[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Rules and Regulations]
[Pages 16285-16290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6792]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2002-F-0198] (formerly Docket No. 2002F-0316)
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Bacteriophage Preparation
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; response to objections and denial of requests for a
hearing and stay of effective date.
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SUMMARY: The Food and Drug Administration (FDA) is responding to
objections and is denying requests that it has received for a hearing
on the final rule that amended the food additive regulations to provide
for the use of a bacteriophage preparation as an antimicrobial agent
against Listeria monocytogenes on ready-to-eat (RTE) meat and poultry
products. After reviewing the objections to the final rule and the
requests for a hearing, the Agency has concluded that the objections do
not raise issues of material fact that justify a hearing or otherwise
provide a basis for revoking the amendment to the regulation. FDA also
is denying the request for a stay of the effective date of the final
rule.
DATES: Effective date of the final rule published in the Federal
Register of August 18, 2006 (71 FR 47729) confirmed: August 18, 2006.
FOR FURTHER INFORMATION CONTACT: James C. Wallwork, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1303.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA published a notice in the Federal Register of July 22, 2002 (67
FR 47823), announcing the filing of food additive petition, FAP 2A4738,
by Intralytix Inc., to amend the food additive regulations by providing
for the safe use of a
[[Page 16286]]
mixture of bacteriophages as an antimicrobial agent against L.
monocytogenes on foods, including fresh meat products, fresh poultry,
and poultry products. On December 18, 2003, the petitioner amended the
petition to limit the petitioned use only to RTE meat and poultry
products. In response to this petition, FDA issued a final rule in the
Federal Register of August 18, 2006 (71 FR 47729), approving the use of
the bacteriophage preparation on RTE meat and poultry products. This
rule will be referred to in this document as the ``bacteriophage final
rule.'' The preamble to the final rule advised that objections to the
final rule and requests for a hearing were due within 30 days of the
publication date (i.e., by September 18, 2006).
II. Objections, Requests for a Hearing, and Request for a Stay of
Effective Date
Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(f)) 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 Institute v. Young, 773 F.2d 1356, 1364 (DC Cir. 1985), cert.
denied, 475 U.S. 1123 (1986)).
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 meet the
following conditions: (1) Must be submitted on or before the 30th day
after the date of publication of the final rule; (2) must be separately
numbered; (3) must specify with particularity the provision of the
regulation or proposed order objected to; (4) must 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) must 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.
Following publication of the bacteriophage final rule, FDA received
more than 70 objections within the 30-day objection period. All but one
of these submissions expressed general opposition to the use of the
bacteriophage preparation on RTE meat and poultry products; however, no
evidence was submitted in support of these objections. As stated
previously, under section 409(f)(1) of the FD&C Act, objections must
``[specify] with particularity the provisions of the order deemed
objectionable, stating reasonable grounds therefor * * *.'' These
submissions did not provide reasonable grounds and identified no
substantive issue to which the Agency can respond. Therefore, these
submissions are denied and will not be considered further. The
submission raising specific objections was a letter from Food & Water
Watch (FWW) with six objections. The FWW letter sought a revocation of
the bacteriophage final rule and requested a hearing on the issues
raised by each objection. The letter also requested that the regulation
be stayed pending a public hearing of the scientific issues. These
objections are addressed in section IV of this document.
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 notice 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.
Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980), reh. denied,
446 U.S. 947 (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. U.S. Environmental
Protection Agency, 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 Rule 56, Federal Rules of Civil Procedure.) The
same principle applies in administrative proceedings. (See Sec.
12.28.)
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 Association 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, the
Agency need not grant a hearing (see Dyestuffs & 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 ``draw in question in a material way the
underpinnings of the regulation at issue'' (Pactra Industries v.
Consumer Product Safety Commission, 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 County, Inc. v. Federal Power Commission, 414 F.2d
1125, 1128-29 and n.5 (D.C. Cir. 1969); Sun Oil Co. v. Federal Power
Commission, 256 F.2d 233, 240-41 (5th Cir.), cert. denied, 358 U.S. 872
(1958)).
Even if the objections raise material issues of fact, FDA need not
grant a hearing if those same issues were adequately raised and
considered in an earlier proceeding. Once an issue has been so raised
and considered, a party cannot raise that same issue in a later
proceeding without new evidence. The various judicial doctrines dealing
with finality can be validly applied to the administrative process. In
explaining
[[Page 16287]]
why these principles ``self evidently'' 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 one fair opportunity.''
Retail Clerks Union, Local 1401 v. National Labor Relations Board, 463
F.2d 316, 322 (DC Cir. 1972). (See Costle v. Pacific Legal Foundation,
supra at 215-220. See also Pacific Seafarers, Inc. v. Pacific Far East
Line, Inc., 404 F.2d 804 (DC Cir. 1968), cert. denied, 393 U.S. 1093
(1969).)
In summary, a hearing request must present sufficient credible
evidence to raise a material issue of fact and the evidence must be
adequate to resolve the issue as requested and to justify the action
requested.
IV. Analysis of Objections and Response to Hearing Requests
The FWW submission raises six objections based on issues that they
believe to be factual and requests a hearing based on these objections.
FDA addresses each of the objections in the following paragraphs, as
well as the evidence and information filed in support of each,
comparing each objection and the information submitted in support of it
to the standards for granting a hearing in Sec. 12.24.
A. FWW's Assertion That FDA Failed To Follow Its Own Guidelines
FWW claims that FDA failed to follow its own guidelines for
assessing the safety of food additives. Specifically, FWW states that
FDA did not ``certify'' that it followed the procedures stated in
current publications of the National Academy of Sciences/National
Research Council (NAS/NRC) when reviewing the bacteriophage petition,
or if different procedures were used, FDA did not ``certify'' that they
are as reliable as the NAS/NRC procedures, as FWW states is required by
Sec. 170.20 (21 CFR 170.20). FWW also contends that FDA did not comply
with the testing set forth in its own guidance entitled ``Toxicological
Principles for the Safety Assessment of Food Ingredients,'' otherwise
known as FDA's Redbook, or establish a 100-fold safety factor for the
additive as set forth in 21 CFR 170.22. If a different safety factor
was used, FWW asserts that FDA did not provide evidence to justify a
different safety factor. FWW also questions the relevance and
applicability of the various studies relied on by the petitioner to
show safety because of either: (1) Deficiencies with how the studies
were conducted, (2) the studies investigated efficacy rather than
safety, or (3) the substance tested is not the same bacteriophage that
is the subject of the petition.
Contrary to what FWW appears to assert, FDA notes that the Agency
does not ``certify'' that the procedures used in evaluating a food
additive petition either followed the current NAS/NRC procedures or
were as reliable as those procedures. Section 170.20 sets forth the
general scientific principles that FDA uses in evaluating a food
additive petition and cites the principles and procedures stated in
current publications of the NAS/NRC as a guide that the Agency uses in
its safety evaluations of food additives. Nevertheless, FDA has
consistently taken the position that many scientifically valid types of
data may properly support a finding that the proposed use of a food
additive will cause ``no harm'' to consumers. Moreover, Sec. 170.20(a)
specifically states that ``A petition will not be denied, however, by
reason of the petitioner's having followed procedures other than those
outlined in the publications of the National Academy of Sciences-
National Research Council if, from available evidence, the Commissioner
finds that the procedures used give results as reliable as, or more
reliable than, those reasonably to be expected from the use of the
outlined procedures.'' Similarly, NAS/NRC acknowledges in the
conclusions of its document regarding procedures for evaluating the
safety of food chemicals that the document's purpose is to ``guide and
stimulate--not replace--informed professional and administrative
judgment'' (Ref. 1).
FDA did not request the petitioner to carry out studies recommended
in NAS/NRC guidelines because the bacteriophages that are the active
component of the food additive infect L. monocytogenes exclusively, and
not mammalian cells. (See discussion at 71 FR 47729 at 47730). As such,
traditional animal testing of the additive as recommended by NAS/NRC
for food chemicals, is neither necessary nor helpful to demonstrate
that the petitioned use of the additive is safe.
Regarding the use of safety factors, the use of a safety factor is
intended to account for the uncertainty of extrapolating animal
toxicity data to humans. Because bacteriophages do not infect mammals,
the use of a safety factor is unnecessary to provide adequate assurance
of safety.
Similarly, due to the nature of this food additive, there is no
need to assign a concern level as set forth in the Redbook. FDA's
Redbook provides guidance that represents the Agency's current thinking
on the information needed for the safety assessment of food
ingredients. As with any Agency guidance, the Redbook does not bind the
petitioner or the Agency to follow specific procedures that are
recommended. Alternative approaches are permissible if such approaches
satisfy the requirement of the applicable statute and regulations.
Importantly, the statute does not prescribe the safety tests to be
performed but leaves that determination to the discretion and
scientific expertise of FDA. Not all food additives require the same
amount or type of testing. The testing and data necessary to establish
the safety of an additive will vary depending on the type and
characteristics of a particular additive and its intended use. Concern
levels are used to determine the recommended toxicity tests for an
additive. It was unnecessary to assign a concern level in the present
case, because FDA's primary concern about the subject additive was the
safety of potential residual components from the host organism, L.
monocytogenes, and not the bacteriophages themselves.
One such residue of concern was Listeriolysin O (LLO), an exotoxin
produced by the host organism. To address this concern, the petitioner
analyzed the bacteriophage preparation for LLO and was unable to detect
it using a method sensitive to 5 hemolytic units per milliliter (HU/
ml). Even when the food additive was concentrated 10-fold, the
petitioner still did not detect any hemolytic activity. Although LLO
was not detected in the bacteriophage preparation, FDA established a
specification of 5 HU/ml for the maximum amount of LLO permitted in the
bacteriophage preparation as a condition of safe use, which is the
limit of detection for the method provided by the petitioner. FDA
concluded that the potential residues of LLO that may be found in the
food additive are negligible (i.e., 5 HU/ml or less) and do not pose a
safety concern for the use of the food additive as an antimicrobial
agent on RTE meat and poultry products. Furthermore, as discussed in
the bacteriophage final rule, the presence of any small amount of LLO
in the bacteriophage preparation may be mitigated by the following
factors: Inactivation of LLO by cholesterol that is present in RTE meat
and poultry products; inactivation of LLO by the low stomach pH; and
inactivation of orally consumed LLO by human defense mechanisms (e.g.,
normal intestinal microflora and cell-mediated immunity reactions) and
degradation by
[[Page 16288]]
proteolytic enzymes in the diet or in the stomach. FDA concluded that
reliable alternative methods from NRC/NAS procedures were used to
establish the safety of the bacteriophage preparation for its use on
RTE meat and poultry products, and that the data considered for this
regulation, when evaluated in its entirety, are sufficient to support
the safety of the bacteriophage preparation for that use.
FWW's submission provides no evidence that FDA failed to follow its
own guidelines for assessing the safety of food additives. The FWW
submission does not raise a genuine and substantial issue of fact and
does not provide any specifically identified reliable evidence that, if
established at a hearing, would be adequate to demonstrate that FDA
acted in violation of its governing statutes and regulations. Thus, a
hearing is not justified based on this objection (Sec. 12.24(b)(1),
(b)(2), and (b)(3)).
B. Inactivation of LLO By Stomach Acid and Cholesterol
FWW contends that FDA relies on conjecture in concluding that foods
treated with a bacteriophage preparation are safe for human
consumption. Specifically, FWW asserts that FDA's conclusion that any
residual LLO will be inactivated by factors such as cholesterol in the
meat or poultry, acidity within the stomach, and proteolytic enzymes
present in the food or in the stomach is based on unsupported
assumptions and not experimental data. Regarding the inactivation of
LLO by cholesterol, FWW's asserts that FDA's conclusion about
mitigation of LLO by cholesterol was not based on any data on the
levels of cholesterol in meat necessary to inactivate LLO, and that the
mechanism for the inactivation of LLO by cholesterol is ``not yet fully
understood by researchers.'' FWW also states that there is a need for a
more thorough study to investigate the reaction of certain sensitive
population groups to this bacteriophage preparation.
As stated in the bacteriophage final rule, the toxicity of LLO has
been shown to be significantly reduced--by as much as 200- to 2,000-
fold--following pre-incubation of LLO with added cholesterol in vitro,
based on results of a study conducted by Jacobs et al (Ref. 2). The
results showed that there is almost no hemolytic if LLO is pretreated
with cholesterol at 1 milligram/100 grams (mg/100g). It is well
established that there are relatively high concentrations of
cholesterol in RTE meat and poultry products (approximately 38 to 156
mg/100 g (Ref. 3)). Therefore, since the bacteriophage preparation is
to be used on RTE meat and poultry products, and these products contain
significant amounts of cholesterol, the findings from Jacobs et al.
directly support FDA's conclusion about inactivation of LLO by
cholesterol in RTE meat and poultry products. While the mechanism by
which added cholesterol inhibits LLO may not be fully understood, that
does not undermine the evidence that supports the Agency's conclusion.
Regarding inactivation of LLO by acidity, the data considered by
FDA in its review of the petition indicate that LLO has activity only
within a pH range between 4.9 and 8 while losing activity at a pH
outside this range, especially in very acidic (low pH) or very alkaline
(high pH) environments. Since the pH inside the stomach is normally
between 1.0 and 3.5 (Ref. 4), the acidic environment in the stomach
would be a defense against any residual LLO from the use of the
additive. No data were submitted by FWW to the contrary, nor was any
information provided that would justify the need for studies to
investigate the reaction of certain sensitive population groups to the
bacteriophage preparation. Because FWW provided no evidence to support
these contentions, FDA is denying the request for a hearing on these
issues; a hearing will not be granted on the basis of mere allegations
or denials or general positions and contentions (Sec. 12.24(b)(2)).
C. FWW's Contention That Petitioner's Efficacy Studies Are Inadequate
FWW contends that the results of the efficacy studies for the
bacteriophage preparation submitted by the petitioner are inadequate to
show that the preparation will sufficiently control L. monocytogenes in
RTE meat and poultry products. In addition, FWW points out that some
other methods for killing bacteria achieve a greater log reduction of
bacteria than the bacteriophage preparation.
During its evaluation of FAP 2A4738, FDA consulted with the Food
Safety and Inspection Service (FSIS) of the U.S. Department of
Agriculture (USDA), consistent with 21 CFR 171.1(n) and with a
memorandum of understanding (MOU) between the two Agencies for
reviewing the safety of substances used in the production of meat and
poultry products. Under the MOU, FDA is responsible for reviewing an
ingredient's safety, and USDA/FSIS is responsible for evaluating its
suitability. (MOU 225-00-2000; see also 65 FR 51758 at 51759, August
25, 2000). Suitability relates to the effectiveness of the ingredient
in performing the intended purpose of use and the assurance that the
conditions of use will not result in an adulterated product or one that
misleads consumers. As we stated in the bacteriophage final rule, ``FDA
recognizes that there may be meat or poultry products considered RTE
for which use of the additive may not be suitable within the meaning of
those statutes. This regulation addresses only the safety standard
under section 409 of the Federal Food, Drug, and Cosmetic Act and does
not address requirements for suitability administered by the USDA.''
(71 FR 47729 at 47731). FSIS concurred with the issuance of FDA's final
rule.
FDA is denying the request for a hearing on this point because a
hearing will not be granted unless there is a genuine and substantial
factual issue to be resolved (Sec. 12.24(b)(1)), and resolution of the
factual issue in the way sought is adequate to justify the action
requested (Sec. 12.24(b)(4)).
D. FWW's Assertion That Key Research Used to Support the Rule Has Not
Been Published in Peer-Reviewed Journals
FWW asserts that key research submitted by the petitioner in
support of their additive was not published in peer-reviewed journals,
which they claim is required under Sec. 170.31(i) (21 CFR 170.3(i)).
Specifically, FWW is referring to the definition of safe or safety
which is defined in Sec. 170.3(i) as ``* * * a reasonable certainty in
the minds of competent scientists that the substance is not harmful
under the intended conditions of use. * * *''
FWW has misinterpreted Sec. 170.3(i). This regulation does not
require that in order to establish safety, the research submitted by a
petitioner in support of a food additive must be published in a peer-
reviewed journal. This regulation states that ``Safety may be
determined by scientific procedures or by general recognition of
safety.'' Importantly, scientific procedures are defined under Sec.
170.3(h) as `` * * * human, animal, analytical, and other scientific
studies, whether published or unpublished, appropriate to establish the
safety of a substance.'' Therefore, FDA does not require the key
research submitted by a petitioner in support of a food additive be
published in a peer-reviewed journal to establish safety. This
objection does not raise a genuine and substantial issue of fact for
resolution at a hearing. FDA is denying the request for a hearing on
this point because a hearing will not be granted if there is no genuine
and substantial factual issue to be resolved (Sec. 12.24(b)(1)).
[[Page 16289]]
E. FWW's Contention That FDA Did Not Adhere to Its Requirements on
Making Information Publicly Available
FWW contends that the Agency did not follow the requirements in
Sec. 171.1(h) (21 CFR 171.1(h)) for making information publicly
available. They cite Sec. 171.1(h)(1), which states: ``The following
data and information in a food additive petition are available for
public disclosure, unless extraordinary circumstances are shown, after
the notice of filing of the petition is published in the Federal
Register * * *.'' FWW states that FDA did not publicly disclose the
releasable information from FAP 2A4738 after the notice of filing of
the petition published in the Federal Register as required under Sec.
171(h)(1). FWW also states ``as of the submission of these objections,
FDA has still not made much of this information, including much of this
petition, available.''
FWW misinterprets Sec. 171.1(h)(1). That paragraph does not mean
that the releasable data and information in a petition are publicly
disclosed when the notice of filing publishes, but merely that the
information in the petition is available for public disclosure. Before
the information in a petition is actually disclosed, the Agency has to
purge all data and information that are protected from disclosure.
Because this is a labor intensive process, FDA does not preemptively
disclose the information in a petition at this time, but rather
releases it in response to requests made under the Freedom of
Information Act (FOIA). To disclose the information in a petition
before a request is received would not be an efficient use of Agency
resources.
In the case of FAP 2A4738, the notice of filing was published in
the Federal Register of July 22, 2002, at which time the releasable
information in the petition was available for public disclosure through
the Agency's FOIA process. The final rule for this petition published
in the Federal Register of August 18, 2006, and the period for
submitting objections to this rule ended on September 18, 2006. Prior
to the beginning of the objection period, FDA had not processed any
FOIA requests for this information. The petition therefore had not been
previously redacted.
On September 7, 2006, arrangements were made for FWW to go to FDA's
offices to review the petition, including specific sections in which
the organization had expressed a particular interest. On September 8,
2006, FWW came to FDA's offices and reviewed releasable parts of the
petition. At the end of their visit, FWW left with approximately 250
pages of documents. In addition, an FOIA request from Wenonah Hauter of
FWW (dated August 31, 2006 and received and logged by FDA's Freedom of
Information Staff on September 5, 2006) was processed, and the
information sent to FWW on February 9, 2007.
The objection provides no evidence to support the contention that
FDA did not follow Sec. 171.1(h) regarding releasable information from
FAP 2A4738. FDA is denying the request for a hearing on this point
because a hearing will not be granted if there is no genuine and
substantial factual issue to be resolved (Sec. 12.24(b)(1)).
F. FWW's Contention That FDA Did Not Provide Adequate and Timely Notice
of the Standards Used To Evaluate the Petition
FWW contends that FDA did not provide timely notice of the
standards it used for evaluating the petition and how the data
justifies the Agency's conclusion. Specifically, FWW contends that FDA
made available the memoranda referenced in the bacteriophage final rule
and select portions of the petition only after much pleading on the
13th and 21st day, respectively, after the start of the statutorily
required 30-day objection period.
On August 17, 2006, the date the bacteriophage final rule was
placed on public display and 1 day before the rule published in the
Federal Register, the four references cited in the final rule were also
placed on public display in the petition docket. However, after
realizing that some of the references contained confidential
information, FDA immediately removed them from the docket to redact any
confidential information. The redacted references were placed back in
the docket on August 31, 2006.
The Agency was first contacted by FWW on August 18, 2006, about the
unavailability of the four references listed in the bacteriophage final
rule. FWW was informed that the review memos had been taken off the
Agency's Web site to be purged of confidential information. While the 4
references cited in the bacteriophage final rule were unavailable to
FWW for 13 days after the publication of the final rule, FWW did obtain
them with more than half the 30-day period for objection still left.
With respect to the select portions of the petition that FWW
objects to having received 21 days after the start of the 30-day
objection period, we understand this objection to refer to the portions
of the petition that FWW examined in FDA's offices on September 8,
2006. These portions of the petition were not among the four references
cited in the bacteriophage final rule and placed on public display as
part of the petition docket. As is discussed previously, it would not
be an efficient use of Agency resources to prepare the entire petition
for release in advance of any requests to view the petition. However,
FDA was nonetheless able to redact significant portions of the petition
in an expedited manner and provide them for FWW's review on September
8, 2006.
FDA is denying the request for a hearing on this point because a
hearing will not be granted unless there is a genuine and substantial
factual issue to be resolved (Sec. 12.24(b)(1)), and resolution of the
factual issue in the way sought is adequate to justify the action
requested (Sec. 12.24(b)(4)). Furthermore, a hearing is justified only
if the objections ``draw in question in a material way the
underpinnings of the regulation at issue'' (Pactra Industries v.
Consumer Product Safety Commission, 555 F.2d at 684), which is not the
case with this objection.
V. Summary and Conclusions
Section 409 of the FD&C Act requires that a food additive be shown
to be safe prior to marketing. Under Sec. 170.3(i), a food additive is
``safe'' if ``* * * there is a reasonable certainty in the minds of
competent scientists that the substance is not harmful under the
intended conditions of use.* * *'' In the final rule approving the use
of a Listeria-specific bacteriophage preparation for treating RTE meat
and poultry products, FDA concluded that the data presented by the
petitioner to establish safety of the additive demonstrate that the use
of the bacteriophage preparation is safe under the conditions of use
stated in the regulation. The petitioner has the burden to demonstrate
the safety of the additive in order to gain FDA approval. (See, e.g.,
Silverman v. Foreman, 631 F.2d 969, 972 (DC Cir. 1980).) Once FDA makes
a finding of safety, the burden shifts to an objector, who must come
forward with evidence that calls into question FDA's conclusion. (See
section 409(f)(1) of the FD&C Act.)
None of the objections received contained evidence to present a
genuine and substantial issue of fact. Nor has the objector established
that the Agency overlooked significant information in reaching its
conclusion. Therefore, the Agency has determined that the objections
that requested a hearing do not raise any substantial issue of fact
that would justify an evidentiary hearing (Sec. 12.24(b)).
Accordingly, FDA is not making any changes in response
[[Page 16290]]
to the objections and is denying the requests for a hearing. In
addition, FWW's request for a stay of the effectiveness of the August
18, 2006, regulation until a hearing is held is moot because FDA is
denying the hearing request. FDA is confirming August 18, 2006, as the
effective date of the regulation.
VI. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m. Monday through Friday.
1. ``Evaluating the Safety of Food Chemicals,'' National Research
Council, National Academy of Sciences, Washington DC, p. 55.
2. Jacobs, T., A. Darji, N. Frahm, et al., ``Listeriolysin O:
Cholesterol Inhibits Cytolysis But Not Binding to Cellular Membranes,''
Molecular Microbiology, 28:1081-1089, 1998.
3. U.S. Department of Agriculture Nutritive Value of Foods, Home
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4. Guyton, A.C., J.E. Hall, Textbook of Medical Physiology (9th
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Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6792 Filed 3-22-11; 8:45 am]
BILLING CODE 4160-01-P