[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26766-26767]
[FR Doc No: 2012-10960]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0880]

Karen L. Blyth: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
debarring Karen L. Blyth for a period of 20 years from importing
articles of food or offering such articles for importation into the
United States. FDA bases this order on a finding that Ms. Blyth was
convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21
U.S.C. 335a(l)(1)(B)), of 10 felony counts under Federal law for
conduct relating to the importation into the United States of an
article of food. Ms. Blyth was given notice of the proposed debarment
and an opportunity to request a hearing within the time frame
prescribed by regulation. As of March 23, 2012 (30 days after receipt
of the notice), Ms. Blyth had not responded. Ms. Blyth's failure to
respond constitutes a waiver of her right to a hearing concerning this
action.

DATES: This order is effective May 7, 2012.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Drive, Rockville,
MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) of the FD&C Act (21 U.S.C.
335a(b)(3)(A)), that the individual has been convicted of a felony for
conduct relating to the importation into the United States of any food.
    On May 4, 2011, Ms. Blyth was convicted, as defined in section
306(l)(1)(B) of the FD&C Act, when the U.S. District Court for the
Southern District of Alabama accepted her plea of

guilty and entered judgment against her for the following offenses: One
count of conspiracy to commit offenses against the laws of the United
States, in violation of 18 U.S.C. 371; nine counts of false labeling
under the Lacey Act, in violation of 16 U.S.C. 3372(d)(2) and
3373(d)(3)(A); two counts of receipt of merchandise imported contrary
to law, in violation of 18 U.S.C. 545; and one count of misbranding, in
violation of 21 U.S.C. 331(a), 333(a)(2) and 343(a)(1) and (b).
    FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein for conduct relating to the importation
into the United States of any food. The factual basis for these
convictions is as follows: As stated in the factual resume accompanying
the plea agreement referenced above and alleged in the indictment filed
against Ms. Blyth, Ms. Blyth was a co-owner, president, and treasurer
of CSE Inc., which was used to buy and sell seafood. She was also a co-
owner, president, and chief executive officer of RF Inc. from on or
about October 1, 2004, through on or about March 2007. RF Inc. also
sold seafood, including but not limited to shrimp, oysters, Lake
Victoria perch, and types of catfish, commonly called basa, swai, and
sutchi.
    Beginning on or about January 1, 2004, and continuing through on or
about November 8, 2006, Ms. Blyth knowingly, willingly, and unlawfully
combined, conspired, confederated, and agreed with her coconspirators
to commit offenses against the laws of the United States related to
importation of food. This conduct was in violation of 18 U.S.C. 371.
Specifically, Ms. Blyth received and bought 81,000 pounds of fish of
the genus Pangasius (a type of catfish commonly called basa, swai, or
sutchi) that she knew had been unlawfully imported from Vietnam. She
knew that the fish was falsely labeled as sole when it was imported,
and that it was imported without the required antidumping duty having
been paid. She created or caused others to create false invoices and
labeling for this fish, and other fish of the genus Pangasius bought
and sold to customers, totaling approximately 101,078 pounds. Ms. Blyth
sold and invoiced the fish as grouper or sole, allowing her to sell the
fish in interstate commerce at higher profit margins and more readily
than if the fish had been accurately labeled and described.
    From on or about February 9, 2005, through on or about June 27,
2005, Ms. Blyth knowingly made and caused to be made a false record,
account, and label for, and false identification of fish, that had been
and was intended to be transported in interstate and foreign commerce,
having a market value greater than $350, and that involved the sale and
purchase, the offer of sale and purchase, and the intent to sell and
purchase fish, and the importation of fish, in that she created and
caused to be created invoices, boxes, and other documents that falsely
identified the fish. Specifically, Ms. Blyth falsely identified fish as
sole and Cynoglossus bilineatus, when in fact it was fish of the genus
Pangasius, a type of catfish. This conduct was in violation of 16
U.S.C. 3372(d)(2) and 3373(3)(A).
    From about March 30, 2005, through April 4, 2005, Ms. Blyth
knowingly received, concealed, bought, sold, and facilitated the
transportation, concealment, and sale of merchandise after importation,
specifically frozen fish fillets of the genus Pangasius, knowing it to
have been imported and brought into the United States contrary to law,
that is falsely declared and with applicable duties having been paid.
This conduct is in violation of 18 U.S.C. 545.
    From approximately March 30, 2005, through approximately June 22,
2005, with intent to defraud and mislead, Ms. Blyth introduced and
delivered and caused to be introduced and delivered into interstate
commerce food, specifically frozen fish fillets, that was misbranded in
that it had been falsely and misleadingly labeled and described as sole
and Cynoglossus bilineatus, when in fact the fish was of the genus
Pangasius. This conduct is in violation of 21 U.S.C. 331(a), 333(a)(2)
and 343(a)(1) and (b).
    As a result of her conviction, on February 17, 2012, FDA sent Ms.
Blyth a notice by certified mail proposing to debar her for a period of
20 years from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Ms. Blyth was convicted
of 10 felony counts under Federal law for conduct relating to the
importation into the United States of an article of food because she:
Conspired to and committed offenses related to the importation of fish
into the United States; falsely identified fish; concealed, bought,
sold, and facilitated the transportation, concealment, and sale of
frozen fish fillets after importation, knowing it to have been imported
and brought into the United States contrary to law; and introduced and
delivered misbranded fish into interstate commerce. The proposal was
also based on a determination, after consideration of the factors set
forth in section 306(c)(3) of the FD&C Act (21 U.S.C. 335a(c)(3)) that
Ms. Blyth should be subject to a 20-year period of debarment. The
proposal also offered Ms. Blyth an opportunity to request a hearing,
providing her 30 days from the date of receipt of the letter in which
to file the request, and advised her that failure to request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. Ms. Blyth failed to respond within
the timeframe prescribed by regulation and has, therefore, waived her
opportunity for a hearing and waived any contentions concerning her
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(1)(C) of the FD&C Act, and
under authority delegated to the Director (Staff Manual Guide 1410.35),
finds that Ms. Karen L. Blyth has been convicted of 10 felony counts
under Federal law for conduct relating to the importation of an article
of food into the United States and that she is subject to a 20-year
period of debarment.
    As a result of the foregoing finding, Ms. Blyth is debarred for a
period of 20 years from importing articles of food or offering such
articles for import into the United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Ms. Blyth is
a prohibited act.
    Any application by Ms. Blyth for termination of debarment under
section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) should be
identified with Docket No. FDA-2011-N-0880 and sent to the Division of
Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 24, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-10960 Filed 5-4-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11328-11330]
[FR Doc No: 2011-4497]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. FDA-2010-F-0200]

Secondary Direct Food Additives Permitted in Food for Human
Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to permit the use of hydrogen peroxide as an
antimicrobial agent in the manufacture of modified whey by
ultrafiltration methods. This action is in response to a petition filed
by Fonterra (USA), Inc.

DATES: This rule is effective March 2, 2011. Submit either electronic
or written objections and requests for a hearing by April 1, 2011. See
section VI of this document for information on the filing of
objections. The incorporation by reference of certain publications
listed in the rule is approved by the Director of the Federal Register
as of March 2, 2011.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing, identified by Docket No. FDA-2010-F-0200, by
any of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2010-F-0200 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section of this document.

    Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Celeste Johnston, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of April 28, 2010 (75
FR 22411), FDA announced that Fonterra (USA), Inc., c/o Burdock Group,
801 N. Orange Ave., suite 710, Orlando, FL 32801 filed a food additive
petition (FAP 0A4781). The petition proposed to amend the food additive
regulations in part 173--Secondary Direct Food Additives Permitted in
Food for Human Consumption (21 CFR part 173) to provide for the safe
use of hydrogen peroxide as an antimicrobial agent in the manufacture
of modified whey by ultrafiltration methods. In ultrafiltration, the
whey stream is directed under pressure against membranes that permit
undesirable substances to pass through the membranes while retaining
the whey protein.
    Hydrogen peroxide is currently affirmed as generally recognized as
safe (GRAS) for use as an antimicrobial agent in the preparation of
modified whey by electrodialysis methods at a maximum treatment level
of 0.04 percent in the whey (Sec.  184.1366 (21 CFR 184.1366)). As a
condition of use, the regulation requires that residual hydrogen
peroxide be removed from the whey during processing by appropriate
chemical and physical means.
    Under 21 CFR 184.1(b)(2), a substance affirmed as GRAS with
specific limitations may be used in food only within such limitations,
including the category of food, functional use, and level of use.
Therefore, any additional uses of hydrogen peroxide in processing food
beyond those limitations set out in Sec.  184.1366 requires either a
food additive regulation or an amendment of Sec.  184.1366. The current
petition proposes to amend the food additive regulations to provide for
the use of hydrogen peroxide in the preparation of modified whey by
ultrafiltration methods, as an alternative to electrodialysis methods,
at a maximum use level of 0.001 percent by weight of the whey,
providing that residual hydrogen peroxide is removed from the whey
during processing by appropriate chemical and physical means.

II. Conclusion

    FDA reviewed data in the petition and other available relevant
material to evaluate the safety of the use of hydrogen peroxide as an
antimicrobial agent in the production of modified whey prepared by
ultrafiltration methods. Based on this information, the Agency
concludes that the proposed use of the additive will accomplish the
intended technical effect, and that, since the proposed use of hydrogen
peroxide in the preparation of modified whey by ultrafiltration would
be substitutional for its already-regulated use in the preparation of
modified whey by electrodialysis under Sec.  184.1366, the exposure to
hydrogen peroxide will not increase and may potentially decrease due to
a lower maximum use level than what is currently permitted in the
manufacture of modified whey by electrodialysis. Based on this
information, FDA concludes that the proposed use of the additive is
safe and the additive will achieve its intended technical effect as an
antimicrobial agent under the proposed conditions of use. Therefore,
the regulations in 21 CFR part 173 should be amended as set forth in
this document.

III. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition will be made available for inspection
at the Center for Food Safety and Applied Nutrition by appointment with
the information contact person (see FOR FURTHER INFORMATION CONTACT).
As provided in Sec.  171.1(h), the Agency will delete from the
documents any materials that are not available for public disclosure
before making the documents available for inspection.

IV. Environmental Impact

    The Agency has previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 0A4781 (75 FR
22411). No new information or comments have been received that would
affect the Agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.

V. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VI. Objections

    Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections by (see DATES). Each objection shall
be separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. It is only necessary to send one set of
documents. It is no longer necessary to send three copies of all
documents. Identify documents with the docket number found in brackets
in the heading of this document. Any objections received in response to
the regulation may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

VII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    FDA's review of this petition was limited to section 409 of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act). This final rule is
not a statement regarding compliance with other sections of the FD&C
Act. For example, the Food and Drug Administration Amendments Act of
2007, which was signed into law on September 27, 2007, amended the FD&C
Act to, among other things, add section 301(ll) (21 U.S.C. 331(ll)).
Section 301(ll) of the FD&C Act prohibits the introduction or delivery
for introduction into interstate commerce of any food that contains a
drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a
biological product licensed under section 351 of the Public Health
Service Act (42 U.S.C. 262), or a drug or biological product for which
substantial clinical investigations have been

instituted and their existence has been made public, unless one of the
exceptions in section 301(ll)(1) to (ll)(4) applies. In our review of
this petition, FDA did not consider whether section 301(ll) of the FD&C
Act or any of its exemptions apply to food containing this additive.
Accordingly, this final rule should not be construed to be a statement
that a food containing this additive, if introduced or delivered for
introduction into interstate commerce, would not violate section
301(ll) of the FD&C Act. Furthermore, this language is included in all
food additive final rules and therefore should not be construed to be a
statement of the likelihood that section 301(ll) of the FD&C Act
applies.

List of Subjects in 21 CFR Part 173

    Food additives, Incorporation by reference.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 173 is amended as follows:

PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION

0
1. The authority citation for 21 CFR part 173 continues to read as
follows:

    Authority: 21 U.S.C. 321, 342, 348.

0
2. Section 173.356 is added to subpart D to read as follows:

Sec.  173.356  Hydrogen peroxide.

    Hydrogen peroxide (CAS Reg. No. 7722-84-1) may be safely used to
treat food in accordance with the following conditions:
    (a) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 496 and 497, which is incorporated by
reference. The Director of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address http://www.usp.org). Copies may be examined at the Center for
Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2163, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal regulations/ibr_locations.html.
    (b) The additive is used as an antimicrobial agent in the
production of modified whey (including, but not limited to, whey
protein concentrates and whey protein isolates) by ultrafiltration
methods, at a level not to exceed 0.001 percent by weight of the whey,
providing that residual hydrogen peroxide is removed by appropriate
chemical or physical means during the processing of the modified whey.

    Dated: February 16, 2011.
Susan M. Bernard,
Acting Director, Office of Regulations, Policy and Social Services,
Center for Food Safety and Applied Nutrition.
[FR Doc. 2011-4497 Filed 3-1-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 1, 2008 (Volume 73, Number 63)]
[Notices]
[Page 17370-17371]
[DOCID:fr01ap08-67]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2008-0208]

Commercial Fishing Industry Vessel Safety Advisory Committee;
Meeting

AGENCY: Coast Guard, DHS.

ACTION: Notice of meeting.

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SUMMARY: The Commercial Fishing Industry Vessel Safety Advisory
Committee (CFIVSAC) will meet in New Orleans, LA, to discuss various
issues relating to commercial vessel safety in the fishing industry.
This meeting will be open to the public.

DATES: CFIVSAC will meet on May 28-30, 2008, from 8 a.m. to 5 p.m. This
meeting may close early if all business is finished. Written material
and requests to make oral presentations should reach the Coast Guard on
or before May 14, 2008. Requests to have a copy of your material
distributed to each member of the committee should reach the Coast
Guard on or before May 14, 2008.

ADDRESSES: CFIVSAC will meet at the Wyndham Riverfront Hotel: 701
Convention Center Boulevard, New Orleans, LA 70130. Send written
material and requests to make oral presentations to Captain Michael
Karr, Designated Federal Officer (DFO) of CFIVSAC, United States Coast
Guard Fishing Vessel Safety Division, 2100 2nd St., SW., Washington, DC
20593. This notice and documents identified in the Supplementary
Information section as being available in the docket may be viewed in
our online docket, USCG-2008-0208, at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Kenneth Vazquez,
Assistant to the Designated Federal Officer of CFIVSAC, by telephone at
202-372-1247, fax<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463).

Agenda of Meeting

    The agenda for the CFIVSAC meeting is as follows:
    (1) Commercial Fishing Vessel Safety District Coordinators updates.
    (2) Industry Update
    (3) Status report on the Commercial Fishing Vessel Safety
Rulemaking.
    (4) Legislation update: The House and Senate fishing vessel safety
related

proposals discussed in their versions of the Coast Guard authorization
bills; Pending final bills outcomes.
    (5) Discussions and working group sessions by the Communications
and Risk Management Subcommittees on current program strategies, future
plans, and long range goals for CFIVSAC.

Procedural

    This meeting is open to the public. Please note the meetings may
close early if all business is finished. At the Chair's discretion,
members of the public may make presentations during the meeting. If you
would like to make an oral presentation at the meeting, please notify
the Designated Federal Officer no later than May 14, 2008. Written
material for distribution at a meeting should reach the Coast Guard no
later than May 14, 2008. If you would like a copy of your material
distributed to each member of the committee in advance of the meeting,
please submit 25 copies to the Executive Director no later than May 14,
2008.

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the Designated Federal Officer as soon as possible but no later than
May 14, 2008.

    Dated: March 25, 2008.
J.G. Lantz,
Director of Commercial Vessel Regulations and Standards, Assistant
Commandant for Marine Safety, Security, and Stewardship.
 [FR Doc. E8-6624 Filed 3-31-08; 8:45 am]

BILLING CODE 4910-15-P