[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Proposed Rules]
[Pages 17113-17116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08262]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 170, 177, and 189

[Docket No. FDA-2015-F-0537]


Natural Resources Defense Council et al.: Response to the 
Objections and Denial of the Requests for a Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; response to objections and denial of public 
hearing requests.

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SUMMARY: The Food and Drug Administration (FDA or we) is overruling the 
objections and is denying the requests for a public hearing, submitted 
by the Environmental Defense Fund, Natural Resources Defense Council, 
Center for Food Safety, Clean Water Action, Center for Science in the 
Public Interest, Breast Cancer Prevention Partners, Center for 
Environmental Health, Environmental Working Group, and Improving Kids' 
Environment.

DATES: April 24, 2019.

FOR FURTHER INFORMATION CONTACT: Hui-Chen (Anita) Chang, Center for 
Food Safety and Applied Nutrition (HFS-275), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-
1161.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 16, 2015 (80 FR 13508), we 
announced the filing of a food additive petition (FAP 4B4808) 
(``petition'') submitted by the Natural Resources Defense Council, 1152 
15th St. NW, Suite 300, Washington, DC 20005; the Center for Food 
Safety, 303 Sacramento St., Second Floor, San Francisco, CA 94111; 
Clean Water Action, 1444 I St. NW, Suite 400, Washington, DC 20005; the 
Center for Science in the Public Interest, 1220 L St. NW, Suite 300, 
Washington, DC 20005; Children's Environmental Health Network, 110 
Maryland Ave. NE, Suite 402, Washington, DC 20002; the Breast Cancer 
Fund (now known as Breast Cancer Prevention Partners), 1388 Sutter St., 
Suite 400, San Francisco, CA 94109-5400; the Center for Environmental 
Health, 2201 Broadway, Suite 302, Oakland, CA 94612; Environmental 
Working Group, 1436 U St. NW, Suite 100, Washington, DC 20009; and 
Improving Kids' Environment, 1915 West 18th St., Indianapolis, IN 46202 
(collectively, ``petitioners''). The petition asked FDA to take three 
separate regulatory actions: (1) Revoke our 2005 approval of Threshold 
of Regulation (TOR) exemption No. 2005-006 allowing as much as 1.2 
percent sodium perchlorate monohydrate in dry food packaging; (2) issue 
a new regulation under part 189 (21 CFR part 189) prohibiting the use 
of perchlorate as a conductivity enhancer in the manufacture of 
antistatic agents to be used in food contact articles; and (3) remove 
potassium perchlorate as an allowed additive in sealing gaskets for 
food containers in existing Sec.  177.1210 (21 CFR 177.1210).
    In the Federal Register of June 30, 2016 (81 FR 42585), we 
announced that we filed a food additive petition (FAP 6B4816) 
(``abandonment petition'') submitted on behalf of Society of the 
Plastics Industry, Inc. (SPI) by Keller and Heckman LLP, 1001 G Street 
NW, Suite 500 West, Washington, DC 20001. The abandonment petition 
proposed to amend Sec.  177.1210 to no longer provide for the use of 
potassium perchlorate as an additive in closure sealing gaskets for 
food containers because the use has

[[Page 17114]]

been intentionally and permanently abandoned.
    In response to the abandonment petition, we issued a final rule in 
the Federal Register on May 4, 2017 (82 FR 20829), to no longer provide 
for the use of potassium perchlorate as an additive in closure-sealing 
gaskets for food containers because this use has been abandoned. The 
final rule removed the entry for ``Potassium perchlorate'' from Sec.  
177.1210(b)(5), table 1.
    Additionally, in the Federal Register of May 4, 2017 (82 FR 20847), 
we announced that we were denying the petition (``2017 denial''). The 
2017 denial advised that objections and requests for a hearing were due 
by June 4, 2017. The 2017 denial explained that the requests to revoke 
TOR exemption No. 2005-006 and issue a regulation under part 189 
prohibiting the use of perchlorate in the manufacture of antistatic 
agents to be used in food-contact articles are not directed at 
regulations issued under the food additive petition process and are not 
subject to the statutory processes for food additive petitions (82 FR 
20847 at 20858). Because the requests to revoke TOR exemption No. 2005-
006 and issue a regulation under part 189 are not within the scope of a 
food additive petition, the provision for objections and a hearing 
under section 409(f) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 348(f)) does not apply to these two requests (Id.). The 
2017 denial also explained that the petitioners' request to remove 
potassium perchlorate as an allowed additive in closure-sealing gaskets 
for food containers in Sec.  177.1210 was moot when we amended Sec.  
177.1210 to no longer authorize this use of potassium perchlorate 
because it had been abandoned (see 82 FR 20847 at 20849).

II. Objections and Requests for Hearing

    Section 409(f) of the FD&C Act provides that, within 30 days after 
publication of an order relating to a food additive regulation, 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. FDA may deny a hearing request if the objections 
to the regulation do not raise genuine and substantial issues of fact 
that can be resolved at a hearing (Community Nutrition Inst. v. Young, 
773 F.2d 1356, 1364 (D.C. Cir. 1985)).
    Under the food additive regulations at 21 CFR 171.110, objections 
and requests for a hearing are governed by part 12 (21 CFR part 12) of 
FDA's regulations. Under Sec.  12.22(a), each 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.
    Within the 30-day objection period following publication of the 
2017 denial, we received one submission raising objections. The 
submission, dated June 4, 2017, from most of the petitioners and the 
Environmental Defense Fund, raised specific objections to the 2017 
denial and requested a hearing on the issues raised by each objection. 
However, as explained in this document, the provision for objections 
and a hearing under section 409(f) of the FD&C Act does not apply to 
all objections in the submission. As further explained in this 
document, for the objections to which this provision does not apply, we 
do not address the submission's arguments and we do not consider the 
related requests for a hearing. For purposes of this document, our use 
of the term ``objections'' does not mean that the provision for 
objections and hearing under section 409(f) of the FD&C Act necessarily 
applies.

III. Standards for Granting a Hearing

    Specific criteria for deciding whether to grant or deny a request 
for a hearing are set out in Sec.  12.24(b). Under that regulation, a 
hearing will be granted if the material submitted by the requester 
shows, among other things, the following: (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 
requester; 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 person 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; and (6) the requirements in other applicable 
regulations, e.g., 21 CFR 10.20 and Sec. Sec.  12.21 and 12.22, and in 
the document issuing the final regulation or the notice of opportunity 
for hearing are met.
    A party seeking a hearing is required to meet a ``threshold burden 
of tendering evidence suggesting the need for a hearing'' (Costle v. 
Pac. Legal Found., 445 U.S. 198, 214 (1980), citing Weinberger v. 
Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-21 (1973)). An 
allegation that a hearing is necessary to ```sharpen the issues' and 
`fully develop the facts' does not meet this test'' (Georgia-Pacific 
Corp. v. U.S. EPA, 671 F.2d 1235, 1241 (9th Cir. 1982)). If a hearing 
request fails to identify any factual evidence that would be the 
subject of a hearing, there is no point in holding 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 judgment as a 
matter of law (see Fed. R. Civ. P. 56). The same principle applies in 
administrative proceedings (see Sec.  12.24).
    A hearing request must not only contain evidence, but that evidence 
should raise a material issue of fact ``concerning which a meaningful 
hearing might be held'' (Pineapple Growers Ass'n 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 Chem., Inc. v. Flemming, 
271 F.2d 281, 286 (8th Cir. 1959)). A hearing is justified only if the 
objections are made in good faith and if they ``draw in question in a 
material way the underpinnings of the regulation at issue'' (Pactra 
Indus. v. CPSC, 555 F.2d 677, 684 (9th Cir. 1977)). A hearing need not 
be held to resolve questions of law or policy (see Citizens for Allegan 
Cnty., 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)).
    Even if the objections raise material issues of fact, FDA need not 
grant a hearing if those same issues were

[[Page 17115]]

adequately raised and considered in an earlier proceeding. Once an 
issue has been so raised and considered, a party is estopped from 
raising that same issue in a later proceeding without new evidence. The 
various judicial doctrines dealing with finality, such as collateral 
estoppel, can be validly applied to the administrative process (see 
Pac. Seafarers, Inc. v. Pac. Far East Line, Inc., 404 F.2d 804, 809 
(D.C. Cir. 1968)). In explaining why these principles ought to apply to 
an agency proceeding, the U.S. Court of Appeals for the District of 
Columbia Circuit wrote: ``The underlying concept is as simple as this: 
justice requires that a party have a fair chance to present his 
position. But overall interests of administration do not require or 
generally contemplate that he will be given more than a fair 
opportunity'' (Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316, 
322 (D.C. Cir. 1972); see also Costle v. Pac. Legal Found., 445 U.S. at 
215-17).

IV. Analysis of Objections and Response to Hearing Requests

    As explained in the 2017 denial (82 FR 20847 at 20849), a food 
additive petition must either propose the issuance of a regulation 
prescribing the conditions under which a food additive may be safely 
used or propose the amendment or repeal of an existing food additive 
regulation (see section 409(b)(1) and (i) of the FD&C Act). The 
petitioners' requests to revoke TOR exemption No. 2005-006 and issue a 
regulation under part 189 prohibiting the use of perchlorate in the 
manufacture of antistatic agents to be used in food-contact articles do 
not propose the issuance of a new food additive regulation or the 
amendment or repeal of an existing food additive regulation (82 FR 
20847 at 20849). As the 2017denial states, the petitioners' TOR 
exemption revocation request and part 189 regulation request are not 
within the scope of a food additive petition and FDA's denial of these 
requests is not an order under section 409(c)(1)(B) of the FD&C Act (82 
FR 20847 at 20858). Therefore, the provision for objections and public 
hearing under section 409(f) of the FD&C Act does not apply to the 
requests to revoke TOR exemption No. 2005-006 and issue a regulation 
under part 189.

A. Objections 1 and 2

    The submission's first two ``objections'' are not subject to the 
objections and hearing procedure in section 409(f) of the FD&C Act. 
Therefore, we will not address the arguments detailed in those 
objections and we do not consider the related requests for a hearing.
    The submission's first ``objection'' asserts that we improperly 
dismissed its request to revoke TOR exemption No. 2005-006 because, it 
claims, we relied on a flawed interpretation of the definition of a 
food additive in the TOR regulation. The submission additionally 
asserts that the use of sodium perchlorate monohydrate allowed under 
TOR exemption No. 2005-006 is not eligible for a TOR exemption and that 
we made ``myriad errors'' in determining that it was eligible for a TOR 
exemption. Because TOR exemption No. 2005-006 is not subject to the 
objections and hearing procedure in section 409(f) of the FD&C Act, we 
will not address the arguments detailed in ``objection'' 1.
    To the extent that any of the arguments made in ``objection'' 1 may 
be construed as also pertaining to the petitioners' request to amend 
Sec.  177.1210 to remove potassium perchlorate as an allowed additive 
in closure-sealing gaskets for food containers, a request that is 
subject to section 409(f) of the FD&C Act, this request became moot 
when we amended Sec.  177.1210 to no longer authorize this use of 
potassium perchlorate because it had been abandoned (see 82 FR 20847 at 
20849). A hearing will not be granted on factual issues that are not 
determinative with respect to the action requested (see Sec.  
12.24(b)(4)). Therefore, to the extent that ``objection'' 1 pertains to 
the petitioners' request to amend Sec.  177.1210, we are overruling the 
submission's objection and denying the submission's request for a 
hearing on this point.
    The submission's second ``objection'' challenges as ``contrary to 
law'' FDA's determination that the petition's requests to revoke TOR 
exemption No. 2005-006 and issue a regulation under part 189 are not 
within the scope of a food additive petition. Section 409(f)(1) of the 
FD&C Act permits objections and requests for a hearing only to orders 
made under section 409(c) and (d) of the FD&C Act. Because FDA's denial 
of the petitioners' TOR revocation request and part 189 request was not 
an order under section 409(c)(1)(B) of the FD&C Act (see 82 FR 20847 at 
20850), the submission's second ``objection'' is not an objection to an 
order under section 409(c)(1)(B) of the FD&C Act and is not subject to 
the objections and hearing procedure in section 409(f) of the FD&C Act. 
Therefore, we will not address the arguments presented in ``objection'' 
2.

B. Objection 3

    Objection 3 challenges FDA's determination that the petitioners' 
request to amend Sec.  177.1210 was moot when we issued a final rule in 
response to the abandonment petition that removed potassium perchlorate 
as an allowed additive in closure-sealing gaskets for food containers. 
Specifically, the submission alleges that FDA's mootness determination 
was ``poor public policy'' because it discourages industry to file 
abandonment petitions except in the face of a petition that may find 
the use no longer safe, and unfair to the petitioners, whose petition 
was filed before the abandonment petition.
    In presenting objection 3, the submission fails to identify any 
specific factual dispute that could be resolved by a hearing. 
Accordingly, we are denying the submission's hearing request on 
objection 3 because a hearing will not be granted on issues of policy 
(Sec.  12.24(b)(1)). We also note that, in granting the abandonment 
petition and removing potassium perchlorate as an allowed additive in 
closure-sealing gaskets for food containers, we took the third action 
requested in the petition. As stated in response to a similar comment 
from the petitioners to the filing notice for the abandonment petition, 
FDA has numerous responsibilities related to food additives, and we 
receive and respond to hundreds of submissions annually under the 
various petition and notification programs that we administer. 
Accordingly, if a use of a food additive is no longer authorized in 
response to an abandonment petition, we may determine that it is 
neither necessary nor an efficient use of our limited resources to 
address safety arguments related to an abandoned use (see 82 FR 20829 
at 20831).

V. Summary and Conclusion

    After evaluating the objections from the submitters, we have 
concluded that ``objections'' 1 and 2 are not within the scope of the 
objections and hearing provision under section 409(f) of the FD&C Act. 
Therefore, we do not address the arguments related to these 
``objections'' and we do not address the related requests for a 
hearing. To the extent that ``objection'' 1 pertains to the 
petitioners' request to amend Sec.  177.1210, this request became moot 
when we amended Sec.  177.1210 to no longer authorize this use of 
potassium perchlorate, and therefore we are overruling the submission's 
objection and denying the request for a hearing on this point. 
Objection 3 does not provide any basis to reconsider our decision to

[[Page 17116]]

deny the petition. We also have determined that objection 3 does not 
raise any genuine and substantial issue of fact that would justify an 
evidentiary hearing. Therefore, we are overruling this objection and 
are denying the related request for a hearing.

    Dated: April 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08262 Filed 4-23-19; 8:45 am]
 BILLING CODE 4164-01-P