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Federal Register / Vol. 71, No.

160 / Friday, August 18, 2006 / Rules and Regulations 47729

specific dates and times established in accordance with 5 U.S.C. 552(a) and 1 SUPPLEMENTARY INFORMATION:
advance by the Notice to Airmen. The CFR part 51 of certain publications in
effective time will thereafter be continuously I. Background
new 21 CFR 172.785 as of August 18,
published in the Airport/Facility Directory. 2006. In a notice published in the Federal
Paragraph 6000 Class E Airspace Areas Register of July 22, 2002 (67 FR 47823),
ADDRESSES: You may submit objections FDA announced that a food additive
Extending Upward From the Surface of the
Earth
and requests for a hearing, identified by petition (FAP 2A4738) had been filed by
Docket No. 2002F–0316 (formerly 02F– Intralytix, Inc., c/o Lewis & Harrison,
* * * * * 0316), by any of the following methods: 122 C St. NW., suite 740, Washington,
ASW NM E Clovis, NM [Revised] Electronic Submissions DC 20001, now represented by Keller &
Cannon AFB, NM Submit electronic objections in the Heckman LLP, 1001 G St., NW., suite
Lat. 34° 22′58″ N, Long. 103°19′20″ W following ways: 500 West, Washington, DC 20001. The
Cannon ILS Localizer • Federal eRulemaking Portal: http:// petition proposed to amend the food
Lat. 34°22′25″ N, Long. 103°20′09″ W www.regulations.gov. Follow the additive regulations to provide for the
Cannon TACAN0 instructions for submitting comments. safe use of a mixture of bacteriophages1
Lat. 34°22′51″ N, Long. 103°19′21″ W • Agency Web site: http://
(phages) as an antimicrobial agent
That airspace extending upward from the www.fda.gov/dockets/ecomments.
surface within a 6-mile radius of Cannon against Listeria monocytogenes (L.
Follow the instructions for submitting
AFB. The Class E airspace area is effective monocytogenes) on foods, including
comments on the agency Web site.
during the specific dates and times fresh meat, meat products, fresh poultry,
Written Submissions
established in advance by the Notice to and poultry products. On December 18,
Submit written objections in the
Airmen. The effective time will thereafter be 2003, the petitioner amended the
continuous published in the Airport/Facility
following ways:
• FAX: 301–827–6870. petition to limit the petitioned use to
Directory. ready-to-eat (RTE) meat and poultry
• Mail/Hand delivery/Courier [For
* * * * * paper, disk, or CD–ROM submissions]: products only.2
Issued in Fort Worth, TX, on August 1, The food additive consists of a
Division of Dockets Management (HFA–
2006. mixture of equal proportions of six
305), Food and Drug Administration,
Donald R. Smith, individually purified phages. The
5630 Fishers Lane, rm. 1061, Rockville,
petitioner’s rationale for incorporating
System Support Group Manager, Central MD 20852.
Service Area. multiple phages in one formulation is to
To ensure more timely processing of
minimize the possibility of L.
[FR Doc. 06–6910 Filed 8–17–06; 8:45am] objections, FDA is no longer accepting
monocytogenes developing a resistance
BILLING CODE 4910–13—M objections submitted to the agency by e-
to the additive. Each phage in the
mail. FDA encourages you to continue
additive is specific against various L.
to submit electronic objections by using
monocytogenes strains, including those
DEPARTMENT OF HEALTH AND the Federal eRulemaking Portal or the
strains known to be associated with
HUMAN SERVICES agency Web site, as described in the
foodborne illness (e.g., L.
Electronic Submissions portion of this
monocytogenes strains, serotypes 1/2a,
Food and Drug Administration paragraph.
Instructions: All submissions received 4b and 1/2b). The phages are lytic3
must include the agency name and double-stranded DNA phages. The
21 CFR Part 172 petitioner has characterized each phage
Docket No(s). and Regulatory
[Docket No. 2002F–0316 (formerly 02F– Information Number (RIN) (if a RIN with respect to physical properties and
0316)] number has been assigned) for this other appropriate identifying factors
rulemaking. All objections received will (e.g., host range, structural protein
Food Additives Permitted for Direct profile, and DNA sequence of complete
Addition to Food for Human be posted without change to http://
www.fda.gov/ohrms/dockets/ genome4).
Consumption; Bacteriophage In the manufacturing process, each
Preparation default.htm, including any personal
phage contained in the additive is
information provided. For detailed
separately produced using a strain of L.
AGENCY: Food and Drug Administration, instructions on submitting objections,
monocytogenes that can serve as a host
HHS. see the ‘‘Objections’’ heading of the
to the specific phage. The host L.
ACTION: Final rule. SUPPLEMENTARY INFORMATION section of
monocytogenes strain is first cultured in
this document.
microbiological media and the specific
SUMMARY: The Food and Drug Docket: For access to the docket to
phage is added to the culture when a
Administration (FDA) is amending the read background documents or
specified cell density is achieved. After
food additive regulations to provide for objections received, go to http://
phage multiplication, which results in
the safe use of a bacteriophage www.fda.gov/ohrms/dockets/
lysis (destruction) of host cells, the
preparation on ready-to-eat meat and default.htm and insert the docket
phage is purified by use of multiple
poultry products as an antimicrobial number, found in brackets in the
filtration steps (to remove bacteria and
agent against Listeria monocytogenes. heading of this document, into the
their components). The six phages
This action is in response to a petition ‘‘Search’’ box and follow the prompts
produced by this process are then
filed by Intralytix, Inc. and/or go to the Division of Dockets
DATES: This rule is effective August 18, Management, 5630 Fishers Lane, rm. 1 Bacteriophages are viruses that infect bacteria
2006. Submit written or electronic 1061, Rockville, MD 20852. only.
objections and requests for a hearing by FOR FURTHER INFORMATION CONTACT: 2 Ready-to-eat products, as used in this final rule,
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September 18, 2006. See section VII of Raphael A. Davy, Center for Food Safety are defined in 9 CFR 430.1.
3 Lytic bacteriophages lyse (destroy) their host
this document for information on the and Applied Nutrition (HFS–265), Food
bacteria as a normal part of their life cycle without
filing of objections. The Director of the and Drug Administration, 5100 Paint integrating into the host genome.
Office of the Federal Register approves Branch Pkwy., College Park, MD 20740, 4 Genome means the genetic content of a cell or

the incorporation by reference in 301–436–1272. virus.

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47730 Federal Register / Vol. 71, No. 160 / Friday, August 18, 2006 / Rules and Regulations

blended in phosphate buffered saline bacteriophages are specific to L. 1. Inactivation of LLO by Cholesterol
solution to formulate the additive. The monocytogenes only. Therefore, FDA The toxicity of LLO has been shown
six phages contained in the additive concludes that the food additive under to be significantly reduced (by as much
have been deposited with the American consideration does not present a as 200- to 2000-fold) following pre-
Type Culture Collection5 (ATCC). toxicological concern for use in food as incubation of LLO with added
The phage preparation will be used as proposed by the petitioner based upon cholesterol in vitro (Ref. 1). Since the
an antimicrobial agent to control L. the explanations provided in the phage preparation will be used on meat
monocytogenes in the production of following sections (Refs. 1 and 3). and poultry products and these
RTE meat and poultry products. The products normally contain significant
phage preparation is directly sprayed on B. Safety Evaluation of Potential
Residue Components From L. (milligram) amounts of cholesterol, then
the surface of the RTE food articles at a any residual amounts of LLO at levels
level of approximately 1 milliliter (mL) monocytogenes
no greater than 5 HU/ml that may be
of the preparation per 500 square present in the additive are likely to be
FDA considered the possibility that
centimeters (cm2) of food surface area inactivated by the cholesterol.
the proposed food additive may contain
just prior to packaging.
L. monocytogenes components as 2. pH and LLO Activity
II. Determination of Safety residues from use of the organism as
host for phage multiplication in the Studies show that LLO activity is lost
Under the general safety standard in or significantly decreased in acidic (low
section 409 of the Federal Food, Drug, manufacturing process. Such residues
pH of less than 4) environments (Ref. 1).
and Cosmetic Act (the act) (21 U.S.C. may include the toxin Listeriolysin O
Residual amounts of LLO, if present, are
348), a food additive cannot be (LLO). Potential residues of L.
likely to be inactivated by the low pH
approved for a particular use unless a monocytogenes other than LLO do not
(less than 4) within the human stomach.
fair evaluation of the data available to present a safety concern (Ref. 1). Based
FDA establishes that the additive is safe on our review of scientific literature on 3. Inactivation of Orally Consumed LLO
for that use. FDA’s food additive the pathogenicity of L. monocytogenes by Human Defense Mechanisms
regulations (21 CFR 170.3(i)) define safe (Ref. 1), FDA finds that LLO is the only In vivo studies demonstrate that both
as ‘‘a reasonable certainty in the minds substance known to be toxic that may normal intestinal microflora and cell-
of competent scientists that the potentially be present as a residue in mediated immunity reactions in the
substance is not harmful under the this food additive after the intestines inhibit LLO (Ref. 1). These
intended conditions of use.’’ manufacturing process. defense mechanisms provide some
In evaluating the safety of the LLO was not detected in the finished protection against low incidental oral
petitioned substance, FDA considered food additive within the assay limits of exposures to LLO (no greater than 5 HU/
the following factors in determining the detection of 5 hemolytic units9 (HU)/ml, ml). Additionally, at these levels, LLO is
safety of the proposed food additive use: and the petitioner provided information expected to be rapidly and irreversibly
(1) The safety of the six phages on the purification process used in the degraded by proteolytic enzymes that
constituting the food additive; (2) the production of the food additive as may be presented in the diet or in the
safety of potential residues from L. additional assurance that LLO would stomach. Thus, LLO at these residual
monocytogenes used in the manufacture not be present at detectable levels in the levels would not pose a toxic threat to
of the food additive and the need for finished food additive. Nevertheless, the humans.
limits related to their levels; (3) whether agency has calculated a worst-case Considering all of the above factors,
undesirable genes are potentially carried FDA concludes that potential residues
exposure to LLO from consumption of
by the food additive; and (4) the need of LLO that may be found in the food
food products treated with the phage
for additional identity and safety additive are negligible (5 HU/ml or less)
preparation. Assuming LLO is present at
specifications. and do not pose a safety concern for the
a maximum level of 5 HU/ml in the
use of the additive as an antimicrobial
A. Safety of the Petitioned Use of the additive, the worst-case exposure to
agent on RTE meat and poultry
Phage Preparation LLO for males aged 20 years or more
products.
that consume RTE foods treated with Although LLO was not detected in the
Phages infect only bacteria, rather
the additive at the maximum intended food additive, the agency concludes that
than mammalian or plant cells.6
use level is 52 HU/person/day (HU/p/d) a specification is necessary to ensure
Moreover, phages are ubiquitous and
at the mean and 104 HU/p/d at the 90th that LLO is not present in detectable
humans are routinely exposed to them
percentile. Males aged 20 years or more amounts to ensure the purity and safe
at high levels through food, water, and
represent the worst-case scenario use of the petitioned food additive.
the environment without adverse
because this population group Thus, the agency is including in this
effect.7 Phages also are a part of the
consumes the highest amount of food regulation a specification of not more
normal microbial population of the
intended to be treated with the additive than 5 HU/ml for LLO (the limit of
humangut.8 However, the petitioner’s
(Ref. 2). In this safety evaluation, FDA detection for the method).
5 ATCC is a nonprofit bioresource center that reviewed all available information on
maintains deposits of bacteria and bacteriophages the identity, toxicity, and the stability of C. Undesirable Genes (Bacterial Toxin
among other biological materials. Their primary LLO. Even if LLO were present at the Genes) Potentially Carried by Phages
mission is to acquire, authenticate, preserve, level of 5 HU/ml, this level does not Lysogenic phages, as opposed to those
develop, and distribute biological material.
6 T.D. Brock and M.T. Madigan, 1998, Biology of
present a toxicological concern for the that are lytic, have the capacity to
Microorganisms, 5th edition; Prentice-Hall, Inc., following reasons (Ref. 1): integrate into the host genome and may
Inglewood Cliffs, NJ. facilitate transfer of toxin or drug
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7 Bergh, O., K.Y. Borsheim, G. Bratbak, and M. 9 1 HU of LLO is equal to one nanogram of protein resistance genes between bacterial cells.
Heldal, 1989, High abundance of viruses found in (as reported in Geoffroy, C. et al. 1987, Purification, FDA has determined that the phages
aquatic environments, Nature, vol. 340 (10): 467– Characterization, and Toxicity of the Sulfhydryl-
468. Activated Hemolysin Listeriolysin O from Listeria
contained in the petitioned food
8 Breitbart et al., 2003; Journal of Bacteriology 185 monocytogenes, Infection and Immunity, vol. 55(7): additive are lytic based on the
(20): 6220–6223. pp. 1641–1646). petitioner’s information on host lysis

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Federal Register / Vol. 71, No. 160 / Friday, August 18, 2006 / Rules and Regulations 47731

characteristics and on genomic analysis V. Environmental Impact 2. Memorandum dated April 11, 2005,
of each phage (Ref. 4). Therefore, FDA from Division of Petition Review, Chemistry
The agency has previously considered Review Group, Hyoung Lee, to Regulatory
concludes that the use of this food the environmental effects of this rule as Group II, R. Davy, entitled ‘‘FAP 2A4738
additive would not result in the spread announced in the notice of filing for (MATS#1137 M 2.3), Petition for the use of
of toxin or drug genes. FAP 2A4738 (67 FR 47823). No new LMP–102TM—a mixture of several
information or comments have been monoclonal bacteriophages as an
D. The Need for Other Specifications antimicrobial agent in ready-to-eat meat and
received that would affect the agency’s
We are also including specifications poultry, Submissions of 10/25/04, 1/18/05, 1/
previous determination that there is no
25/05, and 2/18/05.’’
for potency, absence of undesirable significant impact on the human 3. Memorandum dated February 1, 2006,
genes, phage titer10, absence of L. environment and that an environmental from Division of Petition Review, Toxicology
monocytogenes and other impact statement is not required. Group I, Tina Walker, to Raphael Davy, DPR,
microbiological pathogens, and total entitled ‘‘Addendum to the June 3, 2005
VI. Paperwork Reduction Act of 1995 Final Toxicology Memorandum: Additional
organic carbon (Ref. 2). These
specifications ensure the identity and This final rule contains no collection toxicological evaluation of the potential
safe use of the additive. of information. Therefore, clearance by allergenicity/immunotoxicity of the Listera
the Office of Management and Budget bacteriophage, LMP–102TM.’’
III. Other Considerations 4. Memorandum dated June 1, 2005, from
under the Paperwork Reduction Act of
Division of Biotechnology and GRAS Notice
1995 is not required. Review, Negash Belay, to Raphael A. Davy,
FDA recognizes that while this rule is
issued under the authority of the VII. Objections Division of Petition Review, entitled
Federal Food, Drug, and Cosmetic Act, ‘‘Revised FAP 2A4738.’’
Any person who will be adversely
use of the ingredient must also comply affected by this regulation may file with List of Subjects in 21 CFR Part 172
with the Federal Meat Inspection Act or the Division of Dockets Management Food additives, Incorporation by
the Poultry Products Inspection Act, (see ADDRESSES) written or electronic reference, Reporting and recordkeeping
which are administered by the U.S. objections. Each objection shall be requirements.
Department of Agriculture (USDA). In separately numbered, and each ■ Therefore, under the Federal Food,
particular, those statutes provide that numbered objection shall specify with
the ingredient must be suitable for its Drug, and Cosmetic Act and under
particularity the provisions of the authority delegated to the Commissioner
intended use. FDA recognizes that there regulation to which objection is made
may be meat or poultry products of Food and Drugs, 21 CFR part 172 is
and the grounds for the objection. Each amended as follows:
considered RTE for which use of the numbered objection on which a hearing
additive may not be suitable within the is requested shall specifically so state. PART 172—FOOD ADDITIVES
meaning of those statutes. This Failure to request a hearing for any PERMITTED FOR DIRECT ADDITION
regulation addresses only the safety particular objection shall constitute a TO FOOD FOR HUMAN
standard under section 409 of the waiver of the right to a hearing on that CONSUMPTION
Federal Food, Drug, and Cosmetic Act objection. Each numbered objection for
and does not address requirements for which a hearing is requested shall ■ 1. The authority citation for 21 CFR
suitability administered by the USDA. include a detailed description and part 172 continues to read as follows:
IV. Conclusion analysis of the specific factual Authority: 21 U.S.C. 321, 341, 342, 348,
information intended to be presented in 371, 379e.
FDA reviewed data in the petition and support of the objection in the event ■ 2. Section 172.785 is added to subpart
other available relevant material to that a hearing is held. Failure to include H to read as follows:
evaluate the safety of the use of a phage such a description and analysis for any
preparation as an antimicrobial agent particular objection shall constitute a § 172.785 Listeria-specific bacteriophage
preparation.
against L. monocytogenes on RTE meat waiver of the right to a hearing on the
and poultry products. Based on this objection. Three copies of all documents The additive may be safely used as an
information, the agency concludes that are to be submitted and are to be antimicrobial agent specific for Listeria
the proposed use of the additive is safe. identified with the docket number monocytogenes (L. monocytogenes) in
Therefore, the regulations in part 172 found in brackets in the heading of this accordance with the following
(21 CFR part 172) should be amended as document. Any objections received in conditions:
set forth in this document. response to the regulation may be seen
(a) Identity. (1) The additive consists
In accordance with § 171.1(h) (21 CFR in the Division of Dockets Management
of a mixture of equal proportions of six
171.1(h)), the petition and the between 9 a.m. and 4 p.m., Monday
different individually purified lytic-type
documents that FDA considered and through Friday.
(lacking lysogenic activity)
relied upon in reaching its decision to VIII. References bacteriophages (phages) specific against
approve the petition are available for L. monocytogenes.
inspection at the Center for Food Safety The following references have been
(2) Each phage is deposited at, and
and Applied Nutrition by appointment placed on display in the Division of
assigned an identifying code by, a
with the information contact person (see Dockets Management (see ADDRESSES)
scientifically-recognized culture
FOR FURTHER INFORMATION CONTACT). As
and may be seen by interested persons
collection center, and is made available
provided in § 171.1(h), the agency will between 9 a.m. and 4 p.m., Monday
to FDA upon request.
delete from the documents any through Friday.
1. Memorandum dated June 3, 2005, from
(3) The additive is produced from one
materials that are not available for Division of Petition Review, Toxicology or more cell cultures of L.
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public disclosure before making the Group I, Tina Walker, to Raphael Davy, DPR, monocytogenes in a safe and suitable
documents available for inspection. entitled ‘‘Safety Review of LMP–102TM as an nutrient medium.
antimicrobial agent in ready-to-eat foods, (b) Specifications.
10 A term that refers to the number of phage fresh meat, meat products, fresh poultry, and (1) The additive achieves a positive
particles per milliliter of phage solution. poultry products.’’ lytic result (OD600 ≤ 0.06) when tested

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47732 Federal Register / Vol. 71, No. 160 / Friday, August 18, 2006 / Rules and Regulations

against any of the following L. Listeria monocytogenes Sterility procedures presented in the Federal
monocytogenes isolates available from Testing,’’ dated May 24, 2004, and Claims Collection Standards (FCCS)
American Type Culture Collection printed by Intralytix, Inc., is issued by the Department of the
(ATCC): ATCC 35152 (serogroup 1/2a), incorporated by reference. Copies are Treasury (Treasury) and the Department
ATCC 19118 (serogroup 4b), and ATCC available at locations cited in paragraph of Justice (DOJ). These regulations are
15313 (serogroup 1/2b). The analytical (b)(1) of this section. intended to improve the NLRB’s
method for determining the potency of (6) The additive is negative for gram- collection of debts owed to the United
the additive entitled ‘‘Determination of positive and gram-negative bacteria States.
Potency of LMP–102TM,’’ dated October capable of growing in commonly used DATES: This interim rule is effective on
9, 2003, and printed by Intralytix, Inc., microbiological media (e.g., Luria- August 18, 2006. Comments must be
is incorporated by reference. The Bertani (LB) medium), including received on or before October 17, 2006.
Director of the Office of the Federal Escherichia coli, Salmonella species
ADDRESSES: You may submit comments,
Register approves this incorporation by and coagulase-positive Staphylococci,
identified by [RIN Number], by any of
reference in accordance with 5 U.S.C. as determined by the ‘‘Method to
the following methods:
552(a) and 1 CFR part 51. You may Determine Microbial Contamination,’’ • Mail: For paper, disk, or CD–ROM
obtain a copy from the Office of Food dated July 11, 2003, and printed by submissions, mail to Lester A. Heltzer,
Additive Safety (HFS–200), Center for Intralytix, Inc., is incorporated by Executive Secretary, 1099 14th Street
Food Safety and Applied Nutrition, reference. Copies are available at NW., Room 11610, Washington, DC
Food and Drug Administration, 5100 locations cited in paragraph (b)(1) of 20570.
Paint Branch Pkwy., College Park, MD this section. • E-mail: Lester.Heltzer@nlrb.gov.
20740, or you may examine a copy at (7) Total organic carbon (TOC) is less
Include [RIN Number] in the subject
the Center for Food Safety and Applied than or equal to 36 mg/kg. The
line of the message.
Nutrition’s Library, 5100 Paint Branch analytical method for determining TOC • Fax: Office of the Executive
Pkwy., College Park, MD 20740, or at entitled ‘‘Determination of Total Secretary Fax Number: (202) 273–4270.
the National Archives and Records Organic Carbon by Automated Instructions: All submissions received
Administration (NARA). For Analyzer,’’ dated March 30, 2001, and must include the NLRB’s name and the
information on the availability of this printed by Intralytix, Inc., is Regulatory Information Number (RIN)
material at NARA, call 202–741–6030, incorporated by reference. Copies are for this rulemaking.
or go to: http://www.archives.gov/ available at locations cited in paragraph
FOR FURTHER INFORMATION CONTACT:
federal_register/ (b)(1) of this section.
code_of_federal_regulations/ (c) Conditions of use. The additive is Lester A. Heltzer, Executive Secretary,
ibr_locations.html. used in accordance with current good National Labor Relations Board, Room
(2) The mean phage titer of each manufacturing practice to control L. 11610, 1099 14th Street, NW.,
monophage in the additive is 1 x 109 monocytogenes by direct application to Washington, DC 20570–0001,
plaque forming units (PFU)/ml. The meat and poultry products that comply Telephone (202) 273–1067, e-mail
analytical method for determining with the ready-to-eat definition in 9 CFR address Lester.Heltzer@nlrb.gov.
phage titer entitled ‘‘Method to 430.1. Current good manufacturing SUPPLEMENTARY INFORMATION:
Determine Lytic Activity/Phage Titer,’’ practice is consistent with direct spray I. Background
dated November 6, 2001, and printed by application of the additive at a rate of
Intralytix, Inc., is incorporated by approximately 1 mL of the additive per On April 26, 1996, the Debt Collection
reference. Copies are available at 500 cm2 product surface area. Improvement Act (DCIA) of 1996 (Pub.
locations cited in paragraph (b)(1) of L. 104–134) was enacted. This Act
Dated: August 3, 2006. enhances the Federal Government’s debt
this section.
(3) The phages present in the Jeffrey Shuren, collection activities. The purposes of the
preparation must not contain a Assistant Commissioner for Policy. Act are—
functional portion of any of the toxin- [FR Doc. E6–13621 Filed 8–17–06; 8:45 am] (1) To maximize collections of
encoding sequences described in 40 BILLING CODE 4160–01–S delinquent debts owed to the
CFR 725.421(d). No sequences derived Government by ensuring quick action to
from genes encoding bacterial 16S enforce recovery of debts and the use of
ribosomal RNA are present in the NATIONAL LABOR RELATIONS all appropriate collection tools,
complete genomic sequence of the BOARD (2) To minimize the costs of debt
phages. collection by consolidating related
29 CFR Part 100 functions and activities and using
(4) L. monocytogenes toxin, interagency teams,
listeriolysin O (LLO), is not greater than Debt Collection Procedures (3) To reduce losses arising from debt
5 hemolytic units (HU)/ml. The AGENCY: National Labor Relations Board management activity by requiring
analytical method for determining LLO (NLRB). proper screening of potential borrowers,
entitled ‘‘Quantitation of Listeriolysin O ACTION: Interim Rule with request for aggressive monitoring of all accounts,
Levels in LMP–102TM,’’ dated comments. and sharing of information within and
September 27, 2004, and printed by among Federal agencies,
Intralytix, Inc., is incorporated by SUMMARY: The National Labor Relations (4) To ensure that the public is fully
reference. Copies are available at Board (NLRB) is issuing interim informed of the Federal Government’s
locations cited in paragraph (b)(1) of regulations with a request for comments debt collection policies and that debtors
this section. concerning the procedures used to are aware of their obligations to repay
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(5) The additive is negative for L. collect debts that are owed to the NLRB. amounts owed to the Federal
monocytogenes. The modified version of These interim regulations conform to Government,
the U.S. Department of Agriculture’s the legislative changes enacted in the (5) To ensure that debtors have all
method for determining L. Debt Collection Improvement Act of appropriate due process rights,
monocytogenes entitled ‘‘LMP–102TM 1996 (DCIA) and the amended including the ability to verify,

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