issue-1996-02-08•Federal Register final rules — 1996-02-08
Federal Register final rules — 1996-02-08
issue-1996-02-08Federal Register final rules — 1996-02-08Regulation
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FR Doc. 96-2724 Michigan: Final Authorization of Revisions to State Hazardous Waste Management Program
[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4742-4747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2724]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 271
[FRL-5308-5]
Michigan: Final Authorization of Revisions to State Hazardous
Waste Management Program
AGENCY: Environmental Protection Agency.
ACTION: Immediate final rule.
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SUMMARY: Michigan has applied for final authorization of revisions to
its hazardous waste program under the Resource Conservation and
Recovery Act of 1976 as amended (hereinafter ``RCRA''). The
Environmental Protection Agency (EPA) has reviewed Michigan's
application and has reached a decision, subject to public review and
comment, that Michigan's hazardous waste program revisions satisfy all
the requirements necessary to qualify for final authorization. Thus,
EPA intends to approve Michigan's hazardous waste program revisions,
subject to authority retained by EPA under the Hazardous and Solid
Waste Amendments of 1984 (hereinafter HSWA). Michigan's application for
program revision is available for public review and comment.
EFFECTIVE DATE: Final authorization for Michigan's program revisions
shall be effective April 8, 1996 unless EPA publishes a prior Federal
Register (FR) action withdrawing this immediate final rule. All
comments on Michigan's program revision application must be received by
the close of business on March 9, 1996. If an adverse comment is
received, EPA will publish either: (1) A withdrawal of the immediate
final decision; or (2) a notice containing a response to comments which
either affirms that the immediate final decision takes effect or
reverses the decision.
ADDRESSES: Written comments should be sent to Ms. Judy Feigler,
Michigan Regulatory Specialist, U.S. EPA, Office of RCRA, DR-7J, 77
West Jackson Boulevard, Chicago, Illinois 60604, phone (312) 886-4179.
Copies of Michigan's program revision application are available for
inspection and copying at the following addresses from 9 a.m. to 4
p.m.: Michigan Department of Environmental Quality, 608 W. Allegan,
Hannah Building, Lansing, Michigan. Contact: Ms. Ronda Blayer, Phone:
(517) 373-9548; U.S. EPA, Region V, 77 West Jackson Boulevard, Chicago,
Illinois 60604, contact: Ms. Judy Feigler, (312) 886-4179.
FOR FURTHER INFORMATION CONTACT:
Ms. Judy Feigler, Michigan Regulatory Specialist, U.S. Environmental
Protection Agency, Region V, Office of RCRA, DR-7J, 77 West Jackson
Boulevard, Chicago, Illinois 60604, Phone: (312) 886-4179.
SUPPLEMENTARY INFORMATION:
A. Background
States with final authorization under section 3006(b) of RCRA, 42
U.S.C. 6926(b), have a continuing obligation to maintain a hazardous
waste program that is equivalent to, consistent with, and no less
stringent than the Federal hazardous waste program.
In accordance with 40 CFR 271.21(a), revisions to State hazardous
waste programs are necessary when Federal or State statutory or
regulatory authority is modified or when certain other changes occur.
Most commonly, State program revisions are necessary because of changes
to EPA's regulations in 40 CFR parts 124, 260-268 and 270.
B. Michigan
Michigan initially received final authorization for its base RCRA
program effective on October 30, 1986 (51 FR 36804-36805, October 16,
1986). Michigan received authorization for revisions to its program
effective on January 23, 1990 (54 FR 225, November 24, 1989), June 24,
1991 (56 FR 18517, April 23, 1991), November 30, 1993 (58 FR 51244,
October 1, 1993), and January 13, 1995 (60 FR 3095, January 13, 1995).
On June 18, 1994, Michigan revised its hazardous waste rules. On March
30, 1995, Michigan recodified its hazardous waste statute, Act 64, in
Part 111 of the Natural Resources and Environmental Protection Act,
1994 Public Act 451, as amended (Act 451). On November 9, 1995,
Michigan completed a revision application seeking authorization for the
program revisions. EPA has reviewed this application and has made an
immediate final decision that Michigan's hazardous waste program
revision satisfies all the requirements necessary to qualify for final
authorization. Consequently, EPA intends to grant final authorization
to Michigan for its additional program revisions. The public may submit
written comments on EPA's immediate final decision up until March 9,
1996. Copies of Michigan's application for program revision are
available for inspection and copying at the locations
[[Page 4743]]
indicated in the Addresses section of this notice.
Approval of Michigan's program revision shall become effective in
60 days unless an adverse comment pertaining to the State's revision
discussed in this notice is received by the end of the comment period.
If an adverse comment is received, EPA will publish either (1) a
withdrawal of the immediate final decision, or (2) a notice containing
a response to comments which either affirms that the immediate final
decision takes effect or reverses the decision.
On April 8, 1996 (unless EPA publishes a prior FR action
withdrawing this immediate final rule), Michigan will be authorized to
carry out, in lieu of the Federal program, those provisions of the
State's program which are analogous to the following Federally-
initiated changes to provisions of the Federal program:
------------------------------------------------------------------------
Federal requirement Analogous State authority
------------------------------------------------------------------------
Hazardous and Used Oil Fuel Michigan Combined Laws (MCL),
Criminal Penalties, HSWA Secs. Sections 324.11105, 324.11127,
3006(h), 3008(d), and 3014, 324.11138, and 324.11151, enacted
November 8, 1984. March 30, 1995.
Corrective Action, 50 FR 28702, MCL Sections 324.11102, 324.11105,
July 15, 1985. 324.11115a, and 324.11127, enacted
March 30, 1995; Michigan
Administrative Code (MAC), Rule
(R) 299.9503(3) (a) and (b), R
299.9601 (1) and (2)(j), R
299.9612, R 299.9629(1), R
299.9712, R 299.9713, and R
299.11003(1)(l), effective June
18, 1994
Burning of Waste Fuel and Used Oil MAC R 299.9623(1)(b), effective
Fuel in Boilers and Industrial April 20, 1988; R 299.9802,
Furnaces, 50 FR 49164, November effective February 15, 1989; MAC
29, 1985, as amended at 52 FR Rule R 299.9104(e), R 299.9109(i),
11819, April 13, 1987. R 299.9203(4)(b), R 299.9205 (3)
(a)-(d) and (8), R 299.9206
(2)(e), (3) (c), (g), (h) and (k),
R 299.9601 (1), (3) and (8), R
299.9801(1), R 299.9802, R
299.9805, R 299.9806, R 299.9807,
and R 299.11003(1)(o), effective
June 18, 1994.
Listing of EBDC, 51 FR 37725, MAC R 299.9216 (1) and (2),
October 24, 1986. effective April 20, 1988; MAC R
299.9222 and R 299.11003(1)(i),
effective June 18, 1994.
Revised Manual SW-846; Amended MAC R 299.11005 (1) and (2),
Incorporation by Reference, 52 FR effective June 18, 1994.
8072, March 16, 1987.
California List Waste Restrictions: MAC R 299.9311, R 299.9413, R
Technical Corrections, 52 FR 299.9627, R 299.11003(1)(p), and R
41295, October 27, 1987. 299.11005 (1) and (2), effective
June 18, 1994.
Permit Application Requirements MAC R 299.9508(1)(b), effective
Regarding Corrective Action, 52 FR April 20, 1988; MAC R 299.9504
25788, December 1, 1987. (1)(c) and (18), and R
299.11003(1)(q), effective June
18, 1994.
Corrective Action Beyond the MAC R 299.9629 (2) and (7),
Facility Boundary, 52 FR 45788, effective June 18, 1994.
December 1, 1987.
Corrective Action for Injection MAC R 299.9503 (3)(a)(i) and (5), R
Wells, 52 FR 45788, December 1, 299.9601(4), and R
1987. 299.11003(1)(b), effective June
18, 1994.
Permit Modification, 52 FR 45788, MAC R 299.9519(3)(b), effective
December 1, 1987. June 18, 1994.
Permit as a Shield Provision, 52 FR MAC R 299.9516, effective April 20,
45788, December 1, 1987. 1988.
Permit Conditions to Protect Human MAC R 299.9508(1)(b) and R
Health and the Environment, 52 FR 299.9521(3)(b), effective April
45788, December 1, 1987. 20, 1988; R 299.9504(16),
effective June 18, 1994.
Farmer Exemptions; Technical MAC R 299.9204(3)(b), R
Corrections, 53 FR 27164, July 19, 299.9301(2)(c), R 299.9311, R
1988. 299.9413, R 299.9503(1)(c), R
299.9601 (3), (6), and (8), R
299.9627, and R 299.11003(1) (o)
and (p), effective June 18, 1994.
Treatability Studies Sample MAC R 299.9108(j), and R 299.9204
Exemption, 53 FR 27290, July 19, (7) and (8), effective June 18,
1988. 1994.
Land Disposal Restrictions for MAC R 299.9609 (1)(a) and (2)-(5),
First Third Scheduled Wastes, 53 effective November 19, 1991; MAC R
FR 31138, August 17, 1988, as 299.9311, R 299.9413, R 299.9601
amended at 54 FR 8264, February (1), (2) (c) and (d), (3) and (8),
27, 1989. R 299.9605 (1) and (3), R
299.9627, R 299.9801(3), and R
299.11003(1) (l), (m), (o) and
(p), effective June 18, 1994.
Financial Responsibility for Third MAC R 299.9705(1), effective
Party Liability, Closure, and Post- December 28, 1985; MAC rule R
Closure, 53 FR 33938, September 1, 299.9701(4) and R 299.9709,
1988, as amended at 56 FR 30200, effective February 15, 1989; MAC R
July 1, 1991. 299.9710, effective June 18, 1994.
Standards for Hazardous Waste MAC R 299.9103(b) (i) and (ii), R
Storage and Treatment Tank 299.9109(p)(iii), R 299.9601 (1),
Systems, 53 FR 34079, September 2, (2) (f) and (h), R 299.9613 (1)
1988. and (6), R 299.9615 (1) and (7),
and R 299.11003(1) (l) and (o),
effective June 18, 1994.
Identification and Listing of MAC R 299.9216 (1) and (2),
Hazardous Waste and Designation, effective April 20, 1988; MAC R
Reportable Quantity and 299.9222 and R 299.11003(1)(l),
Notification, 53 FR 35412, effective June 18, 1994.
September 13, 1988.
Permit Modification for Hazardous MAC R 299.9520, effective April 20,
Waste Management Facilities, 53 FR 1988; R 299.9103 (a), (k), and
37912, September 28, 1988, as (aa), R 299.9511, and R 299.9519,
amended at 53 FR 41649, October effective June 18, 1994.
24, 1988.
Statistical Methods for Evaluating MAC R 299.9612 (1) and (2) and R
Ground-Water Monitoring Data from 299.11003(1)(l), effective June
Hazardous Waste Facilities, 53 FR 18, 1994.
39720, October 11, 1988.
Removal of Iron Dextran from List MAC R 299.9216 (1) and (2),
of Hazardous Wastes, 53 FR 43878, effective April 20, 1988; MAC R
October 31, 1988. 299.9225 and R 299.11003(1)(i),
effective June 18, 1994.
Removal of Strontium Sulfide from MAC R 299.9216 (1) and (2),
the List of Hazardous Wastes, 53 effective April 20, 1988; MAC R
FR 43881, October 31, 1988. 299.9224 and R 299.11003(1)(i),
effective June 18, 1994.
Changes to 40 CFR Part 124 Not MAC R 299.9509, R 299.9513, and R
Accounted for by Present RCRA 299.9514(2)(b), effective December
Revision Checklists, 54 FR 246, 28, 1985; MAC R 299.9508 (3) and
January 4, 1989; 53 FR 37396, (4), R 299.9510, R 299.9520(3),
September 26, 1988; 53 FR 28118, and R 299.9521, effective April
July 26, 1988; 48 FR 30113, June 20, 1988; MAC R 299.9503, R
30, 1983; 48 FR 14146, April 1, 299.9504 (15) and (18), R
1983. 299.9511, R 299.9519 (1) and (2),
and R 299.11003(1)(q), effective
June 18, 1994.
Amendments to Hazardous Waste MAC R 299.9626 (4)-(6), effective
Incinerator Permit Requirements, December 28, 1985; MAC R
54 FR 4286, January 30, 1989. 299.9508(1)(b) and R 299.9521 (3)
and (4), effective April 20, 1988;
MAC R 299.9504(4) (a) and (b),
effective June 18, 1994.
[[Page 4744]]
Changes to Interim Status MAC R 299.9501, effective November
Facilities for Hazardous Waste 19, 1991; MAC R 299.9515(1) and R
Management Permits Procedures for 299.9517(2)(b), effective April
Post-Closure Permitting, 54 FR 20, 1988; MAC R 299.9502, R
9596, March 7, 1989. 299.9503, R 299.9518(2)(c), R
299.9522(2), R 299.9601 (1)(a),
(2)(f), and (2)(j), R 299.9629, R
299.11003(1)(q), effective June
18, 1994.
Land Disposal Restrictions for MAC R 299.9311, R 299.9413, R
First Third Scheduled Wastes, 54 299.9627, and R 299.11003(1)(p),
FR 18836, May 2, 1989. effective June 18, 1994.
Land Disposal Restrictions for MAC R 299.9311, R 299.9413, R
Second Third Scheduled Wastes, 54 299.9627, and R 299.11003(1)(p),
FR 26594, June 23, 1989. effective June 18, 1994.
Delisting; Correction, 54 FR 27114, MAC R 299.9211, effective February
June 27, 1989. 15, 1989; MAC R 299.11003(1)(g),
effective June 18, 1994.
Delay of Closure Period for MAC R 299.9702 (1) and (2),
Hazardous Waste Management effective April 20, 1988; MAC R
Facilities, 54 FR 33376, August 299.9601 (1), (2)(f), (3), and
14, 1989. (8), R 299.9605 (1) and (3), R
299.9613 (1) and (6), and R
299.11003(1) (l), (m), and (o),
effective June 18, 1994.
Mining Waste Exclusion I, 54 FR MAC R 299.9204(2) (h) and (i),
36592, September 1, 1989. effective June 18, 1994.
Land Disposal Restrictions: MAC R 299.9311, R 299.9413, R
Corrections to First Third 299.9627, R 299.9801(3), and R
Scheduled Wastes, 54 FR 36967, 299.11003(1)(p), effective June
September 6, 1989, as amended at 18, 1994.
55 FR 23935, June 13, 1990.
Testing and Monitoring Activities, MAC R 299.9216 (1) and (2),
54 FR 40260, September 29, 1989. effective April 20, 1988; MAC R
299.11003(1)(i) and R 299.11005
(1) and (2), effective June 18,
1994.
Reportable Quantity Adjustment MAC R 299.9216 (1) and (2), R
Methyl Bromide Production Wastes, 299.9222, and R 299.11003(1)(i),
54 FR 41402, October 6, 1989. effective June 18, 1994.
Hazardous Waste Management Systems: MAC R 299.9216 (1) and (2),
Identification and Listing CERCLA 299.9220, and 299.11003(1)(i),
Substance Designation Reportable effective June 18, 1994.
Quantity Adjustment, 54 FR 50968,
December 11, 1989.
Mining Waste Exclusion II, 55 FR MAC R 299.9102(n), R
2322, January 23, 1990. 299.9204(2)(h), and R 299.9304
(2)(d) and (4)(h), effective June
18, 1994.
Modification of F019 Listing, 55 FR MAC R 299.9220, effective June 18,
5340, February 14, 1990. 1994.
Testing and Monitoring Activities, MAC R 299.11003(1)(i) and R
55 FR 8948, March 9, 1990. 299.11005(1), effective June 18,
1994.
Toxicity Characteristic Revisions, MAC R 299.9204 (2) (f), (k), and
55 FR 11798, March 29, 1990, as (l) and (9), R 299.9209(5), R
amended at 55 FR 26986, June 29, 299.9212(4), R 299.9217, R
1990. 299.9601 (3) and (8), R
299.11003(1) (l), (o), (p), and
(r), effective June 18, 1994.
Listing of 1,1-dimethylhydrazine MAC R 299.9216 (1) and (2),
Production Wastes, 55 FR 18496, effective April 20, 1988; MAC R
May 2, 1990. 299.9222 and R 299.11003(1)(i),
effective June 18, 1994.
Criteria for Listing Toxic Wastes, MAC R 299.9209 (1) and (7) and R
55 FR 18726, May 4, 1990. 299.11003(1)(h), effective June
18, 1994.
HSWA Codification Rule, Double MAC R 299.9616 (1) and (4),
Liners; Corrections, 55 FR 1926, effective December 28, 1985; MAC R
May 9, 1990. 299.9619 (1) and (6), and R
299.11003(1)(l), effective June
18, 1994.
Land Disposal Restrictions for MAC R 299.9616 (1) and (2), R
Third Third Scheduled Wastes, 55 299.9617 (1) and (3), and R
FR 22520, June 1, 1990. 299.9618 (1) and (2), effective
December 28, 1985; MAC R
299.9214(1)(c), effective November
19, 1991; MAC R 299.9212(6), R
299.9302 (1)(b) and (2), R
299.9311, R 299.9413, R
299.9519(5)(b)(ii), R 299.9601
(1), (3), and (8), R 299.9605 (1)
and (3), R 299.9619 (1) and (6), R
299.9220, R 299.9627, and R
299.11003(1) (i), (l), (o), and
(p), effective June 18, 1994.
Organic Air Emission Standards for MAC R 299.9508(1)(b), effective
Process Vents and Equipment Leaks, April 20, 1988; MAC R 299.9609
55 FR 25454, June 21, 1990. (1)(a), (1)(b), and (5), effective
November 19, 1991; MAC R
299.9206(1) (b)-(d), R 299.9504
(1)(c), (12), (13), and (18), R
299.9601, R 299.9605 (1) and (3),
R 299.9630 (1) and (2), R 299.9631
(1) and (2), R 299.11001(1) (a),
(j), (k), (l), (m), (o), (q), (r),
(s), (t), and (3), effective June
18, 1994.
Petroleum Refinery Primary and MAC R 299.9213 (4)-(7), R 299.9220,
Secondary Oil/Water/Solids and R 299.11003(1)(i), effective
Separation Sludge Listings--F037 June 18, 1994.
and F038, 55 FR 46354, November 2,
1990, as amended at 55 FR 51707,
December 17, 1990.
Wood Preserving Listings, 55 FR MAC R 299.9102(v), R 299.9204(1)
50450, December 6, 1990. (i) and (j), R 299.9220, R
299.9227, R 299.9306, R 299.9504
(14) and (18), R 299.9508(1)(b), R
299.9601, R 299.9615 (1) and (7),
R 299.9632 (1) and (2), and R
299.11003(1) (i), (l), (o), and
(q), effective June 18, 1994.
Land Disposal Restrictions for MAC R 299.9203(5)(a), R
Third Third Scheduled Wastes; 299.9212(6), R 299.9220, R
Technical Amendments, 56 FR 3864, 299.9302(1)(b), R 299.9306(4)(e),
January 31, 1991. R 299.9311, R 299.9413, R
299.9627, and R 299.11003(1)(p),
effective June 18, 1994.
Toxicity Characteristic; MAC R 299.9204(2)(m), effective
Chlorofluorocarbon Refrigerants, June 18, 1994.
56 FR 5910, February 13, 1991.
Removal of Strontium Sulfide from MAC R 299.9216 (1) and (2),
the List of Hazardous Wastes; effective April 20, 1988; MAC R
Technical Amendment, 56 FR 7567, 299.9224, and R 299.11003(1)(i),
February 25, 1991. effective June 18, 1994.
Organic Air Emission Standards for MAC R 299.9609 (1)(a) and (5),
Process Vents and Equipment Leaks; effective November 19, 1991; MAC R
Technical Amendment, 56 FR 19290, 299.9504 (12) and (18), R
April 26, 1991. 299.9601, R 299.9630 (1) and (2),
R 299.9631 (1) and (2), and R
299.11003(1) (l), (m), (o), and
(q), effective June 18, 1994.
[[Page 4745]]
Petroleum Refinery Primary and MAC R 299.9220, effective June 18,
Secondary Oil/Water/Solids 1994.
Separation Sludge Listings--F037
and F038; Revisions, 56 FR 21955,
May 13, 1991.
Mining Waste Exclusion III, 56 FR MAC R 299.9204(2)(h), effective
27300, June 13, 1991. June 18, 1994.
Wood Preserving Listings; Technical MAC R 299.9306(1) (a)-(d) and R
Corrections, 56 FR 30192, July 1, 299.9508(1)(b), effective April
1991. 20, 1988; MAC R 299.9204(1)( i)
and (j), R 299.9227(2)-(4), R
299.9504 (14) and (18), R 299.9601
(1), (3), and (8), R 299.9632 (1)
and (2), and R 299.11003(1) (l),
(o), and (q), effective June 18,
1994.
Land Disposal Restrictions for MAC R 299.9203(4) (c) and (d), R
Electric Arc Furnace Dust--K061, 299.9204(1)(k), R 299.9311, R
56 FR 41164, August 19, 1991. 299.9413, R 299.9627, and R
299.11003(1)(p), effective June
18, 1994.
Exports of Hazardous Waste; MAC R 299.9309 (1) and (4),
Technical Correction, 56 FR 43704, effective April 20, 1988; MAC R
September 4, 1991. 299.11003(1)(j), effective June
18, 1994.
Land Disposal Restrictions for MAC R 299.9311, R 299.9413, R
Third Third Scheduled Wastes; 299.9601 (3) and (8), R 299.9605,
Technical Amendments, 57 FR 8086, R 299.9627, and R 299.11003(1)
March 6, 1992. (l), (o), and (p), effective June
18, 1994.
Used Oil Filter Exemption, 57 FR MAC R 299.9204(2)(o), effective
21524, May 20, 1992. June 18, 1994.
Toxicity Characteristic Revision, MAC R 299.9204(2)(i), effective
57 FR 23062, June 1, 1992. June 18, 1994.
Used Oil Filter Exemption; MAC R 299.9204(2)(o), effective
Technical Corrections, 57 FR June 18, 1994.
29220, July 1, 1992.
Toxicity Characteristic Revisions; MAC R 299.9204(2) (g) and (k),
Technical Corrections, 57 FR effective June 18, 1994.
30657, July 10, 1992.
Wood Preserving Listings, 57 FR MAC R 299.9220, R 299.9601 (1), (3)
61492, December 24, 1992. and (8), R 299.9632, and R
299.11003(1) (l) and (o),
effective June 18, 1994.
------------------------------------------------------------------------
In addition, Michigan will be authorized to carry out, in lieu of
the Federal program, the following State-initiated changes to
provisions of the State's program, which are analogous to the following
Resource Conservation and Recovery Act rules found at Title 40 of the
Code of Federal Regulations:
------------------------------------------------------------------------
State Requirement Federal Requirement
------------------------------------------------------------------------
Michigan Administrative Code (MAC) 40 CFR 262.60(b)(2).
Rule (R) 299.9101(t)*.
MAC R 299.9104(i)*................ 40 CFR 262.60.
MAC R 299.9109(e)*................ 40 CFR 262.60(b)(2).
MAC R 299.9205*................... 40 CFR 261.5.
MAC R 299.9206(1)*................ 40 CFR 261.6(a)(1).
MAC R 299.9206(5)*................ 40 CFR 264.11.
MAC R 299.9207(3)(b)(ii)*......... 40 CFR 261.7(b)(1)(iii)(B).
MAC R 299.9207(5)*................ 40 CFR 261.7(b)(3).
MAC R 299.9212(1)(a)*............. 40 CFR 261.21(a)(1).
MAC R 299.9306(1)(a)(i)*.......... 40 CFR 262.34(a)(1)(i).
MAC R 299.9306(1)(a)(ii)*......... 40 CFR 262.34(a)(1)(ii).
MAC R 299.9306(1)(d)*............. 40 CFR 262.34(a)(4).
MAC R 299.9306(1)(e)*............. 40 CFR 262.34(a)(4).
MAC R 299.9306(2)*................ 40 CFR 262.34(c)(1).
MAC R 299.9306(3)*................ 40 CFR 262.34(b).
MAC R 299.9306(4)*................ 40 CFR 262.34(d).
MAC R 299.9306(4)(c)*............. 40 CFR 262.34(d)(2).
MAC R 299.9306(4)(i)(iii)*........ 40 CFR 262.34(d)(5)(iv)(C).
MAC R 299.9306(4)(j)*............. 40 CFR 262.34(d).
MAC R 299.9306(4)(k)*............. 40 CFR 262.34(d).
MAC R 299.9310(2)(a)*............. 40 CFR 262.60(b)(1).
MAC R 299.9503(1)(a)*............. 40 CFR 270.1(c)(2)(ii).
MAC R 299.9503(3)*................ 40 CFR 270.60(c).
MAC R 299.9503(3)(b)(iii)*........ 40 CFR 270.60.(c)(3)(iv).
MAC R 299.9506(1)(g)*............. 40 CFR 270.14(c)(4).
MAC R 299.9506(2)(a)(ii)*......... 40 CFR 270.14(c)(5) and 264.97(a).
MAC R 299.9506(2)(a)(v)*.......... 40 CFR 270.14(c)(5) and 264.97(a).
MAC R 299.9506(2)(f)*............. 40 CFR 270.14(c)(5) and 264.97(a).
MAC R 299.9506(4)(d)*............. 40 CFR 270.14(c)(7)(iv) and
264.94(a).
MAC R 299.9511*................... 40 CFR 124.6
MAC R 299.9518(1)*................ 40 CFR 270.10(c) and 270.14(a).
MAC R 299.9518(4)*................ 40 CFR 124.10(c)(1)(i).
MAC R 299.9518(5)*................ 40 CFR 264.112(d)(3) and
265.112(d)(3).
MAC R 299.9518(6)*................ 40 CFR 264.112(d)(3) and
265.112(d)(3), 270.51(c)(2).
MAC R 299.9519(1)*................ 40 CFR 270.41.
MAC R 299.9601(2)(b)*............. 40 CFR 265.1(b) and 265.50.
MAC R 299.9601(2)(f)*............. 40 CFR 264.112(d)(3), 264.113, 40
CFR 265.112(d)(3), and 265.113.
MAC R 299.9601(2)(i)*............. 40 CFR 268.1.
MAC R 299.9601(4)*................ 40 CFR 264.1(d).
[[Page 4746]]
MAC R 299.9605(2)*................ 40 CFR 261.7.
MAC R 299.9607(2)*................ 40 CFR 264.56(d).
MAC R 299.9607(3)*................ 40 CFR 264.56(j).
MAC R 299.9611(2)(a)*............. 40 CFR 264.98.
MAC R 299.9611(3)(a)(iii)*........ 40 CFR 264.90(c)(3).
MAC R 299.9612(1)*................ 40 CFR 264.90(a).
MAC R 299.9612(1)(b)*............. 40 CFR 264.97.
MAC R 299.9612(1)(d)*............. 40 CFR 264.94(a).
MAC R 299.9612(1)(e)(i)*.......... 40 CFR 264.97(h).
MAC R 299.9612(1)(f)*............. 40 CFR 264.99(a).
MAC R 299.9612(1)(h)*............. 40 CFR 264.90(b).
MAC R 299.9613(1)*................ 40 CFR 264.110.
MAC R 299.9613(2)*................ 40 CFR 264.112(d)(1).
MAC R 299.9613(3)*................ 40 CFR 264.115.
MAC R 299.9613(5)*................ 40 CFR 264.120.
MAC R 299.9615(2)(a)*............. 40 CFR 264.193(e).
MAC R 299.9615(3)*................ 40 CFR 264.192(a)(3).
MAC R 299.9619(1)*................ 40 CFR 264.316.
MAC R 299.9619(5)(a)(i)*.......... 40 CFR 264.310.
MAC R 299.9619(5)(a)(ii)*......... 40 CFR 264.310.
MAC R 299.9619(6)*................ 40 CFR 264.316.
MAC R 299.9629(4)*................ 40 CFR 264.100 (a) and (b).
MAC R 299.9629(5)*................ 40 CFR 264.100(c).
MAC R 299.9629(6)*................ 40 CFR 264.100(d).
MAC R 299.9629(7)*................ 40 CFR 264.100(e).
MAC R 299.9629(8)*................ 40 CFR 264.100(f).
MAC R 299.9629(9)*................ 40 CFR 264.100(g).
MAC R 299.9629(10)*............... 40 CFR 264.100(h).
------------------------------------------------------------------------
*Effective June 18, 1994
EPA shall administer any RCRA hazardous waste permits, or portions
of permits, that contain conditions based upon the Federal program
provisions for which the State is applying for authorization and which
were issued by EPA prior to the effective date of this authorization.
EPA will suspend issuance of any further permits under the provisions
for which the State is being authorized on the effective date of this
authorization. EPA has previously suspended issuance of permits for the
other provisions on October 30, 1986; January 23, 1990; and June 24,
1991, the effective dates of Michigan's final authorizations for the
RCRA base program and for the Non-HSWA Cluster I, Cluster II, and
Cluster III revisions.
Michigan is not authorized to operate the Federal program on Indian
lands. This authority remains with EPA unless provided otherwise in a
future statute or regulation.
C. Decision
I conclude that Michigan's application for program revision meets
all the statutory and regulatory requirements established by RCRA.
Accordingly, Michigan is granted final authorization to operate its
hazardous waste program as revised. Michigan now has responsibility for
permitting treatment, storage, and disposal facilities within its
borders and carrying out other aspects of the RCRA program described in
its revised program application, subject to the limitations of the
HSWA. Michigan also has primary enforcement responsibilities, although
EPA retains the right to conduct inspections under Section 3007 of RCRA
and to take enforcement actions under Sections 3008, 3013, and 7003 of
RCRA.
D. Incorporation by Reference
EPA incorporates by reference authorized State programs in part 272
of 40 CFR to provide notice to the public of the scope of the
authorized program in each State. Incorporation by reference of these
revisions to the Michigan program will be completed at a later date.
Compliance With Executive Order 12291
The Office of Management and Budget has exempted this rule from the
requirements of section 3 of Executive Order 12291.
Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. When a written statement is needed for an EPA rule, section
205 of the UMRA generally requires EPA to identify and consider a
reasonable number of regulatory alternatives and adopt the least
costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, giving
them meaningful and timely input in the development of EPA regulatory
proposals with significant Federal intergovernmental mandates, and
informing, educating, and advising them on compliance with the
regulatory requirements.
EPA has determined that this rule does not contain a Federal
mandate that
[[Page 4747]]
may result in expenditures of $100 million or more for State, local,
and tribal governments, in the aggregate, or the private sector in any
one year. EPA does not anticipate that the approval of Michigan's
hazardous waste program referenced in today's notice will result in
annual costs of $100 million or more.
EPA's approval of State programs generally have a deregulatory
effect on the private sector because once it is determined that a State
hazardous waste program meets the requirements of RCRA section 3006(b)
and the regulations promulgated thereunder at 40 CFR part 271, owners
and operators of hazardous waste treatment, storage, or disposal
facilities (TSDFs) may take advantage of the flexibility that an
approved State may exercise. Such flexibility will reduce, not
increase, compliance costs for the private sector. Thus, today's rule
is not subject to the requirements of sections 202 and 205 of the UMRA.
EPA has determined that this rule contains no regulatory
requirements that might significantly or uniquely affect small
governments. The Agency recognizes that small governments may own and/
or operate TSDFs that will become subject to the requirements of an
approved State hazardous waste program. However, such small governments
which own and/or operate TSDFs are already subject to the requirements
in 40 CFR parts 264, 265, and 270. Once EPA authorizes a State to
administer its own hazardous waste program and any revisions to that
program, these same small governments will be able to own and operate
their TSDFs with increased levels of flexibility provided under the
approved State program.
Certification Under the Regulatory Flexibility Act
Pursuant to the provisions of 5 U.S.C. 605(b), I hereby certify
that this authorization will not have a significant economic impact on
a substantial number of small entities. This authorization effectively
suspends the applicability of certain Federal regulations in favor of
Michigan's program thereby eliminating duplicative requirements for
handlers of hazardous waste in the State. It does not impose any new
burdens on small entities. This rule, therefore, does not require a
regulatory flexibility analysis.
Paperwork Reduction Act
Under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., Federal
agencies must consider the paperwork burden imposed by any information
request contained in a proposed rule or a final rule. This rule will
not impose any information requirements upon the regulated community.
List of Subjects in 40 Part 271
Environmental Protection, Administrative practice and procedure,
Confidential business information, Hazardous materials transportation,
Hazardous waste, Indian lands, Intergovernmental relations, Penalties,
Reporting and recordkeeping requirements, Water pollution control,
Water supply.
Authority: This notice is issued under the authority of sections
2002(a) 3006, and 7004(b) of the Solid Waste Disposal Act as amended
(42 U.S.C. 6912(a), 6926 and 6974(b).
Dated: January 11, 1996.
Valdas V. Adamkus,
Regional Administrator.
[FR Doc. 96-2724 Filed 2-7-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-2723 Protection of Stratospheric Ozone
[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4736-4742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2723]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-5418-3]
Protection of Stratospheric Ozone
AGENCY: Environmental Protection Agency.
ACTION: Notice of acceptability and clarification of June 13, 1995
final rule.
-----------------------------------------------------------------------
SUMMARY: This notice expands the list of acceptable substitutes for
ozone-depleting substances (ODS) under the U.S. Environmental
Protection Agency's (EPA) Significant New Alternatives Policy (SNAP)
program. SNAP implements section 612 of the amended Clean Air Act of
1990, which requires EPA to evaluate substitutes for the OZONE-
DEPLETING SUBSTANCES (ODS), and regulate the use of substitutes where
other alternatives exist that reduce overall risk to human health and
the environment. Through these evaluations, SNAP generates lists of
acceptable and unacceptable substitutes for each of the major
industrial use sectors. In addition, this Notice clarifies several
points from the June 13, 1995 final rule (60 FR 31092).
On March 18, 1994, EPA promulgated its plan for administering the
SNAP program, and issued decisions on the acceptability and
unacceptability of a number of substitutes (59 FR 13044). In today's
Notice, EPA issues decisions on the acceptability of substitutes not
previously reviewed by the Agency. The intended effect of this action
is to expedite movement away from ozone depleting compounds. To arrive
at determinations on the acceptability of substitutes, the Agency
completed a cross-media sector end-use screening assessment of risks to
human health and the environment.
EFFECTIVE DATE: February 8, 1996.
ADDRESSES: Information relevant to this notice is contained in Air
Docket A-91-42, Central Docket Section, South Conference Room 4, U.S.
Environmental Agency, 401 M Street SW., Washington, DC 20460.
Telephone: (202) 260-7548. The docket may be inspected between 8 a.m.
and 5:30 p.m. weekdays. As provided in 40 CFR part 2, a reasonable fee
may be charged for photocopying.
FOR FURTHER INFORMATION CONTACT: Jeffrey Levy at (202) 233-9727 or fax
(202) 233-9577, U.S. EPA, Stratospheric Protection Division, 401 M
Street, SW., Mail Code 6205J, Washington, DC 20460; EPA Stratospheric
Ozone Protection Hotline at (800) 296-1996; EPA World Wide Web Site at
http://www.epa.gov/docs/ozone/title6/SNAP/snap.html.
SUPPLEMENTARY INFORMATION:
I. Section 612 Program
A. Statutory Requirements
B. Regulatory History
II. Listing of Acceptable Substitutes
A. Refrigeration and Air Conditioning: Substitutes for Class I
Substances
B. Refrigeration and Air Conditioning: Substitutes for Class II
Substances
C. Fire Suppression and Explosion Protection
III. Substitutes Pending Review
IV. Additional Information
Appendix A Summary of Acceptable and Pending Decisions
I. Section 612 Program
A. Statutory Requirements
Section 612 of the Clean Air Act authorizes EPA to develop a
program for evaluating alternatives to ozone-depleting substances. EPA
is referring to this program as the Significant New Alternatives Policy
(SNAP) program. The major provisions of section 612 are:
Rulemaking--Section 612(c) requires EPA to promulgate
rules making it unlawful to replace any class I (chlorofluorocarbon,
halon, carbon tetrachloride, methyl chloroform, methyl bromide, and
hydrobromofluorocarbon) or class II (hydrochlorofluorocarbon) substance
with any substitute that the Administrator determines may present
adverse effects to human health or the environment where the
Administrator has identified an alternative that (1) reduces the
overall risk to human health and the environment, and (2) is currently
or potentially available.
Listing of Unacceptable/Acceptable Substitutes--Section
612(c) also requires EPA to publish a list of the substitutes
unacceptable for specific uses. EPA must publish a corresponding list
of acceptable alternatives for specific uses.
Petition Process--Section 612(d) grants the right to any
person to petition EPA to add a substance to or delete a substance from
the lists published in accordance with section 612(c). The Agency has
90 days to grant or deny a petition. Where the Agency grants the
petition, EPA must publish the revised lists within an additional 6
months.
90-day Notification--Section 612(e) requires EPA to
require any person who produces a chemical substitute for a class I
substance to notify the Agency not less than 90 days before new or
existing chemicals are introduced into interstate commerce for
significant new uses as substitutes for a class I substance. The
producer must also provide the Agency with the producer's unpublished
health and safety studies on such substitutes.
Outreach--Section 612(b)(1) states that the Administrator
shall seek to maximize the use of federal research facilities and
resources to assist users of class I and II substances in identifying
and developing alternatives to the use of such substances in key
commercial applications.
Clearinghouse--Section 612(b)(4) requires the Agency to
set up a public clearinghouse of alternative chemicals, product
substitutes, and alternative manufacturing processes that are available
for products and manufacturing processes which use class I and II
substances.
B. Regulatory History
On March 18, 1994, EPA published the Final Rulemaking (FRM) (59 FR
13044) which described the process for administering the SNAP program
and issued EPA's first acceptability lists for substitutes in the major
industrial use sectors. These sectors include: refrigeration and air
conditioning; foam blowing; solvent cleaning; fire suppression and
explosion protection; sterilants; aerosols; adhesives, coatings and
inks; and tobacco expansion. These sectors compose the principal
industrial sectors that historically consumed the largest volumes of
ozone-depleting compounds.
As described in the final rule for the SNAP program (59 FR 13044),
EPA does not believe that rulemaking procedures are required to list
alternatives as acceptable with no limitations. Such listings do not
impose any sanction, nor do they remove any prior license to use a
substance. Consequently, EPA is adding substances to the list of
acceptable alternatives without first requesting comment on new
listings.
EPA does, however, believe that notice-and-comment rulemaking is
required to place any substance on the list of prohibited substitutes,
to list a substance as acceptable only under certain conditions, to
list substances as acceptable only for certain uses, or to remove a
substance from either the list of prohibited or acceptable substitutes.
Updates to these lists are published as separate notices of rulemaking
in the Federal Register.
The Agency defines a ``substitute'' as any chemical, product
substitute, or
[[Page 4737]]
alternative manufacturing process, whether existing or new, that could
replace a class I or class II substance. Anyone who produces a
substitute must provide the Agency with health and safety studies on
the substitute at least 90 days before introducing it into interstate
commerce for significant new use as an alternative. This requirement
applies to substitute manufacturers, but may include importers,
formulators or end-users, when they are responsible for introducing a
substitute into commerce.
EPA published Notices listing acceptable alternatives on August 26,
1994 (59 FR 44240), January 13, 1995 (60 FR 3318), and July 28, 1995
(60 FR 38729), and published a Final Rulemaking restricting the use of
certain substitutes on June 13, 1995 (60 FR 31092). EPA also published
a Notice of Proposed Rulemaking restricting the use of certain
substitutes on October 2, 1995 (60 FR 51383).
II. Listing of Acceptable Substitutes
This section presents EPA's most recent acceptable listing
decisions for substitutes for class I and class II substances in the
following industrial sectors: refrigeration and air conditioning, foam
blowing, and fire suppression and explosion protection. In this Notice,
EPA has split the refrigeration and air conditioning sector into two
parts: Substitutes for class I substances and substitutes for class II
substances. These decisions represent substitutes not previously
reviewed and add to the lists of acceptable substitutes under SNAP. For
copies of the full list, contact the EPA Stratospheric Protection
Hotline at (800) 296-1996.
Parts A through D below present a detailed discussion of the
substitute listing determinations by major use sector. Tables
summarizing today's listing decisions are in Appendix A. The comments
contained in Appendix A provide additional information on a substitute,
but like the listings of acceptable substitutes, they are not legally
binding. Thus, adherence to recommendations in the comments are not
mandatory for use of a substitute. In addition, the comments should not
be considered comprehensive with respect to other legal obligations
pertaining to the use of the substitute. However, EPA encourages users
of acceptable substitutes to apply all comments to their use of these
substitutes. In many instances, the comments simply allude to sound
operating practices that have already been identified in existing
industry and/or building-code standards. Thus, many of the comments, if
adopted, would not require significant changes in existing operating
practices for the affected industry.
A. Refrigeration and Air Conditioning
Please refer to the final SNAP rule for detailed information
pertaining to the designation of end-uses, additional requirements
imposed under sections 608 and 609, and other information related to
the use of alternative refrigerant.
1. Clarifications From the June 13, 1995 Final Rule
HCFC Blend Beta was listed as containing HFC-134a, HCFC-124, and
isobutane. In fact, according to the submission on file with EPA, this
blend contains butane. The determination that this blend is acceptable
subject to certain use conditions applied to the actual blend, not to
the incorrectly listed one.
In the tables listing unacceptable substitutes for CFC-12 in motor
vehicle air conditioning, a definition for the category ``Flammable
Substitutes'' was inadvertently omitted. As discussed in the preamble,
it should have included the phrase ``as having flammability limits as
measured according to ASTM E-681 with modifications included in Society
of Automotive Engineers Recommended Practice J1657, including blends
which become flammable during fractionation.'' In addition, EPA clearly
does not intend to constrain future findings. Thus, the table should
have included a statement that this category does not include
substitutes discussed explicitly in other rulings.
2. Other Clarification
EPA has received inquiries as to the point at which a blend is
sufficiently different from an already reviewed substitute as to
require a new submission. EPA generally follows similar guidelines used
by the American Society of Heating, Refrigerating, and Air-Conditioning
Engineers (ASHRAE). When new blends are submitted to ASHRAE for
classification, the manufacturer must specify blending tolerances. Any
blend that falls outside those tolerances is defined to be a distinct
refrigerant. EPA requires leak testing of blends to determine whether
they can become flammable after fractionation. The percentage of
flammable components in a blend are usually quite close to the maximum
possible for the blend as a whole to remain nonflammable. Even an
increase of 1% of a flammable component may change the flammability of
the blend. Therefore, blending tolerances are smaller for flammable
components than for nonflammable components. Companies should determine
blending tolerances. If the outside range of those tolerances could
result in a different flammability or toxicity profile, then the blend
will require a new submission. EPA encourages manufacturers to contact
the SNAP refrigerants analyst for assistance in making this
determination.
3. Acceptable Substitutes
a. R-508. R-508, which contains HFC-23 and R-116, is acceptable as
a substitute for CFC-13, R-13B1, and R-503 in retrofitted and new very
low temperature refrigeration. Both components of this blend exhibit
extremely high GWPS and long lifetimes. HFC-23 has a GWP of 9,000 and a
lifetime of 280 years, and R-116, perfluoroethane, has a GWP of 9,000
and a lifetime of 10,000 years. EPA believes this blend could
significantly contribute to global warming if allowed to escape
refrigeration systems. In addition, the long lifetimes of R-116 and
HFC-23 mean any global warming or other effects would be essentially
irreversible. Note that the prohibition on venting, which applies to
all substitute refrigerants, was mandated in section 608(c)(2) and took
effect on November 15, 1995. While the current rule issued under
section 608 of the CAA (58 FR 28660) does not specify recycling or leak
repair requirements, it is illegal to vent this refrigerant at any
time. In addition, EPA anticipates proposing new recycling regulations
for non-ozone-depleting refrigerants in the near future. A fact sheet
on the proposal is available from the EPA Ozone Hotline at (800) 296-
1996. This blend is nonflammable and does not deplete ozone. EPA urges
manufacturers to develop alternatives for R-503 and CFC-13 that do not
contain substances with such high GWPS and long lifetimes.
b. R-411A and R-411B. R-411A and R-411B, which consist of HCFC-22,
HFC-152a, and propylene, are acceptable as substitutes for CFC-12 and
R-502 in the following end-uses:
Reciprocating Chillers
Industrial Process Refrigeration
Cold Storage Warehouses
Refrigerated Transport
Retail Food Refrigeration
Commercial Ice Machines
Vending Machines
Water Coolers
HCFC-22 contributes to ozone depletion, but to a much lesser degree
than CFC-12. Regulations regarding recycling and reclamation issued
under section 608 of the Clean Air Act apply to this blend (58 FR
28660). This blend
[[Page 4738]]
poses less of a threat to the ozone layer than HCFC-22, which has
already been listed as an acceptable substitute for CFC-12. The GWP of
HCFC-22 is somewhat high, but the GWP of HFC-152a is low. Although
propylene and HFC-152a are flammable, R-411A and R-411B have been
designated as A1/A2 refrigerants by the American Society of Heating,
Refrigerating, and Air-Conditioning Engineers (ASHRAE). This
designation means that the blend as formulated is nonflammable, but can
become flammable under worst-case fractionation. However, over 75% of
R-411A and 95% of R-411B must leak from the vapor phase before becoming
flammable. Leaks from the liquid phase do not become flammable,
regardless of the amount leaked.
c. HCFC Blend Beta. HCFC Blend Beta, which consists of HCFC-124, HFC-
134a, and butane, is acceptable as a substitute for CFC-12 in the
following new and retrofitted end-uses:
Reciprocating Chillers
Industrial Process Refrigeration
Cold Storage Warehouses
Refrigerated Transport
Retail Food Refrigeration
Vending Machines
Water Coolers
Commercial Ice Machines
Household Refrigerators
Household Freezers
Residential Dehumidifiers
This blend contains HCFC-124. Therefore, it contributes to ozone
depletion, but to a much lesser degree than CFC-12. HCFC-124 has an ODP
much lower than that of HCFC-22, which has already been listed as an
acceptable substitute for CFC-12. Regulations regarding recycling and
reclamation issued under section 60 of the Clean Air Act (58 FR 28660)
apply to this blend. The GWPS of the components are moderate to low.
This blend is nonflammable, and leak testing has demonstrated that the
blend never becomes flammable.
d. HCFC Blend Delta. HCFC Blend Delta is acceptable as a substitute
for CFC-12 in retrofitted household refrigerators and freezers. The
composition of this blend has been claimed confidential by the
manufacturer. This blend contains at least one HCFC, and therefore
contributes to ozone depletion, but to a much lesser degree than CFC-
12. Regulations regarding recycling and reclamation issued under
section 608 of the Clean Air Act apply to this blend (58 FR 28660). The
GWPS of the components are moderate to low. This blend is nonflammable,
and leak testing has demonstrated that the blend never becomes
flammable.
e. HCFC Blend Lambda. HCFC Blend Lambda, which consists of HCFC-22,
HCFC-142b, and isobutane, is acceptable as a substitute for R-500 in
retrofitted centrifugal chillers and as a substitute for CFC-12 in the
following new and retrofitted end-uses:
Reciprocating Chillers
Industrial Process Refrigeration
Cold Storage Warehouses
Refrigerated Transport
Retail Food Refrigeration
Vending Machines
Water Coolers
Commercial Ice Machines
Household Refrigerators
Household Freezers
Residential Dehumidifiers
HCFC-22 and HCFC-142b contribute to ozone depletion, but to a much
lesser degree than CFC-12. Regulations regarding recycling and
reclamation issued under section 608 of the Clean Air Act apply to this
blend (58 FR 28660). HCFC-142b has an ODP slightly higher than that of
HCFC-22. The GWPS of HCFC-22 and HCFC-142b are somewhat high. Although
HCFC-142b is flammable, the blend is not. Under massive leakage, this
blend becomes weakly flammable. However, this blend contains more HCFC-
22 and less of the two flammable components than R-406A, and therefore
should be at least as safe to use as R-406A. However, users should note
that operating pressures will be higher than when using R-406A, so its
use may not be appropriate in the same types of equipment.
f. HFC-236fa. HFC-236fa, when manufactured using any process that
does not convert perfluoroisobutylene (PFIB) directly to HFC-236fa in a
single step, is acceptable as a substitute for CFC-114 in centrifugal
chillers. HFC-236fa does not harm the ozone layer because it does not
contain chlorine. HFC-236fa has an extremely high 100-year GWP of 8000,
but its lifetime is considerably shorter than that of perfluorocarbons.
Although HCFC-124 is already listed as acceptable in this end-use, it
produces toxic byproducts when it passes through air purification
systems on submarines. Therefore, HCFC-124 is not a feasible
alternative. HFC-236fa is the only alternative identified to date that
is safe for the ozone layer, is low in toxicity, and can withstand the
air purification process. Note that the prohibition on venting, which
applies to all substitute refrigerants, was mandated in section
608(c)(2) and took effect on November 15, 1995. While the current rule
issued under section 608 of the CAA (58 FR 28660) does not specify
recycling or leak repair requirements, it is illegal to vent this
refrigerant at any time. In addition, EPA anticipates proposing new
recycling regulations for non-ozone-depleting refrigerants in the near
future. A fact sheet on the proposal is available from the EPA Ozone
Hotline at (800) 296-1996.
In the March 18, 1994 final SNAP rule (58 FR 13044), EPA required
manufacturers to submit information on manufacturing processes to allow
an assessment of the risks posed to the general public and workers.
However, EPA clarified in that action that acceptability determinations
made on the basis of one company's submission would apply to the same
chemical produced by other manufacturers, obviating the need for
duplicative reporting requirements and review. To date, despite the
fact that some alternatives are manufactured by several companies, no
process has been identified as significantly more hazardous than
another. Therefore, EPA has not yet based SNAP decisions specifically
on the manufacturing process.
EPA is aware, however, of several methods for manufacturing HFC-
236fa, including one that produces HFC-236fa directly from PFIB. PFIB
is an extremely toxic substance that could pose risks in very small
concentrations. Thus, EPA believes it is appropriate to distinguish
among the different methods for producing HFC-236fa. This acceptability
determination does not prohibit the manufacture of HFC-236fa directly
from PFIB. Rather, it finds acceptable the production of HFC-236fa in
processes that do not convert PFIB directly to HFC-236fa in a single
step. If a manufacturer wishes to produce HFC-236fa directly from PFIB,
it must submit that process to EPA for review under SNAP.
A. Refrigeration and Air Conditioning: Substitutes for Class II
Substances
Please refer to the March 18, 1994 SNAP rule (59 FR 13044) for
detailed information pertaining to the designation of end-uses,
additional requirements imposed under sections 608 and 609, and other
information related to the use of alternative refrigerants.
This Notice marks the first time EPA has addressed substitutes for
HCFC-22 in the refrigeration and air conditioning sector. Although the
substitutes listed below were intended specifically to replace HCFC-22,
HCFC-22 is itself frequently used as a substitute for class I
refrigerants (e.g, CFC-11 and CFC-12).
[[Page 4739]]
Therefore, the listings below also describe these HCFC-22
substitutes as acceptable alternatives for class I refrigerants in new
equipment. The underlying reasoning is that if, for instance, HCFC-22
poses lower overall risk than CFC-12, and R-410A poses lower overall
risk than HCFC-22, then R-410A must also pose lower overall risk than
CFC-12. Therefore, even though R-410A isn't designed to be a direct
replacement for CFC-12, in new equipment it may be appropriate to
design for R-410A rather than for another CFC-12 substitute. As with
all listings, however, engineering decisions are required to determine
the best match between a given class I refrigerant and an alternative.
1. Acceptable
a. R-410A and R-410B. R-410A and R-410B, which consist of HFC-32
and HFC-125, are acceptable as substitutes for HCFC-22, and by
extension, class I refrigerants, in equipment in the following new end-
uses:
Centrifugal, Reciprocating, and Screw Chillers
Industrial Process Refrigeration Systems
Very-Low-Temperature Industrial Process Refrigeration
Industrial Process Air Conditioning
Ice Skating Rinks
Refrigerated Transport
Retail Food Refrigeration
Cold Storage Warehouses
Vending Machines
Water Coolers
Commercial Ice Machines
Household Refrigerators and Freezers
Residential Dehumidifiers
Household and Light Commercial Air Conditioning
Both R-410A and R-410B contain HFC-32 and HFC-125 but in slightly
different compositions. Neither blend is flammable when used in these
end uses while maintaining as-formulated composition nor after leak
conditions. Leak testing has demonstrated that their compositions do
not become flammable under any of the conditions found in these end
uses. However, since both blends include HFC-32, which is flammable by
itself, they should not be mixed with high concentrations of air above
atmospheric pressures to minimize the risk of ignition. HFC-125
exhibits a fairly high global warming potential (3,200 at 100 year
integrated time horizon) compared to other HFCs and HCFC-22. However,
its potential for contributing to global warming will be delayed in the
listed end uses through the implementation of the venting prohibition
under Section 608(c)(2) of the Clean Air Act Amendments. Note that the
prohibition on venting, which applies to all substitute refrigerants,
was mandated in section 608(c)(2) and took effect on November 15, 1995.
While the current rule issued under section 608 of the CAA (58 FR
28660) does not specify recycling or leak repair requirements, it is
illegal to vent this refrigerant at any time. In addition, EPA
anticipates proposing new recycling regulations for non-ozone-depleting
refrigerants in the near future. A fact sheet on the proposal is
available from the EPA Ozone Hotline at (800) 296-1996. R-410A and R-
410B do not contain ozone-depleting substances, they are low in
toxicity, and none of their components is regulated as a volatile
organic compound.
b. R-407C. R-407C, which is a blend of HFC-32, HFC-134a and HFC-
125, is acceptable as a substitute for HCFC-22 in new and retrofit
equipment, and by extension, as a substitute for class I refrigerants
in new equipment, in the following end-uses:
Centrifugal, Reciprocating, and Screw Chillers
Industrial Process Refrigeration
Very Low Temperature Industrial Process Refrigeration
Ice Skating Rinks
Refrigerated Transport
Retail Food Refrigeration Systems
Cold Storage Warehouses
Vending Machines
Water Coolers
Commercial Ice Machines
Household Refrigerators and Freezers
Residential Dehumidifiers
Household and Light Commercial Air Conditioning
This blend is not flammable when used in these end uses while
maintaining as-formulated composition or after leak conditions. Leak
testing has demonstrated that its composition, or composition
variations due to fractionation, does not make it flammable under any
of the conditions found in these end uses. This blend includes HFC-32
and HFC-125, therefore the above discussion of these two substances as
part of R-410A and R-410B is applicable. Again, EPA urges users to
reduce leakage and recover and recycle this blend during equipment
servicing and upon the retirement of equipment. R-407C doesn't damage
the ozone layer, it is low in toxicity, and none of its components is
regulated as a volatile organic compound. Note that the prohibition on
venting, which applies to all substitute refrigerants, was mandated in
section 608(c)(2) and took effect on November 15, 1995. While the
current rule issued under section 608 of the CAA (58 FR 28660) does not
specify recycling or leak repair requirements, it is illegal to vent
this refrigerant at any time. In addition, EPA anticipates proposing
new recycling regulations for non-ozone-depleting refrigerants in the
near future. A fact sheet on the proposal is available from the EPA
Ozone Hotline at (800) 296-1996.
c. HFC-134a. HFC-134a is acceptable as a substitute for HCFC-22 in
new Household and Light Commercial Air Conditioning. HFC-134a exhibits
a moderate to high global warming potential (1,300 at 100 year
integrated time horizon) compared to other HFCS. Although much lower
than HFC-125, uncontrolled emissions could have a significant impact on
global warming. Therefore, the above guidance on controlling leaks and
recycling, particularly during disposal, are applicable to HFC-134A in
this end use. HFC-134a does not damage the ozone layer, it is very low
in toxicity, and it is not regulated as a volatile organic compound.
Note that the prohibition on venting, which applies to all substitute
refrigerants, was mandated in section 608(c)(2) and took effect on
November 15, 1995. While the current rule issued under section 608 of
the CAA (58 FR 28660) does not specify recycling or leak repair
requirements, it is illegal to vent this refrigerant at any time. In
addition, EPA anticipates proposing new recycling regulations for non-
ozone-depleting refrigerants in the near future. A fact sheet on the
proposal is available from the EPA Ozone Hotline.
B. Fire Suppression and Explosion Protection
1. Acceptable
a. Total Flooding Agents. (1) [Powdered Aerosol] C is acceptable
for use in normally unoccupied areas. This agent is intended solely for
use in normally unoccupied areas and thus it does not represent a
significant threat to worker safety or health. Use conditions to limit
the risk of inadvertent exposure to personnel in normally unoccupied
areas may be included in future rulemakings.
III. Substitutes Pending Review
The Agency describes submissions as pending if data are incomplete
or for which the 90-day review period is underway and EPA has not yet
reached a final decision. For submissions that are incomplete, the
Agency will contact the submitter to determine a schedule for providing
the missing information if the Agency needs to extend the 90-day review
period. EPA will use its authority under section 114 of the Clean Air
Act to gather this information, if
[[Page 4740]]
necessary. Any delay of the review period does not affect a
manufacturer's ability to sell a product 90 days after notification of
the Agency. Substitutes currently pending completion of review are
listed in Appendix A.
IV. Additional Information
Contact the Stratospheric Protection Hotline at 1-800-296-1996,
Monday-Friday, between the hours of 10:00 a.m. and 4:00 p.m. (Eastern
Standard Time) weekdays.
For more information on the Agency's process for administering the
SNAP program or criteria for evaluation of substitutes, refer to the
SNAP final rulemaking published in the Federal Register on March 18,
1994 (59 FR 13044). Federal Register notices can be ordered from the
Government Printing Office Order Desk (202) 783-3238; the citation is
the date of publication. This Notice can also be retrieved
electronically from EPA's Technology Transfer Network (TTN), Clean Air
Act Amendment Bulletin Board. If you have a 1200 or 2400 bps modem,
dial (919) 541-5742. If you have a 9600 bps modem, dial (919) 541-1447.
For assistance in accessing this service, call (919) 541-5384. Finally,
this notice may be obtained on the World Wide Web at http://
www.epa.gov/docs/ozone/title6/snap/snap.html.
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Reporting and recordkeeping requirements.
Dated: December 19, 1995.
Mary D. Nichols,
Assistant Administrator for Air and Radiation.
Note: The following Appendix will not appear in the Code of
Federal Regulations.
Appendix A: Summary of Acceptable and Pending Decisions
[Refrigerants--Class I Acceptable Substitutes]
----------------------------------------------------------------------------------------------------------------
End-Use Substitute Decision Comments
----------------------------------------------------------------------------------------------------------------
CFC-12 and R-500 Reciprocating R-411A................. Acceptable............. This blend contains the
Chillers; CFC-12 and R-502 R-411B................. Acceptable............. same components as R-
Industrial Process Refrigeration, HCFC blend Beta........ Acceptable............. 406A, but in different
Cold Storage Warehouses, HCFC Blend Lambda...... Acceptable............. percentages.
Refrigerated Transport, Retail Food
Refrigeration, Vending Machines,
Water Coolers, Commercial Ice
Machines (Retrofitted and New).
CFC-12 and R-502 Household HCFC Blend Beta........ Acceptable............. This blend contains the
Refrigerators, Household Freezers, HCFC Blend Lambda...... Acceptable............. same components as R-
and Residential Dehumidifiers. 406A, but in different
percentages.
CFC-13, R-13B1, and R-503 Very Low R-508.................. Acceptable.
Temperature Refrigeration.
CFC-114 Centrifugal Chillers......... HFC-236fa.............. Acceptable.
----------------------------------------------------------------------------------------------------------------
Refrigeration and Air Conditioning Acceptable Substitutes for Class II Substances
----------------------------------------------------------------------------------------------------------------
End-use Substitute Decision Comments
----------------------------------------------------------------------------------------------------------------
Household and Light Commercial Air ....................... ....................... This end use also
Conditioning includes heat pump
systems.
HCFC-22 Systems, New............. R-407C, R-410A, R-410B, Acceptable............. EPA urges recycling.
HFC-134A.
HCFC-22 Systems, Retrofit........ R-407C................. Acceptable............. EPA urges recycling.
Commercial Comfort Air Conditioning ....................... ....................... This end use includes
chillers in general.
HCFC-22 Reciprocating Chillers, R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
New.
CFC-12 Reciprocating Chillers, R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
New.
R-500 Reciprocating Chillers, New R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
CFC-11 Centrifugal Chillers, New. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
CFC-12 Centrifugal Chillers, New. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
HCFC-22 Centrifugal Chillers, New R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
HCFC-22 Centrifugal Chillers, R-407C................. Acceptable............. EPA urges recycling.
Retrofit.
R-500 Centrifugal Chillers, New.. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
HCFC-22 Screw Chillers, New...... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
HCFC-22 Screw Chillers, Retrofit. R-407C................. Acceptable............. EPA urges recycling.
Industrial Process Refrigeration ....................... ....................... It also includes very-
low-temperature
industrial
refrigeration.
HCFC-22 Systems, New............. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
HCFC-22 Systems, Retrofit........ R-407C................. Acceptable............. EPA urges recycling.
CFC-12 Systems, New.............. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
R-500 Systems, New............... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
[[Page 4741]]
R-502 Systems, New............... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
Industrial Process Air Conditioners
HCFC-22 A/C Systems, New......... R-407C, R-410A, R-410B, Acceptable............. EPA urges recycling.
HFC-134a.
HCFC-22 A/C Systems, Retrofit.... R-407C................. Acceptable............. EPA urges recycling.
CFC-12 A/C System, New........... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
CFC-114 A/C System, New.......... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
CFC-12/CFC-114 A/C Systems, New.. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
Ice Skating Rinks
HCFC-22 Systems, New............. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
HCFC-22 Systems, Retrofit........ R-407C................. Acceptable............. EPA urges recycling.
CFC-12 Systems, New.............. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
R-502 Systems, New............... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
Refrigerated Transport
CFC-12 Systems, New.............. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
R-500 Systems, New............... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
R-502 Systems, New............... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
Retail Food Refrigeration ....................... ....................... It also includes cold
storage warehouses.
HCFC-22 Systems, New............. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
HCFC-22 Systems, Retrofit........ R-407C................. Acceptable............. EPA urges recycling.
CFC-12 Systems, New.............. R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
R-502 Systems, New............... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
Ice Machines
CFC-12 Ice Machines, New......... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
Household Refrigerators and Freezers
CFC-12 Household Refrigerators, R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
New.
CFC-12 Household Freezers, New... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
R-502 Household Freezers, New.... R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
Other Refrigerated Appliances ....................... ....................... Includes water coolers,
vending machines, and
dehumidifiers.
CFC-12 Refrigerated Appliances, R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
New.
R-502 Refrigerated Appliances, R-407C, R-410A, R-410B. Acceptable............. EPA urges recycling.
New.
----------------------------------------------------------------------------------------------------------------
Fire Suppression and Explosion Protection
[Total Flooding Agents Acceptable Substitutes]
----------------------------------------------------------------------------------------------------------------
End-Use Substitute Decision Comments
----------------------------------------------------------------------------------------------------------------
Halon 1301........................... Powdered Aerosol C..... Acceptable............. For use in normally
unoccupied areas only.
----------------------------------------------------------------------------------------------------------------
Acceptable Substitutes--Foam Blowing
----------------------------------------------------------------------------------------------------------------
Integral Skin with HCFC-22........... CO2.................... Acceptable.............
HFC-134a............... Acceptable.............
----------------------------------------------------------------------------------------------------------------
[[Page 4742]]
Pending Decisions--Foam Blowing
----------------------------------------------------------------------------------------------------------------
End-use Substitute Comments
----------------------------------------------------------------------------------------------------------------
HCFCs, Polyurethane Integral Skin CO2
HFC-134a.
----------------------------------------------------------------------------------------------------------------
Pending Substitutes--Solvent Cleaning
----------------------------------------------------------------------------------------------------------------
End-use Substitute Comments
----------------------------------------------------------------------------------------------------------------
Metals Cleaning w/ CFC-113 and Chlorobromomethane............... Additional toxicity testing is necessary to
MCF. characterize fully the chronic health
effects such as carcinogenicity that could
arise from repeated exposures. In
addition, decomposition studies and ozone
depletion analyses must be completed
before SNAP decision is rendered.
Electronics Cleaning w/ CFC-113 Chlorobromomethane............... Additional toxicity testing is necessary to
and MCF. characterize fully the chronic health
effects such as carcinogenicity that could
arise from repeated exposures. In
addition, decomposition studies and ozone
depletion analyses must be completed
before SNAP decision is rendered.
Precision Cleaning w/ CFC-113 Chlorobromomethane............... Additional toxicity testing is necessary to
and MCF. characterize fully the chronic health
effects such as carcinogenicity that could
arise from repeated exposures. In
addition, decomposition studies and ozone
depletion analyses must be completed
before SNAP decision is rendered.
----------------------------------------------------------------------------------------------------------------
[FR Doc. 96-2723 Filed 2-7-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-2718 National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List Update
[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4747-4748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2718]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 300
[FRL-5418-4]
National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List Update
AGENCY: Environmental Protection Agency.
ACTION: Notice of deletion of the Clothier Disposal site from the
National Priorities List (NPL).
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA), Region II,
announces the deletion of the Clothier Disposal site from the National
Priorities List (NPL). The NPL is Appendix B of 40 CFR part 300 which
is the National Oil and Hazardous Substances Pollution Contingency Plan
(NCP), which EPA promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA), as amended. EPA and the State of New York have determined
that all appropriate responses under CERCLA have been implemented, and
that no further cleanup by responsible parties is appropriate.
Moreover, EPA and the State of New York have determined that remedial
actions conducted at the site to date have been protective of public
health, welfare, and the environment.
EFFECTIVE DATE: February 8, 1996.
ADDRESSES: For further information contact: Herbert H. King, Remedial
Project Manager, U.S. Environmental Protection Agency, Region II, 290
Broadway, 20th floor, New York, NY 10007-1866.
FOR FURTHER INFORMATION CONTACT: Herbert H. King at (212) 637-4268.
SUPPLEMENTARY INFORMATION: The site to be deleted from the NPL is:
Clothier Disposal site, Granby, New York.
The closing date for comments on the Notice of Intent to Delete was
October 15, 1995. EPA received one comment letter from the counsel for
the Settling Defendants (a group of potentially responsible parties
associated with the site who entered into a consent decree with the
government to pay for the government's past costs and to remediate the
site), indicating that the Settling Defendants support deleting the
site from the NPL, and requesting that the description of the
activities that were undertaken by the Settling Defendants after the
discovery of three buried drums during the first long-term monitoring
event at the site be amplified. EPA acknowledges the Settling
Defendants' efforts subsequent to the discovery of three buried drums,
which included a geophysical investigation in the area surrounding the
drum-discovery site, the excavation of trenches through two magnetic
anomalies identified by the geophysical investigation, the excavation
of metallic debris discovered in one trench, and the off-site disposal
of the metallic debris and the three buried drums. Based on these
efforts and the associated findings, EPA concluded that no further
remedial or investigatory work was necessary at the site.
EPA identifies sites which appear to present a significant risk to
public health, welfare, or the environment and it maintains the NPL as
the list of those sites. Sites on the NPL may be the subject of
Hazardous Substance Response Trust Fund (Fund)-financed remedial
actions. Any site deleted from the NPL remains eligible for Fund-
financed remedial actions in the unlikely event that conditions at the
site warrant such action. Section 300.425 (e)(3) of the NCP states that
Fund-financed actions may be taken at sites deleted from the NPL.
Deletion of a site from the NPL does not affect responsible party
liability or impede EPA's efforts to recover costs associated with
response efforts.
List of Subjects in 40 CFR Part 300
Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.
[[Page 4748]]
Dated: January 2, 1996.
William J. Muszynski,
Acting Regional Administrator.
40 CFR part 300 is amended as follows:
PART 300--[AMENDED]
1. The authority citation for part 300 continues to read as
follows:
Authority: 33 U.S.C. 1321 (c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p.193.
Appendix B--[Amended]
2. Table 1 of Appendix B to part 300 is amended by removing the
Clothier Disposal site, Granby, New York.
[FR Doc. 96-2718 Filed 2-7-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-2688 21 CFR Part 510
[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4735-4736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2688]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 61, No. 27 / Thursday, February 8, 1996 /
Rules and Regulations
[[Page 4735]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor Name and Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor name and address from
DuPont Pharmaceuticals to DuPont Merck Pharmaceutical Co.
EFFECTIVE DATE: February 8, 1996.
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0213.
SUPPLEMENTARY INFORMATION: DuPont Pharmaceuticals, One Rodney Square,
Wilmington, DE 19898, has informed FDA of a change of sponsor name and
address to DuPont Merck Pharmaceutical Co., DuPont Merck Plaza, MR2117,
Wilmington, DE 19805. Accordingly, the agency is amending the
regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of
sponsor name and address.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is
amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
2. Section 510.600 is amended in the table in paragraph (c)(1) by
removing the entry for ``DuPont Pharmaceuticals '' and by
alphabetically adding a new entry for ``DuPont Merck Pharmaceutical
Co.,'' and in the table in paragraph (c)(2) in the entry for ``000056''
by revising the sponsor name and address to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address-- Drug labeler code
------------------------------------------------------------------------
* * * *
* * *
DuPont Merck Pharmaceutical Co., 000056
DuPont Merck Plaza, MR2117,
Wilmington, DE 19805.
* * * *
* * *
------------------------------------------------------------------------
--(2)-* * *
------------------------------------------------------------------------
Drug labeler code----- Firm name and address
------------------------------------------------------------------------
* * * *
* * *
000056----............................ DuPont Merck Pharmaceuticals
Co., DuPont Merck Plaza,
MR2117, Wilmington, DE 19805
* * * *
* * *
------------------------------------------------------------------------
-
[[Page 4736]]
Dated: February 1, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-2688 Filed 2-7-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-2666 Antacid Drug Products for Over-the-Counter Human Use; Amendment of Antacid Monograph
[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4822-4823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2666]
[[Page 4821]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 331
Antacid Drug Products for Over-the-Counter Human Use; Amendment of
Antacid Monograph; Final Rule
Federal Register / Vol. 61, No. 27 / Thursday, February 8, 1996 /
Rules and Regulations
-----------------------------------------------------------------------
[[Page 4822]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 331
[Docket No. 88N-0327]
RIN 0905-AA06
Antacid Drug Products for Over-the-Counter Human Use; Amendment
of Antacid Monograph
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
that amends the monograph for over-the-counter (OTC) antacid drug
products by deleting parts of the testing procedures in subpart C. This
final rule is part of the ongoing review of OTC drug products conducted
by FDA. Also, this final rule is part of the Administration's
``Reinventing Government'' initiative which seeks to streamline
government and to ease the burden on regulated industry and consumers.
EFFECTIVE DATE: February 10, 1997.
FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug
Evaluation and Research (HFD-105), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2304.
SUPPLEMENTARY INFORMATION:
-I. Background
-In the Federal Register of June 4, 1974 (39 FR 19862), FDA issued
a final monograph for OTC antacid drug products (21 CFR part 331) that
included procedures for testing antacid drug products. An acid
neutralizing capacity test is described in Sec. 331.26. When the final
monograph was issued in 1974, the United States Pharmacopeia (USP) did
not include an acid neutralizing capacity test. However, in 1980 an
acid neutralizing capacity test was included in the USP (Ref. 1). That
test is substantially the same as the test found in the final monograph
for OTC antacid drug products. Several revisions in the USP acid
neutralizing capacity test have been made since 1980 to increase the
accuracy and utility of the test. The current USP 23/National Formulary
(N.F.) 18 acid neutralizing capacity test (Ref. 2) differs from the
agency's antacid monograph testing procedures, which have not been
revised.
-The FDA recommended disintegration test method (in Sec. 331.24)
and the methods in current USP 23/N.F. 18 monographs for antacid
tablets also have some differences. Current USP 23/N.F. 18 procedures
include tests for powder and suspension dosage forms and for products
having an acid neutralizing capacity greater than 25 milliequivalents
(meq) of acid, as well as a more detailed sample preparation procedure
for capsule dosage forms.
-In the Federal Register of September 23, 1993 (58 FR 49826), the
agency issued a notice of proposed rulemaking to amend the final
monograph for OTC antacid drug products to delete parts of the testing
procedures in subpart C, as discussed above in this document. The
agency discussed the differences between its antacid monograph
standards and those in the USP. The agency mentioned that it could
amend its antacid monograph to be consistent with the USP, but opted to
delete portions of its monograph testing procedures and refer to the
USP procedures for determination of the antacid product's acid
neutralizing capacity in place thereof. The agency noted that USP
procedures do not include a ``preliminary antacid test'' (as contained
in Sec. 331.25 of the antacid monograph) or a procedure for the
``determination of percent contribution of active ingredients'' in a
combination antacid drug product (as contained in Sec. 331.21 of the
antacid monograph). The agency does not consider the ``preliminary
antacid test'' as essential to the determination of a product's acid
neutralizing capacity. However, manufacturers may elect to continue to
use this test as a preliminary screening procedure. The agency stated
that it was retaining Sec. 331.21 (``determination of percent
contribution of active ingredients'') in the monograph (redesignated as
Sec. 331.20) so that a procedure will be available for making that
determination. No comments were received in response to the agency's
proposed changes in the antacid monograph.
References
(1) ``United States Pharmacopeia XX--National Formulary XV,''
United States Pharmacopeial Convention, Inc., Rockville, MD, p. 912,
1980.
(2) ``United States Pharmacopeia 23--National Formulary 18,''
United States Pharmacopeial Convention, Inc., Rockville, MD, pp. 54-
55 and 1791-1793, 1994.
II. The Agency's Final Conclusions on the Amendment to the
Monograph for OTC Antacid Drug Products
-In the proposal, the agency referred to the acid neutralizing
capacity test procedures in USP XXII/N.F. XVII. Since the proposal was
published, USP 23/N.F. 18 became official on January 1, 1995. The test
procedures in both editions of the USP are the same. Therefore, the
agency is referencing USP 23/N.F. 18 in this final rule.
The agency is removing the following sections from ``Subpart C--
Testing Procedures'' in ``Part 331--Antacid Products for Over-the-
Counter (OTC) Human Use'': Secs. 331.20, 331.22, 331.23, 331.24,
331.25, and 331.26. The agency is redesignating Sec. 331.21 as
Sec. 331.20 and amending it to refer to the USP 23/N.F. 18 test
procedure in place of Sec. 331.26, which is being removed. The agency
is retaining Sec. 331.29 (``test modifications'') in case there is a
need for any manufacturer to petition for a test modification, is
redesignating this section as Sec. 331.21, and is amending it to
reference the USP 23/N.F. 18 test procedure. The agency is also
amending Secs. 331.10(a) and 331.80(a)(1) to refer to USP 23/N.F. 18.
-III. Analysis of Impacts
-An analysis of the cost and benefits of this regulation, conducted
under Executive Order 12291, was discussed in the proposed rule (58 FR
49826 at 49827). No comments were received in response to the agency's
request for specific comment on the economic impact of this rulemaking.
Executive Order 12291 has been superseded by Executive Order 12866.
-FDA has examined the impacts of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub L. 96-354).
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 agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and, thus, is not subject to review 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. Manufacturers of OTC antacid drug products should
not be affected by the deletion of certain testing procedures that have
already been incorporated into the USP/N.F. Accordingly, the agency
certifies that the final rule will not have a significant economic
impact on a substantial
[[Page 4823]]
number of small entities. Therefore, under the Regulatory Flexibility
Act, no further analysis is required. -
-IV. Environmental Impact
-The agency has determined under 21 CFR 25.24(c)(6) 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.
-List of Subjects in 21 CFR Part 331
-Labeling, Over-the-counter drugs.
-Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 331 is amended as follows:
-PART 331--ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
-1. The authority citation for 21 CFR part 331 continues to read
as follows:
-Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371).
-2. Section 331.10 is amended by revising paragraph (a) to read as
follows:
Sec. 331.10 Antacid active ingredients.
-(a) The active antacid ingredients of the product consist of one
or more of the ingredients permitted in Sec. 331.11 within any maximum
daily dosage limit established, each ingredient is included at a level
that contributes at least 25 percent of the total acid neutralizing
capacity of the product, and the finished product contains at least 5
meq of acid neutralizing capacity as measured by the procedure provided
in the United States Pharmacopeia 23/National Formulary 18. The method
established in Sec. 331.20 shall be used to determine the percent
contribution of each antacid active ingredient.
*- *- *- *- *
Sec. 331.20 [Removed]
-3. Section 331.20 Apparatus and reagents is removed from subpart
C.
Sec. 331.21 [Redesignated as Sec. 331.20]
-4. Section 331.21 is redesignated as Sec. 331.20 and revised to
read as follows:
Sec. 331.20 Determination of percent contribution of active
ingredients.
-To determine the percent contribution of an antacid active
ingredient, place an accurately weighed amount of the antacid active
ingredient equal to the amount present in a unit dose of the product
into a 250-milliliter (mL) beaker. If wetting is desired, add not more
than 5 mL of alcohol (neutralized to an apparent pH of 3.5), and mix to
wet the sample thoroughly. Add 70 mL of water, and mix on a magnetic
stirrer at 30030 r.p.m. for 1 minute. Analyze the acid
neutralizing capacity of the sample according to the procedure provided
in the United States Pharmacopeia 23/National Formulary 18 and
calculate the percent contribution of the antacid active ingredient in
the total product as follows:
-Percent contribution = (Total meq. Antacid Active Ingredient
x100)/(Total meq. Antacid Product).
Sec. 331.22 [Removed]
-5. Section 331.22 Reagent standardization is removed.
Sec. 331.23 [Removed]
-6. Section 331.23 Temperature standardization is removed.
Sec. 331.24 [Removed]
-7. Section 331.24 Tablet disintegration test is removed.
Sec. 331.25 [Removed]
-8. Section 331.25 Preliminary antacid test is removed.
Sec. 331.26 [Removed]
-9. Section 331.26 Acid neutralizing capacity test is removed.
Sec. 331.29 [Redesignated as Sec. 331.21]
10. Section 331.29 is redesignated as Sec. 331.21 and revised to
read as follows:
Sec. 331.21 Test modifications.
-The formulation or mode of administration of certain products may
require a modification of the United States Pharmacopeia 23/National
Formulary 18 acid neutralizing capacity test. Any proposed modification
and the data to support it shall be submitted as a petition under the
rules established in Sec. 10.30 of this chapter. All information
submitted will be subject to the disclosure rules in part 20 of this
chapter.
-11. Section 331.80 is amended by revising paragraph (a)(1) to read
as follows:
Sec. 331.80 Professional labeling.
-(a) * * *
-(1) Shall contain the neutralizing capacity of the product as
calculated using the procedure set forth in United States Pharmacopeia
23/National Formulary 18 expressed in terms of the dosage recommended
per minimum time interval or, if the labeling recommends more than one
dosage, in terms of the minimum dosage recommended per minimum time
interval.
* * * * *
Dated: January 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-2666 Filed 2-7-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-2665 Tin-Coated Lead Foil Capsules for Wine Bottles
[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4816-4820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2665]
[[Page 4815]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 189
Tin-Coated Lead Foil Capsules for Wine Bottles; Final Rule
Federal Register / Vol. 61, No. 27 / Thursday, February 8, 1996 /
Rules and Regulations
=======================================================================
-----------------------------------------------------------------------
[[Page 4816]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 189
[Docket No. 91N-0326]
RIN 0910-AA06
Tin-Coated Lead Foil Capsules for Wine Bottles
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to prohibit the use of tin-coated lead foil capsules (i.e.,
coverings for the cork and neck area) on wine bottles. Lead in these
capsules may, as a result of their intended use, become a component of
the wine. FDA is taking this action to reduce exposure to lead to the
extent feasible.
DATES: Effective February 8, 1996. Wine is adulterated under the
Federal Food, Drug, and Cosmetic Act (the act) if a tin-coated lead
foil capsule is applied to the wine bottle on or after February 8,
1996.
FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, -
200 C St. SW., -Washington, DC 20204, 202-205-4681.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 25, 1992 (57 FR 55485), FDA
published a proposed rule to prohibit the use of tin-coated lead foil
capsules on wine bottles (hereinafter referred to as the 1992
proposal). The 1992 proposal was based on evidence from studies on
bottled wine capped with tin-coated lead foil capsules that showed that
the lead in the foil becomes a component of food. No food additive
regulation exists for this use of tin-coated lead foil, nor is there a
prior sanction for this use. Moreover, this use of tin-coated lead foil
is not generally recognized as safe (GRAS). Therefore, FDA tentatively
found that tin-coated lead foil capsules used on wine bottles are an
unsafe food additive under section 409 of the act (21 U.S.C. 348), and
wine is adulterated under section 402 (a)(2)(C) of the act (21 U.S.C.
342(a)(2)(C)), if a tin-coated lead foil capsule is applied to the wine
bottle on or after February 8, 1996. Given the longstanding use of tin-
coated lead foil capsules as a packaging material for wine, the agency
proposed to prohibit use of this capsule by regulation to make its
regulatory status clear. FDA proposed to make any final rule that
issued based upon the 1992 proposal effective on its date of
publication.
II. Summary of and Response to Comments
A. Summary of Comments
The agency received 16 comments in response to the 1992 proposal.
Thirteen comments were from domestic and imported wine merchants,
associations representing domestic winemakers, and a foreign national
trade association representing exporters of wine. In addition, one
comment was received from an international trade commission, and two
were received from foreign governments.
All comments supported the proposal in principle. However, some
comments sought clarification of what the proposal was intended to
prohibit. Some comments raised issues concerning other types of
capsules that may contain lead used on wine bottles. Some comments
raised concerns about regulatory action by individual States concerning
capsules used on wine bottles.
The majority of the comments reacted favorably to the proposed
effective date, but two comments expressed the need for further
clarification on this issue.
One comment asserted that the wine industry is being charged with
an extraordinary share of the lead-reduction burden.
B. Responses to Comments
1. Several comments stated that the 1992 proposal did not clearly
identify the specific type of capsule that FDA proposed to prohibit.
One comment requested that the 1992 proposal be amended to provide a
clearer definition of what is prohibited. The comment also stated that
if the prohibition is to be based on the amount of lead that is present
in the capsule, then fairness requires that reasonable notice be given
of the precise requirement of the final rule before it becomes
effective. Another comment stated that since some traces of lead may
appear in alternative types of capsules, the final rule should be
written in such a way that no ambiguity is possible concerning the
amount of lead that the capsule may contain.
These comments apparently derive in large measure from the fact
that the State of California has acted to prohibit the use of capsules
that contain more than 0.3 percent lead. These comments are responding
to the 1992 proposal's lack of a quantitative level of lead in a
capsule that would subject it to prohibition, inasmuch as the State's
action included such a level.
In response to these comments, FDA emphasizes that the intent of
the 1992 proposal was not to set a maximum permissible level of lead in
a capsule. The intent was to prohibit the use of tin-coated lead foil
capsules as a covering for the cork and neck areas of wine bottles. In
the preamble to the 1992 proposed rule, FDA defined ``tin-coated lead
foil capsules'' as ``capsules composed of lead foil coated on both
sides with a thin layer of tin.'' This identification is not ambiguous.
It clearly differentiates between tin-coated lead foil capsules, in
which lead is intentionally used, and other types of capsules known to
be used in the bottling of wine (e.g., all tin capsules) that may
unavoidably contain some lead as an impurity.
Nonetheless, given the concerns expressed by the comments, to
eliminate the possibility of any ambiguity in the final regulation, the
agency is modifying proposed Sec. 189.301(a) to incorporate the
definition of ``tin-coated lead foil'' as it appeared in the preamble
of the 1992 proposal.
2. Several comments requested that the agency define ``all tin-
capsules'' (an alternative to tin-coated lead foil capsules) to include
the amount of lead that may be present in the capsule as an unintended
impurity.
As stated above, this final rule is a prohibition of, and applies
exclusively to, tin-coated lead foil capsules.
It is not FDA's intent in this rulemaking to address the regulatory
status of any other type of capsule (e.g., tin, aluminum, or plastic).
However, FDA recognizes that it is conceivable that materials, both
metallic and nonmetallic, used in other types of capsules could become
components of wine, thus subjecting these capsules to the provisions of
the act. FDA provides the following guidance in response to the
comments that sought an opinion on the status of various types of
capsules that may be used in the bottling of wine.
If a substance, such as tin or aluminum, has a history of use as a
capsule for wine bottles predating January 1, 1958, and the substance
could become a component of food as a result of its intended use, the
use may be GRAS based on common use in food or food contact. The
criteria for determining whether the use is GRAS are described in
Sec. 170.30(c) (21 CFR 170.30(c)). Any substance whose use in capsules
for wine bottles began after January 1, 1958, would either have to be
GRAS for such use on the basis of scientific procedures described in
[[Page 4817]]
Sec. 170.30(b) or would be required to be used in accordance with a
food additive regulation that prescribes safe conditions of use. In
either case, the substance must be of a purity suitable for its
intended use.
FDA is aware that the occurrence of some amount of lead in tin is
unavoidable because lead is a naturally occurring impurity in tin ore.
Manufacturers are expected to take steps to control this source of
exposure to lead by securing raw materials of the highest purity
practicable.
3. Several comments expressed concern that the States have or may
enact inconsistent and conflicting laws that restrict the amount of
lead that may be present in ``all-tin capsules.'' Therefore, the
comments requested that FDA establish a national definition of ``all-
tin capsules'' based on the California definition \1\ to eliminate
inconsistencies and conflicts, to level the playing field among States,
and to protect imported wine from State-imposed nontariff trade
barriers.
\1\ The ``California definition'' refers to a definition agreed
to by the State of California and several wine producers and
importers in a December 6, 1991, consent decree (People of the State
of California v. Gallo Vineyards, Inc. et al., No. 640951, San Diego
County Superior Court). This decree states in part that ``lead
foil'' or ``tin-lead foil'' capsules are ``* * * any foil capsules *
* * containing lead as an intended constituent at concentrations
greater than .3% by dry weight.''
---------------------------------------------------------------------------
The agency understands that some comments may wish to have a
preemptive Federal regulation defining ``all-tin capsules.'' However,
this final rule is a prohibition of, and applies exclusively to, tin-
coated lead foil capsules as defined by this agency.
It appears that the comments contemplate that some States may
promulgate regulations that are different from, or more restrictive,
than the ``California definition'' of ``all-tin capsules.'' The agency
recognizes that if individual States establish variable limits on the
lead content of capsule materials, burdens on interstate commerce can
result. However, the potential for such action by individual States,
and the question of what would be an appropriate course of action by
the Federal government in such a case, is outside the scope of this
rulemaking. The prohibition of tin-coated lead foil capsules is
absolute. More restrictive action by the States with respect to such
capsules is not possible. As for other materials used to make wine
capsules, interested persons may wish to petition the agency to
establish limits on lead in such materials that have preemptive effect.
Agency action on such petitions would be based on the merits of the
petition and the availability of agency resources.
4. One comment stated that it is unfair for FDA, and for other
agencies of the United States, to place excessive responsibility on the
wine industry to achieve lead reduction in food and not require similar
efforts from other industries.
FDA disagrees with the comment's allegation that the agency is
imposing excessive responsibility on the wine industry to achieve lead
reduction. The prohibition on the use of tin-coated lead foil capsules
is only one of the actions that the agency has taken to implement its
policy to reduce exposure to lead in food to the maximum extent
practicable. Other actions include a recently published final rule
formally banning lead-soldered food cans (60 FR 33106, June 27, 1995),
a final rule lowering the allowable level of lead in bottled water (59
FR 26933, May 25, 1994), the lowering of action guidelines for
leachable lead from ceramicware (57 FR 29734, July 6, 1992), and a
final rule requiring a warning label on decorative ceramicware, which
could be mistakenly used to hold food, in order to exempt it from the
action guidelines for leachable lead (59 FR 1638, January 12, 1994).
FDA is also considering action to reduce the specifications for lead in
food and color additives and in GRAS ingredients, as described in an
advance notice of proposed rulemaking that was published in 1994 (59 FR
5363, February 4, 1994).
5. Several foreign comments sought assurance that wines capped with
tin-coated lead foil capsules before January 1, 1993, will be permitted
to enter the United States, and that marketing of wines capped with
tin-coated lead foil capsules and imported before January 1, 1993, will
be permitted.
FDA's 1992 proposal specifically stated that the prohibition on the
use of tin-lead foil capsules is applicable to products capped after
the effective date of this final rule. Thus, this prohibition will not
be retroactively applied to any product capped before February 8, 1996,
nor is any action required to recall and retrofit any product capped
before that date. Consequently, European wines capped before the
European Commission (EC) ban of January 1, 1993, will not be prohibited
from being imported into the United States or marketed in the United
States by this rule.
In the 1992 proposal, FDA proposed that the effective date of this
final rule be the date that it is published in the Federal Register. In
the 1992 proposal, the agency stated that information that it had
already received indicated that the industry anticipated the
availability of adequate supplies of alternative capsules by no later
than November 1992. The industry desired that the prohibition of the
use of tin-coated capsules not precede the availability of adequate
supplies of alternative capsules. No comments indicating that the
industry would not be able to comply with the effective date were
received.
III. Conclusions
After review and consideration of the comments received in response
to the 1992 proposal, FDA concludes that no evidence or information has
been presented that would cause the agency not to adopt Sec. 189.301,
which prohibits the capping of bottled wine with ``tin-coated lead foil
capsules.''
Therefore, FDA is amending 21 CFR part 189 as proposed with the
exception that the agency has modified Sec. 189.301 to include the
definition of ``Tin-coated lead foil capsules'' as discussed in comment
1 of this document and made minor editorial changes.
IV. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (57 FR 55485, November 25,
1992). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
V. Economic Impact
FDA has examined the impacts of this final rule to prohibit the use
of tin-coated lead foil capsules for wine bottles as required by
Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-
354). 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 Regulatory
Flexibility Act requires agencies to analyze regulatory options that
would minimize any significant impact of a rule on small entities. FDA
finds that this final rule is not a significant regulatory action as
defined by Executive Order 12866. In compliance with the Regulatory
Flexibility Act, the agency certifies that the final rule will not have
a significant economic impact on a substantial number of small
entities.
[[Page 4818]]
On November 25, 1992, FDA published an analysis of the economic
impacts of the proposed requirements under the previous Executive Order
(Executive Order 12291). In that analysis the agency stated that
banning the use of tin-lead capsules for wine bottles would require the
wine industry to use other materials for capsules, such as
polyvinylchloride (PVC), aluminum, or tin. The cost estimates reported
in this regulation did not include costs to the wine industry in
California because California State law already prohibited the use of
these capsules in wine bottles.
The impact of the proposed regulation was expected to be an
increase in the cost of capsule material and bottling equipment to the
portion of the industry that still used tin-lead capsules. At the time
of publication of the proposal it was assumed that the most likely
alternative to tin-lead foil capsules to be used was tin capsules at a
total cost to the industry of $4.5 million annually.
A. Costs
Since the publication of the 1992 proposal to ban tin-lead foil
capsules, several new alternatives have emerged and existing ones have
been improved through better quality, lower prices, or both. According
to a recent trade publication, there are four basic capsules that may
be used, which are listed in the chart below (Ref. 1).
------------------------------------------------------------------------
------------------------------------------------------------------------
PVC (polyvinylchloride)................ $40 per 1,000 capsules
Polylam (aluminum/plastic laminate).... $60 per 1,000 capsules
Aluminum............................... $85 per 1,000 capsules
Tin.................................... $90 per 1,000 capsules
------------------------------------------------------------------------
It is assumed in this analysis that only imported wines still
continue to use tin-lead foil capsules, not including those imported
from the European Union (EU). Approximately 15 percent of wines
consumed in the United States are imported and 5 percent of all wines
are from countries other than the EU. Thus, if all such wines used tin-
lead foil capsules, 8.6 million bottles of imported wine would be
expected to be converted away from tin-lead foil capsules as a result
of this final rule. Since tin-lead foil capsules cost the same as
polylam capsules, only those wineries who choose tin or aluminum will
incur additional costs. Assuming that all conversions will be evenly
distributed between the four options above, costs of using different
capsules are expected to be approximately $90,000 per year.
B. Benefits
Benefits of this regulation will be realized in reduced exposure to
lead by children and pregnant women (fetuses), groups that are
particularly sensitive to exposure to lead. Adverse health effects of
lead exposure in these population groups occur at lower blood lead
levels than in adults. Exposure to very low levels of lead can
adversely affect the production of the iron-containing component of
hemoglobin in children and can cause neurobehavioral and growth
deficits at prenatal (maternal) stages. The agency has previously
stated that for infants and children, the lowest observed effect level
of lead in blood is 10 micrograms per deciliter (g/dL) (57 FR
55485 at 55487, November 25, 1992).
The following table shows estimates of the current blood lead
incidence levels in the two population groups predicted to exceed 10
g/dL (Ref. 2).
TABLE 1.--Background Incidence of Blood Lead Levels >10 g/dL
------------------------------------------------------------------------
Population Group Estimated Incidence
------------------------------------------------------------------------
Children, age 2 years................ 10%
Women of child-bearing age........... 1%
------------------------------------------------------------------------
1. Benefit Estimation for Children Ages 3 through 6
Using the estimates in Table 1 and assuming that the same incidence
levels apply for children ages 3 through 6 as for 2-year olds, then
approximately 1.4 million children between the ages of 3 and 6 have
blood lead levels greater than 10 g/dL.
Wine consumption data were obtained from the United States
Department of Agriculture (USDA) Nationwide Consumption Survey. This
survey provided the percentage of children who consumed wine at least
once in a 3-day period and the daily consumption distribution (in grams
(g)) for each group. Approximately 0.12 percent of the children ages 3
through 6 in this survey, or 1,680 children (1.4 million x 0.0012 =
1,680), consumed wine once in 3 days. The average daily consumption of
wine for children ages 3 through 6 is 51 g/day per child.
Assuming that children who consume imported wine do so in the same
proportion as national consumption (e.g., 5 percent of the total wine
consumed is imported from non-EU countries), then an estimated 84
children (5 percent of 1,680) may be at risk.
The capsule contribution of lead from imported wine is, on average,
6 g lead (Pb)/day (120 parts per billion (ppb)). By using an
absorption rate factor of 0.16 for children, the blood lead level
increase attributable to the consumption of imported wine by these
children is estimated to be 1 g Pb/dL (Ref. 3).
To assess monetary benefits from reducing this lead intake, this
analysis uses a study by the Centers for Disease Control (CDC) that
looked at the effect of lead reduction on the lifetime earnings of
consumers. The CDC study used three ``pathways'' with associated
parameter estimates to measure the change in lifetime earnings that
would result from a change in 1 g Pb/dL blood. Each pathway
included an estimate of a quarter of an intelligence quotient (IQ)
point decrease for each 1 g Pb/dL of blood increase.
The CDC study measured the impacts of a change in blood lead on IQ
through changes in wages, educational attainment, and labor force
participation rates. Because each of these effects are highly
correlated (wages, education, and labor force participation), FDA will
conservatively use only the strongest effect, education. FDA used a
similar
[[Page 4819]]
approach in the economic impact analysis of the proposed rule to ban
lead soldered food cans (58 FR 33860, June 21, 1993). For this factor,
it is estimated that an increment of 1 g Pb/dL blood decreases
lifetime earning levels by approximately 0.2 percent.
Starting from an average expected lifetime earnings rate of
$260,000, the decrease in the net present value of lifetime earnings
from a 1 g/dL change in blood lead levels will be $512 (.00197
x 260,000). For the 84 children estimated to be at risk, the lower
bound annual benefit of reducing blood lead levels by 1 g Pb/
dL from domestic wine consumption is estimated to be $43,000 (512 per
child). It should be noted that the amount may be understated to the
extent that this estimate, a human capital approach, does not represent
utility from a higher IQ in nonlabor activities which would be included
in a willingness-to-pay estimate.
The above calculations are also considered to be lower bound, as
they only estimate benefits for children with blood lead levels above
10 g/dL. Using the same wine consumption levels as above (51
g/day), but allowing for effects (linear) below 10 g Pb/dL
blood, the annual benefit of reducing blood lead levels by 1
g/dL would be $4.6 million.
Assuming that half the problem is solved each year, over the next
20 years total discounted benefits may range between $81,000 and $5.7
million.
2. Benefit Estimation for Fetuses
There are approximately 58 million women between the ages of
childbearing age (15 to 44 years). Each year, approximately 3 million
(6 percent) are pregnant at any given time. Using the incidence
estimates in Table 1 (1 percent of 3 million), 30,000 of these women
(pregnancies) are estimated to have blood lead levels above 10
g/dL.
Dietary exposure to lead (from tin-lead foil capsules) for pregnant
women has been evaluated in a manner similar to that used for children.
The USDA food consumption survey (1977-1978) reported average wine
intake per day for individuals who drank wine on 1, 2, and 3 days over
a 3-day period. It also provided the wine consumption data for women of
different age groups, including those of childbearing age (15 to 44
years). After eliminating the tin-lead capsules in wine bottles, the
lead levels in imported wine would be reduced by an average of 120 ppb.
A 120 ppb reduction is equivalent to 120 g/kilogram of wine.
Thus, if a pregnant woman consumes 100 g of wine per day, the lead
intake from wine will be reduced by 12 g Pb/day. Using the
maternal (adult) absorption rate of 0.04, the blood lead level in the
fetus would be reduced by 0.50 g Pb/dL blood (Ref. 3).
The figures in the following table were derived from the USDA food
consumption survey data utilizing data on lead levels in imported wine
attributable to the use of tin-lead foil capsules and the maternal
absorption rate factor just noted. Blood lead level reductions for each
group of wine consumers are the result of eliminating the capsule's
lead contribution.
TABLE 2.--Blood Lead Level Reductions After Eliminating Tin-Lead Capsules
(Pregnant women who consume wine and are at risk of reaching blood lead levels over 10 g/dL)
----------------------------------------------------------------------------------------------------------------
Blood Pb
Number of Number of level
Age females wine imported wine reduction
consumers consumers1 (g/
dL blood)
----------------------------------------------------------------------------------------------------------------
Drink once in 3 days
15-18.............................................................. 37 1.8 0.29
19-34.............................................................. 1,542 77 0.37
35-44.............................................................. 74 3.7
Drink two of 3 days
15-18.............................................................. 3 1.4 0.37
19-34.............................................................. 411 20 0.70
35-44.............................................................. 28 1.4 0.54
Drink all 3 days
15-18.............................................................. 0 0 0
19-34.............................................................. 179 8.9 1.34
35-44.............................................................. 26 1.3 0.94
TOTAL.............................................................. 2,300 1152
----------------------------------------------------------------------------------------------------------------
\1\ Excludes consumers of wine imported from the EC.
\2\ Pregnancies resulted in live births only.
Assuming 115 fetuses have their blood lead levels reduced by the
amounts shown in Table 2 above, the increase in the value of lifetime
earnings is estimated to be $16,000.
Again, assuming the relationship between IQ and income is linear
benefits are estimated for all fetuses with nonzero blood lead levels.
The annual upper bound benefit in terms of an increase in the value of
lifetime earnings is estimated to be $1.6 million.
Thus, the benefit of reducing maternal blood lead levels ranges
from $16,000 to $1.6 million.
Assuming half of the lead problem is solved each year, the total
discounted benefits (at 6 percent) to pregnant women (fetuses) is
estimated to be $30,000 to $3 million.
C. Summary
For this analysis, FDA has assumed that only imported wines still
continue to use tin-lead foil capsules, excluding those imported from
the EU. Costs of conversion are expected to be approximately $90,000
annually. Total discounted costs (6 percent) are estimated to be $1.2
million.
Assuming that, (1) the population growth rate in the United States
continues to be near the replacement rate, and (2) half of the lead
problem is reduced each year, the reduction of blood lead levels due to
ingestion of wine is expected to result in discounted benefits ranging
from $97,000 to $8.7 million.
VI. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
1. Walker, L., ``What's Next in the Wine Capsule Department?,''
Wine & Vines, 74(3):20(3), March 1993.
2. Carrington, C., P. M. Bolger, and R. J. Scheupleia, ``Risk
Analysis of Dietary Lead Exposure,'' in press.
[[Page 4820]]
3. FDA memorandum, ``Provisional Tolerable Exposure Levels for
Lead,'' Clark D. Carrington, Division of Toxicological Review and
Evaluation, to Elizabeth Campbell, Division of Regulatory Guidance,
November 16, 1990.
List of Subjects in 21 CFR Part 189
Food ingredients, Food packaging.
Therefore, under the Federal Food, Drug, and Cosmetic Act, as
amended, and under authority delegated to the Commissioner of Food and
Drugs, 21 CFR part 189 is amended as follows:
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
1. The authority citation for 21 CFR part 189 continues to read as
follows:
-Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
2. New Sec. 189.301 is added to subpart C to read as follows:
Sec. 189.301 Tin-coated lead foil capsules for wine bottles.
(a) Tin-coated lead foil is composed of a lead foil coated on one
or both sides with a thin layer of tin. Tin-coated lead foil has been
used as a capsule (i.e., as a covering applied over the cork and neck
areas) on wine bottles to prevent insect infestation, as a barrier to
oxygen, and for decorative purposes. Information received by the Food
and Drug Administration establishes that the use of such a capsule on
wine bottles may reasonably be expected to result in lead becoming a
component of the wine.
(b) The capping of any bottles of wine after February 8, 1996, with
a tin-coated lead foil capsule renders the wine adulterated and in
violation of section 402(a)(2)(C) of the Federal Food, Drug, and
Cosmetic Act because lead from the capsule, which is an unsafe food
additive within the meaning of section 409 of the act, may reasonably
be expected to become a component of the wine.
Dated: January 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-2665 Filed 2-7-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-2648 Revocation of Secretarial Order of June 17, 1908; Washington
[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4752-4753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2648]
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DEPARTMENT OF THE INTERIOR
43 CFR Public Land Order 7183
[OR-943-1430-01; GP5-194; OR-22189 (WASH)]
Revocation of Secretarial Order of June 17, 1908; Washington
AGENCY: Bureau of Land Management, Interior.
ACTION: Public Land Order.
-----------------------------------------------------------------------
SUMMARY: This order revokes in its entirety a Secretarial order which
withdrew 50 acres of National Forest System land for use by the Forest
Service, Department of Agriculture, for the Laurier Administrative
Site. The land is no longer needed for this purpose and the revocation
is needed to permit disposal of the land through exchange. This action
will open the land to surface entry, subject to Section 24 of the
Federal Power Act. The land is temporarily closed to mining by the
Forest Service exchange proposal. The land has been and will remain
open to mineral leasing.
EFFECTIVE DATE: March 11, 1996.
FOR FURTHER INFORMATION CONTACT: Betty McCarthy, BLM Oregon/Washington
State Office, P.O. Box 2965, Portland, Oregon 97208-2965, 503-952-6155.
By virtue of the authority vested in the Secretary of the Interior
by Section 204 of the Federal Land Policy and Management Act of 1976,
43 U.S.C. 1714 (1988), it is ordered as follows:
1. Secretarial Order dated June 17, 1908, which withdrew the
following
[[Page 4753]]
described land is hereby revoked in its entirety:
Willamette Meridian
Colville National Forest
T. 40 N., R. 36 E.,
Sec. 3, SE\1/4\SW\1/4\SE\1/4\ and SE\1/4\SE\1/4\.
The area described contains 50 acres in Ferry County.
2. At 8:30 a.m. on March 11, 1996, the lands will be opened to such
forms of disposition as may by law be made of National Forest System
land, subject to valid existing rights, the provisions of existing
withdrawals, the provisions of Section 24 of the Federal Power Act,
other segregations of record, and the requirements of applicable law.
Dated: January 26, 1996.
Bob Armstrong,
Assistant Secretary of the Interior.
[FR Doc. 96-2648 Filed 2-7-96; 8:45 am]
BILLING CODE 4310-33-P
Complete official Federal Register PDF
FR Doc. 96-2433 Promotion of Development, Reduction of Royalty on Heavy Oil
[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4748-4752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2433]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
43 CFR Part 3100
[WO-310-00-1310-2411]
RIN 1004-AC26
Promotion of Development, Reduction of Royalty on Heavy Oil
AGENCY: Bureau of Land Management, Interior.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Bureau of Land Management is issuing this final rule to
amend the regulations relating to the waiver, suspension, or reduction
of rental, royalty, or minimum royalty. This action is being taken to
promote the production of heavy oil. The amendment establishes the
conditions under which the operators of properties that produce ``heavy
oil'' (crude oil with a gravity of less than 20 degrees) can obtain a
reduction in the royalty rate. The amendment should encourage the
operators of Federal heavy oil leases to place marginal or uneconomical
shut-in oil wells back in production, provide an economic incentive to
implement enhanced oil recovery projects, and delay the plugging of
these wells until the maximum amount of economically recoverable oil
can be obtained from the reservoir or field.
DATES: This rule will be effective March 11, 1996.
ADDRESSES: Inquiries should be sent to: Director (140), Bureau of Land
Management, Room 5558, Main Interior Building, 1849 C Street, N.W.,
Washington, D.C. 20240.
FOR FURTHER INFORMATION CONTACT: Dr. John W. Bebout, Bureau of Land
Management, (202) 452-0340.
SUPPLEMENTARY INFORMATION:
I. Introduction
II. Summary of Rule Adopted
III. Responses to Public Comments
IV. Procedural Matters
V. Regulatory Text
I. Introduction
A proposed rule to provide royalty relief for producers of heavy
oil was published in the Federal Register notice of April 10, 1995 (60
FR 18081) with the comment period ending June 9, 1995. The comment
period was reopened June 16, 1995 (60 FR 31663) and closed July 17,
1995.
On March 30, 1995, an outdated version of this proposed rule was
published in the Federal Register (60 FR 16424) by mistake. That
proposed rule publication was withdrawn, and the Federal Register
notice of April 10, 1995 (60 FR 18081) was published in its place as
the proposed rule.
The following are questions and answers designed to provide an
introduction to this rule.
When does the Department of the Interior (Department) consider
granting royalty relief?
In order to encourage the greatest ultimate recovery of oil and in
the interest of conservation, the Secretary, upon a determination that
it is necessary to promote development, may reduce the royalty on an
entire leasehold or any portion thereof (Section 39 of the Mineral
Leasing Act, 30 U.S.C. 209).
Existing section 3103.4-1 of Title 43, Code of Federal Regulations,
provides two forms of Federal oil and gas royalty reduction--on a case-
by-case basis upon application and for stripper wells. The provision
concerning stripper well properties allows royalty reduction for
properties that produce an average of less than 15 barrels of oil per
eligible well per well-day.
The Bureau of Land Management (BLM) believes that royalty relief
for producers of heavy crude oil is needed to promote the development
of heavy oil.
Why is heavy oil royalty relief needed?
Above all, this royalty relief is needed to promote the development
of heavy oil. Eliminating all royalties would be the most effective way
to promote development, but that would jeopardize the Department's
efforts in securing a fair return for public land resources. Royalty
relief has to be considered in light of all the Department's
responsibilities and objectives. The balance this rule strikes is to
have a royalty rate that promotes development while ensuring the public
receives reasonable compensation.
Cyclical swings in the price for crude oil are common. BLM believes
that future price decreases are possible, or even likely. The effect of
this rule will provide a buffer against these decreases for heavy oil
produced from Federal land. As many as two-thirds of all marginal
properties (including non-heavy oil properties) could be lost during a
period of sustained low oil prices (Marginal Wells, A Report of the
National Petroleum Council, 1994, p. 3). The danger in losing the
marginal wells is that, although production from individual wells may
be small, their collective production is significant, accounting for
one-third of lower-48 State onshore domestic production. Heavy oil
production, from both Federal and non-Federal lands, makes up almost
one-half of this third (Marginal Wells, A Report of the National
Petroleum Council, 1994, p. 50). Heavy oil wells typically incur higher
production costs, thus increasing their vulnerability. Were these heavy
oil wells abandoned, the United States would lose this significant
portion of domestic production.
What will happen as a result of this rule?
This rule should encourage the operators of Federal heavy oil
leases to place marginal or uneconomical shut-in oil wells back in
production, provide an economic incentive to implement enhanced oil
recovery projects, and delay the plugging of these wells until the
maximum amount of economically recoverable oil can be obtained from the
reservoir or field.
According to a Department of Energy (DOE) analysis of its TORIS
(Tertiary Oil Recovery Information System) data, the size of
economically recoverable reserves from Federal lands will be
significantly enhanced by this amendment. For instance, at a West Texas
Intermediate (WTI) crude oil price of $16 a barrel, DOE projects that
this rule will increase recoverable reserves of about 54 million
barrels to about 87 million barrels for the State of California. At $18
a barrel, DOE projects that this rule will increase recoverable
reserves of about 103 million barrels to about 130 million barrels for
the State of California. At $20 a barrel, DOE projects that this rule
will increase recoverable reserves of about 133 million barrels to
about 229 million barrels for the State of California. A
proportionately larger increase in recoverable reserves is anticipated
when oil prices range toward $20 a barrel because major recovery
projects may
[[Page 4749]]
become economically feasible. Were this rule not promulgated, DOE
projects these increases in recoverable reserves would most likely not
occur.
Since the State of California produces almost 91 percent of lower-
48 State onshore heavy oil production, the vast majority of recoverable
reserve increases stemming from this royalty relief will most likely
come from this State. Significant recoverable reserve increases are not
anticipated in the other States since fewer properties will qualify for
the relief.
When will this rule apply?
The rule will take effect March 11, 1996. However, the BLM may
suspend or terminate all royalty reductions granted under this rule and
terminate the availability of further relief under this rule--
(1) upon 6 month's notice in the Federal Register when BLM
determines that the average WTI oil price has remained above $24 per
barrel over a period of 6 consecutive months or
(2) after September 10, 1999, if the royalty rate reductions
authorized by this rule have not been effective in reducing the loss of
otherwise recoverable reserves.
How will this royalty relief affect royalties and revenues?
According to the DOE TORIS analysis, although oil royalties may
decline in some instances, the effects to overall Federal and State
revenues should be largely neutral except in the State of California.
(Revenues include all forms of income including royalties.) Slight
decreases in overall revenue could be possible at some oil prices for
States with moderate levels of heavy oil production. In California, the
DOE analysis projects small decreases or sizable increases in State
revenues depending on the price of oil (Letter Report from Department
of Energy dated July 29, 1994).
II. Summary of Rule Adopted
The final rule establishes a sliding scale royalty rate for
qualifying heavy-oil-producing properties. The sliding scale is
intended to somewhat offset the reduced prices paid for oil as oil
gravity decreases. The reduced royalty rate applies to qualifying heavy
oil properties rather than individual wells, because production is
normally not reported for individual oil wells, and is based on the
average gravity of the oil weighted by the production of heavy oil from
each well within the property. A weighted average gravity is used to
prevent gravity manipulation by selectively producing wells on a
property with heavier gravity crude. Using a weighted average of oil
gravity encourages maximum recovery from all wells within a property by
removing the economic advantage of selective production.
The rule provides that either the operator (as defined at 43 CFR
3100.0-5) or the payor (as defined at 30 CFR 208.2) must calculate the
weighted average gravity of the oil--measured on the American Petroleum
Institute (API) scale--produced from a property every 12 months to
determine the appropriate royalty rate. In no case, however, would the
royalty rate exceed the rate established by the terms of the lease.
The section amended by this rule also provides for royalty rate
reductions for stripper oil wells. Some provisions of this final rule
are similar to the provisions of the existing regulations that pertain
to stripper wells.
The final rule was modified in response to comments and for
clarification. Section 3103.4 was redesigned to aid the reader in
distinguishing the various forms of royalty reduction and accompanying
provisions. Separate sections were established for the stripper oil and
heavy oil royalty reduction provisions. The discussion of royalty rate
determinations in Sec. 3103.4-3(b)(5) was modified by adding two
examples and clarifying the text. Section 3103.4-3(b)(6) was modified
to extend the review period until 1999. Cross references were modified
where appropriate throughout Part 3100 to reflect the redesign of
Sec. 3103.4.
III. Responses to Public Comments
A total of 209 comments were received on the proposed rule. An
overwhelming majority supported the proposed rule. A few commenters
recommended changes.
Comments suggested that the review period be extended for a period
of 4 or 5 years rather than the 2 years stated in the proposed rule. It
was always the BLM's intention that the rule be in place at least 4
years before it was evaluated. Unanticipated delays in the rulemaking
process, however, have rendered the original 1997 deadline unreasonably
short. Therefore, the BLM concurs with this suggestion and the rule has
been modified to extend the review period until 1999.
A comment stated that the $24 trigger for rule suspension was too
high while another comment stated that $24 was too low. Based on data
developed from DOE's TORIS database, the BLM believes that $24 is an
appropriate trigger to suspend the rule. The data indicate that State
and Federal Royalty reductions are offset by increased recoverable
reserves up until the point that WTI crude oil prices reach
approximately $24/bbl. Past that point, recoverable reserve increases
appear to taper off. In addition, the TORIS data show that when WTI
prices climb above $24/bbl the royalty reduction is no longer a
determining factor for decisions regarding investments in enhanced oil
recovery techniques.
Comments suggested that the CFR 3103.4-1 regulations be revised for
clarity and simplicity. The BLM agrees and has revised the section for
clarity.
A comment suggested that the qualifying period for a heavy oil
royalty rate reduction coincide with the one established for a stripper
oil property royalty reduction. While the BLM agrees that there is
value in making the stripper and heavy oil royalty rate reduction
processes as similar as possible, this is not always practicable. The
heavy oil rule qualifying period was made flexible in order to
acknowledge the fact that many qualifying, low-production properties
may not remove or sell oil every month even if their production is
continuous. Thus, many properties may require even more than a calendar
year (the stripper property qualifying period) to accumulate 3 months
of sales or oil removal.
One comment requested that the notification period for requesting a
reduced royalty rate be extended beyond the proposed 60 days. The BLM
believes that 60 days is sufficient time for an operator to notify the
BLM of a new royalty rate. The stripper property royalty reduction
program has a similar notification period which appears to be working
well.
Some comments stated that a greater royalty rate reduction was
necessary. They suggested that this be accomplished by using a power
curve rather than a straight line to calculate royalty rates. The BLM
considered calculating royalty rates by both power curves and straight-
line methods. The DOE's TORIS data, however, indicated that neither
method was clearly advantageous over the other in terms of increasing
recoverable reserves except within a narrow range of WTI crude oil
prices. Because it is not possible to predict future oil prices, the
BLM has chosen to remain with a straight-line royalty reduction for
purposes of simplicity as well as to parallel the stripper property
royalty reduction rule.
Some comments stated that the rule should use 25 degrees as a
``heavy oil'' cutoff (rather than the 20 degrees proposed) in order to
maximize the rule's effects and to provide the rule's benefits to as
many operators as possible. Although there is no single accepted
definition for ``heavy oil,''
[[Page 4750]]
standard academic and industry practice is to reserve the term for
crude oils of less than 20 degrees API. The U.S. tax code also uses a
20 degree definition.
One comment stated that BLM should evaluate the stripper oil
royalty reduction before granting heavy oil royalty relief. The BLM is
in the process of evaluating the stripper well provisions. The stripper
well provisions have not been in place long enough to make a
substantive assessment.
One comment strongly opposed heavy oil royalty relief, stating that
the BLM has no data which demonstrate that the leases eligible for the
relief cannot be operated successfully under the lease terms or that
the continued operation of each heavy crude lease is in serious,
unavoidable jeopardy. Although this is an important consideration, this
is not the criterion for relief that is serving as the basis of this
determination. The Secretary, acting through the Assistant Secretary--
Land and Minerals Management, concludes, based on the DOE analysis
cited in the introduction, that this rule is necessary to promote the
development of heavy oil. Recoverable reserves are projected to be
significantly less in the absence of the royalty relief provided by
this rule.
One comment stated that this rule will provide insufficient relief
on leases in true jeopardy and windfalls for those without need. The
BLM believes that there are enough similarities in terms of the
economic pressures on producers of heavy oil that any such relative
disparities in levels of relief should be inconsequential. Furthermore,
the rule is sensitive to the particular gravity of the heavy oil being
produced, so that producers of less valuable heavy oil receive a higher
proportion of royalty relief.
One comment stated that even if State revenues increase, royalty
reductions will hurt State services. (Revenues include all forms of
income including royalties.) According to the DOE analysis, the effects
to Federal and State revenues should be largely neutral. Slight royalty
decreases could be possible at some oil prices for States with moderate
levels of heavy oil production.
In California, where almost 91 percent of the heavy oil production
takes place, the DOE analysis generally projects small to moderate
decreases in royalties. For instance, at $16 a barrel (WTI), DOE
projects that this rule will decrease California royalties by about
$3.5 million, while increasing California public sector revenue by
about $15 million. At $18 a barrel (WTI), DOE projects that this rule
will decrease California royalties by about $24 million, while
decreasing California public sector revenue by about $1 million. At $20
a barrel (WTI), DOE projects that this rule will increase California
royalties by about $1 million, while increasing California public
sector revenue by about $104 million. The wide variations in
sensitivity to the price of oil are due to numerous variables,
including the propensity for oil companies to invest in major recovery
projects at certain oil prices. (Letter Report from Department of
Energy dated July 29, 1994.)
IV. Procedural Matters
This rule is not a major Federal action significantly affecting the
quality of the human environment and that no detailed statement
pursuant to Section 102 (2)(C) of the National Environmental Policy Act
of 1969 (42 U.S.C. 4332(2)(C)) is required.
This rule has been reviewed under Executive Order 12866.
The BLM has determined that this final rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). The BLM
has prepared a regulatory flexibility analysis. It is available upon
request from the address listed at the beginning of this rule.
Additionally the BLM has determined, under Executive Order 12630, that
the rulemaking will not cause a taking of private property.
The BLM has certified that these regulations meet the applicable
standards provided in sections 2(a) and 2(b)(2) of Executive Order
12778.
The information collection requirements of this rule have been
approved by the Office of Management and Budget under 44 U.S.C. 3501 et
seq. and assigned clearance numbers 1010-0090 and 1004-0145.
The principal author of this final rule is Dr. John W. Bebout,
Senior Technical Specialist, Fluids Group, assisted by Charles Hunt of
the Regulatory Management Team, Bureau of Land Management.
List of Subjects for 43 CFR Part 3100
Land Management Bureau, Public Lands--mineral resources, Oil and
gas production, Mineral royalties.
For the reasons stated in the preamble, and under the authorities
cited below, Part 3100, Group 3100, Subchapter C, Chapter II of Title
43 of the Code of Federal Regulations is amended as set forth below:
V. Regulatory Text
PART 3100--OIL AND GAS LEASING
1. The authority citation for part 3100 continues to read as
follows:
Authority: 30 U.S.C. 181, et seq., 30 U.S.C. 351-359.
Subpart 3103--Fees, Rentals and Royalty
Sec. 3103.2-2 [Amended]
2.-3. Section Sec. 3103.2-2 is amended by removing the cross
reference ``Sec. 3103.4-2(d)'' in the introductory text and adding in
its place the cross reference ``Sec. 3103.4-4(d).''
4. Sec. 3103.4 is amended by revising the heading to read as
follows:
Sec. 3103.4 Production incentives.
Sec. 3103.4-2 [Redesignated as Sec. 3103.4-4]
5. Section 3103.4-2 is redesignated as Sec. 3103.4-4.
6. Section 3103.4-1 is amended by redesignating paragraphs (c) and
(d) as paragraphs (a) and (b) of a new Sec. 3103.4-2, ``Stripper well
royalty reductions.'' Section 3103.4-1 is further amended by
redesignating paragraph (e) as (c), and revising the section heading
and paragraph (b)(1) to read as follows:
Sec. 3103.4-1 Royalty reductions.
* * * * *
(b)(1) An application for the benefits under paragraph (a) of this
section on other than stripper oil well leases or heavy oil properties
must be filed by the operator/payor in the proper BLM office. (Royalty
reductions specifically for stripper oil well leases or heavy oil
properties are discussed in Sec. 3103.4-2 and Sec. 3103.4-3
respectively.) The application must contain the serial number of the
leases, the names of the record title holders, operating rights owners
(sublessees), and operators for each lease, the description of lands by
legal subdivision and a description of the relief requested.
7. Newly designated Sec. 3103.4-2, paragraph (b)(3)(iii)(A) is
amended by removing the cross reference ``(d)(3)(ii)'' and adding in
its place the cross reference ``(b)(3)(ii).''
8. A new Sec. 3103.4-3 is added to read as follows:
Sec. 3103.4-3 Heavy oil royalty reductions.
(a)(1) A heavy oil well property is any Federal lease or portion
thereof segregated for royalty purposes, a communitization area, or a
unit participating area, operated by the same operator, that produces
crude oil with a weighted average gravity of less than 20 degrees as
measured on the American Petroleum Institute (API) scale.
[[Page 4751]]
(2) An oil completion is a completion from which the energy
equivalent of the oil produced exceeds the energy equivalent of the gas
produced (including the entrained liquefiable hydrocarbons) or any
completion producing oil and less than 60 MCF of gas per day.
(b) Heavy oil well property royalty rate reductions will be
administered according to the following requirements and procedures:
(1) The Bureau of Land Management requires no specific application
form for the benefits under paragraph (a) of this section for heavy oil
well properties. However, the operator/payor must notify, in writing,
the proper BLM office that it is seeking a heavy oil royalty rate
reduction. The letter must contain the serial number of the affected
leases (or, as appropriate, the communitization agreement number or the
unit agreement name); the names of the operators for each lease; the
calculated new royalty rate as determined under paragraph (b)(2) of
this section; and copies of the Purchaser's Statements (sales receipts)
to document the weighted average API gravity for a property.
(2) The operator must determine the weighted average API gravity
for a property by averaging (adjusted to rate of production) the API
gravities reported on the operator's Purchaser's Statement for the last
3 calendar months preceding the operator's written notice of intent to
seek a royalty rate reduction, during each of which at least one sale
was held. This is shown in the following 3 illustrations:
(i) If a property has oil sales every month prior to requesting the
royalty rate reduction in October of 1996, the operator must submit
Purchaser's Statements for July, August, and September of 1996;
(ii) If a property has sales only every 6 months, during the months
of March and September, prior to requesting the rate reduction in
October of 1996, the operator must submit Purchaser's Statements for
the months of September 1995, and March and September 1996; and
(iii) If a property has multiple sales each month, the operator
must submit Purchaser's Statements for every sale for the 3 entire
calendar months immediately preceding the request for a rate reduction.
(3) The following equation must be used by the operator/payor for
calculating the weighted average API gravity for a heavy oil well
property:
[GRAPHIC] [TIFF OMMITTED] TR08FE96.000
Where:
V1=Average Production (bbls) of Well #1 over the last 3
calendar months of sales
V2=Average Production (bbls) of Well #2 over the last 3
calendar months of sales
Vn=Average Production (bbls) of each additional well (V3,
V4, etc.) over the last 3 calendar months of sales
G1=Average Gravity (degrees) of oil produced from Well #1 over
the last 3 calendar months of sales
G2=Average Gravity (degrees) of oil produced from Well #2 over
the last 3 calendar months of sales
Gn=Average Gravity (degrees) of each additional well (G3,
G4, etc.) over the last 3 calendar months of sales
Example: Lease ``A'' has 3 wells producing at the following
average rates over 3 sales months with the following associated
average gravities: Well #1, 4,000 bbls, 13 deg. API; Well #2, 6000
bbls, 21 deg. API; Well #3, 2,000 bbls, 14 deg. API. Using the
equation above--
[GRAPHIC] [TIFF OMMITTED] TR08FE96.001
(4) For those properties subject to a communitization agreement
or a unit participating area, the weighted average API oil gravity
for the lands dedicated to that specific communitization agreement
or unit participating area must be determined in the manner
prescribed in paragraph (b)(3) of this section and assigned to all
property subject to Federal royalties in the communitization
agreement or unit participating area.
(5) The operator/payor must use the following procedures in
order to obtain a royalty rate reduction under this section:
(i) Qualifying royalty rate determination.
(A) The operator/payor must calculate the weighted average API
gravity for the property proposed for the royalty rate reduction in
order to verify that the property qualifies as a heavy oil well
property.
(B) Properties that have removed or sold oil less than 3 times
in their productive life may still qualify for this royalty rate
reduction. However, no additional royalty reductions will be granted
until the property has a sales history of at least 3 production
months (see paragraph (b)(2) of this section).
(ii) Calculating the qualifying royalty rate. If the Federal
leases or portions thereof (e.g., communitization or unit
agreements) qualify as heavy oil property, the operator/payor must
use the weighted average API gravity rounded down to the next whole
degree (e.g., 11.7 degrees API becomes 11 degrees), and determine
the appropriate royalty rate from the following table:
Royalty Rate Reduction for Heavy Oil
------------------------------------------------------------------------
Royalty Rate
Weighted average API gravity (degrees) (percent)
------------------------------------------------------------------------
6....................................................... 0.5
7....................................................... 1.4
8....................................................... 2.2
9....................................................... 3.1
10...................................................... 3.9
11...................................................... 4.8
12...................................................... 5.6
13...................................................... 6.5
14...................................................... 7.4
15...................................................... 8.2
16...................................................... 9.1
17...................................................... 9.9
18...................................................... 10.8
19...................................................... 11.6
20...................................................... 12.5
------------------------------------------------------------------------
(iii) New royalty rate effective date. The new royalty rate will be
effective on the first day of production 2 months after BLM receives
notification by the operator/payor. The rate will apply to all oil
production from the property for the next 12 months (plus the 2
calendar month grace period during which the next 12 months' royalty
rate is determined in the next year). If the API oil gravity is 20
degrees or greater, the royalty rate will be the rate in the lease
terms.
Example: BLM receives notification from an operator on June 8,
1996. There is a two month period before new royalty rate is
[[Page 4752]]
effective--July and August. New royalty rate is effective September 1,
1996.
(iv) Royalty rate determinations in subsequent years.
(A) At the end of each 12-month period, beginning on the first day
of the calendar month the royalty rate reduction went into effect, the
operator/payor must determine the weighted average API oil gravity for
the property for that period. The operator/payor must then determine
the royalty rate for the following year using the table in paragraph
(b)(5)(ii) of this section.
(B) The operator/payor must notify BLM of its determinations under
this paragraph and paragraph (b)(5)(iv)(A) of this section. The new
royalty rate (effective for the next 12 month period) will become
effective the first day of the third month after the prior 12 month
period comes to a close, and will remain effective for 12 calendar
months (plus the 2 calendar month grace period during which the next 12
months' royalty rate is determined in the next year). Notification must
include copies of the Purchaser's Statements (sales receipts) and be
mailed to the proper BLM office. If the operator does not notify the
BLM of the new royalty rate within 60 days after the end of the subject
12-month period, the royalty rate for the heavy oil well property will
return to the rate in the lease terms.
Example: On September 30, 1997, at the end of a 12-month royalty
reduction period, the operator/payor determines what the weighted
average API oil gravity for the property for that period has been.
The operator/payor then determines the new royalty rate for the next
12 month using the table in paragraph (b)(5)(ii) of this section.
Given that there is a 2-month delay period for the operator/payor to
calculate the new royalty rate, the new royalty rate would be
effective December 1, 1997 through November 30, 1998 (plus the 2
calendar month grace period during which the next 12 months' royalty
rate is determined--December 1, 1998 through January 31, 1999).
(v) Prohibition. Any heavy oil property reporting an API average
oil gravity determined by BLM to have resulted from any manipulation of
normal production or adulteration of oil sold from the property will
not receive the benefit of a royalty rate reduction under this
paragraph (b).
(vi) Certification. The operator/payor must use the applicable
royalty rate when submitting the required royalty reports/payments to
the Minerals Management Service (MMS). In submitting royalty reports/
payments using a royalty rate reduction authorized by this paragraph
(b), the operator/payor must certify that the API oil gravity for the
initial and subsequent 12-month periods was not subject to manipulation
or adulteration and the royalty rate was determined in accordance with
the requirements and procedures of this paragraph (b).
(vii) Agency action. If an operator/payor incorrectly calculates
the royalty rate, the BLM will determine the correct rate and notify
the operator/payor in writing. Any additional royalties due are payable
to MMS immediately upon receipt of this notice. Late payment or
underpayment charges will be assessed in accordance with 30 CFR
218.102. The BLM will terminate a royalty rate reduction for a property
if BLM determines that the API oil gravity was manipulated or
adulterated by the operator/payor. Terminations of royalty rate
reductions for individual properties will be effective on the effective
date of the royalty rate reduction resulting from a manipulated or
adulterated API oil gravity so that the termination will be retroactive
to the effective date of the improper reduction. The operator/payor
must pay the difference in royalty resulting from the retroactive
application of the non-manipulated rate. The late payment or
underpayment charges will assessed in accordance with 30 CFR 218.102.
(6) The BLM may suspend or terminate all royalty reductions granted
under this paragraph (b) and terminate the availability of further
heavy oil royalty relief under this section--
(i) Upon 6 month's notice in the Federal Register when BLM
determines that the average oil price has remained above $24 per barrel
over a period of 6 consecutive months (based on the WTI Crude average
posted prices and adjusted for inflation using the implicit price
deflator for gross national product with 1991 as the base year), or
(ii) After September 10, 1999, if the Secretary determines the
royalty rate reductions authorized by this paragraph (b) have not been
effective in reducing the loss of otherwise recoverable reserves. This
will be determined by evaluating the expected versus the actual
abandonment rate, the number of enhanced recovery projects, and the
amount of operator reinvestment in heavy oil production that can be
attributed to this rule.
(7) The heavy oil well property royalty rate reduction applies to
all Federal oil produced from a heavy oil property.
(8) If the lease royalty rate is lower than the benefits provided
in this heavy oil well property royalty rate reduction program, the
lease rate prevails.
(9) If the property qualifies for a stripper well property royalty
rate reduction, as well as a heavy oil well property reduction, the
lower of the two rates applies.
(10) The operator/payor must separately calculate the royalty for
gas production (including condensate produced in association with gas)
from oil completions using the lease royalty rate.
(11) The minimum royalty provisions of Sec. 3103.3-2 will continue
to apply.
Sec. 3140.1-4 [Amended]
9. Section Sec. 3140.1-4(c)(3) is amended by removing the cross
reference ``Sec. 3103.4-1'' and adding in its place the cross reference
``Sec. 3103.4.''
Sec. 3165.1 [Amended]
10. Section Sec. 3165.1(b) is amended by removing the cross
reference ``Sec. 3103.4-2'' and adding in its place the cross reference
``Sec. 3103.4-4.''
Dated: November 8, 1995.
Bob Armstrong,
Assistant Secretary of the Interior.
[FR Doc. 96-2433 Filed 2-7-96; 8:45 am]
BILLING CODE 4310-84-P
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