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42 U.S.C. § 7671a — Listing of class I and class II substances
Federal law — U.S. Code and appendices · legal_authorities
Page 7449
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 7671a
Employees. For complete classification of this Act to
the Code, see Short Title note set out under section 601
of Title 5 and Tables.
The Equal Access to Justice Act, referred to in sub-
secs. (d)(2) and (e)(1)(B), is title II of Pub. L. 96–481, Oct.
21, 1980, 94 Stat. 2325. For complete classification of this
Act to the Code, see Short Title note set out under sec-
tion 504 of Title 5.
SUBCHAPTER VI—STRATOSPHERIC OZONE
PROTECTION
§ 7671. Definitions
As used in this subchapter—
(1) Appliance
The term ‘‘appliance’’ means any device
which contains and uses a class I or class II
substance as a refrigerant and which is used
for household or commercial purposes, includ-
ing any air conditioner, refrigerator, chiller,
or freezer.
(2) Baseline year
The term ‘‘baseline year’’ means—
(A) the calendar year 1986, in the case of
any class I substance listed in Group I or II
under section 7671a(a) of this title,
(B) the calendar year 1989, in the case of
any class I substance listed in Group III, IV,
or V under section 7671a(a) of this title, and
(C) a representative calendar year selected
by the Administrator, in the case of—
(i) any substance added to the list of
class I substances after the publication of
the initial list under section 7671a(a) of
this title, and
(ii) any class II substance.
(3) Class I substance
The term ‘‘class I substance’’ means each of
the substances listed as provided in section
7671a(a) of this title.
(4) Class II substance
The term ‘‘class II substance’’ means each of
the substances listed as provided in section
7671a(b) of this title.
(5) Commissioner
The term ‘‘Commissioner’’ means the Com-
missioner of the Food and Drug Administra-
tion.
(6) Consumption
The
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Page 7449
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 7671a
Employees. For complete classification of this Act to
the Code, see Short Title note set out under section 601
of Title 5 and Tables.
The Equal Access to Justice Act, referred to in sub-
secs. (d)(2) and (e)(1)(B), is title II of Pub. L. 96–481, Oct.
21, 1980, 94 Stat. 2325. For complete classification of this
Act to the Code, see Short Title note set out under sec-
tion 504 of Title 5.
SUBCHAPTER VI—STRATOSPHERIC OZONE
PROTECTION
§ 7671. Definitions
As used in this subchapter—
(1) Appliance
The term ‘‘appliance’’ means any device
which contains and uses a class I or class II
substance as a refrigerant and which is used
for household or commercial purposes, includ-
ing any air conditioner, refrigerator, chiller,
or freezer.
(2) Baseline year
The term ‘‘baseline year’’ means—
(A) the calendar year 1986, in the case of
any class I substance listed in Group I or II
under section 7671a(a) of this title,
(B) the calendar year 1989, in the case of
any class I substance listed in Group III, IV,
or V under section 7671a(a) of this title, and
(C) a representative calendar year selected
by the Administrator, in the case of—
(i) any substance added to the list of
class I substances after the publication of
the initial list under section 7671a(a) of
this title, and
(ii) any class II substance.
(3) Class I substance
The term ‘‘class I substance’’ means each of
the substances listed as provided in section
7671a(a) of this title.
(4) Class II substance
The term ‘‘class II substance’’ means each of
the substances listed as provided in section
7671a(b) of this title.
(5) Commissioner
The term ‘‘Commissioner’’ means the Com-
missioner of the Food and Drug Administra-
tion.
(6) Consumption
The term ‘‘consumption’’ means, with re-
spect to any substance, the amount of that
substance produced in the United States, plus
the amount imported, minus the amount ex-
ported to Parties to the Montreal Protocol.
Such term shall be construed in a manner con-
sistent with the Montreal Protocol.
(7) Import
The term ‘‘import’’ means to land on, bring
into, or introduce into, or attempt to land on,
bring into, or introduce into, any place subject
to the jurisdiction of the United States,
whether or not such landing, bringing, or in-
troduction constitutes an importation within
the meaning of the customs laws of the United
States.
(8) Medical device
The term ‘‘medical device’’ means any de-
vice (as defined in the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321)), diagnostic prod-
uct, drug (as defined in the Federal Food,
Drug, and Cosmetic Act), and drug delivery
system—
(A) if such device, product, drug, or drug
delivery system utilizes a class I or class II
substance for which no safe and effective al-
ternative has been developed, and where nec-
essary, approved by the Commissioner; and
(B) if such device, product, drug, or drug
delivery system, has, after notice and oppor-
tunity for public comment, been approved
and determined to be essential by the Com-
missioner in consultation with the Adminis-
trator.
(9) Montreal Protocol
The terms ‘‘Montreal Protocol’’ and ‘‘the
Protocol’’ mean the Montreal Protocol on
Substances that Deplete the Ozone Layer, a
protocol to the Vienna Convention for the
Protection of the Ozone Layer, including ad-
justments adopted by Parties thereto and
amendments that have entered into force.
(10) Ozone-depletion potential
The term ‘‘ozone-depletion potential’’ means
a factor established by the Administrator to
reflect the ozone-depletion potential of a sub-
stance, on a mass per kilogram basis, as com-
pared to chlorofluorocarbon-11 (CFC–11). Such
factor shall be based upon the substance’s at-
mospheric lifetime, the molecular weight of
bromine and chlorine, and the substance’s
ability to be photolytically disassociated, and
upon other factors determined to be an accu-
rate measure of relative ozone-depletion po-
tential.
(11) Produce, produced, and production
The terms ‘‘produce’’, ‘‘produced’’, and ‘‘pro-
duction’’, refer to the manufacture of a sub-
stance from any raw material or feedstock
chemical, but such terms do not include—
(A) the manufacture of a substance that is
used and entirely consumed (except for trace
quantities) in the manufacture of other
chemicals, or
(B) the reuse or recycling of a substance.
(July 14, 1955, ch. 360, title VI, § 601, as added
Pub. L. 101–549, title VI, § 602(a), Nov. 15, 1990, 104
Stat. 2649.)
Editorial Notes
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in par. (8), is act June 25, 1938, ch. 675, 52 Stat. 1040,
which is classified generally to chapter 9 (§ 301 et seq.)
of Title 21, Food and Drugs. For complete classification
of this Act to the Code, see section 301 of Title 21 and
Tables.
§ 7671a. Listing of class I and class II substances
(a) List of class I substances
Within 60 days after November 15, 1990, the Ad-
ministrator shall publish an initial list of class
I substances, which list shall contain the fol-
lowing substances:
Group I
chlorofluorocarbon-11 (CFC–11)
Page 7450
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 7671a
1 So in original. Probably should be section ‘‘7671f’’.
chlorofluorocarbon-12 (CFC–12)
chlorofluorocarbon-113 (CFC–113)
chlorofluorocarbon-114 (CFC–114)
chlorofluorocarbon-115 (CFC–115)
Group II
halon-1211
halon-1301
halon-2402
Group III
chlorofluorocarbon-13 (CFC–13)
chlorofluorocarbon-111 (CFC–111)
chlorofluorocarbon-112 (CFC–112)
chlorofluorocarbon-211 (CFC–211)
chlorofluorocarbon-212 (CFC–212)
chlorofluorocarbon-213 (CFC–213)
chlorofluorocarbon-214 (CFC–214)
chlorofluorocarbon-215 (CFC–215)
chlorofluorocarbon-216 (CFC–216)
chlorofluorocarbon-217 (CFC–217)
Group IV
carbon tetrachloride
Group V
methyl chloroform
The initial list under this subsection shall also
include the isomers of the substances listed
above, other than 1,1,2-trichloroethane (an iso-
mer of methyl chloroform). Pursuant to sub-
section (c), the Administrator shall add to the
list of class I substances any other substance
that the Administrator finds causes or contrib-
utes significantly to harmful effects on the
stratospheric ozone layer. The Administrator
shall, pursuant to subsection (c), add to such list
all substances that the Administrator deter-
mines have an ozone depletion potential of 0.2 or
greater.
(b) List of class II substances
Simultaneously with publication of the initial
list of class I substances, the Administrator
shall publish an initial list of class II sub-
stances, which shall contain the following sub-
stances:
hydrochlorofluorocarbon-21 (HCFC–21)
hydrochlorofluorocarbon-22 (HCFC–22)
hydrochlorofluorocarbon-31 (HCFC–31)
hydrochlorofluorocarbon-121 (HCFC–121)
hydrochlorofluorocarbon-122 (HCFC–122)
hydrochlorofluorocarbon-123 (HCFC–123)
hydrochlorofluorocarbon-124 (HCFC–124)
hydrochlorofluorocarbon-131 (HCFC–131)
hydrochlorofluorocarbon-132 (HCFC–132)
hydrochlorofluorocarbon-133 (HCFC–133)
hydrochlorofluorocarbon-141 (HCFC–141)
hydrochlorofluorocarbon-142 (HCFC–142)
hydrochlorofluorocarbon-221 (HCFC–221)
hydrochlorofluorocarbon-222 (HCFC–222)
hydrochlorofluorocarbon-223 (HCFC–223)
hydrochlorofluorocarbon-224 (HCFC–224)
hydrochlorofluorocarbon-225 (HCFC–225)
hydrochlorofluorocarbon-226 (HCFC–226)
hydrochlorofluorocarbon-231 (HCFC–231)
hydrochlorofluorocarbon-232 (HCFC–232)
hydrochlorofluorocarbon-233 (HCFC–233)
hydrochlorofluorocarbon-234 (HCFC–234)
hydrochlorofluorocarbon-235 (HCFC–235)
hydrochlorofluorocarbon-241 (HCFC–241)
hydrochlorofluorocarbon-242 (HCFC–242)
hydrochlorofluorocarbon-243 (HCFC–243)
hydrochlorofluorocarbon-244 (HCFC–244)
hydrochlorofluorocarbon-251 (HCFC–251)
hydrochlorofluorocarbon-252 (HCFC–252)
hydrochlorofluorocarbon-253 (HCFC–253)
hydrochlorofluorocarbon-261 (HCFC–261)
hydrochlorofluorocarbon-262 (HCFC–262)
hydrochlorofluorocarbon-271 (HCFC–271)
The initial list under this subsection shall also
include the isomers of the substances listed
above. Pursuant to subsection (c), the Adminis-
trator shall add to the list of class II substances
any other substance that the Administrator
finds is known or may reasonably be anticipated
to cause or contribute to harmful effects on the
stratospheric ozone layer.
(c) Additions to the lists
(1) The Administrator may add, by rule, in ac-
cordance with the criteria set forth in sub-
section (a) or (b), as the case may be, any sub-
stance to the list of class I or class II substances
under subsection (a) or (b). For purposes of ex-
changes under section 7661f 1 of this title, when-
ever a substance is added to the list of class I
substances the Administrator shall, to the ex-
tent consistent with the Montreal Protocol, as-
sign such substance to existing Group I, II, III,
IV, or V or place such substance in a new Group.
(2) Periodically, but not less frequently than
every 3 years after November 15, 1990, the Ad-
ministrator shall list, by rule, as additional
class I or class II substances those substances
which the Administrator finds meet the criteria
of subsection (a) or (b), as the case may be.
(3) At any time, any person may petition the
Administrator to add a substance to the list of
class I or class II substances. Pursuant to the
criteria set forth in subsection (a) or (b) as the
case may be, within 180 days after receiving
such a petition, the Administrator shall either
propose to add the substance to such list or pub-
lish an explanation of the petition denial. In any
case where the Administrator proposes to add a
substance to such list, the Administrator shall
add, by rule, (or make a final determination not
to add) such substance to such list within 1 year
after receiving such petition. Any petition under
this paragraph shall include a showing by the
petitioner that there are data on the substance
adequate to support the petition. If the Admin-
istrator determines that information on the sub-
stance is not sufficient to make a determination
under this paragraph, the Administrator shall
use any authority available to the Adminis-
trator, under any law administered by the Ad-
ministrator, to acquire such information.
(4) Only a class II substance which is added to
the list of class I substances may be removed
from the list of class II substances. No substance
referred to in subsection (a), including methyl
chloroform, may be removed from the list of
class I substances.
(d) New listed substances
In the case of any substance added to the list
of class I or class II substances after publication
of the initial list of such substances under this
section, the Administrator may extend any
schedule or compliance deadline contained in
section 7671c or 7671d of this title to a later date
than specified in such sections if such schedule
or deadline is unattainable, considering when
such substance is added to the list. No extension
Page 7451
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 7671b
under this subsection may extend the date for
termination of production of any class I sub-
stance to a date more than 7 years after January
1 of the year after the year in which the sub-
stance is added to the list of class I substances.
No extension under this subsection may extend
the date for termination of production of any
class II substance to a date more than 10 years
after January 1 of the year after the year in
which the substance is added to the list of class
II substances.
(e) Ozone-depletion and global warming poten-
tial
Simultaneously with publication of the lists
under this section and simultaneously with any
addition to either of such lists, the Adminis-
trator shall assign to each listed substance a nu-
merical
value
representing
the
substance’s
ozone-depletion potential. In addition, the Ad-
ministrator shall publish the chlorine and bro-
mine loading potential and the atmospheric life-
time of each listed substance. One year after No-
vember 15, 1990 (one year after the addition of a
substance to either of such lists in the case of a
substance added after the publication of the ini-
tial lists of such substances), and after notice
and opportunity for public comment, the Ad-
ministrator shall publish the global warming po-
tential of each listed substance. The preceding
sentence shall not be construed to be the basis
of any additional regulation under this chapter.
In the case of the substances referred to in table
1, the ozone-depletion potential shall be as spec-
ified in table 1, unless the Administrator adjusts
the substance’s ozone-depletion potential based
on criteria referred to in section 7671(10) of this
title:
TABLE 1
Substance
Ozone-
depletion
potential
chlorofluorocarbon-11 (CFC–11) ....................
1.0
chlorofluorocarbon-12 (CFC–12) ....................
1.0
chlorofluorocarbon-13 (CFC–13) ....................
1.0
chlorofluorocarbon-111 (CFC–111) .................
1.0
chlorofluorocarbon-112 (CFC–112) .................
1.0
chlorofluorocarbon-113 (CFC–113) .................
0.8
chlorofluorocarbon-114 (CFC–114) .................
1.0
chlorofluorocarbon-115 (CFC–115) .................
0.6
chlorofluorocarbon-211 (CFC–211) .................
1.0
chlorofluorocarbon-212 (CFC–212) .................
1.0
chlorofluorocarbon-213 (CFC–213) .................
1.0
chlorofluorocarbon-214 (CFC–214) .................
1.0
chlorofluorocarbon-215 (CFC–215) .................
1.0
chlorofluorocarbon-216 (CFC–216) .................
1.0
chlorofluorocarbon-217 (CFC–217) .................
1.0
halon-1211 .....................................................
3.0
halon-1301 .....................................................
10.0
halon-2402 .....................................................
6.0
carbon tetrachloride ....................................
1.1
methyl chloroform .......................................
0.1
hydrochlorofluorocarbon-22 (HCFC–22) ........
0.05
hydrochlorofluorocarbon-123 (HCFC–123) .....
0.02
hydrochlorofluorocarbon-124 (HCFC–124) .....
0.02
hydrochlorofluorocarbon-141(b)
(HCFC–141(b)) ............................................
0.1
hydrochlorofluorocarbon-142(b)
(HCFC–142(b)) ............................................
0.06
Where the ozone-depletion potential of a sub-
stance is specified in the Montreal Protocol, the
ozone-depletion potential specified for that sub-
stance under this section shall be consistent
with the Montreal Protocol.
(July 14, 1955, ch. 360, title VI, § 602, as added
Pub. L. 101–549, title VI, § 602(a), Nov. 15, 1990, 104
Stat. 2650.)
§ 7671b. Monitoring and reporting requirements
(a) Regulations
Within 270 days after November 15, 1990, the
Administrator shall amend the regulations of
the Administrator in effect on such date regard-
ing monitoring and reporting of class I and class
II substances. Such amendments shall conform
to the requirements of this section. The amend-
ed regulations shall include requirements with
respect to the time and manner of monitoring
and reporting as required under this section.
(b) Production, import, and export level reports
On a quarterly basis, or such other basis (not
less than annually) as determined by the Admin-
istrator, each person who produced, imported, or
exported a class I or class II substance shall file
a report with the Administrator setting forth
the amount of the substance that such person
produced, imported, and exported during the
preceding reporting period. Each such report
shall be signed and attested by a responsible of-
ficer. No such report shall be required from a
person after April 1 of the calendar year after
such person permanently ceases production, im-
portation, and exportation of the substance and
so notifies the Administrator in writing.
(c) Baseline reports for class I substances
Unless such information has previously been
reported to the Administrator, on the date on
which the first report under subsection (b) is re-
quired to be filed, each person who produced, im-
ported, or exported a class I substance (other
than a substance added to the list of class I sub-
stances after the publication of the initial list of
such substances under this section) shall file a
report with the Administrator setting forth the
amount of such substance that such person pro-
duced, imported, and exported during the base-
line year. In the case of a substance added to the
list of class I substances after publication of the
initial list of such substances under this section,
the regulations shall require that each person
who produced, imported, or exported such sub-
stance shall file a report with the Administrator
within 180 days after the date on which such
substance is added to the list, setting forth the
amount of the substance that such person pro-
duced, imported, and exported in the baseline
year.
(d) Monitoring and reports to Congress
(1) The Administrator shall monitor and, not
less often than every 3 years following Novem-
ber 15, 1990, submit a report to Congress on the
production, use and consumption of class I and
class II substances. Such report shall include
data on domestic production, use and consump-
tion, and an estimate of worldwide production,
use and consumption of such substances. Not
less frequently than every 6 years the Adminis-
trator shall report to Congress on the environ-
mental and economic effects of any strato-
spheric ozone depletion.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
Page 36
TITLE 21—FOOD AND DRUGS
§ 321
1 So in original. Probably should be ‘‘Pharmacopeia,’’.
of this title and section 210 of Title 42, The Public
Health and Welfare, and enacting provisions set out as
notes under sections 321, 342, and 451 of this title] may
be cited as the ‘Food Additives Amendment of 1958’.’’
SEVERABILITY
Pub. L. 113–54, title I, § 106(b), Nov. 27, 2013, 127 Stat.
598, provided that: ‘‘If any provision of this Act [see
Short Title of 2013 Amendment note above] (including
the amendments made by this Act) is declared uncon-
stitutional, or the applicability of this Act (including
the amendments made by this Act) to any person or
circumstance is held invalid, the constitutionality of
the remainder of this Act (including the amendments
made by this Act) and the applicability thereof to other
persons and circumstances shall not be affected.’’
Pub. L. 110–85, title XI, § 1105, Sept. 27, 2007, 121 Stat.
975, provided that: ‘‘If any provision of this Act [see
Short Title of 2007 Amendment note above], an amend-
ment made [by] this Act, or the application of such pro-
vision or amendment to any person or circumstance is
held to be unconstitutional, the remainder of this Act,
the amendments made by this Act, and the application
of the provisions of such to any person or cir-
cumstances shall not be affected thereby.’’
HAZARDOUS SUBSTANCES
Federal Hazardous Substances Act as not modifying
this chapter, see Pub. L. 86–613, § 18, July 12, 1960, 74
Stat. 380, set out as an Effect Upon Federal and State
Laws note under section 1261 of Title 15, Commerce and
Trade.
SUBCHAPTER II—DEFINITIONS
§ 321. Definitions; generally
For the purposes of this chapter—
(a)(1) The term ‘‘State’’, except as used in the
last sentence of section 372(a) of thi
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
**(a) List of class I substances** Within 60 days after November 15, 1990, the Administrator shall publish an initial list of class I substances, which list shall contain the following substances: Group I chlorofluorocarbon-11 (CFC–11) chlorofluorocarbon-12 (CFC–12) chlorofluorocarbon-113 (CFC–113) chlorofluorocarbon-114 (CFC–114) chlorofluorocarbon-115 (CFC–115) Group II halon-1211 halon-1301 halon-2402 Group III chlorofluorocarbon-13 (CFC–13) chlorofluorocarbon-111 (CFC–111) chlorofluorocarbon-112 (CFC–112) chlorofluorocarbon-211 (CFC–211) chlorofluorocarbon-212 (CFC–212) chlorofluorocarbon-213 (CFC–213) chlorofluorocarbon-214 (CFC–214) chlorofluorocarbon-215 (CFC–215) chlorofluorocarbon-216 (CFC–216) chlorofluorocarbon-217 (CFC–217) Group IV carbon tetrachloride Group V methyl chloroform The initial list under this subsection shall also include the isomers of the substances listed above, other than 1,1,2-trichloroethane (an isomer of methyl chloroform). Pursuant to subsection (c), the Administrator shall add to the list of class I substances any other substance that the Administrator finds causes or contributes significantly to harmful effects on the stratospheric ozone layer. The Administrator shall, pursuant to subsection (c), add to such list all substances that the Administrator determines have an ozone depletion potential of 0.2 or greater.
**(b) List of class II substances** Simultaneously with publication of the initial list of class I substances, the Administrator shall publish an initial list of class II substances, which shall contain the following substances: hydrochlorofluorocarbon-21 (HCFC–21) hydrochlorofluorocarbon-22 (HCFC–22) hydrochlorofluorocarbon-31 (HCFC–31) hydrochlorofluorocarbon-121 (HCFC–121) hydrochlorofluorocarbon-122 (HCFC–122) hydrochlor
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 7671a
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