[Federal Register Volume 60, Number 186 (Tuesday, September 26, 1995)]
[Proposed Rules]
[Pages 49529-49531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23775]



-----------------------------------------------------------------------


DEPARTMENT OF JUSTICE
21 CFR Part 1310

[DEA-135P/RIN 1117-AA30]


Manufacturer Reporting

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule is issued by the Deputy Administrator of 
the Drug Enforcement Administration (DEA) to implement provisions of 
the Domestic Chemical Diversion Control Act of 1993 (Public Law 103-
200) (DCDCA) to specify certain reporting requirements for 
manufacturers of listed chemicals. In a proposed rule published in the 
Federal Register on October 13, 1994 (59 FR 51887), the DEA previously 
proposed regulations to implement the requirement that bulk 
manufacturers of listed chemicals report certain data to the DEA. After 
receiving comments from the affected chemical industry, on December 9, 
1994 (59 FR 63738) the DEA withdrew the portions of the proposed rule 
pertaining to manufacturer reporting requirements, for further study 
and consultation with industry. The proposed manufacturer reporting 
requirements as specified in this Notice of Proposed Rulemaking have 
been prepared with additional input from the affected chemical 
industry.

DATES: Written comments and objections must be received by November 27, 
1995.

ADDRESSES: Comments and objections should be submitted in quintuplicate 
to the Administrator, Drug Enforcement Administration, Washington DC 
20537, Attention: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Howard McClain Jr., Chief, Drug and 
Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, D.C. 20537, Telephone (202) 
307-7183.

SUPPLEMENTARY INFORMATION: The Domestic Chemical Diversion Control Act 
of 1993 (Pub. L. 103-200) (DCDCA) was signed into law on December 17, 
1993 and became effective on April 16, 1994. A final rule implementing 
most of the provisions of the DCDCA (60 FR 32447) was published on June 
22, 1995.
    The DCDCA amended 21 U.S.C. 830(b) to require that regulated 
persons who manufacture a listed chemical (other than a drug product 
that is exempted under 21 U.S.C. 802(39)(A)(iv) report annually to DEA 
information detailing the specific quantities manufactured. The purpose 
of this provision is to provide DEA with information on the amounts of 
listed chemicals available in the U.S. and to enable the DEA to provide 
the International Narcotics Control Board (INCB) with aggregate data 
regarding the production and availability of chemicals controlled under 
provisions of the 1988 United Nations Convention Against Illicit 
Traffic in Narcotic Drugs and Psychotropic Substances.
    In a proposed rule published in the Federal Register on October 13, 
1994 (59 FR 51887), the DEA proposed regulations to implement the 
provisions of the DCDCA. That notice proposed to amend Section 1310.03 
to require that bulk manufacturers of listed chemicals report certain 
data to the DEA. In addition, Sections 1310.05 and 1310.06 were 
proposed to be amended to set forth the specific requirements for the 
chemical manufacturer reports. Comments received from the affected 
industry expressed concerns that the proposed manufacturer reports as 
set forth in Sections 1310.05 and 1310.06 may duplicate existing 
reports made by chemical manufacturers, did not take into consideration 
the treatment of confidential business information and were unduly 
burdensome. Therefore, on December 9, 1994, the DEA published a notice 
in the Federal Register (59 FR 63738) to withdraw the proposed 
provisions for manufacturer reporting (as set forth in 1310.05 and 
1310.06) for reassessment and consultation with industry. Subsequent to 
the withdrawal, the DEA has solicited further input and advice from 
representatives of the affected chemical industry. Following 

[[Page 49530]]
further discussions and consultation with the Chemical Manufacturers 
Association (CMA) and other relevant industry groups, the DEA has 
prepared the proposed regulations for manufacturer reporting.
    These reporting requirements will apply only to bulk manufacturers 
of listed chemicals. The term bulk manufacturer as used in this 
regulation means a person who manufactures a listed chemical by means 
of chemical synthesis or by extraction from other substances. It does 
not include persons whose sole activity consists of repackaging or 
relabeling listed chemical products or the manufacture of drug dosage 
form products which contain a listed chemical.
    Industry groups expressed concerns regarding the burden of 
generating special reports to satisfy this new reporting requirement. 
In order to minimize such a burden and avoid duplicate reporting, the 
DEA will accept existing reports which contain the required data, 
provided the data is separate or readily retrievable from other data in 
the report. Thus, if an existing standard industry report contains the 
information required in Section 1310.06(h), the preparation of a 
separate report will not be necessary.
    Industry groups also expressed concerns that the DEA would require 
each manufacturer to perform ``mass balance'' accountabilities for each 
listed chemical. In addition, industry representatives also raised 
concerns regarding such accountabilities as they pertain to the 
production of chemical mixtures. However, the DEA wishes to emphasize 
that the purpose of this reporting requirement is to allow the DEA to 
monitor the overall availability of each listed chemical in the U.S. 
and report aggregate information to the INCB, when requested. For each 
listed chemical, each manufacturer is required to report annually to 
DEA (1) the year-end inventory, (2) the aggregate quantity 
manufactured, (3) the aggregate quantity used for internal consumption 
and (4) the aggregate quantity converted to a product exempted under 
Section 1310.01(f)(1)(iv) or 1310.01(f)(1)(v) during the preceding 
calendar year. While manufacturers are required to report the 
quantities of listed chemicals used in the production of exempted 
products (e.g. exempted drug products and chemical mixtures), the 
manufacturer is not required to report data regarding the aggregate 
quantity of the exempted products produced.
    For purposes of these reporting requirements, internal consumption 
shall be defined as any quantity of a listed chemical otherwise not 
available for further resale or distribution to any outside party. 
Internal consumption shall include (but not be limited to) quantities 
used for quality control testing, quantities consumed in-house or 
production losses. Internal consumption does not include the quantities 
of a listed chemical consumed in the production of exempted products. 
(These quantities used in the production of exempted products shall be 
reported separately.)
    Industry groups also expressed concern regarding the protection of 
data provided to the DEA if it is designated as confidential business 
information. The DEA has considerable experience in safeguarding 
similar confidential business information. The issue of protection of 
confidential business information has been addressed by the DEA in the 
Federal Register Notice published on June 22, 1995 which finalizes 
specific provisions of the DCDCA (60 FR 32453).
    The release of confidential business information that is protected 
from disclosure under Exemption 4 of the Freedom of Information Act, 5 
U.S.C. 552(b)(4) (FOIA), is governed by section 830(c) of the CSA (21 
U.S.C. 830(c)) and the Department of Justice procedures set forth in 28 
CFR 16.7.
    Section 830(c) of the CSA provides that information collected under 
section 830 that is protected from disclosure under Exemption 4 may 
only be released in circumstances related to the enforcement of 
controlled substance or chemical laws, customs laws, or for compliance 
with U.S. obligations under treaty or international agreements. The 
Department of Justice procedures establish that if a FOIA request is 
received for release of information that is protected under Exemption 
4, the submitter of the protected information must be notified of such 
a request, given an opportunity to object to the disclosure and allowed 
to provide justification as to why the information should not be 
disclosed.
    In addition to the statutory and regulatory requirements, DEA has 
established internal guidelines governing the handling of confidential 
business information, including provisions that the material be 
maintained in locked containers, that access to the information be on a 
need-to-know basis, and that any disclosure under section 830 be made 
only pursuant to a non-disclosure agreement by the receiving party.
    As proposed, data provided under these reporting requirements shall 
be submitted annually to the Drug and Chemical Evaluation Section, Drug 
Enforcement Administration, Washington DC 20537, on or before the 15th 
day of March of the year immediately following the calendar year for 
which submitted.Therefore, the first annual reports which detail 
manufacturing data for calendar year 1995, shall be submitted on or 
before March 15, 1996.
    The Attorney General has delegated authority under the CSA and all 
subsequent amendments to the CSA to the Administrator of the DEA (28 
CFR 0.100). The Administrator, in turn, has redelegated this authority 
to the Deputy Administrator pursuant to 28 CFR 0.104. The Deputy 
Administrator hereby certifies that this proposed rulemaking will have 
no significant impact upon entities whose interests must be considered 
under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. The DEA 
estimates that only approximately 210 manufacturers of listed chemicals 
will be impacted by these reporting requirements. The impact is minimal 
since the requested information is frequently maintained in the normal 
course of business operation. In an effort to further minimize the 
impact of these reporting requirements and avoid duplicate reporting, 
the DEA will accept existing reports which contain the required the 
required data, the DEA will accept existing reports which contain the 
required data, provided the data is separate or readily retrievable 
from other data in the report.
    The proposed rule is not a significant regulatory action and 
therefore has not been reviewed by the Office of Management and Budget 
pursuant to Executive Order 12866.
    This action has been analyzed in accordance with the principles and 
criteria in E.O. 12612, and it has been determined that the proposed 
rule does not have sufficient federalism implications to warrant the 
preparation of a Federalism Assessment.

List of Subjects in 21 CFR Part 1310

    Drug traffic control, Reporting and recordkeeping requirements, 
List I and List II chemicals.

    For reasons as set out above, 21 CFR part 1310 is proposed to be 
amended as follows:

PART 1310--[AMENDED]

    1. The authority citation for part 1310 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 830, 871(b).


    2. Section 1310.03 is proposed to be amended by redesignating the 
introductory text as paragraph (a) and adding a new paragraph (b) to 
read as follows:

[[Page 49531]]



Sec. 1310.03  Persons required to keep records and file reports.

    (a) * * *
    (b) Each regulated person who manufacturers a listed chemical shall 
file reports regarding such manufactures as specified in Sec. 1310.05.
    3. Section 1310.05 is proposed to be amended by adding a new 
paragraph (d) to read as follows:


Sec. 1310.05  Reports.

* * * * *
    (d) Each regulated bulk manufacturer of a listed chemical shall 
submit manufacturing, inventory and use data on an annual basis as set 
forth in Sec. 1310.06(h). This data shall be submitted annually to the 
Drug and Chemical Evaluation Section, Drug Enforcement Administration 
(DEA), Washington, DC 20537, on or before the 15th day of March of the 
year immediately following the calendar year for which submitted. This 
reporting requirement does not apply to drug or other products which 
are exempted under Sec. 1310.01(f)(1)(iv) or Sec. 1310.01(f)(1)(v) 
except as set forth in Sec. 1310.06(h)(5). If an existing standard 
industry report contains the information required in Sec. 1310.06(h) 
and such information is separate or readily retrievable from the 
report, that report may be submitted in satisfaction of this 
requirement. Each report shall be submitted to the DEA under company 
letterhead and signed by an appropriate, responsible official. For 
purposes of this paragraph only, the term regulated bulk manufacturer 
of a listed chemical means a person who manufactures a listed chemical 
by means of chemical synthesis or by extraction from other substances. 
The term bulk manufacturer does not include persons whose sole activity 
consists of the repackaging or relabeling of listed chemical products 
or the manufacture of drug dosage form products which contain a listed 
chemical.
    4. Section 1310.06 is proposed to be amended by adding a new 
paragraph (h) to read as follows:


Sec. 1310.06  Content of records and reports.

* * * * *
    (h) Each annual report required by Sec. 1310.05(d) shall provide 
the following information for each listed chemical manufactured:
    (1) The name, address and chemical registration number (if any) of 
the manufacturer and person to contact for information.
    (2) The aggregate quantity of each listed chemical that the company 
manufactured during the preceding calendar year.
    (3) The year-end inventory of each listed chemical as of the close 
of business on the 31st day of December of each year. (For each listed 
chemical, if the prior period's ending inventory has not previously 
been reported to DEA, this report should also detail the beginning 
inventory for the period.)
    (4) The aggregate quantity of each listed chemical used for 
internal consumption during the preceding calendar year.
    (5) The aggregate quantity of each listed chemical manufactured and 
converted to a product exempted under Sec. 1310.01(f)(1)(iv) or 
Sec. 1310.01(f)(1)(v) during the preceding calendar year.
    (6) Data shall identify the specific isomer, salt or ester when 
applicable but quantitative data shall be reported as anhydrous base or 
acid to the nearest kilogram.

    Dated: September 11, 1995.
Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 95-23775 Filed 9-25-95; 8:45 am]
BILLING CODE 4410-09-M