Information on Foreign Chain of Distribution for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
Notice Of Proposed Rulemaking.
The Combat Methamphetamine Epidemic Act of 2005 (CMEA), which was enacted on March 9, 2006, requires DEA to collect from importers of ephedrine, pseudoephedrine, and phenylpropanolamine all information known to the importer on the foreign chain of distribution of the chemical from the manufacturer to the importer. DEA is proposing to amend its regulations to incorporate the requirement for this information into the import declaration.
Information on Foreign Chain of Distribution for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
4 actions from March 31st, 2008 to May 4th, 2010
March 31st, 2008
May 30th, 2008
- NPRM Comment Period End
March 5th, 2010
- Final Action
May 4th, 2010
- Final Action Effective
Table of Contents Back to Top
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- DEA's Legal Authority
- Import Declaration Requirements
- Revision of DEA Form 486: Import/Export Declaration for List I and List II Chemicals
- Implementation of this Rule
- Regulatory Certifications
- Regulatory Flexibility Act
- Executive Order 12866
- Paperwork Reduction Act
- Overview of Information Collection 1117-0023
- Executive Order 12988
- Executive Order 13132
- Unfunded Mandates Reform Act of 1995
- Congressional Review Act
- List of Subjects in 21 CFR Part 1313
- PART 1313—IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS
DATES: Back to Top
Written comments must be postmarked, and electronic comments must be sent, on or before May 30, 2008.
ADDRESSES: Back to Top
To ensure proper handling of comments, please reference “DocketNo. DEA-295” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be directly sent to DEA electronically by sending an electronic message to: email@example.com. 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 attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file formats other than those specifically listed here.
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 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. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.
FOR FURTHER INFORMATION CONTACT: Back to Top
Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington DC 20537 at (202) 307-7297.
SUPPLEMENTARY INFORMATION: Back to Top
DEA's Legal Authority Back to Top
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 (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, distribution, import, and export 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.
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). The changes proposed here are needed to implement the statutory provisions. The statute is self-implementing; the provisions related to information to be collected at the importation of ephedrine, pseudoephedrine, and phenylpropanolamine became effective on March 9, 2006. The changes proposed in this rulemaking provide conforming amendments to make the language of the regulations consistent with that of the statute. DEA must implement the statute and is simply conforming its regulations to, and implementing, the statute.
Import Declaration Requirements Back to Top
Under existing DEA regulations (21 CFR part 1313), importers of listed chemicals are required to provide DEA with advance notification of imports unless the importer has met the requirements as a regular importer of the listed chemical; for regular importers, the notification must be filed by the date of importation. In the importation declaration (DEA Form 486), the importer must provide information on the chemical (name, size and weight of the container, number of containers, total weight of chemical), importation (date, foreign port of shipment, United States port of entry) and the foreign supplier (name, address, contact information).
CMEA imposes several new requirements on imports of listed chemicals. CMEA amended 21 U.S.C. 971, “Notification, suspension of shipment, and penalties with respect to importation and exportation of listed chemicals”, to require DEA to collect information regarding persons to whom the United States importer, exporter, broker, or trader transfers the listed chemical, actual quantities shipped, and the date the shipment occurred. If the person to whom the listed chemical is to be transferred is not a regular customer of the United States importer or exporter, then the importer or exporter must notify DEA no later than 15 days before the transaction is to take place. Further, if the person to whom the chemical is to be transferred changes subsequent to initial notification of DEA, or if the amount of the chemical to be transferred increases, the importer or exporter shall update the notice to DEA to identify the most recent prospective transferee or the most recent quantity or both (as the case may be) and may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the update is submitted to DEA, except that such 15-day restriction does not apply if the prospective transferee identified in the update is a regular customer. These changes apply to all listed chemicals. On April 9, 2007, DEA published an Interim Final Rule with Request for Comment codifying these provisions (72 FR 17401). Subsequently, due to requests from the regulated industry, DEA temporarily stayed certain provisions of that rule (72 FR 28601, May 22, 2007). That Interim Final Rule became effective June 8, 2007.
CMEA added a new paragraph (h) to 21 U.S.C. 971 that applies specifically to the importation of ephedrine, pseudoephedrine, and phenylpropanolamine. In paragraph (h)(1), the Act states that the import declaration “shall include all information known to the importer on the chain of distribution of such chemical from the manufacturer to the importer.” Paragraphs 971(h)(2) and (3) state that the Attorney General may ask foreign manufacturers and distributors to provide information known to them on distribution of the chemical, including sales. If the foreign manufacturer or distributor refuses to cooperate, the Attorney General may issue an order prohibiting the importation of the three chemicals if the foreign manufacturer or distributor is part of the chain of distribution. Not later than 60 days prior to issuing the order, the Attorney General must publish in the Federal Register a notice of intent to issue the order. Imports handled by the foreign distributor may not be restricted during the 60-day period. In the Conference Report (H.R. 109-333), Congress stated that the “provision will assist U.S. law enforcement agencies to better track where meth precursors come from, and how they get to the U.S. At present, very little information exists about the international ‘chain of distribution' for these chemicals, hindering effective controls.”
DEA is proposing to add a new paragraph (d) to 21 CFR 1313.13, Contents of import declaration, to state that importers of ephedrine, pseudoephedrine, and phenylpropanolamine must provide information known to them on the chain of distribution from the manufacturer to the importer. DEA is also proposing to add a new 21 CFR 1313.42 to cover the provisions of paragraphs (h)(2) and (3) on orders to prohibit imports from foreign manufacturers and distributors who refuse to cooperate with requests for information.
Revision of DEA Form 486: Import/Export Declaration for List I and List II Chemicals Back to Top
To comply with the changes made to the Controlled Substances Act by the Combat Methamphetamine Epidemic Act of 2005, DEA is proposing to establish a new DEA Form 486A to be used by persons importing ephedrine, pseudoephedrine, or phenylpropanolamine, or drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine. This new form responds to the requirement regarding the foreign chain of distribution discussed above, as well as to requirements implemented regarding import quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. In a separate rulemaking, “Import and Production Quotas for Certain List I Chemicals” [Docket No. DEA-293, RIN 1117-AB08] (72 FR 37439, July 10, 2007), DEA implemented the import quota provisions of CMEA. Importers of ephedrine, pseudoephedrine, and phenylpropanolamine will be required to provide information about their individual import quota on the DEA Form 486A so that DEA may determine whether the importer has enough quota remaining to import the quantity requested.
Thus, in addition to the fields currently present on the DEA Form 486, the DEA Form 486A contains the following fields:
- Name and address of foreign distributor (if applicable).
- Import quota, including: quota for current year; quota used to date for current year; and, amount of quota remaining.
Once the new DEA Form 486A is implemented, DEA will make both the DEA Form 486 and the DEA Form 486A fully interactive forms. That is, these forms would be able to be completed and submitted electronically. Currently, forms can be completed electronically, but must be printed and sent to DEA via facsimile. DEA notes that the availability of a fully interactive form has been long sought by the regulated industry.
Implementation of this Rule Back to Top
Effective 30 days after publication of a Final Rule implementing these regulations in the Federal Register, all United States importers of the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine would be required to use the new DEA Form 486A “Importation of the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine” to notify DEA of their imports.
Regulatory Certifications Back to Top
Regulatory Flexibility Act
The Acting Administrator hereby certifies that this rulemaking has been drafted in accordance with the provisions of the Regulatory Flexibility Act (5 U.S.C. 601-612). This rule is necessary to comply with statutory mandates which require that notices of importation for imports of the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine provide to DEA all information known to the importer on the foreign chain of distribution of the chemical. As noted above, changes to the forms also respond to provisions regarding import quotas, requiring that importers note on the form the amount of quota issued and available for each chemical. Without these changes, DEA will be unable to comply with statutory mandates and will not be able to fully administer the system of import and production quotas mandated for ephedrine, pseudoephedrine, and phenylpropanolamine.
DEA notes that the statute requires importers to provide only information that is known to them; the burden associated with providing names on the foreign chain of distribution will be minimal. This rule does not impose any new costs. DEA notes that, prior to this rule, importers of ephedrine, pseudoephedrine, and phenylpropanolamine were required to complete a DEA Form 486 to import these List I chemicals. Only the information on the form has changed. Therefore, this rule will not have a significant economic impact on a substantial number of small entities.
Executive Order 12866
The Acting Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 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 and involves no agency discretion. This statutory change imposes minimal costs on importers; they simply have to file a form with DEA in advance of transactions that includes information that is known to them. They are not required to conduct research to obtain information. DEA notes that the requirement to complete the form is already present in DEA regulations. This rule merely requires that importers of these three List I chemicals provide information known to them regarding the foreign chain of distribution of the chemicals.
Paperwork Reduction Act
DEA is proposing to revise an existing information collection by establishing a new form for the reporting of imports of the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. Specifically, DEA is creating new DEA Form 486A, “Import Declaration for Ephedrine, Pseudoephedrine, and Phenylpropanolamine”. This form permits the reporting of any information known to the United States importer regarding the foreign chain of distribution of the List I chemical(s).
Specifically, DEA estimates that 30 respondents will import ephedrine, pseudoephedrine, and phenylpropanolamine annually. These persons will conduct 350 individual importations, necessitating the submission of 350 forms. Because of the additional information required on the DEA Form 486A, DEA estimates that this form will take 20 minutes to complete, as opposed to the DEA Form 486, which DEA estimates takes 15 minutes to complete. DEA notes here that the completion of the DEA Form 486A will be in lieu of the currently-required completion of the DEA Form 486. Therefore, while the number of responses remains constant, the hour burden increases due to the greater time associated with the DEA Form 486A. The net increase for this collection is 13 hours annually.
The Department of Justice, Drug Enforcement Administration, has submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with review procedures of the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies.
All comments, suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537.
Written comments and suggestions from the public and affected agencies concerning the collection of information are encouraged. Your comments on the information collection-related aspects of this rule should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Overview of Information Collection 1117-0023
(1) Type of Information Collection: Revision of an existing collection.
(2) Title of the Form/Collection: Import/Export Declaration for List I and List II Chemicals.
(3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:
Form Number: DEA Form 486 and DEA Form 486A. Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice.
(4) Affected public who will be asked or required to respond, as well as a brief abstract:
Primary: Business or other for-profit.
Abstract: Persons importing, exporting, and conducting international transactions with List I and List II chemicals must notify DEA of those transactions in advance of their occurrence, including information regarding the person(s) to whom the chemical will be transferred and the quantity to be transferred. Persons must also provide return declarations, confirming the date of the importation and transfer, and the amounts of the chemical transferred. For the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, importers must report all information known to them on the chain of distribution of the chemical from the manufacturer to the importer. This information is used to prevent shipments not intended for legitimate purposes.
(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:
|Number of respondents||Number of responses||Average time per response||Total (in hours)|
|* DEA assumes 10% of all imports will not be transferred in the first thirty days and will necessitate submission of a subsequent return declaration.|
|Form 486 (export)||239||7,997||0.2 hour (12 minutes)||1,599.4|
|Form 486 (Export Return Declaration)||239||7,997||0.08 hour (5 minutes)||666.4|
|Form 486 (import)||230||2000||0.25 hour (15 minutes)||500|
|Form 486 (import return declaration)*||230||2200||0.08 hour (5 minutes)||183.3|
|Form 486A (import)||30||350||0.33 hour (20 minutes)||116.7|
|Form 486A (import return declaration)*||30||385||0.08 hour (5 minutes)||32.1|
|Form 486 (international transaction)||9||111||0.2 hour (12 minutes)||22.2|
|Form 486 (international transaction return declaration||9||111||0.08 hour (5 minutes)||9.25|
|Quarterly reports for imports of acetone, 2-butanone, and toluene||110||440||0.5 hour (30 minutes)||220|
(6) An estimate of the total public burden (in hours) associated with the collection: DEA estimates that this collection will take 3,350 hours annually.
If additional information is required, contact Lynn Bryant, Department Clearance Officer, Information Management and Security Staff, Justice Management Division, Department of Justice, Patrick Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform.
This rulemaking does not preempt or modify any provision of state law; nor does it 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.
For the reasons set out above, 21 CFR part 1313 is proposed to be amended as follows:
PART 1313—IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS Back to Top
1. The authority citation for part 1313 continues to read as follows:
2. Section 1313.13 is amended by adding paragraph (d) to read as follows:
§ 1313.13 Contents of import declaration.
* * * * *
(d) Any regulated person importing ephedrine, pseudoephedrine, or phenylpropanolamine must submit, on the import declaration, all information known to the importer on the chain of distribution of the chemical from the manufacturer to the importer. Ephedrine, pseudoephedrine, or phenylpropanolamine include each of the salts, optical isomers, and salts of optical isomers of the chemical.
3. Section 1313.42 is added to read as follows:
§ 1313.42 Prohibition of shipments from certain foreign sources.
(a) If the Administrator determines that a foreign manufacturer or distributor of ephedrine, pseudoephedrine, or phenylpropanolamine has refused to cooperate with a request by the Administrator for information known to the manufacturer or distributor on the distribution of the chemical, including sales, the Administrator may issue an order prohibiting the importation of the chemical in any case where the manufacturer or distributor is part of the chain of distribution.
(b) Not later than 60 days prior to issuing the order to prohibit importation, the Administrator shall publish in the Federal Register a notice of intent to issue the order. During the 60 day period, imports from the foreign manufacturer or distributor may not be restricted under this section.
Dated: March 14, 2008.
Michele M. Leonhart,
[FR Doc. E8-6357 Filed 3-28-08; 8:45 am]
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