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[Federal Register: March 23, 2010 (Volume 75, Number 55)]
[Proposed Rules]               
[Page 13702-13705]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr10-28]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1314

[Docket No. DEA-328P]
RIN 1117-AB25

 
Implementation of the Methamphetamine Production Prevention Act 
of 2008

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: In October 2008, the President signed the Methamphetamine 
Production Prevention Act of 2008, which clarifies the information 
entry and signature requirements for electronic logbook systems 
permitted for the retail sale of scheduled listed chemical products. 
DEA is promulgating this rule to incorporate the statutory provisions 
and make its regulations consistent with the new requirements. Once 
finalized, this action will make it easier for regulated sellers to 
maintain electronic logbooks by allowing greater flexibility as to how 
information may be captured.

DATES: Written comments must be postmarked and electronic comments must 
be submitted on or before May 24, 2010. Commenters should be aware that 
the electronic Federal Docket Management System will not accept 
comments after midnight Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-328'' on all written and electronic correspondence. 
Written comments sent via regular or express mail should be sent to 
Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. 
Comments may be sent to DEA by sending an electronic message to 
dea.diversion.policy@usdoj.gov. Comments may also be sent 
electronically through http://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the http://www.regulations.gov Web site. DEA will 
accept electronic comments containing MS word, WordPerfect, Adobe PDF, 
or Excel files only. DEA will not accept any file formats other than 
those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern time on the day the comment period 
closes because http://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern time on the day the 
comment period closes. Commenters in time zones other than Eastern time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152, 
Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first

[[Page 13703]]

paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. Please note 
that the Freedom of Information Act applies to all comments received. 
If you wish to inspect the agency's public docket file in person by 
appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

DEA's Legal Authority

    DEA implements the Comprehensive Drug Abuse Prevention and Control 
Act of 1970, often referred to as the Controlled Substances Act (CSA) 
and the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 
801-971), as amended. DEA publishes the implementing regulations for 
these statutes in Title 21 of the Code of Federal Regulations (CFR), 
Parts 1300 to 1399. These regulations are designed to ensure that there 
is a sufficient supply of controlled substances for legitimate medical, 
scientific, research, and industrial purposes and to deter the 
diversion of controlled substances to illegal purposes.
    The CSA mandates that DEA establish a closed system of control for 
manufacturing, distributing, and dispensing controlled substances. Any 
person who manufactures, distributes, dispenses, imports, exports, or 
conducts research or chemical analysis with controlled substances must 
register with DEA (unless exempt) and comply with the applicable 
requirements for the activity.
    The CSA as amended also requires DEA to regulate the manufacture 
and distribution of chemicals that may be used to manufacture 
controlled substances illegally. Listed chemicals that are classified 
as List I chemicals are important to the manufacture of controlled 
substances. Those classified as List II chemicals may be used to 
manufacture controlled substances.

Background

    On March 9, 2006, the President signed the Combat Methamphetamine 
Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT 
Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). CMEA 
amended the CSA to change the regulations for selling products that 
contain ephedrine, pseudoephedrine, and phenylpropanolamine, their 
salts, optical isomers, and salts of optical isomers, that may be 
marketed or distributed lawfully in the United States under the Federal 
Food, Drug, and Cosmetic Act as nonprescription drugs. CMEA defines 
these products as ``scheduled listed chemical products'' (21 U.S.C. 
802(45)). Ephedrine, pseudoephedrine, and phenylpropanolamine are List 
I chemicals because they are used in, and important to, the illegal 
manufacture of methamphetamine and amphetamine, both Schedule II 
controlled substances.

Requirements for Retail Sales of Scheduled Listed Chemical Products

    CMEA defines nonprescription drug products marketed or distributed 
lawfully in the United States under the Federal Food, Drug, and 
Cosmetic Act containing ephedrine, pseudoephedrine, or 
phenylpropanolamine as ``scheduled listed chemical products'' (21 
U.S.C. 802(45)). Direct, in-person sales to a customer, whether by a 
regulated seller (e.g., grocery store, general merchandise store, drug 
store) (21 U.S.C. 802(46), (49)) or a mobile retail vendor (e.g., 
kiosk, flea market), (21 U.S.C. 802(47)) are subject to requirements 
for training of employees who either are responsible for delivering 
scheduled listed chemical products into the custody of purchasers or 
who deal directly with purchasers by obtaining payments for the 
products (21 U.S.C. 830(e)(1)(A)(vii)). The regulated seller must 
certify to DEA that the employees have been trained (21 U.S.C. 
830(e)(1)(B)). These regulated sellers must also check identifications 
of purchasers and maintain specific records (the logbook) of each sale 
of scheduled listed chemical products (21 U.S.C. 830(e)(1)(A)). The 
only sales exempt from recordkeeping are sales of single packages where 
the package contains not more than 60 milligrams of pseudoephedrine (21 
U.S.C. 830(e)(1)(A)(iii)).
    On September 26, 2006, DEA published in the Federal Register an 
Interim Final Rule, ``Retail Sales of Scheduled Listed Chemical 
Products; Self-Certification of Regulated Sellers of Scheduled Listed 
Chemical Products'' (71 FR 56008; corrected at 71 FR 60609, October 13, 
2006). That rule incorporated the standards set forth by the CMEA, 
requiring regulated sellers of scheduled listed chemical products to 
maintain logbooks regarding their sales on and after September 30, 
2006. If a regulated seller maintains the logbook on paper, DEA 
requires that the book be bound, as is currently the case for records 
of sales of Schedule V controlled substances that are sold without a 
prescription (21 CFR 1314.30(a)(2)). The records must be readily 
retrievable and available for inspection and copying by DEA or other 
State or local law enforcement agencies (21 U.S.C. 830(e)(1)(C)(i), 21 
CFR 1314.30(i)). Logs must be kept for not fewer than two years from 
the date the entry was made (21 CFR 1314.30(g). CMEA required the logs 
include the information entered by the purchaser (name, address, 
signature, date and time of sale) and the quantity and form of the 
product sold.
    Where the record is entered electronically, the computer system may 
enter the date and time automatically. An electronic signature system, 
such as the ones many stores use for credit card purchases, can be 
employed to capture the signature for electronic logs (21 CFR 
1314.30(c)). The information that the seller must enter can be 
accomplished through a point-of-sales system and bar code reader.

Changes to Sec.  1314.30

    On October 14, 2008, the President signed the Methamphetamine 
Production Prevention Act of 2008 (Pub. L. 110-415). The Act amends the 
existing language in 21 U.S.C. 830(e)(1)(A)) by revising clauses (iv) 
through (vi). The purpose of this Act is to facilitate the creation of 
electronic logbooks. Several options are provided for obtaining 
signatures of purchasers and recording transactions at the time of the 
sale.
    Specifically, the requirements now state that a regulated seller of 
scheduled listed chemical products may not sell such a product unless 
the purchaser:
     Presents a government issued photographic identification; 
and
     Signs the written logbook with his or her name, address, 
time and date of the sale, or signs in one of the following ways:
    [cir] In the case of an electronic logbook, the device must capture 
the signature in an electronic format.
    [cir] In the case of a bound paper book, a printed sticker must be 
affixed to the book at the time of sale adjacent to the

[[Page 13704]]

signature line. The sticker must display the product name, quantity, 
name of purchaser, date and address, or a unique identification that 
can be linked to that information.
    [cir] In the case of a printed document, the document must include 
a clear line for the purchaser's signature and include product name, 
quantity, name and address of purchaser, and date and time of sale.
    The Methamphetamine Production Prevention Act expressly permits the 
regulated seller to capture information regarding the name of the 
product and the quantity sold through bar code, electronic data 
capture, or similar technology. The regulated seller remains 
responsible for determining that the name entered corresponds to the 
photographic identification presented by the purchaser. The 
Methamphetamine Production Prevention Act indicates that if the 
prospective purchaser enters the information into the logbook, the 
regulated seller must determine that the name entered in the logbook 
corresponds to the name provided on the photographic identification and 
must determine that the date and time of the sale as entered by the 
purchaser are correct. If the regulated seller enters the information 
into the logbook, the prospective purchaser must verify that the 
information is correct.
    In addition, the written or electronic logbook must continue to 
include a notice to purchasers that entering false statements or 
misrepresentations in the logbook, or supplying false information or 
identification that results in the entry of false statements or 
misrepresentations, may subject the purchaser to criminal penalties 
under section 1001 of title 18 of the U.S. Code (21 U.S.C. 
830(e)(1)(A)(v)). The logbook must be maintained by the regulated 
seller for not fewer than two years after the date on which the entry 
is made (21 U.S.C. 830(e)(1)(A)(vi)).
    The changes made by the Methamphetamine Production Prevention Act 
and implemented in this rulemaking will provide greater flexibility for 
regulated sellers of scheduled listed chemical products. These persons 
may now choose several alternative ways in which to capture and 
maintain required logbook information: a fully written logbook, a fully 
electronic logbook, or a logbook where some information is captured 
electronically and the prospective purchaser's signature is captured 
and linked to that information.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator hereby certifies that this 
rulemaking has been drafted in accordance with the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601-612). This rule simply codifies 
statutory provisions, implementing the Methamphetamine Production 
Prevention Act. This rule will provide greater flexibility to regulated 
sellers, permitting them to capture required logbook information in a 
variety of ways.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
rulemaking has been drafted in accordance with the principles in 
Executive Order 12866 Section 1(b). It has been determined that this is 
a significant regulatory action. Therefore, this action has been 
reviewed by the Office of Management and Budget. As discussed above, 
this action is codifying statutory provisions. This statutory change 
imposes no new costs on regulated sellers of the List I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine. Rather, it 
provides greater flexibility for regulated sellers who may choose to 
capture required logbook information in a written form, in an 
electronic form, or in a manner that combines written and electronic 
information.

Paperwork Reduction Act of 1995

    Although the requirements of the Methamphetamine Production 
Prevention Act revise the ways in which logbook information may be 
captured or presented, these requirements are not substantially 
different than the previously existing requirements for documentation 
of sales in logbooks. DEA believes that these revised requirements will 
have a negligible impact on the time estimated to document a sale. 
Estimates of this time burden are included in information collection 
1117-0046, ``Certification, Training, and Logbooks for Regulated 
Sellers of Scheduled Listed Chemical Products.'' Therefore, as DEA does 
not believe that the burden associated with this collection will 
measurably change, DEA is not revising this information collection.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of State 
law; impose enforcement responsibilities on any State; nor does it 
diminish the power of any State to enforce its own laws. Accordingly, 
this rulemaking does not have federalism implications warranting the 
application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.

Congressional Review Act

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act). This rule will not result in an annual 
effect on the economy of $100,000,000 or more; a major increase in 
costs or prices; or significant adverse effects on competition, 
employment, investment, productivity, innovation, or on the ability of 
United States-based companies to compete with foreign-based companies 
in domestic and export markets.

List of Subjects in 21 CFR Part 1314

    Drug traffic control, Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1314 is proposed to be 
amended as follows:

PART 1314--RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS

    1. The authority citation for part 1314 continues to read as 
follows:

    Authority:  21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a.

    2. Sec.  1314.30 is revised to read as follows:


Sec.  1314.30  Recordkeeping for retail transactions.

    (a) Except for purchase by an individual of a single sales package 
containing not more than 60 milligrams of pseudoephedrine, the 
regulated seller must maintain, in accordance with criteria issued by 
the Administrator, a written or electronic list of each scheduled 
listed chemical product sale that identifies the products by name, the 
quantity sold, the names and addresses

[[Page 13705]]

of the purchasers, and the dates and times of the sales (referred to as 
the ``logbook'').
    (b) The regulated seller must not sell a scheduled listed chemical 
product at retail unless the sale is made in accordance with the 
following:
    (1) The purchaser presents an identification card that provides a 
photograph and is issued by a State or the Federal Government, or a 
document that, with respect to identification, is considered acceptable 
for purposes of 8 CFR 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B).
    (2) The purchaser signs the logbook as follows:
    (i) For written logbooks, enters in the logbook his name, address, 
and the date and time of the sale.
    (ii) For electronic logbooks, provides a signature using one of the 
following means:
    (A) Signing a device presented by the seller that captures 
signatures in an electronic format. The device must display the warning 
notice in paragraph (d) of this section. Any device used must preserve 
each signature in a manner that clearly links that signature to the 
other electronically captured logbook information relating to the 
prospective purchaser providing that signature.
    (B) Signing a bound paper book. The bound paper book must include, 
for such purchaser, either--
    (1) A printed sticker affixed to the bound paper book at the time 
of sale that either displays the name of each product sold, the 
quantity sold, the name and address of the purchaser, and the date and 
time of the sale, or a unique identifier which can be linked to that 
electronic information, or
    (2) A unique identifier that can be linked to that information and 
that is written into the book by the seller at the time of sale. The 
purchaser must sign adjacent to the printed sticker or written unique 
identifier related to that sale. The bound paper book must display the 
warning notice in paragraph (d) of this section.
    (C) Signing a printed document that includes, for the purchaser, 
the name of each product sold, the quantity sold, the name and address 
of the purchaser, and the date and time of the sale. The document must 
be printed by the seller at the time of the sale. The document must 
contain a clearly identified signature line for a purchaser to sign. 
The printed document must display the warning notice in paragraph (d) 
of this section. Each signed document must be inserted into a binder or 
other secure means of document storage immediately after the purchaser 
signs the document.
    (3) The regulated seller must enter in the logbook the name of the 
product and the quantity sold. Examples of methods of recording the 
quantity sold include the weight of the product per package and number 
of packages of each chemical, the cumulative weight of the product for 
each chemical, or quantity of product by Universal Product Code. These 
examples do not exclude other methods of displaying the quantity sold. 
Such information may be captured through electronic means, including 
through electronic data capture through bar code reader or similar 
technology. Such electronic records must be provided pursuant to 
paragraph (g) of this section in a human readable form such that the 
requirements of paragraph (a) of this section are satisfied.
    (c) The logbook maintained by the seller must include the 
prospective purchaser's name, address, and the date and time of the 
sale, as follows:
    (1) If the purchaser enters the information, the seller must 
determine that the name entered in the logbook corresponds to the name 
provided on the identification and that the date and time entered are 
correct.
    (2) If the seller enters the information, the prospective purchaser 
must verify that the information is correct.
    (3) Such information may be captured through electronic means, 
including through electronic data capture through bar code reader or 
similar technology.
    (d) The regulated seller must include in the written or electronic 
logbook or display by the logbook, the following notice:

    WARNING: Section 1001 of Title 18, United States Code, states 
that whoever, with respect to the logbook, knowingly and willfully 
falsifies, conceals, or covers up by any trick, scheme, or device a 
material fact, or makes any materially false, fictitious, or 
fraudulent statement or representation, or makes or uses any false 
writing or document knowing the same to contain any materially 
false, fictitious, or fraudulent statement or entry, shall be fined 
not more than $250,000 if an individual or $500,000 if an 
organization, imprisoned not more than five years, or both.

    (e) The regulated seller must maintain each entry in the written or 
electronic logbook for not fewer than two years after the date on which 
the entry is made.
    (f) A record under this section must be kept at the regulated 
seller's place of business where the transaction occurred, except that 
records may be kept at a single, central location of the regulated 
seller if the regulated seller has notified the Administration of the 
intention to do so. Written notification must be submitted by 
registered or certified mail, return receipt requested, to the Special 
Agent in Charge of the DEA Divisional Office for the area in which the 
records are required to be kept.
    (g) The records required to be kept under this section must be 
readily retrievable and available for inspection and copying by 
authorized employees of the Administration under the provisions of 
section 510 of the Act (21 U.S.C. 880).
    (h) A record developed and maintained to comply with a State law 
may be used to meet the requirements of this section if the record 
includes the information specified in this section.

    Dated: March 16, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2010-6175 Filed 3-22-10; 8:45 am]
BILLING CODE 4410-09-P
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