[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