[Code of Federal Regulations]
[Title 40, Volume 15]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR82.4]

[Page 331-335]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 82--PROTECTION OF STRATOSPHERIC OZONE--Table of Contents
 
             Subpart A--Production and Consumption Controls
 
Sec. 82.4  Prohibitions for class I controlled substances.

    (a)(1) Prior to January 1, 1996, for all Groups of class I 
controlled substances, and prior to January 1, 2005, for class I, Group 
VI controlled substances, no person may produce, at any time in any 
control period, (except that are transformed or destroyed domestically 
or by a person of another Party) in excess of the amount of unexpended 
production allowances or unexpended Article 5 allowances for that 
substance held by that person under the authority of this subpart at 
that time for that control period. Every kilogram of excess production 
constitutes a separate violation of this subpart.
    (2) Effective January 1, 2003, production of class I, Group VI 
controlled substances is not subject to the prohibitions in paragraph 
(a)(1) of this section if it is solely for quarantine or preshipment 
applications as defined in this subpart.
    (b) Effective January 1, 1996, for any class I, Group I, Group II, 
Group III, Group IV, Group V, or Group VII controlled substances, and 
effective January 1, 2005, for any class I, Group VI controlled 
substances, no person may

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produce, at any time in any control period, (except that are transformed 
or destroyed domestically or by a person of another Party) in excess of 
the amount of conferred unexpended essential-use allowances or 
exemptions under this section, the amount of unexpended Article 5 
allowances as allocated under Sec. 82.9, or the amount of conferred 
unexpended destruction and transformation credits as obtained under 
Sec. 82.9 for that substance held by that person under the authority of 
this subpart at that time for that control period. Every kilogram of 
excess production constitutes a separate violation of this subpart.
    (c)(1) Prior to January 1, 1996, for all Groups of class I 
controlled substances, and prior to January 1, 2005, for class I, Group 
VI controlled substances, no person may produce or (except for 
transhipments, heels or used controlled substances) import, at any time 
in any control period, (except for controlled substances that are 
transformed or destroyed) in excess of the amount of unexpended 
consumption allowances held by that person under the authority of this 
subpart at that time for that control period. Every kilogram of excess 
production or importation (other than transhipments, heels or used 
controlled substances) constitutes a separate violation of this subpart.
    (2) Effective January 1, 2003, production and import of class I, 
Group VI controlled substances is not subject to the prohibitions in 
paragraph(c)(1) of this section if it is solely for quarantine or 
preshipment applications as defined in this subpart.
    (d) Effective January 1, 1996, for any class I , Group I, Group II, 
Group III, Group IV, Group V, or Group VII controlled substances, and 
effective January 1, 2005, for any class I, Group VI controlled 
substances, no person may import (except for transhipments or heels), at 
any time in any control period (except for controlled substances that 
are transformed or destroyed, or transfers of essential-use CFCs) in 
excess of the amount of unexpended essential-use allowances or 
exemptions as allocated under this section, or the amount of unexpended 
destruction and transformation credits obtained under Sec. 82.9 held by 
that person under the authority of this subpart at that time for that 
control period. Every kilogram of excess importation (other than 
transhipments or heels) constitutes a separate violation of this 
subpart. It is a violation of this subpart to obtain unused class I ODSs 
under the general laboratory exemption in excess of actual need and to 
recycle that material for sale into other markets.
    (e) Effective January 1, 1996, no person may place an order by 
conferring essential-use allowances for the production of the class I 
controlled substance, at any time in any control period, in excess of 
the amount of unexpended essential-use allowances, held by that person 
under the authority of this subpart at that time for that control 
period. Effective January 1, 1996, no person may import a class I 
controlled substance with essential-use allowances, at any time in any 
control period, in excess of the amount of unexpended essential-use 
allowances, held by that person under the authority of this subpart at 
that time for that control period. No person may import or place an 
order for the production of a class I controlled substance with 
essential-use allowances, at any time in any control period, other than 
for the class I controlled substance(s) for which they received 
essential-use allowances under paragraph (u) of this section. Every 
kilogram of excess production ordered in excess of the unexpended 
essential-use allowances conferred to the producer constitutes a 
separate violation of this subpart. Every kilogram of excess import in 
excess of the unexpended essential-use allowances held at that time 
constitutes a separate violation of this subpart.
    (f) Effective January 1, 1996, no person may place an order by 
conferring transformation and destruction credits for the production of 
the class I controlled substance, at any time in any control period, in 
excess of the amount of transformation and destruction credits, held by 
that person under the authority of this subpart at that time for that 
control period. Effective January 1, 1996, no person may import class I 
controlled substance, at any time in any control period, in excess of 
the amount of transformation and destruction credits, held by that 
person under

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the authority of this subpart at that time for that control period. No 
person may import or place an order for the production of a class I 
controlled substance with transformation and destruction credits, at any 
time in any control period, other than for the class I controlled 
substance(s) for which they received transformation and destruction 
credits as under Sec. 82.9(f). Every kilogram of excess production 
ordered in excess of the unexpended transformation and destruction 
credits conferred to the producer constitutes a separate violation of 
this subpart. Every kilogram of excess import in excess of the 
unexpended transformation and destruction credits held at that time 
constitutes a separate violation of this subpart.
    (g) Effective January 1, 1996, the U.S. total production and 
importation of a class I controlled substance (except Group VI) as 
allocated under this section for essential-use allowances and 
exemptions, and as obtained under Sec. 82.9 for destruction and 
transformation credits, may not, at any time, in any control period 
until January 1, 2000, exceed the percent limitation of baseline 
production in appendix H of this subpart, as set forth in the Clean Air 
Act Amendments of 1990. No person shall cause or contribute to the U.S. 
exceedance of the national limit for that control period.
    (h) In addition to total production permitted under paragraph (f) of 
this section, effective January 1, 1996, for class I, Group I, Group 
III, Group IV and Group V controlled substances, and effective January 
1, 1995, for class I, Group II, a person may, at any time, in any 
control period until January 1, 2000, produce 10 percent of baseline 
production as apportioned under Sec. 82.5 for export to Article 5 
countries. In addition to total production permitted under paragraph (f) 
of this section, effective January 1, 2001, for class I, Group VI 
controlled substances, a person may, at any time, until January 1, 2002, 
produce 15 percent of baseline production as apportioned under Sec. 82.5 
for export to Article 5 countries. No person may, at any time, in any 
control period until January 1, 2000, produce class I, Group I, Group 
II, Group III, Group IV, and Group V controlled substances, and no 
person may, at any time until January 1, 2002, produce class I Group VI 
controlled substances for export to Article 5 countries in excess of the 
Article 5 allowances allocated under Sec. 82.9(a). No person may sell in 
the U.S. any class I controlled substance produced explicitly for export 
to an Article 5 country.
    (i) Effective January 1, 1995, no person may import, at any time in 
any control period, a heel of any class I controlled substance that is 
greater than 10 percent of the volume of the container in excess of the 
amount of unexpended consumption allowances, or unexpended destruction 
and transformation credits held by that person under the authority of 
this subpart at that time for that control period. Every kilogram of 
excess importation constitutes a separate violation of this subpart.
    (j) Effective January 1, 1995, no person may import, at any time in 
any control period, a used class I controlled substance, without having 
received a non-objection notice from the Administrator in accordance 
with Sec. 82.13(g)(2) and (3). A person who receives a non-objection 
notice for the import of an individual shipment of used controlled 
substances may not transfer or confer the right to import, and may not 
import any more than the exact quantity, in kilograms, of the used 
controlled substance cited in the non-objection notice. Every kilogram 
of importation of used controlled substance in excess of the quantity 
cited in the non-objection notice issued by the Administrator in 
accordance with Sec. 82.13(g)(2) and (3) constitutes a separate 
violation.
    (k)(1) Prior to January 1, 1996, for all Groups of class I 
controlled substances, and prior to January 1, 2005, for class I, Group 
VI controlled substances, a person may not use production allowances to 
produce a quantity of a class I controlled substance unless that person 
holds under the authority of this subpart at the same time consumption 
allowances sufficient to cover that quantity of class I controlled 
substances nor may a person use consumption allowances to produce a 
quantity of class I controlled substances unless the person holds under 
authority of this subpart

[[Page 334]]

at the same time production allowances sufficient to cover that quantity 
of class I controlled substances. However, prior to January 1, 1996, for 
all class I controlled substances, and prior to January 1, 2005, for 
class I, Group VI controlled substances, only consumption allowances are 
required to import, with the exception of transhipments, heels, and used 
controlled substances. Effective January 1, 1996, for all Groups of 
class I controlled substances, except Group VI, only essential-use 
allowances or exemptions are required to import class I controlled 
substances, with the exception of transhipments, heels and used 
controlled substances.
    (2) Notwithstanding paragraph (k)(1) of this section, effective 
January 1, 2003, for class I, Group VI controlled substances, 
consumption allowances are not required to import quantities solely for 
quarantine or preshipment applications as defined in this subpart.
    (l) Every kilogram of a controlled substance, and every controlled 
product, imported or exported in contravention of this subpart 
constitutes a separate violation of this subpart, thus no person may:
    (1) Import or export any quantity of a controlled substance listed 
in Class I, Group I or Group II, in appendix A to this subpart from or 
to any foreign state not listed as a Party to the 1987 Montreal Protocol 
unless that foreign state is complying with the 1987 Montreal Protocol 
(See appendix C, Annex 2 of this subpart);
    (2) Import or export any quantity of a controlled substance listed 
in Class I, Group III, Group IV or Group V, in appendix A to this 
subpart, from or to any foreign state not Party to the London Amendments 
(as noted in appendix C, Annex l, to this subpart), unless that foreign 
state is complying with the London Amendments (as noted in appendix C, 
Annex 2, to this subpart); or
    (3) Import a controlled product, as noted in appendix D, Annex 1 to 
this subpart, from any foreign state not Party to the 1987 Montreal 
Protocol (as noted in appendix C, Annex 1, to this subpart), unless that 
foreign state is complying with the Protocol (as noted in appendix C, 
Annex 2, to this subpart).
    (4) Import or export any quantity of a controlled substance listed 
in Class I, Group VII, in Appendix A to this subpart, from or to any 
foreign state not Party to the Copenhagen Amendments (as noted in 
Appendix C, Annex l, to this subpart), unless that foreign state is 
complying with the Copenhagen Amendments (as noted in Appendix C, Annex 
2, to this subpart.
    (m) Effective October 5, 1998, no person may export a controlled 
product to a Party listed in Appendix J of this subpart in any control 
period after the control period in which EPA publishes a notice in the 
Federal Register listing that Party in Appendix J of this subpart. EPA 
will publish a notice in the Federal Register that lists a Party in 
Appendix J if the Party formally presents to the U.S. a government 
document through its embassy in the United States stating that it has 
established a ban on the import of controlled products and a ban on the 
manufacture of those same controlled products.
    (n) Effective January 1, 1996, essential-use allowances are 
apportioned to a person under paragraphs (t)(2) and (t)(3) of this 
section for the exempted production or importation of specified class I 
controlled substances solely for the purposes listed in paragraphs 
(t)(1)(i) through (iii) of this section.
    (1) Essential-uses for the production or importation of controlled 
substances as agreed to by the Parties to the Protocol and subject to 
the periodic revision of the Parties are:
    (i) Metered dose inhalers (MDIs) for the treatment of asthma and 
chronic obstructive pulmonary disease that were approved by the Food and 
Drug Administration before December 31, 2000.
    (ii) Space Shuttle--solvents.
    (iii) Essential Laboratory and Analytical Uses (Defined at appendix 
G of this subpart).
    (2) Persons in the following list are allocated essential-use 
allowances or exemptions for quantities of a specific class I controlled 
substance for a specific essential-use (the Administrator reserves the 
right to revise the allocations based on future decisions of the 
Parties).

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        Table I--Essential Use Allocation for Calendar Year 2003
------------------------------------------------------------------------
                                                             Quantity
            Company                      Chemical          (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals......  CFC-11 or CFC-12 or CFC-            574
                                  114.
Aventis........................  CFC-11 or CFC-12 or CFC-             48
                                  114.
Boehringer Ingelheim             CFC-11 or CFC-12 or CFC-            907
 Pharmaceuticals.                 114.
GlaxoSmithKline................  CFC-11 or CFC-12 or CFC-            535
                                  114.
Schering-Plough Corporation....  CFC-11 or CFC-12 or CFC-            937
                                  114.
Sidmak Laboratories............  CFC-11 or CFC-12 or CFC-            136
                                  114.
3M Pharmaceuticals.............  CFC-11 or CFC-12 or CFC-            133
                                  114.
--------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space
                    Shuttle Rockets and Titan Rockets
------------------------------------------------------------------------
National Aeronautics and Space   Methyl Chloroform......             9.8
 Administration (NASA)/Thiokol
 Rocket.
United States Air Force/Titan    Methyl Chloroform......             3.4
 Rocket.
------------------------------------------------------------------------

    (3) A global exemption for class I controlled substances for 
essential laboratory and analytical uses shall be in effect through 
December 31, 2005 subject to the restrictions in appendix G of this 
subpart, and subject to the record keeping and reporting requirements at 
Sec. 82.13(u) through (z). There is no amount specified for this 
exemption.
    (4) Any person acquiring unused class I ODSs produced under the 
authority of essential-use allowances or the essential-use exemption in 
paragraph (t)(3) of this section for use in anything other than an 
essential-use (i.e. for uses other than those specifically listed in 
paragraph (t)(1) of this section) is in violation of this subpart. Each 
kilogram of unused class I ODS produced or imported under the authority 
of essential-use allowances or the essential-use exemption and used for 
a non-essential-use is a separate violation of this subpart. Any person 
selling unused class I material produced or imported under the authority 
of essential-use allowances or the essential-use exemption for uses 
other than an essential-use is in violation of this subpart. Each 
kilogram of unused class I ODS produced under the authority of 
essential-use allowances or the essential-use exemption and sold for a 
use other than an essential-use is a separate violation of this subpart. 
It is a violation of this subpart to obtain unused class I ODSs under 
the exemption for laboratory and analytical uses in excess of actual 
need and to recycle that material for sale into other markets.
    (o) [Reserved]
    (p) Critical use exemption. [Reserved]
    (q) Emergency use exemption. [Reserved]

[60 FR 24986, May 10, 1995, as amended at 63 FR 4363, Jan. 28, 1998; 63 
FR 41642, Aug. 4, 1998; 63 FR 53290, Oct. 5, 1998; 64 FR 1096, Jan. 7, 
1999; 65 FR 728, Jan. 6, 2000; 65 FR 40535, June 30, 2000; 65 FR 70803, 
Nov. 28, 2000; 66 FR 1470, Jan. 8, 2001; 66 FR 14770, Mar. 13, 2001; 66 
FR 37767, July 19, 2001; 67 FR 6359, Feb. 11, 2002; 67 FR 79511, Dec. 
27, 2002; 67 FR 79872, Dec. 31, 2002; 68 FR 251, Jan. 2, 2003; 68 FR 
2848, Jan. 21, 2003]