86290 Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Proposed Rules 

1On December 21, 2022, the Commission also 

published a notice of availability and request for 

comment on a report from SEA, Ltd. titled ‘‘Study 

of Debris Penetration of Recreational Off-Highway 

Vehicle (ROV) Proof-of-Concept (POC) Floorboard 

Guards’’ (87 FR 78037). 

2To obtain access to the data, a request can be 

submitted to: https://forms.office.com/g/ 

Yz4tNFdhDp; a website link to access the data will 

be sent to the email address provided. 

3The Commission voted (4–1) on October 22, 

2024, to publish this document. 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1421 

[Docket No. CPSC–2021–0014] 

Notice of Availability and Request for 

Comment: Data Regarding Debris 

Penetration Hazards for Recreational 

Off-Highway Vehicles and Utility Task/ 

Terrain Vehicles; Extension of 

Comment Period 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: The U.S. Consumer Product 

Safety Commission (Commission or 

CPSC) published a notice of proposed 

rulemaking (NPR) in July 2022 to 

address debris penetration hazards for 

recreational off-highway vehicles 

(ROVs) and utility task/terrain vehicles 

(UTVs). On October 4, 2024, the 

Commission published a notice of 

availability and request for comment 

(NOA) to announce the availability of, 

and to seek comments on, details about 

incident data relevant to the NPR. The 

NOA invited the public to submit 

written comments during a 30-day 

comment period ending on November 4, 

2024. In response to a request for an 

extension of the NOA comment period, 

the Commission is extending the 

comment period to December 4, 2024. 

DATES: The comment period for the 

proposed rule published on October 4, 

2024, at 89 FR 80831, is extended. 

Submit comments by December 4, 2024. 

ADDRESSES: Submit comments, 

identified by Docket No. CPSC–2021– 

0014, by any of the following methods: 

Electronic Submissions: Submit 

electronic comments to the Federal 

eRulemaking Portal at: https://

www.regulations.gov. Follow the 

instructions for submitting comments. 

CPSC does not accept comments 

submitted by email, except as described 

below. CPSC encourages you to submit 

electronic comments by using the 

Federal eRulemaking Portal. 

Mail/Hand Delivery/Courier Written 

Submissions: Submit comments by 

mail/hand delivery/courier to: Office of 

the Secretary, U.S. Consumer Product 

Safety Commission, 4330 East West 

Highway, Bethesda, MD 20814; 

telephone: (301) 504–7479. If you wish 

to submit confidential business 

information, trade secret information, or 

other sensitive or protected information 

that you do not want to be available to 

the public, you may submit such 

comments by mail, hand delivery, or 

courier, or you may email them to: cpscos@cpsc.gov. 

Instructions: All submissions must 

include the agency name and docket 

number. CPSC may post all comments 

without change, including any personal 

identifiers, contact information, or other 

personal information provided, to: 

https://www.regulations.gov. Do not 

submit electronically: confidential 

business information, trade secret 

information, or other sensitive or 

protected information that you do not 

want to be available to the public. If you 

wish to submit such information, please 

submit it according to the instructions 

for mail/hand delivery/courier written 

submissions. 

Docket: To read background 

documents or comments received, go to: 

https://www.regulations.gov, insert 

Docket No. CPSC–2021–0014 in the 

‘‘Search’’ box, and follow the prompts. 

FOR FURTHER INFORMATION CONTACT: Han 

Lim, Project Manager, Office of Hazard 

Identification and Reduction, 

Directorate for Engineering Sciences, 

U.S. Consumer Product Safety 

Commission, 5 Research Place, 

Rockville, MD 20850; telephone: (301) 

987–2327; email: hlim@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Section 7(a) of the Consumer Product 

Safety Act authorizes the Commission to 

promulgate a mandatory consumer 

product safety standard that sets forth 

performance or labeling requirements 

for a consumer product, if such 

requirements are reasonably necessary 

to prevent or reduce an unreasonable 

risk of injury. 15 U.S.C. 2056(a). Under 

this statutory authority, in 2021, the 

Commission initiated a rulemaking to 

reduce the risk of injuries and deaths 

associated with penetration of ROVs 

and UTVs by debris such as fallen tree 

branches. The Commission published 

an advance notice of proposed 

rulemaking (ANPR) on May 11, 2021 (86 

FR 25817), and an NPR on July 21, 2022 

(87 FR 43688).1

On October 4, 2024 (89 FR 80831), the 

Commission published in the Federal 

Register a notice of availability and 

request for comment to announce the 

availability of, and to seek comments 

on, details about incident data relevant 

to the NPR. The NOA invited the public 

to submit written comments during a 

30-day comment period ending on 

November 4, 2024. 

B. Comment Period Extension 

On October 8, 2024, the Outdoor 

Power Equipment Institute (OPEI) and 

the Recreational Off-Highway Vehicle 

Association (ROHVA) submitted a 

request to extend the public comment 

period of the NOA for an additional 30 

days to December 4, 2024. In particular, 

OPEI and ROHVA asserted that, given 

the volume of the data and the format 

in which CPSC has provided access to 

the data,2 a 30-day extension is 

necessary to permit OPEI, ROHVA, and 

other members of the public to have a 

meaningful opportunity to comment. 

The Commission has considered OPEI’s 

and ROHVA’s request to extend the 

comment period. Currently, the 

comment period is due to close on 

November 4, 2024. To provide the 

public additional time to review and 

comment on the data, the Commission 

will grant the requested 30-day 

extension of the comment period, until 

December 4, 2024.3

Alberta E. Mills, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2024–25132 Filed 10–29–24; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 175, 176, 177, and 178 

[Docket No. FDA–2016–F–1253] 

Environmental Defense Fund, et al.; 

Response to Objections and Requests 

for a Public Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; response to 

objections and denial of public hearing 

requests. 

SUMMARY: The Food and Drug 

Administration (FDA or we) received 

objections and requests for a public 

hearing submitted by the Environmental 

Defense Fund, Learning Disabilities 

Association of America, Center for Food 

Safety, Center for Environmental Health, 

Center for Science in the Public Interest, 

Breast Cancer Prevention Partners, 

Defend our Health, and Alaska 

Community Action on Toxics on the 

denial of a food additive petition (FAP 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Proposed Rules 86291 

6B4815) requesting that we revoke 

specified regulations to no longer 

provide for the food contact use of 28 

ortho-phthalates. We are overruling the 

objections and denying the requests for 

a public hearing. 

DATES: October 30, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Urbelis, Office of Food Chemical 

Safety, Dietary Supplements, and 

Innovation, Human Foods Program, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–5187; or Carrol Bascus, Office 

of Policy, Regulations and Information, 

Human Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of May 20, 

2016 (81 FR 31877), we announced the 

filing of a food additive petition (FAP 

6B4815) (petition) submitted by the 

Breast Cancer Fund (now Breast Cancer 

Prevention Partners), Center for 

Environmental Health, Center for Food 

Safety, Center for Science in the Public 

Interest, Clean Water Action, Consumer 

Federation of America, Earthjustice, 

Environmental Defense Fund, 

Improving Kids’ Environment, Learning 

Disabilities Association of America, and 

Natural Resources Defense Council 

(hereinafter, petitioners). 

The petition, received March 18, 

2016, initially requested that we amend 

or revoke specified food additive 

regulations under parts 175, 176, 177, 

and 178 (21 CFR parts 175, 176, 177, 

and 178) to no longer provide for the 

food contact uses of 30 substances that 

the petition identified as orthophthalates. Additionally, petitioners 

requested that we amend regulations in 

part 181 (21 CFR part 181) related to 

prior-sanctioned uses of five orthophthalates and issue a new regulation in 

part 189 (21 CFR part 189) prohibiting 

the use of eight specific ortho-phthalates 

in food contact articles. We declined to 

file these portions of the submissions as 

a food additive petition because those 

requests were not within the scope of a 

food additive petition (81 FR 31877 at 

31878). 

Following our May 20, 2016, 

announcement that we had filed the 

food additive petition, the petitioners 

provided supplementary information on 

October 8, 2016, and August 24, 2017 

(see FAP 6B4815 regarding orthophthalates/Responses to September 1, 

2016, request from Tom Neltner, Breast 

Cancer Fund, et al., dated October 8, 

2016, and August 24, 2017) (Supp., 

October 8, 2016, and Supp., August 24, 

2017, respectively). In the October 8, 

2016, supplement, the petitioners also 

requested that FDA remove two 

substances from the petitioner’s original 

list of 30 substances, stating that they 

are not ortho-phthalates (Supp., October 

8, 2016 at 2). Consequently, the subject 

of the food additive petition was limited 

to food additive regulations for 28 orthophthalates. In addition, regarding the 

certain portions of the submissions that 

we declined to file as a food additive 

petition because those requests were not 

within the scope of a food additive 

petition, on April 19, 2016, the 

petitioners submitted a citizen petition 

containing those requests (see Citizen 

Petition from Nancy Buermeyer, Breast 

Cancer Fund, et al., submitted to the 

Dockets Management Staff, Food and 

Drug Administration, dated April 19, 

2016 (Comment ID FDA–2016–P–1171– 

0001) (citizen petition). Specifically, the 

citizen petition requested that we 

initiate rulemaking to remove the prior 

sanctions in part 181 for five orthophthalates and that we add a new 

section to part 189 prohibiting the use 

of eight ortho-phthalates (citizen 

petition at 1 through 2). On May 12, 

2022, we denied the citizen petition. 

The core premise of FAP 6B4815 was 

that the 28 subject ortho-phthalates are 

chemically and pharmacologically 

related and should therefore be treated 

as a class for purposes of evaluating 

their safety. The petitioners argued that 

a single purported acceptable daily 

intake (ADI) for one substance should be 

applied to the purported class of 28 

ortho-phthalates and that the 

cumulative exposure to all 28 orthophthalates significantly exceeded the 

purported ADI for the one substance 

petitioners selected, thereby rendering 

the entire purported class unsafe for use 

as food additives. 

In the Federal Register of May 20, 

2022 (87 FR 31066), we announced that 

we were denying FAP 6B4815. In that 

Federal Register document (hereinafter, 

denial order), we explained that the 

petition did not provide sufficient 

information to support a finding that 

there is no longer a reasonable certainty 

of no harm for the authorized uses of the 

proposed class of 28 ortho-phthalates. 

As an additional matter, based on the 

information available to FDA, the denial 

order stated that we did not have a basis 

to conclude that dietary exposure levels 

from the authorized ortho-phthalates 

exceed a safe level (87 FR 31066 at 

31075). The denial order advised that 

objections and requests for a hearing 

were due by June 21, 2022 (87 FR 

31066). Subsequently, we received one 

submission from a group of eight 

objectors that raised several objections 

and requests for hearing in response to 

the denial order. 

Following receipt of FAP 6B4815 in 

March 2016, on June 25, 2018, we 

received a food additive petition (FAP 

8B4820) submitted by the Flexible Vinyl 

Alliance (hereinafter, the abandonment 

petition). The abandonment petition 

proposed that we amend our food 

additive regulations in parts 175, 176, 

177, and 178 to revoke the approvals of 

25 plasticizer substances that the 

petition identified as ortho-phthalates 

for various food contact applications 

because such uses were permanently 

abandoned. In response to the 

abandonment petition, we issued a final 

rule on May 20, 2022 (87 FR 31080) 

amending the food additive regulations 

in parts 175, 176, 177, and 178 to revoke 

the authorization of the 25 substances 

that were the subject of the petition for 

various food contact applications (the 

abandonment final order). FDA issued 

the abandonment final order 

concurrently with its denial order for 

FAP 6B4815. On May 20, 2022, we also 

issued a request for information (RFI) 

seeking scientific data and information 

on current uses, use levels, dietary 

exposure, and safety data for orthophthalates that remain authorized for 

use in food contact applications (87 FR 

31090). The objections and requests for 

hearing we received refer to the denial 

order, citizen petition, abandonment 

final order, and RFI. 

Ortho-phthalates also are included on 

FDA’s list of chemicals in the food 

supply that are under review (see 

https://www.fda.gov/food/foodchemical-safety/list-select-chemicalsfood-supply-under-fda-review). We are 

committed to continuing the evaluation 

of all relevant scientific information and 

data to determine whether additional 

regulatory action regarding orthophthalates is warranted to ensure the 

safety of all authorized food contact 

uses of ortho-phthalates. 

II. Objections and Requests for Hearing 

Section 409(f)(1) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 348(f)(1)) provides that, within 

30 days after publication of an order 

denying a food additive petition, any 

person adversely affected by such order 

may file objections, specifying with 

particularity the provisions of the order 

deemed objectionable, stating 

reasonable grounds therefor, and 

requesting a public hearing upon such 

objections. 

Under our regulations at 21 CFR 

171.110, objections and requests for a 

hearing relating to food additive 

regulations are governed by part 12 (21 

CFR part 12). Under § 12.22(a), each 


ddrumheller on DSK120RN23PROD with PROPOSALS1
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objection must: (1) be submitted on or 

before the 30th day after the date of 

publication of the final rule; (2) be 

separately numbered; (3) specify with 

particularity the provision of the 

regulation or proposed order objected 

to; (4) specifically state each objection 

on which a hearing is requested (failure 

to request a hearing on an objection 

constitutes a waiver of the right to a 

hearing on that objection); and (5) 

include a detailed description and 

analysis of the factual information to be 

presented in support of the objection if 

a hearing is requested (failure to include 

a description and analysis for an 

objection constitutes a waiver of the 

right to a hearing on that objection). 

We received one submission, on June 

21, 2022, from the Environmental 

Defense Fund, Learning Disabilities 

Association of America, Center for Food 

Safety, Center for Environmental Health, 

Center for Science in the Public Interest, 

Breast Cancer Prevention Partners, 

Defend Our Health, and Alaska 

Community Action on Toxics 

(hereinafter, objectors) (see Objections 

and Request for Evidentiary Public 

Hearing Regarding FDA’s Denial of 

Phthalates Food Additive Petition (FAP 

6B4815)), submitted by Katherine K. O’ 

Brien, Earthjustice, dated June 21, 2022, 

to the Dockets Management Staff, Food 

and Drug Administration (Comment ID 

FDA–2016–F–1253–0462) (Objections). 

The submission raises eight specific 

objections to the denial and requests 

hearings on six objections. 

III. Standards for Granting a Hearing 

The criteria for granting a hearing are 

set out in § 12.24(b). Under that 

regulation, a hearing will be granted if 

the material submitted by an objector 

shows that: (1) there is a genuine and 

substantial factual issue for resolution at 

a hearing (a hearing will not be granted 

on issues of policy or law); (2) the 

factual issue can be resolved by 

available and specifically identified 

reliable evidence (a hearing will not be 

granted on the basis of mere allegations 

or denials or general descriptions of 

positions and contentions); (3) the data 

and information submitted, if 

established at a hearing, would be 

adequate to justify resolution of the 

factual issue in the way sought by the 

objector (a hearing will be denied if the 

data and information submitted are 

insufficient to justify the factual 

determination urged, even if accurate); 

(4) resolution of the factual issue in the 

way sought by the objector is adequate 

to justify the action requested (a hearing 

will not be granted on factual issues that 

are not determinative with respect to the 

action requested, e.g., if the action 

would be the same even if the factual 

issue were resolved in the way sought); 

(5) the action requested is not 

inconsistent with any provision in the 

FD&C Act or any FDA regulation 

particularizing statutory standards (the 

proper procedure in those 

circumstances is for the person 

requesting the hearing to petition for an 

amendment or waiver of the regulation 

involved); and (6) the requirements in 

other applicable regulations, e.g., 21 

CFR 10.20, 12.21, 12.22, 314.200, 

514.200, and 601.7(a), and in the 

document issuing the final regulation or 

the notice of opportunity for a hearing 

are met. 

In general, in an administrative 

proceeding under section 409(f) of the 

FD&C Act, FDA is authorized to issue a 

decision without holding a part 12 

hearing when a party’s objections do not 

raise a genuine and material issue of fact 

that, if proved in that party’s favor, 

would suffice to warrant the relief 

requested (see Community Nutrition 

Inst. v. Young, 773 F.2d 1356, 1364 

(D.C. Cir. 1985), cert. denied, 475 U.S. 

1123 (1986); see also Vermont Dep’t of 

Pub. Serv. v. FERC, 817 F.2d 127, 140 

(D.C. Cir. 1987)). A party seeking a 

hearing must meet a ‘‘threshold burden 

of tendering evidence suggesting the 

need for a hearing’’ (Costle v. Pacific 

Legal Foundation, 445 U.S. 198, 214– 

215 (1980), citing Weinberger v. Hynson, 

Westcott & Dunning, Inc., 412 U.S. 609, 

620–621 (1973)). An allegation that a 

hearing is necessary to ‘‘sharpen the 

issues’’ or to ‘‘fully develop the facts’’ 

does not meet this test (Georgia Pacific 

Corp. v. EPA, 671 F.2d 1235, 1241 (9th 

Cir. 1982)). If a hearing request fails to 

identify sufficient factual evidence that 

would be the subject of a hearing, there 

is no reason to hold one. In judicial 

proceedings, a court is authorized to 

issue summary judgment without an 

evidentiary hearing whenever it finds 

that there are no genuine issues of 

material fact in dispute, and a party is 

entitled to judgement as a matter of law 

(see Rule 56, Federal Rules of Civil 

Procedure). The same principle applies 

to administrative proceedings (§ 12.24). 

In reviewing whether an objecting party 

made ‘‘an adequate proffer of evidence’’ 

to show that an ‘‘actual dispute 

exist[s],’’ courts consider whether the 

dispute lies in ‘‘a highly technical area 

[within] the agency’s expertise’’ (see 

Cerro Wire & Cable Co. v. FERC, 677 

F.2d 124, 129 (D.C. Cir. 1982)). 

A hearing request must not only 

contain evidence, but that evidence also 

must raise a material issue of fact 

‘‘concerning which a meaningful 

hearing might be held’’ (Pineapple 

Growers Ass’n of Haw. v. FDA, 673 F.2d 

1083, 1085 (9th Cir. 1982)). Where the 

issues raised in the objection are, even 

if true, legally insufficient to alter the 

decision, an agency need not grant a 

hearing (see Dyestuffs and Chemicals, 

Inc. v. Flemming, 271 F.2d 281, 286 (8th 

Cir. 1959), cert. denied, 362 U.S. 911 

(1960)). A hearing is justified only if the 

objections are made in good faith and if 

they raise ‘‘ ‘material’ issues of fact’’ 

(Pineapple Growers Ass’n, 673 F.2d at 

1085 (quoting Pactra Indus., Inc. v. 

CPSC, 555 F.2d 677, 684 (9th Cir. 

1977)). The issues raised in objections 

‘‘must be material to the question 

involved; that is, the legality of the 

order attached’’ (Pineapple Growers 

Ass’n, 673 F.2d at 1085 (quoting 

Dyestuffs and Chemicals, 271 F.2d at 

286)). A hearing need not be held to 

resolve questions of law and policy (see 

Kourouma v. FERC, 723 F.3d 274, 278 

(D.C. Cir. 2013) (citing Citizens for 

Allegan County, Inc. v. FPC, 414 F.2d 

1125, 1128 (D.C. Cir. 1969)); Sun Oil Co. 

v. FPC, 256 F.2d 233, 240 (5th Cir. 

1958)). 

IV. Analysis of Objections and 

Response to Hearing Requests 

The submission from the 

Environmental Defense Fund et al., 

contains eight numbered objections, 

some with multiple parts, and six 

requests for a hearing. We address each 

objection below, as well as any evidence 

and/or information filed in support of 

each. For each objection that requests a 

hearing, we evaluate whether the 

objection and any evidence and/or 

information submitted in support of it 

satisfies the standards for granting a 

hearing in § 12.24(b). 

A. Objection 1 

In Objection 1, the objectors argue 

that ‘‘FDA unlawfully placed on the 

petitioners the burden of proving that 

the approved food-additive uses of 

phthalates are not safe’’ (Objections at 

8). The objectors assert that ‘‘this legal 

error infected FDA’s entire analysis and 

requires FDA to withdraw’’ its order 

denying FAP 6B4815 (Objections at 13). 

Because this objection raises a purely 

legal dispute, no hearing is warranted to 

adjudicate it (§ 12.24(b)(1)). Even if a 

hearing were available, the objectors did 

not request one with respect to this 

objection and, therefore, waive any right 

to a hearing (§ 12.22(a)(4)). The only 

remaining issue on this objection, then, 

is whether it establishes that FDA’s 

order denying FAP 6B4815 should be 

modified or revoked. As described 

below, we conclude that the objectors 

have not established a basis for 

modifying or revoking the denial order. 


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In Objection 1, the objectors assert 

that FDA reviewed FAP 6B4815 under 

an incorrect legal standard. The 

objectors argue that FDA must not 

expect revocation petitions to 

demonstrate the lack of safety of the 

food additives whose approvals the 

petitions seek to revoke. The objectors 

state that ‘‘parties petitioning FDA to 

revoke approval of a food additive on 

safety grounds do not bear the burden 

of proving that the additive is unsafe, 

i.e., that it will cause harm to human 

health under the intended conditions of 

use’’ (Objections at 9). Placing such a 

burden on the party seeking revocation 

would, the objectors assert, ‘‘be 

inconsistent with the Food Act’s central 

premise for food-additive regulation, 

namely, that food additives are 

presumptively unsafe and may not be 

used unless the available evidence 

establishes with ‘reasonable certainty’ 

that their use ‘will be safe’ ’’ (id. 

(quoting section 409(c)(3)(A) of the 

FD&C Act)). (The reference to the ‘‘Food 

Act’’ is a reference to the FD&C Act.) 

The objectors also assert that FDA’s 

basis for denying FAP 6B4815 is 

inconsistent with our regulations. The 

objectors point to § 171.130 (21 CFR 

171.130), which provides that petitions 

seeking amendments or repeals of 

existing food additive approvals must 

‘‘include an assertion of facts, supported 

by data, showing that new information 

exists with respect to the food additive 

or that new uses have been developed 

or old uses abandoned, that new data 

are available as to toxicity of the 

chemical, or that experience with the 

existing regulation may justify its 

amendment or repeal’’ (Objections at 

10). The objectors interpret this 

regulation to mean that repeal petitions 

are required only to ‘‘[tender] new 

information regarding a food additive’s 

toxicity or otherwise demonstrating that 

amendment or repeal of the additive’s 

authorization may be justified’’ but do 

not bear ‘‘the burden of persuasion on 

the ultimate question of an additive’s 

safety’’ (id.). Therefore, the objectors 

contend, ‘‘the burden of persuasion on 

the ultimate question of safety lies with 

the party advocating for continued 

authorization of the product’’ (id. at 11). 

The objectors state that FDA applied an 

incorrect standard to evaluating FAP 

6B4815 because ‘‘FDA did not assess in 

the Order whether the petitioners 

provided ‘new information’ regarding 

the ‘toxicity of the chemical[s]’ at issue, 

as its regulations require, nor whether 

that information ‘establish[es] the 

existence of safety questions significant 

enough to support a finding that there 

is no longer a reasonable certainty of no 

harm from the currently approved 

uses’ ’’ (id. at 12 (quoting § 171.130(b) 

and the denial order at 87 FR 31066 at 

31067)). 

The objectors state that their position 

is consistent with League of United 

Latin Am. Citizens v. Regan, 996 F.3d 

673 (9th Cir. 2021), a case involving the 

U.S. Environmental Protection Agency’s 

(EPA’s) regulation of pesticides 

(Objections at 10–11). The objectors 

further state their position is consistent 

with FDA’s statement in a final rule 

concerning the food additive olestra (61 

FR 3118, January 30, 1996) as well as 

the standard FDA applied in revoking 

food-additive authorizations for certain 

long-chain perfluorinated compounds 

(81 FR 5, January 4, 2016) (Objections at 

12). 

The crux of these arguments is that 

‘‘FDA unlawfully placed the burden of 

proof regarding the safety of the 

phthalate additives on the petitioners, 

asserting that FDA need only revoke a 

food additive authorization if presented 

with new evidence that ‘approved 

additives are in fact unsafe’ ’’ 

(Objections at 12 (emphasis in original)). 

Finally, the objectors criticize FDA’s 

approach in denying FAP 6B4815 on the 

same day that we amended our 

regulations to no longer provide for 

most phthalates to be used in food 

contact applications because these uses 

were abandoned by industry (Objections 

at 12). The objectors state that the 

abandonment action ‘‘significantly 

altered the scope of food-additive 

authorizations for phthalates that 

remain in effect, and for which a safety 

evaluation is still required’’ (id.). The 

objectors state that our action ‘‘reflects 

FDA’s erroneous position that it may 

leave the extant food-additive 

authorizations in effect unless and until 

petitioners prove that they are in fact 

unsafe’’ (id. at 12–13). 

FDA Response: We disagree with the 

assertion that FDA applied an incorrect 

legal standard in evaluating FAP 

6B4815. It is fundamental that a food 

additive petition—whether requesting 

an authorization, modification, or 

repeal—must provide sufficient support 

for its request. 

We denied FAP 6B4815 because it 

failed to provide sufficient support for 

its request to revoke the authorization 

for the 28 ortho-phthalates that were the 

subject of the petition. In reviewing FAP 

6B4815, we observed that the petition 

was premised on three distinct 

assertions (which, for ease of reference, 

we referred to as Assertions A, B, and 

C). Assertion A claimed that the 28 

subject ortho-phthalates are chemically 

and pharmacologically related and 

should therefore be treated as a class for 

purposes of evaluating their safety. 

Under Assertion B, the petition 

proposed applying a purported ADI for 

di(2-ethylhexyl) phthalate (DEHP) to all 

28 ortho-phthalates (i.e., the petition 

proposed applying the proposed ADI to 

the entire purported class). Assertion C 

stated that the estimated daily intake 

(EDI) for the asserted class of 28 orthophthalates significantly exceeded the 

proposed ADI, thus rendering the 

purported class unsafe for their 

authorized uses as food contact 

substances. Our denial order explained 

in detail why the petition did not 

adequately support any of these three 

assertions. Consequently, we concluded 

that the petition did not contain 

sufficient data to support a finding that 

there is no longer a reasonable certainty 

of no harm from the approved uses (87 

FR 31066 at 31075). As an additional 

matter, we noted that, based on the 

information available to FDA, we did 

not have a basis to conclude that dietary 

exposure levels from authorized orthophthalates exceeded a safe level (id.). 

We stated that, as new information 

becomes available to us, we will 

continue to examine such data as 

appropriate to assess whether there 

remains a reasonable certainty of no 

harm (id.). 

Objection 1 rests on a flawed 

interpretation of the FD&C Act’s legal 

framework governing food additives—in 

particular, its provisions concerning the 

premarket review of food additives. 

Under this framework, food additives 

are deemed unsafe and prohibited 

except to the extent FDA authorizes 

their use (see, e.g., sections 301(a), 

301(k), and 409(a) of the FD&C Act (21 

U.S.C. 331(a), 331(k), and 348(a))). 

Section 409 of the FD&C Act sets forth 

a process under which a person can 

submit a petition requesting that FDA 

issue a regulation prescribing the 

conditions under which a food additive 

may be safely used (see section 409(b)(1) 

of the FD&C Act). The statute specifies 

that a person must support such a 

petition by supplying the data specified 

in section 409(b)(2) of the FD&C Act. 

After a person submits a petition 

seeking approval of a food additive’s 

use, FDA may issue a regulation 

authorizing the use only if the data 

before us establish that the proposed use 

of the food additive will be safe (see 

section 409(c)(3)(A) of the FD&C Act). 

In addition to establishing the 

procedure for issuing regulations 

authorizing food additives, Congress 

directed FDA to establish a regulatory 

procedure prescribing how regulations 

authorizing food additives may be 

amended or repealed (see section 409(i) 

of the FD&C Act). Importantly, the 


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statute specifies that this regulatory 

‘‘procedure shall conform to the 

procedure provided in this section for 

the promulgation of such regulations’’ 

(id.) (emphasis added) (section 409(i) of 

the FD&C Act). FDA’s regulation at 

§ 171.130 establishes the procedure by 

which interested persons may petition 

FDA for amending or repealing a food 

additive authorization. 

FDA’s approach to evaluating FAP 

6B4815 was fully consistent with the 

legal framework described above. The 

provisions of section 409 of the FD&C 

Act make clear that the evidentiary 

burden to support authorization of a 

food additive’s use lies with the 

petitioner seeking such authorization 

(see section 409(b) and (c) of the FD&C 

Act). Given the FD&C Act’s directive 

that the regulatory procedure for 

amending or repealing an authorization 

‘‘shall conform’’ to the statutory 

procedure for granting an authorization, 

it follows that a person seeking 

amendment or repeal likewise must 

provide a well-supported petition 

adequately justifying such action. See 

section 409(i) of the FD&C Act; In re 

Nat. Res. Def. Council, 645 F.3d 400, 

403 (D.C. Cir. 2011) (‘‘When a food 

additive petition seeks to amend an 

existing regulation, the petitioner must 

include full information on each 

proposed change’’) (internal quotations 

and citations omitted). FDA’s denial 

order thoroughly explained why the 

petition did not provide adequate 

evidence to support its requested 

postmarket remedy: the repeal of 

already-authorized food additive uses. 

This conclusion did not conflict in any 

way with the premarket review 

framework invoked by the objectors. 

Moreover, to the extent the objectors 

contend that FDA disregarded any 

general statutory obligation to remove 

unsafe products from the market, we 

note that we have made no finding that 

the subject food additives are unsafe. 

Indeed, our denial order stated that we 

did not have a basis to conclude that 

dietary exposure levels from authorized 

ortho-phthalates exceeded a safe level 

(87 FR 31066 at 31075). 

The objectors’ argument that FDA 

disregarded its own regulations is also 

in error. This argument relies on a 

portion of § 171.130(b) providing that 

petitions for amendment or repeal must 

include an assertion of facts, supported 

by data, showing that new information 

exists. Citing this excerpt, the objectors 

maintain that this regulation 

‘‘establishes that petitioners seeking 

revocation of a food-additive regulation 

bear a burden of production— 

specifically, the burden of tendering 

new information regarding a food 

additive’s toxicity or otherwise 

demonstrating that amendment or 

repeal of the additive’s authorization 

may be justified’’ (Objections at 10). To 

the extent that the objectors assert that 

a repeal petition need only point to the 

existence of new toxicity data, this 

argument disregards the concluding 

sentence of § 171.130(b). 

The concluding sentence provides 

that new data must be furnished in the 

form specified in § 171.1 (21 CFR 171.1) 

for submitting petitions. Under 

§ 171.1(c), a petition must include ‘‘full 

reports of investigations made with 

respect to the safety of the food 

additive.’’ In addition, § 171.1(c) 

provides that a petition ‘‘may be 

regarded as incomplete unless it 

includes full reports of adequate tests 

reasonably applicable to show whether 

or not the food additive will be safe for 

its intended use.’’ Further, under 

§ 171.1(c), for petitions seeking 

modification of existing regulations 

issued pursuant to section 409(c)(1)(A) 

of the FD&C Act (i.e., a regulation 

authorizing the use of a food additive 

under specified conditions), ‘‘full 

information on each proposed change 

that is to be made in the original 

regulation must be submitted.’’ 

Accordingly, petitions seeking 

revocation of a food additive regulation 

must do more than merely identify the 

existence of new toxicity studies. See 

also In re NRDC, 645 F.3d at 403 

(considering petition to repeal existing 

food additive authorization and citing 

§ 171.1 to conclude that food additive 

petitions seeking to amend existing food 

additive authorizations must include 

full information on each proposed 

change). Thus, FDA’s regulations make 

clear that repeal petitions such as FAP 

6B4815 must include adequate 

supporting information. We therefore 

acted consistently with our regulations 

when we evaluated FAP 6B4815 to 

determine whether its assertions were 

supported and whether the petition 

contained sufficient data to support a 

finding that there is no longer a 

reasonable certainty of no harm from the 

currently approved uses. 

Next, the objectors maintain that 

FDA’s approach in evaluating FAP 

6B4815 was inconsistent with the 

following: (1) the League of United Latin 

Am. Citizens v. Regan, 996 F.3d 673 

(9th Cir. 2021), a case involving EPA’s 

regulation of pesticides; (2) an FDA 

statement in a food additive proceeding 

involving olestra; and (3) FDA’s action 

on three specific perfluoroalkyl ethylcontaining food-contact substances. We 

address each of these in turn. 

First: The League of United Latin Am. 

Citizens (LULAC) case cited by the 

objectors is not germane because its 

holding was based on a distinct 

statutory scheme applicable to 

pesticides under section 408 of the 

FD&C Act (21 U.S.C. 346a) and factual 

circumstances different from the facts 

underlying this proceeding. In that case, 

EPA had received a petition asking the 

agency to prohibit foods that contained 

any residue of the insecticide, 

chlorpyrifos (996 F.3d at 673). EPA 

argued that the agency could leave in 

effect tolerances for the pesticide while 

the agency continued to evaluate the 

science (id. at 688). The LULAC court 

held that EPA has a continuing 

obligation under section 408 of the 

FD&C Act to ensure the safety of 

established pesticide tolerances that 

were previously found to be safe (id. at 

691) (finding that EPA ‘‘has its own 

continuing duty under [section 408 of 

the FD&C Act] to determine whether a 

tolerance that was once thought to be 

safe still is’’). The court’s conclusion 

regarding EPA’s continuing obligation 

was based on statutory language in 

section 408 of the FD&C Act that is 

materially different from the language in 

section 409 of the FD&C Act at issue in 

this proceeding. 

Under section 408(b)(2)(A)(i) of the 

FD&C Act, EPA ‘‘may establish or leave 

in effect a tolerance for a pesticide 

chemical residue in or on a food only 

if the Administrator determines that the 

tolerance is safe’’ (emphasis added). In 

contrast, section 409 of the FD&C Act 

does not contain anything comparable 

to the ‘‘leave in effect a tolerance . . . 

only if the Administrator determines 

that the [substance] is safe’’ language in 

section 408, which was the linchpin for 

the LULAC court’s conclusion that EPA 

had ‘‘a continuous duty’’ to determine 

whether a tolerance for a pesticide 

chemical reside is safe (id. at 692 

(‘‘[Section 408 of the FD&C Act] 

imposes a continuous duty upon the 

EPA by permitting it to ‘leave in effect’ 

a tolerance ‘only’ if it finds it is safe. To 

‘leave’ something in effect means ‘to 

cause or allow [it] to be or remain in a 

specified condition. Denying the 2007 

Petition caused the chlorpyrifos 

tolerances to remain in place . . . . But 

in so doing, the EPA did not 

‘[determine] that the tolerance is 

safe.’ ’’)) (Compare Sec. 409 of the FD&C 

Act). 

Further, unlike section 408 of the 

FD&C Act, section 409 of the FD&C Act 

directs FDA to establish procedures for 

repealing food additive authorizations 

that ‘‘shall conform’’ to the statutory 

procedure for promulgating 

authorizations, under which the 

evidentiary burden to support 

authorization of a food additive’s use 


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lies with the petitioner seeking such 

authorization (see section 409(c) and (i) 

of the FD&C Act). Given the statutory 

framework established in section 409 of 

the FD&C Act and the ways in which it 

differs from the framework established 

in section 408 of the FD&C Act, it was 

entirely reasonable that FDA assessed 

the information in the objectors’ repeal 

petition to determine whether there was 

sufficient data to establish the existence 

of safety questions significant enough to 

support a finding that there is no longer 

a reasonable certainty of no harm from 

the approved ortho-phthalates’ uses. 

Furthermore, the factual circumstances 

are distinct. In LULAC, the record 

showed that EPA ‘‘repeatedly 

determined’’ that the pesticide at issue 

was unsafe under the approved 

tolerance levels. Here, however, FDA 

has never determined the orthophthalates at issue in this proceeding to 

be unsafe. Instead, our denial order 

explained that FDA did not have a basis 

to conclude that dietary exposure levels 

from approved ortho-phthalates exceed 

a safe level (87 FR 31066 at 31075). 

Second: The objectors cite as support 

for their argument the following 

statement in the Federal Register 

document announcing FDA’s decision 

to approve olestra: ‘‘It is important to 

recognize that to institute a proceeding 

to limit or revoke the approval of 

olestra, FDA would not be required to 

show that olestra is unsafe. Rather, the 

agency would only need to show that 

based upon new evidence, FDA is no 

longer able to conclude that the 

approved use of olestra is safe, i.e., that 

there is no longer a reasonable certainty 

of no harm from the use of the additive’’ 

(Objections at 11 (quoting 61 FR 3118 at 

3169)). The objectors also refer to a 

statement in the olestra proceeding 

where FDA stated that ‘‘in any 

proceeding to [withdraw] or limit the 

approval of olestra, Procter and Gamble 

would have the burden to establish the 

safety of the additive’’ (Objections at 11, 

n. 39 (quoting 61 FR 3118 at 3169); see 

also § 12.87(c)). The objectors cite these 

excerpts from the olestra proceeding as 

support for the following proposition: 

‘‘FDA has stated plainly that when FDA 

is in the position of raising concerns 

about the safety of a food additive or 

other product that it has previously 

authorized, the agency bears only an 

initial burden of producing new 

information that calls into question its 

previous safety finding; the burden of 

persuasion on the ultimate question of 

safety lies with the party advocating for 

continued authorization of the product’’ 

(Objections at 11). However, contrary to 

the objectors’ suggestion, FDA did not 

say or imply that we would initiate 

revocation proceedings based merely on 

new information that might ‘‘[call] into 

question its previous safety finding,’’ 

nor did FDA say or imply that we would 

be required to initiate such a proceeding 

upon being presented with such 

information. Instead, FDA stated that, to 

initiate the withdrawal process, we 

would ‘‘need to show that based upon 

new evidence, FDA is no longer able to 

conclude that the approved use of 

olestra is safe, i.e., that there is no longer 

a reasonable certainty of no harm from 

the use of the additive’’ (61 FR 3118 at 

3169). Subsequently, in a hearing 

regarding the withdrawal of olestra, we 

stated that the sponsor, Procter and 

Gamble, would then have the burden of 

establishing safety (id. (citing 

§ 12.87(c)). Our review of FAP 6B4815 

was entirely consistent with the 

statements from the olestra proceeding 

cited by the objectors as to the evidence 

necessary to initiate the process of 

repealing a food additive authorization. 

In reviewing FAP 6B4815, we 

concluded that its assertions were not 

adequately supported, and therefore, the 

petition did not contain sufficient data 

to support a finding that there is no 

longer a reasonable certainty of no harm 

from the currently approved uses of the 

subject ortho-phthalate food additives 

(87 FR 31066 at 31075). Accordingly, we 

did not grant the petition’s request that 

we institute proceedings to repeal the 

authorizations that were the subject of 

FAP 6B4815. 

Third: Regarding FDA’s action to 

revoke the authorizations for the food 

additive uses of three specific 

perfluoroalkyl-ethyl-containing foodcontact substances (see 81 FR 5), the 

objectors state that FDA did so ‘‘based 

on data raising ‘significant questions as 

to the safety of the authorized uses’ ’’ 

(Objections at 9). However, the 

objectors’ characterization of what 

FDA’s perfluoroalkyl ethyl action was 

‘‘based on’’ misunderstands the basis for 

that action. FDA stated in the 

perfluoroalkyl ethyl order that ‘‘we 

conclude that there is no longer a 

reasonable certainty of no harm for the 

food contact use of these [substances]’’ 

and that we were, therefore, taking the 

revocation action (81 FR 5 at 7). 

FDA did not state that the 

perfluoroalkyl ethyl revocation action 

was being instituted based on a finding 

of ‘‘significant questions’’ in isolation. 

Instead, FDA stated that ‘‘[i]n order for 

FDA to grant a petition that seeks an 

amendment to a food additive 

regulation based upon new data 

concerning the toxicity of the food 

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 substance’’ (81 FR 

5 at 7) (FDA’s statements in the orthophthalates denial order were consistent, 

see 87 FR 31066 at 31067). 

Finally, the objectors criticize FDA’s 

approach in denying FAP 6B4815 on the 

same day that we amended our 

regulations to no longer provide for 25 

ortho-phthalates to be used in food 

contact applications because these uses 

were abandoned by industry (i.e., the 

abandonment final order). We issued 

the abandonment final order in response 

to a separate food additive petition that 

was based on abandonment, not safety 

(see 87 FR 31080). While the objectors 

assert that our decision to take action 

based on abandonment ‘‘reflects FDA’s 

erroneous position that it may leave the 

extant food-additive authorizations in 

effect unless and until petitioners prove 

that they are in fact unsafe,’’ this 

assertion is unsupported. 

We did not deny FAP 6B4815 for the 

reason that the petition failed to prove 

that the ortho-phthalates are in fact 

unsafe (i.e., they cause harm under their 

intended conditions of use); that was 

not the necessary showing. Instead, we 

denied FAP 6B4815 because the 

assertions in the petition were not 

adequately supported and the petition 

did not contain sufficient data to 

support a finding that there is no longer 

a reasonable certainty of no harm from 

the approved uses (i.e., FAP 6B4815 did 

not contain sufficient data to support a 

finding that there is no longer a 

reasonable certainty in the minds of 

competent scientists that the substances 

are not harmful under the conditions of 

their intended use, see § 170.3(i) (21 

CFR 170.3(i)). Our denial order (87 FR 

31066) correctly stated that a petition 

that seeks to amend or repeal existing 

regulations based on safety must contain 

sufficient data to establish the existence 

of safety questions significant enough to 

support a finding that there is no longer 

a reasonable certainty of no harm from 

the currently approved uses (see 87 FR 

31066 at 31067 (citing section 409(c) of 

the FD&C Act) (describing the data 

requirements); §§ 171.1 through 171.130 

(prescribing food additive petition 

regulations)). 

For all these reasons, we disagree 

with the objectors’ assertion that we 

committed any legal error that justifies 

modifying or revoking our denial order. 

B. Objection 2 

In Objection 2, the objectors state that 

‘‘FDA unlawfully failed to evaluate the 

safety of the food-additive uses of 

phthalates that remain authorized’’ 

(Objections at 13). The objectors refer to 

the fact that FDA issued the denial order 


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on the same day that we issued the 

abandonment final order, which 

amended our regulations to remove food 

additive authorizations for the use of 25, 

but not all, authorized ortho-phthalates 

that were the subject of FAP 6B4815 

(see 87 FR 31080). FDA took this action 

based on evidence that the authorized 

food additive uses of most, but not all, 

of those ortho-phthalates were 

abandoned (id. at 31086). We did not 

receive evidence showing abandonment 

for the following five ortho-phthalates 

that remain authorized as food additives 

for specified uses: diisononyl phthalate 

(DINP) (CAS No. 28553–12–0), 

diisodecyl phthalate (DIDP) (CAS No. 

26761–40–0), di(2-ethylhexyl) phthalate 

(DEHP) (CAS No. 117–81–7), 

dicyclohexyl phthalate (DCHP) (CAS 

No. 84–61–7), and diallyl phthalate 

(DAP) (CAS No. 131–17–9, for use as a 

monomer). Therefore, the food additive 

authorizations for these five orthophthalates remain in place. 

The objectors assert that FDA failed to 

meet its obligation to oversee the safety 

of the food supply by not conducting a 

new safety analysis for these five orthophthalates that remain authorized as 

food additives (Objections at 13). The 

objectors assert that FDA failed to 

satisfy its obligations to evaluate 

whether FAP 6B4815 contained ‘‘ ‘new 

data . . . that would justify amendment’ 

of the applicable authorizations’’ by 

assessing both ‘‘the data and 

information in the petition and other 

available relevant material.’ ’’ (id. at 14 

(quoting 81 FR 7, FDA’s revocation of 

certain perfluoroalkyl ethyl-containing 

food-contact substances)). The objectors 

also state that FDA’s separate RFI (87 FR 

31090) regarding the still-authorized 

ortho-phthalates constituted an 

‘‘attempt to kick the proverbial can 

down the road’’ that discredits FDA’s 

assertion in its response to FAP 6B4815 

that it had adequately assessed currently 

available research regarding phthalates, 

and that ‘‘unlawfully . . . defer[red]’’ 

consideration of an ‘‘[issue] that FDA 

was required to address—years ago—in 

response to [FAP 6B4815]’’ (id. at 15– 

16). 

The objectors do not request a 

hearing. Therefore, the objectors waive 

their right to a hearing on this objection 

(§ 12.22(a)(4)). The only remaining issue 

on Objection 2, then, is whether it 

establishes that FDA’s order denying 

FAP 6B4815 should be modified or 

revoked. As described below, we 

conclude that the objectors have not 

established a basis for modifying or 

revoking the denial order. 

FDA Response: We do not agree with 

the objectors’ assertions that FDA’s 

response to FAP 6B4815 was unlawful 

because FDA did not conduct a new 

safety analysis of DINP, DIDP, DEHP, 

DCHP, and DAP; i.e., the five orthophthalates that were the subject of their 

petition that still have food additive 

authorizations in effect. When we 

originally authorized the use of these 

five additives, we concluded that the 

use of the food additives satisfied the 

statutory safety standard. 

FAP 6B4815 did not identify 

deficiencies with our original approval 

of phthalates for food contact use. 

Instead, FAP 6B4815 proposed a classbased grouping approach for evaluating 

the safety of the subject orthophthalates. In FAP 6B4815, the 

petitioners proposed that the 

authorizations should be revoked 

because, according to the petition: the 

subject ortho-phthalates share common 

chemical and pharmacological 

characteristics that justify grouping 

them as a class; a single ADI value from 

one ortho-phthalate should be applied 

to all members of the proposed class 

collectively; and both the EDI value for 

select phthalates as well as the 

cumulative estimated daily intake for 

the proposed class significantly exceeds 

the purported ADI value for the 

proposed class. In Objection 2, the 

objectors turn their attention to the 

phthalates that remain authorized as 

food additives. Regarding these orthophthalates that remain authorized, we 

conducted additional analysis by 

evaluating, in a supplementary 

memorandum, whether the core premise 

of FAP 6B4815 (i.e., the assertion that 

the subject ortho-phthalates should be 

grouped as a class for purposes of a 

safety assessment) could be applied to 

the five still-authorized orthophthalates. Our review used the 

information contained in the petition as 

well as other available information, 

including assessments from other 

regulatory bodies (Ref. 1). In that 

memorandum, which we made publicly 

available on the docket, we explained 

why the information before us did not 

support the grouping of these five 

substances for purposes of a safety 

assessment (id.). We based this 

conclusion on the structural variations 

and the differences in metabolites, 

metabolism, and toxicological endpoints 

across the substances. We described 

these differences and the scientific 

literature we reviewed in the 

memorandum (id.). 

Objection 2 urges us to disregard the 

very approach for analyzing food 

additive safety that the petitioners 

proposed in FAP 6B4815. Specifically, 

Objection 2 asserts that FDA committed 

legal error by not conducting a new 

safety assessment for the five stillauthorized ortho-phthalates even 

though FDA analyzed these substances 

in accordance with the class-grouping 

approach proposed by FAP 6B4815. 

Therefore, Objection 2 ignores the fact 

that we assessed the appropriateness of 

class grouping the five still-authorized 

ortho-phthalates (Ref. 1). Objection 2 

largely recasts the arguments made in 

Objection 1 but with respect to the five 

still-authorized ortho-phthalates. It does 

this by citing FDA’s statement in the 

Federal Register document in which we 

authorized olestra, where we referred to 

‘‘the agency’s continuing obligation to 

oversee the safety of the food supply’’ 

(61 FR 3118 at 3168; see also Objections 

at 13–14 and 16). 

Our responses to Objection 1’s 

assertions apply with equal force to 

Objection 2’s assertions that we are 

required to conduct a new safety 

assessment with respect to the five stillauthorized ortho-phthalates; as 

explained earlier, a petition that seeks to 

amend or repeal existing regulations 

based on safety must contain sufficient 

data to establish the existence of safety 

questions significant enough to support 

a finding that there is no longer a 

reasonable certainty of no harm from the 

currently approved uses. This standard 

for review is consistent with FDA’s 

actions in the olestra proceeding. 

Moreover, the administrative record 

makes it clear that we satisfied our 

duties in reviewing FAP 6B4815. We 

reviewed the assertions in FAP 6B4815 

in detail. In a separate memorandum, 

we evaluated the five still-authorized 

ortho-phthalates, using the same core 

premise of class grouping proposed in 

FAP 6B4815 (Ref. 1). 

Objection 2 also accuses FDA of 

publishing its RFI (87 FR 31090) to 

‘‘unlawfully . . . defer its evaluation of 

whether the agency’s current 

authorizations for food-contact uses of 

phthalates are in fact safe’’ (Objections 

at 15). However, our publication of the 

RFI, which sought scientific data and 

information on current uses, use levels, 

dietary exposure, and safety data of 

certain ortho-phthalates, was intended 

to seek any data that we do not possess, 

which ‘‘may add to our knowledge of 

ortho-phthalates that remain authorized 

for use’’ (see 87 FR 31090–31091). The 

fact that we sought data from the public 

to inform our oversight of authorized 

ortho-phthalates does not reflect any 

deficiency in our evaluation of the 

specific assertions in FAP 6B4815 based 

on the information that was in the 

record. 

Objection 2 also takes issue with 

FDA’s response to a comment to the 

docket concerning FAP 6B4815, in 

which we stated that ‘‘FDA is aware of 


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the research that has been conducted 

with respect to phthalates and that FDA 

considered ‘the research in its 

evaluation of the petition’ ’’ (Objections 

at 14 (quoting 87 FR 31066 at 31076)). 

The objectors criticize FDA for not 

disclosing how we considered ‘‘the 

research that has been conducted with 

respect to phthalates’’ (Objections at 14). 

The objectors also assert that FDA’s 

statement about having considered the 

research related to phthalates ‘‘cannot 

be credited’’ given that we issued the 

RFI on the same day that we denied 

FAP 6B4815. The statements that the 

objectors excerpt in Objection 2 were 

made in response to comments that 

referred to literature describing 

phthalates as hormone disrupting 

chemicals that are linked to certain 

adverse health outcomes (see 87 FR 

31066 at 31076). We responded to the 

comments by stating that we are 

generally aware of the research on 

phthalates and considered the research 

cited in the comments (id.). 

The denial order, as well as the 

memoranda we made publicly available 

when we published the denial order 

(specifically, the chemistry 

memorandum, the toxicology 

memorandum, and the memorandum 

evaluating the five still-authorized 

ortho-phthalates), demonstrate that we 

considered the numerous research 

studies in the administrative record, 

including the research cited in the 

comments (Refs. 1, 3, and 4). While we 

are generally aware of updated 

toxicological and use information that is 

publicly available, we published the RFI 

so that we could obtain a more complete 

picture of the data relevant to the 

general safety, dietary exposure, and 

usage of ortho-phthalates, which may 

include data that stakeholders have not 

made public (see 87 FR 31090). 

Objection 2 also includes certain 

other arguments. In the last paragraph of 

Objection 2, the objectors repeat 

arguments they made in Objection 1 

regarding the type of evidence that FAP 

6B4815 was required to proffer 

(Objections at 16). Because we address 

these arguments in response to 

Objection 1, we do not repeat our 

evaluation of these arguments here. A 

footnote in Objection 2 also refers to the 

premarket review requirements for food 

additives (Objections at 14, n.48). 

However, as explained in response to 

Objection 1, FAP 6B4815 is a request for 

postmarket action, and our response to 

the petition did not conflict with the 

premarket review framework invoked by 

the objectors. Additionally, Objection 2 

asserts that FDA should have evaluated 

FAP 6B4815 to determine whether it 

presented new data (Objections at 16). 

As explained in our response to 

Objection 1 regarding the olestra 

proceeding, repeal petitions must do 

more than merely point to the existence 

of new data. 

For these reasons, we disagree with 

the objectors’ assertion that we 

committed any legal error that justifies 

modifying or revoking our denial order. 

C. Objection 3 

In Objection 3, the objectors argue 

that FDA’s denial order ‘‘fails to address 

new toxicity information that raises 

significant questions about the safety of 

the approved food-additive uses of 

phthalates’’ (Objections at 17). In 

particular, the objectors state that new 

information became available since 

petitioners last supplemented the record 

for FAP 6B4815 in 2017. The objectors 

point to numerous studies and 

declarations concerning the health 

effects of ortho-phthalates. Most of these 

studies and declarations were submitted 

to the docket dedicated to their citizen 

petition addressing ortho-phthalates. In 

light of these studies and declarations, 

the objectors state that FDA should not 

have allowed DAP, DCHP, DEHP, DINP, 

and DIDP to remain authorized for foodcontact use ‘‘without addressing the 

substantial body of relevant toxicity 

information’’ (Objections at 17). 

The information that the objectors 

identify in Objection 3 includes studies 

that they describe as linking DEHP 

exposure to developmental toxicity, 

developmental neurotoxicity, adult 

neurotoxicity, reproductive toxicity, 

endocrine disruption, hepatoxicity, 

metabolic toxicity, immunotoxicity, and 

epigenetic alterations (id. at 17–18). The 

objectors describe these studies as 

‘‘provid[ing] evidence for a number of 

DEHP-related adverse health outcomes, 

including altered adult sex behavior, 

delayed puberty, insulin sensitivity, 

obesity, hypothyroidism, cognitive 

impairment, and even depressive-link 

behaviors’’ (Objections at 18). The 

objectors further assert that animal 

studies have linked DINP exposure to 

hepatoxicity and exacerbated nerve cell 

damages and decline in learning and 

memory, as well as elevated cholesterol 

(id.). In addition, the objectors assert 

that two studies ‘‘found that phthalate 

mixtures induced reproductive tract 

malformations in male rats’’ and point 

to epidemiological studies they describe 

as ‘‘providing relevant toxicity 

information’’ with respect to 

associations between DEHP and 

multiple adverse health outcomes (id. at 

18). The objectors reference studies they 

describe as linking DINP and/or DEHP 

to insulin resistance, delayed puberty 

onset in boys, preterm birth, and 

neurodevelopmental harm (id. at 19). 

The objectors further point to certain 

publications by federal and European 

agencies (id.). Finally, the objectors 

point to the declarations they submitted 

to FDA that assert that phthalate 

exposure causes harm (id. at 20). The 

objectors request a hearing on Objection 

3. They state that the hearing would 

address ‘‘whether the many years’ worth 

of data and information regarding the 

human health hazards of phthalates 

found in the diet presented in support 

of the Petition and Objections raise 

significant questions regarding the 

safety of the authorized food-additive 

uses of DAP, DCHP, DEHP, DINP, and 

DIDP’’ (Objections at 21). 

FDA Response: To justify a hearing on 

this objection, it is not enough for the 

objectors to simply name health effects 

linked to the still-authorized orthophthalates or to list publications and 

declarations that address the topic of 

ortho-phthalates generally. The 

objectors cite numerous recent studies 

and publications but do not provide 

meaningful analysis or explanation for 

why these materials support a finding 

that there are significant questions about 

the safety of the still-authorized orthophthalates for their currently authorized 

conditions of use. The objectors’ mere 

citation of these studies and 

declarations is not adequate to justify 

resolution in the objectors’ favor of the 

factual question about safety of the stillauthorized food additive uses of orthophthalates; the existence of toxicity 

findings, alone, is insufficient to 

establish significant questions about 

whether there is no longer a reasonable 

certainty of no harm for an authorized 

use and is, therefore, insufficient to 

justify resolution of the factual question 

of safety (§ 12.24(b)(3)). 

All substances exhibit toxic effects at 

high enough exposure levels, and most 

substances exhibit an exposure 

threshold below which they do not 

exhibit a toxic effect. To support an 

assertion that the authorized use of a 

substance is unsafe or presents 

significant safety questions, it is not 

sufficient to cite studies that indicate 

that a substance is associated with a 

toxic effect; rather, that effect must be 

placed in the context of exposure. For 

this reason, when evaluating the safety 

of a substance, scientists will often 

determine the ‘‘dose-response’’ 

relationship of substance exposure and 

toxic effect. 

To establish with reasonable certainty 

whether a food additive is harmful 

under its intended conditions of use, 

FDA considers the projected human 

dietary exposure to the food additive, 

the additive’s toxicological data, and 


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other available relevant information 

(such as published literature). To 

determine safety, one approach we may 

use is to compare the estimated dietary 

intake of the food additive to an ADI 

level established by appropriate 

toxicological data. An ADI is the 

amount of a substance that is considered 

safe to consume each day over the 

course of a person’s lifetime (Ref. 2). 

The ADI is typically based on an 

evaluation of toxicological studies to 

determine the highest appropriate 

experimental exposure dose level in 

animal studies that was shown to cause 

no adverse effect (also known as the noobserved-adverse-effect level, or 

NOAEL), divided by an appropriate 

safety factor (id.). A calculated dietary 

exposure to the food additive (i.e., the 

EDI) at or below the ADI is considered 

consistent with a reasonable certainty of 

no harm (id.). 

The objectors list publications of 

various animal and in vitro studies in 

Objection 3, yet they do not attempt to 

address whether the publications are 

relevant to assessing an appropriate 

ADI, calculating an EDI, or whether the 

dietary exposure could result in a toxic 

effect (i.e., the estimated daily exposure 

exceeds an appropriate ADI). The 

petitioners proposed an ADI in their 

underlying food additive petition, but 

our denial order explained why the 

proposed ADI was not supported and 

Objection 3 does not address or 

otherwise engage with FDA’s identified 

concerns. Furthermore, the ADI that 

FAP 6B4815 proposed in the underlying 

petition was not based on any of the 

studies cited in Objection 3. 

The information provided in 

Objection 3 consists largely of studies 

that link some phthalates to certain 

identified health effects. Some studies 

are useful for hazard identification to 

determine additional hypotheses for 

future research, but these studies are not 

designed to provide information to 

show at which threshold level of dietary 

exposure these effects may occur. Such 

hazard identification is the first step in 

a risk assessment, but the existence of 

a possible effect does not necessarily 

mean that the effect is the appropriate 

endpoint to use for a risk assessment, 

that the effect will occur at the level of 

the substance in the diet, or that the 

substance is in fact unsafe for its 

intended use. As the hazard 

identification studies do not examine a 

dose-response relationship, these data 

are not adequate for identifying a 

NOAEL to perform a risk assessment for 

the food contact uses of the stillauthorized phthalates. The data from 

such hazard identification studies are, 

therefore, not adequate to establish 

significant questions about whether 

there is no longer a reasonable certainty 

of no harm from the authorized uses and 

are insufficient to justify resolution of 

the factual question of safety. 

The other information the objectors 

cite in Objection 3 includes 

epidemiological studies. While 

epidemiological studies may suggest a 

possibility of occurrence of an effect, 

they are generally not useful for risk 

assessment due to a lack of control of 

confounders such as dietary, medical, 

and lifestyle factors, socioeconomic 

status, and characterization of past 

exposures. Some studies may also 

include self-reported data by the test 

subjects which increases the potential 

for biases and inaccuracies, making it 

challenging to establish a consistent and 

reliable relationship between the cause 

and effect. Therefore, although 

epidemiological studies may be 

considered supplementary to the 

available toxicological data for 

conducting a safety evaluation, in 

general, they are not suitable to provide 

primary or sufficient basis for 

performing a risk assessment. 

The objection also cites the two 

declarations that were also submitted to 

the docket for the ortho-phthalates 

citizen petition. The declarations cite 

numerous epidemiological studies and a 

few animal studies that provide 

information on potential hazard 

identification. The declarations do not 

provide any dietary exposure estimates 

for the remaining five phthalates from 

their authorized food additive uses or 

additional supporting information for 

assessing the safety of the uses of the 

phthalates studied as food contact 

substances. 

The Federal and European 

publications cited in Objection 3 are the 

‘‘Toxicological Profile for DEHP’’ 

released by the Agency for Toxic 

Substances and Disease Registry 

(‘‘ATSDR’’) (Ref. 5), the ‘‘Technical 

Report on the Toxicology and 

Carcinogenesis Studies of Di(2- 

etyhylhexyl) Phthalate’’ (Ref. 6) released 

by the National Toxicology Program 

(NTP), and an updated risk assessment 

of DEHP, DBP, BBP, DINP, and DIDP 

(Ref. 7) for use in food-contact materials 

released by the European Food Safety 

Authority (EFSA). Objection 3 states 

that these studies ‘‘provide novel 

insights and weight of evidence 

analyses that are relevant to the safety 

reevaluations that FDA must conduct’’ 

(Objections at 19). However, the 

objection does not provide any 

explanation for how these studies 

would be adequate to assess the safety 

of the substances’ authorized food 

additive uses and, therefore, the 

objection does not establish that these 

studies create significant questions 

about whether there is no longer a 

reasonable certainty of no harm such 

that they would resolve the factual 

question of safety. 

The objection also cites two doseresponse studies to state that 

‘‘examining the cumulative effects of 

several phthalates (including DCHP and 

DEHP) found that phthalate mixtures 

induced reproductive tract 

malformations in male rats at doses well 

below those associated with harm from 

individual chemicals’’ (Objections at 

18). However, the objection fails to 

mention that, while the study 

referenced (Conley, et al. 2021) (Ref. 8) 

did include two of the five phthalates 

that still have food additive uses in the 

United States (DEHP and DCHP), the 

study examined effects using a mixture 

of nine phthalates and five nonphthalate pesticides cumulatively, 

which cannot separate adverse effects 

caused by either a single phthalate, 

group of phthalates, or the nonphthalate pesticides. Similarly, the 

other study referenced (Conley, et al. 

2018) (Ref. 12) dosed the rats using a 

mixture of 18 chemicals, which 

included 9 phthalates (including DEHP 

and DCHP) and nine non-phthalate 

pesticides or drugs. Therefore, the two 

dose-response studies cited in Objection 

3 do not directly address the safety of 

the food contact uses of the five stillauthorized ortho-phthalate food 

additives. 

For these reasons, the objectors failed 

to demonstrate how the cited studies, 

publications, declarations, and facts 

asserted would be sufficient to justify 

resolution of the safety question in the 

objectors’ favor. The objectors did not 

justify why the studies cited in 

Objection 3 would establish questions 

significant enough to support a finding 

that there is no longer reasonable 

certainty of no harm or that there are 

‘‘significant questions regarding the 

safety of the authorized food-additive 

uses of DAP, DCHP, DEHP, DINP, and 

DIDP.’’ In other words, the objectors did 

not establish that the information in the 

record is adequate to justify their factual 

assertion regarding safety. Accordingly, 

§ 12.24(b)(3) supports denial of the 

request for the hearing. A hearing will 

not be granted when the information 

cited is not sufficient to support the 

factual assertion (§ 12.24(b)(3)). 

Furthermore, a hearing will not be 

held unless resolution of the factual 

issue in the way sought by the objector 

is adequate to justify the action 

requested (§ 12.24(b)(4)). In Objection 3, 

the objectors alter the action requested 

from what they originally sought in FAP 


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1While FDA is denying this request for a hearing, 

we again note that, in the Federal Register of May 

20, 2022, we issued an RFI seeking scientific data 

and information on current uses, use levels, dietary 

exposure, and safety data for ortho-phthalates that 

remain authorized for use in food contact 

applications (87 FR 31090). Any future evaluation 

may be informed by, among other things, 

appropriate scientific data and information 

submitted in response to the RFI. 

6B4815, which was the revocation of 

food additive approvals for 28 orthophthalates. They now seek a hearing 

‘‘regarding the safety of . . . DAP, 

DCHP, DEHP, DINP, and DIDP’’ 

(Objections at 21)—the five orthophthalates that remain authorized for 

use as food additives. This objection 

does not demonstrate how the outcome 

of the proceeding would be different if 

the factual issues addressed in this 

objection were resolved in the way 

sought, because this objection does not 

address the underlying requested action. 

The underlying requested action was 

that FDA revoke the food additive 

authorizations for the 28 subject orthophthalates based on their grouping as a 

class. The basis for the underlying 

requested action was that FDA should: 

(1) consider the 28 subject orthophthalates to be a single class of 

chemically and pharmacologically 

related substances for safety evaluation; 

(2) apply FAP 6B4815’s proposed ADI to 

the purported class; and (3) determine 

that the EDI for the class exceeds that 

ADI. However, Objection 3 focuses only 

on five of the 28 ortho-phthalates and 

asks that we take action with respect to 

these five. Thus, we are denying the 

request for a hearing in Objection 3 

because a hearing will not be granted on 

factual issues that are not determinative 

of the action requested in the 

proceeding (§ 12.24(b)(4)). 

It is important to note that the 

objectors claim that our denial order 

was deficient because it did not address 

questions they failed to ask, and to take 

actions they failed to request, in the 

petition that is the subject of this 

proceeding.1 Such matters are outside 

the scope of the process set forth in 

section 409(f)(1) of the FD&C Act, which 

requires objections to ‘‘[to specify] . . . 

the provisions of the [denial] order 

deemed objectionable.’’ Because this 

objection and the corresponding request 

for a hearing seek determinations 

regarding issues that are outside the 

scope of the provisions of FDA’s denial 

order, the objection and hearing request 

are improper. The assertions and 

information cited in Objection 3 

regarding the health effects of the five 

still-authorized ortho-phthalate food 

additives would not change our 

conclusion that the requested action in 

FAP 6B4815 to remove the food contact 

authorizations for a purported class of 

28 ortho-phthalates was not adequately 

supported. A hearing will not be granted 

unless resolution of a factual issue in 

the way sought by the objector is 

adequate to justify the action requested 

(§ 12.24(b)(4)). This conclusion does not 

change the fact that FDA may, in the 

future, consider a subset of orthophthalates that remain authorized for 

use in food contact applications to be a 

single class of chemically and 

pharmacologically related substances 

for purposes of a safety evaluation. 

D. Objection 4 

In Objection 4, the objectors take the 

position that we misapplied section 

409(c)(5)(B) of the FD&C Act, which 

provides that, in determining whether a 

food additive is safe under section 409 

of the FD&C Act, FDA is to ‘‘consider 

among other relevant factors’’ the 

cumulative effect of such additive in the 

diet of man or animals, taking into 

account any chemically or 

pharmacologically related substance or 

substances in such diet. The objectors 

assert that to ‘‘conduct the safety 

evaluations the Food Act demands, FDA 

must withdraw the Order and properly 

apply the statutory standard for 

chemically or pharmacologically related 

substances to account for the 

cumulative effects of all related 

phthalates in the diet’’ (Objections at 

26). Because this objection raises a 

purely legal dispute, no hearing is 

warranted to adjudicate it 

(§ 12.24(b)(1)). Even if a hearing were 

available, the objectors did not request 

one with respect to this objection and 

therefore waive any right to a hearing 

(§ 12.22(a)(4)). The only remaining issue 

on Objection 4, then, is whether the 

objection establishes that FDA’s order 

denying FAP 6B4815 should be 

modified or revoked. As described 

below, we conclude that the objectors 

have not established a basis for 

modifying or revoking of the denial 

order. 

The objectors assert that while the 

denial order ‘‘does not articulate FDA’s 

interpretation of what constitutes a 

‘related’ substance,’’ FDA nevertheless 

‘‘applied an erroneous interpretation of 

‘chemically or pharmacologically 

related’ substances for which the Food 

Act mandates a cumulative effects 

analysis’’ (Objections at 22). In 

describing our review of FAP 6B4815, 

the objectors assert that FDA ‘‘appeared 

to interpret’’ this provision of the FD&C 

Act as only applying if substances that 

are known to share all of the following 

three factors: ‘‘(1) well-defined 

similarities in chemical structure, and 

(2) a common defined toxicological 

endpoint, and (3) a common mechanism 

of action associated with that common 

endpoint’’ (internal quotations omitted) 

(Objections at 23). The objectors 

disagree with this purported 

requirement and state that ‘‘FDA’s 

regulations make the focus on common 

effects, as opposed to a common 

mechanism of action’’ (citing 

§ 170.18(a)) (Objections at 24). The 

objectors assert the proper focus is on 

common health effects (id.). The 

objectors state, ‘‘it would be irrational 

and contrary to the Food Act’s safety 

mandate to ignore the cumulative effects 

of substances in the diet that are known 

to contribute to the same adverse health 

effect because the mechanism of action 

is not known to be the same for both 

substances or is not known at all’’ (id.). 

Finally, the objectors assert in Objection 

4 that we ‘‘erred in asserting that it is 

only required to consider the 

cumulative effects of substances that 

would be suitable for grouping into a 

single category for risk assessment’’ 

(internal quotations omitted) (id.). 

FDA Response: Objection 4 questions 

FDA’s evaluation of the claim made in 

FAP 6B4815 that the 28 subject orthophthalates are chemically and 

pharmacologically related and should 

therefore be treated as a class for 

purposes of evaluating their safety. In 

describing FDA’s evaluation of this 

claim, the objectors assert that FDA 

required all of the following three 

factors to be satisfied: ‘‘(1) well-defined 

similarities in chemical structure, and 

(2) a common defined toxicological 

endpoint, and (3) a common mechanism 

of action associated with that common 

endpoint’’ (Objections at 23). As support 

for the proposition that FDA imposed 

such a requirement, Objection 4 cites to 

both the denial order and FDA’s 

toxicology memorandum supporting the 

denial order (Ref. 4). 

There is no place in the denial order 

where we imposed such a requirement. 

In the denial order, we noted that other 

regulatory and scientific bodies have 

grouped phthalates based on these three 

considerations (87 FR 31066 at 31071). 

We also noted in our denial order that 

FAP 6B4815’s approach to class 

grouping was not consistent with the 

approach taken by other regulatory and 

scientific bodies, given that FAP 6B4815 

identified the work of those other bodies 

as a basis for the requested action (id.). 

To support their claim in Objection 4 

that FDA required FAP 6B4815 to 

satisfy the three factors that the 

objectors identify, the objectors cite 

page 10 of our toxicology memorandum 

for FAP 6B4815 (Ref. 4). The toxicology 

memorandum, however, did not suggest 

that FDA required the three factors as a 


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condition for grouping. Rather, this 

portion of the toxicology memorandum 

addressed the claim in FAP 6B4815 that 

the 28 subject ortho-phthalates have 

similar health effects. In doing so, the 

toxicology memorandum noted that 

while FAP 6B4815 asserted that all 

ortho-phthalates must be assumed to 

have ‘‘reproductive/developmental, and 

endocrine health effects,’’ the terms 

‘‘reproductive, developmental, and 

endocrine effects are broad terms that 

cover a wide range of toxicological 

effects that are not necessarily similar 

and can be caused by a variety of 

mechanisms.’’ 

The toxicology memorandum also 

noted that the endocrine system is a 

generic term which encompasses 

multiple organs and multiple hormonal 

pathways, and disruption of different 

hormonal pathways may not result in 

common health outcomes (i.e., are not 

related). The toxicology memorandum 

further stated that the proposed 

grouping of phthalates based on these 

broad terms was not consistent with the 

types of grouping undertaken by other 

scientific bodies. As with the denial 

order, the toxicology memorandum 

discussed the considerations underlying 

the groupings undertaken by these other 

scientific bodies because FAP 6B4815 

pointed to the evaluations by these 

bodies as support for the requested 

action—not because FDA was 

presenting or imposing the three factors 

that the objectors identify. Thus, 

Objection 4 is incorrect in asserting that 

FDA required the three factors the 

objectors identify. 

Likewise, the objectors 

mischaracterize FDA’s denial order by 

stating that, in assessing whether the 

subject ortho-phthalates are 

pharmacologically related, we erred in 

assessing whether the 28 orthophthalates exhibit a common 

mechanism of action; the objectors state 

that the more appropriate focus is 

whether there are common health 

effects (Objections at 24). According to 

Objection 4, ‘‘it would be irrational and 

contrary to the Food Act’s safety 

mandate to ignore the cumulative effects 

of substances in the diet that are known 

to contribute to the same adverse health 

effect because the mechanism of action 

is not known to be the same for both 

substances or is not known at all’’ (id.). 

In fact, we did evaluate the claim in 

FAP 6B4815 regarding common health 

effects, and our denial order explained 

why this claim was lacking. 

Specifically, our denial order explained 

that the generalized assertion in FAP 

6B4815 that all the cited effects are 

pharmacologically related because they 

‘‘result from the effects of orthophthalates on the endocrine system’’ 

does not acknowledge that the 

endocrine system is a generic term that 

encompasses multiple organs and 

multiple hormonal pathways (87 FR 

31066 at 31070). A substance that 

exhibits activity in one hormonal 

pathway may not have any effect on a 

different hormonal pathway, and 

disruption of different hormonal 

pathways may not result in common 

health outcomes (id.). 

Our denial order also explained that 

the claim in FAP 6B4815 that all 

studied ortho-phthalates demonstrate 

similar effects on the endocrine system 

was directly contradicted by data cited 

in the petition (id.). We explained that 

one of the most commonly studied 

pharmacological effects for phthalates is 

antiandrogenicity and that the data cited 

in the petitioners’ literature search 

indicates that, among the 12 phthalates 

with available toxicological information, 

seven phthalates exhibit antiandrogenic 

effects, but four phthalates have been 

shown to not exhibit antiandrogenic 

effects (id. at 31070 through 31071). 

Thus, FDA’s evaluation of FAP 6B4815 

did, in fact, evaluate whether the 28 

ortho-phthalates have common health 

effects. Objection 4, therefore, errs in 

suggesting that FDA’s evaluation was 

‘‘irrational and contrary to the Food 

Act’’ by virtue of disregarding evidence 

that the 28 ortho-phthalates cause 

common health effects. 

Finally, Objection 4 is misplaced in 

asserting that FDA’s denial order 

maintained that FDA ‘‘is only required 

to consider the cumulative effects of 

substances that would be suitable for 

grouping into a single ‘category for risk 

assessment’ ’’ (Objections at 24). FDA’s 

denial document made no such 

statement. The internal quotation 

appears to refer to the following 

sentence in our denial order: ‘‘the 

common functional group rationale 

should be supported with a discussion 

of any structural variations within that 

common functional group definition 

and an explanation of why the 

chemical-structural differences between 

members would not impact the 

suitability of the category for risk 

assessment’’ (87 FR 31066 at 31069) 

(emphasis added). Contrary to the claim 

in Objection 4, this sentence does not 

announce any legal interpretation 

regarding when FDA may consider the 

cumulative effects of different food 

additives. Rather, it addresses one of the 

rationales offered by FAP 6B4815 for 

grouping the 28 ortho-phthalates: that 

the substances share a common 

functional group. In the sentence that 

petitioners quote from in Objection 4, 

we explain the type of scientific 

evidence that is recommended to 

support an assertion of a common 

functional group, as outlined in the 

Organization for Economic Co-operation 

and Development (OECD) guidance that 

the original petition cites as support of 

its assertion that the 28 ortho-phthalates 

share a common functional group (Ref. 

9). 

For these reasons, we disagree with 

the assertion in Objection 4 that FDA 

committed legal error that justifies 

modifying or revoking our denial order. 

We also note that, even if there was a 

legal error with FDA’s application of 

section 409(c)(5)(B) of the FD&C Act, 

our resolution of FAP 6B4815 would 

have been the same. Our denial order 

did not rest solely on the question of 

whether the 28 ortho-phthalates should 

be considered a class for purposes of 

safety evaluation. Our denial order also 

rested on our conclusion that petitioners 

did not adequately support the other 

key assertions in FAP 6B4815 (i.e., the 

assertion proposing a purported ADI for 

DEHP, the assertion that the purported 

ADI should be applied to all 28 

phthalates, and the assertion that the 

EDI for the asserted class of orthophthalates significantly exceeds the 

proposed ADI). Thus, even if FAP 

6B4815 had established that there was 

sufficient evidence to support treating 

the 28 subject ortho-phthalates as a 

class, FDA would have denied the 

petition because it failed to establish the 

two subsequent assertions supporting 

the petition’s request to revoke the 

authorizations of such substances. 

E. Objection 5, 5–A, 5–B, and 5–C 

In Objection 5, the objectors argue 

that ‘‘FDA acted arbitrarily and 

unlawfully’’ by not considering the 

relatedness of smaller groups of orthophthalates (Objections at 26). The 

objection contends that the relatedness 

of different groups of ortho-phthalates 

would mean that ‘‘FDA must consider 

their cumulative effects’’ (id. at 26). The 

premise of this objection is that FDA’s 

denial order erred in analyzing the 

relatedness of all the 28 orthophthalates that were the subject of FAP 

6B4815, because on the same day that 

FDA issued the denial order we also 

issued the abandonment order. In 

Objection 5, the objectors assert that 

FDA’s analysis of the relatedness of the 

28 ortho-phthalates was ‘‘irrational on 

its face’’ (id.). The objectors separate 

Objection 5 into three separate subobjections. In each sub-objection, the 

objectors propose that FDA grant a 

public hearing to determine that the 

proposed groupings of phthalates show 

that the phthalates are chemically or 

pharmacologically ‘‘related.’’ The 


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specific groupings proposed in 

Objection 5 are: 

(A) A group of nine ortho-phthalates, 

consisting of the five ortho-phthalates 

that remain approved as food additives 

following FDA’s abandonment order 

combined with four ortho-phthalates 

that are authorized for use as foodcontact substances because they were 

sanctioned prior to the food additive 

amendments to the FD&C Act (i.e., they 

are prior sanctioned). A ‘‘prior 

sanction’’ is ‘‘an explicit approval 

granted with respect to use of a 

substance in food prior to September 6, 

1958,’’ by the FDA or the United States 

Department of Agriculture, pursuant to 

the FD&C Act, the Poultry Products 

Inspection Act, or the Meat Inspection 

Act (§ 170.3(l)). The term ‘‘prior 

sanction’’ derives from section 201(s)(4) 

of the FD&C Act (21 U.S.C. 321(s)(4)), 

which excepts from the definition of a 

‘‘food additive’’ any substance ‘‘used in 

accordance with a sanction or approval 

granted prior to’’ September 6, 1958, the 

date of enactment of the Food Additives 

Amendment to the FD&C Act. Before 

that date, FDA had approved specific 

uses of various food-contact materials or 

food ingredients by issuing letters and 

other statements that stated that in 

FDA’s view these substances were ‘‘not 

considered unsafe,’’ that they did ‘‘not 

present a hazard,’’ or that FDA ‘‘did not 

object to their use.’’ 

The nine ortho-phthalates that are at 

issue in this sub-objection are Di(2- 

ethylhexyl) phthalate (DEHP), 

Dicyclohexyl phthalate (DCHP), 

Diisononyl phthalate (DINP), Diisodecyl 

phthalate (DIDP), Dialyl phthalate 

(DAP), Diethyl phthalate (DEP), Butyl 

phthalyl butyl glycolate (BPBG), 

Diisooctyl phthalate (DIOP), and Ethyl 

phthalyl ethyl glycolate (EPEG). The 

objectors assert that these nine orthophthalates should be grouped because 

they are ‘‘chemically related’’ and 

grouping them due to a common 

functional group would be consistent 

with the Organization for Economic Cooperation and Development (OECD) 

Guidance on Grouping Chemicals 

(Objections at 28). 

(B) A group of seven ortho-phthalates, 

which consist of a subgroup of the nine 

ortho-phthalates that remain either 

approved in our food additive 

regulations or authorized because they 

are prior sanctioned. These orthophthalates are DCHP, DEHP, DINP, 

DAP, DEP, DIDP, and DIOP. The 

objectors state that these orthophthalates are ‘‘pharmacologically 

related substances on account of their 

common effect on developmental 

toxicity’’ (Objections at 31). 

(C) A group of four ortho-phthalates, 

which consist of a subgroup of the nine 

ortho-phthalates that remain approved 

in our food additive regulations or 

authorized because they are prior 

sanctioned. These ortho-phthalates are 

DCHP, DEHP, DINP, and DIOP. The 

objectors state that these orthophthalates should be considered 

cumulatively ‘‘based on their structural 

similarity and common antiandrogenic 

effects associated with the mechanism 

of action of reduced fetal testosterone 

production’’ (Objections at 35). 

FDA Response: Even if the objectors’ 

statements regarding the asserted 

relatedness of these different groups of 

ortho-phthalates were shown to be 

correct, the outcome of FDA’s denial 

order would not be altered. FAP 6B4815 

did not seek to establish the relatedness 

of these different groups of orthophthalates, consisting of both food 

additives and prior sanctioned 

substances, for purposes of safety 

assessment. Rather, FAP 6B4815 

proposed that FDA take a different 

approach. Specifically, FAP 6B4815 

requested that we treat 28 orthophthalates authorized for food contact 

use in our food additive regulations as 

a class, apply a single ADI to the 

purported class, and then compare 

exposure estimates for the 28-member 

class to the proposed ADI. FAP 6B4815 

did not ask us to consider these 

proposed groups of nine, seven, and 

four ortho-phthalates. As Objection 5 

does not demonstrate how the outcome 

of this proceeding would be different 

based on the new assertions of the new 

proposed groupings, we deny the 

request for a hearing. A hearing will not 

be granted unless resolution of a factual 

issue in the way sought by the objector 

is adequate to justify the action 

requested (§ 12.24(b)(4)). As courts have 

recognized, the issues raised in 

objections ‘‘must be material to the 

question involved; that is, the legality of 

the order attached’’ (Pineapple Growers 

Ass’n of Haw., 673 F.2d at 1085). 

The objectors claim that our denial 

order was deficient because it did not 

address questions they failed to ask, and 

to take actions they failed to request, in 

the petition that is the subject of this 

proceeding. Such matters are outside 

the scope of the process set forth in 

section 409(f)(1) of the FD&C Act, which 

requires objections to ‘‘[to specify] . . . 

the provisions of the [denial] order 

deemed objectionable.’’ The type of 

information necessary to consider for 

grouping chemicals for safety 

assessment is complex and proposing 

new groupings at the objection phase— 

when those groupings were not within 

the scope of the denial order—does not 

allow for full consideration of the 

complex scientific issues involved (see 

e.g., Ref. 1). Because Objection 5 and the 

corresponding request for a hearing seek 

determinations regarding issues that are 

outside the scope of the provisions of 

FDA’s denial order, the objection and 

hearing request are improper. 

Separately, the objectors claim that 

FDA’s review of FAP 6B4815 failed to 

account for our abandonment order 

(Objections at 26). We disagree. On the 

same day that we issued our denial 

order, we published a detailed 

memorandum in which we addressed 

the purported relatedness of the five 

ortho-phthalates that remained 

approved as food additives following 

FDA’s action on the abandonment 

petition (Ref. 1). FDA evaluated whether 

the five still-approved ortho-phthalates 

should be treated as a class for purposes 

of safety assessment and concluded that 

the five substances should not be 

grouped together for safety assessment. 

We based this conclusion on the 

structural variations and the differences 

in metabolites, metabolism, and 

toxicological endpoints across the 

substances. We described these 

differences in the memorandum that is 

in the docket (id.). 

F. Objection 6 

In Objection 6, the objectors assert 

that FDA should have treated a group of 

eight ortho-phthalates as a class because 

the eight ortho-phthalates, are 

‘‘antiandrogenic and are likely present 

in the diet’’ (Objections at 38). The eight 

ortho-phthalates that Objection 6 

identifies for treatment as a class are 

Di(2-ethylhexyl) phthalate (DEHP), 

Dicyclohexyl phthalate (DCHP), 

Diisononyl phthalate (DINP), Diisooctyl 

phthalate (DIOP), Butyl benzyl 

phthalate (BBP), Dibutyl phthalate 

(DBP), Diisobutyl phthalate (DiBP), and 

Dihexyl phthalate (DnHexP). The eight 

ortho-phthalates are a subset of the 28 

ortho-phthalates that were the subject of 

FAP 6B4815. This proposed class 

consists of a subgroup of the orthophthalates that remain approved for 

food-contact use under our food 

additive regulations (DCHP, DEHP, and 

DINP), one that is prior sanctioned 

(DIOP), and four that are no longer 

authorized for food-contact use due to 

our abandonment order (DiBP, DBP, 

BBP, and DnHexP). The objection 

contends that the relatedness of these 

eight ortho-phthalates triggers FDA’s 

obligation to take into account their 

cumulative effect, and the fact that 

FDA’s denial order did not identify 

them as a class means that FDA acted 

‘‘contrary to the Food Act and its 

regulations by failing to account for the 


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cumulative effects of dietary exposure’’ 

to this proposed group (id.). 

The objectors request a hearing on 

Objection 6. They state that the hearing 

would address ‘‘whether FDA 

unlawfully failed to consider the 

cumulative effects of phthalates in the 

diet that are chemically or 

pharmacologically related to phthalates 

that remain approved for food-additive 

use’’ (internal quotations omitted) 

(Objections at 39 through 40). The 

objectors state that at a hearing they 

would ‘‘offer expert testimony regarding 

the presence of BBP, DBP, DIBP, and 

DnHP in the diet; the chemical and 

pharmacological relationship among 

these substances and DEHP, DINP, 

DCHP, and DIOP; and the approach or 

approaches FDA could take to 

appropriately account for the 

cumulative effects of these substances’’ 

(id. at 40). 

FDA Response: Even if the objectors’ 

asserted statements regarding the 

chemical and pharmacological 

relatedness of this group of eight orthophthalates were shown to be correct, the 

outcome of FDA’s denial order would 

not be altered. The underlying 

proceeding did not address the 

relatedness of this smaller group of 

ortho-phthalates for purposes of safety 

assessment. FAP 6B4815 proposed that 

FDA take a different course of action. 

Specifically, as stated earlier, FAP 

6B4815 requested that we group 

together 28 ortho-phthalates approved 

for food contact use in our food additive 

regulations, apply a single ADI to the 

purported class, and then compare 

exposure estimates for the 28-member 

class to the proposed ADI. FAP 6B4815 

did not ask us to consider this new 

proposed group of eight orthophthalates. 

As Objection 6 does not demonstrate 

how the outcome of this proceeding 

would be different if the assertions 

regarding the new proposed grouping in 

Objection 6 were shown to be correct, 

we deny the request for the hearing. A 

hearing request will not be granted 

unless resolution of a factual issue in 

the way sought by the objector is 

adequate to justify the action requested 

(§ 12.24(b)(4)). As courts have 

recognized, the issues raised in 

objections ‘‘must be material to the 

question involved; that is, the legality of 

the order attached’’ (see Pineapple 

Growers Ass’n of Hawaii, 673 F.2d at 

1085). With this Objection, petitioners 

would have us address a question that 

was not involved in the underlying 

proceeding. As noted earlier, the 

objectors claim that our denial order 

was deficient because it did not address 

questions they failed to ask, and to take 

actions they failed to request, in the 

petition that is the subject of this 

proceeding. However, such matters are 

outside the scope of the process set forth 

in section 409(f)(1) of the FD&C Act, 

which requires objections to ‘‘[to 

specify] . . . the provisions of the 

[denial] order deemed objectionable.’’ 

Because Objection 6 and the 

corresponding request for a hearing seek 

determinations regarding issues that are 

outside the scope of the provisions of 

FDA’s denial order, the objection and 

hearing request are improper. 

Additionally, FDA did consider the 

relatedness of the 28 ortho-phthalates 

that were the subject of FAP 6B4815 as 

well as the five ortho-phthalates that 

remain approved for food-contact use in 

our food additive regulations and did 

not find that the substances should be 

grouped as a class for purposes of safety 

assessment (87 FR 31066 at 31075 and 

Ref. 1). 

G. Objection 7 

In Objection 7, the objectors argue 

that ‘‘FDA erred insofar as it required 

the petitioners to prove that current 

dietary exposure to the approved 

phthalates exceeds a safe level’’ 

(Objections at 40). The objectors assert 

that FDA’s evaluation of the information 

in FAP 6B4815 related to exposure ‘‘is 

contrary to the applicable statutory and 

regulatory provisions, the proper burden 

of proof, and FDA’s past practice’’ 

(Objections at 42). Because this 

objection raises a purely legal dispute, 

no hearing is warranted to adjudicate it 

(§ 12.24(b)(1)). Even if a hearing were 

available, the objectors did not request 

one with respect to this objection and 

therefore waive any right to a hearing 

(§ 12.22(a)(4)). The only remaining issue 

on Objection 7, then, is whether this 

objection establishes that FDA’s order 

denying FAP 6B4815 should be 

modified or revoked. As described 

below, we conclude that the objectors 

have not established a basis for 

modifying or revoking the denial order. 

In Objection 7, the objectors assert 

that, while FDA is to consider exposure 

data when approving new food 

additives, ‘‘FDA’s regulation governing 

petitions to amend or repeal food 

additive regulations does not require the 

petitioners to tender exposure data’’ 

(Objections at 40). The objectors 

contend that, rather than requiring 

repeal petitions to provide exposure 

data, FDA’s regulations provide that 

repeal petitions ‘‘may be based solely on 

‘new data as to the toxicity of the 

chemical’ or other ‘new information’ 

showing ‘that experience with the 

existing regulation may justify its 

amendment or repeal’ ’’ (quoting 

§ 171.130(b)) (id.). The objectors 

acknowledge that § 171.130(b) provides 

for new data to be furnished in the form 

specified in § 171.1 but argue that ‘‘[t]o 

the extent that the substantive 

requirements of section 171.1 are 

applicable to petitions seeking 

revocation or repeal of food additive 

regulations, that provision also does not 

require exposure data’’ (Objections at 

41). The objectors further state that ‘‘to 

the extent that FDA interprets [§ 171.1] 

to require exposure information, it must 

apply that requirement in a manner that 

comports with the burden of production 

the Food Act places on petitioners 

seeking revocation of food additive 

authorizations based on safety 

concerns,’’ such that ‘‘FDA cannot 

lawfully require such petitioners to 

tender data proving that existing 

exposure to the additives at issue and 

related substances is unsafe’’ (id. at 41). 

The objectors assert that FDA’s action 

on certain long-chain perfluorinated 

compounds (81 FR 5) was consistent 

with this interpretation (id. at 41 

through 42). 

FDA Response: We disagree with the 

assertion that we applied an incorrect 

legal standard in evaluating FAP 

6B4815. We reviewed the exposure 

information provided in FAP 6B4815 

based on the petition’s specific 

assertions. FAP 6B4815 asserted that the 

estimated dietary exposure for the 

asserted class of ortho-phthalates 

significantly exceeded the proposed ADI 

for the purported class, and the petition 

included dietary exposure estimates for 

select phthalates. In our denial order, 

we evaluated the proposed dietary 

exposure values and explained why 

they were not adequately supported. 

Specifically, we observed that FAP 

6B4815 did not account for: (1) The 

imprecision of relying on exposures 

estimates derived from biomonitoring 

studies to assess dietary exposure; (2) 

the diverse parameters used in the cited 

dietary exposure analyses to determine 

which analysis, if any, most accurately 

reflects true U.S. dietary exposure; and 

(3) the contradiction in reported dietary 

exposure values between those analyses 

(87 FR 31066 at 31075; see also Ref. 3). 

Under our food additive regulations, 

petitioners must do more than request 

changes to FDA’s food additive 

regulations. Petitioners must provide 

support for the requested changes. Food 

additive petitions seeking amendments 

to existing authorizations ‘‘must include 

full information on each proposed 

change’’ (In re Natural Resources 

Defense Council, 645 F.3d 400, 403 

(D.C. Cir. 2011) (internal quotations and 

citations omitted)). Here, FAP 6B4815 


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included dietary exposure estimates, 

and our denial order evaluated those 

estimates and explained why they were 

lacking. In doing so, we did not advance 

any new standards for the type of 

information that must be included in 

repeal petitions. 

Further, our denial order was not 

inconsistent with our action on longchain perfluorinated compounds. In that 

action, we evaluated available exposure 

information and explained why we were 

not able to determine migration of the 

relevant food contact substances (FCSs) 

into food as a result of their approved 

food-contact use. For this reason, FDA 

was unable to calculate consumer 

exposure to the substances in a manner 

which would allow a quantitative 

assessment of the safety of that 

exposure. However, FDA’s review noted 

that available data demonstrate that 

long-chain perfluorocarboxylic acids 

and fluorotelomer alcohols biopersist in 

animals and that this biopersistence also 

occurs in humans. Although available 

migration information did not allow a 

quantitative assessment of the safety of 

exposure to these FCSs, the 

reproductive and development toxicity 

of the three food contact substances 

could be qualitatively assessed in the 

context of biopersistence and the 

expectation that chronic dietary 

exposure to these substances would 

result in a systemic exposure to the 

substances or their metabolic byproducts at levels higher than their 

daily dietary exposure (81 FR 5 at 7). 

There is not comparable evidence in the 

administrative record for FAP 6B4815 to 

allow FDA to conclude that there is no 

longer a reasonable certainty of no harm 

regarding the subject ortho-phthalates 

for their intended use in the absence of 

adequate exposure information. While 

FDA had a basis for qualitatively 

assessing exposure in the action on 

long-chained perfluorinated 

compounds, the record here does not 

support that approach. 

For these reasons, we disagree with 

the objectors’ assertion that FDA 

committed any legal error that justifies 

modifying or revoking our denial order. 

H. Objection 8 

The final objection argues that 

‘‘contrary to FDA’s conclusion, the 

available exposure information raises 

serious safety questions regarding the 

approved food additive uses of 

phthalates’’ (Objections at 43). The 

objectors request a hearing on Objection 

8 and state that the hearing would 

address whether biomonitoring data 

from the National Health and Nutrition 

Examination Survey (NHANES) ‘‘and 

other available exposure information 

together establish significant questions 

concerning the safety of the food 

additive uses of phthalates that remain 

approved’’ (Objections at 49). The 

objectors state that ‘‘FDA did not 

address this issue in the order. Instead, 

it dismissed the NHANES 

biomonitoring data provided with the 

Petition based on arguments that are 

legally and factually unsupported, and 

it did not evaluate the most recent 

NHANES data in conjunction with 

ATSDR’s MRL for DEHP’’ (id. at 49). 

FDA Response: A hearing will not be 

granted on factual issues that are not 

determinative with respect to the action 

requested (§ 12.24(b)(4)). In this 

objection, the objectors challenge our 

evaluation of the information they 

provided in FAP 6B4815 related to 

exposure. However, our denial order 

made clear that our evaluation of 

exposure data was not the sole reason 

we denied FAP 6B4815. Instead, we 

based our denial on the lack of adequate 

support for each of the three assertions 

made in FAP 6B4815: (1) that the 28 

ortho-phthalates should be treated as a 

class for purposes of evaluating their 

safety; (2) that a purported ADI for 

DEHP should be applied to all 28 orthophthalates that were the subject of the 

petition; and (3) that the EDI for the 

asserted class of ortho-phthalates 

significantly exceeded the proposed 

ADI, thus rendering the purported class 

unsafe for their use as food contact 

substances. Our denial order explained 

in detail why the petition did not 

adequately support any of these three 

assertions. Because we found that the 

petition was not adequately supported, 

we concluded that the petition did not 

contain sufficient data to support a 

finding that there is no longer a 

reasonable certainty of no harm from the 

approved uses (87 FR 31066 at 31075). 

To the extent that Objection 8 is based 

on the premise that FDA’s evaluation of 

the exposure data was determinative to 

how we evaluated FAP 6B4815, that 

premise is incorrect. Even if FDA were 

to have found, as Objection 8 urges, that 

the data in the record show that the 

exposure to certain ortho-phthalates 

significantly exceeds the ADI proposed 

by FAP 6B4815 for the reference orthophthalate selected (DEHP), such a 

finding would not have answered the 

antecedent questions of whether the 28 

ortho-phthalates should be treated as a 

class or whether the proposed ADI for 

the selected ortho-phthalate should be 

applied to the purported class of 28 

ortho-phthalates. Because FDA’s 

conclusion regarding exposure data in 

the record was not determinative with 

respect to the repeal action requested in 

FAP 6B4815, the objectors’ request for a 

hearing on this subject is denied. 

In addition, we are denying the 

request for a hearing on this objection 

because the data and information 

identified by the objectors in support of 

the objection, even if established at a 

hearing, would not be adequate to 

justify the factual determination about 

unsafe exposure urged by the objectors 

(see § 12.24(b)(3)). This is for two 

distinct reasons. 

First, Objection 8 claims that ‘‘diet is 

a major, if not primary, source of 

exposure to the phthalates at issue’’ 

(Objections at 43). The objection points 

to the 2014 report from the Chronic 

Hazard Advisory Panel on Phthalates 

and Phthalate Alternatives (CHAP 

report), two declarations that cite the 

CHAP report as support, and a 

statement in ATSDR’s 2022 

toxicological profile of DEHP that ‘‘the 

principal route of human exposure to 

DEHP is oral,’’ and that the ingestion of 

food accounts for the majority of total 

oral exposure to DEHP (Objections at 

45) (Ref. 10). The objectors state that 

FDA’s denial order ‘‘does not dispute 

the CHAP’s conclusions regarding the 

primacy of diet as an exposure source 

for multiple approved phthalates and 

related substances’’ and that FDA ‘‘must 

qualitatively consider’’ conclusions by 

CHAP or ATSDR that diet is a ‘‘critically 

important source of exposure to DEHP 

and other phthalates at issue’’ (id. at 45). 

This criticism is misplaced. Even if FDA 

were to reach the general conclusion 

that the diet is a major source of 

exposure to approved ortho-phthalates, 

that would not answer the question of 

whether or not a specific approved food 

additive use is safe. Regarding the 

CHAP report, it did not answer the 

question of whether specific food 

additive uses of ortho-phthalates are 

safe. To the extent that this objection 

asserts that FDA did not evaluate the 

CHAP report in responding to FAP 

6B4815, that is not the case. The denial 

order and FDA’s supporting memoranda 

discussed the CHAP report at length 

(Refs. 3 and 4). Regarding ATSDR’s 

report on DEHP, this report states that 

the intake approximations calculated for 

DEHP indicate that the general 

population is exposed to DEHP at levels 

that are 3–4 orders of magnitude lower 

than those observed to cause adverse 

health effects in animal studies. 

Accordingly, the ATSDR report does not 

justify resolution of the factual question 

about unsafe exposure in the objectors’ 

favor. 

The second reason the data and 

information identified by the objectors 

in support of the objection, even if 

established at a hearing, would not be 


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adequate to justify resolution of the 

factual question about unsafe exposure 

relates to FDA’s evaluation of 

biomonitoring studies. Objection 8 

asserts that ‘‘FDA irrationally dismissed 

the relevance of biomonitoring data 

from the CDC’s NHANES, which tracks 

metabolites of DEHP, DCHP, DEP, and 

DINP, among other phthalates, in 

human urine’’ (Objections at 45). The 

objectors assert that FDA’s denial order 

was mistaken in stating that petitioners 

relied on biomonitoring data ‘‘alone’’ as 

information presented in the petition 

established the primacy of diet as a 

source of exposure to multiple 

phthalates (Objections at 46). The 

objectors state that ‘‘the NHANES 

biomonitoring data must be evaluated in 

light of evidence that most human 

exposures to these phthalates come from 

the diet’’ (id.). Here, the objectors make 

several claims that are not supported. 

We did not, in fact, dismiss the 

potential relevance of biomonitoring 

evidence presented in the petition. 

Rather, our denial order specifically 

noted that human biomonitoring studies 

can be ‘‘part of an appropriate 

postmarket approach to determine 

dietary exposure for a substance that is 

already authorized for use as a food 

contact substance’’ (87 FR 31066 at 

31074). However, we also explained that 

‘‘many factors should be addressed to 

determine the suitability of any given 

dataset for determining dietary 

exposure’’ (id.). We explained that the 

approach of directly comparing 

biomonitoring-based exposure values to 

a proposed ADI for the purpose of 

assessing the safety of a food additive is 

not scientifically appropriate (id.). 

Relying on biomonitoring data alone 

does not differentiate the amount of 

exposure that results from the diet 

compared to environmental and other 

sources (id.). Because FAP 6B4815 did 

not account for these limitations by 

addressing how the biomonitoring data 

accounts for dietary exposure, we 

concluded that the petition’s direct 

comparison of biomonitoring-based 

exposure values to the purported ADI 

was scientifically flawed. Our 

evaluation did not amount to a 

summary dismissal. We considered the 

information provided in the petition 

and found it lacking. The objectors’ 

claim that we stated that FAP 6B4815 

relied on biomonitoring data ‘‘alone’’ is 

also wrong. In our denial order, we 

discussed other evidence in FAP 

6B4815 that was related to exposure 

(and identified shortcomings with the 

petition’s evaluation of that data) (id.). 

Thus, the record shows that we 

considered all relevant exposure-related 

data included in the petition. 

The objectors’ claims regarding the 

primacy of the diet and FDA’s dismissal 

of biomonitoring data, even if 

established at a hearing, would not be 

sufficient to justify resolution of the 

factual conclusion urged by the 

objectors (§ 12.24(b)(3)). These claims 

were intended to support a conclusion 

that the available exposure information 

raises serious safety questions regarding 

the approved food-additive uses of 

phthalates. The information presented 

to support these claims do not provide 

a factual basis for determining that any 

ortho-phthalates have unsafe dietary 

exposure levels or that there are 

significant safety questions regarding 

the dietary exposure levels because 

these claims do not proffer evidence of 

unsafe dietary exposure levels for any 

ortho-phthalates with authorized uses. 

These arguments do not provide a basis 

for a hearing. 

A separate argument that objectors 

put forth in Objection 8 purports to 

provide more direct data regarding 

exposure. The objectors described a new 

exposure analysis and provided a 

supporting memorandum (Objections at 

48, n. 174) that calculated EDIs for 10 

phthalates (DEHP, BBP, DBP, DIBP, 

DCHP, DEP, DIDP, DINP, DMP, and 

DnOP) using urinary metabolite 

concentrations from the most recent 

NHANES biomonitoring data (collection 

occurred from 2015 to 2016). The 

objectors state that the EDI estimate for 

DEHP (at the 90th and 95th percentiles) 

is above the 0.10 micrograms per 

kilogram body weight per day 

intermediate minimal risk level (MRL) 

for oral exposure established for DEHP 

by ATSDR in 2022 (id. at 48). The 

objectors state that this ‘‘indicate[s] 

unsafe exposure levels across the U.S. 

population’’ (id.). As explained in our 

denial order and above, relying on 

biomonitoring data alone to calculate an 

exposure estimate does not differentiate 

the amount of exposure that results from 

the diet compared to other sources. 

Neither the objectors nor the supporting 

memorandum accounts for these 

limitations by addressing how the 

biomonitoring data is representative of 

an estimate to dietary exposure only. 

Furthermore, the MRL for DEHP cited 

by the objectors was determined based 

on a single study that used only one 

dose level and only a limited number of 

animals. Due to the use of a single dose 

and limited animals, there is not enough 

supporting information to rely on this 

value for the purposes of a safety 

assessment for DEHP or to apply it as a 

value for risk assessments of the other 

substances cited by the objectors. 

The objectors also assert that certain 

studies involving mixtures of orthophthalates ‘‘underscore the need for 

FDA to consider the available exposure 

information in response to these 

objections, and the importance of 

cumulative effects analysis to that 

assessment’’ (Objections at 49). The 

objectors state that ‘‘EPA scientists 

[who] have documented the magnitude 

of the cumulative effect of mixtures of 

anti-androgenic ortho-phthalates, and 

mixtures of anti-androgenic orthophthalates and other substances with 

similar anti-androgenic effects. 

Collectively, these studies found that 

ortho-phthalates in mixtures with 

structurally and pharmacologically 

related substances induced antiandrogenic effects at doses that were 

orders of magnitude lower than those 

associated with anti-androgenic effects 

of individual phthalates’’ (id. at 48). 

However, the objectors do not provide 

any dietary exposures to the proposed 

related anti-androgenic substances in 

the diet, nor do they identify what those 

related anti-androgenic substances are. 

While the Howdeshell (2017) (Ref. 11) 

and Conley et al., (2018 and 2021) (Refs. 

8 and 12) studies demonstrate some 

additive effects of mixtures of antiandrogenic substances, the Conley et al., 

(2018 and 2021) studies also report a 

level of exposure of these phthalate and 

non-phthalate mixtures where no 

antiandrogenic effects were detected. 

Likewise, beyond the MRL for DEHP, 

the objectors do not provide a suitable 

safe level or a risk assessment value to 

compare that cumulative dietary 

exposure level for the purposes of 

conducting a safety assessment. The 

objectors do not demonstrate how 

determining that anti-androgenic effects 

from multiple substances may be 

additive would demonstrate Objection 

8’s assertion that the available exposure 

information raises serious safety 

questions regarding the approved foodadditive uses of phthalates. 

Separately, the objectors contend that 

FDA committed legal error in evaluating 

the exposure information included in 

FAP 6B4815. The objectors assert that 

FDA evaluated their petition ‘‘as if diet 

were the sole source of exposure to the 

approved phthalates,’’ which Objection 

8 describes as being in tension with the 

‘‘among other relevant factors’’ text in 

section 409(c)(5) of the FD&C Act 

(Objections at 46). The applicability of 

the ‘‘among other relevant factors’’ text 

in section 409(c)(5) of the FD&C Act is 

a legal issue, and a hearing will not be 

granted on issues of law (§ 12.24(b)(1)). 

We note that, in determining whether a 

food additive is safe under section 


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409(c)(5) of the FD&C Act, FDA is to 

‘‘consider among other relevant factors’’ 

the following: (1) probable consumption 

of the additive; (2) cumulative effect of 

such additive ‘‘in the diet of man or 

animals, taking into account any 

chemically or pharmacologically related 

substance or substances in such diet;’’ 

and (3) safety factors ‘‘generally 

recognized’’ by qualified experts ‘‘as 

appropriate for the use of animal 

experimentation data.’’ 

Section 409(c)(5) of the FD&C Act 

does not impose a ‘‘legal obligation’’ for 

FDA to consider exposure from nondietary sources in determining safety. 

Rather, section 409(c)(5) of the FD&C 

Act makes clear that FDA has discretion 

to review a number of factors to 

determine whether a food additive is 

safe. Besides the factors enumerated in 

subparagraphs (A), (B), and (C), section 

409(c)(5) of the FD&C Act gives us 

discretion to decide, in our scientific 

expertise, whether there are other 

factors that are ‘‘relevant’’ to the safety 

of a food additive in the context of a 

particular petition. Moreover, the text of 

subparagraphs (A) and (B), which 

contemplate FDA considering foodrelated uses in assessing safety, 

provides additional support that it is not 

required for FDA to consider exposure 

from non-dietary sources as a relevant 

factor. Specifically, subparagraph (A) 

states that in determining safety, the 

Secretary shall consider ‘‘the probable 

consumption of the additive and of any 

substance formed in or on food because 

of the use of the additive,’’ and 

subparagraph (B) refers to the diet of 

man or animals’’ (emphasis added). 

Subparagraph 409(c)(5)(C) of the FD&C 

Act, which directs FDA to consider 

safety factors that ‘‘are generally 

recognized as appropriate for the use of 

animal experimentation data,’’ does not 

suggest that FDA must consider 

exposure from non-dietary sources. 

Therefore, the objectors’ argument that 

non-dietary exposure must be part of the 

safety analysis under section 409(c)(5) 

of the FD&C Act is incorrect. While the 

objectors state that other federal 

agencies ‘‘frequently consider 

background exposures when evaluating 

and regulating harmful chemicals,’’ we 

administer the FD&C Act and not 

authorities that are applicable to other 

Federal agencies. 

V. Summary and Conclusions 

After evaluating the objections, we 

conclude that the submission does not 

provide a basis to support modifying or 

revoking the denial of FAP 6B4815. 

Therefore, we are overruling the 

objections and denying the requests for 

a public hearing. 

VI. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff, (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852, 240–402–7500 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 https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

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. * FDA Memorandum from J. Urbelis to 

Administrative File for Food Additive 

Petition (FAP) 6B4815, May 11, 2022. 

2. * FDA, Guidance for Industry, 

‘‘Toxicological Principles for the Safety 

Assessment of Food Ingredients: 

Redbook 2000,’’ July 2007 (available at 

https://www.fda.gov/media/79074/ 

download). 

3. * FDA Chemistry Memorandum from R. 

Brinas to J. Urbelis, May 11, 2022. 

4. * FDA Toxicology Memorandum from T– 

F. Cheng to J. Urbelis, May 11, 2022. 

5. * Agency for Toxic Substances and Disease 

Registry (ATSDR) ‘‘Toxicological Profile 

for Di(2-ethylhexyl) Phthalate (DEHP),’’ 

January 2022. 

6. * ‘‘NTP Technical Report on the 

Toxicology and Carcinogenesis Studies 

of Di(2-ethylhexyl) Phthalate 

Administered in Feed to Sprague Dawley 

Rats,’’ December 2021. 

7. European Food Safety Authority Panel on 

Food Contact Materials, Enzymes and 

Processing Aids, ‘‘Update of the Risk 

Assessment of Di-Butylphthalate (DBP), 

Butyl-Benzyl-Phthalate (BBP), Bis(2- 

ethylhexyl)Phthalate (DEHP), DiIsononylphthalate (DINP) and DiIsodecylphthalate (DIDP) for Use in Food 

Contact Materials,’’ European Food 

Safety Authority Journal, 17(12):5838, 

2019. 

8. Conley, J., C.S. Lambright, N. Evans, et. al., 

‘‘A Mixture of 15 Phthalates and 

Pesticides Below Individual Chemical 

No Observed Adverse Effects Levels 

(NOAELs) Produces Reproductive Tract 

Malformations in the Male Rat,’’ 

Environment International, 156:106615, 

2021. 

9. ** 2014 Organization for Economic 

Cooperation and Development (OECD) 

Guidance on Grouping of Chemicals. 

10. ** 2014 Chronic Hazard Advisory Panel 

(CHAP) on Phthalates and Phthalate 

Alternatives Final Report. 

11. Howdeshell, K., A.K. Hotchkiss, L.E. Gray 

Jr., et al., ‘‘Cumulative Effects of 

Antiandrogenic Chemical Mixtures and 

Their Relevance to Human Health Risk 

Assessment,’’ International Journal of 

Hygiene and Environmental Health 220 

(2Pt A):179, 2017. 

12. Conley, J., C.S. Lambright, N. Evans, et. 

al., ‘‘Mixed Antiandrogenic Chemicals at 

Low Individual Doses Produce 

Reproductive Tract Malformations in the 

Male Rat,’’ Toxicological Sciences 

164(1):166, 2018. 

Dated: October 22, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–25120 Filed 10–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R08–OAR–2024–0207; FRL–12341– 

01–R8] 

Air Plan Approval; Revisions to 

Colorado Common Provisions 

Regulation 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

revisions to the Common Provisions 

Regulation of the Colorado State 

Implementation Plan (SIP). These 

revisions were submitted by the State of 

Colorado in response to the EPA’s June 

12, 2015, Findings of Substantial 

Inadequacy and ‘‘SIP call’’ for certain 

provisions in the SIP related to 

affirmative defenses applicable to excess 

emissions during startup, shutdown, 

and malfunction (SSM) events. The EPA 

is proposing approval of these SIP 

revisions because the Agency has 

determined that they are in accordance 

with the requirements for SIP provisions 

under the Clean Air Act (CAA or the 

Act). 

DATES: Written comments must be 

received on or before November 29, 

2024. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R08– 

OAR–2024–0207, to the Federal 

Rulemaking Portal: https://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or removed from https://

www.regulations.gov. The EPA may 

publish any comment received to its 

public docket. Do not submit 

electronically any information you 

consider to be Confidential Business 


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