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Federal Register / Vol. 72, No.

47 / Monday, March 12, 2007 / Rules and Regulations 10925

42 CFR Part 121 § 121.7 Identification of organ recipient. II chemicals acetone, ethyl ether, 2-
* * * * * butanone, and toluene shall be exempt
Healthcare, Hospitals, Reporting and
(e) Blood vessels considered part of an from CSA chemical recordkeeping and
recordkeeping requirements.
organ. A blood vessel that is considered reporting requirements.
■ Therefore, under the Public Health part of an organ under this part shall be DATES: This Final Rule is effective
Service Act and under authority subject to the allocation requirements March 12, 2007.
delegated to the Commissioner of Food and policies pertaining to the organ
and Drugs and to the Administrator, FOR FURTHER INFORMATION CONTACT:
with which the blood vessel is procured Christine A. Sannerud, Ph.D., Chief,
Health Resources and Services until and unless the transplant center
Administration, 21 CFR part 1271 and Drug & Chemical Evaluation Section,
receiving the organ determines that the Office of Diversion Control, Drug
42 CFR part 121 are amended as blood vessel is not needed for the
follows: Enforcement Administration,
transplantation of that organ. Washington, DC 20537, telephone (202)
21 CFR Chapter I * * * * * 307–7183.
Dated: December 8, 2006. SUPPLEMENTARY INFORMATION:
PART 1271—HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED Elizabeth M. Duke,
I. Background
PRODUCTS Administrator, Health Resources and Services
Administration. Historical Legal Status of Chemical
■ 1. The authority citation for 21 CFR Mixtures
Dated: February 2, 2007.
part 1271 continues to read as follows: Jeffrey Shuren, The Chemical Diversion and
Authority: 42 U.S.C. 216, 243, 263a, 264, Assistant Commissioner for Policy, Food and Trafficking Act of 1988 (CDTA), (Pub. L.
271. Drug Administration. 100–690) created the definition of
■ 2. Section 1271.3 is amended by [FR Doc. 07–1131 Filed 3–9–07; 8:45 am] ‘‘chemical mixture’’ (21 U.S.C. 802(40)),
adding paragraph (d)(8) to read as BILLING CODE 4160–01–S
and exempted chemical mixtures from
follows: regulatory control. The CDTA
established 21 U.S.C. 802(39)(A)(vi), as
§ 1271.3 How does FDA define important DEPARTMENT OF JUSTICE amended by Title VII of Public Law
terms in this part? 109–177, to exclude ‘‘any transaction in
* * * * * Drug Enforcement Administration a chemical mixture’’ from the definition
(d) * * * of a ‘‘regulated transaction.’’ The
(8) Blood vessels recovered with an 21 CFR Part 1310 exemption of all chemical mixtures,
organ, as defined in 42 CFR 121.2, that [Docket No. DEA–137F3]
however, provided traffickers with an
are intended for use in organ unregulated source for obtaining listed
transplantation and labeled ‘‘For use in RIN 1117–AA31 chemicals for use in the illicit
organ transplantation only.’’ manufacture of controlled substances.
Exemption of Chemical Mixtures To remedy this situation, the
* * * * *
AGENCY: Drug Enforcement Domestic Chemical Diversion Control
42 CFR Chapter I Act of 1993 (Pub. L. 103–200) (DCDCA),
Administration (DEA), U.S. Department
of Justice. enacted in April 1994, subjected
PART 121—ORGAN PROCUREMENT
ACTION: Final rule. chemical mixtures containing listed
AND TRANSPLANTATION NETWORK
chemicals to CSA regulatory
■ 3. The authority citation for 42 CFR SUMMARY: On December 15, 2004, the requirements, unless specifically
part 121 continues to read as follows: Drug Enforcement Administration exempted by regulation. The DCDCA,
(DEA) published a Final Rule corrected therefore, subjected all regulated
Authority: Sections 215, 371–376 of the January 4, 2005) that implemented new chemical mixtures to recordkeeping,
Public Health Service Act (42 U.S.C. 216, reporting, and security requirements of
regulations concerning chemical
273–274d); and sections 1102, 1106, 1138,
and 1871 of the Social Security Act (42 mixtures that contain any of the 27 the CSA. Additionally, the DCDCA
U.S.C. 1302, 1306, 1320b–8 and 1395hh). listed chemicals. The Final Rule added added a registration requirement for
a new provision not previously raised handlers of regulated List I chemical
■ 4. Section 121.2 is amended by adding by DEA in any proposed rulemaking. mixtures.
a sentence at the end of the definition This newly introduced provision The DCDCA, however, also amended
of ‘‘Organ’’ to read as follows: exempted domestic and import 21 U.S.C. 802(39)(A)(vi), as amended by
§ 121.2 Definitions transactions in chemical mixtures that Title VII of Public Law 109–177, to
* * * * * are regulated solely due to the presence provide the Attorney General with the
of the List II solvent chemicals acetone, authority to establish regulations
Organ * * * Blood vessels recovered
ethyl ether, 2-butanone, or toluene from exempting chemical mixtures from the
from an organ donor during the recovery
the Controlled Substances Act (CSA) definition of a ‘‘regulated transaction’’
of such organ(s) are considered part of
recordkeeping and reporting ‘‘based on a finding that the mixture is
an organ with which they are procured
requirements. Because this exemption formulated in such a way that it cannot
for purposes of this part if the vessels
was not previously proposed in any be easily used in the illicit production
are intended for use in organ
rulemaking, DEA implemented this of a controlled substance and that the
transplantation and labeled ‘‘For use in
exemption on an interim basis and listed chemical or chemicals contained
organ transplantation only.’’
requested public comment on this in the mixture cannot be readily
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* * * * * exemption provision. recovered’’ (21 U.S.C. 802(39)(A)(vi) as


■ 5. Section 121.7 is amended by Based upon a review of all comments, amended by Title VII of Pub. L. 109–
redesignating paragraph (e) as paragraph DEA is finalizing this exemption. As 177). This authority has been delegated
(f) and by adding paragraph (e) to read such, domestic and import transactions to the Administrator of DEA by 28 CFR
as follows: in chemical mixtures containing the List 0.100 and redelegated to the Deputy

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10926 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations

Administrator under 28 CFR Appendix is present to aid in the delivery of the supported efforts by DEA to regulate
to Subpart R, section 12. listed chemical so it can be used in chemical mixtures that have potential
Prior to publication of a final some chemical process. Examples use to drug traffickers. Each comment
rulemaking, chemical mixtures include, but are not limited to, solutions specifically supported finalization of the
containing listed chemicals have been of listed chemicals such as methylamine exemption for domestic and import
treated as exempt from CSA regulatory in water or hydrogen chloride dissolved transactions for chemical mixtures
control. Regulations regarding the in water or alcohol. Persons who containing the List II solvent chemicals
exemption of chemical mixtures were question if their formulations are acetone, ethyl ether, 2-butanone, and
initially proposed by DEA on October chemical mixtures should contact DEA toluene.
13, 1994, as part of its proposed for guidance. Two comments, however, requested
regulations to implement the DCDCA that the exemption be expanded to
(59 FR 51888). In response to industry New Interim Chemical Mixture include certain exports of such chemical
concerns, the proposed regulations were Exemption Category mixtures. The comments suggested that
withdrawn on December 9, 1994, (59 FR The Final Rule published on DEA only regulate exports of such
63738). December 15, 2004, (69 FR 74957; mixtures to certain specific countries of
DEA proposed new regulations corrected at 70 FR 294, January 4, 2005) concern. Given the applicability of such
regarding the exemption of chemical also added, on an interim basis, a new solvents for both cocaine and heroin
mixtures by publishing a new NPRM exemption category. DEA determined processing, however, the geographic
entitled ‘‘Exemption of Chemical that certain solvent-based mixtures regions of concern are extremely
Mixtures’’ on September 16, 1998 (63 involving silicon-based products, paint- widespread. Additionally, DEA has
FR 49506). DEA proposed the following related materials, and other solvent- concerns that exports of solvent
three-tiered approach to identify which based chemical mixtures containing chemical mixtures can be subject to re-
chemical mixtures qualify for automatic acetone, ethyl ether, 2-butanone, and exportation from destination countries.
exemption: (1) It contains a listed toluene are not likely to be diverted DEA believes that such exports of
chemical at or below an established domestically. These solvent chemicals chemical mixtures should not be
concentration limit; or (2) it falls within are mostly a concern because they are exempted since exports of these
a specifically defined category; or (3) the used in cocaine and heroin processing, chemical mixtures could have
manufacturer of the mixture applies for which occurs outside the United States. significant potential for diversion.
and is granted a specific exemption for Therefore, the December 15, 2004 Therefore, these chemical mixtures,
the product. rulemaking created a new exemption unless otherwise exempt, are subject to
On December 15, 2004, DEA category for these mixtures. Domestic the export and other CSA chemical
published a final rule which specified and import transactions in chemical regulatory requirements.
criteria used to determine whether mixtures that are regulated solely due to One commenter expressed concerns
chemical mixtures qualify for automatic the presence of the List II solvent regarding the regulatory language found
exemption from CSA chemical chemicals acetone, ethyl ether, 2- in 21 CFR 1310.08(l) stating that,
regulatory controls for 27 listed butanone, or toluene were removed, on ‘‘Domestic and import transactions in
chemicals (69 FR 74957; corrected at 70 an interim basis, from the definition of chemical mixtures that contain acetone,
FR 294, January 4, 2005). Those a regulated transaction by adding a new ethyl ether, 2-butanone, or toluene
chemical mixtures that do not meet the paragraph to 21 CFR 1310.08. Methyl unless regulated because of being
exemption criteria are treated as isobutyl ketone, also a List II solvent formulated with another listed chemical
regulated chemicals and therefore, chemical, was not included because above the concentration limit’’ shall be
subject to CSA chemical regulatory domestic and import transactions in that excluded transactions. The commenter
controls. chemical have already been excluded stated that the regulatory language does
from the definition of a regulated not make it clear that this exemption
Chemical Mixture Definition
transaction at 21 CFR 1310.08. applies if the mixture contains more
Title 21 U.S.C. 802(40) defines the This new exemption (for domestic than one of these chemicals (i.e.
term ‘‘chemical mixture’’ as ‘‘a and import transactions in chemical contains two or more of the following:
combination of two or more chemical mixtures containing the List II acetone, ethyl ether, 2-butanone or
substances, at least one of which is not chemicals acetone, ethyl ether, 2- toluene). The commenter expressed
a List I chemical or a List II chemical, butanone, and toluene) was not concerns that enforcement officials may
except that such term does not include discussed in the original NPRM deem chemical mixtures containing
any combination of a List I chemical or published on September 16, 1998 (63 FR more than ‘‘one’’ of these solvents as
a List II chemical with another chemical 49506). Therefore, this exemption was regulated if the total quantity exceeded
that is present solely as an impurity.’’ implemented on an interim basis with the List II concentration limits. DEA
Therefore, a chemical mixture contains opportunity for public comment in the agrees. Therefore, DEA is modifying 21
any number of listed chemicals along December 15, 2004 rulemaking (69 FR CFR 1310.08(l) to read, ‘‘Domestic and
with any number of non-listed 74957; corrected at 70 FR 294, January import transactions in chemical
chemicals. A combination of only listed 4, 2005). DEA solicited comments on mixtures that contain acetone, ethyl
chemicals is, therefore, not a chemical this portion of the rulemaking. ether, 2-butanone, and/or toluene,
mixture pursuant to the CSA definition. unless regulated because of being
As such, the regulatory controls II. Comments Received Regarding the
formulated with other List I or List II
pertaining to each individual listed Interim Regulations
chemical(s) above the concentration
chemical are applicable. DEA received three comments in limit’’ shall be excluded.
It is DEA’s longstanding policy that response to the December 15, 2004,
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the combination of a listed chemical in rulemaking (69 FR 74957) from Clarification of Concentration Limits
an inert carrier is not considered a interested parties. Two comments were As DEA stated in its Final Rule
chemical mixture. An inert carrier can from trade associations, and one establishing concentration limits for the
be any chemical that does not interfere comment was from a chemical vast majority of chemical mixtures (69
with the listed chemical’s function but manufacturer. In general, the comments FR 74957, December 15, 2004), and

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Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations 10927

codified at 21 CFR 1310.14(c), mixtures these chemical mixtures occur annually. Executive Order 12866
containing a listed chemical in DEA determined that the regulation of This regulation has been drafted and
concentrations equal to or less than domestic and import transactions in reviewed in accordance with Executive
those specified in the ‘‘Table of mixtures containing the chemicals Order 12866, Section 1(b), Principles of
Concentration Limits’’ are designated as acetone, ethyl ether, 2-butanone, and Regulation. DEA has determined that
exempt from specified provisions set toluene were unnecessary for this rule is a ‘‘significant regulatory
forth in that section. The concentration enforcement of the CSA and should be action’’ under Executive Order 12866,
limit is set at 35 percent (by weight or removed from the definition of a Section 3(f), Regulatory Planning and
volume) for the cumulative amount of regulated transaction. Review, and accordingly this rule has
acetone, methyl ethyl ketone (MEK), Since the NPRM to this rulemaking been reviewed by the Office of
methyl isobutyl ketone (MIBK), toluene, did not discuss this exemption, the Management and Budget. This rule
and ethyl ether. Therefore, the table in public did not have the opportunity to finalizes an exemption for domestic and
21 CFR 1310.14(c) specifies that for comment on the exclusion of these import transactions involving the List II
exports, the limit applies to the specific transactions from the definition of a chemicals acetone, ethyl ether, 2-
chemical or any combination of acetone, regulated transaction. butanone, and toluene.
ethyl ether, 2-butanone, methyl isobutyl However, to avoid unnecessary
ketone, and toluene, if present in the burdens on affected companies during Executive Order 12988
mixture by summing the concentrations the pendency of proceedings in this This regulation meets the applicable
for each chemical. For example, an matter, DEA decided to include as part standards set forth in Sections 3(a) and
export involving a chemical mixture of its December 15, 2004, Final Rule an 3(b)(2) of Executive Order 12988.
containing 20 percent acetone and 20 interim rule, with request for comment,
percent ethyl ether would not be exempt removing these transactions from the Executive Order 13132
because the cumulative total of 40 definition of a regulated transaction. This rulemaking does not preempt or
percent exceeds the 35 percent Now that DEA has had the opportunity modify any provision of state law; nor
concentration limit. to solicit and review comments, the does it impose enforcement
exemption is being finalized in this rule. responsibilities on any state; nor does it
Final Action Taken in This Rulemaking
diminish the power of any state to
After considering all comments, DEA IV. Regulatory Certifications enforce its own laws. Accordingly, this
has decided to exempt domestic and Regulatory Flexibility Act rulemaking does not have federalism
import transactions in chemical implications warranting the application
mixtures that contain acetone, ethyl DEA has become aware that a
of Executive Order 13132.
ether, 2-butanone, and/or toluene under substantial number of chemical
21 CFR 1310.08 pursuant to 21 U.S.C. mixtures that are not useful to Unfunded Mandates Reform Act of 1995
802(39)(A)(iii) because regulation of traffickers could potentially be regulated This rule will not result in the
such transactions has been determined if the chemical mixtures that are subject expenditure by state, local, and tribal
to be unnecessary for the enforcement of to this rulemaking were not excluded governments, in the aggregate, or by the
the CSA. DEA determined that there is from certain regulatory requirements. private sector, of $118,000,000 or more
not a significant risk of domestic DEA determined that the regulation of in any one year, and will not
diversion for these chemical mixtures. these chemical mixtures is not significantly or uniquely affect small
necessary for enforcement of the CSA. governments. Therefore, no actions were
Specific Requirements That Will Apply Therefore, DEA decided to exempt these deemed necessary under the provisions
to Regulated Chemical Mixtures chemical mixtures from regulatory of the Unfunded Mandates Reform Act
Containing List II Chemicals Upon controls by exemption of certain types of 1995.
Publication of This Final Rule of transactions.
The above exemption only exempts DEA notes that the List II solvent Congressional Review Act
such chemical mixtures from the chemicals acetone, ethyl ether, 2- This rule is not a major rule as
domestic recordkeeping and import butanone, and toluene contribute to the defined by Section 804 of the Small
notification requirements. All other CSA largest number of potentially regulated Business Regulatory Enforcement
chemical regulatory provisions, as chemical mixtures of List II chemicals. Fairness Act of 1996 (Congressional
specified in detail in the December 15, To limit the number of potentially Review Act). This rule will not result in
2004 rule [69 FR 74957; corrected at 70 regulated chemical mixtures to those an annual effect on the economy of
FR 294, January 4, 2005], shall apply. necessary for enforcement of the CSA, $100,000,000 or more; a major increase
DEA decided to define all domestic and in costs or prices; or significant adverse
III. Exemption Authority import transactions of mixtures in these effects on competition, employment,
The CSA authorizes DEA, pursuant to List II solvent chemicals as exempt investment, productivity, innovation, or
21 U.S.C. 802(39)(A)(iii), to remove transactions. This exemption applies to on the ability of United States-based
certain transactions in listed chemicals all persons that handle these chemical companies to compete with foreign-
from the definition of a regulated mixtures and not only to those who are based companies in domestic and
transaction that are unnecessary for represented in the comments. DEA export markets.
enforcement of the CSA. Based on previously implemented this exemption
comments to the Federal Register and is finalizing the exemption in this Paperwork Reduction Act
proposed rule ‘‘Exemption of Chemical rulemaking. This rulemaking finalizes an
Mixtures’’ (63 FR 49506, September 16, In accordance with the Regulatory exemption provision which reduced the
1998), DEA identified certain Flexibility Act (5 U.S.C. 605(b)), the paperwork burden on handlers of
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transactions in mixtures of acetone, Deputy Administrator has reviewed this acetone, ethyl ether, 2-butanone and
ethyl ether, 2-butanone, and toluene regulation and by approving it certifies toluene. By exempting domestic and
that are unlikely sources for diversion. that this regulation will not have a import transactions involving chemical
DEA was informed that tens of significant economic impact upon a mixtures containing these List II
thousands of domestic transactions in substantial number of small entities. chemicals DEA is not subjecting these

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10928 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations

transactions to CSA recordkeeping and Act). Previously, we approved an We announced receipt of Missouri’s
reporting requirements. Domestic and emergency rule that allowed Missouri to proposed ‘‘emergency rule’’ amendment
import transactions involving chemical transition from a ‘‘bond pool’’ approach in the November 29, 2005, Federal
mixtures containing acetone, ethyl to bonding to a ‘‘full cost bond’’ Register (70 FR 71425). In the same
ether, 2-butanone and toluene are not approach in a timely manner. We are document, we opened the public
subject to the following information now approving Missouri’s permanent comment period and provided an
collections: DEA information collection rule concerning this same topic. opportunity for a public hearing or
1117–0023: Import/Export Declaration Missouri proposed to revise its program meeting on the adequacy of the
for List I and List II Chemicals [imports to improve operational efficiency. amendment. We did not hold a public
only]; and DEA information collection DATES: Effective Date: March 12, 2007. hearing or meeting because no one
1117–0029: Annual Reporting FOR FURTHER INFORMATION CONTACT: requested one and we did not receive
Requirement for Manufacturers of Listed Andrew R. Gilmore, Chief, Alton Field any comments. We also stated in this
Chemicals. Division. Telephone: (618) 463–6460. E- Federal Register document that if
mail: MCR_AMEND@osmre.gov. Missouri submitted a ‘‘permanent rule’’
List of Subjects In 21 CFR Part 1310 with language that has the same
SUPPLEMENTARY INFORMATION:
Drug traffic control, List I and List II meaning as the ‘‘emergency rule,’’ we
chemicals, Reporting and I. Background on the Missouri Program would publish a final rule and
II. Submission of the Amendment
Recordkeeping requirements. Missouri’s ‘‘permanent rule’’ would
III. OSM’s Findings
IV. Summary and Disposition of Comments become part of the Missouri program.
■ For the reasons set out above, 21 CFR
V. OSM’s Decision Because Missouri’s ‘‘permanent rule’’
part 1310 is amended to read as follows:
VI. Procedural Determinations has the same meaning as the
PART 1310—[AMENDED] ‘‘emergency rule,’’ we are proceeding
I. Background on the Missouri Program with the final rule.
■ 1. The authority citation for part 1310 Section 503(a) of the Act permits a
continues to read as follows: III. OSM’s Findings
State to assume primacy for the
Authority: 21 U.S.C. 802, 827(h), 830, regulation of surface coal mining and Following are the findings we made
871(b), 890. reclamation operations on non-Federal concerning Missouri’s ‘‘permanent rule’’
and non-Indian lands within its borders amendment under SMCRA and the
■ 2. Section 1310.08 is amended by
by demonstrating that its State program Federal regulations at 30 CFR 732.15
revising paragraph (l) to read as follows:
includes, among other things, ‘‘a State and 732.17. We are approving the
§ 1310.08 Excluded Transactions. law which provides for the regulation of amendment as described below. Any
* * * * * surface coal mining and reclamation revisions that we do not specifically
(l) Domestic and import transactions operations in accordance with the discuss below concern nonsubstantive
in chemical mixtures that contain requirements of this Act * * *; and wording or editorial changes.
acetone, ethyl ether, 2-butanone, and/or rules and regulations consistent with A. Minor Revisions to Missouri’s
toluene, unless regulated because of regulations issued by the Secretary Regulations
being formulated with other List I or pursuant to this Act.’’ See 30 U.S.C.
1253(a)(1) and (7). On the basis of these Missouri’s definition for ‘‘regulatory
List II chemical(s) above the authority,’’ found at 10 CSR [Code of
concentration limit. criteria, the Secretary of the Interior
conditionally approved the Missouri State Regulations] 40–8.010(82), means
Dated: March 1, 2007. the Land Reclamation Commission
program on November 21, 1980. You
Michele M. Leonhart, can find background information on the (commission), the director, or their
Deputy Administrator. Missouri program, including the designated representatives and
[FR Doc. E7–4314 Filed 3–9–07; 8:45 am] Secretary’s findings, the disposition of employees unless otherwise specified in
BILLING CODE 4410–09–P comments, and conditions of approval, the State’s rules. Missouri proposed to
in the November 21, 1980, Federal replace the words ‘‘commission’’ or
Register (45 FR 77017). You can also ‘‘regulatory authority’’ with the word
DEPARTMENT OF THE INTERIOR find later actions concerning the ‘‘director’’ in the following regulations:
Missouri program and program 10 CSR 40–7.011(2)(A), (3)(C), (4)(B),
Office of Surface Mining Reclamation amendments at 30 CFR 925.10, 925.12, (6)(B)1., 5., 6., and 7., (6)(C)1. and 8.,
and Enforcement 925.15, and 925.16. (6)(D)2., and (6)(D)2.B, 3.B, 3.B(I) and
5.C; and 10 CSR 40–7.041(1)(A), (B)1.
II. Submission of the Amendment and (B)2. Missouri proposed to improve
30 CFR Part 925
By letter dated October 11, 2006 operational efficiency by specifying that
[Docket No. MO–039–FOR] (Administrative Record No. MO–666), the director is to perform certain duties.
Missouri sent us a ‘‘permanent rule’’ We find that the substitution of the
Missouri Regulatory Program
amendment to its program regarding word ‘‘director’’ for the words
AGENCY: Office of Surface Mining bonding under SMCRA (30 U.S.C. 1201 ‘‘commission’’ or ‘‘regulatory authority’’
Reclamation and Enforcement, Interior. et seq.). This amendment was sent as a will not render Missouri’s regulations
ACTION: Final rule; approval of replacement for Missouri’s ‘‘emergency less effective than the Federal
amendment. rule’’ that we previously approved on regulations because in accordance with
June 8, 2006 (71 FR 33243). The Missouri’s definition for regulatory
SUMMARY: We, the Office of Surface ‘‘emergency rule’’ allowed Missouri to authority, the director is a regulatory
Mining Reclamation and Enforcement transition from a ‘‘bond pool’’ approach authority as is the commission and the
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(OSM), are approving an amendment to to bonding to a ‘‘full cost bond’’ certain duties specified in the
the Missouri regulatory program approach in a timely manner. The regulations cited above are not duties
(Missouri program) regarding bonding ‘‘permanent rule’’ amendment, when reserved solely for the commission
under the Surface Mining Control and approved, will become a permanent part according to section 444.810 of
Reclamation Act of 1977 (SMCRA or the of Missouri’s program. Missouri’s surface coal mining law.

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