10922 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations 

Related Information 

(h) France AD No. F–2005–146, dated 

August 17, 2005, also pertains to the 

subject of this AD. 

(i) Contact Tracy Murphy, Aerospace 

Engineer, Boston Aircraft Certification 

Office, FAA, Engine & Propeller 

Directorate, 12 New England Executive 

Park, Burlington, MA 01803; telephone 

(781) 238–7172; fax (781) 238–7170, for 

more information about this AD. 

Material Incorporated by Reference 

(j) You must use Microturbo Alert 

Service Bulletin No. 095–49A11, 

Edition 2, dated October 7, 2005 to do 

the actions required by this AD, unless 

the AD specifies otherwise. 

(1) The Director of the Federal 

Register approved the incorporation by 

reference of this service information 

under 5 U.S.C. 552(a) and 1 CFR part 51. 

(2) For service information identified 

in this AD, contact Microturbo SA; 

Technical Publications Department; 8 

Chemin du pont de Rupe, BP 62089; 

31019 Toulouse Cedex 2, France; 

telephone 33 0 5 61 37 55 00; fax 33 0 

5 61 70 74 45. 

(3) You may review copies at the 

FAA, New England Region, Office of the 

Regional Counsel, 12 New England 

Executive Park, Burlington, MA; or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030, 

or go to: http://www.archives.gov/

federal-register/cfr/ibr-locations.html. 

Issued in Burlington, Massachusetts, on 

March 2, 2007. 

Robert J. Ganley, 

Acting Manager, Engine and Propeller 

Directorate, Aircraft Certification Service. 

[FR Doc. E7–4140 Filed 3–9–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1271 

[Docket No. 2006N–0051] 

RIN 0910–AF65 

Health Resources and Services 

Administration 

42 CFR Part 121 

Blood Vessels Recovered With Organs 

and Intended for Use in Organ 

Transplantation 

AGENCIES: Food and Drug 

Administration, Health Resources and 

Services Administration, HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) and the Health 

Resources and Services Administration 

(HRSA) are amending their regulations 

to include as part of an organ those 

blood vessels recovered with the organ 

that are intended for use in organ 

transplantation (HRSA regulation); and 

to exclude such blood vessels from the 

definition of human cells, tissues, or 

cellular or tissue-based products (HCT/ 

Ps) (FDA regulation). The purpose of 

this final rule is to amend the 

regulations so that blood vessels 

recovered with organs and intended for 

use in organ transplantation, and 

labeled as such, are governed by the 

regulations pertaining to organs. The 

regulation of other recovered blood 

vessels remains unchanged. We (HRSA 

and FDA) believe that this change will 

eliminate the burden resulting from an 

organ procurement organization’s efforts 

to comply with both FDA and HRSA 

rules with respect to blood vessels (FDA 

jurisdiction) and organs (HRSA 

jurisdiction). 

DATES: This rule is effective on April 11, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

For information regarding FDA’s rule: 

Denise Sa ́nchez, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 

20852–1448, 301–827–6210. 

For information regarding HRSA’s 

rule: Jim Burdick, Division of 

Transplantation, Healthcare 

Systems Bureau, Health Resources 

and Services Administration 

(HRSA), 5600 Fishers Lane, rm. 

12C–06, Rockville, MD 20857, 301–

443–7577. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

HRSA oversees transplantation of 

organs through the Organ Procurement 

and Transplantation Network (OPTN), 

which sets policies related to the 

procurement, transplantation, and 

allocation of human organs (see 42 CFR 

part 121). FDA currently regulates blood 

vessels. However, FDA does not regulate 

vascularized human organs (see 21 CFR 

1270.3(j)(4) and 1271.3(d)(1)). FDA’s 

jurisdiction over blood vessels intended 

for use in organ transplantation overlaps 

with HRSA’s oversight of the OPTN. 

There is a routine practice of 

recovering blood vessels intended for 

use in organ transplantation during 

organ procurement and using such 

blood vessels to connect donor organ 

and recipient vessels. Blood vessels 

intended for use in organ 

transplantation are recovered with 

human organs by Organ Procurement 

Organizations (OPOs) and stored for use 

at transplant centers. Both OPOs and 

transplant centers are already subject to 

HRSA oversight because of their organ 

procurement and transplantation 

activities. The application of both HRSA 

and FDA regulatory requirements to 

these facilities in relation to organs and 

blood vessels procured for use in organ 

transplantation is not supported by a 

need for such dual oversight. In order to 

avoid the duplication of efforts and 

reduce the burden on affected facilities, 

this final rule transfers from FDA to 

HRSA jurisdiction over blood vessels 

intended and labeled for use in organ 

transplantation. This final rule does not 

affect the regulation of blood vessels 

intended for transplantation that do not 

involve organ transplantation. 

Jurisdiction over such blood vessels 

remains with FDA. 

Under this final rule, blood vessels 

labeled and intended solely for use in 

organ transplantation will be subject to 

HRSA requirements in 42 CFR part 121 

and any enforceable OPTN policies 

established under 42 CFR part 121. To 

be regulated under HRSA requirements, 

such blood vessels intended for use in 

organ transplantation must be labeled 

‘‘For use in organ transplantation only.’’

However, they are not required to be 

attached to the organ(s), transplanted 

simultaneously with such organ(s) to 

the same recipient, or transplanted with 

the organ(s) from the same donor. For 

example, occasionally blood vessels not 

used immediately for the 

transplantation of a donated organ are 

stored for a number of days and 

subsequently used to modify the organ 

transplant in the same recipient or to 

accomplish transplantation in the 


hsrobinson on PROD1PC76 with RULES
Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations 10923 

1See http://www.optn.org/PoliciesandBylaws2/ 

policies/pdfs/policy_17.pdf. (FDA and HRSA have 

verified the Web site address, but the agencies are 

not responsible for subsequent changes to the Web 

site after this document publishes in the Federal 

Register). 

recipient of an organ from a different 

donor. Such blood vessels intended and 

labeled for use in organ transplantation 

may be used in these ways when the use 

is consistent with HRSA requirements. 

II. Background 

In the Federal Register of May 12, 

2006, we published a direct final rule 

and a companion proposed rule (71 FR 

27606 and 27649, respectively) to revise 

HRSA’s definition of ‘‘organ’’ to include 

blood vessels recovered from an organ 

donor during the same recovery 

procedure of such organ(s) and intended 

and labeled for use in organ 

transplantation; and to exclude such 

blood vessels from FDA’s definition of 

human cells, tissues, or cellular or 

tissue-based products (HCT/Ps) (21 CFR 

1271.3(d)). The direct final rule 

amended the regulations so that blood 

vessels intended and labeled for use in 

organ transplantation were under the 

same regulatory scheme as organs, 

thereby making blood vessels intended 

and labeled for use in organ 

transplantation readily available to meet 

organ transplant needs. Such direct final 

rule would become effective unless we 

received significant adverse comment. 

We published a companion proposed 

rule to provide a procedural framework 

within which the rule could be finalized 

in the event we received any significant 

adverse comments regarding the direct 

final rule, and the direct final rule had 

to be withdrawn. 

We received comments from health 

care professionals and a nonprofit 

organization. Among the comments 

received, one comment fully supported 

the rulemaking. Another comment 

concerned the use and tracking of blood 

vessels recovered from a deceased organ 

donor but not transplanted with the 

recovered organ, and questioned the 

transfer of regulatory responsibility for 

such blood vessels from FDA to HRSA. 

Another comment suggested that the 

rulemaking distinguish between organ 

transplant recipients based on the type 

of their organ donor (living, nonrelated; 

living, related; or deceased) and use 

these distinctions to define who may 

receive the blood vessels addressed in 

the rulemaking. The comments received 

and our responses to the comments are 

discussed in section IV of this 

document. Because we received 

significant adverse comment in 

response to the rulemaking, we 

published a notice in the Federal 

Register of September 14, 2006 (71 FR 

54198), withdrawing the direct final 

rule. 

III. Highlights of the Final Rule 

To transfer from FDA to HRSA 

jurisdiction over blood vessels intended 

for use in organ transplantation, the 

final rule amends 21 CFR 1271.3(d), 42 

CFR 121.2, and 42 CFR 121.7 as follows: 

A. 21 CFR 1271.3(d) 

21 CFR 1271.3(d) defines HCT/Ps as 

‘‘articles containing or consisting of 

human cells or tissues that are intended 

for implantation, transplantation, 

infusion, or transfer into a human 

recipient.’’ In the definition, we also 

exclude certain articles from the 

definition of HCT/Ps. This final rule 

adds § 1271.3(d)(8), excluding from the 

definition of HCT/Ps blood vessels 

intended for use in organ 

transplantation. The rule excludes such 

blood vessels intended for use in organ 

transplantation only when they are 

labeled as ‘‘For use in organ 

transplantation only,’’ to distinguish 

such vessels from blood vessels not 

intended for use in organ 

transplantation. By labeling such blood 

vessels ‘‘For use in organ 

transplantation only,’’ we expect that 

they will not be used for other purposes. 

Under the final rule, blood vessels 

intended for other uses remain subject 

to 21 CFR part 1271. 

B. 42 CFR 121.2 

Under 42 CFR 121.2, ‘‘Organ’’ means 

a human kidney, liver, heart, lung, or 

pancreas. This final rule adds to that 

definition ‘‘Blood vessels recovered 

from an organ donor during the recovery 

of such organ(s) are considered part of 

an organ with which they are procured 

for purposes of this Part if the vessels 

are intended for use in organ 

transplantation and labeled ‘For use in 

organ transplantation only’.’’ Blood 

vessels intended for use in organ 

transplantation are required to be in 

compliance with HRSA provisions for 

donor screening and testing. The 

labeling provision is required in order 

for such blood vessels to fall under this 

regulatory program. Any OPTN labeling 

policies, whether voluntary or 

enforceable, supplement this 

requirement. 

C. 42 CFR 121.7 

In 42 CFR 121.7, we are redesignating 

paragraph (e) as paragraph (f), and 

adding a new paragraph (e). Under 42 

CFR 121.7(e), a blood vessel intended 

for use in organ transplantation is 

subject to the allocation requirements 

under 42 CFR part 121 and enforceable 

OPTN policies pertaining to the organ 

with which the blood vessel is 

procured. These provisions apply until 

the transplant center receiving the organ 

determines that the blood vessel is not 

needed for the transplantation of that 

organ. This allocation priority assures 

that vessels that may be necessary for 

the immediate transplantation of the 

organs with which they are recovered 

are made available for that use prior to 

being diverted to other organ transplant 

uses. 

IV. Comments on the Proposed Rule 

and HRSA and FDA Responses 

(Comment 1) One comment supported 

the proposed rule. The comment stated 

that the Organ Procurement and 

Transplantation Network/United 

Network for Organ Sharing (OPTN/ 

UNOS) Board of Directors has approved 

a policy to provide guidance for the 

recovery, use, and storage of deceased 

donor vascular allografts. The comment 

also stated that the OPTN/UNOS policy 

does not result in undue burden to the 

transplant community and is consistent 

with the provisions of the proposed 

rule. 

(Response) We appreciate the 

supportive comment. One of our reasons 

for the proposed rule is to eliminate the 

burden of dual oversight, by FDA and 

HRSA, of those blood vessels used in 

organ transplantation. The policy 

discussed in the comment is OPTN/ 

UNOS Policy 5.7.1 OPTN/UNOS Policy 

5.7 addresses practices for blood vessel 

recovery, storage, and transplant by 

transplant centers and OPOs. The policy 

will only be implemented once this 

final rule goes into effect. 

(Comment 2) One comment stated 

that patients would be better protected 

under the existing regulatory scheme. 

The comment questioned the safety of 

transplanting blood vessels recovered 

from a deceased organ donor into third 

party recipients who received organs 

from other donors. The comment 

explained that use of blood vessels in 

these recipients poses disease 

transmission and human leukocyte 

antigen (HLA) sensitization risks that 

jeopardize patient safety. The comment 

also stated that the OPTN and organ 

transplant programs lack adequate 

tracking and traceability mechanisms 

for such blood vessels. 

(Response) We acknowledge that the 

use of blood vessels poses disease 

transmission and HLA sensitization 

risks in third party recipients. The 

intent of this rule is to facilitate the 

successful completion of life-saving 

organ transplants in medical procedures 


hsrobinson on PROD1PC76 with RULES
10924 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations 

where the vasculature of the donated 

organ is inadequate, or to salvage a graft 

that would otherwise be lost. It is up to 

the organ transplant surgeon to assess 

the risks and benefits of, and 

alternatives to, using a particular vessel 

to accomplish or modify an organ 

transplant. Moreover, the risks of 

disease transmission and HLA 

sensitization would apply even if FDA 

retained jurisdiction over these blood 

vessels as HCT/Ps. FDA regulations, like 

HRSA policies, reduce, but cannot 

entirely eliminate, the risk of disease 

transmission, and FDA tissue 

regulations do not address HLA 

sensitization. In addition, the OPTN has 

long-established mechanisms for 

tracking of organs from the donor to the 

recipient, which require the reporting of 

transplant outcomes. HRSA intends to 

monitor the use and outcomes of these 

vessels used in organ transplantation, 

and to work with the OPTN to modify 

policies governing their use as needed. 

(Comment 3) One comment suggested 

that the rulemaking should distinguish 

between organ recipients based on the 

type of their organ donor (living, 

nonrelated; living, related; or deceased) 

and use these distinctions to define the 

types of transplant recipients who may 

receive these vessels for organ 

transplant use. The comment asked 

whether a surgeon may use vessels from 

a deceased donor to repair a thrombosed 

renal artery in the recipient of a living 

donor kidney. 

(Response) We decline to make these 

suggested changes to the rulemaking. 

The language in 42 CFR 121.7(e) 

establishes a priority allocation for use 

of vessels with organs from the same 

donor. If vessels are not needed for this 

use, the rule does not preclude vessels 

recovered from deceased donors and 

labeled ‘‘For use in organ 

transplantation only’’ from being 

transplanted into recipients of organs 

from living donors, either to perform the 

initial transplant of the organ or to later 

modify the organ transplant. The 

situation described in the comment 

would be an example of the use of such 

vessels to modify a transplant. 

V. Legal Authority 

We are issuing these regulations 

under the authority of the National 

Organ Transplant Act as amended 

(NOTA) and section 361 of the Public 

Health Service Act (the PHS Act). 

NOTA authorizes HRSA, by delegation 

from the Secretary, to issue regulations 

governing the operation of the OPTN. 

NOTA, as amended, also authorizes the 

Secretary to define human organs to be 

covered by the OPTN. Section 374 of the 

PHS Act specifically states, ‘‘[t]he term 

‘organ’ means the human kidney, liver, 

heart, lung, pancreas, and any other 

human organ (other than corneas and 

eyes) specified by the Secretary by 

regulation.* * *.’’ (42 U.S.C. 

§ 274b(d)(2)) (emphasis supplied). 

Accordingly, HRSA is issuing this 

regulation to modify the definition of 

‘‘organ,’’ and to make blood vessels 

labeled and intended for use in the 

transplantation of organs subject to 

regulations governing the operation of 

the OPTN. Extending the definition of 

organs governed by HRSA in 42 CFR 

121.2 to add blood vessels recovered 

with organs that are intended for use in 

organ transplantation, and labeled as 

such, furthers the Secretary’s charge 

under NOTA. 

Under the authority of section 361 of 

the PHS Act delegated to the 

Commissioner of FDA, the Department 

of Health and Human Services may 

make and enforce regulations necessary 

to prevent the introduction, 

transmission, or spread of 

communicable diseases between the 

States or from foreign countries into the 

States. This modification of FDA’s 

existing regulation reflects FDA’s reevaluation of the level of regulation that 

is necessary to prevent disease 

transmission involving blood vessels 

intended for use in organ 

transplantation. 

VI. Analysis of Impacts 

FDA and HRSA have examined the 

impacts of the final rule under 

Executive Order 12866 and the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agencies believe that this final rule is 

not a significant regulatory action under 

the Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the agencies do not 

expect that the transfer from FDA to 

HRSA of jurisdiction over the blood 

vessels described in the rule will result 

in substantial changes in the way 

transplant hospitals and OPOs procure, 

store, and transplant such blood vessels, 

FDA and HRSA certify that the final 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $122 

million, using the most current (2005) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

VII. The Paperwork Reduction Act of 

1995 

This final rule contains no collections 

of information. Therefore, clearance by 

OMB under the Paperwork Reduction 

Act of 1995 is not required. 

VIII. Environmental Impact 

FDA and HRSA have determined 

under 21 CFR 25.30(j) that this action is 

of a type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IX. Federalism 

FDA and HRSA have analyzed this 

final rule in accordance with the 

principles set forth in Executive Order 

13132. FDA and HRSA have determined 

that the rule does not contain policies 

that have substantial direct effects on 

the States, on the relationship between 

the National Government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, FDA 

and HRSA have concluded that the rule 

does not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

X. Effective Date 

This final rule is effective on April 11, 

2007. 

List of Subjects 

21 CFR Part 1271 

Biologics, Communicable diseases, 

Drugs, HIV/AIDS, Human cells, tissues, 

and cellular and tissue-based products, 

Medical devices, Reporting and 

recordkeeping requirements. 


hsrobinson on PROD1PC76 with RULES
Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations 10925 

42 CFR Part 121 

Healthcare, Hospitals, Reporting and 

recordkeeping requirements. 

■ Therefore, under the Public Health 

Service Act and under authority 

delegated to the Commissioner of Food 

and Drugs and to the Administrator, 

Health Resources and Services 

Administration, 21 CFR part 1271 and 

42 CFR part 121 are amended as 

follows: 

21 CFR Chapter I 

PART 1271—HUMAN CELLS, TISSUES, 

AND CELLULAR AND TISSUE-BASED 

PRODUCTS 

■ 1. The authority citation for 21 CFR 

part 1271 continues to read as follows: 

Authority: 42 U.S.C. 216, 243, 263a, 264, 

271. 

■ 2. Section 1271.3 is amended by 

adding paragraph (d)(8) to read as 

follows: 

§ 1271.3 How does FDA define important 

terms in this part? 

* * * * * 

(d) * * * 

(8) Blood vessels recovered with an 

organ, as defined in 42 CFR 121.2, that 

are intended for use in organ 

transplantation and labeled ‘‘For use in 

organ transplantation only.’’

* * * * * 

42 CFR Chapter I 

PART 121—ORGAN PROCUREMENT 

AND TRANSPLANTATION NETWORK 

■ 3. The authority citation for 42 CFR 

part 121 continues to read as follows: 

Authority: Sections 215, 371–376 of the 

Public Health Service Act (42 U.S.C. 216, 

273–274d); and sections 1102, 1106, 1138, 

and 1871 of the Social Security Act (42 

U.S.C. 1302, 1306, 1320b–8 and 1395hh). 

■ 4. Section 121.2 is amended by adding 

a sentence at the end of the definition 

of ‘‘Organ’’ to read as follows: 

§ 121.2 Definitions 

* * * * * 

Organ * * * Blood vessels recovered 

from an organ donor during the recovery 

of such organ(s) are considered part of 

an organ with which they are procured 

for purposes of this part if the vessels 

are intended for use in organ 

transplantation and labeled ‘‘For use in 

organ transplantation only.’’

* * * * * 

■ 5. Section 121.7 is amended by 

redesignating paragraph (e) as paragraph 

(f) and by adding paragraph (e) to read 

as follows: 

§ 121.7 Identification of organ recipient. 

* * * * * 

(e) Blood vessels considered part of an 

organ. A blood vessel that is considered 

part of an organ under this part shall be 

subject to the allocation requirements 

and policies pertaining to the organ 

with which the blood vessel is procured 

until and unless the transplant center 

receiving the organ determines that the 

blood vessel is not needed for the 

transplantation of that organ. 

* * * * * 

Dated: December 8, 2006. 

Elizabeth M. Duke, 

Administrator, Health Resources and Services 

Administration. 

Dated: February 2, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy, Food and 

Drug Administration. 

[FR Doc. 07–1131 Filed 3–9–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1310 

[Docket No. DEA–137F3] 

RIN 1117–AA31 

Exemption of Chemical Mixtures 

AGENCY: Drug Enforcement 

Administration (DEA), U.S. Department 

of Justice. 

ACTION: Final rule. 

SUMMARY: On December 15, 2004, the 

Drug Enforcement Administration 

(DEA) published a Final Rule corrected 

January 4, 2005) that implemented new 

regulations concerning chemical 

mixtures that contain any of the 27 

listed chemicals. The Final Rule added 

a new provision not previously raised 

by DEA in any proposed rulemaking. 

This newly introduced provision 

exempted domestic and import 

transactions in chemical mixtures that 

are regulated solely due to the presence 

of the List II solvent chemicals acetone, 

ethyl ether, 2-butanone, or toluene from 

the Controlled Substances Act (CSA) 

recordkeeping and reporting 

requirements. Because this exemption 

was not previously proposed in any 

rulemaking, DEA implemented this 

exemption on an interim basis and 

requested public comment on this 

exemption provision. 

Based upon a review of all comments, 

DEA is finalizing this exemption. As 

such, domestic and import transactions 

in chemical mixtures containing the List 

II chemicals acetone, ethyl ether, 2- 

butanone, and toluene shall be exempt 

from CSA chemical recordkeeping and 

reporting requirements. 

DATES: This Final Rule is effective 

March 12, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, Ph.D., Chief, 

Drug & Chemical Evaluation Section, 

Office of Diversion Control, Drug 

Enforcement Administration, 

Washington, DC 20537, telephone (202) 

307–7183. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Historical Legal Status of Chemical 

Mixtures 

The Chemical Diversion and 

Trafficking Act of 1988 (CDTA), (Pub. L. 

100–690) created the definition of 

‘‘chemical mixture’’ (21 U.S.C. 802(40)), 

and exempted chemical mixtures from 

regulatory control. The CDTA 

established 21 U.S.C. 802(39)(A)(vi), as 

amended by Title VII of Public Law 

109–177, to exclude ‘‘any transaction in 

a chemical mixture’’ from the definition 

of a ‘‘regulated transaction.’’ The 

exemption of all chemical mixtures, 

however, provided traffickers with an 

unregulated source for obtaining listed 

chemicals for use in the illicit 

manufacture of controlled substances. 

To remedy this situation, the 

Domestic Chemical Diversion Control 

Act of 1993 (Pub. L. 103–200) (DCDCA), 

enacted in April 1994, subjected 

chemical mixtures containing listed 

chemicals to CSA regulatory 

requirements, unless specifically 

exempted by regulation. The DCDCA, 

therefore, subjected all regulated 

chemical mixtures to recordkeeping, 

reporting, and security requirements of 

the CSA. Additionally, the DCDCA 

added a registration requirement for 

handlers of regulated List I chemical 

mixtures. 

The DCDCA, however, also amended 

21 U.S.C. 802(39)(A)(vi), as amended by 

Title VII of Public Law 109–177, to 

provide the Attorney General with the 

authority to establish regulations 

exempting chemical mixtures from the 

definition of a ‘‘regulated transaction’’

‘‘based on a finding that the mixture is 

formulated in such a way that it cannot 

be easily used in the illicit production 

of a controlled substance and that the 

listed chemical or chemicals contained 

in the mixture cannot be readily 

recovered’’ (21 U.S.C. 802(39)(A)(vi) as 

amended by Title VII of Pub. L. 109–

177). This authority has been delegated 

to the Administrator of DEA by 28 CFR 

0.100 and redelegated to the Deputy 


hsrobinson on PROD1PC76 with RULES