Color Additive Petition From Environmental Defense Fund et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene

Issuing agencies

Abstract

The Food and Drug Administration (FDA or we) is partially granting a color additive petition submitted by Environmental Defense Fund et al. (petitioners), by amending our color additive regulations, on the basis of the Delaney Clause, to remove the authorized use of methylene chloride as a diluent in color additive mixtures in inks for marking fruit and vegetables. The petitioners provided data demonstrating that this additive induces cancer in laboratory animals. We are denying the remaining petition requests to remove ethylene dichloride, methylene chloride, and trichloroethylene from the list of authorized extraction solvents for annatto extract, paprika oleoresin, and turmeric oleoresin, because any residue of the solvent would be an impurity in the color additive and such impurities are not subject to the Delaney Clause.

Full Text

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<title>Federal Register, Volume 91 Issue 216 (Tuesday, November 10, 2026)</title>
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[Federal Register Volume 91, Number 216 (Tuesday, November 10, 2026)]
[Rules and Regulations]
[Pages 72413-72419]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22865]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2023-C-5679]


Color Additive Petition From Environmental Defense Fund et al.; 
Request To Amend the Color Additive Regulations To Remove the Solvents 
Ethylene Dichloride, Methylene Chloride, and Trichloroethylene

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; order; notification of partial denial of 
petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is partially 
granting a color additive petition submitted by Environmental Defense 
Fund et al. (petitioners), by amending our color additive regulations, 
on the basis of the Delaney Clause, to remove the authorized use of 
methylene chloride as a diluent in color additive mixtures in inks for 
marking fruit and vegetables. The petitioners provided data 
demonstrating that this additive induces cancer in laboratory animals. 
We are denying the remaining petition requests to remove ethylene 
dichloride, methylene chloride, and trichloroethylene from the list of 
authorized extraction solvents for annatto extract, paprika oleoresin, 
and turmeric oleoresin, because any residue of the solvent would be an 
impurity in the color additive and such impurities are not subject to 
the Delaney Clause.

DATES: This order is effective January 11, 2027. If any provisions are 
delayed or stayed by the filing of proper objections, FDA will publish 
such notification in the Federal Register. Submit either electronic or 
written objections and requests for a hearing on the order by December 
10, 2026. See section X for further information on the filing of 
objections.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system 
will accept objections until 11:59 p.m. Eastern Time at the end of 
December 10, 2026. Objections received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
received on or before that date.

Electronic Submissions

    Submit electronic objections in the following way:

[[Page 72414]]

    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your objection, that information will be 
posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper instructions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper objections submitted to the Dockets 
Management Staff, FDA will post your objection, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-C-5679 for ``Color Additive Petition from Environmental 
Defense Fund et al.; Request to Amend the Color Additive Regulations to 
Remove the Solvents Ethylene Dichloride, Methylene Chloride, and 
Trichloroethylene.'' Received objections, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objection only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We 
will review this copy, including the claimed confidential information, 
in our consideration of objections. The second copy, which will have 
the claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your objections and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Paulette M. Gaynor, Office of Pre-
Market Additive Safety, Human Foods Program, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1192; 
or Alexandra Beliveau, Office of Regulations and International 
Programs, Human Foods Program, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

Table of Contents:

I. Introduction
II. Background
    A. Statutory and Regulatory Background of Color Additive 
Regulation
    B. History of the Color Additive Regulations Where Amendments 
Are Requested
III. Summary and Context of Determination
IV. Evaluation of Petition
    A. 21 CFR 73.1 ``Diluents in Color Additive Mixtures for Food 
Use Exempt From Certification''
    B. 21 CFR 73.30 ``Annatto Extract''
    C. 21 CFR 73.345 ``Paprika Oleoresin''
    D. 21 CFR 73.615 ``Turmeric Oleoresin''
V. Comments Related to the Petition
VI. Conclusion
VII. Public Disclosure
VIII. Analysis of Environmental Impacts
IX. Paperwork Reduction Act of 1995
X. Objections
XI. References

I. Introduction

    In the Federal Register of January 11, 2024 (89 FR 1856), we 
announced that we filed a color additive petition (CAP 4C0327) 
submitted by Environmental Defense Fund, Breast Cancer Prevention 
Partners, Center for Environmental Health, Environmental Working Group, 
and Lisa Lefferts, c/o Lisa Lefferts, Nellysford, VA 22958 (currently 
c/o Liora Fiksel, 1875 Connecticut Ave. NW, Washington, DC 20009).
    The petition proposed that we amend Sec. Sec.  73.1 (21 CFR 73.1, 
``Diluents in color additive mixtures for food use exempt from 
certification''), 73.30 (21 CFR 73.30, ``Annatto extract''), 73.345 (21 
CFR 73.345, ``Paprika oleoresin''), and 73.615 (21 CFR 73.615, 
``Turmeric oleoresin'') to remove the use of three specified solvents.
    The three solvents that are the subject of this petition are:

1. Ethylene dichloride (Chemical Abstract Service (CAS) No. 107-06-
2);
2. Methylene chloride (CAS No. 75-09-2); and
3. Trichloroethylene (CAS No. 79-01-6).

    Specifically, the petitioners state these substances have been 
found to induce cancer in animals and, therefore, are not safe pursuant 
to section 721(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 379e(b)(5)(B)).
    The notification of petition gave interested parties until March 
11, 2024, to submit comments on the filed color additive petition. The 
petition was made available in the docket. In the Federal Register of 
May 28, 2026 (91 FR 31680), we reopened the comment period for 30 days 
to allow for the submission of any updated data and other information 
over the last two years.
    This order grants the petition's request to amend the regulations 
to no longer provide for the use of methylene chloride as a diluent in 
color additive mixtures in inks for marking fruit and vegetables. This 
order denies the petition's remaining requests. However, as noted in 
section VI of this document, FDA is taking action on these remaining 
requests in response to a separate petition based on industry's 
abandonment of these uses.

[[Page 72415]]

II. Background

A. Statutory and Regulatory Background of Color Additive Regulation

    The FD&C Act authorizes us to regulate ``color additives'' (see 
section 721(b) of the FD&C Act). The FD&C Act defines ``color 
additive'' as a material which is a dye, pigment, or other substance 
made by a process of synthesis or similar artifice, or extracted, 
isolated, or otherwise derived, with or without intermediate or final 
change of identity, from a vegetable, animal, mineral, or other source, 
and that when added or applied to a food, drug, or cosmetic, or to the 
human body or any part thereof, is capable (alone or through reaction 
with another substance) of imparting color (``color'' includes black, 
white, and intermediate grays) thereto (see section 201(t) of the FD&C 
Act (21 U.S.C. 321(t))). Color additives used in or on a food, drug, 
cosmetic, or certain medical devices are deemed unsafe and prohibited 
except to the extent that we approve their use (see section 721(a) of 
the FD&C Act). Certain color additives must be certified by FDA (see 
section 721(c) of the FD&C Act).
    The FD&C Act provides a process through which any person who wishes 
to use a color additive in or on food, drugs, certain devices, or 
cosmetics may submit a petition proposing the issuance of a color 
additive regulation listing such use with supporting information. A 
color additive petition may also be submitted to propose the amendment 
or repeal of any existing color additive regulation (see section 
721(b)(5)(C) and (d) of the FD&C Act). In response to a color additive 
petition, FDA may issue a regulation listing a color additive for use 
in or on food, drugs, devices, or cosmetics only if it determines that 
the additive is suitable and safe for such use (see section 721(b)(1) 
of the FD&C Act).
    Under section 721(b) of the FD&C Act, we will not establish a 
regulation for the use of a color additive if a fair evaluation of the 
data fails to establish that the proposed use of the color additive, 
under the conditions of use to be specified in the regulation, will be 
safe. To determine whether a color additive is safe, the FD&C Act 
requires FDA to consider, among other relevant factors: (1) probable 
consumption of, or other relevant exposure from, the additive and of 
any substance formed in or on food, drugs or devices, or cosmetics 
because of the use of the additive; (2) cumulative effect, if any, of 
such additive ``in the diet of man or animals,'' taking into account 
the same or any chemically or pharmacologically related substance or 
substances in such diet; and (3) safety factors recognized by experts 
``as appropriate for the use of animal experimentation data'' (see 
section 721(b)(5)(A) of the FD&C Act) (referred to as the ``general 
safety clause''). FDA's determination that a color additive is safe 
means that there is convincing evidence that establishes with 
reasonable certainty that no harm will result from the intended 
condition of use of the color additive (Sec.  70.3(i) (21 CFR 
70.3(i))). We refer to this safety standard as ``a reasonable certainty 
of no harm.''
    In addition, section 721(b)(5)(B) of the FD&C Act, often referred 
to as the Delaney Clause, deems a color additive unsafe under certain 
circumstances. The Delaney Clause for color additives consists of two 
parts. The first part (section 721(b)(5)(B)(i) of the FD&C Act) 
pertains specifically to ingested color additives. The second part 
(section 721(b)(5)(B)(ii) of the FD&C Act) applies to non-ingested 
color additives. For purposes of our review of this petition, we 
reviewed these uses of the solvents ethylene dichloride, methylene 
chloride, and trichloroethylene under the first part because these uses 
result in ingestion. Section 721(b)(5)(B)(i) of the FD&C Act states 
that a color additive shall be deemed unsafe for any use which will or 
may result in ingestion of all or part of such additive if the additive 
is found by the Secretary to induce cancer when ingested by man or 
animal, or if it is found by the Secretary, after tests which are 
appropriate for the evaluation of the safety of additives for use in 
food, to induce cancer in man or animal. Courts have concluded that the 
Delaney Clause is to be interpreted very rigidly. In Public Citizen v. 
Young, 831 F.2d 1108, 1122 (D.C. Cir. 1987), the court held that 
Congress intended for the Delaney Clause to be ``extraordinarily 
rigid,'' to protect the public from cancer-causing substances without 
exception, rejecting FDA's argument that a particular color additive 
should be approved because it did not pose more than a de minimis 
cancer risk; see also Les v. Reilly, 968 F.2d 985, 986 (9th Cir. 1992) 
(holding that the U.S. Environmental Protection Agency's (EPA) refusal 
to revoke regulations permitting the use of certain pesticides, which 
were regulated as food additives at the time of the court decision and 
subject to a similarly worded Delaney Clause for food additives, on the 
grounds that they pose a de minimis cancer risk, is contrary to the 
provisions of the Delaney Clause). Importantly, however, the Delaney 
Clause applies to the additive itself and not to constituents (such as 
nonfunctional chemicals present in the additive) or impurities in the 
additive. That is, where an additive itself has not been shown to cause 
cancer but contains a carcinogenic constituent or impurity, the 
additive is properly evaluated under the general safety clause using 
risk assessment procedures to determine whether there is a reasonable 
certainty that no harm will result from the intended use of the 
additive (Scott v. FDA, 728 F.2d 322 (6th Cir. 1984)).
    There is a similar Delaney Clause provision for food additives 
under section 409(c)(3) of the FD&C Act (21 U.S.C. 348(c)(3)), which 
states that no food additive shall be deemed safe if it is found to 
induce cancer when ingested by man or animal, or if it is found, after 
tests which are appropriate for the evaluation of the safety of food 
additives, to induce cancer in man or animal. In revoking certain 
authorizations for food additives under the Delaney Clause, FDA stated 
that the Delaney Clause limits FDA's discretion to determine the safety 
of food additives. FDA stated that the Delaney Clause prevents FDA from 
finding a food additive to be safe if it has been found to induce 
cancer when ingested by humans or animals, ``regardless of the 
probability, or risk, of cancer associated with exposure to the 
additive or of the extent to which the experimental conditions of the 
animal study or the carcinogenic mode of action provide insight into 
the health effects of human consumption and use of the additive in 
question'' (83 FR 50490 at 50492, October 9, 2018).
    Section 721(d) of the FD&C Act provides for the issuance, 
amendment, or repeal of regulations authorizing the use of a color 
additive, and, among other things, it specifies that the safety 
provisions of section 721(b)(5) of the FD&C Act apply to such actions. 
For FDA to grant a petition that seeks repeal of a color additive 
regulation based upon new data concerning the safety of the color 
additive, such data must be adequate for FDA to conclude that there is 
no longer a reasonable certainty of no harm for the intended use of the 
color additive or that it must be deemed unsafe under the Delaney 
Clause.

B. History of the Color Additive Regulations Where Amendments Are 
Requested

    In the Federal Register of June 20, 1963 (28 FR 6351), FDA 
established 21 CFR 8.305 for the listing of annatto extract in food use 
exempt from certification, now codified in Sec.  73.30. Ethylene 
dichloride, methylene chloride, and trichloroethylene are allowed as 
food-grade extractants in the

[[Page 72416]]

preparation of annatto extract (Sec.  73.30(a)(1)(ii)). In the Federal 
Register of October 8, 1964 (29 FR 13893), FDA established 21 CFR 8.390 
for the listing of diluents in color additive mixtures for food use 
exempt from certification, including methylene chloride (with a 
restriction of no residues) for the special use in inks for marking 
fruit and vegetables, now codified in Sec.  73.1.
    In the Federal Register of January 27, 1966 (31 FR 1063), FDA 
established, among other things, 21 CFR 8.308 and 8.310 for the listing 
of paprika oleoresin and turmeric oleoresin, now codified in Sec. Sec.  
73.345 and 73.615, respectively. Ethylene dichloride, methylene 
chloride, and trichloroethylene are allowed as solvents in the 
preparation of both paprika oleoresin and turmeric oleoresin 
(Sec. Sec.  73.345(a)(1) and 73.615(a)(1)).

III. Summary and Context of Determination

    We have evaluated the data and other information submitted in the 
petition, as well as other relevant data. FDA finds that ethylene 
dichloride, methylene chloride, and trichloroethylene induce cancer in 
animals. We must revoke the authorizations providing for any color 
additive use of these substances on the basis of the Delaney Clause. As 
described further in section IV of this document, we conclude that 
methylene chloride is a color additive in Sec.  73.1. Therefore, we are 
amending the regulations to remove the use of this color additive under 
section 721(b)(5)(B) of the FD&C Act as a matter of law.
    We are denying the petition's remaining requests. As described 
further in section IV of this document, we conclude that ethylene 
dichloride, methylene chloride, and trichloroethylene are not color 
additives in Sec. Sec.  73.30, 73.345, and 73.615. Therefore, the 
Delaney Clause does not apply to these uses.

IV. Evaluation of Petition

    The petitioners assert that the Delaney Clause applies to ethylene 
dichloride, methylene chloride, and trichloroethylene in Sec. Sec.  
73.1, 73.30, 73.345, and 73.615. The petitioners state that ethylene 
dichloride, methylene chloride, and trichloroethylene have been shown 
to induce cancer in animals. The petitioners cite to studies sponsored 
by the Department of Health and Human Services' National Toxicology 
Program (NTP) (Refs. 1-3).
    For ethylene dichloride, in the National Cancer Institute Technical 
Report No. 55 (1978) on 1, 2--dichloroethane, the authors reported that 
the test material caused significantly increased incidence of squamous 
cell carcinomas of the forestomach and hemangiosarcomas of the 
circulatory system in male rats and adenocarcinomas of the mammary 
gland in female rats (Ref. 1). FDA previously evaluated these data and 
found that ethylene dichloride induced cancer in animals (Refs. 4 and 
5).
    For methylene chloride, in the NTP Report No. 306 (January 1986) on 
inhalation studies in F344/N rats and B6C3F<INF>1</INF> mice, the 
authors reported that the test material (Dichloromethane (Methylene 
Chloride) (CAS Reg. No. 75-09-2)) caused an increased incidence of 
liver cell neoplasms and lung neoplasms in both male and female 
B6C3F<INF>1</INF> mice (Ref. 2). FDA previously evaluated these data 
and found that methylene chloride induced cancer in animals (Ref. 6).
    For trichloroethylene, the National Cancer Institute Technical 
Report No. 2 presents a synopsis of the results of a carcinogenesis 
bioassay of trichloroethylene using mice and rats and concludes that 
trichloroethylene induces liver cancer in mice (Ref. 3). FDA previously 
evaluated these data and found that trichloroethylene induced cancer in 
animals (Ref. 7).
    Based on these studies, we conclude that ethylene dichloride and 
trichloroethylene have been ``found by the Secretary to induce cancer 
when ingested by . . . animal[s]'' (Refs. 1 and 3).
    We also conclude that methylene chloride is an animal carcinogen 
based on an NTP-sponsored two-year inhalation study in mice (NTP 
inhalation mouse study) and that this study is appropriate for 
evaluating the safety of this additive for its intended use. 
Previously, FDA concluded that data from the NTP inhalation mouse study 
were appropriate for the safety evaluation of methylene chloride as a 
food additive (50 FR 51551 and Refs. 8 and 9).
    In the NTP inhalation mouse study with methylene chloride, 
carcinogenic incidences were reported in lungs and also in liver, an 
organ removed from the site of administration (Ref. 8). These effects 
occurred independent of each other (id.). Further, FDA compared data 
from the NTP inhalation mouse study with those from a National Coffee 
Association-sponsored two-year drinking water study conducted with the 
same strain of mice but at lower dose levels (Ref. 8). While the 
drinking water studies did not demonstrate any carcinogenic effects in 
the liver or lungs, increased incidences of non-neoplastic 
proliferative lesions were observed in the liver (Ref. 6), and FDA 
concluded that mice receiving methylene chloride in the drinking water 
study may not have been tested at levels comparable to the NTP 
inhalation study (Ref. 6). Making an assumption that methylene chloride 
induced cancer just below the detection limit of the doses tested in 
the drinking water studies, FDA concluded that the upper-bound cancer 
risk of methylene chloride from the drinking water studies was 
approximately the same as its upper-bound cancer risk from the NTP 
inhalation study (Ref. 9).
    On a case-by-case basis, data from non-oral animal toxicity 
studies, such as studies based on inhalation exposure route, can be 
used in place of oral animal toxicity studies to evaluate the safety of 
substances after oral exposure (Refs. 10 and 11). This assessment 
involves examining and comparing chemical and toxicological profiles of 
the substance between oral and inhalation exposure routes (id.). In 
general, substances that have a high vapor pressure and are therefore 
considered volatile can enter the blood after inhalation exposure and 
potentially induce toxic effects in internal organs away from the site 
of administration (id.). For such substances, data from non-oral 
exposure studies (e.g., inhalation studies) are considered relevant to 
evaluate their safety after oral exposure (Ref. 10). Methylene chloride 
is a volatile substance with a high vapor pressure (see 29 CFR 
1910.1052 Appendix A). Further, in the NTP inhalation mouse study, 
methylene chloride induced carcinogenic effects in the liver--an organ 
removed from the site of administration.
    Therefore, data from the NTP inhalation mouse study of methylene 
chloride is applicable to its evaluation of safety after oral exposure, 
and this study is appropriate for the evaluation of the safety of this 
additive for color additive use. Thus, the reported results from the 
NTP inhalation mouse study are appropriate when considering the 
applicability of the Delaney Clause for methylene chloride, and based 
on this study, we conclude that methylene chloride has been found ``to 
induce cancer in . . . animal.'' We also conclude that the NTP 
inhalation mouse study (Ref. 2) for methylene chloride is ``appropriate 
for the evaluation of the safety of additives for such use.''
    Because these solvents (ethylene dichloride, methylene chloride, 
and trichloroethylene) have been ``found to induce cancer in . . . 
animal[s],'' the Delaney Clause applies to their use as a color 
additive. The Delaney Clause prevents FDA from finding the color

[[Page 72417]]

additive uses of these solvents to be safe if the solvents have been 
found to induce cancer in animals, regardless of the probability, or 
risk, of cancer associated with exposure from the color additive uses.
    Finally, we evaluated the uses of ethylene dichloride, methylene 
chloride, and trichloroethylene in these color additive regulations to 
determine whether, based on the specific authorized uses, these 
substances are color additives (which are subject to the Delaney 
Clause) or are constituents or impurities in a color additive (which 
are not subject to the Delaney Clause).
    The discussion that follows describes FDA's evaluation of whether 
ethylene dichloride, methylene chloride, and trichloroethylene, as they 
appear in Sec. Sec.  73.1, 73.30, 73.345, and 73.615, are considered 
color additives or constituents or impurities in the color additive. 
For uses of substances that we determine to be color additives, the 
Delaney Clause applies, and the authorization for such uses must be 
revoked. For uses of substances that we determine to be constituents or 
impurities in a color additive, the Delaney Clause does not apply. As 
the petition's request is based on the Delaney Clause, we are denying 
its request to revoke the applicable authorizations on the basis of the 
Delaney Clause for uses that we determine result in these solvents 
being constituents or impurities in a color additive rather than the 
color additive itself.

A. 21 CFR 73.1 ``Diluents in Color Additive Mixtures for Food Use 
Exempt From Certification''

    Under Sec.  73.1(b)(1)(ii), methylene chloride is allowed as a 
diluent in color additive mixtures for use in inks for marking fruit 
and vegetables with the restriction of no residue. A color additive 
mixture is a color additive that is made, in relevant part, by mixing 
``one or more straight colors and one or more diluents'' (Sec.  
70.3(k)). While such diluents do not impart color and are not by 
themselves a color additive (Sec.  70.3(m)), they are regulated as 
color additives when they are intentionally mixed with a color to make 
a color additive mixture. Because of a diluent's functional purpose in 
the color additive mixture, we consider the authorized use of methylene 
chloride in Sec.  73.1(b)(1)(ii), as a diluent in color additive 
mixtures for use in inks for marking fruit and vegetables, to be a 
color additive that is subject to the Delaney Clause. Therefore, we are 
amending the regulation to no longer provide for the use of methylene 
chloride as a diluent in color additive mixtures for use in inks for 
marking fruit and vegetables in Sec.  73.1(b)(1)(ii) under section 
721(b)(5)(B) of the FD&C Act as a matter of law.

B. 21 CFR 73.30 ``Annatto Extract''

    Under Sec.  73.30(a)(1)(ii), ethylene dichloride, methylene 
chloride, and trichloroethylene are each allowed as a food-grade 
extractant to manufacture the color additive ``annatto extract.'' 
Annatto extract must contain no more solvent residue than is allowed of 
the corresponding solvents in spice oleoresins under applicable food 
additive regulations in parts 170 through 189 (21 CFR parts 170 through 
189) (see Sec.  73.30(b)). Total chlorinated solvents residues are 
limited to 30 parts per million (ppm) (milligram per kilogram (mg/kg)) 
(see Sec. Sec.  173.230 (21 CFR 173.230), 173.255 (21 CFR 173.255), and 
173.290 (21 CFR 173.290)). Through the extraction process, ethylene 
dichloride, methylene chloride, and trichloroethylene may end up as a 
residue of, and therefore an impurity in, the color additive ``annatto 
extract.'' While these extractants may end up as impurities in the 
color additive ``annatto extract,'' they are not color additives 
themselves in Sec.  73.30. Therefore, we are denying the petition's 
request to remove ethylene dichloride, methylene chloride, and 
trichloroethylene from the list of approved food-grade extractants in 
Sec.  73.30 under section 721(b)(5)(B) of the FD&C Act. As discussed in 
section II.A of this document, the Delaney Clause is applicable to 
color additives but not to impurities in a color additive.

C. 21 CFR 73.345 ``Paprika Oleoresin''

    Under Sec.  73.345(a), ethylene dichloride, methylene chloride, and 
trichloroethylene are each allowed as a solvent for the extraction of 
paprika to obtain the color additive ``paprika oleoresin.'' Paprika 
oleoresin must contain no more solvent residue than is allowed of the 
corresponding solvents in spice oleoresins under applicable food 
additive regulations in parts 170 through 189 (see Sec.  73.345(b)). 
Total chlorinated solvents are limited to 30 ppm (mg/kg) (see 
Sec. Sec.  173.230, 173.255, and 173.290). Through the extraction 
process, ethylene dichloride, methylene chloride, and trichloroethylene 
may end up as a residue of, and therefore an impurity in, the color 
additive ``paprika oleoresin.'' While these solvents may end up as 
impurities in the color additive ``paprika oleoresin,'' they are not 
color additives themselves in Sec.  73.345. Therefore, we are denying 
the petition's request to remove ethylene dichloride, methylene 
chloride, and trichloroethylene from the list of approved solvents in 
Sec.  73.345 under section 721(b)(5)(B) of the FD&C Act. As discussed 
in section II.A of this document, the Delaney Clause is applicable to 
color additives but not to impurities in a color additive.

D. 21 CFR 73.615 ``Turmeric Oleoresin''

    Under Sec.  73.615(a), ethylene dichloride, methylene chloride, and 
trichloroethylene are each allowed as a solvent for extraction of 
turmeric to obtain the color additive ``turmeric oleoresin.'' Turmeric 
oleoresin must contain no more solvent residue than is allowed of the 
corresponding solvents in spice oleoresins under applicable food 
additive regulations in parts 170 through 189 (see Sec.  73.615(b)). 
Total chlorinated solvents are limited to 30 ppm (mg/kg) (see 
Sec. Sec.  173.230, 173.255, and 173.290). Through the extraction 
process, ethylene dichloride, methylene chloride, and trichloroethylene 
may end up as a residue of, and therefore an impurity in, the color 
additive ``turmeric oleoresin.'' While these solvents may end up as an 
impurity in the color additive ``turmeric oleoresin,'' they are not 
color additives themselves in Sec.  73.615. Therefore, we are denying 
the petition's request to remove ethylene dichloride, methylene 
chloride, and trichloroethylene from the list of approved extractants 
in Sec.  73.615 under section 721(b)(5)(B) of the FD&C Act. As 
discussed in section II.A of this document, the Delaney Clause is 
applicable to color additives but not to impurities in a color 
additive.

V. Comments Related to the Petition

    FDA received several comments in response to the notification of 
petition and the reopening of the comment period. Most comments 
expressed general support for the petition's requested revocation of 
the provisions allowing for the use of these solvents in foods. Some 
comments addressed matters outside the scope of this petition, and some 
comments were duplicate submissions.
    We summarize and respond to relevant portions of comments in this 
final order. We have numbered each comment to help distinguish between 
different comments. We have grouped similar comments together under the 
same number, and, in some cases, we have separated different issues 
discussed in the same comment and designated them as distinct comments 
for purposes of our responses. The number assigned to each comment is 
for organizational purposes only and does not signify the comment's 
value,

[[Page 72418]]

importance, or the order in which it was submitted.
    (Comment 1) One comment stated that chlorinated solvents are no 
longer used for the manufacture of color additives. The comment further 
encouraged FDA to take this opportunity to consider removing ethylene 
dichloride, methylene chloride, and trichloroethylene as extraction 
solvents, as well as methylene chloride as a diluent in inks for 
marking fruits and vegetables based on the abandonment of these 
authorized uses.
    (Response 1) We did not consider abandonment for the approved uses 
of these solvents as part of our evaluation of this petition because 
the petition is based on the Delaney Clause. We note, however, that 
elsewhere in this issue of the Federal Register, we have published a 
final order in response to CAP 5C0340, submitted by the International 
Association of Color Manufacturers, partially granting that petition 
and amending the color additive regulations to no longer provide for 
the extraction solvent uses of ethylene dichloride, methylene chloride, 
and trichloroethylene which are covered by this petition because these 
uses have been abandoned.
    (Comment 2) Some comments raised EPA's proposed actions to 
eliminate or restrict the use of trichloroethylene and methylene 
chloride under the Toxic Substances Control Act or otherwise noted 
uses(s) of a chlorinated solvent that would be under EPA's 
jurisdiction.
    (Response 2) While FDA and EPA may both regulate a particular 
substance, each agency regulates the uses of substances under its own 
applicable legal authority.
    (Comment 3) Several comments expressed support for the removal of 
the authorizations for the use of these solvents from our color 
additive regulations. Some comments stated that these authorizations 
should be removed because there are alternatives.
    (Response 3) We are taking this action to revoke the authorization 
for the use of methylene chloride as a diluent in color additive 
mixtures in inks for marking fruit and vegetables, because the color 
additive use of this solvent is deemed unsafe under the Delaney Clause. 
The existence of alternatives is not a factor in determining whether a 
color additive is safe under either the Delaney Clause or the general 
safety clause (see section 721(b)(5)(B) of the FD&C Act).
    (Comment 4) Some comments mentioned other substances that FDA 
should also review for removal from our color additive regulations.
    (Response 4) This color additive petition requests the removal of 
the three specified solvents from Sec. Sec.  73.1, 73.30, 73.345, and 
73.615. Therefore, these comments are outside the scope of this order.
    (Comment 5) Some comments discussed the regulatory status of 
ethylene dichloride, methylene chloride, and trichloroethylene in other 
countries and questioned how FDA could continue to allow these 
substances in the U.S. food supply.
    (Response 5) FDA's regulatory decisions are based on its own 
assessments of the available scientific information supporting the 
safety of color additives and on the statutory and regulatory framework 
in the United States.
    (Comment 6) One comment expressed support for the petition and 
discussed evidence related to the use of these solvents and potential 
negative health impacts to humans. The comment cited certain studies to 
support their claims.
    (Response 6) The petition's request is based on the Delaney Clause, 
and therefore our review of these solvents is based on the Delaney 
Clause. If the Delaney Clause applies, regardless of the safety of this 
use under the general safety clause, such an additive may not ``be 
deemed to be safe'' as a matter of law. Therefore, under the Delany 
Clause, FDA must revoke the authorization for the color additive use of 
methylene chloride. By contrast, ethylene dichloride, methylene 
chloride, and trichloroethylene are not color additives in Sec. Sec.  
73.30, 73.345, and 73.615, but rather they are impurities in those 
color additives. Therefore, we are denying the petition's request to 
revoke these authorizations, and any further review is outside the 
scope of this order responding to the petition.

VI. Conclusion

    Ethylene dichloride, methylene chloride, and trichloroethylene have 
been shown to cause cancer in laboratory animals. Under the Delaney 
Clause, this finding of carcinogenicity renders a color additive 
``unsafe'' as a matter of law. Therefore, FDA is revoking the 
authorization for methylene chloride as a diluent in color additive 
mixtures in inks for marking fruit and vegetables. We are amending 
Sec.  73.1 as set forth in this document.
    Our revocation of this authorization is based on a finding under 
the Delaney Clause that methylene chloride can induce cancer in 
animals. It is not based on a finding that the intended use is no 
longer safe under the general safety clause. Upon the effective date of 
this order (see DATES), the use of methylene chloride as a diluent in 
color additive mixtures in inks for marking fruit and vegetables is no 
longer authorized. FDA is revoking this authorization in a manner 
consistent with its international obligations. This decision is 
consistent with the United States' long-standing Appropriate Level of 
Protection regarding carcinogenic additives in food, which seeks to 
eliminate exposure to additives that have been found to induce cancer 
in man or animals.
    The Delaney Clause is applicable to the color additive itself but 
not to constituents or impurities in the additive. Residues of ethylene 
dichloride, methylene chloride, and trichloroethylene, when used as an 
extractant for annatto extract, paprika oleoresin, and turmeric 
oleoresin, may end up as an impurity in the color additive and would be 
considered an impurity in the color additive, not a color additive 
itself. The Delaney Clause applies to color additives, and not to 
impurities in a color additive. Because the Delaney Clause does not 
provide a basis for removing these authorizations, FDA is denying the 
petition's request to remove the authorized uses of ethylene 
dichloride, methylene chloride, and trichloroethylene in Sec. Sec.  
73.30, 73.345, and 73.615. We note, however, that elsewhere in this 
issue of the Federal Register, we have published a final order amending 
the color additive regulations to no longer provide for these uses of 
ethylene dichloride, methylene chloride, and trichloroethylene because 
these uses have been abandoned. Therefore, FDA is taking all of the 
actions requested by the petitioners.

VII. Public Disclosure

    In accordance with Sec.  71.15 (21 CFR 71.15), the petition and the 
documents that we considered and relied upon in reaching our decision 
to approve the petition in part and to deny the petition in part will 
be made available for public disclosure (see FOR FURTHER INFORMATION 
CONTACT). As provided in Sec.  71.15, we will delete from the documents 
any materials that are not available for public disclosure. As stated 
in the notification of filing for CAP 4C0327, the petition is available 
in the docket.

VIII. Analysis of Environmental Impacts

    As stated in the January 11, 2024, Federal Register notification of 
petition for CAP 4C0327 (89 FR 1856), the petitioner claimed that this 
action is categorically excluded under Sec.  25.32(m) (21 CFR 25.32(m)) 
because it constitutes an action to prohibit or otherwise

[[Page 72419]]

restrict or reduce the use of a substance in food, food packaging, or 
cosmetics. We further stated that, if FDA determines a categorical 
exclusion applies, neither an environmental assessment nor an 
environmental impact statement is required. We did not receive any new 
information or comments regarding this claim of categorical exclusion. 
We considered the petitioner's claim of categorical exclusion and 
determined that this action is categorically excluded under Sec.  
25.32(m) (Ref. 12). Therefore, neither an environmental assessment nor 
an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This order contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

X. Objections

    This order is effective as shown in the DATES section, except as to 
any provisions that may be stayed by the filing of proper objections. 
If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Dockets Management Staff (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object and the 
grounds for your objection. Within each numbered objection, you must 
specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen 
in the Dockets Management Staff office between 9 a.m. and 4 p.m., 
Monday through Friday, and will be posted to the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. We will publish notice of the objections that we 
have received or lack thereof in the Federal Register.

XI. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public 
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. Although FDA verified the website addresses 
in this document, please note that websites are subject to change over 
time.

*1. National Cancer Institute. 1978. Bioassay of 1,2-Dichloroethane 
for Possible Carcinogenicity. Bethesda, MD: National Cancer 
Institute. DHEW Publication No. (NIH) 78-1361. Accessed February 4, 
2026. Available at: <a href="https://ntp.niehs.nih.gov/publications/reports">https://ntp.niehs.nih.gov/publications/reports</a>.
*2. National Toxicology Program. 1986. NTP Technical Report on the 
Toxicology and Carcinogenesis Studies of Dichloromethane (Methylene 
Chloride) (CAS Reg. No. 75-09-2) in F344/N Rats and 
B6C3F<INF>1</INF> Mice (Inhalation Studies). Research Triangle Park, 
NC: National Toxicology Program. Technical Report 306. Accessed 
February 4, 2026. Available at: <a href="https://ntp.niehs.nih.gov/publications/reports">https://ntp.niehs.nih.gov/publications/reports</a>.
*3. National Cancer Institute. 1976. Carcinogenesis Bioassay of 
Trichloroethylene. Bethesda, MD: National Cancer Institute. DHEW 
Publication No. (NIH) 76-802. Accessed February 4, 2026. Available 
at: <a href="https://ntp.niehs.nih.gov/publications/reports">https://ntp.niehs.nih.gov/publications/reports</a>.
*4. Memorandum of Conference concerning ``1,2-Dichloroethane,'' 
Cancer Assessment Committee, Bureau of Foods, March 20, 1979.
*5. Memorandum of Conference concerning ``1,2-Dichloroethane,'' 
Cancer Assessment Committee, Bureau of Foods, June 12, 1979.
*6. Memorandum of Conference concerning ``Methylene Chloride,'' 
Cancer Assessment Committee, Bureau of Foods, January 20, 1983, 
August 8, 1984, and June 13, 1985.
*7. Memorandum of Conference concerning ``1,1,2-Trichloroethylene,'' 
Cancer Assessment Committee, Bureau of Foods, July 24, 1979.
*8. Quantitative Risk Assessment Committee, ``Preliminary Assessment 
of Upper-Bound Cancer Risk from Exposure to Methylene Chloride Used 
in Cosmetic Aerosol Sprays,'' April 23, 1985.
*9. Quantitative Risk Assessment Committee, ``Upper Bound Estimate 
of Cancer Risk of Methylene Chloride (MC) in MC-based Decaffeinated 
Coffee Products,'' November 15, 1985.
10. Kabadi, S.V., J. Fisher, B. Hung, and J. Aungst. 
``Considerations for applying route-to-route extrapolation to assess 
the safety of oral exposure to substances.'' Biomolecules, 13(1), 5, 
2023. Accessed February 4, 2026. Available at <a href="https://doi.org/10.3390/biom13010005">https://doi.org/10.3390/biom13010005</a>.
11. Gerrity, T.R.; and C. J. Henry. Principles of Route-Route 
Extrapolation for Risk Assessment: Proceedings of the Workshops on 
Principles of Route-to-Route Extrapolation for Risk Assessment held 
March 19-21, 1990, in Hilton Head, South Carolina and July 10-11, 
1990, in Durham, North Carolina; Elsevier: New York, NY, USA, 1990.
*12. Memorandum from L. Proffitt, Office of Policy Initiatives and 
Projects, Office of Policy and International Engagement, Human Foods 
Program (HFP), FDA to P. Gaynor, Division of Food Ingredients, 
Office of Pre-Market Additive Safety, Office of Food Chemical 
Safety, Dietary Supplements and Innovation, HFP, FDA, April 9, 2026.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for part 73 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.


Sec.  73.1  [Amended]

0
2. Amend Sec.  73.1 in the table in paragraph (b)(1)(ii) by removing 
the entry for ``Methylene chloride''.


Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-22865 Filed 11-9-26; 8:45 am]
BILLING CODE 4164-01-P


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