation is not adopted. However, the 

listing is amended to add the annotation 

‘‘production by the oxidation of Dglucose with bromine water is 

prohibited.’’ This will allow only the 

microbial and enzymes oxidation 

production methods. 

Six comments were received in favor 

of adding Animal enzymes-(Rennetanimal derived; Catalase-bovine liver; 

Animal lipase; Pancreatin; Pepsin; and 

Trypsin) to the National List. All agreed, 

however, that it should be listed in 

§ 205.605 (a) as an allowed nonsynthetic 

rather than § 205.605 (b) as an allowed 

synthetic. Because the NOSB 

recommended it as an allowed 

nonsynthetic, and it was inadvertently 

listed as an allowed synthetic, the 

substance will be moved to § 205.605 

(a), allowed nonsynthetics. 

Six comments were received in favor 

of adding Cellulose to the National List. 

One commenter was opposed to adding 

this substance to the National List 

because the substance is synthetic and 

the commenter believes that the 

substance is not essential to any product 

formulation. The commenter also stated 

that there are a number of analogous 

substances already on the National List 

as allowed substances that can fulfill the 

role. One commenter requested that the 

annotation be separated to avoid 

confusion with other cellulose derivates 

that are used as food additives and have 

been rejected by the NOSB. The NOSB 

considered the issues raised by both 

commenters in formulating its 

recommendation and we believe that no 

further change is needed based on these 

comments. In light of this, this 

substance will be added to the National 

List as proposed. 

Tertrasodium Pyrophospate received 

six comments, three in favor of and 

three opposed to inclusion on the 

National List. Several commenters 

expressed concern over the 

recommended annotation. They 

indicated that the annotation is vague, 

confusing, undefined and needs 

clarification. They stated that the 

primary use of this substance appears to 

be to create a texture that is similar to 

a meat product, and that this directly 

conflicts with the criterion established 

in § 205.600(b)(4):

the substance’s primary use is not as a 

preservative or to recreate or improve flavors, 

colors, textures, or nutritive value lost during 

processing, except where the replacement of 

nutrients is required by law.

We believe these comments have 

merit, and accordingly, we have not 

added this substance to the National 

List. We will return the NOSB’s 

recommendation on this substance to 

the NOSB for reconsideration.

Potassium hydroxide received six 

comments, five in favor of and one 

opposed to amending the annotation. 

The commenter opposed to the 

annotation amendment did not agree 

that the substance was essential to the 

peeling of peaches. The commenter 

stated that peach peeling production 

trials, without using the substance, were 

not exhaustive of the possibilities they 

could have employed to gain a 

successful outcome and therefore the 

substance should not be allowed. The 

petitioner of this substance provided 

substantial supporting data that the 

NOSB considered in its review of the 

substance. The NOSB’s recommended 

annotation change is based on all of the 

evidence provided. One commenter 

suggested this not be restricted to just 

peaches, but allowed for ‘‘peeling of 

Stone Fruit.’’ However, the petitioner 

and the NOSB considered only peaches 

and not stone fruit generally. 

Accordingly, the annotation is amended 

as proposed. 

Pursuant to 5 U.S.C. 553, it is found 

and determined that good cause exists 

for not postponing the effective date of 

this action until 30 days after 

publication in the Federal Register. 

This rule reflects recommendations 

submitted to the Secretary by the NOSB. 

The substances to be added to the 

National List were based on petitions 

from the industry and evaluated by the 

NOSB using criteria in the Act and 

regulations. Because these substances 

are critical to organic production and 

handling, the National List should be 

amended as soon as possible.

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agriculture, Animals, 

Archives and records, Imports, Labeling, 

Organically produced products, Plants, 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation.

■ For the reasons set forth in the 

preamble, 7 CFR part 205, subpart G is 

amended as follows:

PART 205—NATIONAL ORGANIC 

PROGRAM

■ 1. The authority citation for 7 CFR part 

205 continues to read as follows:

Authority: 7 U.S.C. 6501–6522.

■ 2. Section 205.605 is amended by:

■ a. Adding three substances to 

paragraph (a).

■ b. Adding one substance to paragraph 

(b).

■ c. Revising Potassium hydroxide in 

paragraph (b). 

The additions and revisions read as 

follows:

§ 205.605 Nonagricultural (nonorganic) 

substances allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ or 

‘‘made with organic (specified ingredients 

or food group(s)).’’

* * * * *

(a) * * * 

62218 Federal Register / Vol. 68, No. 212 / Monday, November 3, 2003 / Rules and Regulations 

Animal enzymes—(Rennet—animals 

derived; Catalase—bovine liver; Animal 

lipase; Pancreatin; Pepsin; and Trypsin).

* * * * *

Calcium sulfate—mined.

* * * * *

Glucono delta-lactone—production by 

the oxidation of D-glucose with bromine 

water is prohibited.

* * * * *

(b) * * *

* * * * *

Cellulose—for use in regenerative 

casings, as an anti-caking agent (nonchlorine bleached) and filtering aid.

* * * * *

Potassium hydroxide—prohibited for 

use in lye peeling of fruits and 

vegetables except when used for peeling 

peaches during the Individually Quick 

Frozen (IQF) production process.

* * * * *

Dated: October 27, 2003. 

A.J. Yates, 

Administrator, Agricultural Marketing 

Service.

[FR Doc. 03–27416 Filed 10–31–03; 8:45 am] 

BILLING CODE 3410–02–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection 

Service 

7 CFR Part 331 

9 CFR Part 121 

[Docket No. 02–088–3] 

RIN 0579–AB47 

Agricultural Bioterrorism Protection 

Act of 2002; Possession, Use, and 

Transfer of Biological Agents and 

Toxins

AGENCY: Animal and Plant Health 

Inspection Service, USDA.

ACTION: Interim rule and request for 

comments. 

SUMMARY: We are amending the 

regulations governing the possession, 

use, and transfer of listed biological 

agents and toxins in order to allow for 

the issuance of provisional registration 

certificates for individuals and entities 

and provisional grants of access to listed 

biological agents and toxins for 

individuals. These provisional measures 

are designed to provide additional time 

for the Attorney General to complete 

security risk assessments for those 

individuals and entities for which the 

Attorney General has received, by 

November 12, 2003, all of the 

information required to conduct a 

security risk assessment. This action is 

necessary to ensure that research and 

educational programs are not disrupted.

DATES: This interim rule is effective on 

November 3, 2003. We will consider all 

comments that we receive on or before 

January 2, 2004.

ADDRESSES: You may submit comments 

by postal mail/commercial delivery or 

by e-mail. If you use postal mail/

commercial delivery, please send four 

copies of your comment (an original and 

three copies) to: Docket No. 02–088–3, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3C71, 4700 River 

Road Unit 118, Riverdale, MD 20737–

1238. Please state that your comment 

refers to Docket No. 02–088–3. If you 

use e-mail, address your comment to 

regulations@aphis.usda.gov. Your 

comment must be contained in the body 

of your message; do not send attached 

files. Please include your name and 

address in your message and ‘‘Docket 

No. 02–088–3’’ on the subject line. 

You may read any comments that we 

receive on this docket in our reading 

room. The reading room is located in 

room 1141 of the USDA South Building, 

14th Street and Independence Avenue 

SW., Washington, DC. Normal reading 

room hours are 8 a.m. to 4:30 p.m., 

Monday through Friday, except 

holidays. To be sure someone is there to 

help you, please call (202) 690–2817 

before coming. 

APHIS documents published in the 

Federal Register, and related 

information, including the names of 

organizations and individuals who have 

commented on APHIS dockets, are 

available on the Internet at http://

www.aphis.usda.gov/ppd/rad/

webrepor.html.

FOR FURTHER INFORMATION CONTACT: For 

information concerning the regulations 

in 7 CFR part 331, contact Dr. Robert 

Flanders, Chief, Pest Permit Evaluations 

Branch, PPQ, APHIS, 4700 River Road 

Unit 133, Riverdale, MD 20737–1236, 

(301) 734–8758. 

For information concerning the 

regulations in 9 CFR part 121, contact 

Dr. Denise Spencer, Senior Staff 

Veterinarian, Technical Trade Services, 

National Center for Import and Export, 

VS, APHIS, 4700 River Road Unit 40, 

Riverdale, MD 20737–1231, (301) 734–

3277.

SUPPLEMENTARY INFORMATION: 

Background 

On June 12, 2002, the President 

signed into law the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (Pub. L. 107–

188). Title II of Pub. L. 107–188, 

‘‘Enhancing Controls on Dangerous 

Biological Agents and Toxins’’ (sections 

201 through 231), provides for the 

regulation of certain biological agents 

and toxins by the Department of Health 

and Human Services (subtitle A, 

sections 201–204) and the Department 

of Agriculture (subtitle B, sections 211–

213, cited as the ‘‘Agricultural 

Bioterrorism Protection Act of 2002’’), 

and provides for interagency 

coordination between the two 

departments regarding overlap agents 

and toxins (subtitle C, section 221). For 

the Department of Health and Human 

Services, the Centers for Disease Control 

and Prevention (CDC) has been 

designated as the agency with primary 

responsibility for implementing the 

provisions of the Act; the Animal and 

Plant Health Inspection Service (APHIS) 

is the agency fulfilling that role for the 

Department of Agriculture. The 

Criminal Justice Information Services 

(CJIS) Division of the Federal Bureau of 

Investigation has been designated as the 

agency with primary responsibility for 

implementing the Attorney General’s 

responsibilities under the Act (i.e., the 

security risk assessments). 

In accordance with the requirements 

of the Act, on December 13, 2002, we 

published in the Federal Register (67 

FR 76908–76938, Docket No. 02–088–1) 

an interim rule that established the 

standards and procedures governing the 

possession, use, and transfer of 

biological agents and toxins that have 

been determined to have the potential to 

pose a severe threat to both human and 

animal health (referred to as overlap 

agents and toxins), to animal health, to 

plant health, or to animal and plant 

products (7 CFR part 331 for the plantrelated provisions and 9 CFR part 121 

for the overlap and animal-related 

provisions; referred to below 

collectively as the regulations). Also on 

December 13, 2002, the CDC published 

in the Federal Register (67 FR 76886–

76905) an interim rule that established 

the standards and procedures governing 

the possession, use, and transfer of other 

select agents (42 CFR part 73). 

The regulations require that 

individuals or entities possessing, using, 

or transferring biological agents or 

toxins listed in 7 CFR 331.3 or 9 CFR 

121.3(d) must register with APHIS, 

while individuals or entities possessing, 

using, or transferring overlap agents or 

toxins must register with either APHIS 

or CDC. As part of the registration 

process, the responsible official(s), the 

alternate responsible official(s), the 

entity, and, where applicable, the 

individual(s) who owns or controls the 

entity must undergo a security risk 

assessment by the CJIS Division. 

Moreover, those individuals identified